The DOI matches its Crossref record; 147 of the 147 references it cites were found in a registry or an index; 42 of the 117 sources its claims cite were checked for support.
Lessons from HeLa Cells: The Ethics and Policy of Biospecimens
Open accessAbstract
Human biospecimens have played a crucial role in scientific and medical advances. Although the ethical and policy issues associated with biospecimen research have long been the subject of scholarly debate, the story of Henrietta Lacks, her family, and the creation of HeLa cells captured the attention of a much broader audience. The story has been a catalyst for policy change, including major regulatory changes proposed in the United States surrounding informed consent. These proposals are premised in part on public opinion data, necessitating a closer look at what such data tell us. The development of biospecimen policy should be informed by many considerations—one of which is public input, robustly gathered, on acceptable approaches that optimize shared interests, including access for all to the benefits of research. There is a need for consent approaches that are guided by realistic aspirations and a balanced view of autonomy within an expanded ethical framework.
Overview
AI snapshot
Written from the paper’s full text.
TL;DR
This review uses the Henrietta Lacks/HeLa case to examine ethics and policy for biospecimen research, especially informed consent and proposed US regulatory changes. It argues that public opinion data are more complex than the NPRM suggests and that consent should be part of a broader ethical framework with oversight and balanced autonomy.
Key findings
- The HeLa controversy helped catalyze proposed US regulatory changes: the 2015 NPRM would define a human subject to include living individuals about whom an investigator “obtains, uses, studies or analyzes biospecimens” regardless of identifiability, and would generally require consent for research use of all biospecimens, including broad consent for future unspecified research and exemptions for secondary use with safeguards.
- The public opinion studies cited by the NPRM do not show consensus: Kaufman et al. (n = 4,659) found 48% preferred broad consent, 42% study-specific consent, and 10% categorical consent; a subset (n = 3,347) found 51% broad vs. 49% study-specific. Vermeulen et al. (n = 133) found 43% preferred opt-out plus, 34% one-time consent, 16% standard opt-out, and 8% no information. Simon et al. (n = 48 focus groups; n = 751 survey) found 63%/67% preferred opt-in initial consent, with broad consent preferred by 54%/41%, study-specific by 21%/29%, and categorical by 21%/25%.
- Preference differs from acceptability: in Simon et al., opt-out was preferred by only 18% but supported by 78%; in Ewing et al., 76% of broad-consent and 74% of study-specific-consent respondents said they would participate. The paper also argues informed consent cannot bear the weight asked of it: consent forms are too long and complex, comprehension is often poor, and across four systematic reviews only one-on-one discussion consistently improved understanding.
- The author recommends broad consent coupled with oversight, active opt-out for residual clinical specimens, and expanded ethical frameworks that balance autonomy with other principles and ensure research benefits are accessible to all.
Methods
- Narrative review and critical synthesis, not a systematic review or new empirical study.
- Draws on the HeLa case, current US Common Rule and the 2015 NPRM, public opinion studies cited by the NPRM, systematic reviews of biobanking attitudes, and informed consent literature.
- Main analysis compares proposed biospecimen policy against empirical public opinion data and ethical principles, then discusses consent models and alternatives.
Limitations
- Stated: public opinion data are not definitive; attitudes may reflect misunderstanding, bias, selfishness, self-deception, or other problematic factors, and public opinion alone should not dictate policy.
- Stated: reviews of biobanking attitudes are limited by heterogeneous underlying studies, and hypothetical scenarios may not accurately predict real-life behavior; evidence on consent interventions is notably limited.
- Evident from the text: this is a single-author narrative review with no systematic search strategy or new data collection, and its policy focus is primarily on the United States.
Model-written summary. Check it against the paper before relying on it.
Integrity signals
Registry
Cites
Statistics
Verification
Claims the paper makes
20 No full text of the sources · 16 Supported · 14 Own interpretation · 13 Partly supported · 11 Not checked yet · 6 Supported so far · 3 Sources not found · 2 Not supported · 2 No basis given · accuracy not yet measured
At least one cited source doesn’t support this claim or points to a different paper, and none confirmed it — see the verdicts below.
In the paper
“These attempts have met with minimal success; across four systematic reviews (25, 39, 100, 136), the only intervention consistently shown to be effective was one-on-one discussion with a person knowledgeable about the study.”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > ELICITING AND USING PUBLIC OPINION > Expectations of Informed Consent
What the sources say
- Not checked — no full text of the sourcecites [25] source
- Not checked — no full text of the sourcecites [39] source
- Disputedcites [100] sourceExperimental — accuracy not yet measured
The Discussion (page unavailable) says extended discussions had the most consistent results, but only 50% significantly improved understanding; it concludes that no intervention category had consistent efficacy. It also reports significant improvements from enhanced consent forms, contrary to the claim that one-on-one discussion was the only effective intervention. (LLM, conf=0.88)
Checked by a reasoning model — may be wrong.
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
At least one cited source doesn’t support this claim or points to a different paper, and none confirmed it — see the verdicts below.
In the paper
“In contrast to traditional opt-out, in which a brief mention of research use may be buried in a consent-to-treat form, actively notifying patients that their biospecimens may be used for research and alerting them to their right to opt out arguably affords the same benefits elucidated in Table 4, but at a lower “cost.””
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > ELICITING AND USING PUBLIC OPINION > Alternatives to Traditional Consent
What the sources say
- Disputedcites [44] sourceExperimental — accuracy not yet measured
The “Lower Financial Costs” section says a thin opt-out procedure is less expensive, while adding adequate information and a genuine opportunity to object requires more effort and money. The “Concluding Remarks” also say a thin procedure is insufficient, rather than affording the same protections as an actively communicated, thick opt-out procedure. The paper compares opt-out costs with opt-in costs; it does not support a lower cost for active opt-out than for traditional thin opt-out. Page numbers are unavailable in our copy. (LLM, conf=0.88)
Checked by a reasoning model — may be wrong.
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- Disputed
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“In a more recent publication (not cited in the NPRM), Kaufman and colleagues (110) winnowed the full data set from the 2007–2008 survey by various criteria and analyzed a subset (n = 3,347) in which 51% preferred broad consent and 49% preferred study-specific consent.”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > PUBLIC OPINION ON CONSENT FOR BIOSPECIMEN RESEARCH
What the sources say
- Partly supportedcites [110] sourceExperimental — accuracy not yet measured
The Analysis Methods section confirms that the authors selected a subset of 3,347 respondents after exclusions. It reports 52% preferring broad consent and 48% preferring study-by-study consent, not the cited 51% and 49%. No page number is available in our copy. (LLM, conf=0.90)
plainn = 3,347- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- Partly supported
Every source the paper cites for this claim was checked and supports it.
In the paper
“Although the NPRM does not mention Henrietta Lacks, her influence is clear in a publication about the proposed changes authored by leaders of these reforms (65), which stated that “the controversy that followed the 2013 publication of the genome sequence of the HeLa cell line…underscores the need for greater involvement of and respect for research participants” (p. 2293) and that “just as the L”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > Proposed US Regulations
What the sources say
- Supportedcites [65] source
The article’s discussion of research participation (p. 2293) explicitly says the HeLa genome-sequence controversy underscores the need for greater involvement of and respect for participants. Its conclusion also says the Lacks family’s experience helped clarify how research needed to change. These passages support the influence attributed to Lacks in this publication; the statement about what the NPRM omits is the citing authors’ framing, not a claim established by this source. (LLM, conf=0.91)
boosteddirectSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- Supported
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“Actual practice varies, as collections of biospecimens (or biobanks) are highly heterogeneous in terms of tissue type, procurement situation, and geographic, social, and historical context (56, 58,60, 126, 146).”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > INFORMED CONSENT FOR BIOSPECIMEN RESEARCH
What the sources say
- Partly supportedcites [56] sourceExperimental — accuracy not yet measured
The Results and discussion (Specimen collections; page not specified) document variation in specimen types and how biobanks acquire them. The Conclusions (page not specified) connect that diversity to questions about consent and governance, but do not establish that actual informed-consent practices vary or document heterogeneity specifically by geographic, social, and historical context. (LLM, conf=0.85)
- Not checked — no full text of the sourcecites [58] source
- Not checked — no full text of the sourcecites [60] source
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- Partly supported
Every source the paper cites for this claim was checked and supports it.
In the paper
“The story has been a catalyst for policy change, including major regulatory changes proposed in the United States surrounding informed consent.”
- Also stated in: § INTRODUCTION · plain
“The story of Henrietta Lacks, her family, and the creation of HeLa cells has been a catalyst for policy change (64), including major regulatory changes proposed in the United States for informed consent for biospecimen research.”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > Abstract
What the sources say
- Supportedcites [64] source
In WEIGHING THE OPTIONS, the authors say Henrietta Lacks’ story is “catalysing enduring changes in policy.” The same section describes a US regulatory review that sought comment on requiring consent for future research using biospecimens and says a new proposal was being prepared. (LLM, conf=0.90)
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- Also stated in: § INTRODUCTION · plain
Every source the paper cites for this claim was checked and supports it.
In the paper
“Particularly when patients are facing dire situations, we cannot simply assume that an elicited choice will be actively and freely made based on careful consideration and adequate understanding of the information (27).”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > ELICITING AND USING PUBLIC OPINION > Expectations of Informed Consent
What the sources say
- Supportedcites [27] source
In “Discussion and conclusion,” Corrigan says that seriously ill patients can find trial invitations burdensome and that informed consent cannot be assumed to produce active choices when patients are in pain, shock, or anxiety. “Informed subjects?” also cautions against treating consent as a purely rational decision based on information alone, while “Field of ‘choice’” describes patients who did not understand their alternatives. (LLM, conf=0.90)
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- Supported
The sources with a verdict support this claim; the rest weren’t checked yet, have no full text we could read, or their verdicts aren’t rated yet.
In the paper
“Empirical research has amply shown that consent forms are too long and written at too high a grade level (1, 4,19,29, 76, 84, 85, 105, 106, 125)”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > ELICITING AND USING PUBLIC OPINION > Expectations of Informed Consent
What the sources say
- Not checked — no full text of the sourcecites [1] Albala I, 2010, IRB
- Supportedcites [4] source
The paper’s results report that consent forms grew from a median of seven pages in 2000 to 11 in 2005, and that patients had better objective understanding when forms were seven pages or fewer. Its concluding paragraph explicitly identifies increasing length as a problem and calls for more succinct forms. The supplied copy does not give page numbers. (LLM, conf=0.93)
- Not checked — no full text of the sourcecites [19] source
boosted- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“These attempts have met with minimal success; across four systematic reviews (25, 39, 100, 136), the only intervention consistently shown to be effective was one-on-one discussion with a person knowledgeable about the study.”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > ELICITING AND USING PUBLIC OPINION > Expectations of Informed Consent
What the sources say
- Not checked — no full text of the sourcecites [25] source
- Not checked — no full text of the sourcecites [39] source
- Partly supportedcites [100] sourceExperimental — accuracy not yet measured
The Discussion says extended discussions produced the most consistent improvement in understanding, supporting the claim's emphasis on conversation. But only three of six extended-discussion interventions showed significant improvement, and the paper explicitly says no intervention category had consistent efficacy. This review also does not establish the asserted conclusion across four systematic reviews. (LLM, conf=0.88)
boosteddirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
The sources with a verdict support this claim; the rest weren’t checked yet, have no full text we could read, or their verdicts aren’t rated yet.
In the paper
“and, not surprisingly, many participants do not understand the information disclosed (4–6,70,71, 83, 87, 97), including biobank participants (93,104,114).”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > ELICITING AND USING PUBLIC OPINION > Expectations of Informed Consent
What the sources say
- Supportedcites [4] source
The paper's main text (page unavailable) says that knowledge and adequacy of informed consent among clinical-trial participants have been suboptimal, and its conclusion says longer consent forms compromise patient understanding. This source is cited for the general participant-understanding clause; the citing sentence attaches separate citations to the biobank example. (LLM, conf=0.88)
- Not checked — no full text of the sourcecites [5] source
- Not checked — no full text of the sourcecites [6] source
- Not checked — no full text of the sourcecites [70] source
- Not checked — no full text of the sourcecites [71] source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- Supported
- It may state two separate claims as one. 46
- Probably not a substantial claim. 28
Every source the paper cites for this claim was checked and supports it.
In the paper
“Respondents who were younger, female, and more highly educated and considered themselves to be the owners of their tissue were more likely to prefer onetime consent and opt-out plus over standard opt-out. In all subgroups, opt-out plus was preferred more often than other approaches.”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > PUBLIC OPINION ON CONSENT FOR BIOSPECIMEN RESEARCH
What the sources say
- Supportedcites [144] source
Split into 2 atoms — 2 confirmed, 0 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Supported
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“Among the respondents, 82% of those in the onetime consent group and 65% of those in the opt-out plus group felt well informed; by contrast, 73% of those in the control group had not seen or did not remember having read the information about tissue research.”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > PUBLIC OPINION ON CONSENT FOR BIOSPECIMEN RESEARCH
What the sources say
- Partly supportedcites [144] sourceExperimental — accuracy not yet measured
Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Partly supported
Every source the paper cites for this claim was checked and supports it.
In the paper
“For example, Johnsson et al. (73) compared hypothetical to factual willingness to participate in biobank research in studies matched by country and time frame. Among 22 pairwise comparisons, 12 suggested that factual willingness was greater than hypothetical, 6 indicated the reverse, and 4 were inconclusive.”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > ELICITING AND USING PUBLIC OPINION > What We Ask and How We Ask It
What the sources say
- Supportedcites [73] source
Split into 2 atoms — 2 confirmed, 0 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
hedged- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Supported
The sources with a verdict support this claim; the rest weren’t checked yet, have no full text we could read, or their verdicts aren’t rated yet.
In the paper
“In support of proposed regulatory changes, the NPRM cited four articles reporting public opinions about biospecimen research (77, 128, 140, 144). But as summarized below, these publications do not necessarily suggest consensus.”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > PUBLIC OPINION ON CONSENT FOR BIOSPECIMEN RESEARCH
What the sources say
- Not checked — no full text of the sourcecites [77] source
- Supportedcites [128] source
The citation identifies this paper as one of the articles reporting public opinions about biospecimen research. Its Purpose section says it explores public perspectives on biobank consent models, and its Results section reports survey participants’ preferences. The statement about what the publications collectively suggest is the citing authors’ summary, not a finding attributed specifically to this paper. (LLM, conf=0.90)
- Supportedcites [140] source
The Background section reports public and participant views on biospecimen research, including mixed preferences for blanket consent versus re-consent. It therefore supports citing this paper as an article on those opinions and supports the citing authors’ observation that the publications need not imply consensus. The NPRM’s citation count is the citing authors’ description, not a finding attributed to this paper. (LLM, conf=0.88)
hedged- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
Every source the paper cites for this claim was checked and supports it.
In the paper
“The authors noted that, theoretically, the proportions that preferred study-specific and categorical consent could be combined on the grounds that both models promote control and choice over future use. If so, a general control/choice model could be seen as preferred (by 42% and 54% of focus group and survey participants, respectively) over broad consent.”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > PUBLIC OPINION ON CONSENT FOR BIOSPECIMEN RESEARCH
What the sources say
- Supportedcites [128] source
The Discussion section (“Broad, categorical, and study-specific consent”) explicitly presents this as a possible reinterpretation: combining categorical and study-specific preferences yields 42% of focus group participants and 54% of survey participants favoring a control/choice-promoting model over broad consent. The citing sentence preserves that conditional framing. (LLM, conf=0.95)
hedged- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
- Supported
Every source the paper cites for this claim was checked and supports it.
In the paper
“A majority (63% of focus group participants and 67% of survey participants) preferred an opt-in approach to initial consent. Common reasons included that opt-in provided the opportunity to make a more positive, active, and informed choice and would receive greater public acceptance as fitting with traditional notions of consent. Opt-out was preferred by 25% and 18% of focus group and survey”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > PUBLIC OPINION ON CONSENT FOR BIOSPECIMEN RESEARCH
What the sources say
- Supportedcites [128] source
The Results report that 63% of focus-group participants and 67% of survey participants preferred opt-in consent. The Discussion gives the corresponding opt-out preferences as 25% and 18%, and the Survey results report that 5% preferred no consent. (LLM, conf=0.94)
plainn = 751- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
- Supported
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“In terms of scope, broad consent was the most commonly preferred (54% of focus group participants and 41% of survey participants), for reasons such as greater ease and flexibility for research (and thus a boost to research output) and recognized uncertainties regarding future research. Study-specific consent was preferred by 21% and 29% of focus group and survey participants, respectively, and”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > PUBLIC OPINION ON CONSENT FOR BIOSPECIMEN RESEARCH
What the sources say
- Partly supportedcites [128] sourceExperimental — accuracy not yet measured
The Results (Survey results, page unavailable) give the claimed survey preferences: 41% broad, 29% study-specific, and 25% categorical. The Results (Focus group results, page unavailable) say broad consent received the strongest support and describe participants’ reasons, including research flexibility and uncertainty about future studies. Our copy does not give the claimed separate focus-group percentages of 54%, 21%, and 21%; the Discussion reports only that 42% preferred categorical or study-specific consent combined. (LLM, conf=0.84)
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
- Partly supported
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“Despite heightened scrutiny of these issues, a team of researchers posted the whole genome sequence of one strain of HeLa cells online in 2013. Doing so broke no laws or rules; large-scale sharing of genomic data sets is required by many funding sources (107) and journals to promote replication of findings and further research.”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > REFLECTIONS ON THE STORY OF HENRIETTA LACKS
What the sources say
- Partly supportedcites [107] sourceExperimental — accuracy not yet measured
The “Challenges, responses and anticipated growth” section reports publication of HeLa whole-genome sequence data in 2013, and “Submission and use of dbGaP data” says many journals require data sharing. The paper describes NIH data-sharing policies, but does not establish that many funding sources required this release or that posting the HeLa sequence online broke no laws or rules. No page numbers were available in our copy. (LLM, conf=0.85)
plaindirectSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Partly supported
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“Discussion in professional literature comprised a similar array of themes, including marked emphasis on informed consent (20, 22,33,37, 49, 79, 123, 135, 147), as well as commercialization and compensation (123, 141); privacy and confidentiality (20, 33, 49); race, poverty, and health disparities (42, 123); familial implications of genetic information (14, 22,64, 96, 135); ownership of biospecimen”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > REFLECTIONS ON THE STORY OF HENRIETTA LACKS
What the sources say
- Partly supportedcites [20] sourceExperimental — accuracy not yet measured
The “Lessons from HeLa” section discusses informed consent, privacy, the Lacks family’s genetic information, and investigators benefiting from HeLa cells while the family remained poor. The Introduction also discusses control over samples, and a later section addresses skepticism about biomedical research. The paper does not assess how frequently these themes appeared across professional literature, so it does not establish the claimed marked emphasis. (LLM, conf=0.82)
- Partly supportedcites [22] sourceExperimental — accuracy not yet measured
The Legal and Policy Uncertainty section discusses consent, control of specimens, and relatives’ interests; the Conclusion also addresses commercialization, financial benefit to the Lacks family, privacy, and public trust (page numbers unavailable). The paper does not address race, poverty, or health disparities as themes, nor does it establish how prominently each theme appeared across professional literature. (LLM, conf=0.87)
- Supportedcites [33] source
The cited paper discusses the HeLa case in terms of informed consent and the privacy of the Lacks family (Abstract; page unavailable), matching the themes for which this source is cited in the printed sentence. It also discusses trust in research. The sentence assigns its other themes to separate citations, so they are not required of this source. (LLM, conf=0.90)
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Partly supported
Every source the paper cites for this claim was checked and supports it.
In the paper
“Human biospecimens have played a crucial role in scientific and medical advances.”
- Also stated in: § INTRODUCTION · plain
“Human biospecimens have played a crucial role in scientific and medical advances, and their continued widespread availability for research will be vital to realizing the goals of precision medicine (13).”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > Abstract
What the sources say
- Supportedcites [13] source
The Introduction’s “Importance of Human Specimens in Research” section says that human specimens have been critical to current medical care and have enabled major advances in treatment and human biology. This supports the citing sentence’s claim that they played a crucial role in scientific and medical advances. (LLM, conf=0.94)
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Also stated in: § INTRODUCTION · plain
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“As illustrated by current US regulations, the result has sometimes been ambiguity, inadvertent constraints on research access, and research proceeding without consent (40, 47, 69).”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > INFORMED CONSENT FOR BIOSPECIMEN RESEARCH
What the sources say
- Not checked — no full text of the sourcecites [40] source
- Partly supportedcites [47] sourceExperimental — accuracy not yet measured
The Abstract states that variation in consent practices has caused confusion, inadvertent constraints on future research, and research without consent. The Introduction likewise describes uncertainty limiting specimen use, and 'The Argument for Consent for Research with Biospecimens' explains that current U.S. guidance permits some research without consent. The paper does not specifically attribute all three outcomes to non-specific or non-harmonized regulations; it attributes them to variation in consent practices. (LLM, conf=0.84)
- Not checked — no full text of the sourcecites [69] source
hedgeddirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
Every source the paper cites for this claim was checked and supports it.
In the paper
“Nisbet & Fahy (99) found that, in the popular press, informed consent dominated discussion of the book. The welfare of the vulnerable and compensation were also prominent themes. Scientific progress, patient control, and accountability were discussed to a lesser degree, and privacy, public education, and advocacy even less so.”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > REFLECTIONS ON THE STORY OF HENRIETTA LACKS
What the sources say
- Supportedcites Nisbet & Fahy [99] source
The Abstract’s Results and the Results section report the same ranking: informed consent dominated, welfare of the vulnerable and compensation were prominent, scientific progress, patient control, and accountability formed a second tier, and privacy, public education, and advocacy were least prominent. (LLM, conf=0.95)
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Supported
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“These developments come at a time when public concern about biospecimen research and informed consent has already been stoked not only by the story of Henrietta Lacks, but also by lawsuits over the research use of newborn screening samples (18, 30) and biospecimens from indigenous populations (28, 95).”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > Current US Regulations
What the sources say
- Partly supportedcites [18] sourceExperimental — accuracy not yet measured
Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
- Supportedcites [30] source
This source is cited for the newborn-screening lawsuits, not the separate references to Henrietta Lacks or indigenous populations. The Legal actions section reports that public concerns about stored newborn bloodspots escalated to lawsuits alleging failures of informed consent; the Discussion also describes public concern evident in media and lawsuits. (LLM, conf=0.92)
- Not checked — no full text of the sourcecites [28] source
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
- Partly supported
Every source the paper cites for this claim was checked and supports it.
In the paper
“Themes mentioned in the commentary included trust in Group Health and ACT investigators, altruistic motivations, and little concern about privacy, confidentiality, or discrimination. The authors concluded that many participants view themselves as having an ongoing stake in research to which they have contributed, and “want to be asked (or at least kept informed) about changes in research” (140, p.”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > PUBLIC OPINION ON CONSENT FOR BIOSPECIMEN RESEARCH
What the sources say
- Supportedcites [140] source
Split into 2 atoms — 2 confirmed, 0 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
- Supported
The sources with a verdict support this claim; the rest weren’t checked yet, have no full text we could read, or their verdicts aren’t rated yet.
In the paper
“Some of the reviews rated the quality of the evidence (24, 43), but their synthesized findings are limited by nontrivial limitations in the underlying studies.”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > PUBLIC OPINION ON CONSENT FOR BIOSPECIMEN RESEARCH
What the sources say
- Not checked — no full text of the sourcecites [24] source
- Supportedcites [43] 43. Garrison NA, Sathe NA, Antommaria AHM, Holm IA, Sanderson SC, et al. 2016. A systematic literature review of individuals’ perspectives on broad consent and data sharing in the United States. Genet. Med. 18:663–71 source
The Methods section says the reviewers assessed study quality, and Results reports good, fair, and poor ratings. The Discussion and Conclusion section states that limitations in the underlying studies limited the review’s generalizability and comparability. The supplied passages do not give section-specific page numbers. (LLM, conf=0.93)
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“However, this rapidly evolving research arena has been accompanied by equally rapid confirmation that genomic data can never be truly anonymized. A steady stream of provocative studies (51, 62, 68, 122) has demonstrated that it is possible to discover the identities of individuals whose genomic data had otherwise been considered deidentified.”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > Current US Regulations
What the sources say
- Not checked — no full text of the sourcecites [51] source
- Partly supportedcites [62] sourceExperimental — accuracy not yet measured
The Discussion shows that summary-level statistics, used in part to mask individual-level data, can reveal whether a specific person is in a study. That supports a privacy risk, but the method tests for the presence of a person whose genotype is already known; it does not demonstrate discovering an unknown person's identity or establish that genomic data can never be anonymized. (LLM, conf=0.86)
- Not checked — no full text of the sourcecites [68] source
boosteddirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
Every source the paper cites for this claim was checked and supports it.
In the paper
“An opt-out approach to initial consent was the preferred choice for only 18%, but it was supported by 78%.”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > ELICITING AND USING PUBLIC OPINION > What We Ask and How We Ask It
What the sources say
- Supportedcites [128] source
The Results section (‘Initial, prospective informed consent’) reports that 18% of survey participants preferred opt-out consent, while 78% supported it. The Methods section (‘Phone survey’) confirms that participants were asked separately about support and their preferred prospective consent model. (LLM, conf=0.95)
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Supported
Every source the paper cites for this claim was checked and supports it.
In the paper
“The authors concluded that motivational factors, such as altruism, trust, and sense of duty, may be less influential in hypothetical contexts, and thus the value of such scenarios in predicting factual willingness to participate may be limited.”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > ELICITING AND USING PUBLIC OPINION > What We Ask and How We Ask It
What the sources say
- Supportedcites [73] source
Split into 2 atoms — 2 confirmed, 0 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
- Supported
Every source the paper cites for this claim was checked and supports it.
In the paper
“An agreement was reached by which NIH-funded researchers who sequence HeLa cell lines are expected to deposit the data in a controlled-access database; applications to study these data are reviewed by a committee that includes members of the Lacks family (64).”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > REFLECTIONS ON THE STORY OF HENRIETTA LACKS
What the sources say
- Supportedcites [64] source
Split into 2 atoms — 2 confirmed, 0 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Supported
Every source the paper cites for this claim was checked and supports it.
In the paper
“The collection, storage, and research use of biospecimens and data, however, raise deep questions about informed consent, oversight, large-scale data sharing, privacy and confidentiality, commercialization, access to research results, and the ability to withdraw (94).”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > INTRODUCTION
What the sources say
- Supportedcites [94] source
The section “Informed Consent for the Collection and Storage of Biospecimens and Data” identifies future research use, large-scale data sharing, commercial products, privacy and confidentiality, research results, and withdrawal as complex or controversial consent topics. The “Researcher access” and “Informed Consent for the Research Use of Stored Specimens and Data” sections also discuss ethics review and oversight. No page numbers are provided in the supplied passages. (LLM, conf=0.95)
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. It may state two separate claims as one.
- Supported
Every source the paper cites for this claim was checked and supports it.
In the paper
“Among all respondents, 43% preferred opt-out plus, 34% preferred onetime consent, 16% preferred the standard opt-out procedure, and 8% said that no information at all was needed.”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > PUBLIC OPINION ON CONSENT FOR BIOSPECIMEN RESEARCH
What the sources say
- Supportedcites [144] source
The Results section, under “Preferences for consent procedures,” reports the preferences for all groups combined: 43% opt-out plus, 34% one-time consent, 16% opt-out, and 8% no information at all. These match the cited sentence. (LLM, conf=0.95)
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Supported
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“In this subset, older, male, and white non-Hispanic participants were more likely to prefer broad consent. However, these differences were explained by logistic regression models that included responses to questions regarding beliefs about the study: Broad consent was preferred by those who agreed that the study could lead to improved treatments, cures, and lives saved; that participating would”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > PUBLIC OPINION ON CONSENT FOR BIOSPECIMEN RESEARCH
What the sources say
- Partly supportedcites [110] sourceExperimental — accuracy not yet measured
The Results sections on beliefs and demographic factors (page not provided) support the stated associations between consent preference and beliefs about treatments, contributing to society, ease of participation, repeated permission requests, and researchers having samples and information. The Discussion says beliefs accounted for some demographic differences, including race and ethnicity, but not all: age and gender remained significant after adjustment. Thus the claim overstates that the demographic differences were explained. (LLM, conf=0.89)
plaindirectn = 3,347- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Partly supported
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“Broad consent is commonly conceptualized as consent to governance (82, 91), and studies of public opinion about broad consent are predicated on descriptions that involve entrusting decisions about specific studies to an ethics review board or other oversight body.”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > ELICITING AND USING PUBLIC OPINION > Alternatives to Traditional Consent
What the sources say
- Partly supportedcites [82] sourceExperimental — accuracy not yet measured
In the main text (page unavailable), Koenig describes a model in which participants consent to a governance scheme rather than make specific upfront choices. The paper presents this as an emerging alternative for genomic research, not as a commonly held conceptualization of broad consent. (LLM, conf=0.85)
- Not checked — no full text of the sourcecites [91] source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim.
- Partly supported
Every source the paper cites for this claim was checked and supports it.
In the paper
“Given the general limitations of informed consent, the creation of ever more elaborate processes raises the specter of what has been called “the tyranny of choice” (115), as well as legitimate questions about the claims for these models regarding increased autonomy, engagement, control, and reciprocity (133).”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > ELICITING AND USING PUBLIC OPINION > Alternatives to Traditional Consent
What the sources say
- Supportedcites [115] Ram N, 2008, Jurimetrics
The Abstract warns that expanding choices for tissue providers too much can undermine informed consent, and the Conclusion cautions that more options do not always yield greater provider control. This supports the 'tyranny of choice' concern attributed to this paper; the separate claims about autonomy, engagement, control, and reciprocity are attached to citation 133, not this source. (LLM, conf=0.91)
- Supportedcites [133] source
The Abstract (page not provided) identifies dynamic consent’s claimed advantages in autonomy, engagement, control, and reciprocity, then says closer examination reveals weaknesses. The sections on autonomy, participation, and control question those advantages. The separate “tyranny of choice” phrase is attached to citation 115, not this source’s citation 133. (LLM, conf=0.94)
plainconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. It may state two separate claims as one.
- Supported
A claim is checked only against the cited paper’s full text, never its abstract, and none is available for its sources.
In the paper
“With regard to the collection of biospecimens specifically for research, the ethical acceptability of broad consent for future unspecified use has long been discussed (21, 52, 54, 61, 75, 109), but surveys suggest that it is now common in the United States (57) and possibly other countries (40, 109).”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > Proposed US Regulations
What the sources say
hedged- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“With regard to what we ask, a substantial portion of empirical research to date has asked about preferences. What individuals might prefer, however, is not the same as what they might find acceptable, once they are aware of the risks, benefits, costs, and trade-offs at stake for the array of interests they would like to see advanced.”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > ELICITING AND USING PUBLIC OPINION > What We Ask and How We Ask It
hedged- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Even in a world of ideally designed and conducted studies, the role of public opinion in developing research policy on ethically challenging topics is a fundamental question.”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > ELICITING AND USING PUBLIC OPINION > The Role of Public Opinion in Policy Development
plain- Asserted: passes — The authors put it forward as true.
- Checkable: fails — It may be too vague to check against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. It may be too vague to check against evidence.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Broad consent was preferred in one study, with study-specific consent a close second, whereas in another study, an opt-out procedure involving verbal notification was clearly preferred over broad consent.”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > PUBLIC OPINION ON CONSENT FOR BIOSPECIMEN RESEARCH
boosted- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“Since 2010, this literature has been the subject of at least seven published reviews (Table 2). These reviews encompass a wide array of studies that differ substantially in context, purpose, design, samples, results, and conclusions.”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > PUBLIC OPINION ON CONSENT FOR BIOSPECIMEN RESEARCH
What the sources say
- Not matchedcites Table 2
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Not matched
In the paper
“Under these conditions—when there is no intervention or interaction with the individuals who were the sources of the samples, and researchers cannot readily ascertain their identities—research can be determined not to involve human subjects (143), and thus informed consent is not required.”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > Current US Regulations
What the sources say
- Not checked yetcites [143] US Dep. Health Hum. Serv, 2008
plainconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Although Henrietta Lacks’s story is compelling and has prompted much-needed public discussion, it is an extraordinary case in many respects.”
- Also stated in: § REFLECTIONS ON THE STORY OF HENRIETTA LACKS · hedged
“Caution is warranted in drawing lessons for biospecimen policy from any exceptional case.”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > REFLECTIONS ON THE STORY OF HENRIETTA LACKS
plain- Asserted: passes — The authors put it forward as true.
- Checkable: fails — It may be too vague to check against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. It may be too vague to check against evidence. The paper’s conclusions may not depend on it. It may state two separate claims as one.
- Also stated in: § REFLECTIONS ON THE STORY OF HENRIETTA LACKS · hedged
In the paper
“As stated by Gottweis et al. (45), “most of these studies yield interesting data, but currently we are confronted with a heterogeneous patchwork of insights rather than a coherent picture of evidence” (p. 434).”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > PUBLIC OPINION ON CONSENT FOR BIOSPECIMEN RESEARCH
What the sources say
- Not checked — no full text of the sourcecites [45] source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
In the paper
“In September 2015, the federal government published a notice of proposed rulemaking (NPRM) to overhaul the Common Rule (102). Citing the changing research landscape, including the volume and diversity of studies, analytic sophistication, and growing use and global sharing of massive electronic data sets, the stated goals of the NPRM are to increase human subjects’ability and opportunity to make in”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > Proposed US Regulations
What the sources say
- Not checked yetcites [102] 102. Not. Propos. Rulemaking. 2015. Federal policy for the protection of human subjects. 80 Fed. Reg. 53931 (Sep. 8).https://federalregister.gov/a/2015-21756
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“However, the HeLa story aptly illustrates enduring and escalating questions about research use of human biospecimens.”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > REFLECTIONS ON THE STORY OF HENRIETTA LACKS
boostedcorrelationalSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: fails — It may be too vague to check against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. It may be too vague to check against evidence.
In the paper
“With regard to consent, 48% said they would prefer to give permission once, at the beginning of the study, for all research approved by an oversight committee. Slightly fewer (42%) said they would prefer to be asked for permission for each research project separately, and only 10% preferred to select categories of research for which they would let their materials be used.”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > PUBLIC OPINION ON CONSENT FOR BIOSPECIMEN RESEARCH
What the sources say
- Not checked — no full text of the sourcecites [77] source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“These articles represent perspectives from decidedly different “publics” who were asked about different kinds of biobanks and presented with different options from which to indicate their preference.”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > PUBLIC OPINION ON CONSENT FOR BIOSPECIMEN RESEARCH
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“Robust mixed-methods approaches, combining both quantitative and qualitative techniques, can help to both elucidate and explain patterns of attitudes, opinions, beliefs, and actions (45).”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > ELICITING AND USING PUBLIC OPINION > What We Ask and How We Ask It
What the sources say
- Not checked — no full text of the sourcecites [45] source
plainconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
In the paper
“Although the reviews themselves all centered on studies of public, patient, and/or participant perspectives, they varied widely with regard to stated research question(s), methodology, and inclusion/exclusion criteria.”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > PUBLIC OPINION ON CONSENT FOR BIOSPECIMEN RESEARCH
What the sources say
- Not matchedcites Table 2
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
- Not matched
In the paper
“Secondary use of biospecimens to establish a biobank would be exempt, subject only to limited IRB review to ensure that initial broad consent has been obtained and specified privacy and security safeguards are in place.”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > Proposed US Regulations
What the sources say
- Not checked yetcites [102] 102. Not. Propos. Rulemaking. 2015. Federal policy for the protection of human subjects. 80 Fed. Reg. 53931 (Sep. 8).https://federalregister.gov/a/2015-21756
hedged- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
In the paper
“The definition of a human subject would be modified to include living individuals about whom an investigator “obtains, uses, studies or analyzes biospecimens” (102, p. 54004), regardless of identifiability.”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > Proposed US Regulations
What the sources say
- Not checked yetcites [102] 102. Not. Propos. Rulemaking. 2015. Federal policy for the protection of human subjects. 80 Fed. Reg. 53931 (Sep. 8).https://federalregister.gov/a/2015-21756
hedged- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Beyond these particular studies, lay attitudes toward biobanking have been the focus of considerable empirical research, and the same challenging picture emerges.”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > PUBLIC OPINION ON CONSENT FOR BIOSPECIMEN RESEARCH
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: unclear — It is unclear why the paper says it holds.
It may state two separate claims as one.
A claim is checked only against the cited paper’s full text, never its abstract, and none is available for its sources.
In the paper
“The use of hypothetical scenarios—like all methodologies—has disadvantages, but it also has important advantages as a practical, flexible, and efficient way to study complex ethical concerns (142). In the face of emerging issues, hypothetical scenarios can be used to anticipate public reactions, manipulate key contextual variables, and contribute to the development of evidence-based interventions”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > ELICITING AND USING PUBLIC OPINION > What We Ask and How We Ask It
What the sources say
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
In the paper
“Although 90% of respondents said they would be somewhat or very concerned about privacy, 60% said they definitely or probably would be willing to participate.”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > PUBLIC OPINION ON CONSENT FOR BIOSPECIMEN RESEARCH
What the sources say
- Not checked — no full text of the sourcecites [77] source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A claim is checked only against the cited paper’s full text, never its abstract, and none is available for its sources.
In the paper
“Attention to features such as verbal immediacy, temporal proximity, level of detail, format of response options, and cognitive demand may help improve predictive accuracy (108). Similar to the difference between asking about preference and asking about acceptability, constructing hypotheticals in second-person as opposed to third-person language matters, as does eliciting “should” as opposed to “”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > ELICITING AND USING PUBLIC OPINION > What We Ask and How We Ask It
What the sources say
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Few participants in these studies selected categorical consent as their preferred model—but if these participants are combined with those who wanted study-specific consent, one could deduce a desire for more choice and control.”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > PUBLIC OPINION ON CONSENT FOR BIOSPECIMEN RESEARCH
hedgedcorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“With few exceptions, consent would be required for research use of all biospecimens— regardless of whether they were originally collected for research, clinical, or other purposes and whether they are deidentified (notably, consent would not be required for secondary research use of nonidentified private information, such as medical records).”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > Proposed US Regulations
What the sources say
- Not checked yetcites [102] 102. Not. Propos. Rulemaking. 2015. Federal policy for the protection of human subjects. 80 Fed. Reg. 53931 (Sep. 8).https://federalregister.gov/a/2015-21756
hedged- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim.
A claim is checked only against the cited paper’s full text, never its abstract, and none is available for its sources.
In the paper
“Furthermore, regulations and guidelines concerning informed consent are not necessarily specific to biospecimen research, nor are they harmonized (40, 59).”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > INFORMED CONSENT FOR BIOSPECIMEN RESEARCH
What the sources say
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“Research using materials that have been stored for secondary use would be exempt from the regulations and required only to have safeguards in place (with no IRB review). Investigators could use a to-be-created decision tool to make the exempt determination themselves.”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > Proposed US Regulations
What the sources say
- Not checked yetcites [102] 102. Not. Propos. Rulemaking. 2015. Federal policy for the protection of human subjects. 80 Fed. Reg. 53931 (Sep. 8).https://federalregister.gov/a/2015-21756
hedged- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
A claim is checked only against the cited paper’s full text, never its abstract, and none is available for its sources.
In the paper
“The proposed changes have been the subject of intense debate.”
- Also stated in: § Proposed US Regulations · plain
“Although some support the NPRM’s clarification and specification of procedures for biospecimen research (34), others say the consequences will be missed opportunities and lost lives caused by delays in important research (50).”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > Proposed US Regulations
What the sources say
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
- Also stated in: § Proposed US Regulations · plain
In the paper
“Informed consentis premised on well-established ethical principles, including respect for persons, beneficence, and justice (98).”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > INFORMED CONSENT FOR BIOSPECIMEN RESEARCH
What the sources say
- Not checked yetcites [98] Natl Comm, 1979
boosted- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
In the paper
“The NPRM justifies these changes based in no small part on appeals to public opinion, stating that “continuing to allow secondary research with biospecimens collected without consent for research places the publicly-funded research enterprise in an increasingly untenable position because it is not consistent with the majority of the public’s wishes, which reflect legitimate autonomy interests” (p.”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > Proposed US Regulations
What the sources say
- Not checked yetcites [102] 102. Not. Propos. Rulemaking. 2015. Federal policy for the protection of human subjects. 80 Fed. Reg. 53931 (Sep. 8).https://federalregister.gov/a/2015-21756
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. It may state two separate claims as one.
In the paper
“There is no doubt that understanding public perspectives on these issues is vital, and as illustrated by the destruction of millions of newborn bloodspots, failure to take it into account can have harsh consequences (69).”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > ELICITING AND USING PUBLIC OPINION > The Role of Public Opinion in Policy Development
What the sources say
- Not checked — no full text of the sourcecites [69] source
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A claim is checked only against the cited paper’s full text, never its abstract, and none is available for its sources.
In the paper
“(b) attitudes and opinions may be expressions of intense moral reflection or the product of misunderstanding, bias, selfishness, self-deception, and other problematic factors (116, 120);”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > ELICITING AND USING PUBLIC OPINION > The Role of Public Opinion in Policy Development
What the sources say
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: fails — It may be too vague to check against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. It may be too vague to check against evidence. It may state two separate claims as one.
A claim is checked only against the cited paper’s full text, never its abstract, and none is available for its sources.
In the paper
“Public input is one factor among many that should inform policy, and this input can be invaluable for assessing public understanding and areas of concern, identifying previously unrecognized ethical issues, describing facts relevant to normative arguments, avoiding solutions likely to be rejected by many, and learning from people’s lived experiences (32, 86).”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > ELICITING AND USING PUBLIC OPINION > The Role of Public Opinion in Policy Development
What the sources say
plainconditional- Asserted: passes — The authors put it forward as true.
- Checkable: fails — It may be too vague to check against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. It may be too vague to check against evidence. It may state two separate claims as one.
In the paper
“Finally, too much weight on consent elevates autonomy—a word referenced 43 times in the NPRM—as the guiding ethical principle at a high cost to other principles and values (17).”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > ELICITING AND USING PUBLIC OPINION > Expectations of Informed Consent
What the sources say
- Not checked — no full text of the sourcecites [17] source
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: fails — It may be too vague to check against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. It may be too vague to check against evidence.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“In proposing the standardized use of broad consent, a significant shortcoming of the NPRM is that it removes IRB review of secondary uses of biospecimens and does not contemplate any other oversight mechanisms independent of the researchers.”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > ELICITING AND USING PUBLIC OPINION > Alternatives to Traditional Consent
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: unclear — It is unclear why the paper says it holds.
It may state two separate claims as one.
A claim is checked only against the cited paper’s full text, never its abstract, and none is available for its sources.
In the paper
“(c) normative judgments must be grounded in, or at least reconciled with, foundational principles (21, 116, 120).”
§ Lessons from HeLa Cells: The Ethics and Policy of Biospecimens > ELICITING AND USING PUBLIC OPINION > The Role of Public Opinion in Policy Development
What the sources say
plain- Asserted: passes — The authors put it forward as true.
- Checkable: fails — It may be too vague to check against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. It may be too vague to check against evidence.
The paper relies on this without support.
Many if not most people have no preexisting knowledge or opinions about biobanking or the ethical and policy issues and controversies so familiar to “experts.”
“Many if not most people have no preexisting knowledge or opinions about biobanking or the ethical and policy issues and controversies so familiar to “experts.””
The paper relies on this without support.
The Common Rule was developed in response to revelations of extreme research abuses of vulnerable populations and was designed primarily to protect human beings from physical risks involved in experimental research.
“In the United States, federal regulations (known as the Common Rule) were developed in response to revelations of extreme research abuses of vulnerable populations; these regulations were designed primarily to protect human beings from physical risks involved in experimental research.”
The paper relies on this without support.
Complete deidentification of biospecimens and data is illusory.
“These have occurred in the context of rapid scientific and technological innovation and the inescapable recognition that complete deidentification of biospecimens and data is illusory.”
The paper relies on this without support.
Proposed regulatory changes look prominently to routine consent for research use of biospecimens, regardless of whether they were originally collected for research or clinical purposes.
“As a solution, proposed regulatory changes look prominently to routine consent for research use of biospecimens, regardless of whether they were originally collected for research or clinical purposes.”
Citations
Cites
A New Initiative on Precision Medicine
Collins, F. S., & Varmus, H. (2015) · New England Journal of Medicine · doi:10.1056/nejmp1500523 · Cited by 5,202
Eckstein, S. (2003) · Cambridge University Press eBooks · doi:10.1017/cbo9780511550089.028 · Cited by 3,514
Identifying Personal Genomes by Surname Inference
Gymrek, M., McGuire, A. L., Golan, D., Halperin, E., & Erlich, Y. (2013) · Science · doi:10.1126/science.1229566 · Cited by 1,228
Homer, N., Szelinger, S., Redman, M., Duggan, D., Tembe, W., Muehling, J., Pearson, J. V., Stephan, D. A., Nelson, S. F., & Craig, D. W. (2008) · PLoS Genetics · doi:10.1371/journal.pgen.1000167 · Cited by 1,221 · cited 1×
“A steady stream of provocative studies (51, 62, 68, 122) has demonstrated that it is possible to discover the identities of individuals whose genomic data had otherwise been considered deidentified.”
BackgroundFlory, J., & Emanuel, E. (2004) · JAMA · doi:10.1001/jama.292.13.1593 · Cited by 1,067 · cited 1×
“These attempts have met with minimal success; across four systematic reviews (25, 39, 100, 136), the only intervention consistently shown to be effective was one-on-one discussion with a person knowledgeable about the study.”
BackgroundDynamic consent: a patient interface for twenty-first century research networks
Kaye, J., Whitley, E. A., Lund, D., Morrison, M., Teare, H., & Melham, K. (2015) · European Journal of Human Genetics · doi:10.1038/ejhg.2014.71 · Cited by 780 · cited 1×
“Finally, other nontraditional approaches to informed consent may be appropriate for certain populations and studies, including open (2, 90), dynamic (78, 127, 132), meta (111), and cascading (89) consent.”
BackgroundReadability Standards for Informed-Consent Forms as Compared with Actual Readability
Paasche‐Orlow, M. K., Taylor, H. A., & Brancati, F. L. (2003) · New England Journal of Medicine · doi:10.1056/nejmsa021212 · Cited by 763 · cited 1×
“Empirical research has amply shown that consent forms are too long and written at too high a grade level (1, 4,19,29, 76, 84, 85, 105, 106, 125) and, not surprisingly, many participants do not understand the information disclosed (4–6,70,71, 83, 87, 97), including biobank participants (93,104,114).”
BackgroundThe Immortal Life of Henrietta Lacks
Bloom, S. (2010) · The Yale Journal of Biology and Medicine · doi:10.1172/jci43410 · Cited by 692 · cited 2×
“The 2010 publication of The Immortal Life of Henrietta Lacks (130) garnered widespread attention.”
Quality of informed consent in cancer clinical trials: a cross-sectional survey
Joffe, S., Cook, E. F., Cleary, P. D., Clark, J. W., & Weeks, J. C. (2001) · The Lancet · doi:10.1016/s0140-6736(01)06805-2 · Cited by 655
Enduring and Emerging Challenges of Informed Consent
Grady, C. (2015) · New England Journal of Medicine · doi:10.1056/nejmra1411250 · Cited by 548
Hughes, R. (1998) · Sociology of Health & Illness · doi:10.1111/1467-9566.00107 · Cited by 537 · cited 1×
“Similar to the difference between asking about preference and asking about acceptability, constructing hypotheticals in second-person as opposed to third-person language matters, as does eliciting “should” as opposed to “would” responses (66).”
BackgroundNishimura, A., Carey, J., Erwin, P. J., Tilburt, J. C., Murad, M. H., & McCormick, J. B. (2013) · BMC Medical Ethics · doi:10.1186/1472-6939-14-28 · Cited by 521 · cited 1×
“These attempts have met with minimal success; across four systematic reviews (25, 39, 100, 136), the only intervention consistently shown to be effective was one-on-one discussion with a person knowledgeable about the study.”
BackgroundEmpty ethics: the problem with informed consent
Corrigan, O. (2003) · Sociology of Health & Illness · doi:10.1046/j.1467-9566.2003.00369.x · Cited by 436 · cited 1×
“Particularly when patients are facing dire situations, we cannot simply assume that an elicited choice will be actively and freely made based on careful consideration and adequate understanding of the information (27).”
BackgroundShould donors be allowed to give broad consent to future biobank research?
Hansson, M. G., Dillner, J., Bartram, C. R., Carlson, J. A., & Helgesson, G. (2006) · The Lancet Oncology · doi:10.1016/s1470-2045(06)70618-0 · Cited by 382 · cited 1×
“With regard to the collection of biospecimens specifically for research, the ethical acceptability of broad consent for future unspecified use has long been discussed (21, 52, 54, 61, 75, 109), but surveys suggest that it is now common in the United States (57) and possibly other countries (40, 109).”
BackgroundFederal Policy for the Protection of Human Subjects
Grigsby, R. K., & Roof, H. L. (1993) · Research on Social Work Practice · doi:10.1177/104973159300300406 · Cited by 362 · cited 5×
“In September 2015, the federal government published a notice of proposed rulemaking (NPRM) to overhaul the Common Rule (102).”
BackgroundInfluentialThe Havasupai Indian tribe case--lessons for research involving stored biologic samples.
Mello, M. M., & Wolf, L. (2010) · New England Journal of Medicine · doi:10.1056/nejmp1005203 · Cited by 348 · cited 1×
“These developments come at a time when public concern about biospecimen research and informed consent has already been stoked not only by the story of Henrietta Lacks, but also by lawsuits over the research use of newborn screening samples (18, 30) and biospecimens from indigenous populations (28, 95).”
BackgroundBroad Consent for Research With Biological Samples: Workshop Conclusions
Grady, C., Eckstein, L., Berkman, B., Brock, D., Cook-Deegan, R., Fullerton, S. M., Greely, H., Hansson, M. G., Hull, S., Kim, S., et al. (2015) · The American Journal of Bioethics · doi:10.1080/15265161.2015.1062162 · Cited by 332 · cited 3×
“’s (47) considerations for obtaining consent for biospecimen research”
BackgroundSteinsbekk, K. S., Kåre Myskja, B., & Solberg, B. (2013) · European Journal of Human Genetics · doi:10.1038/ejhg.2012.282 · Cited by 320 · cited 1×
“legitimate questions about the claims for these models regarding increased autonomy, engagement, control, and reciprocity (133).”
BackgroundHuman genetic research: emerging trends in ethics
Knoppers, B. M., & CHADWICK, R. F. (2005) · Nature Reviews Genetics · doi:10.1038/nrg1505 · Cited by 282 · cited 6×
“Knoppers BM, Chadwick R. Human genetic research: emerging trends in ethics.”
InfluentialPublic Opinion about the Importance of Privacy in Biobank Research
Kaufman, D. J., Murphy-Bollinger, J., Scott, J., & Hudson, K. L. (2009) · The American Journal of Human Genetics · doi:10.1016/j.ajhg.2009.10.002 · Cited by 279 · cited 3×
“(77), 48% of respondents preferred broad consent and 42% preferred study-specific consent.”
BackgroundGarrison, N., Sathe, N. A., Antommaria, A. H. M., Holm, I. A., Sanderson, S. C., Smith, M. E., McPheeters, M. L., & Clayton, E. W. (2016) · Genetics in Medicine · doi:10.1038/gim.2015.138 · Cited by 258 · cited 3×
“2016 (43) Systematic review of 48 quantitative and qualitative studies of public opinion on broad consent and data sharing, 2001–2015 (United States) ■ Although the majority of respondents often expressed support for broad consent when that was the only choice offered, only a minority favored broad consent when other…”
BackgroundSolidarity and equity: new ethical frameworks for genetic databases
CHADWICK, R. F., & Berg, K. (2001) · Nature Reviews Genetics · doi:10.1038/35066094 · Cited by 254 · cited 5×
“Chadwick R, Berg K. Solidarity and equity: new ethical frameworks for genetic databases.”
BackgroundInfluentialThe Uneasy Ethical and Legal Underpinnings of Large-Scale Genomic Biobanks
Greely, H. T. (2007) · Annual Review of Genomics and Human Genetics · doi:10.1146/annurev.genom.7.080505.115721 · Cited by 241 · cited 1×
“Although the ethical and policy issues associated with biospecimen research have long been the subject of scholarly analysis and debate (48, 118, 124), the publication of Rebecca Skloot’s bestselling book The Immortal Life of Henrietta Lacks (130) captured the attention of a much broader audience.”
BackgroundGenomic research and wide data sharing: Views of prospective participants
Trinidad, S. B., Fullerton, S. M., Bares, J. M., Jarvik, G. P., Larson, E. B., & Burke, W. (2010) · Genetics in Medicine · doi:10.1097/gim.0b013e3181e38f9e · Cited by 210 · cited 1×
“This research included efforts to contact individuals who had consented to a cohort study of aging and dementia [called Adult Changes in Thought (ACT)] in order to obtain additional consent for widespread data sharing, a survey of ACT participants who did provide this reconsent, and focus groups with ACT participants…”
Informed Consent in Genomics and Genetic Research
McGuire, A. L., & Beskow, L. M. (2010) · Annual Review of Genomics and Human Genetics · doi:10.1146/annurev-genom-082509-141711 · Cited by 204 · cited 1×
“The collection, storage, and research use of biospecimens and data, however, raise deep questions about informed consent, oversight, large-scale data sharing, privacy and confidentiality, commercialization, access to research results, and the ability to withdraw (94).”
BackgroundSelf-citationCharacterizing biobank organizations in the U.S.: results from a national survey
Henderson, G. E., Cadigan, R. J., Edwards, T. P., Conlon, I., Nelson, A. G., Evans, J. P., Davis, A. M., Zimmer, C., & Weiner, B. J. (2013) · Genome Medicine · doi:10.1186/gm407 · Cited by 198 · cited 1×
“Actual practice varies, as collections of biospecimens (or biobanks) are highly heterogeneous in terms of tissue type, procurement situation, and geographic, social, and historical context (56, 58,60, 126, 146).”
BackgroundBroadening consent—and diluting ethics?: Table 1
Hofmann, B. (2009) · Journal of Medical Ethics · doi:10.1136/jme.2008.024851 · Cited by 191 · cited 1×
“With regard to the collection of biospecimens specifically for research, the ethical acceptability of broad consent for future unspecified use has long been discussed (21, 52, 54, 61, 75, 109), but surveys suggest that it is now common in the United States (57) and possibly other countries (40, 109).”
BackgroundActive choice but not too active: Public perspectives on biobank consent models
Simon, C. M., L’Heureux, J., Murray, J. C., Winokur, P., Weiner, G., Newbury, E., Shinkunas, L., & Zimmerman, B. (2011) · Genetics in Medicine · doi:10.1097/gim.0b013e31821d2f88 · Cited by 168 · cited 2×
“In support of proposed regulatory changes, the NPRM cited four articles reporting public opinions about biospecimen research (77, 128, 140, 144).”
BackgroundBeardsley, E., Jefford, M., & Mileshkin, L. (2007) · Journal of Clinical Oncology · doi:10.1200/jco.2006.10.3341 · Cited by 162 · cited 1×
“Empirical research has amply shown that consent forms are too long and written at too high a grade level (1, 4,19,29, 76, 84, 85, 105, 106, 125) and, not surprisingly, many participants do not understand the information disclosed (4–6,70,71, 83, 87, 97), including biobank participants (93,104,114).”
BackgroundThe changing privacy landscape in the era of big data
Schadt, E. E. (2012) · Molecular Systems Biology · doi:10.1038/msb.2012.47 · Cited by 161 · cited 1×
“Solutions to the identifiability problem that better support the interests of all stakeholders would focus not only on disclosing risks to prospective participants, but also on minimizing potential harms by ensuring the scientific merit of proposed studies (116) and prohibiting misuse of information (33, 121).”
Background(1971) · PubMed · Cited by 157
Hewitt, R., & Watson, P. (2013) · Biopreservation and Biobanking · doi:10.1089/bio.2013.0042 · Cited by 157
Bayesian method to predict individual SNP genotypes from gene expression data
Schadt, E. E., Woo, S., & Hao, K. (2012) · Nature Genetics · doi:10.1038/ng.2248 · Cited by 152 · cited 1×
“A steady stream of provocative studies (51, 62, 68, 122) has demonstrated that it is possible to discover the identities of individuals whose genomic data had otherwise been considered deidentified.”
BackgroundThe Complexities of Genomic Identifiability
Rodriguez, L. L., Brooks, L. D., Greenberg, J. H., & Green, E. D. (2013) · Science · doi:10.1126/science.1234593 · Cited by 144 · cited 1×
“Furthermore, the original source of HeLa cells is decidedly famous; usually, identifying the source of a genetic sample from which identifiers have been removed would require intent and technical wherewithal, as well as motivation and a means by which to exploit this information (117).”
BackgroundConsent Documents for Oncology Trials: Does Anybody Read These Things?
Sharp, S. (2004) · American Journal of Clinical Oncology · doi:10.1097/01.coc.0000135925.83221.b3 · Cited by 143 · cited 1×
“Empirical research has amply shown that consent forms are too long and written at too high a grade level (1, 4,19,29, 76, 84, 85, 105, 106, 125) and, not surprisingly, many participants do not understand the information disclosed (4–6,70,71, 83, 87, 97), including biobank participants (93,104,114).”
BackgroundImproving the informed consent process for research subjects with low literacy: a systematic review
Tamariz, L., Palacio, A., Robert, M., & Marcus, E. N. (2013) · Journal of General Internal Medicine · doi:10.1007/s11606-012-2133-2 · Cited by 140 · cited 1×
“These attempts have met with minimal success; across four systematic reviews (25, 39, 100, 136), the only intervention consistently shown to be effective was one-on-one discussion with a person knowledgeable about the study.”
BackgroundAssessing the understanding of biobank participants
Ormond, K. E., Cirino, A. L., Helenowski, I., Chisholm, R. L., & Wolf, W. A. (2009) · American Journal of Medical Genetics Part A · doi:10.1002/ajmg.a.32635 · Cited by 128 · cited 1×
“Empirical research has amply shown that consent forms are too long and written at too high a grade level (1, 4,19,29, 76, 84, 85, 105, 106, 125) and, not surprisingly, many participants do not understand the information disclosed (4–6,70,71, 83, 87, 97), including biobank participants (93,104,114).”
BackgroundBench to Bedside: Mapping the Moral Terrain of Clinical Research
Joffe, S., & Miller, F. G. (2008) · Hastings Center Report · doi:10.1353/hcr.2008.0019 · Cited by 122 · cited 1×
“In contrast to clinical care, the goal of research is not to optimize individual preferences, but rather to generate socially valuable scientific knowledge (72).”
BackgroundPetrini, C. (2009) · Social Science & Medicine · doi:10.1016/j.socscimed.2009.10.004 · Cited by 118 · cited 1×
“With regard to the collection of biospecimens specifically for research, the ethical acceptability of broad consent for future unspecified use has long been discussed (21, 52, 54, 61, 75, 109), but surveys suggest that it is now common in the United States (57) and possibly other countries (40, 109).”
BackgroundInformed Consent for Biorepositories: Assessing Prospective Participants' Understanding and Opinions
Beskow, L. M., & Dean, E. (2008) · Cancer Epidemiology Biomarkers & Prevention · doi:10.1158/1055-9965.epi-08-0086 · Cited by 117 · cited 1×
“At Duke University’s Program for Empirical Bioethics, we have conducted a body of research on informed consent for biobanking (8, 11, 12), including development of a simplified consent form (10) and a consensus-based definition of what constitutes adequate comprehension (9).”
MethodSelf-citationImproving Participant Comprehension in the Informed Consent Process
Cohn, E., & Larson, E. (2007) · Journal of Nursing Scholarship · doi:10.1111/j.1547-5069.2007.00180.x · Cited by 115 · cited 1×
“These attempts have met with minimal success; across four systematic reviews (25, 39, 100, 136), the only intervention consistently shown to be effective was one-on-one discussion with a person knowledgeable about the study.”
BackgroundExpanding the Ethical Analysis of Biobanks
Rothstein, M. A. (2005) · The Journal of Law Medicine & Ethics · doi:10.1111/j.1748-720x.2005.tb00213.x · Cited by 113 · cited 1×
“Although the ethical and policy issues associated with biospecimen research have long been the subject of scholarly analysis and debate (48, 118, 124), the publication of Rebecca Skloot’s bestselling book The Immortal Life of Henrietta Lacks (130) captured the attention of a much broader audience.”
BackgroundParticipant Comprehension of Research for Which They Volunteer: A Systematic Review
Montalvo, W., & Larson, E. (2014) · Journal of Nursing Scholarship · doi:10.1111/jnu.12097 · Cited by 113
Biobanks, consent and claims of consensus
Master, Z., Nelson, E., Murdoch, B., & Caulfield, T. (2012) · Nature Methods · doi:10.1038/nmeth.2142 · Cited by 106 · cited 1×
“There are, however, several reasons why public opinion alone should not dictate policy: (a) Data on public perspectives are not definitive (21, 92, 120); (b) attitudes and opinions may be expressions of intense moral reflection or the product of misunderstanding, bias, selfishness, self-deception, and other problemati…”
BackgroundIm, H. K., Gamazon, E. R., Nicolae, D. L., & Cox, N. J. (2012) · The American Journal of Human Genetics · doi:10.1016/j.ajhg.2012.02.008 · Cited by 103 · cited 1×
“A steady stream of provocative studies (51, 62, 68, 122) has demonstrated that it is possible to discover the identities of individuals whose genomic data had otherwise been considered deidentified.”
BackgroundEMPIRICAL ETHICS AND ITS ALLEGED META‐ETHICAL FALLACIES
DE VRIES, R., & GORDIJN, B. (2009) · Bioethics · doi:10.1111/j.1467-8519.2009.01710.x · Cited by 103
Harvard Personal Genome Project: lessons from participatory public research
Ball, M. P., Bobe, J. R., Chou, M. F., Clegg, T., Estep, P. W., Lunshof, J. E., Vandewege, W., Zaranek, A. W., & Church, G. M. (2014) · Genome Medicine · doi:10.1186/gm527 · Cited by 103 · cited 1×
“Finally, other nontraditional approaches to informed consent may be appropriate for certain populations and studies, including open (2, 90), dynamic (78, 127, 132), meta (111), and cascading (89) consent.”
BackgroundData use under the NIH GWAS Data Sharing Policy and future directions
Committees, T. N. I. O. H. G. D. S. G. (2014) · Nature Genetics · doi:10.1038/ng.3062 · Cited by 100 · cited 1×
“Doing so broke no laws or rules; largescale sharing of genomic data sets is required by many funding sources (107) and journals to promote replication of findings and further research.”
BackgroundHypothetical and factual willingness to participate in biobank research
Johnsson, L., Helgesson, G., Rafnar, T., Halldorsdottir, I., Chia, K.-S., Eriksson, S., & Hansson, M. G. (2010) · European Journal of Human Genetics · doi:10.1038/ejhg.2010.106 · Cited by 98
Biobanks and Blanket Consent: The Proper Place of the Public Good and Public Perception Rationales
Caulfield, T. (2007) · King's Law Journal · doi:10.1080/09615768.2007.11427674 · Cited by 96 · cited 2×
“With regard to the collection of biospecimens specifically for research, the ethical acceptability of broad consent for future unspecified use has long been discussed (21, 52, 54, 61, 75, 109), but surveys suggest that it is now common in the United States (57) and possibly other countries (40, 109).”
BackgroundDeveloping a Simplified Consent Form for Biobanking
Beskow, L. M., Friedman, J. Y., Hardy, N. C., Lin, L., & Weinfurt, K. P. (2010) · PLoS ONE · doi:10.1371/journal.pone.0013302 · Cited by 96 · cited 1×
“At Duke University’s Program for Empirical Bioethics, we have conducted a body of research on informed consent for biobanking (8, 11, 12), including development of a simplified consent form (10) and a consensus-based definition of what constitutes adequate comprehension (9).”
MethodSelf-citationD’Abramo, F., Schildmann, J., & Vollmann, J. (2015) · BMC Medical Ethics · doi:10.1186/s12910-015-0053-5 · Cited by 92 · cited 2×
“(p. 44) D’Abramo et al. 2015 (31) Content analysis of 10 quantitative and qualitative studies of biobank participants’ perceptions and ■ The majority of research participants opted for some version of limited consent when being informed about such a possibility.”
BackgroundPersky, S., Kaphingst, K. A., Condit, C. M., & McBride, C. M. (2007) · Genetics in Medicine · doi:10.1097/gim.0b013e318159a344 · Cited by 91 · cited 2×
“Attention to features such as verbal immediacy, temporal proximity, level of detail, format of response options, and cognitive demand may help improve predictive accuracy (108).”
BackgroundTissue donation to biobanks: a review of sociological studies
Lipworth, W. L., Forsyth, R., & Kerridge, I. (2011) · Sociology of Health & Illness · doi:10.1111/j.1467-9566.2011.01342.x · Cited by 89 · cited 2×
“(p. 433) Lipworth et al. 2011 (88) Narrative review of 36 qualitative studies of lay perceptions of biobanking, 2002–2009 (international) ■ Any “sociology of biobanking” would need to be nuanced and draw on a variety of social theories in order to account for the donor population, the type of…”
BackgroundBiobanking for research: a survey of patient population attitudes and understanding
Rahm, A. K., Wrenn, M., Carroll, N. M., & Feigelson, H. S. (2013) · Journal of Community Genetics · doi:10.1007/s12687-013-0146-0 · Cited by 88 · cited 1×
“Empirical research has amply shown that consent forms are too long and written at too high a grade level (1, 4,19,29, 76, 84, 85, 105, 106, 125) and, not surprisingly, many participants do not understand the information disclosed (4–6,70,71, 83, 87, 97), including biobank participants (93,104,114).”
BackgroundPlatt, J., Bollinger, J., Dvoskin, R., Kardia, S. L. R., & Kaufman, D. (2014) · Genetics in Medicine · doi:10.1038/gim.2013.59 · Cited by 88 · cited 1×
“In a more recent publication (not cited in the NPRM), Kaufman and colleagues (110) winnowed the full data set from the 2007–2008 survey by various criteria and analyzed a subset (n = 3,347) in which 51% preferred broad consent and 49% preferred study-specific consent.”
BackgroundMeta consent: a flexible and autonomous way of obtaining informed consent for secondary research
Ploug, T., & Holm, S. (2015) · BMJ · doi:10.1136/bmj.h2146 · Cited by 88 · cited 1×
“Finally, other nontraditional approaches to informed consent may be appropriate for certain populations and studies, including open (2, 90), dynamic (78, 127, 132), meta (111), and cascading (89) consent.”
BackgroundResearch Practice and Participant Preferences: The Growing Gulf
Trinidad, S. B., Fullerton, S. M., Ludman, E. J., Jarvik, G. P., Larson, E. B., & Burke, W. (2011) · Science · doi:10.1126/science.1199000 · Cited by 87 · cited 3×
“(140) that informally referred to a few findings from research at Group Health, a nonprofit health care system in Seattle, Washington.”
BackgroundMcCarty, C. A., Nair, A., Austin, D. M., & Giampietro, P. F. (2007) · Public Health Genomics · doi:10.1159/000096274 · Cited by 87 · cited 1×
“Empirical research has amply shown that consent forms are too long and written at too high a grade level (1, 4,19,29, 76, 84, 85, 105, 106, 125) and, not surprisingly, many participants do not understand the information disclosed (4–6,70,71, 83, 87, 97), including biobank participants (93,104,114).”
BackgroundHave We Asked Too Much of Consent?
Koenig, B. A. (2014) · Hastings Center Report · doi:10.1002/hast.329 · Cited by 87 · cited 1×
“Broad consent is commonly conceptualized as consent to governance (82, 91), and studies of public opinion about broad consent are predicated on descriptions that involve entrusting decisions about specific studies to an ethics review board or other oversight body.”
BackgroundPersonal medicine—the new banking crisis
Scott, C. T., Caulfield, T., Borgelt, E., & Illes, J. (2012) · Nature Biotechnology · doi:10.1038/nbt.2116 · Cited by 85
Why do participants enroll in population biobank studies? A systematic literature review
Nobile, H., Vermeulen, E., Thys, K., Bergmann, M. M., & Borry, P. (2012) · Expert Review of Molecular Diagnostics · doi:10.1586/erm.12.116 · Cited by 83 · cited 2×
“2013 (101) Systematic review of 13 quantitative and qualitative studies of biobank participants’ reasons for enrolling, 2006–2012 (international) ■ Reasons for enrolling in population biobank studies stem from personal attitudes (altruism, trust, or optimism), subjective perceptions of costs (ease of procedure or an i…”
BackgroundMeeting the Governance Challenges of Next-Generation Biorepository Research
Fullerton, S. M., Anderson, N., Guzauskas, G. F., Freeman, D., & Fryer-Edwards, K. A. (2010) · Science Translational Medicine · doi:10.1126/scitranslmed.3000361 · Cited by 81 · cited 1×
“(140), which was cited in the NPRM in support of the expanded use of consent, emphasized other innovations, such as better communication about research being done with biospecimens and data (7), transparent and accountable oversight processes (41, 148), and opportunities for community engagement and input on stewardsh…”
BackgroundHELGESSON, G. (2012) · Cambridge Quarterly of Healthcare Ethics · doi:10.1017/s096318011100048x · Cited by 80 · cited 1×
“With regard to the collection of biospecimens specifically for research, the ethical acceptability of broad consent for future unspecified use has long been discussed (21, 52, 54, 61, 75, 109), but surveys suggest that it is now common in the United States (57) and possibly other countries (40, 109).”
BackgroundDonors Perceptions of Consent to and Feedback from Biobank Research: Time to Acknowledge Diversity?
Hoeyer, K. (2010) · Public Health Genomics · doi:10.1159/000262329 · Cited by 77 · cited 1×
“Actual practice varies, as collections of biospecimens (or biobanks) are highly heterogeneous in terms of tissue type, procurement situation, and geographic, social, and historical context (56, 58,60, 126, 146).”
BackgroundCustodianship as an Ethical Framework for Biospecimen-Based Research
Yassin, R., Lockhart, N. C., del Riego, M. G., Pitt, K. E., Thomas, J. W., Weiss, L. K., & Compton, C. C. (2010) · Cancer Epidemiology Biomarkers & Prevention · doi:10.1158/1055-9965.epi-10-0029 · Cited by 77
Structuring Public Engagement for Effective Input in Policy Development on Human Tissue Biobanking
O’Doherty, K. C., & Hawkins, A. (2010) · Public Health Genomics · doi:10.1159/000279621 · Cited by 76 · cited 1×
“(140), which was cited in the NPRM in support of the expanded use of consent, emphasized other innovations, such as better communication about research being done with biospecimens and data (7), transparent and accountable oversight processes (41, 148), and opportunities for community engagement and input on stewardsh…”
BackgroundInformed consent for biobanking: consensus-based guidelines for adequate comprehension
Beskow, L. M., Dombeck, C., Thompson, C. P., Watson-Ormond, J. K., & Weinfurt, K. P. (2014) · Genetics in Medicine · doi:10.1038/gim.2014.102 · Cited by 76 · cited 2×
“■ Sufficient information: Patients need adequate information to make a choice (16)—our consensus-based definition of adequate comprehension for biobanking consent (9) may provide a useful starting point—and should have ready access to additional details if desired (44).”
BackgroundMethodSelf-citationDemographic Differences in Willingness to Provide Broad and Narrow Consent for Biobank Research
Ewing, A. T., Erby, L. H., Bollinger, J. M., Tetteyfio, E., Ricks‐Santi, L. J., & Kaufman, D. (2015) · Biopreservation and Biobanking · doi:10.1089/bio.2014.0032 · Cited by 73 · cited 1×
“Some members of the same research team recently conducted a very similar online survey of US adults (36) in which participants were randomly assigned to one of two scenarios in order to examine acceptance of broad consent (n = 1,528) versus study-specific consent (n = 1,533).”
BackgroundLength and Complexity of US and International HIV Consent Forms from Federal HIV Network Trials
KASS, N. E., Chaisson, L. H., Taylor, H. A., & Lohse, J. (2011) · Journal of General Internal Medicine · doi:10.1007/s11606-011-1778-6 · Cited by 72 · cited 1×
“Empirical research has amply shown that consent forms are too long and written at too high a grade level (1, 4,19,29, 76, 84, 85, 105, 106, 125) and, not surprisingly, many participants do not understand the information disclosed (4–6,70,71, 83, 87, 97), including biobank participants (93,104,114).”
BackgroundTaylor, P. A. (2008) · Nature · doi:10.1038/456032a · Cited by 71 · cited 7×
“Taylor P. Personal genomes: when consent gets in the way.”
BackgroundInfluential(2010) · PubMed · Cited by 70
Enduring and Emerging Challenges of Informed Consent
Lagler, F. B., Weineck, S. B., & Schwab, M. (2015) · New England Journal of Medicine · doi:10.1056/nejmc1503813 · Cited by 70 · cited 1×
“There is a chasm between the theoretical ideals of informed consent and what it accomplishes in actual practice (46, 53, 55).”
BackgroundWhat is a biobank? Differing definitions among biobank stakeholders
Shaw, D., Elger, B. S., & Colledge, F. (2013) · Clinical Genetics · doi:10.1111/cge.12268 · Cited by 69 · cited 1×
“Actual practice varies, as collections of biospecimens (or biobanks) are highly heterogeneous in terms of tissue type, procurement situation, and geographic, social, and historical context (56, 58,60, 126, 146).”
BackgroundBringing the Common Rule into the 21st Century
Hudson, K. L., & Collins, F. S. (2015) · New England Journal of Medicine · doi:10.1056/nejmp1512205 · Cited by 69 · cited 1×
“Although the NPRM does not mention Henrietta Lacks, her influence is clear in a publication about the proposed changes authored by leaders of these reforms (65), which stated that “the controversy that followed the 2013 publication of the genome sequence of the HeLa cell line.”
BackgroundPublic Attitudes Regarding the Use of Residual Newborn Screening Specimens for Research
Botkin, J. R., Rothwell, E., Anderson, R., Stark, L., Goldenberg, A., Lewis, M., Burbank, M., & Wong, B. (2012) · Pediatrics · doi:10.1542/peds.2011-0970 · Cited by 68 · cited 1×
“These developments come at a time when public concern about biospecimen research and informed consent has already been stoked not only by the story of Henrietta Lacks, but also by lawsuits over the research use of newborn screening samples (18, 30) and biospecimens from indigenous populations (28, 95).”
BackgroundReduction in Ephedra Poisonings after FDA Ban
Zell-Kanter, M., Quigley, M. A., & Leikin, J. B. (2015) · New England Journal of Medicine · doi:10.1056/nejmc1502505 · Cited by 64
The ethical use of existing samples for genome research
Bathe, O. F., & McGuire, A. L. (2009) · Genetics in Medicine · doi:10.1097/gim.0b013e3181b2e168 · Cited by 62 · cited 1×
“Routinely obtaining consent for the research use of residual clinical specimens, however, would be a substantial departure from current practice (3).”
BackgroundKnowledge and understanding among cancer patients consenting to participate in clinical trials
Bergenmar, M., Molin, C., Wilking, N., & Brandberg, Y. (2008) · European Journal of Cancer · doi:10.1016/j.ejca.2008.08.013 · Cited by 62
Henderson, G. E. (2011) · The American Journal of the Medical Sciences · doi:10.1097/maj.0b013e31822a6c47 · Cited by 61 · cited 1×
“There is a chasm between the theoretical ideals of informed consent and what it accomplishes in actual practice (46, 53, 55).”
BackgroundOffering aggregate results to participants in genomic research: opportunities and challenges
Beskow, L. M., Burke, W., Fullerton, S. M., & Sharp, R. R. (2012) · Genetics in Medicine · doi:10.1038/gim.2011.62 · Cited by 60 · cited 1×
“(140), which was cited in the NPRM in support of the expanded use of consent, emphasized other innovations, such as better communication about research being done with biospecimens and data (7), transparent and accountable oversight processes (41, 148), and opportunities for community engagement and input on stewardsh…”
BackgroundSelf-citationHypothetical Vignettes in Empirical Bioethics Research
Ulrich, C. M., & Ratcliffe, S. J. (2007) · Advances in Bioethics · doi:10.1016/s1479-3709(07)11008-6 · Cited by 56 · cited 2×
“The use of hypothetical scenarios—like all methodologies—has disadvantages, but it also has important advantages as a practical, flexible, and efficient way to study complex ethical concerns (142).”
BackgroundReforming Biobank Consent Policy: A Necessary Move Away from Broad Consent Toward Dynamic Consent
Stein, D. T., & Terry, S. F. (2013) · Genetic Testing and Molecular Biomarkers · doi:10.1089/gtmb.2013.1550 · Cited by 56 · cited 1×
“Finally, other nontraditional approaches to informed consent may be appropriate for certain populations and studies, including open (2, 90), dynamic (78, 127, 132), meta (111), and cascading (89) consent.”
BackgroundJefford, M., Mileshkin, L., Matthews, J., Raunow, H., O’Kane, C., Cavicchiolo, T., Brasier, H., Anderson, M., & Reynolds, J. (2011) · Supportive Care in Cancer · doi:10.1007/s00520-010-0829-6 · Cited by 55
Informed consent: A broken contract
Check Hayden, E. (2012) · Nature · doi:10.1038/486312a · Cited by 53 · cited 1×
“There is a chasm between the theoretical ideals of informed consent and what it accomplishes in actual practice (46, 53, 55).”
BackgroundLevitt, M. (2003) · Health Care Analysis · doi:10.1023/a:1025381828650 · Cited by 52 · cited 1×
“and this input can be invaluable for assessing public understanding and areas of concern, identifying previously unrecognized ethical issues, describing facts relevant to normative arguments, avoiding solutions likely to be rejected by many, and learning from people’s lived experiences (32, 86).”
BackgroundPaying Patients for Their Tissue: The Legacy of Henrietta Lacks
Truog, R. D., Kesselheim, A. S., & Joffe, S. (2012) · Science · doi:10.1126/science.1216888 · Cited by 52 · cited 2×
“informed consent (20, 22,33,37, 49, 79, 123, 135, 147), as well as commercialization and compensation (123, 141); privacy and confidentiality (20, 33, 49); race, poverty, and health disparities (42, 123); familial implications of genetic information (14, 22,64, 96, 135); ownership of biospecimens (22, 123); and trust…”
BackgroundHudson, K. L., & Collins, F. S. (2013) · Nature · doi:10.1038/500141a · Cited by 52 · cited 3×
“An agreement was reached by which NIH-funded researchers who sequence HeLa cell lines are expected to deposit the data in a controlled-access database; applications to study these data are reviewed by a committee that includes members of the Lacks family (64).”
BackgroundBiospecimen Use in Cancer Research Over Two Decades
Hughes, S. E., Barnes, R. O., & Watson, P. (2010) · Biopreservation and Biobanking · doi:10.1089/bio.2010.0005 · Cited by 52 · cited 1×
“In oncology research, for example, biospecimen use has increased dramatically in recent decades (67), helping illuminate molecular mechanisms that drive cancer and generating knowledge that, in some instances, has profound”
BackgroundEthical Endgames: Broad Consent for Narrow Interests; Open Consent for Closed Minds
Karlsen, J. R., Solbakk, J. H., & Holm, S. (2011) · Cambridge Quarterly of Healthcare Ethics · doi:10.1017/s0963180111000314 · Cited by 52 · cited 1×
“With regard to the collection of biospecimens specifically for research, the ethical acceptability of broad consent for future unspecified use has long been discussed (21, 52, 54, 61, 75, 109), but surveys suggest that it is now common in the United States (57) and possibly other countries (40, 109).”
BackgroundSimplifying informed consent for biorepositories: Stakeholder perspectives
Beskow, L. M., Friedman, J. Y., Hardy, N. C., et al. (2010) · Genetics in Medicine · doi:10.1097/gim.0b013e3181ead64d · Cited by 50 · cited 1×
“At Duke University’s Program for Empirical Bioethics, we have conducted a body of research on informed consent for biobanking (8, 11, 12), including development of a simplified consent form (10) and a consensus-based definition of what constitutes adequate comprehension (9).”
MethodSelf-citationBergenmar, M., Johansson, H., & Wilking, N. (2011) · Clinical Trials · doi:10.1177/1740774510384516 · Cited by 49
Prospective Biorepository Participants' Perspectives on Access to Research Results
Beskow, L. M., & Smolek, S. J. (2009) · Journal of Empirical Research on Human Research Ethics · doi:10.1525/jer.2009.4.3.99 · Cited by 49 · cited 1×
“At Duke University’s Program for Empirical Bioethics, we have conducted a body of research on informed consent for biobanking (8, 11, 12), including development of a simplified consent form (10) and a consensus-based definition of what constitutes adequate comprehension (9).”
MethodSelf-citationInclusion of Residual Tissue in Biobanks: Opt-In or Opt-Out?
Giesbertz, N. A. A., Bredenoord, A. L., & van Delden, J. J. M. (2012) · PLoS Biology · doi:10.1371/journal.pbio.1001373 · Cited by 48 · cited 4×
“Moreover, active opt-out procedures for the research use of residual clinical specimens merit further consideration (44).”
BackgroundInfluentialBiobanks and the phantom public
Gottweis, H., Chen, H., & Starkbaum, J. (2011) · Human Genetics · doi:10.1007/s00439-011-1065-y · Cited by 43 · cited 8×
“…M anuscript A uthor M anuscript Table 2 Summary of review articles on lay attitudes toward biobanking Review Description Main findings Conclusion Gottweis et al. 2011 (45) Narrative review of 23 quantitative and qualitative studies of public perceptions of biobanks, 2003– 2010 (international) ■…”
BackgroundMethodInfluentialReading level and length of written research consent forms
Larson, E., Foe, G., & Lally, R. (2015) · Clinical and Translational Science · doi:10.1111/cts.12253 · Cited by 42 · cited 1×
“Empirical research has amply shown that consent forms are too long and written at too high a grade level (1, 4,19,29, 76, 84, 85, 105, 106, 125) and, not surprisingly, many participants do not understand the information disclosed (4–6,70,71, 83, 87, 97), including biobank participants (93,104,114).”
BackgroundStewardship Practices of U.S. Biobanks
Henderson, G. E., Edwards, T., Cadigan, R. J., Davis, A. M., Zimmer, C., Conlon, I., & Weiner, B. J. (2013) · Science Translational Medicine · doi:10.1126/scitranslmed.3007362 · Cited by 41
A trial of consent procedures for future research with clinically derived biological samples
Vermeulen, E., Schmidt, M. K., Aaronson, N. K., Kuenen, M., Baas-Vrancken Peeters, M.-J., van der Poel, H., Horenblas, S., Boot, H., Verwaal, V. J., Cats, A., et al. (2009) · British Journal of Cancer · doi:10.1038/sj.bjc.6605339 · Cited by 39 · cited 3×
“(144)], and their awareness could be reinforced through video spots on waiting room and patient room TVs, email and smartphone messaging, newsletters, brochures, posters, websites, and newspaper and radio stories (16).”
BackgroundBledsoe, M. J., & Grizzle, W. E. (2013) · Diagnostic Histopathology · doi:10.1016/j.mpdhp.2013.06.015 · Cited by 39 · cited 1×
“Human biospecimens have played a crucial role in scientific and medical advances, and their continued widespread availability for research will be vital to realizing the goals of precision medicine (13).”
BackgroundResearchers to Return Blood Samples to the Yanomamö
Couzin-Frankel, J. (2010) · Science · doi:10.1126/science.328.5983.1218 · Cited by 39 · cited 1×
“These developments come at a time when public concern about biospecimen research and informed consent has already been stoked not only by the story of Henrietta Lacks, but also by lawsuits over the research use of newborn screening samples (18, 30) and biospecimens from indigenous populations (28, 95).”
BackgroundAlternative consent approaches for biobank research
Maschke, K. J. (2006) · The Lancet Oncology · doi:10.1016/s1470-2045(06)70590-3 · Cited by 38 · cited 1×
“Broad consent is commonly conceptualized as consent to governance (82, 91), and studies of public opinion about broad consent are predicated on descriptions that involve entrusting decisions about specific studies to an ethics review board or other oversight body.”
BackgroundKoh, J., Goh, E., Yu, K., et al. (2011) · Journal of Medical Ethics · doi:10.1136/jme.2010.040972 · Cited by 37
Nisbet, M. C., & Fahy, D. (2013) · BMC Medical Ethics · doi:10.1186/1472-6939-14-10 · Cited by 35 · cited 3×
“Nisbet & Fahy (99) found that, in the popular press, informed consent dominated discussion of the book.”
BackgroundReform of Clinical Research Regulations, Finally
Emanuel, E. J. (2015) · New England Journal of Medicine · doi:10.1056/nejmp1512463 · Cited by 34 · cited 1×
“Although some support the NPRM’s clarification and specification of procedures for biospecimen research (34), others say the consequences will be missed opportunities and lost lives caused by delays in important research (50).”
BackgroundReadability of consent form templates: a second look.
Paasche‐Orlow, M. K., Brancati, F. L., Taylor, H. A., et al. (2013) · PubMed · Cited by 32
The Health Insurance Portability and Accountability Act and the Informed Consent Process
Breese, P., Burman, W., Rietmeijer, C., & Lezotte, D. (2004) · Annals of Internal Medicine · doi:10.7326/0003-4819-141-11-200412070-00034 · Cited by 32
The Henrietta Lacks legacy grows
Greely, H. T., & Cho, M. K. (2013) · EMBO Reports · doi:10.1038/embor.2013.148 · Cited by 29 · cited 2×
“informed consent (20, 22,33,37, 49, 79, 123, 135, 147), as well as commercialization and compensation (123, 141); privacy and confidentiality (20, 33, 49); race, poverty, and health disparities (42, 123); familial implications of genetic information (14, 22,64, 96, 135); ownership of biospecimens (22, 123); and trust…”
BackgroundSalloch, S., Vollmann, J., & Schildmann, J. (2014) · Journal of Medical Ethics · doi:10.1136/medethics-2012-101253 · Cited by 29 · cited 1×
“There are, however, several reasons why public opinion alone should not dictate policy: (a) Data on public perspectives are not definitive (21, 92, 120); (b) attitudes and opinions may be expressions of intense moral reflection or the product of misunderstanding, bias, selfishness, self-deception, and other problemati…”
BackgroundElectronic Consent Channels: Preserving Patient Privacy Without Handcuffing Researchers
Shelton, R. (2011) · Science Translational Medicine · doi:10.1126/scitranslmed.3002037 · Cited by 24 · cited 1×
“Finally, other nontraditional approaches to informed consent may be appropriate for certain populations and studies, including open (2, 90), dynamic (78, 127, 132), meta (111), and cascading (89) consent.”
BackgroundCunningham, S., O’Doherty, K. C., Sénécal, K., Secko, D., & Avard, D. (2015) · Journal of Community Genetics · doi:10.1007/s12687-014-0206-0 · Cited by 21 · cited 1×
“These developments come at a time when public concern about biospecimen research and informed consent has already been stoked not only by the story of Henrietta Lacks, but also by lawsuits over the research use of newborn screening samples (18, 30) and biospecimens from indigenous populations (28, 95).”
BackgroundHirschberg, I., Kahrass, H., & Strech, D. (2014) · Journal of Medical Genetics · doi:10.1136/jmedgenet-2014-102692 · Cited by 21 · cited 1×
“Furthermore, regulations and guidelines concerning informed consent are not necessarily specific to biospecimen research, nor are they harmonized (40, 59).”
Background(2007) · Cited by 20
Medical research: Cell division
Wadman, M. (2013) · Nature · doi:10.1038/498422a · Cited by 20
Chan, T. W., Mackey, S., & Hegney, D. G. (2012) · International Journal of Evidence-Based Healthcare · doi:10.1111/j.1744-1609.2011.00251.x · Cited by 20 · cited 3×
“(p. 792) Chan et al. 2012 (24) Systematic review of 18 qualitative and ■ All of the authors of the reviewed studies failed to clearly describe the methodology and paradigm used in their research.”
BackgroundThe emerging need for family-centric initiatives for obtaining consent in personal genome research
Minari, J., Teare, H., Mitchell, C., Kaye, J. S., & Kato, K. (2014) · Genome Medicine · doi:10.1186/s13073-014-0118-y · Cited by 20 · cited 1×
“informed consent (20, 22,33,37, 49, 79, 123, 135, 147), as well as commercialization and compensation (123, 141); privacy and confidentiality (20, 33, 49); race, poverty, and health disparities (42, 123); familial implications of genetic information (14, 22,64, 96, 135); ownership of biospecimens (22, 123); and trust…”
BackgroundEngaging Research Participants and Building Trust
Horn, E. J., Edwards, K., & Terry, S. F. (2011) · Genetic Testing and Molecular Biomarkers · doi:10.1089/gtmb.2011.1526 · Cited by 20 · cited 1×
“(140), which was cited in the NPRM in support of the expanded use of consent, emphasized other innovations, such as better communication about research being done with biospecimens and data (7), transparent and accountable oversight processes (41, 148), and opportunities for community engagement and input on stewardsh…”
BackgroundA Social Justice Framework for Health and Science Policy
Faden, R., & Powers, M. (2011) · Cambridge Quarterly of Healthcare Ethics · doi:10.1017/s0963180111000338 · Cited by 18 · cited 1×
“informed consent (20, 22,33,37, 49, 79, 123, 135, 147), as well as commercialization and compensation (123, 141); privacy and confidentiality (20, 33, 49); race, poverty, and health disparities (42, 123); familial implications of genetic information (14, 22,64, 96, 135); ownership of biospecimens (22, 123); and trust…”
BackgroundKoyfman, S. A., Agre, P., Carlisle, R., et al. (2013) · JNCI Journal of the National Cancer Institute · doi:10.1093/jnci/djt143 · Cited by 18 · cited 1×
“Empirical research has amply shown that consent forms are too long and written at too high a grade level (1, 4,19,29, 76, 84, 85, 105, 106, 125) and, not surprisingly, many participants do not understand the information disclosed (4–6,70,71, 83, 87, 97), including biobank participants (93,104,114).”
BackgroundBiobank Classification: Communicating Biorepository Diversity
Watson, P. H. (2014) · Biopreservation and Biobanking · doi:10.1089/bio.2014.1231 · Cited by 18 · cited 1×
“Actual practice varies, as collections of biospecimens (or biobanks) are highly heterogeneous in terms of tissue type, procurement situation, and geographic, social, and historical context (56, 58,60, 126, 146).”
BackgroundPublic Perceptions and Biobanking: What Does the Research Really Say?
Rachul, C. M., McGuire, A. L., & Caulfield, T. (2012) · Studies in Ethics Law and Technology · doi:10.1515/1941-6008.1177 · Cited by 17 · cited 2×
“(p. 9) Rachul et al. 2012 (113) Systematic review of 87 quantitative and qualitative studies of public perceptions of biobanking, 1996–2011 (international) ■ The public seems relatively comfortable with a variety of consent scenarios; however, when forced to choose a preference, there is little…”
BackgroundCressey, D. (2012) · Nature · doi:10.1038/482016a · Cited by 17 · cited 1×
“Empirical research has amply shown that consent forms are too long and written at too high a grade level (1, 4,19,29, 76, 84, 85, 105, 106, 125) and, not surprisingly, many participants do not understand the information disclosed (4–6,70,71, 83, 87, 97), including biobank participants (93,104,114).”
BackgroundDoes family always matter? Public genomes and their effect on relatives
Bloss, C. S. (2013) · Genome Medicine · doi:10.1186/gm511 · Cited by 16 · cited 1×
“informed consent (20, 22,33,37, 49, 79, 123, 135, 147), as well as commercialization and compensation (123, 141); privacy and confidentiality (20, 33, 49); race, poverty, and health disparities (42, 123); familial implications of genetic information (14, 22,64, 96, 135); ownership of biospecimens (22, 123); and trust…”
BackgroundInternational guidelines on biobank research leave researchers in ambiguity: why is this so?
Forsberg, J. S., Hansson, M. G., & Evers, K. (2013) · European Journal of Epidemiology · doi:10.1007/s10654-013-9815-x · Cited by 16 · cited 3×
“Furthermore, regulations and guidelines concerning informed consent are not necessarily specific to biospecimen research, nor are they harmonized (40, 59).”
BackgroundTake Another Little Piece of My Heart: Regulating the Research Use of Human Biospecimens
Javitt, G. H. (2013) · Journal of Law, Medicine & Ethics · doi:10.1111/jlme.12053 · Cited by 13 · cited 3×
“More generally, a modernized framework for research ethics could, for example, help develop a coherent view of whether people who are the sources of biospecimens are research participants or donors, and whether their specimens are a gift or a contribution—distinctions that lead to different conceptualizations of relat…”
BackgroundTed Slavin's Blood and the Development of HBV Vaccine
(1985) · New England Journal of Medicine · doi:10.1056/nejm198501173120322 · Cited by 13 · cited 1×
“Rarely do biospecimens obtained from one individual prove particularly valuable (15, 74,119, 134, 141, 145).”
BackgroundA Troubled Past? Reassessing Ethics in the History of Tissue Culture
Wilson, D. (2015) · Health Care Analysis · doi:10.1007/s10728-015-0304-0 · Cited by 11 · cited 1×
“informed consent (20, 22,33,37, 49, 79, 123, 135, 147), as well as commercialization and compensation (123, 141); privacy and confidentiality (20, 33, 49); race, poverty, and health disparities (42, 123); familial implications of genetic information (14, 22,64, 96, 135); ownership of biospecimens (22, 123); and trust…”
BackgroundAssessing comprehension of clinical research
Lipton, L. R., Santoro, N. F., Taylor, H. S., et al. (2011) · Contemporary Clinical Trials · doi:10.1016/j.cct.2011.04.014 · Cited by 9
The Immortal Life of Henrietta LacksReconsidered
Gamble, V. N. (2014) · The Hastings Center Report · doi:10.1002/hast.239 · Cited by 9 · cited 1×
“informed consent (20, 22,33,37, 49, 79, 123, 135, 147), as well as commercialization and compensation (123, 141); privacy and confidentiality (20, 33, 49); race, poverty, and health disparities (42, 123); familial implications of genetic information (14, 22,64, 96, 135); ownership of biospecimens (22, 123); and trust…”
BackgroundPolicy Uncertainty, Sequencing, and Cell Lines
Caulfield, T., & McGuire, A. L. (2013) · G3 Genes|Genomes|Genetics · doi:10.1534/g3.113.007435 · Cited by 9 · cited 1×
“informed consent (20, 22,33,37, 49, 79, 123, 135, 147), as well as commercialization and compensation (123, 141); privacy and confidentiality (20, 33, 49); race, poverty, and health disparities (42, 123); familial implications of genetic information (14, 22,64, 96, 135); ownership of biospecimens (22, 123); and trust…”
BackgroundCase study. Is longer always better? Commentary.
Emanuel, E., & Grady, C. (2008) · PubMed · Cited by 9
Cells that save lives are a mother's legacy.
Skloot, R. (2001) · PubMed · Cited by 9
Feldman, R. (2011) · PubMed · Cited by 9
Genomic data-sharing: what will be our legacy?
Callier, S., Husain, R., & Simpson, R. (2014) · Frontiers in Genetics · doi:10.3389/fgene.2014.00034 · Cited by 8 · cited 1×
“informed consent (20, 22,33,37, 49, 79, 123, 135, 147), as well as commercialization and compensation (123, 141); privacy and confidentiality (20, 33, 49); race, poverty, and health disparities (42, 123); familial implications of genetic information (14, 22,64, 96, 135); ownership of biospecimens (22, 123); and trust…”
BackgroundGrizzle, W. E. (2015) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-15-2513 · Cited by 8 · cited 1×
“Although some support the NPRM’s clarification and specification of procedures for biospecimen research (34), others say the consequences will be missed opportunities and lost lives caused by delays in important research (50).”
BackgroundCascading Consent for Research on Biobank Specimens
Loe, J. D., Robertson, C. T., & Winkelman, D. A. (2015) · The American Journal of Bioethics · doi:10.1080/15265161.2015.1062174 · Cited by 7 · cited 1×
“Finally, other nontraditional approaches to informed consent may be appropriate for certain populations and studies, including open (2, 90), dynamic (78, 127, 132), meta (111), and cascading (89) consent.”
BackgroundFixing Research Subjects Protection in the United States: Moving Beyond Consent
Koenig, B. A. (2013) · Mayo Clinic Proceedings · doi:10.1016/j.mayocp.2013.03.010 · Cited by 7 · cited 1×
“First and foremost, informed consent cannot bear the weight it is being asked to shoulder (16, 81).”
BackgroundBuilding Trust in 21st Century Genomics
Szego, M. J., Buchanan, J. A., & Scherer, S. W. (2013) · G3 Genes Genomes Genetics · doi:10.1534/g3.113.007690 · Cited by 7 · cited 1×
“informed consent (20, 22,33,37, 49, 79, 123, 135, 147), as well as commercialization and compensation (123, 141); privacy and confidentiality (20, 33, 49); race, poverty, and health disparities (42, 123); familial implications of genetic information (14, 22,64, 96, 135); ownership of biospecimens (22, 123); and trust…”
BackgroundCommon Reading Programs: Trends, Traps, Tips
Thorne, A. (2015) · Academic Questions · doi:10.1007/s12129-015-9497-9 · Cited by 5 · cited 1×
“The book is a popular teaching tool and book club favorite (138), and the book and its author have been the subject of numerous reviews, news stories, features, commentaries, profiles, and interviews (99).”
Background(1985) · PubMed · Cited by 4
Love Thy Neighbor: Replacing Paternalistic Protection as the Grounds for Research Ethics
Rhodes, R. (2015) · The American Journal of Bioethics · doi:10.1080/15265161.2015.1062183 · Cited by 3 · cited 2×
“Solutions to the identifiability problem that better support the interests of all stakeholders would focus not only on disclosing risks to prospective participants, but also on minimizing potential harms by ensuring the scientific merit of proposed studies (116) and prohibiting misuse of information (33, 121).”
BackgroundPrivacy and protection in the genomic era
(2013) · Nature Medicine · doi:10.1038/nm.3342 · Cited by 3
Crushing Consent Under the Weight of Expectations
Botkin, J. R. (2015) · The American Journal of Bioethics · doi:10.1080/15265161.2015.1062181 · Cited by 2 · cited 4×
“First and foremost, informed consent cannot bear the weight it is being asked to shoulder (16, 81).”
BackgroundInfluentialKnoppers, B. M. (2013) · G3 Genes Genomes Genetics · doi:10.1534/g3.113.007443 · Cited by 2 · cited 1×
“informed consent (20, 22,33,37, 49, 79, 123, 135, 147), as well as commercialization and compensation (123, 141); privacy and confidentiality (20, 33, 49); race, poverty, and health disparities (42, 123); familial implications of genetic information (14, 22,64, 96, 135); ownership of biospecimens (22, 123); and trust…”
BackgroundWaving Goodbye to Waivers of Consent
Botkin, J. R. (2015) · Hastings Center Report · doi:10.1002/hast.520 · Cited by 2 · cited 2×
“Finally, too much weight on consent elevates autonomy—a word referenced 43 times in the NPRM—as the guiding ethical principle at a high cost to other principles and values (17).”
BackgroundStone, J. (1988) · PubMed · Cited by 2
Guarding children's genetic privacy
Lunshof, J. E., & Gurwitz, D. (2013) · Nature · doi:10.1038/494430d · Cited by 2
Emanuel, E., & Grady, C. (2008) · The Hastings Center Report · doi:10.1353/hcr.0.0018 · Cited by 2
Research works printed but not linked: 11
- Albala I, 2010, IRB, 32, 7
- Feldman R, 2011, Stanford Law Rev., 63, 1377
- Jones HW, 1971, Obstet. Gynecol., 38, 945
- Paasche-Orlow MK, 2013, IRB, 35, 12
- Ram N, 2008, Jurimetrics, 48, 253
- Royston I, 1985, Clin. Res., 33, 442
- Schulman AN, 2012, New Atlantis, 35, 99
- Skloot R, 2001, New York Times
- Skloot R, 2013, New York Times
- Stone J, 1988, Discover, 9, 33
- US Dep. Health Hum. Serv, 2008, Guidance on research using coded private information or specimens
Cited by
Sorted by citations
Biobanking in health care: evolution and future directions
Coppola, L., Cianflone, A., Grimaldi, A., Incoronato, M., Bevilacqua, P., Messina, F., Baselice, S., Soricelli, A., Mirabelli, P., & Salvatore, M. (2019) · Journal of Translational Medicine · doi:10.1186/s12967-019-1922-3 · Cited by 429
Cancer Cell Lines Are Useful Model Systems for Medical Research
Mirabelli, P., Coppola, L., & Salvatore, M. (2019) · Cancers · doi:10.3390/cancers11081098 · Cited by 346
“The advent of cancer cell lines, with the stabilization of the HeLa cell line, revolutionized the approach to in vitro cancer research [23,87].”
BackgroundThe Need for a Human Pangenome Reference Sequence
Miga, K. H., & Wang, T. (2021) · Annual Review of Genomics and Human Genetics · doi:10.1146/annurev-genom-120120-081921 · Cited by 137
“Other obvious instances of research abuse, including the expansive use of HeLa cells, pervaded medical research before and during the Tuskegee experiments, and they have significant implications for the public’s perception of genomic research as well as creating ongoing challenges to informed consent, privacy, and dat…”
BackgroundDisparities in Breast Cancer Associated With African American Identity
Stringer-Reasor, E. M., Elkhanany, A. M., Khoury, K. E., Simon, M. A., & Newman, L. A. (2021) · American Society of Clinical Oncology Educational Book · doi:10.1200/edbk_319929 · Cited by 85
Promoting Ethical Payment in Human Infection Challenge Studies
Lynch, H. F., Darton, T. C., Levy, J., McCormick, F., Ogbogu, U., Payne, R., Roth, A. E., Shah, A. J., Smiley, T., & Largent, E. A. (2021) · The American Journal of Bioethics · doi:10.1080/15265161.2020.1854368 · Cited by 70
“Payment may sometimes be useful for recruiting a more diverse study population, depending on whether the reasons driving non-enrollment can be influenced by payment or are appropriate to influence by payment (Wendler et al. 2006; Durant et al. 2014; Beskow 2016; Niranjan et al. 2020).”
Background
Metadata
- Authors
- Beskow, L. M.
- Affiliations
- Duke University (US)
- Corresponding author
- Beskow, Laura M.
- ORCID
- Beskow, Laura M.
- Venue
- Annual Review of Genomics and Human Genetics
- Publisher
- Annual Reviews
- Published
- 2016-08-31
- Volume
- 17
- Issue
- 1
- Pages
- 395-417
- ISSN
- 1527-8204 (ISSN-L)
- 1545-293X
- PMC
- PMC5072843
- OpenAlex
- W2297837302
- Cited by
- 146
- References
- 147
- Citations by year
- 2026: 15 · 2025: 22 · 2024: 12 · 2023: 23 · 2022: 21 · 2021: 20 · 2020: 13 · 2019: 8 · 2018: 5 · 2017: 5 · 2016: 2
- FWCI
- 0.99
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Annual Review of Genomics and Human Genetics (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion, cc-by)
- PubMed Central (acceptedVersion, cc-by)
- Funders
- National Institutes of Health (UL1TR001117, 7r01hg007733-04)
- National Human Genome Research Institute (R01HG006621, R01-HG-007733)
- U.S. National Library of Medicine (R01LM012178)
- National Center for Advancing Translational Sciences
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics and bioethics in healthcare
- Health Sciences › Nursing › Issues, ethics and legal aspects › Biomedical Ethics and Regulation
- Keywords
- HeLa cells, Henrietta Lacks, human biospecimens, informed consent, public opinion, research autonomy
- MeSH terms
- HeLa Cells, Humans, United States, Biological Specimen Banks
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
A language model drew the claims from the paper on 2026-10-28, under version 3 of the claim definition (model deepseek-v4.1-flash, prompt extract-v3).
A second model labelled each claim on 2026-10-28 (model jev-1.13-20260917, definition revision gold-guideline-v0.2).
Cited sources are checked with a language model’s help (gpt-6-sol).
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
