Informed consent, comparative effectiveness, and learning health care
Abstract
The authors argue that in a learning health care system with ethically robust oversight policies, a streamlined consent process could replace formal written informed-consent procedures for many studies, and patient consent would not be required at all for some trials.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
The recent INDEPENDENT trial replicated these findings in a low-resource setting (India).
“The recent INDEPENDENT trial replicated these findings in a low-resource setting (India). 615”
From Time for united action on depression: a Lancet–World Psychiatric Association Commission (2022) · cites this paper as [615]
Cites
Faden, R. R., Kass, N. E., Goodman, S. N., Pronovost, P., Tunis, S., & Beauchamp, T. L. (2013) · Hastings Center Report · doi:10.1002/hast.134 · Cited by 498 · see citing works
Self-citationKass, N. E., Faden, R. R., Goodman, S. N., Pronovost, P., Tunis, S., & Beauchamp, T. L. (2013) · Hastings Center Report · doi:10.1002/hast.133 · Cited by 235 · see citing works
Self-citationIs Informed Consent Always Necessary for Randomized, Controlled Trials?
Truog, R. D., Robinson, W. M., Randolph, A. G., & Morris, A. H. (1999) · New England Journal of Medicine · doi:10.1056/nejm199903113401013 · Cited by 192 · see citing works
Faden, R., KASS, N. E., Whicher, D. M., Stewart, W., & Tunis, S. (2013) · Medical Care · doi:10.1097/mlr.0b013e31829b1e4b · Cited by 75 · see citing works
Self-citationRandomized, controlled trials as minimal risk: An ethical analysis*
Morris, M. C., & Nelson, R. M. (2007) · Critical Care Medicine · doi:10.1097/01.ccm.0000257333.95528.b8 · Cited by 28 · see citing works
Flagged first, then by citations
Cited by
Sorted by citations
Time for united action on depression: a Lancet–World Psychiatric Association Commission
Herrman, H., Patel, V., Kieling, C., Berk, M., Buchweitz, C., Cuijpers, P., Furukawa, T. A., Kessler, R. C., Kohrt, B. A., Maj, M., et al. (2022) · The Lancet · doi:10.1016/s0140-6736(21)02141-3 · Cited by 1,104 · see citing works
Paul, M., Daikos, G. L., Durante‐Mangoni, E., Yahav, D., Carmeli, Y., Benattar, Y. D., Skiada, A., Andini, R., Eliakim‐Raz, N., Nutman, A., et al. (2018) · The Lancet Infectious Diseases · doi:10.1016/s1473-3099(18)30099-9 · Cited by 626 · see citing works
Enduring and Emerging Challenges of Informed Consent
Grady, C. (2015) · New England Journal of Medicine · doi:10.1056/nejmra1411250 · Cited by 477 · see citing works
Mosquera, R. A., Avritscher, E. B. C., Samuels, C. L., Harris, T. S., Pedroza, C., Evans, P. W., Navarro, F., Wootton, S. H., Pacheco, S. E., Clifton, G. T., et al. (2014) · JAMA · doi:10.1001/jama.2014.16419 · Cited by 259 · see citing works
Primary care physicians and avoidable hospitalizations.
Parchman, M. L., & Culler, S. D. (1994) · PubMed · Cited by 218 · see citing works
Grady, C., Cummings, S. R., Rowbotham, M. C., McConnell, M. V., Ashley, E. A., & Kang, G. (2017) · New England Journal of Medicine · doi:10.1056/nejmra1603773 · Cited by 217 · see citing works
Reframing Consent for Clinical Research: A Function-Based Approach
Dickert, N. W., Eyal, N., Goldkind, S. F., Grady, C., Joffe, S., Lo, B., Miller, F. G., Pentz, R. D., Silbergleit, R., Weinfurt, K. P., et al. (2017) · The American Journal of Bioethics · doi:10.1080/15265161.2017.1388448 · Cited by 138 · see citing works
Camazine, M. N., Hemmila, M. R., Leonard, J. C., Jacobs, R. A., Horst, J. A., Kozar, R. A., Bochicchio, G. V., Nathens, A. B., Cryer, H. M., & Spinella, P. C. (2015) · The Journal of Trauma: Injury, Infection, and Critical Care · doi:10.1097/ta.0000000000000641 · Cited by 127 · see citing works
Attitudes Toward Risk and Informed Consent for Research on Medical Practices
Cho, M. K., Magnus, D. C., Constantine, M. L., Lee, S. S., Kelley, M. C., Kraft, S. A., Korngiebel, D. M., James, C., Kuwana, E., Gallagher, T. H., et al. (2015) · Annals of Internal Medicine · doi:10.7326/m15-0166 · Cited by 105 · see citing works
Stone, J. G., Zussman, B. M., Tonetti, D. A., Brown, M., Desai, S. M., Gross, B. A., Jadhav, A. P., Jovin, T. G., & Jankowitz, B. T. (2020) · Journal of NeuroInterventional Surgery · doi:10.1136/neurintsurg-2019-015642 · Cited by 104 · see citing works
Goldstein, C. E., Weijer, C., Brehaut, J., Fergusson, D. A., Grimshaw, J., Horn, A. R., & Taljaard, M. (2018) · BMC Medical Ethics · doi:10.1186/s12910-018-0253-x · Cited by 96 · see citing works
Use of altered informed consent in pragmatic clinical research
McKinney, R. E., Beskow, L. M., Ford, D. E., Lantos, J. D., McCall, J., Patrick‐Lake, B., Pletcher, M. J., Rath, B., Schmidt, H. K., & Weinfurt, K. P. (2015) · Clinical Trials · doi:10.1177/1740774515597688 · Cited by 95 · see citing works
English, M., Irimu, G., Agweyu, A., Gathara, D., Oliwa, J. N., Ayieko, P., Were, F., Paton, C., Tunis, S., & Forrest, C. B. (2016) · PLoS Medicine · doi:10.1371/journal.pmed.1001991 · Cited by 89 · see citing works
Objecting to experiments that compare two unobjectionable policies or treatments
Meyer, M. N., Heck, P. R., Holtzman, G. S., Anderson, S. M., Cai, W., Watts, D. J., & Chabris, C. F. (2019) · Proceedings of the National Academy of Sciences · doi:10.1073/pnas.1820701116 · Cited by 87 · see citing works
Clinical research and medical care: towards effective and complete integration
Sacristán, J. A. (2015) · BMC Medical Research Methodology · doi:10.1186/1471-2288-15-4 · Cited by 85 · see citing works
The Integration of Clinical Trials With the Practice of Medicine
Angus, D. C., Huang, A. J., Lewis, R. J., Abernethy, A. P., Califf, R. M., Landray, M., KASS, N. E., Bibbins-Domingo, K. B., Abbasi, A. B., Abebe, K. Z., et al. (2024) · JAMA · doi:10.1001/jama.2024.4088 · Cited by 79 · see citing works
Self-citationFrom Doxastic to Epistemic: A Typology and Critique of Qualitative Interview Styles
Berner-Rodoreda, A., Bärnighausen, T., Kennedy, C. E., Brinkmann, S., Sarker, M., Wikler, D. I., Eyal, N., & McMahon, S. A. (2018) · Qualitative Inquiry · doi:10.1177/1077800418810724 · Cited by 79 · see citing works
Young‐Afat, D. A., Verkooijen, H. M., van Gils, C. H., van der Velden, J. M., Burbach, J. P. M., Elias, S. G., van Delden, J. J., Relton, C., van Vulpen, M., & van der Graaf, R. (2016) · Epidemiology · doi:10.1097/ede.0000000000000435 · Cited by 76 · see citing works
The ethics and regulatory landscape of including vulnerable populations in pragmatic clinical trials
Welch, M. J., Lally, R. C., Miller, J. E., Pittman, S., Brodsky, L., Caplan, A. L., Uhlenbrauck, G., Louzao, D. M., Fischer, J. H., & Wilfond, B. S. (2015) · Clinical Trials · doi:10.1177/1740774515597701 · Cited by 73 · see citing works
When and Why Is Research without Consent Permissible?
Gelinas, L. C., Wertheimer, A., & Miller, F. G. (2016) · The Hastings Center Report · doi:10.1002/hast.548 · Cited by 73 · see citing works
Telemedicine for Children With Medical Complexity: A Randomized Clinical Trial
Mosquera, R. A., Avritscher, E. B. C., Pedroza, C., Lee, K. H., Ramanathan, S., Harris, T. S., Eapen, J. C., Yadav, A., Caldas‐Vasquez, M., Poe, M., et al. (2021) · PEDIATRICS · doi:10.1542/peds.2021-050400 · Cited by 66 · see citing works
Heyland, D. K., Patel, J. J., Bear, D. E., Sacks, G. S., Nixdorf, H., Dolan, J., Aloupis, M., Licastro, K., Jovanović, V., Rice, T. W., et al. (2018) · Journal of Parenteral and Enteral Nutrition · doi:10.1002/jpen.1449 · Cited by 63 · see citing works
Fiscella, K. A., Tobin, J. N., Carroll, J. K., He, H., & Ogedegbe, G. G. (2015) · BMC Medical Ethics · doi:10.1186/s12910-015-0056-2 · Cited by 62 · see citing works
The Heimdall framework for supporting characterisation of learning health systems
McLachlan, S., POTTS, H. W. W., Dube, K., Buchanan, D., Lean, S., Gallagher, T., Johnson, O. A., Daley, B. J., Marsh, W., & Fenton, N. (2018) · BMJ Health & Care Informatics · doi:10.14236/jhi.v25i2.996 · Cited by 57 · see citing works
Pragmatic Randomized Trials Without Standard Informed Consent?
Nayak, R., Wendler, D. S., Miller, F. G., & Kim, S. Y. H. (2015) · Annals of Internal Medicine · doi:10.7326/m15-0817 · Cited by 56 · see citing works
Sacristán, J. A., & Dilla, T. (2015) · Journal of Evaluation in Clinical Practice · doi:10.1111/jep.12350 · Cited by 53 · see citing works
Use of pragmatic and explanatory trial designs in acute care research: lessons from COVID-19
Casey, J. D., Beskow, L. M., Brown, J., Brown, S. M., Gayat, É., Gong, M. N., Harhay, M. O., Jaber, S., Jentzer, J. C., Laterre, P., et al. (2022) · The Lancet Respiratory Medicine · doi:10.1016/s2213-2600(22)00044-3 · Cited by 52 · see citing works
Gallego, B., Walter, S. R., Day, R. O., Dunn, A. G., Sivaraman, V., Shah, N. H., Longhurst, C., & Coiera, E. W. (2015) · Journal of Comparative Effectiveness Research · doi:10.2217/cer.15.12 · Cited by 49 · see citing works
Hospital Consultation From Outpatient Clinicians for Medically Complex Children
Mosquera, R. A., Avritscher, E. B. C., Pedroza, C., Bell, C., Samuels, C. L., Harris, T. S., Eapen, J. C., Yadav, A., Poe, M., Parlar-Chun, R. L., et al. (2020) · Archives of Pediatrics and Adolescent Medicine · doi:10.1001/jamapediatrics.2020.5026 · Cited by 46 · see citing works
Series: Pragmatic trials and real world evidence: Paper 4. Informed consent
Kalkman, S., van Thiel, G. J. M. W., Zuidgeest, M. G. P., GOETZ, I. A., Pfeiffer, B. M., Grobbee, D. E., & van Delden, J. J. M. (2017) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2017.03.019 · Cited by 44 · see citing works
Gobat, N., Gal, M., Francis, N. A., Hood, K., Watkins, A. K., Turner, J., Moore, R., Webb, S. A. R., Butler, C., & Nichol, A. (2015) · Trials · doi:10.1186/s13063-015-1110-6 · Cited by 43 · see citing works
Informed consent within a learning health system: A scoping review
Cumyn, A., Barton, A., Dault, R., Cloutier, A., Jalbert, R., & Éthier, J. (2019) · Learning Health Systems · doi:10.1002/lrh2.10206 · Cited by 42 · see citing works
Low risk pragmatic trials do not always require participants’ informed consent
Dal‐Ré, R., Avendaño, C., Bloechl‐Daum, B., de Boer, A., Eriksson, S., Fuhr, U., Holm, S., James, S. K., Mentz, R. J., Perucca, E., et al. (2019) · BMJ · doi:10.1136/bmj.l1092 · Cited by 39 · see citing works
Learning health care systems: Highly needed but challenging
Wouters, R. H. P., van der Graaf, R., Voest, E. E., & Bredenoord, A. L. (2020) · Learning Health Systems · doi:10.1002/lrh2.10211 · Cited by 39 · see citing works
Ethical and scientific considerations for patient enrollment into concurrent clinical trials
Myles, P. S., Williamson, E., Oakley, J. G., & Forbes, A. B. (2014) · Trials · doi:10.1186/1745-6215-15-470 · Cited by 38 · see citing works
KASS, N. E., Faden, R., FABI, R. E., Morain, S. R., Hallez, K., Whicher, D. M., Tunis, S., Moloney, R., Messner, D. A., & Pitcavage, J. M. (2016) · AJOB Empirical Bioethics · doi:10.1080/23294515.2016.1156188 · Cited by 38 · see citing works
Self-citationDenburg, A., Galindo, C. R., & Joffe, S. (2016) · The American Journal of Bioethics · doi:10.1080/15265161.2016.1170230 · Cited by 38 · see citing works
Proposals to Conduct Randomized Controlled Trials Without Informed Consent: a Narrative Review
Flory, J., Mushlin, A. I., & Goodman, Z. I. (2016) · Journal of General Internal Medicine · doi:10.1007/s11606-016-3780-5 · Cited by 38 · see citing works
Gobat, N., Butler, C. C., Mollison, J., Francis, N. A., Gal, M., Harris, V., Webb, S. A. R., Byrne, J.-P., Watkins, A., Sukumar, P., et al. (2019) · Public Health · doi:10.1016/j.puhe.2019.07.005 · Cited by 36 · see citing works
Generating and using real-world data: A worthwhile uphill battle
Verkerk, K., & Voest, E. E. (2024) · Cell · doi:10.1016/j.cell.2024.02.012 · Cited by 39 · see citing works
Sutherland, S. M., Kaelber, D. C., Downing, N. L., Goel, V. V., & Longhurst, C. (2016) · Pediatric Clinics of North America · doi:10.1016/j.pcl.2015.12.002 · Cited by 33 · see citing works
HEAT-PPCI sheds light on consent in pragmatic trials
Shaw, D. (2014) · The Lancet · doi:10.1016/s0140-6736(14)61040-0 · Cited by 32 · see citing works
Needs and Challenges for Big Data in Radiation Oncology
McNutt, T., Moore, K. L., & Quon, H. (2015) · International Journal of Radiation Oncology*Biology*Physics · doi:10.1016/j.ijrobp.2015.11.032 · Cited by 32 · see citing works
The spectrum of ethical issues in a Learning Health Care System: a systematic qualitative review
McLennan, S., Kahrass, H., Wieschowski, S., Strech, D., & Langhof, H. (2018) · International Journal for Quality in Health Care · doi:10.1093/intqhc/mzy005 · Cited by 32 · see citing works
Sharing data under the 21st Century Cures Act
Majumder, M. A., Guerrini, C. J., Bollinger, J. M., Cook-Deegan, R. M., & McGuire, A. L. (2017) · Genetics in Medicine · doi:10.1038/gim.2017.59 · Cited by 31 · see citing works
Novel Methodology for Comparing Standard-of-Care Interventions in Patients With Cancer
Hilton, J. F., Mazzarello, S., Fergusson, D. A., Joy, A. A., Robinson, A. G., Arnaout, A., Hutton, B., Vandermeer, L., & Clemons, M. J. (2016) · Journal of Oncology Practice · doi:10.1200/jop.2016.013474 · Cited by 30 · see citing works
Harms, benefits, and the nature of interventions in pragmatic clinical trials
Ali, J., Andrews, J. E., Somkin, C. P., & Rabinovich, C. E. (2015) · Clinical Trials · doi:10.1177/1740774515597686 · Cited by 30 · see citing works
A protocol for the 0.9% saline versus Plasma-Lyte 148 for intensive care fluid therapy (SPLIT) study
Reddy, S. K., Bailey, M., Beasley, R. W., Bellomo, R., Henderson, S. J., Mackle, D., McArthur, C. J., Mehrtens, J. E., Myburgh, J., McGuinness, S., et al. (2014) · Critical Care and Resuscitation · doi:10.1016/s1441-2772(23)01619-8 · Cited by 29 · see citing works
Informed Consent for Comparative Effectiveness Trials
Faden, R., Beauchamp, T. L., & Kass, N. (2014) · New England Journal of Medicine · doi:10.1056/nejmc1403310 · Cited by 29 · see citing works
Self-citationGrant, R. W., Uratsu, C. S., Estacio, K. R., Altschuler, A., Kim, E. S., Fireman, B. H., Adams, A. S., Schmittdiel, J. A., & Heisler, M. (2016) · Contemporary Clinical Trials · doi:10.1016/j.cct.2016.01.012 · Cited by 29 · see citing works
Whicher, D. M., KASS, N. E., Saghai, Y., Faden, R., Tunis, S., & Pronovost, P. J. (2015) · Journal of Empirical Research on Human Research Ethics · doi:10.1177/1556264615571558 · Cited by 28 · see citing works
Self-citationMorain, S. R., & KASS, N. E. (2016) · eGEMs (Generating Evidence & Methods to improve patient outcomes) · doi:10.13063/2327-9214.1212 · Cited by 28 · see citing works
Self-citationZandi, P. P., Wang, Y., Patel, P. D., Katzelnick, D. J., Turvey, C., Wright, J. H., Ajilore, O., Coryell, W. H., Schneck, C. D., Guille, C., et al. (2020) · Psychiatric Services · doi:10.1176/appi.ps.201900481 · Cited by 27 · see citing works
User Experience and Usability of Voice User Interfaces: A Systematic Literature Review
Deshmukh, A. M., & Chalmeta, R. (2024) · Information · doi:10.3390/info15090579 · Cited by 26 · see citing works
Ali, J., Califf, R. M., & Sugarman, J. (2015) · Accountability in Research · doi:10.1080/08989621.2015.1023951 · Cited by 26 · see citing works
Lewis, J., Kerridge, I., & Lipworth, W. L. (2015) · Journal of Clinical Oncology · doi:10.1200/jco.2015.61.2838 · Cited by 26 · see citing works
Creating a pragmatic trials program for breast cancer patients: Rethinking Clinical Trials (REaCT)
Basulaiman, B. M., Awan, A. A., Fergusson, D. A., Vandermeer, L., Arnaout, A., Hilton, J. F., Hutton, B., Joy, A. A., Robinson, A. G., Califaretti, N., et al. (2019) · Breast Cancer Research and Treatment · doi:10.1007/s10549-019-05274-0 · Cited by 25 · see citing works
Taljaard, M., Weijer, C., Grimshaw, J., Ali, A., Brehaut, J., Campbell, M., Carroll, K. A., Edwards, S., Eldridge, S. M., Forrest, C. B., et al. (2018) · Trials · doi:10.1186/s13063-018-2895-x · Cited by 24 · see citing works
Living laboratory: whole‐genome sequencing as a learning healthcare enterprise
Angrist, M. H., & Jamal, L. (2014) · Clinical Genetics · doi:10.1111/cge.12461 · Cited by 23 · see citing works
Patients' views concerning research on medical practices: Implications for consent
Weinfurt, K. P., Bollinger, J. M., Brelsford, K. M., Crayton, T. J., Topazian, R. J., KASS, N. E., Beskow, L. M., & Sugarman, J. (2015) · AJOB Empirical Bioethics · doi:10.1080/23294515.2015.1117536 · Cited by 24 · see citing works
Self-citationPaul, M., Bronstein, E., Yahav, D., Goldberg, E., Bishara, J., & Leibovici, L. (2015) · BMJ Open · doi:10.1136/bmjopen-2015-008838 · Cited by 23 · see citing works
What gives them the right? Legal privilege and waivers of consent for research
Baker, F. X., & Merz, J. F. (2018) · Clinical Trials · doi:10.1177/1740774518803122 · Cited by 22 · see citing works
Care and research concepts should be revised to practice outcome-based medical care
Raymond, J., Darsaut, T. E., & Roy, D. J. (2019) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2019.05.025 · Cited by 22 · see citing works
Reddy, S. K., Young, P. J., Beasley, R. W., Mackle, D., McGuinness, S., McArthur, C. J., Henderson, S. J., Weinberg, L., French, C., Orford, N. R., et al. (2015) · Critical Care and Resuscitation · doi:10.1016/s1441-2772(23)01524-7 · Cited by 21 · see citing works
Can informed consent to research be adapted to risk?
Bromwich, D., & Rid, A. (2014) · Journal of Medical Ethics · doi:10.1136/medethics-2013-101912 · Cited by 21 · see citing works
Patient Perspectives on the Ethical Implementation of a Rapid Learning System for Oncology Care
Jones, R. D., Sabolch, A. N., Aakhus, E., Spence, R., Bradbury, A. R., & Jagsi, R. (2017) · Journal of Oncology Practice · doi:10.1200/jop.2016.016782 · Cited by 21 · see citing works
Mbuthia, D., Molyneux, S. C., Njue, M., Mwalukore, S., & Marsh, V. (2019) · BMC Medical Ethics · doi:10.1186/s12910-018-0343-9 · Cited by 20 · see citing works
The ethics of ‘Trials within Cohorts’ (TwiCs): 2nd international symposium
the SPIN investigators, Relton, C., Burbach, M., Collett, C., Flory, J., Gerlich, S., Holm, S., Hunn, A., Kim, S., Kwakkenbos, L., et al. (2017) · Trials · doi:10.1186/s13063-017-1961-0 · Cited by 20 · see citing works
Gould, M. K., Smith‐Bindman, R., Kelly, K. L., Altman, D. E., Barjaktarević, I., Creekmur, B., de Bie, E., Dyer, D. S., Barbosa, E. J. M., Mularski, R. A., et al. (2019) · Annals of the American Thoracic Society · doi:10.1513/annalsats.201903-268sd · Cited by 20 · see citing works
Antiplatelet Therapy May Be Continued After Intracerebral Hemorrhage
Salman, R. A., & Dennis, M. S. (2014) · Stroke · doi:10.1161/strokeaha.114.005786 · Cited by 19 · see citing works
Evolution of medical ethics in resuscitation and end of life
Mentzelopoulos, S. D., Haywood, K. L., Cariou, A., Mantzanas, M., & Bossaert, L. L. (2016) · Trends in Anaesthesia and Critical Care · doi:10.1016/j.tacc.2016.08.001 · Cited by 19 · see citing works
Scicluna, V. M., Goldkind, S. F., Mitchell, A. R., Pentz, R. D., Speight, C. D., Silbergleit, R., & Dickert, N. W. (2019) · Journal of the American Heart Association · doi:10.1161/jaha.119.012599 · Cited by 19 · see citing works
Alternative Consent Models in Pragmatic Palliative Care Clinical Trials
Carpenter, J. G., Ulrich, C. M., Hodgson, N. A., Hanson, L. C., & Ersek, M. T. (2020) · Journal of Pain and Symptom Management · doi:10.1016/j.jpainsymman.2020.09.044 · Cited by 17 · see citing works
Pragmatic randomized trials in drug development pose new ethical questions: a systematic review
Kalkman, S., van Thiel, G. J. M. W., Grobbee, D. E., & van Delden, J. J. M. (2015) · Drug Discovery Today · doi:10.1016/j.drudis.2015.03.005 · Cited by 17 · see citing works
Ethics of Informed Consent for Pragmatic Trials with New Interventions
Kalkman, S., Kim, S. Y. H., van Thiel, G. J. M. W., Grobbee, D. E., & van Delden, J. J. M. (2017) · Value in Health · doi:10.1016/j.jval.2017.04.005 · Cited by 17 · see citing works
Public Attitudes toward Consent When Research Is Integrated into Care—Any “Ought” from All the “Is”?
Morain, S. R., & Largent, E. A. (2021) · The Hastings Center Report · doi:10.1002/hast.1242 · Cited by 17 · see citing works
Hemkens, L. G., Saccilotto, R. T., Reyes, S. L., Glinz, D., Zumbrunn, T., Grolimund, O., Gloy, V., Raatz, H., Widmer, A. F., Zeller, A., et al. (2016) · BMC Infectious Diseases · doi:10.1186/s12879-016-1739-0 · Cited by 17 · see citing works
New modes of engagement for big data research
Winickoff, D. E., Jamal, L., & Anderson, N. (2016) · Journal of Responsible Innovation · doi:10.1080/23299460.2016.1190443 · Cited by 17 · see citing works
Patients’ beliefs regarding informed consent for low-risk pragmatic trials
Dal‐Ré, R., Carcas, A. J., Carné, X., & Wendler, D. S. (2017) · BMC Medical Research Methodology · doi:10.1186/s12874-017-0424-3 · Cited by 16 · see citing works
Ethical and Regulatory Issues for Embedded Pragmatic Trials Involving People Living with Dementia
Largent, E. A., Hey, S. P., Harkins, K. A., Hoffman, A. K., Joffe, S., Lima, J. C., London, A. J., & Karlawish, J. H. (2020) · Journal of the American Geriatrics Society · doi:10.1111/jgs.16620 · Cited by 16 · see citing works
Revisiting the Declaration of Helsinki—A Patient-Centered Perspective
Bloom, L. C. (2024) · JAMA · doi:10.1001/jama.2024.22077 · Cited by 15 · see citing works
Drug and Vaccine Access in the Ebola Epidemic: Advising Caution in Compassionate Use
Hantel, A., & Olopade, C. O. (2014) · Annals of Internal Medicine · doi:10.7326/m14-2002 · Cited by 15 · see citing works
Courtright, K. R., Halpern, S. D., Joffe, S., Ellenberg, S. S., Karlawish, J. H., Madden, V. L., Gabler, N. B., Szymanski, S., Yadav, K. N., & Dember, L. M. (2017) · Trials · doi:10.1186/s13063-017-2217-8 · Cited by 15 · see citing works
Ensuring respect for persons in COMPASS: a cluster randomised pragmatic clinical trial
Andrews, J. E., Moore, J. B., Weinberg, R. B., Sissine, M. E., Gesell, S. B., Halladay, J. R., Rosamond, W. D., Bushnell, C., Jones, S. B., Means, P., et al. (2018) · Journal of Medical Ethics · doi:10.1136/medethics-2017-104478 · Cited by 15 · see citing works
Streamlining cardiovascular clinical trials to improve efficiency and generalisability
Zannad, F. M., Pfeffer, M. A., Bhatt, D. L., Bonds, D. E., BORER, J. S., Calvo, G., Fiore, L. D., Lund, L. H., Madigan, D., Maggioni, A. P., et al. (2017) · Heart · doi:10.1136/heartjnl-2017-311191 · Cited by 15 · see citing works
Muskens, I. S., Gupta, S., Hulsbergen, A. F. C., Moojen, W. A., & Broekman, M. L. D. (2017) · Journal of the American College of Surgeons · doi:10.1016/j.jamcollsurg.2017.07.1068 · Cited by 15 · see citing works
Morain, S. R., Tambor, E. S., Moloney, R., KASS, N. E., Tunis, S., Hallez, K., & Faden, R. (2017) · Learning Health Systems · doi:10.1002/lrh2.10047 · Cited by 15 · see citing works
Self-citationKaye, D. K. (2019) · BMC Pediatrics · doi:10.1186/s12887-019-1600-x · Cited by 15 · see citing works
Patient Experiences, Trust, and Preferences for Health Data Sharing
Jones, R. D., Krenz, C. D., Griffith, K. A., Spence, R., Bradbury, A. R., Vries, R. G. D., Hawley, S. T., Zon, R. T., Bolte, S., Sadeghi, N., et al. (2021) · JCO Oncology Practice · doi:10.1200/op.21.00491 · Cited by 14 · see citing works
Bromley, E., Mendoza-Graf, A., Berry, S., Nebeker, C., & Khodyakov, D. (2020) · The Journal of Law Medicine & Ethics · doi:10.1177/1073110520917007 · Cited by 14 · see citing works
Lin, L. Y., Jochym, N., & Merz, J. F. (2021) · Contemporary Clinical Trials · doi:10.1016/j.cct.2021.106361 · Cited by 14 · see citing works
Siriwardana, A. N., Smyth, B. J., & Jardine, M. (2025) · BMJ Open · doi:10.1136/bmjopen-2024-091896 · Cited by 13 · see citing works
Closing the evidence gap in infectious disease: point-of-care randomization and informed consent
Huttner, A. C., Leibovici, L., Theuretzbacher, U., Huttner, B. D., & Paul, M. (2016) · Clinical Microbiology and Infection · doi:10.1016/j.cmi.2016.07.029 · Cited by 13 · see citing works
Transparency and choice in learning healthcare systems
Botkin, J. R. (2017) · Learning Health Systems · doi:10.1002/lrh2.10049 · Cited by 13 · see citing works
Consumer Perceptions of Eco-Friendly Products
Isaacs, S. M. (2015) · ScholarWorks (Walden University) · Cited by 13 · see citing works
Optimizing patient recruitment into clinical trials of antimicrobial-resistant pathogens
Paul, M., Dishon‐Benattar, Y., Dickstein, Y., & Yahav, D. (2022) · JAC-Antimicrobial Resistance · doi:10.1093/jacamr/dlad005 · Cited by 12 · see citing works
Public preferences on written informed consent for low‐risk pragmatic clinical trials in Spain
Dal‐Ré, R., Carcas, A. J., Carné, X., & Wendler, D. S. (2017) · British Journal of Clinical Pharmacology · doi:10.1111/bcp.13305 · Cited by 12 · see citing works
Understanding preferences regarding consent for pragmatic trials in acute care
Dickert, N. W., Wendler, D. S., Devireddy, C. M., Goldkind, S. F., Ko, Y., Speight, C. D., & Kim, S. Y. H. (2018) · Clinical Trials · doi:10.1177/1740774518801007 · Cited by 12 · see citing works
Rogers, A., Flynn, R., Mackenzie, I. S., & MacDonald, T. M. (2019) · BMC Medical Research Methodology · doi:10.1186/s12874-019-0663-6 · Cited by 12 · see citing works
High-Impact RCTs without Prospective Informed Consent: A Systematic Review
Dhamanaskar, R., & Merz, J. F. (2020) · Journal of Investigative Medicine · doi:10.1136/jim-2020-001481 · Cited by 14 · see citing works
- Authors
- Faden, R. R., Beauchamp, T. L., & Kass, N. E.
- Affiliations
- Johns Hopkins University (US)
- Georgetown University (US)
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2014-02-20
- Volume
- 370
- Issue
- 8
- Pages
- 766-768
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2022826022
- Cited by
- 214
- References
- 5
- Citations by year
- 2026: 8 · 2025: 9 · 2024: 12 · 2023: 5 · 2022: 15 · 2021: 11 · 2020: 15 · 2019: 20 · 2018: 17 · 2017: 20 · 2016: 20 · 2015: 39 · 2014: 21
- FWCI
- 33.02
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- 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 › Medicine › Physiology › Biomedical Ethics and Regulation
- Keywords
- informed consent, comparative effectiveness research, clinical trials, ethical oversight, patient consent, research ethics
- MeSH terms
- Delivery of Health Care, Humans, Informed Consent, Patient Participation, Randomized Controlled Trials as Topic, Ethics, Research, Comparative Effectiveness Research
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.
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