References

Research/Clinical Practice Integration/Distinctions

• Faden R, Kass N, Goodman S, Pronovost P, Tunis S, Beauchamp T. An ethics framework for a learning health care system: A departure from traditional research ethics and clinical ethics. Hastings Center Report. 2013; 43: S16-S27.
• Grady C, Wendler D. Making the transition to a learning health care system. Hastings Center Report. 2013; 43: S32-S33.
• Kass N, Faden R, Goodman SN, Pronovost P, Tunis S, Beauchamp TL. The research-treatment distinction: A problematic approach for determining which activities should have ethical oversight. Hastings Center Report. 2013; 43: S1-S15.
• Largent EA, Joffe S, Miller FG. Can research and care be ethically integrated? Hastings Center Report. 2011; 41: 37-46.
• Largent EA, Miller FG, Joffe S. Commentary. A prescription for ethical learning. Hastings Center Report. 2013; 43: S28-S29.
• Menikoff J. Commentary. The unbelievable rightness of being in clinical trials. Hastings Center Report. 2013; 43: S30-S31.
• Platt R, Grossmann C, Selker HP. Commentary. Evaluation as part of operations: Reconciling the common rule and continuous improvement. Hastings Center Report. 2013; 43: S37-S39.

Ethical issues in Clinical Care

• Braddock CH, Edwards KA, Hasenberg NM, Laidley TL, Levinson W. Informed decision making in outpatient practice: Time to get back to basics. Journal of the American Medical Association. 1999; 282: 2313-2320.
• Modi N. How not to reduce uncertainties in care. British Medical Journal. 2013; 346: f3786.

Ethical issues in Clinical Research

• Fortune-Greeley AK, Hardy NC, Lin L, et al. Patient reactions to confidentiality, liability, and financial aspects of informed consent in cardiology research. Circulation: Cardiovascular Quality & Outcomes. 2010; 3: 151-158.
• Gross CP, Krumholz HM, Van Wye G, Emanuel EJ, Wendler D. Does random treatment assignment cause harm to research participants? PLoS Medicine. 2006; 3: 800-808.
• Kirkby HM, Calvert M, McManus RJ, Draper H. Informing potential participants about research: Observational study with an embedded randomized controlled trial. PLOS ONE. 2013; 8: 1-8.
• Kraft SA, Constantine M, Magnus D, Porter KM, Lee SS, Green M, Kass NE, Wilfond BS, Cho MK. A randomized study of multimedia informational aids for research on medical practices: Implications for informed consent. Clin Trials. 2017; 14: 94-102.
• Paris A, Brandt C, Cornu C, Maison P, Thalamas C, Cracowski JL. Informed consent document improvement does not increase patients’ comprehension in biomedical research. British Journal of Clinical Pharmacology. 2009; 69: 231-237.
• Resnik DB, Patrone D, Peddada S. Evaluating the quality of information about alternatives to research participation in oncology consent forms. Contemporary Clinical Trials. 2010; 31: 18-21.
• Shah A, Porter K, Juul S, Wilfond BS. Precluding consent by clinicians who are both the attending and the investigator: an outdated shibboleth? Am J Bioeth. 2015; 15: 80-82.
• Vist GE, Bryant D, Somerville L, Birminghem T, Oxman AD. Outcomes of patients who participate in randomized controlled trials compared to similar patients receiving similar interventions who do not participate. Cochrane Database of Systematic Reviews. 2008; issue 3, art. no. MR000009.
• Wilfond BS, Kraft SA. Attending to the Interrelatedness of the Functions of Consent. Am J Bioeth. 2017; 17: 12-13.

Ethical issues for Research on Medical Practices

• Califf RM, Sugarman J. Exploring the ethical and regulatory issues in pragmatic clinical trials. Clin Trials 2015; 12: 436-441.
• Cho MK, Magnus D, Wilfond BS. Informed Consent for Research on Medical Practices. Ann Intern Med. 2015; 163: 725-726.
• Faden RR, Beauchamp TL, Kass NE. Informed consent, comparative effectiveness, and learning health care. New England Journal of Medicine. 2014; 370: 766-768.
• Feudtner C, Schreiner M, Lantos JD. Risks (and benefits) in comparative effectiveness research trials. New England Journal of Medicine. 2013; 369: 892-894.
• Kass N, Faden R, Tunis S. Addressing low-risk comparative effectiveness research in proposed changes to US federal regulations governing research. Journal of the American Medical Association. 2012; 307: 1589-90.
• Kim SYH, Miller FG. Informed consent for pragmatic trials—the integrated consent model. New England Journal of Medicine. 2014; 370: 769-772.
• Kim SY, Miller FG. Ethical complexities in standard of care randomized trials: a case study of morning versus nighttime dosing of blood pressure drugs. Clin Trials 2015; 12: 557-563.
• Kim SYH, Miller F. Waivers and alterations to consent in pragmatic clinical trials: respecting the principle of respect for persons. IRB: Ethics & Human Research 2016; 38: 1–5.
• Kraft SA, Porter KM, Shah SK, Wilfond BS. Comprehension and Choice Under the Revised Common Rule: Improving Informed Consent by Offering Reasons Why Some Enroll in Research and Others Do Not. Am J Bioeth. 2017; 17: 53-55.
• Kraft SA, Porter K, Wilfond BS, and the Research on Medical Practices Group. Research on Medical Practices and the Patient-Physician Relationship: What Can Regulators Learn from Patients? AMA Journal of Ethics. 2015; 17:1160-1165.
• Lantos JD. U.S. Research Regulations: Do They Reflect the Views of the People They Claim to Protect? Ann Intern Med. 2015 May 19;162(10):690-6.
• Lantos JD, D’Angio C, Magnus D, Patrick-Lake B, Tyson J, and Wilfond B. OHRP’s Dangerous Draft Guidance. Bioethics Forum 12/21/2014
• Lantos JD, Wendler D, Septimus E, et al. Considerations in the evaluation and determination of minimal risk in pragmatic clinical trials. Clin Trials 2015; 12: 485-493.
• Magnus D, Wilfond BS. Research on Medical Practices and the Ethics of Disclosure. Pediatrics 2015; 135:2 208-210.
• Magnus D, Wilfond B. Commentary on Kim Miller. Clin Trials. 2015 Dec; 12(6): 564-6.
• McKinney RE Jr, Beskow LM, Ford DE, et al. Use of altered informed consent in pragmatic clinical research. Clin Trials 2015; 12: 494-502.
• O’Rourke PP, Carrithers J, Patrick-Lake B, et al. Harmonization and streamlining of research oversight for pragmatic clinical trials. Clin Trials 2015; 12: 449-456.
• Platt R, Kass NE, McGraw D. Ethics, regulation, and comparative effectiveness research: time for a change. JAMA 2014; 311: 1497-1498.
• Sugarman J, Califf RM. Ethics and regulatory complexities for pragmatic clinical trials. JAMA 2014; 311: 2381-2382.
• Weiss EM, Joffe S. Promoting informed decision making for comparative effectiveness randomized trials. JAMA Pediatr 2015; 169: 803-804.
• Wendler D. “Targeted” consent for pragmatic clinical trials. J Gen Intern Med 2015; 30: 679-682.
• Whicher DM, Miller JD, Dunham KM, Joffe S. Gatekeepers for pragmatic clinical trials. Clin Trials 2015; 12: 442-448.
• Wilfond BS, Magnus DC. The potential harms and benefits from research on medical practices. Hastings Cent Rep. 2015 May-Jun;45(3):5-6.

The SUPPORT Trial

• Drazen JM, Solomon CG, Greene MF. Informed consent and SUPPORT. New England Journal of Medicine. 2013; 368: 1929-1931.
• Lantos J. and Feudtner C. SUPPORT and the Ethics of Study Implementation: Lessons for Comparative Effectiveness Research from the Trial of Oxygen Therapy for Premature Babies. Hastings Center Report 45, no. 1 (2014): 30-40. DOI: 10.1002/hast.407
• Macklin R, Shepherd L. Informed consent and standard of care: What must be disclosed. American Journal of Bioethics. 2013; 13: 9-13.
• Macklin R, Shepherd L, Dreger A, et al. The OHRP and SUPPORT—another view. New England Journal of Medicine. 2013; 369: e3, 1-3.
• Magnus D, Caplan AL. Risk, consent, and SUPPORT. New England Journal of Medicine. 2013; 368: 1864-1865.
• Rich WD, Auten KJ, Gantz MG, et al. Antenatal consent in the SUPPORT trial: Challenges, costs, and representative enrollment. Pediatrics. 2010; 126: 1-13.
• Wendler D. What should be disclosed to research participants. American Journal of Bioethics. 2013; 13: 3-8.
• Wilfond BS. Quality improvement ethics: Lessons from the SUPPORT study. American Journal of Bioethics. 2013; 13: 14-19.
• Wilfond BS, Magnus D, et al. The OHRP and SUPPORT. New England Journal of Medicine. 2013; 366: e36 1-3.
• U.S. Department of Health & Human Services. Public Meeting: Matters Related to Protection of Human Subjects and Research Considering Standard of Care Interventions. August 28, 2013.

Regulations and Guidance

• US Department of Health and Human Services. Draft guidance on disclosing reasonably foreseeable risks in research evaluating standards of care. October 20, 2014.
• US Department of Health and Human Services. Notice of proposed rulemaking summary. September 8, 2015.

Stakeholder attitudes about Research on Medical Practices

• Anderson ML, Califf RM, Sugarman J; participants in the NIH Health Care Systems Research Collaboratory Cluster Randomized Trial Workshop. Ethical and regulatory issues of pragmatic cluster randomized trials in contemporary health systems. Clin Trials 2015; 12: 276-286.
• Cho MK, Magnus D, Constantine M, Lee SS, Kelley M, Alessi S, et al. Attitudes Toward Risk and Informed Consent for Research on Medical Practices: A Cross-sectional Survey Ann Intern Med. 2015;162(10):731-732.
• Kelley M, James C, Kraft SA, Korngiebel D, Wijangco I, Joffe S, Cho MK, Wilfond B, Lee SS. The Role of Patient Perspectives in Clinical Research Ethics and Policy: Response to Open Peer Commentaries on “Patient Perspectives on the Learning Health System”. Am J Bioeth. 2016; 16: W7-9.
• Kelley M, James C, Alessi Kraft S, Korngiebel D, Wijangco I, Rosenthal E, Joffe S, Cho MK, Wilfond B, Lee SS. Patient Perspectives on the Learning Health System: The Importance of Trust and Shared Decision Making. Am J Bioeth. 2015 Sep;15(9):4-17.
• Kraft SA, Cho MK, Constantine M, Lee SS, Kelley M, Korngiebel D, James C, Kuwana E, Meyer A, Porter K, Diekema D, Capron AM, Alicic R, Wilfond BS, Magnus D. A comparison of institutional review board professionals’ and patients’ views on consent for research on medical practices. Clinical Trials. 2016; 13: 555-565.
• Kraft SA, Porter KM, Korngiebel DM, James C, Constantine M, Kelley M, Capron AM, Diekema D, Lee SS, Cho MK, Magnus D, Wilfond BS. Research on medical practices: Willingness to participate and the investigational misconception. IRB: Ethics and Human Research. 2017; 39: 10-16.
• Lee SS, Kelley M, Cho M, et al. Adrift in the gray zone: IRB perspectives on research in the learning health system. AJOB Empirical Bioeth. 2016: 7.
• Nayak RK, Wendler D, Miller FG, Kim SY. Pragmatic randomized trials without standard informed consent?: a national survey. Ann Intern Med 2015; 163: 356-364.
• Porter K, Cho MK, Kraft SA, Korngiebel DM, Constantine M, Lee SS, Kelley M, James C, Kuwana E, Meyer A, Diekema D, Capron AM, Magnus D, Wilfond BS. Research on medical practices (ROMP): Attitudes of IRB personnel about randomization and informed consent. IRB: Ethics & Human Research. 2017: 39: 10-16.
• Whicher D, Kass N, Faden R. Stakeholders’ views of alternatives to prospective informed consent for minimal-risk pragmatic comparative effectiveness trials. J Law Med Ethics 2015; 43: 397-409.
• Whicher D, Kass N, Saghai Y, et al. The views of quality improvement professionals and comparative effectiveness researchers on ethics, IRBs, and oversight. J Empir Res Hum Res Ethics 2015; 10: 132-144.