A comparison of institutional review board professionals' and patients' views on consent for research on medical practices.

BACKGROUND/AIMS: In the context of research on medical practices, which includes comparative effectiveness research and pragmatic clinical trials, empirical studies have begun to raise questions about the extent to which institutional review boards' interpretations and applications of research regulations align with patients' values. To better understand the similarities and differences between these stakeholder groups, we compare and contrast two surveys: one of institutional review board professionals and one of patients, which examine views on consent for research on medical practices. METHODS: We conducted online surveys of two target populations between July 2014 and March 2015. We surveyed 601 human subjects research professionals out of 1500 randomly selected from the Public Responsibility in Medicine and Research membership list (40.1% response rate), limiting analysis to 537 respondents who reported having had institutional review board experience. We also surveyed 120 adult patients out of 225 approached at subspecialty clinics in Spokane, Washington (53.3% response rate). Our survey questions probed attitudes about consent in the context of research on medical practices using medical record review and randomization. The patient survey included three embedded animated videos to explain these concepts. RESULTS: A majority of institutional review board professionals distinguished between consent preferences for medical record review and randomization, ranked clinicians as the least preferred person to obtain participant consent (54.6%), and viewed written or verbal permission as the minimum acceptable consent approach for research on medical practices using randomization (87.3%). In contrast, most patients had similar consent preferences for research on medical practices using randomization and medical record review, most preferred to have consent conversations with their doctors rather than with researchers for studies using randomization (72.6%) and medical record review (67.0%), and only a few preferred to see research involving randomization (16.8%) or medical record review (13.8%) not take place if obtaining written or verbal permission would make the research too difficult to conduct. Limitations of our post hoc analysis include differences in framing, structure, and language between the two surveys and possible response bias. CONCLUSION: Our findings highlight a need to identify appropriate ways to integrate patient preferences into prevailing regulatory interpretations as institutional review boards increasingly apply research regulations in the context of research on medical practices. Dialogue between institutional review boards and research participants will be an important part of this process and should inform future regulatory guidance.

Attitudes Toward Risk and Informed Consent for Research on Medical Practices: A Cross-sectional Survey.

BACKGROUND: The U.S. Office for Human Research Protections has proposed that end points of randomized trials comparing the effectiveness of standard medical practices are risks of research that would require disclosure and written informed consent, but data are lacking on the views of potential participants. OBJECTIVE: To assess attitudes of U.S. adults about risks and preferences for notification and consent for research on medical practices. DESIGN: Cross-sectional survey conducted in August 2014. SETTING: Web-based questionnaire. PATIENTS: 1095 U.S. adults sampled from an online panel (n = 805) and an online convenience river sample (n = 290). MEASUREMENTS: Attitudes toward risk, informed consent, and willingness to participate in 3 research scenarios involving medical record review and randomization of usual medical practices. RESULTS: 97% of respondents agreed that health systems should evaluate standard treatments. Most wanted to be asked for permission to participate in each of 3 scenarios (range, 75.2% to 80.4%), even if it involved only medical record review, but most would accept nonwritten (oral) permission or general notification if obtaining written permission would make the research too difficult to conduct (range, 70.2% to 82.7%). Most perceived additional risk from each scenario (range, 64.0% to 81.6%). LIMITATION: Use of hypothetical scenarios and a nonprobability sample that was not fully representative of the U.S. population. CONCLUSION: Most respondents preferred to be asked for permission to participate in observational and randomized research evaluating usual medical practices, but they are willing to accept less elaborate approaches than written consent if research would otherwise be impracticable. These attitudes are not aligned with proposed regulatory guidance. PRIMARY FUNDING SOURCE: National Center for Advancing Translational Sciences at the National Institutes of Health.

Conflicts of Interest and Distribution of Resources to Community Partners: An Organizational Ethics Dilemma.

BACKGROUND: Conflicts of interest can arise when faculty and staff administer programs that distribute research funds, training opportunities, and other resources across academic and community partners. We describe the ethical concerns encountered by a Clinical Translational Science Award (CTSA) program in administering its community-focused pilot grant program and how its Research Bioethics Consultation service helped to address them.Ethical Concerns: CTSA program faculty and staff identified ethical concerns in several areas, including appropriateness of including Regional Research Collaborations (RRC) faculty as principal or co-investigators on applications, determining how much help RRC faculty and staff should provide to prospective applicants, and creating a fair and effective application review process. DISCUSSION: The CTSA program identified common goals and values for its community-focused pilot grant program, and resolved the conflicts of interest with the new pilot grant policies. This approach could generalize to conflicts of interest that arise in other academic-community partnerships.