A comparison of institutional review board professionals’ and patients’ views on consent for research on medical practices
- 1 June 2016
- journal article
- research article
- Published by SAGE Publications in Clinical Trials
- Vol. 13 (5), 555-565
- https://doi.org/10.1177/1740774516648907
Abstract
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.This publication has 29 references indexed in Scilit:
- What should be disclosed to research participants?American Journal of Bioethics, 2013
- Engaging African-Americans about biobanks and the return of research resultsJournal of Community Genetics, 2012
- Biobank participation and returning research results: Perspectives from a deliberative engagement in South Side ChicagoAmerican Journal of Medical Genetics Part A, 2012
- Ethical and practical challenges of sharing data from genome-wide association studies: The eMERGE Consortium experienceGenome Research, 2011
- Genomic research and wide data sharing: Views of prospective participantsGenetics in Medicine, 2010
- Public and Biobank Participant Attitudes toward Genetic Research Participation and Data SharingPublic Health Genomics, 2010
- Cluster randomized trials to study the comparative effectiveness of therapeutics: stakeholders' concerns and recommendationsPharmacoepidemiology and Drug Safety, 2009
- Patients' Views on Identifiability of Samples and Informed Consent for Genetic ResearchAmerican Journal of Bioethics, 2008
- Patients, privacy and trust: Patients’ willingness to allow researchers to access their medical recordsSocial Science & Medicine (1982), 2007
- Managing Conflicts of Interest in the Conduct of Clinical TrialsJAMA, 2002