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AJOB Primary Research.

Healthy individuals’ perspectives on clinical research protocols and influences on enrollment decisions

Background: Understanding the perspectives of healthy individuals is important ethically and for the advancement of science. We assessed perceptions of risk associated with research procedures, comparing views of healthy individuals with and without experience in clinical research, and the respondents’ reported willingness to volunteer. Methods: Semistructured interviews and written surveys were conducted. Study participants were healthy individuals, half of whom were currently enrolled in clinical research and half of whom had no prior experience in clinical research. Participants were queried regarding seven “minimal risk” or “greater than minimal risk” protocol vignettes with procedures of three types: routine diagnostic tests, more burdensome (i.e., more effort or potential harm) diagnostic tests, and pharmacologic interventions. Views of influences on enrollment decisions were also assessed. Results: Most healthy individuals indicated that protocols with more burdensome or pharmacologic interventions were very risky (59%, 58%), as opposed to routine diagnostic test procedures (32%). Respondents’ willingness to enroll in protocols varied by type of protocol (pvalue < .001) and was inversely correlated with risk assessments (regression coefficients from GEE = −0.4; −0.5; −0.7). The odds of healthy individuals with research experience expressing strong willingness to enroll in the depicted protocols were twice the odds of healthy individuals without research experience expressing the same level of willingness (OR = 2.0 95% CI: [1.1, 3.9]). Respondents did not assign risk categories as institutional review boards (IRBs) would, as indicated by low agreement (26%) between respondent and expert opinion on minimal risk protocols. Conclusions: Perceptions of procedure risk appear to influence healthy individuals’ willingness to enroll in protocols. Participants with experience in clinical research were far more likely to express willingness to enroll, a finding with important scientific and ethical implications. The lack of alignment between healthy individuals’ views of protocol risk and IRB categorization warrants further study.

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Volume 8, Issue 2
April 2017

Target Articles.

Qualitative study of participants' perceptions and preferences regarding research dissemination Rachel S. Purvis, Traci H. Abraham, Christopher R. Long, M. Kathryn Stewart, T. Scott Warmack & Pearl Anna McElfish
Does experience matter? Implications for community consultation for research in emergency settings Victoria M. Scicluna, Mohammed K. Ali, Rebecca D. Pentz, David W. Wright & Neal W. Dickert
When bins blur: Patient perspectives on categories of results from clinical whole genome sequencing Leila Jamal, Jill O. Robinson, Kurt D. Christensen, Jennifer Blumenthal-Barby, Melody J. Slashinski, Denise Lautenbach Perry, Jason L. Vassy, Julia Wycliff, Robert C. Green & Amy L. McGuire
Primary care physicians' views about gatekeeping in clinical research recruitment: A qualitative study Marilys Guillemin, Rosalind McDougall, Dominique Martin, Nina Hallowell, Alison Brookes & Lynn Gillam
Adolescent oncofertility discussions: Recommendations from a systematic literature review Dorit Barlevy, Bernice S. Elger, Tenzin Wangmo & Vardit Ravitsky
The interactions of Canadian ethics consultants with health care managers and governing boards during times of crisis Chris Kaposy, Victor Maddalena, Fern Brunger, Daryl Pullman & Richard Singleton