AJOB Primary Research.

To report or not to report: Exploring healthy volunteers’ rationales for disclosing adverse events in Phase I drug trials

Background: Phase I trials test the safety and tolerability of investigational drugs and often use healthy volunteers as research participants. Adverse events (AEs) are collected in part through participants’ self-reports of any symptoms they experience during the trial. In some cases, experiencing AEs can result in trial participation being terminated. Because of the economic incentives underlying their motivation to participate, there is concern that healthy volunteers routinely fail to report AEs and thereby jeopardize the validity of the trial results. Methods: We interviewed 131 U.S. healthy volunteers about their experiences with AEs, including their rationales for reporting or failing to report symptoms. Results: We found that participants have three primary rationales for their AE reporting behavior: economic, health-oriented, and data integrity. Participants often make decisions about whether to report AEs on a case-by-case basis, evaluating what effects reporting or not reporting might have on the compensation they receive from the trial, the risk to their health, and the results of the particular clinical trial. Participants’ interpretations of clinic policies, staff behaviors, and personal or vicarious experiences with reporting AEs also shape reporting decisions. Conclusions: Our findings demonstrate that participants’ reporting behavior is more complex than previous portraits of healthy volunteers have suggested. Rather than finding participants who were so focused on the financial compensation that they were willing to subvert trial results, our study indicates that participants are willing in most cases to forgo their full compensation if they believe not reporting their symptoms jeopardizes their own safety or the validity of the research.

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Volume 9, Issue 2
June 2018

Target Articles.

Undisclosed conflicts of interest among biomedical textbook authors Brian J. Piper, Drew A. Lambert, Ryan C. Keefe, Phoebe U. Smukler, Nicolas A. Selemon & Zachary R. Duperry
An empirical assessment of the short-term impacts of a reading of Deborah Zoe Laufer's drama Informed Consent on attitudes and intentions to participate in genetic research Erin Rothwell, Jeffrey R. Botkin, Sydney Cheek-O'Donnell, Bob Wong, Gretchen A. Case, Erin Johnson, Trent Matheson, Alena Wilson, Nicole R. Robinson, Jared Rawlings, Brooke Horejsi, Ana Maria Lopez & Carrie L. Byington
Patient perspectives on compensation for biospecimen donation Samuel C. Allen, Minisha Lohani, Kristopher A. Hendershot, Travis R. Deal, Taylor White, Margie D. Dixon & Rebecca D. Pentz
How acceptable is paternalism? A survey-based study of clinician and nonclinician opinions on paternalistic decision making Kunal Bailoor, Thomas Valley, Chithra Perumalswami, Andrew G. Shuman, Raymond DeVries & Darin B. Zahuranec
Cross-cultural perspectives on decision making regarding noninvasive prenatal testing: A comparative study of Lebanon and Quebec Hazar Haidar, Meredith Vanstone, Anne-Marie Laberge, Gilles Bibeau, Labib Ghulmiyyah & Vardit Ravitsky