Our parent grant focuses on the intersection of the worlds of non-human animal research and Phase I healthy volunteer clinical trials. This supplement proposes investigating both the effects of policy reform on the ground and the perceptions of researchers and regulatory staff (i.e., IRB and IACUC) about the importance and value of sex as a biological variable. This empirical study will generate key findings about barriers to and opportuni- ties for ensuring that research is inclusive of female organisms and that analyses of drug safety attend to sex differences before drugs are made available on the market. The proposed supplement has 2 primary aims: (1) Determine how Phase I investigators and non-human animal researchers account for sex/gender in their re- search and (2) Determine how IRB and IACUC members understand NIH's sex as a biological variable (SABV) policy. To address these aims, we will conduct 90 interviews with expert informants from Phase I healthy vol- unteer research, animal studies, and bioethics and regulatory perspectives about the key ethical, policy, and translational issues at stake. This includes the addition of 30 interviews beyond the parent grant as well as new interview questions, which will be asked of all 90 participants, about sex as a biological variable.

Public Health Relevance

This supplement to the parent grant will generate important information about how to better promote and implement research that incorporates sex as a biological variable. It will also contribute to the aims of the parent grant by highlighting the need to account for sex and gender in the ethics and policy guidance we craft to better protect healthy volunteers in Phase I trials.

Agency
National Institute of Health (NIH)
Institute
National Institute of General Medical Sciences (NIGMS)
Type
Research Project (R01)
Project #
3R01GM099952-07S1
Application #
9671657
Study Section
Societal and Ethical Issues in Research Study Section (SEIR)
Program Officer
Krasnewich, Donna M
Project Start
2012-09-05
Project End
2021-05-31
Budget Start
2018-06-01
Budget End
2019-05-31
Support Year
7
Fiscal Year
2018
Total Cost
Indirect Cost
Name
University of North Carolina Chapel Hill
Department
Other Health Professions
Type
Schools of Medicine
DUNS #
608195277
City
Chapel Hill
State
NC
Country
United States
Zip Code
27599
Walker, Rebecca L; Fisher, Jill A (2018) Companion Animal Studies: Slipping Through a Research Oversight Gap. Am J Bioeth 18:62-63
McManus, Lisa; Fisher, Jill A (2018) To report or not to report: Exploring healthy volunteers' rationales for disclosing adverse events in Phase I drug trials. AJOB Empir Bioeth 9:82-90
Walker, Rebecca L; Cottingham, Marci D; Fisher, Jill A (2018) Serial Participation and the Ethics of Phase 1 Healthy Volunteer Research. J Med Philos 43:83-114
Williams, Quintin; Fisher, Jill A (2018) Captive to the Clinic: Phase I Clinical Trials as Temporal Total Institutions. Sociol Inq 88:724-748
Fisher, Jill A; McManus, Lisa; Wood, Megan M et al. (2018) Healthy Volunteers' Perceptions of the Benefits of Their Participation in Phase I Clinical Trials. J Empir Res Hum Res Ethics 13:494-510
Cottingham, Marci D; Fisher, Jill A (2017) From fantasy to reality: managing biomedical risk emotions in and through fictional media. Health Risk Soc 19:284-300
Cottingham, Marci D; Fisher, Jill A (2016) Risk and Emotion Among Healthy Volunteers in Clinical Trials. Soc Psychol Q 79:222-242
Edelblute, Heather B; Fisher, Jill A (2015) Using ""clinical trial diaries"" to track patterns of participation for serial healthy volunteers in U.S. phase I studies. J Empir Res Hum Res Ethics 10:65-75
Monahan, Torin; Fisher, Jill A (2015) 'I'm still a hustler': entrepreneurial responses to precarity by participants in phase I clinical trials. Econ Soc 44:545-566