Assessing Social Risks Prior to Commencement of a Clinical Trial: Due Diligence or Ethical Inflation?

The American Journal of Bioethics, Vol. 9, No, 1, pp. 48-54, 2009

Temple Law School Working Paper

11 Pages Posted: 4 Dec 2009 Last revised: 11 Feb 2014

See all articles by Corey S. Davis

Corey S. Davis

Network for Public Health Law

Scott Burris

Center for Public Health Law Research, Temple University - James E. Beasley School of Law

Date Written: December 2, 2009

Abstract

Assessing social risks has proven difficult for IRBs. We undertook a novel effort to empirically investigate social risks before an HIV prevention trial among drug users in Thailand and China. The assessment investigated whether law, policies and enforcement strategies would place research subjects at significantly elevated risk of arrest, incarceration, physical harm, breach of confidentiality, or loss of access to health care relative to drug users not participating in the research. The study validated the investigator’s concern that drug users were subject to serious social risks in the site localities, but also suggested that participation in research posed little or no marginal increase in risk and might even have a protective effect. Our experience shows that it is feasible to inform IRB deliberations with actual data on social risks, but also raises the question of whether and when such research is an appropriate use of scarce research resources.

Keywords: human subject research, social risks, IRB, research ethics, injection drug use, HIV, HPTN

Suggested Citation

Davis, Corey S. and Burris, Scott C., Assessing Social Risks Prior to Commencement of a Clinical Trial: Due Diligence or Ethical Inflation? (December 2, 2009). The American Journal of Bioethics, Vol. 9, No, 1, pp. 48-54, 2009. Available at SSRN: https://ssrn.com/abstract=1517306

Corey S. Davis

Network for Public Health Law ( email )

Saint Paul, MN
United States

Scott C. Burris (Contact Author)

Center for Public Health Law Research, Temple University - James E. Beasley School of Law ( email )

1719 N. Broad Street
Philadelphia, PA 19122
United States
215-204-6576 (Phone)
215-204-1185 (Fax)

HOME PAGE: http://www.phlr.org

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