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

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 scare research resources.

Keywords:

• ethics committees
• human subjects research
• institutional review board
• IRB
• research ethics

Acknowledgment

RPAR was developed by Patricia Case, Zita Lazzarini, Joseph Welsh and Scott Burris. The Chinese research team was led by Zhang Youchun and Fu Xiaoxing, and included Yi Jing, Sheng Li, Li Sihong, Guan Ye, Yang Aiying, Wei Lingbo and Mei Shan. Wang Zhengzhi conducted the legal research. We thank Wang Ruotao, chair of the IRB of the China CDC, for his guidance. The Thai research team consisted of Somnaek Chatchawan,Wichulada Matanbun, and Sukanya Isarangkun Na Ayuddhaya. Indrajit Pandey conducted the legal research.

This study was supported by the HIV Prevention Trials Network (HPTN) and sponsored by the National Institute of Allergy and Infectious Diseases, National Institute of Child Health and Human Development, National Institute on Drug Abuse, National Institute of Mental Health, and Office of AIDS Research, of the National Institutes of Health, U.S. Department of Health and Human Services under award #U01 AI046749. Burris' work was also supported by an Investigator Award in Health Policy Research from the Robert Wood Johnson Foundation. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Allergy And Infectious Diseases or the National Institutes of Health or the Robert Wood Johnson Foundation.