225619 Benefit-sharing arrangements and material transfer agreements: Two tools to reduce exploitation in international collaborative research

Monday, November 8, 2010 : 12:48 PM - 1:06 PM

Emily Rugel, MPH , National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health (NIH), Bethesda, MD
Public health research collaborations involving institutions from developed and developing countries risk exacerbating existing social injustices. In such collaborations, researchers from developed countries are often perceived as selecting the focus, determining authorship and credit, and controlling access to data and samples. As a result, international collaborative research (ICR) may be unresponsive to host community needs and fail to develop local research capacity. Moreover, developing-nation researchers may have less freedom to pursue projects that align with their individual interests and feel compelled to enter into collaborations on unfavorable terms. A comprehensive review of guidelines governing ICR, including those issued by CIOMS and the Medical Research Council of the UK, showed that while many address responsiveness, few discuss broader equity and social justice issues. Attempts to integrate benefit-sharing arrangements an accepted framework for ensuring that the burdens and gains from research are fairly distributed have also met with resistance, as demonstrated by the ongoing debate among members of the World Health Organization's Global Influenza Surveillance Network. We propose further operationalizing benefit-sharing by incorporating plans for access to pooled samples, data-sharing, authorship, and patenting into the material transfer agreements (MTAs) already in wide use. In addition, we outline substantive and procedural criteria for ensuring MTAs are fair. Incorporating these elements into MTAs would reduce the potential for exploitation. Because such agreements are created on a project-by-project basis, this represents a grassroots, easily implementable solution to achieve at least one measure of social justice in ICR.

Learning Areas:
Ethics, professional and legal requirements
Public health or related laws, regulations, standards, or guidelines
Public health or related research

Learning Objectives:
1. Describe the factors that increase the potential for exploitation in externally sponsored research efforts conducted in low- and middle-income countries. 2. Discuss current guidelines and conventions governing international collaborative research. 3. Explain the proposed framework for operationalizing benefit-sharing arrangements in the context of material transfer agreements.

Keywords: Ethics, International Health

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I am qualified to present because I am a Presidential Management Fellow who explored ethical issues related to international collaborative research while working in the Department of Bioethics at the NIH Clinical Center.
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.