Impact of Donor-Imposed Requirements and Restrictions on Standard of Care in Microbicide Trials Sean Philpott, PhD, MSBioethics Policy and Ethics Officer Microbicides 2008 New Delhi, India

Acknowledgments Lori Heise. Kathy Shapiro. Katie West. Trial network and research site staff.

Standard of Care In 2006, GCM began an exercise to map the standards of care being provided in ongoing trials. As part of this exercise, we looked at the impact of donor-imposed requirements and restrictions on study design and execution.

Questions Asked Do donors have policies related to standard of care or access to treatment in the context of HIV prevention research? To what extent do donor-imposed requirements or restrictions affect care-related decisions at microbicide trial sites?

Donor-Imposed Requirements and Restrictions There are no donor policies that establish a minimum level of prevention and care that should be provided to research participants. Most requirements and restrictions are interpreted and enforced in ways that limit provision of care at trial sites.

Types of Restrictions Barriers to enrolling sex workers. Condom promotion restrictions. Abortion- and family planning- related restrictions. Ancillary care restrictions. Capacity-building restrictions.

Anti-Prostitution Clause Under the Global AIDS Act of 2003, in order to receive AIDS funds from the US, all grantees must: –Explicitly oppose prostitution and sex trafficking; and –Agree to not promote or advocate for the legalisation of sex work.

Anti-Prostitution Clause (2) Evidence suggests the clause makes it difficult to establish the necessary trust to recruit particular vulnerable groups. For one organization conducting a trial in South Africa, signing the clause sparked debate as South Africa is considering legalisation of sex work.

Abortion Counseling and Services USAID and other US Federal Agencies have restrictions on the use of funds for abortion services, including counseling. The Mexico City Policy restricts any organization that receives USAID funding from engaging in abortion-related activities.

Abortion Counseling and Services (2) Many investigators and staff remain unclear as to whether or not HIV prevention research funded by the US is exempt from the Mexico City policy. At most trial sites, discussions of abortion services often are limited by real or perceived restrictions.

Non-Trial-Related Care Provision of ancillary care is a morally-praiseworthy way of improving participant retention and increasing participant benefit. Many donors, such as the NIH, have policies and procedures that restrict or prevent the use of funds to provide ancillary care.

Non-Trial-Related Care (2) These restrictions, coupled with concerns about burdening staff, prevent trials from offering ancillary care services openly. At most sites, some degree of ancillary care is provided – often informally and “under the table.”

Recommendations Donors should develop funding policies that are clear, objective, and enable researchers to ratchet up standard of care in a sustainable manner. Donors should provide resources for non-trial related services, to increase participant retention and to improve the local standard of care.