Are there benefits to volunteering for clinical trials?

• Patients may gain access to new treatments not yet available to the general public.
• Patients receive expert study-related medical care from Vanderbilt University's Infectious Diseases Department specialists.
• There are no costs for study drugs, study-related clinic visits, examinations, or laboratory tests associated with the study.
• Patients have the opportunity to help others who are infected with HIV by contributing to HIV/AIDS medical research.

Are there risks of participation?

• It is possible that investigational drugs may not have the clinical benefits expected.
• New drugs may have unpredicted side effects.
• Studies may require additional demands on patients' time and frequent trips to the clinic for routine study visits.
• For most studies, the study protocol (rules) requires participants to share similar medical status. Therefore, not everyone interested in a specific study will be eligible.

What about confidentiality?

The ACTC clinical care team is sensitive to the privacy concerns of participants. Every effort is made to insure that records are protected. In all study records a numerical code (patient identifier or "PID") is assigned to each participant. Actual names do not appear on the study records. The patient roster, which connects a name to a PID, is kept in a secured confidential binder.

How is participant safety protected?

All clinical trials are reviewed by the Food and Drug Aministration (FDA) and by Vanderbilt's Institutional Review Board (IRB). IRBs are independent committees whose job is to make sure participants' rights are fully protected and that volunteers are not exposed to any unnecessary risks.