Men's decisions, women's lives: How we can make it easier for women to participate in research and still protect human subjects

Background: Researchers at two universities collaborated on a study of quality of life among breast cancer survivors. Cases, identified through a state cancer registry, were contacted and consented by mail and interviewed by phone 1 year post-diagnosis (T1). Controls, matched by age group, county of residence and race (3 areas) were contacted through random-digit-dialing, consented by phone and interviewed simultaneously. Both groups were re-interviewed 1 year later (T2). One institutional Review Board (IRB) classified the study as “minimal risk.” The IRB at the institution conducting interviews classified it as “high risk”: all cases had to sign 3 forms (permission to release confidential information, informed consent and HIPAA authorization).

Purpose: To: 1) examine participation of target groups (older women, inner city and rural women; African-American women); and 2) assess impact of the “high risk” classification on participation.

Methods: A Certified Tumor Registrar identified potentially eligible cases in the database. The research team sent a cover letter and 2 copies of each form to each woman. If all 3 signed forms were returned, contact information was provided to interviewers.

Results: From June 2007 to January 2009, 3,944 women met eligibility criteria. Of these, 157 were excluded due to death, disability or inability to speak English. Less than 40% of eligible cases were interviewed at T1; nearly 90% of T1 cases were re-interviewed at T2. Enrollment percentages for target groups and reasons for non- participation will be presented.

Conclusions: Some target populations were under-represented. Classification as a high-risk study negatively impacted participation.