1. 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. Background: Researchers at Washington University (WU) in St. Louis and the University of Missouri-Columbia (MU) collaborated on a study of quality of life among breast cancer survivors. Cases (women with breast cancer, Missouri residents 25 years of age or older at diagnosis) were identified through the Missouri Cancer Registry (MCR), located at MU. Eligible women were sent a cover letter and “permission to release confidential information” form; they also received, in a sealed envelope, a 2-page HIPAA authorization and 3-page consent form, which explained that participation would entail two 35-45 minute interviews (the first occurring1-year post diagnosis (T1) and the second, a year later (T2)); upon completion of each interview, they would receive a gift card for $10 (T1) or $15 (T2). WU’s Institutional Review Board (IRB) classified the study as “minimal risk.” MU’s Health Sciences IRB classified the study as “high risk.” Since all T1 cases and controls were to be interviewed at MU, as a high-risk study all women with breast cancer had to sign all three forms, rather than only the statutorily-required permission form. Obtaining verbal consent and HIPAA authorization was not an option. Controls (women without any type of reportable cancer and matched by age group, county of residence and race (in three metropolitan areas), identified through random-digit-dialing (RDD), could be verbally consented at the start of the interview. Controls received the same T1 and T2 gift-card compensation as cases. Conclusions: Some target populations (older women, African- American women and inner-city women) were under-represented. Classification as a high-risk study and lack of accurate addresses for cases negatively impacted participation of women with breast cancer. Discussion: Central cancer registries (CCRs) that have primarily focused on public health surveillance may encounter unexpected challenges when they try to incorporate research involving contact with patients in their activities. Two major barriers encountered in this project were lack of an accurate current address for cases and IRB classification as a high-risk project which meant all cases had to sign and return three documents rather than a single-page form. These barriers significantly raised costs and lowered the response rate for women with breast cancer. By entering into a business associate agreement with an authorized post office, a CCR can obtain and verify current addresses. To be effective, this must be done on a regular basis. Investigators should discuss behavioral research projects involving cancer patients with IRB staff prior to submitting an IRB application. There needs to be an understanding between the investigator and the IRB about potential risk to participants. Methods: A Certified Tumor Registrar identified potentially eligible cases in the database. The research team sent a cover letter and two copies of each form to each woman. If all three signed forms were returned, contact information was provided to interviewers. RDD was used to identify and interview matched controls. MCR is supported in part by a cooperative agreement between the CDC and the Missouri Department of Health and Senior Services (DHSS) (#U58/DP000820-03) and a Surveillance Contract between DHSS and the University of Missouri. This project was supported by a contract between Washington University in St. Louis and the University of Missouri. Results: From June 2007 through May 2009, 4,171 women with primary breast cancer potentially met eligibility criteria. Of these, 151 were excluded due to death, illness/disability or inability to speak English; thus, 3,070 women possibly met eligibility criteria. 30% (N = 1,200) signed all 3 forms 40% (N = 1,727) refused to participate If 323 women with whom no contact was made are excluded, 3,697 would meet eligibility criteria, increasing participation to 32% (N = 1,200) and refusal to 44% (N = 1,727). Of the 1,200 consented cases, 1,164 completed the T1 interview. 27% (319) of interviewed cases were age 25-49 compared with 13% (216) of eligible women who refused. 44% (527) of interviewed cases were age 50-64 compared with 35% (574) of eligible women who refused. 29% (348) of interviewed cases were age 65 or older compared with 52% (837) of eligible women who refused. Of the 1,164 cases interviewed at T1, 6% (71) were African American compared with 11% of eligible women who were not interviewed and 9% of eligible women who were not interviewed but could be contacted. The CASRO response rate for controls at T1 was 69% (N = 1,965). How can we make it easier for women with cancer to participate in research while protecting human subjects? J. Jackson-Thompson, MSPH, PhD 1,2, S. Culter, BSN, RN, PhD 1,2,, C. Schmaltz, MA 1,3, Y. Liang, MA 1,3 University of Missouri-Columbia 1 Missouri Cancer Registry, 2 Department of Health Management & Informatics, 3 Department of Statistics