IRB perspectives on the return of individual results from genomic research.

PURPOSE: Return of individual research results from genomic studies is a hotly debated ethical issue in genomic research. However, the perspective of key stakeholders-institutional review board (IRB) professionals-has been missing from this dialogue. This study explores the positions and experiences of IRB members and staff regarding this issue. METHODS: In-depth interviews with 31 IRB professionals at six sites across the United States. RESULTS: IRB professionals agreed that research results should be returned to research participants when results are medically actionable but only if the participants want to know the results. Many respondents expected researchers to address the issue of return of results (ROR) in the IRB application and informed-consent document. Many respondents were not comfortable with their expertise in genomics research and only a few described actual experiences in addressing ROR. Although participants agreed that guidelines would be helpful, most were reticent to develop them in isolation. Even where IRB guidance exists (e.g., Clinical Laboratory Improvement Act (CLIA) lab certification required for return), in practice, the guidance has been overruled to allow ROR (e.g., no CLIA lab performs the assay). CONCLUSION: An IRB-researcher partnership is needed to help inform responsible and feasible institutional approaches to returning research results.

Patient interest in recording family histories of cancer via the Internet.

PURPOSE: This study investigated the interest of mammogram patients in using electronic tools for recording their family histories of cancer (FHC). METHODS: Semistructured interviews were conducted with 65 patients visiting a breast center at a referral hospital in Cleveland, Ohio. RESULTS: Most (n = 40; 62%) respondents expressed interest in using an electronic tool for recording FHC and associated its use with a range of benefits to themselves, their families, and their health care providers. Women who were not interested (n = 25; 38%) in using an electronic tool for recording FHC were concerned about privacy issues, computer proficiency, and giving up the opportunity to provide family history information directly to the health care provider. Interest in using an electronic tool for recording FHC was not significantly associated with age, race, level of education or income, personal or FHC, or Internet access and frequency of use. CONCLUSION: Electronic documentation of FHC was seen as largely desirable. However, clinical services to facilitate systematic family history documentation are likely to require more than one avenue for collecting and communicating this information, as not everyone who wants to provide a FHC to a health care provider is comfortable using the Internet to do so.