Native Hawaiian preferences for informed consent and disclosure of results from genetic research.

BACKGROUND: Informed consent is generally waived when using anonymous stored specimens in research because individual harm is minimal; however, group harm may arise if specimens contain ethnic identifiers. METHODS: We assessed preferences for informed consent and disclosure of results from genetic research through a survey (N = 429, 83.2% Native Hawaiian). RESULTS: Native Hawaiians were more likely than non-Hawaiians to require informed consent for genetic research using personally identified (81% vs 77.8%), anonymous (40.9% vs 34.7%), and ethnically identified specimens (51.3% vs 33.3%). Most respondents wanted results reported to them (87.6%) and to their physicians (79.0%). CONCLUSIONS: Recognizing community preferences for informed consent and disclosure of research results may alleviate concerns about group harms inherent in genetic research.

Native Hawaiian preferences for informed consent and disclosure of results from research using stored biological specimens.

Increasingly, genetic and biomedical researchers are developing protocols to reexamine human tissue specimens that were obtained and stored during clinical care or previous research studies. Although some communities and associations are developing guidelines for human-tissue research, guideline development rarely considers consumer preferences for informed consent and disclosure of results. This study, examining Native Hawaiian preferences for informed consent and disclosure of results (n = 429, 83.2% Native Hawaiian), was modeled after a national study of consumer preferences, allowing comparison between the national sample and the Hawai'i-based sample. The interview schedule included two scenarios on research requiring the re-use of clinically derived and research-derived biological specimens. For each, participants were asked if informed consent should be required: a) in general; b) if the specimen was personally identified; and c) if the specimen was de-identified, or anonymized. Participants were also asked if they would want to know the results of the research and if they would want their doctor to be told. Regardless of how specimens were obtained, 78% of Native Hawaiians would want to be asked for their consent for the re-use of identified specimens and about 35% would want to be consented for the re-use of anonymized specimens. In both cases, Native Hawaiians in the Hawai'i sample were more likely than Whites in the national sample to want an informed consent process. Similar proportions in both samples would want findings from research on stored specimens reported to them (about 90%) and to their physicians (about 80%). These findings call into question the "Common Rule" and the guidelines of the American Society of Human Genetics, which do not require researchers to obtain informed consent for research use of anonymized specimens.