DESCRIPTION (provided by applicant): Obtaining adequate informed consent from potential research participants is a significant challenge for biobank-dependent research. To maintain public trust and support, it is important to establish an informed decision-making process for the collection and use of biospecimens collected within clinical settings. For the majority of all infants born in the US, residual dried blood biospecimens are generated after newborn screening is completed. Some programs have chosen to store these specimens for several uses including biomedical research. For example, the Michigan BioTrust retains and catalogs newborn screening residual biospecimens for use in medical and public health research studies. Identifying ways to improve comprehension about broad consent for future biobank-dependent research is a national priority. Specific Aim 1: Identify the key information items necessary to make an informed decision about broad consent for the retention and future research use of residual biospecimens. Methods include focus groups with new parents to determine key information elements relevant to consent for use of residual biospecimens within the Michigan BioTrust. Additional meetings with IRB personnel within the participating hospitals, health departments and universities will also be conducted to ascertain their expectations and requirements for the consent process. Specific Aim 2: Based on the data collected in Aim 1, create a state-of-the-art electronic informed consent information (EICI) tool for use in the clinicl setting about the retention and use of residual biospecimens. The award-winning Genetic Science Learning Center will develop the professional EICI in Spanish and English. Validation of the EICI will be completed using feedback from both community and scientific advisory boards for the Michigan BioTrust. Specific Aim 3: Evaluate the EICI consent approach by comparing it to: a) traditional consent delivered on an electronic tablet; and b) the current paper-based consent approach. Both Spanish and English speaking parents (n = 630) in the state of Michigan, where informed consent is required for biobank research during postpartum clinical care, will be recruited and randomized to one of three groups. Specific Aim 4: Assess feasibility of the EICI through focus groups and interviews with birthing hospitals and Department of Community Health staff before and after the intervention.

PUBLIC HEALTH RELEVANCE: The informed consent process for the retention and research use of biospecimens acquired through clinical care has serious limitations and may be a barrier to the effective use of biobanks as a resource for research. We will address this national problem within the context of residual newborn screening biospecimens in the Michigan BioTrust. We have not only a legal, but an ethical obligation, to assess novel multi-media approaches to improve the consent process.