The Effect of Electronic Informed Consent Information (EICI) on Residual Newborn Specimen Research

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 choose to store these specimens for several uses including biomedical research. 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 clinical 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. * Hypothesis 1) Women in the Interactive technology group (Group A) and the video group (Group B) will demonstrate higher knowledge at Time 1 and Time 2 about the consent elements and the BioTrust than those who do not receive either EICI tool (Group C). * Hypothesis 2) Women in the EICI groups (Groups A and B) will demonstrate lower decisional conflict at Time 1 and Time 2 toward biobanking than those who do not receive the EICI (Group C). * Hypothesis 3) Women in the EICI groups (Groups A and B) will not differ significantly in their choices about biobanking and attitudes toward NBS and biobank research compared to participants who do not receive EICI tool (Group C).

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Last update posted Sep 30, 2019 · Synced Sep 8, 2026

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