-
NIH Sep 26, 2009 | RC1
Informed Consent and Data Access Issues in State-based Biobanks
Institution: UNIVERSITY OF MICHIGAN AT ANN ARBOR
FOA Number: RFA-OD-09-003
Abstract
The ethical, legal, and social issues (ELSI) underlying the development and implementation of state-sponsored birth cohort studies and their accompanying biobanks are complex and potentially volatile. Michigan and other states, such as Connecticut and California, are in the midst of investigating and deliberating on how to set up biobanks and there is a pressing need for practical ELSI research and guidelines for these historic initiatives. Consequently, to facilitate the development of state-sponsored population birth cohort databases for a wide range of studies, including genetics, research is urgently needed to address how recruitment, informed consent, and data access issues are affected by community members' hopes, expectations, and anxieties about research use of new born blood spots. Our proposal specifically addresses the Challenge Area 02-HG- 101* Informed consent and data access policies. We propose the following specific aims to investigate whether a method of ameliorating these concerns through a new health information technology adequately addresses community member's needs. Aim 1: To develop and test a multi-leveled participant-centric informed consent, privacy, and data access educational system and protocol that utilizes an already existing on-line health information technology system called Private Access. Aim 2: To evaluate the impact of participant-driven levels of informed consent and data access on potential recruitment into studies (e.g. the Michigan Neonatal Biobank) using both in-person 'Town Hall" meetings and on-line testing in 15 diverse Michigan communities in five geographical locations. Specifically, we will examine how demographics, types of research, and types of researcher (government, academic, private company), consent options, types of privacy control, and data access options affected community leaders and participants knowledge, attitudes, and consent to participate in a large birth cohort and biobanking effort in the state of Michigan.
FUNDING AGENCY:
Funder:
NIHInstitute:
NATIONAL HUMAN GENOME RESEARCH INSTITUTEFunding Type:
RC1Project Number:
RC1HG005439Start Date:
Sep 26, 2009End Date:
Jul 31, 2011PROJECT TERMS:
Adult, Affect, Anxiety, Area, Attitude, Back, base, biobank, Bioethics, Birth, Blood, Blood specimen, California, cohort, Cohort Studies, Communities, Complex, Computerized Medical Record, Connecticut, Consent, Data, Databases, Democracy, demographics, Development, Diagnosis, Disease, Disease Outcome, Environmental Exposure, Epidemiology, ethical legal social implication, expectation, Exposure to, gene environment interaction, Genetic, Genetic Research, Genomics, Geographic Locations, Government, Guidelines, Health, Health Care Costs, health information technology, Health Status, Infectious Agent, Information Systems, Informed Consent, Knowledge, Life, Measures, Medical Records, meetings, member, Methods, Michigan, Names, Neonatal, Neonatal Screening, Newborn Infant, Nutritional, Onset of illness, Outcome, Participant, Persons, Policies, Population, population based, population health, Privacy, Process, Proteins, Protocols documentation, Research, Research Design, Research Infrastructure, Research Personnel, Resources, Running, Selection Bias, Spottings, Staging, System, Test Result, Testing, Toxin, trait, Variant
Skip to main content
