Genome-Wide Association Studies (GWAS): NIH Points to Consider for IRBs and Institutions in their Review of Data Submission Plans for Institutional Certifications Under NIH's Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS) 12 November 2007. Accessed 12 May 2008 from: http://grants.nih.gov/grants/gwas/gwas_ptc.pdf
These guidelines go beyond the regulatory requirements of 45 CFR part 46 as outlined by the OHRP's 2004 policy guidance regarding privacy and biobanks (see NOT-OD-05-020 and http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.pdf). In addition to addressing the NIH's recent emphasis on open-access publication in the context of genomic research, this document provides a de facto outline of the many consent, privacy, and disclosure issues in biobank research. Although it is a must read for anyone conducting or reviewing NIH supported GWAS research, it is also an excellent resource to skim when thinking about the ethical issues and risks of benefit sharing and biobank research.