IRB Professional Development Series

Institutional Review Boards have been established at the majority of tribal colleges and a significant number established by tribal nations. These 1.5-day professional development sessions are for members of IRBs serving these tribal communities and tribal colleges. These regional sessions provide an overview of the purpose, scope, and mission of IRBs including the requirements that must be met according to Title 45 CFR, Part 46 as administered by the U.S. Department of Health and Human Services. Most specifically, the focus will examine the nuances of research in Indian country and the challenges presented to these IRBs.

Documents and Presentations:

  1. OHRP Decision Charts
    The Office for Human Research Protections (OHRP) provides the following graphic aids as a guide for institutional review boards (IRBs), investigators, and others who decide if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR part 46. OHRP welcomes comment on these decision charts. The charts address decisions on: whether an activity is research that must be reviewed by an IRB, whether the review may be performed by expedited procedures, and whether informed consent or its documentation may be waived.
  2. Protocol for Review of Environmental and Scientific Research Proposals
    This protocol was developed by the Akwesasne Task Force on the Environment Research Advisory Committee.
  3. Resources and Tools for IRBs
    Dr. Deana Around Him presents essential tools and resources for Institutional Review Boards.
  4. A Brief History Resulting in the Need for Regulation
    Dr. William Freeman presents a brief background of research issues and violations that resulted in the need to regulate and protect human subjects with regard to research.
  5. Summary of the Capstone Research Project
    Provided by Dr. William Freeman, this document is in the format of a generic "Summary of a proposed Capstone Project" and not in the format of a formal IRB application.
  6. Excerpts from the application to the IRB
    Provided by Dr. William Freeman, this document includes the Information Sheet/Consent Form and Survey and an updated content of the Summary. This version is more like a full-fledged CBPR/TECR/DMSOA-like project that can be used in your own mock IRB as training as what a good research plan should look like and has only a few omissions from what the fed regs & tribal-based IRBs require.
  7. History of Research Ethics in Native Communities
    Lands of the Anishinaabe and the respective tribal colleges by Dr. William Freeman.