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.
Agenda and Presenter Profiles for the September 27–28, 2018, session.

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. Data and Materials Sharing and Ownership Agreement (DMSOA)—with explanatory footnotes
    Sample DMSOA—clean copy
    These sample DMSOA's were developed by a collaborative effort of Offices of Tribal Attorney of three Tribes, Offices of Sponsored Programs of several research-intensive universities, Tribal Colleges and Universities and their national organization American Indian Higher Education Consortium, Indian Health Boards (tribal-based organizations whose members are representatives chosen by tribes), American Indian Health Consortium of Washington State, and Northwest Indian College and its Institutional Review Board. The document represents a fair and reasonable consensus among the collaborating parties to help ensure research with tribes.