Research Regulation

Checklists to Facilitate Tribal IRB Review and Monitoring of Research

These IRB Reviewer Checklists were developed specifically for use by American Indian Tribal Institutional Review Boards or research review committees charged with the ethical review of research. The checklists are designed to address ethical concerns unique to Tribal Nations and are informed by federal human subjects protections regulations. They are also designed to serve as training tools for board members new to the task of ethical review of research.

We offer several specialized checklists (as opposed to 1 all-inclusive checklist) to allow for a) use of select checklists only when relevant to a project and b) for detailed and comprehensive review of items or topic areas that merit special attention, such as research involving ‘pregnant women and/or fetuses’, or ‘genetics research’.

IRB Reviewer Checklist - Continuation [ for print ] [ electronic ]

IRB Reviewer Checklist - Informed Consent [ for print ] [ electronic ]

IRB Reviewer Checklist - Initial Review [ for print ] [ electronic ]

IRB Reviewer Checklist - Pregnant Women and Fetuses [ for print ] [ electronic ]

IRB Reviewer Checklist - Publications [ for print ] [ electronic ]

CRCAIH Tribal IRB Toolkit

Research Regulation

This toolkit contains practical tools and guidance for starting a Tribal lRB. It is intended to serve as a resource for American Indian Tribal Nations or other Indigenous Nations developing Institutional Review Boards (IRBs) for the ethical review and monitoring of research on Tribal land. Click here to access the toolkit.

TribalIRBToolkit Page 001

Template Investigator Submission Forms for Tribal Institutional Review Boards (IRBs)

Research Regulation

These Template IRB Submission forms were developed specifically for use by American Indian Tribal Institutional Review Boards or Research Review Committees charged with the ethical review of research. These are forms for research investigators to complete and submit to the Tribal IRB or Research Review body. They are informed by both federal human subjects protections regulations and the community protections and research concerns unique to Tribal Nations; including protections for research that does not involve human subjects. They are available in Word format for Tribes to use and customize as needed.

Initial Review Submission Form [ for print ] [ electronic ]

Continuation Submission Form [ for print ] [ electronic ]

Amendment Approval Submission Form [ for print ] [ electronic ]

Project Termination Closeout Form [ for print ] [ electronic ]

Application of Research Protections Standards Regulations

Resource Research Regulation

Fort Peck IRB - The Ceremony of Research

Research Regulation

‘The Ceremony of Research’ project involved a partnership between the Fort Peck Assiniboine & Sioux Tribes and Montana State University. An overarching goal of the project is to “…build the community capacity at the Fort Peck Reservation to design, implement, analyze, translate and disseminate health research relevant to the Fort Peck Tribes.” Several of the specific aims overlap with the CRCAIH aims (Link to information: “Ceremony of Research”).

This video was made at the completion of their project and funding, and includes feedback and commentary from researchers and Tribal partners.

Click here to view the video on YouTube

Glossary: Human Subjects Protections

Resource Research Regulation

Human Research Protections Standards Regulations

Resource Research Regulation

NCAI PRC Research Policy Update

Resource Research Regulation

Research Policy Update Common Rule NIH sIRB Page 1

Tribal Implications of the Revised Common Rule & NIH sIRB Policy

MAIN POINTS
• Two revised policies specify that federally funded researchers are required to follow tribal research laws.
• Tribes can develop laws to ensure research benefits and protections beyond individual protections required in
federal research policies.
• New federal requirements for single IRB review in multi-site studies allow for exemptions when tribal law
requires local review.
• Tribes should review their current laws related to research and consider updates.

Read more

The National Congress of American Indians (NCAI) Policy Research Center

Research Regulation

“The Policy Research Center works collaboratively with a variety of tribes, organizations, and academic institutions to support, conduct, and utilize research in Native communities.”

http://www.ncai.org/initiatives/ncai-policy-research-center