The Portland Area Indian Health Service (IHS) Institutional Review Board has the responsibility to review, and the authority to approve or disapprove, all research activities that use IHS facilities, data, staff resources, or funding in the Portland Area, moreover, they retain the same responsibility to previously approved activities.
The IRBs review research proposals to assess the risks and benefits for the Portland Area American Indian and Alaska Native population and tribes to be studied. Each proposal is reviewed using criteria described in the Office for Human Research Protections (OHRP; formerly Office for Protection from Research Risk), Protection of Human Subjects, Title 45, Code of Federal Regulations (CFR), Part 46, 1991. The research proposals are reviewed for safety, confidentiality (information about individuals is not released to anyone), degree of benefit, and the need for and quality of informed consent.
The Portland Area IHS IRB is one of 12 IRBs under the Indian Health Service Research Program. The IHS Research Program located in Rockville, MD, houses the National IHS IRB which oversees Area IRBs and serves as the IRB of record for those areas without their own Area IRB. Their website (http://www.ihs.gov/Research/index.cfm?module=hrpp_about) has many reference materials; including sample consent forms and IRB review checklists.
Researcher’s Responsibilities…
Review IRB research guidelines to ensure compliance.
Evaluate requirements of funding agency regarding IRB review.
Review IRB protocols to determine if you are eligible for exemption or expedited review.
Submit proposal to the Portland Area IHS IRB.
Submit progress reports and renewal requests annually.
Obtain IRB approval for all manuscripts prior to submission for publication and all presentations once accepted, at least 2 weeks prior to the scheduled date of presentation.
Goals
- Portland Area IHS IRB reviews research proposals to assess the individual and community-level risks and benefits for the Portland Area American Indian and Alaska Native (AI/AN) population and tribes who have voluntarily agreed to participate in research projects.
- Review each proposal using criteria described in the Office of Human Research Protections (OHRP), Protection of Human Subjects, Title 45 Code of Federal Regulations (CFR), Part 46, 1991.
- Provide educational and networking opportunities for the IRB committee members.
- Improve the timeliness and quality of protocol reviews.
History
Mission:
The mission of the Portland Area Indian Health Service Institutional Review Board is to protect American Indian and Alaska Native (AI/AN) population and tribes involved in research programs, by reviewing all research activities that use IHS facilities, data, staff resources, or funding.
Data/Statistics
The Portland Area Indian Health Service Institutional Review Board serves the 43 federally recognized tribes in Idaho, Oregon, and Washington.
Data Improvement
Strategies:
- Convene monthly meetings at which submitted protocols are reviewed by the IRB committee for safety, confidentiality, degree of benefit, and the need for and quality of informed consent.
- Provide comment and direction for each submission to ensure compliance with OHRP and the National Indian Health Service Institutional Review Board
- Distribute informational materials for researches regarding research ethics in general and research considerations specifically involving AI/AN populations.
- Provide feedback on the timeliness of IRB reviews, develop procedures to make the review process more efficient, ensure that IRB members have access to training materials and other educational opportunities.
Resource Links and Reports
Guidelines and Information for Researchers…
Guidelines for Researchers, including researcher responsibilities, components of the research proposal, working with tribes and IHS, and a flowchart of the Portland Area IHS IRB (PDF)
Developing a Protocol (PDF)
Sample Research Protocol (PDF)
Sample Protocol Submission Letter to the Portland Area IHS IRB (PDF)
Sample Institution IRB Approval (PDF)
Sample IHS Service Unit Letter of Support (PDF)
Sample Tribal Business Council Resolution (PDF)
Sample Consent Forms (PDF)
IHS IRB Checklist (PDF)
IHS IRB Status Report and Annual Renewal Application Report (PDF)
The Role of Tribal Government in Regulating Research (PDF)
The Protection of Potential Individual Volunteers and Tribal Communities in Research Involving the Indian Health Service (PDF)
What are the Possible Harms in Genetic Research? (Microsoft Word)
What are the Possible Benefits in Genetic Research? (Microsoft Word)
Program Contacts
All meeting documents are password protected, to receive your password please contact:
Clarice Charging (MHA Nation)
IRB Coordinator
Northwest Portland Area Indian Health Board
2121 SW Broadway, Suite 300
Portland, OR 97201
Phone: 503-416-3256
Fax: (503) 228-4801
Additional Contact Source:
