Submitting Materials
Materials that Need to be Submitted to the IRB…
The Portland Area IHS IRB reviews research proposals, annual progress reports, and papers being submitted for publication.
Research Proposals
A research packet must contain the following items to be considered complete:
A clear description of the research to be conducted.
A copy of the consent form.
Information on the consent process.
If applicable, a copy of the assent form.
If applicable, information on the assent process.
If the Principal Investigator or Co-Investigator is faculty of a university or institution, a copy of the university or institution’s IRB decision needs to be submitted.
A copy of the Service Unit approval letter.
A copy of the tribal approval letter from each participating tribe.
A copy of proposed procedures to maintain confidentiality and anonymity.
If the proposal includes a survey or questionnaire, copies need to be submitted.
CV’s or resume of all project staff
Budget
Timeline
A complete application expedites the review process.
Please submit the original protocol plus 14 copies to the Portland Area IHS IRB:
The Headquarters-Rockville, MD Area Combined IHS IRB website (http://www.ihs.gov/NonMedicalPrograms/Research/irb.htm)
has many reference materials; including sample consent forms and IRB review checklists.
Procedures for IRB Review…
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.
Renew IRB approvals annually.
Submit annual progress reports.
Obtain IRB approval for all manuscripts that are to be submitted for publication.
