Human Subjects Research Protections
Human participant research conducted in IHS facilities or with IHS staff or resources must be approved by an IHS Institutional Review Board (IRB). This includes research done in Tribal or Urban facilities since IHS, Tribal, and Urban sites fall under the IHS federal-wide assurance (FWA) #00008894. The FWA is the IHS Director's assurance to the DHHS Office for Human Research Protections (OHRP) that all research conducted under his/her purview will follow Title 45, Code of Federal Regulations part 46 (45 CFR 46) and the Belmont Report. Tribal and Urban facilities may obtain their own FWA with OHRP, independent of IHS. IHS encourages and will assist Tribal and Urban health programs engaging in research to obtain independent FWAs.
All proposed research must first have obtained the formal, written approval of the appropriate Tribal government(s). This approval must be submitted with the original application to the IHS IRB. Evidence of support from the facility's Chief Executive Officer (CEO) must also be provided, to document that the project will not use IHS resources in a manner that would adversely impact the health care provided at the facility. Presentations or publications based on research approved by the IHS IRB(s) must be approved by the Publications Review Committee (PRC) or the IRB(s) that reviewed and approved the research study. Some IHS Areas have a PRC but do not staff and operate a full IRB. Manuscripts submitted for publication that contain with findings about specific Tribes, even if the Tribes are not named in the manuscript, must be accompanied by approval from the relevant Tribal government(s).
Research projects to be conducted within IHS Areas that have a functioning IRB should be submitted to the IRB Chair or Administrator for that Area. Projects to be conducted in Areas without a functioning IRB should be submitted the National IRB (NIRB) by emailing the proposal to IRB@ihs.gov and mailing one full hard copy to NIRB, c/o Rachael Tracy at 5600 Fishers Lane, MS 09E10D, Rockville, MD 20857.
All proposed research projects planning to collecting information for non-clinical purposes from groups of IHS patients should review their protocol with the appropriate IRB Chair to determine whether the proposed activities are considered research or whether the proposed activities are not covered by 45 CFR 46. Activities not covered may include quality assurance (QA) projects or public health surveillance activities. Such non-research activities, however, may still fall under the privacy requirements of the Health Insurance Portability and Accountability Act (HIPAA), Privacy Act, or require other approvals.
Submitting Your Protocol for IRB Review
Once you have determined to which IHS IRB your protocol should be submitted, we recommend that you contact the IRB Chair or administrator to discuss your protocol and what will be required for its review. All protocols deemed greater than minimal risk or that use a test article regulated by FDA will require approval by the NIRB, after the relevant Area IRB has completed their review and approved the consent form. Projects that extend over more than one IHS Area must be submitted to the NIRB for review.
Your submission packet to the NIRB should include:
- A cover letter briefly describing the project and suggesting the type of review or exemption that the investigator feels is warranted. If the study includes specific protected groups such as children or prisoners, then the category of study and regulatory citation allowing the study should be included.
- An IRB submission form: We recognize that most investigators who plan to conduct research with the IHS will also have at least one other IRB to satisfy, such as their university IRB. Therefore, we accept other IRBs' submission forms, as long as they are accompanied by an approval letter from that IRB. For investigators that are not submitting to any other IRB, we recommend use of the excellent submission forms from the Friends Research Institute of Baltimore or the Western IRB.
- Your Protocol: We accept most protocol formats that have been approved by other IRBs. Your protocol must include any survey instruments you plan to use, as well as consent (and, if indicated, assent) forms that comply with all regulatory requirements.
- A letter of support from the CEO or SUD of the IHS facility where the research is to be conducted. If more than one facility in an area is to be included, then one letter of support for all participating facilities can be accepted from the Area Director. This letter should include a statement that conduct of the study will not significantly divert resources from the provision of health care services to the population served by the facility(ies). If there will be any significant diversion of resources from regular clinical care, than an analysis must be included of the benefits expected for the local population from the study.
- A letter of support from the Tribal government(s) of the specific Tribes served by the facility and/or involved in the study. This requirement can be fulfilled by a Tribal Council resolution, or an approval from a Tribal research review committee or Tribal Health Official to whom this authority has been delegated by the Council. For multi-Tribal studies in a group of Tribes served by a Council of Tribal Leaders, a resolution from that council may also be accepted.
- Certificates attesting to the current training of the Investigators and Key personnel in human research subject protection. In some IHS Areas, specific training may be required. For instance, the Alaska Area IRB requires training from the Collaborative IRB Training Initiative (CITI) at the University of Miami. For most other Areas, certificates from the web-based, 2 hour NCI course or other equivalent course may be accepted.
- If your protocol includes use of a test article regulated by the FDA, then copies of all relevant FDA forms must be included with your submission.
- If your protocol is being funded by another agency, foundation, or other extramural source, then your grant application and review from the funder must be included.
- For submissions to the IHS NIRB, Scans of all signed letters and other electronic files should be emailed to: email@example.com. Hard copies of all documents should be sent to:
National Institutional Review Board
Rachael Tracy, MPH, Research Director
Division of Planning, Evaluation, and Research
Office of Public Health Support
Indian Health Service
5600 Fishers Lane, MS 09E10D
Rockville, MD, 20857