Scientific Inquiry and Practice-Based Evidence for the Health of American Indians and Alaska Natives
Participating in Research
If you are participating in research at an IHS funded facility or being conducted by IHS personnel, and you are concerned about any aspect of your treatment or feel that you or your community may have been harmed by this research, please call the following toll-free number:
Toll Free: 888-228-6155
You don't have to give us your name when you call, although it might be helpful if you want us to look further into your complaint. We would be happy to answer any questions about your rights as a participant in IHS-related research
All human participant research conducted in IHS facilities or with IHS staff or resources must be approved by an IHS Institutional Review Board (IRB). This also includes all research in Tribally managed or Urban facilities. This is because all such facilities fall under the IHS federal-wide assurance (FWA00008894). This 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), the Belmont Report, and the instructions of the IHS IRB(s) with jurisdiction. The sole exception to this is that urban or Tribally managed facilities may obtain their own independent FWA with OHRP. In that case, the Tribe may use an IHS IRB or any other IRB of it’s own choosing. The IHS encourages (and will assist) Tribally managed health programs engaging in research to obtain independent FWAs.
All IHS approved research conducted in facilities serving specific Tribes 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 on the health care provided at the facility. Presentations or publications based on research approved by the IHS IRB(s) must also be approved by the same IRB(s) or by the Area Publication Review Committee (in areas that have such a committee but not a full IRB, see here). Applications for publication/presentation approval with findings about specific Tribes must be accompanied by approval from the relevant Tribal government(s), even if the Tribes are not named in the manuscript.
Research projects to be conducted within IHS Areas that have a functioning IRB (see here) should be submitted to the IRB Chair or Administrator listed below. Projects to be conducted in other areas should be submitted the National IRB (NIRB). Projects submitted to the NIRB should be emailed to IRB@ihs.gov with one full hard copy sent c/o Ms. Mary Eve Mahsetky at IHS Headquarters.
All projects planning to collect information for non-clinical purposes from groups of IHS patients should be reviewed with the appropriate IRB Chair to determine whether they are research or whether they are activities that do not fall under 45 CFR 46, such as quality assurance (QA) or public health surveillance. Such non-research activities may still fall under the requirements of HIPAA or may require approval of the IHS Principal Statistician
To understand why your project may be research or might be research eligible for exemption or expedited review by the IRB, you can use this set of Human Subject Regulations Decision Charts [PDF - 85K]. These decision charts from OHRP provide graphic aids used by IHS IRBs, investigators, and others to determine if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of 45 CFR 46. The charts address decisions on the following:
Remember that although it may seem clear to the investigator from this chart that his/her project is exempt, that decision can only be made by an IRB chair or administrator.
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 (under an IND or IDE) will also require approval by the NIRB, after the relevant Area IRB has completed their review and approved the consent form. For protocols that will extend over more than one area, please contact the IHS Research Director at the number below or by email to email@example.com.
Your submission packet to the NIRB should include:
An increasing number of Tribes are forming their own IRBs [WORD - 52K] under 45 CFR 46. Research projects at IHS direct care facilities serving a Tribal Nation that has its own IRB must have the approval of BOTH the Tribal IRB AND the IHS IRB. Projects at facilities managed by the Tribal Nations with their own IRB and FWA require approval of only the Tribal IRB. Protocols approved by Tribal Research Review Committees that do not meet the formal requirements of 45 CFR 46 for an IRB should also be forwarded to the IHS IRB for approval. A formal letter of approval from the Tribal Research Committee or IRB is required for consideration by an IHS IRB. This generally takes the place of the Council Resolution or approval letter from an authorized Tribal Health Official that would ordinarily be required.