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Human Research Participant Protection in the Indian Health Service

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). [PDF - 10KB] 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. Juanita Neconie 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:

• Whether an activity is research that must be reviewed by an IRB,

• Whether the review may be performed by expedited procedures, and

• Whether informed consent or its documentation may be waived.

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.

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 (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 irb@ihs.gov.

Your submission packet to the NIRB should include:

1. 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.
2. 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 Western IRB (WIRB), publicly available at: http://www.wirb.com/shell.php?content=content/quick_download_forms
3. Your Protocol: We accept most protocol formats that have been approved by other IRBs. If writing your protocol from scratch, we recommend you consider the WIRB Suggested Guidelines for Writing a Research Protocol at: http://www.wirb.com/shell.php?content=content/spo_guidelines. 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.
4. 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.
5. 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.
6. 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 (available over the web at no cost)from the Collaborative IRB Training Initiative (CITI) at the University of Miami, available at: http://www.citiprogram.org/ . For most other Areas, certificates from the web-based, 2 hour NCI course at http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asp or other equivalent course will be accepted.
7. 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.
8. 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.
9. For submissions to the IHS NIRB, Scans of all signed letters and other electronic files should be emailed to: irb@ihs.gov. Hardcopies of all documents should be sent to:

IHS-NIRB

c/o Ms. Mary Eve Mahsetky

801 Thompson Ave. TMP 450

Rockville, MD, 20852

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Tribal IRBs

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.

Other Human Research Participant Protection Information

• Indian Health Service Institutional Review Boards (IRB)
• Training Requirements
• HIPAA
• Forms and Other Resources

For further information please feel free to contact:
Indian Health Service
Office of Public Health Support
Division of Planning, Evaluation, and Research

Dr. Alan Trachtenberg (301) 443-0578
801 Thompson Avenue, TMP, Suite 450
Rockville, Maryland 20852
Fax: (301) 443-0114

This file last modified: Thursday September 6, 2007  7:37 AM