The Collaborative Research Center for American Indian Health Tribal IRB Toolkit contains 101 pages, covering all aspects of initiating and running an IRB. Included is the following Tribal IRB Pre-Review Checklist:

Type of Submission

- Application for initial review

- Application for continuation

- Amendment

- Final report/closure

- Response to IRB request

- Other

Initial Review — New Protocols Only

1. Determine if the activity is research. Refer to ‘Determine if Research’ flowchart.

2. Determine if activity involves human subjects. Refer to ‘Determine if Activity Involves Human Subjects’ flowchart.

3. Determine if the research is within the jurisdiction of the tribe, i.e. on reservation land.

4. Identify relevant tribal, state, federal, or international law that may apply to the research. Reference federal and international research protection laws in these resources:

- Human Research Protections Standards & Regulations, and

- Application of Research Protections Standards & Regulations.

5. Review application form and/or documents submitted. Check for missing material.

6. If missing material is found, send letter to the investigator requesting this information. If application is complete, schedule the project on the next IRB meeting agenda. Send a letter to the investigator, notifying them of scheduled date. See ‘Letter Templates.’

7. Check to see if the investigator is already listed in the IRB records (for conducting research on the reservation previously). If not, enter contact information, CV, and human research protections certifications into IRB records.

8. Determine the board member expertise that is most relevant for review of this research project. Identify what special determinations the IRB needs to make in order to approve the submission (e.g., risk to vulnerable populations). If board member expertise is not sufficient, a consultant may be needed.

- Notes

Continuing Review Protocols Only

1. Look for changes in the submission from the most recent approval.

2. If applicable, check whether the consent forms and scripts being used are the most recently approved versions.

3. If needed, communicate with the investigator regarding missing material or to resolve any questions about the material submitted for ‘continuation review.’

4. If application is complete, schedule the submission for continuation on the next IRB meeting agenda. Send a letter to the investigator, notifying them of scheduled date. Refer to ‘Letter Templates.’

5. Send the Continuation Review Checklist together with the submission materials for review, at least two weeks prior to the scheduled board meeting.

Responses to IRB Requests

1. Review relevant minutes and determine if the investigator responded to the request appropriately (e.g., made required modifications or provided additional information). Communicate IRB response to investigator. Refer to ‘letter templates.’

- Notes

Project Termination/Close Out

1. Ensure that the investigator has submitted a complete ‘Project Termination/Close Out’ Report form. Check for missing information.

2. Determine if any new information about the research project has been provided (e.g., new risk to participants or the Tribe).

3. If applicable, ensure that the investigator has submitted a completed ‘Data Return Form’ and accompanying materials.

4. If needed, communicate with the investigator regarding missing material or to resolve any questions. If determined that project close-out will be on an IRB agenda, send investigator communication regarding this. Refer to ‘Letter Templates.’

5. Once verified that all material has been received, send a letter to investigator acknowledging receipt. Refer to ‘Letter Templates.’

6. Ensure files of project information contain all research submissions from the investigator and all records of correspondence between the IRB and the investigator.

7. If applicable, ensure that data returned by the investigator is filed correctly.

- Notes

Other Submissions

1. Review application form and/or documents submitted for missing material.

2. If missing material is found, send letter to the investigator requesting this information.

3. If all submitted material is complete, choose the relevant form of written communication to the investigator. (e.g., send letter to investigator confirming submission, or schedule item on the next meeting agenda and send letter with the date). Refer to ‘Letter Templates.’

4. If the submission requires board review, identify what special determinations the IRB needs to make in order to approve the submission (e.g., risk to vulnerable populations) and prepare appropriate checklists and supplemental reference material for the board.

5. If applicable, identify relevant Tribal, state, federal, or international law that may apply to the research. Reference federal and international research protection laws in these resources:

- Human Research Protections Standards & Regulations, and

- Application of Research Protections Standards & Regulations.

- Notes