1. Institutional Review Board (IRB) Process Tim Noe Coordinating Center

3. Grantees receive program description, consent forms, advertisements and data collection instruments by June 30. We will seek blanket IHS approval by July 1 Grantees revise descriptions and consents provided to them to meet local IRB requirements before August 1. Grantees will need to submit for local approval by August 1 Grantees will need to have local approval by Oct 1. General Overview of IRB Approval Process

4. General IRB Requirements –Description of what will be done –Consent Forms –Copies of advertisements –Copies of questionnaires/data collection instruments –HIPAA Authorization Forms (if applicable)

5. Descriptions of What will be Done Typically, IRBs want the following information. So, this is what we will provide to grantees: –Objectives –Background (i.e., rationale and a discussion of why you are doing what you are doing). –A concise description of how the objectives will be achieved. This will include:

6. –The description will include: –*How you will recruit participants –*How participants will consent (if applicable) –HIPAA Authorization procedures (if applicable) –*Program activities –*The number of subjects that will sign a consent form) *These will need to be revised/adapted for each local site.

7. –How long the program will last. –The protected health information that will be collected (if applicable), with whom it will be shared, and how the participant. can request access to it. –Any risks to participants. –Benefits for participating.

8. Consent Forms will need to include –The purpose of the program and the expected duration of participation. –*A description of the activities –A description of any risks or discomforts to participants (if applicable) *Will need to be revised/adapted for each local site.

9. –A description of any benefits for participants. –How information collected will be kept confidential. –*Who participants can contact if they have questions. –Explanation that participation is voluntary *Will need to be revised/adapted for each local site.

10. General Requirements for Advertising Materials Advertisements used to recruit participants may need to be approved by the IRB prior to posting, mailing, publication or broadcast. This includes all posters, flyers, letters, brochures, radio, television and Internet ads. *Templates will be provided to grantees but they will need to be revised/adapted for each local site

11. HIPAA Requirements –We are reviewing the potential requirements at the local level to determine what the requirements may be –All data coming from grantees to the Coordinating Center will need to have all personal identifiers removed –Two types of Authorization may be required (HIPAA Authorization A and B)

12. HIPAA Authorization AHIPAA Authorization B Typical Requirements:  Applies to health care entities only  Providers must have permission to disclose a patient’s name for recruitment by an outside agency  Providers can recruit patients without prior authorization Typical Requirements:  Applies to health care entities only  Participants in evaluation studies must give their permission for personal health information to be shared with other outside of the health care organization  This is usually signed at the same time as a consent form Variability:  Depends on whether or not the person recruiting participants has a clinical relationship with them  Depends on whether the organization is a health care entity  This requirement is usually dependent upon the local HIPAA policy Variability:  If the data collected are de-identified (no personal identifiers are included in the data), no authorization is required.  Often the best approach is to obtain HIPAA Authorization B from everyone who signs a consent form. This ensures compliance.

13. Potential reviews of protections required by type of grantee organization: Tribal ProgramsIHS Service Units/Clinics Urban Indian Health Programs Tribal Health Committee IHS IRB Tribal CouncilTribal Health Committee Health Board IRB Tribal IRBTribal CouncilInstitutional IRB/Approval IHS IRBTribal IRB

14. Questions?