Institutional Review Board (IRB) Process

Tim NoeCoordinating Center

Grantees receive program description, consent forms, advertisements and data collection instruments by June 30.

Grantees receive program description, consent forms, advertisements and data collection instruments by June 30.

We will seek blanket IHS approval by July 1We 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 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 1Grantees will need to submit for local approval by August 1

Grantees will need to have local approval by Oct 1.Grantees will need to have local approval by Oct 1.

General Overview of IRB Approval Process

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)

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:

– 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.

–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.

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.

– 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.

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

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)

HIPAA Authorization A HIPAA 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.

Potential reviews of protections required by type of grantee organization:Tribal Programs IHS Service

Units/ClinicsUrban Indian Health Programs

Tribal Health Committee

IHS IRB IHS IRB

Tribal Council Tribal Health Committee

Health Board IRB

Tribal IRB Tribal Council Institutional IRB/Approval

IHS IRB Tribal IRB

Questions?