IRB Member Corner

For IRB Members

IRB Member Roles and Responsibilities

The McLaren IRB is charged with the review of proposed research protocols to safeguard the rights of human subjects and ensure that any risk of harm to subjects is minimized. The framework for the protection of human subjects is set in federal policy and regulation. Committee Members work with McLaren IRB staff to ensure compliance with McLaren policies and procedures, federal policy and regulations, and state and local laws relative to the review of human subject’s research studies.

The Community Member has the specific responsibility of bringing the perspective of the volunteer research participant to the review of protocols.

General Member responsibilities include reviewing all assigned research protocols to ensure that:

Research design is sound and study hypothesis is reasonable.
Risks to subjects are minimized.
Risks to subjects are reasonable in relation to anticipated benefits.
Selection of subjects is equitable.
Informed consent is obtained or appropriately waived from all prospective subjects and documented.
The research protocol includes a plan for data and safety monitoring.
Subject’s privacy and confidentiality are protected.
Appropriate additional safeguards are incorporated for any vulnerable subjects.
To attend all Committee meetings and to notify IRB staff in advance if there is a need to be absent from a scheduled meeting.
To complete required human subjects protection training and HIPAA training, if applicable.
To maintain confidentiality regarding reviewed protocols.
To act as primary or secondary reviewer for specific assigned protocols.
To act as a resource for researchers in the design of human subjects protection aspects of protocol development.
To participate in Committee discussion of protocols.
To comply with Committee conflict of interest policy and procedure.

Specific application of responsibilities:

To consider the risks and benefits of the study.
To consider the inclusion/exclusion criteria and determine if it has an ethical basis.
To consider the consent document to determine if the consent matches the protocol, if it is clear, and if it is understandable for research participants.