Institutional Review Board

About the Institutional Review Board

The Institutional Review Board of INTEGRIS Health serves to approve the initiation of and to conduct continuing review of research involving human subjects under the jurisdiction of Federal Wide Project Assurance 3082. This review is conducted to protect the rights of the human subjects in research and in accordance with the terms of the FWA and regulations located in the Code of Federal Regulations Title 45 Part 46 and Title 21 Parts 50 and 56. Federal regulations require a review of the scientific merit of the protocol by the IRB to determine if the risk/benefit ratio is appropriate.

The IRB’s role is to assure

• Risks to the subjects are minimized,
• Risks to subjects are reasonable in relation to anticipated benefits and the importance of the knowledge that may be expected to result,
• Selection of research subjects is equitable,
• Informed consent will be sought from each prospective subject or the subject’s legally authorized representative and will be documented in accordance with and to the extent required by Federal Regulations,
• Adequate provisions are made for monitoring the data collected to ensure the safety of research subjects,
• Adequate provisions are made to protect the privacy of research subjects and to maintain the confidentiality of data, and
• Appropriate additional safeguards have been included to protect the rights and welfare of research subjects who are members of a particularly vulnerable group.

The IRB’s primary function is to protect the rights and welfare of human subjects involved in research and to assist the investigator and the institution in their mutual obligation to comply with all federal, and state regulations and all institutional policies with respect to these subjects. INTEGRIS Health IRB approval must be obtained if any of the following circumstances apply:

• The research is sponsored by INTEGRIS Health.
• The research is conducted by or under the direction of any INTEGRIS Health employee,
• The research is conducted by or under the direction of any INTEGRIS Health employee using any subjects, property or facility at INTEGRIS Health,
• The research involves the use of INTEGRIS Health’s non-public information to identify or contact human research subjects or prospective subjects,
• The research is conducted by or under the direction of an individual employed by any of the affiliated sites and who is performing the research at that site.