1/11/10, 4/19/10, 9/9/10, 7/30/11
Roles and Responsibilities of the Institutional Review Board (IRB) and Office of the Institutional Review Board (OIRB)
INSTITUTIONAL REVIEW BOARD
The UAB Institutional Review Board (IRB) is a committee established to protect the rights and welfare of human research subjects involved in research activities as prescribed by federal regulations. Currently, there are two IRBs on campus; in addition, UAB since December 2003 has contracted with Western IRB for review of industry-sponsored clinical trials. In this document, the term "IRB" or "UAB IRB" includes all on-campus IRBs.
At UAB, the IRB must review all human subjects research as defined in UAB Policy on the Protection of Human Subjects in Research (POL001). All activities that meet the DHHS definition of "research" and involve "human subjects" as defined by DHHS regulations must be reviewed under the DHHS regulations. All activities that meet the FDA definition of "research" and involve "human subjects" as defined by FDA regulations must be reviewed under the FDA regulations. Activities that meet both DHHS and FDA definitions must be reviewed under both regulations. In addition, the IRB is responsible for reviewing authorizations for research and granting waivers of, or alterations to, such authorization under the privacy regulations promulgated under the Health Insurance Portability and Accountability Act (HIPAA). In performing the above reviews, the IRB has the authority to approve, require modifications to secure approval, or disapprove any research activity. Also, the IRB has authority to suspend or terminate ongoing, previously approved research that is not being conducted in accordance with the IRB’s requirements, or that has been associated with unexpected serious harm to subjects. UAB IRBs have authority to observe or have a third party observe the consent process and the research.
The major purpose of IRB review is to ensure that the rights and welfare of research subjects are adequately protected. To meet this goal, the UAB IRBs have specific responsibilities in the following areas:
A. Expertise. In performance of its review activities each IRB:
B. Communication. The IRB will provide the investigator and the institution with written notification of decisions to approve or disapprove research and of modifications required to secure IRB approval of the research activity; the written notification must include reasons for the decision and give the investigator an opportunity to respond in person or writing.
C. Criteria for Approval. Each IRB will determine that elements are satisfied prior to approval of research activities. Each IRB will determine that all the requirements of the criteria for IRB approval of the research in 45 CFR 46.111 and 21 CFR 56.111, DoD, DOE, DE, DOJ, and ICH-GCP (E6) guidelines, if applicable, are satisfied:
D. Expedited Review. Each on-campus IRB must conduct expedited review in accordance with DHHS and/or FDA regulations and guidance. Expedited review procedures may be used for initial or continuing review of research contained in the list of eligible research published by the FDA and/or Office for Human Research Protections (OHRP) or for review of minor changes in previously approved research during an authorized approval period.
E. Convened Meetings. Each IRB must review research in convened meetings at which a majority of the IRB members are present including at least one member whose primary concerns are non-scientific areas (i.e., quorum). No action may be taken unless a quorum is present. IRB actions must be decided by a simple majority vote. Meetings of the IRB must be scheduled with a frequency appropriate to the level of research and adequate to oversee the programs of research. Meetings may be held via audio or video conference call in accordance with OHRP recommendations.
F. IRB Minutes. The IRB must maintain minutes that include:
G. Continuing Review. Each IRB will conduct continuing review, which is substantive and meaningful, of approved ongoing research not less than once per year. The frequency of continuing review will be appropriate to the degree of risk. Continuing review will be based on receipt of appropriate progress reports from the investigator and include study-wide findings where available.
H. HIPAA Privacy Review. UAB IRBs are designated by UAB to review individual authorization forms for use and disclosure of protected health information involved in research protocols and to grant waivers of, or alterations to, individual authorizations using the standards and procedures delineated in the HIPAA privacy regulations at 45 CFR Parts 160, 164 (specifically 45 CFR §§164.508, 164.512).
I. Significant Risk Device Determination. Under FDA regulations, when a sponsor proposes to initiate a clinical investigation of a device other than a significant risk device, the IRB must make an independent determination of whether the device meets the criteria of a significant risk device at 21 CFR §812.3(m) after the sponsor provides an explanation of why the device is not a significant risk device in the sponsor’s opinion.
If the IRB concludes that the device is does not meet the criteria for a significant risk device then the IRB may approve the protocol without issuance of an Investigational Device Exemption (IDE) number from the FDA. If the IRB determines that an investigation presented for approval involves a significant risk device, the IRB will notify the investigator and, where appropriate, the sponsor. A sponsor may not begin an investigation of a proposed non-significant device in the face of an IRB determination that the device has significant risk without an FDA IDE application.
OFFICE OF THE INSTITUTIONAL REVIEW BOARD (OIRB)
The OIRB is an administrative unit of UAB established for the purpose of aiding IRB function and meeting UAB’s institutional needs for protection of human subjects. The administrative responsibilities of the OIRB include the following:
A. IRB Record Keeping. The OIRB prepares and maintains documentation of IRB activities including scientific evaluations; copies of reviewed research protocols; DHHS-approved sample informed consent documents; IRB-approved informed consent documents and HIPAA authorizations; progress reports and reports of unanticipated problems with the research, serious or continuing non-compliance, and/or injury to subjects related to the research; records of continuing review activities; copies of all correspondence between IRB and investigators; and statements of significant new findings provided to subjects. Also, the OIRB keeps minutes of IRB meetings, a roster of IRB members, written procedures of the IRB, and copies of communication to outside sponsors and/or agencies.
B. Reporting. The OIRB provides certification of IRB approval of proposed research to appropriate federal agencies and makes reports to federal agencies of IRB actions in accordance with federal regulations and UAB policy.
C. Communication/Education. The OIRB shall promote both the awareness of ethical conduct in human research and the importance of safeguarding the rights and welfare of research subjects. It is responsible for the establishment and implementation of initial and ongoing training programs in regard to federal regulations and institutional policies on the protection of human subjects. Part of this responsibility is to maintain up-to-date and accurate records of training by individuals. The OIRB is responsible for maintaining copies of UAB’s Federalwide Assurance, federal regulations, polices and guidelines, and UAB’s policies and procedures (including IRB policies and procedures) related to human subject research. OIRB personnel are responsible for reviewing research protocol submissions and assessing whether the protocol falls under IRB jurisdiction, and if so, whether it meets the IRB requirements for review; preparing and disseminating materials for consideration by the IRB; and notifying investigators of administrative errors or deficiencies in submissions for IRB consideration. The OIRB is also responsible for communicating IRB actions to investigators and UAB.
D. Monitoring and Oversight. The OIRB engages in monitoring of research records to ensure compliance with UAB IRB requirements. Monitoring visits must be conducted at reasonable times and in a reasonable manner by authorized individuals. Monitoring visits may be initiated by a specific request from the IRB, in response to a complaint to the IRB, or as a part of a routine monitoring plan. During such visits, a monitor may request to make copies of research records which must be accommodated by the investigator at the time of the visit or at a later time by mutual consent. The OIRB is responsible for ensuring that all collaborative and cooperative review arrangements conducted by UAB are performed in accordance with regulations and properly documented in writing. In addition, the OIRB is responsible for administrative arrangements in which UAB relies on the IRB of another institution or another institution relies on the UAB IRB for review.
E. Research Exempt from Federal Regulations. The OIRB is responsible for making determinations of whether a research activity is exempt from federal regulations on protection of human subjects. Such determinations must be performed by OIRB personnel who have a working knowledge of the federal regulations using published guidance and information on exempt research from the Office for Human Research Protections or other agencies. Determinations on whether a research activity is exempt or non-exempt must be in writing and provide the basis of the decision.
Approved on July 30, 2011 by:
Richard B. Marchase, PhD
Vice President for Research and Economic Development
Ferdinand Urthaler, MD
Denise Ball, CIP
OIRB Interim Director