Institutional Review Board (IRB)

There are multiple Institutional Review Boards constituted at the Health Center. Institutional policy number 2002-42, Review and Approval of Research Involving Human Subjects (PDF), assigns authority and responsibility to the IRBs. Each panel meets once per month. With one exception studies requiring full board review are assigned to a panel based on the submission date of the initial application. Once a study is assigned to a panel it remains under the oversight of that same panel for the life of the study. The one exception is that any study proposing to involve prisoners must be assigned to Panel 02 which has a prisoner advocate as a member. Members are appointed by the Director of the Human Subjects Protection Office and are selected for their experience and expertise, as well as for their diverse backgrounds. The IRB Office is located on the 2nd floor of the Munson Building.

Federal mandate (45 CFR 46, referred to as the Common Rule) requires that the IRB review and approve any biomedical or behavioral research involving human participants, data or specimens that may be identifiable directly or through codes prior to it being started and that, in the majority of cases, legally effective informed consent of the subject or the subject's legally authorized representative is obtained prior to any involvement in the study.

Vested with an ethical imperative to safeguard the rights and welfare of human subjects in research studies, the IRB reviews protocols to assure that the research activities proposed include no unnecessary risks, minimize potential risks to subjects, and that overall potential benefit to the subject, or to society, is reasonable in relation to the risks. The Board also measures the importance and significance of the scientific knowledge potentially gained against risks to study subjects.

"Risks to subjects are minimized by:

• using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk;
• and whenever appropriate using procedures already being performed on the subjects for diagnostic or therapeutic purposes."

Appropriate safeguards to protect potentially vulnerable populations (e.g., pregnant women, fetuses, children, the mentally disabled, etc.) are required.

The IRB further examines and approves all proposed informed consent forms to ensure that subjects are provided with a clear and complete explanation of the study and its potential benefits and risks.

Investigators have many obligations, including designing the study so that the incidence of risk and stress are minimized to the greatest degree possible and that these risks are accurately described in the protocol. Investigators must also make appropriate provisions for the overall care of the patient. Moreover, the Investigator bears responsibility for terminating the study when hazards or risks to the subject become apparent or may be incompatible with the benefits of the study; further, investigators must report any adverse reactions, unanticipated problems that increase risks to subjects or others, or protocol deviations associated with the study to the IRB in accordance with policy.

In general, the membership of IRB meets on the first, third and fourth Mondays of each month; applications (Word) requiring review by the full IRB are due 12 working days prior to the meeting. Applications requesting exempt status or expedited review may be submitted at any time. Once approved, protocols must be reviewed at least annually, excluding exempt studies. All studies, including exempt studies, are subject to audit by the Research Compliance Monitors.

Protocols that do not qualify for expedited review or exempt status are reviewed by the full committee. If special expertise is required to conduct the review, a consultant may be called upon to assist in the process.

At the discretion of the Chair and where there exists no more than a minimal risk to subjects and where subjects are within specified categories, an expedited (Word) review may be granted.

The IRB also determines research (e.g., studies of existing pathological specimens where the identity of subjects cannot be known, anonymous surveys/questionnaires, etc.) which may be exempt (Word) from continuing review.

Finally, approval for emergency and therapeutic use of investigational new drugs (IND's) must be obtained from the IRB.

Please contact the IRB Office at 860-679-1019 if you have any questions pertaining to human subject protection issues or the IRB review process.