Institutional Review Board (IRB)
Investigators, study personnel and students are strongly
encouraged to contact
(860-679-8802) for educational assistance in preparing an
IRB application and supporting documentation. The IRB
Coordinators (Donna Horne x4851, Patricia Gneiting x4849, Pamela
Colwell x1019) and Research Compliance Monitor (Judy Gaffney
x7555) are also available to provide assistance if Mayra is not
There are multiple
(PDF) 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. Three panel
meets once per month, the CICATS panel is scheduled to meet
one per month, as necessary. With the following exceptions,
studies requiring full board review are assigned to a panel
based on the submission date of the initial application.
- any study proposing to involve prisoners must be
assigned to Panel 02 which has a prisoner advocate as a
- any new study associated with the CT Institute for
Clinical and Translational Science (CICATS) must be assigned
to the dedicated CICATS panel
Once a study is assigned to a panel it remains under the
oversight of that same panel for the life of the study.
The IRB Office is located on the 2nd floor of the Munson
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
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
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
In general, the membership of
IRB meets on the first, third and fourth Mondays of each
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.