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Prior
to each convened meeting, members are asked if they
will attend the meeting. This is necessary to determine
whether the requirement for quorum is met and that
members with the appropriate scientific expertise
will be in attendance. The IRB Chairpersons or designee
reviews the agenda and list of members expected to
attend and assigns reviewers to each protocol.
When
making reviewer assignments, the IRB Chairpersons
and alternates take into consideration the scientific
area or discipline, the study population, and study
procedures and the experience and expertise of the
members attending the meeting.
Assignments
are made based on the member’s knowledge and expertise.
When the agenda includes protocols that involve vulnerable
populations, the IRB Chairpersons or designated alternate(s)
are responsible for ensuring that at least one member
attending the meeting has knowledge and experience
in working with the study population. Partners IRBs
reserve the right to reschedule protocols for review
based on the experience and expertise of the members
attending the IRB meeting.
When
assigning primary and secondary reviewers, consideration
is given to the reviewer’s area of experience and
expertise (e.g., pediatrics, obstetrics, neonatology,
neurology, psychiatry) and representative capacity
(i.e., physician scientist, nonscientist, other scientist).
Typically
the primary reviewer is a physician scientist or other
scientist with experience and expertise in the type
of research under consideration, though this is not
an absolute requirement, depending upon the type of
study.
The
secondary reviewer is typically an individual who
can provide another perspective, for example, lay
person, genetic counselor, nurse or parent. The secondary
reviewer, therefore, complements the scientific expertise
of the primary reviewer.
Both
the primary and secondary reviewers are expected to
fully and carefully review all aspects of the protocol,
consent form and associated materials, including when
applicable, the NIH grant application, with particular
focus on “Section E” related to human subjects involvement.
The
primary reviewer presents a brief synopsis of the
research protocol, with the expectation that the other
members have reviewed the protocol materials. The
primary reviewer is expected to cover study design,
how the research differs from and compares to standard
care, rationale for subject selection, appropriateness
of the inclusion/exclusion criteria, risks, benefits
and alternatives, and other points relevant to implementation
of the study. The primary reviewer is expected to
refer to the reviewer worksheet and the document “Points
to Consider” for the regulatory requirements for IRB
approval, required elements for consent forms, and
issues to consider. These documents are provided with
the agenda and review materials.
Primary
reviewers are encouraged, though not required, to
contact the principal investigator if they have questions
about the protocol, particularly if there are significant
concerns related to the study, or the reviewer believes
additional information is needed for the Committee
to assess the risks and benefits.
Secondary
reviewers are asked to present any additional clarifications
or commentary on the study plan, and any questions
or concerns, or modifications required for approval.
After
the primary and secondary reviewer has presented the
study and review comments, the protocol is opened
up for discussion by the IRB members. The Chairperson
may direct specific questions to the assigned reviewers
or other members of the IRB with specific expertise
or viewpoints (e.g., a layperson, nurse or other member
who may bring a different perspective to the discussion).
Both
the primary and secondary reviewers are asked to evaluate
the consent form carefully. Both general comments
on the reading level and style of the consent form
are expected from both reviewers, as well as detailed
suggestions for improvement. Consent form comments
may be handwritten on the form, or provided in written
commentary as part of the review.
Members
who are not assigned to specific protocols on the
agenda are expected to review the protocol summary,
consent forms and any study specific items such as
questionnaires or survey materials, as well as advertisements
for subject recruitment.
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