Membership
HSC # 1 Roster (Meets 2nd and 4th Tuesdays of each month) - Revised 1/28/2008
HSC # 3 Roster (Meets 1st and 3rd Tuesdays of each month) - Revised 2/15/2008
Composition of the Committee
Identification and Selection of Members
Roles and Responsibilities of HSC Members
Composition of
the Committee
Composition of the Human Subjects Committee (HSC is governed by
DHHS and FDA regulations (45 CFR 46 and 21 CFR 56), which include
the following requirements:
- The HSC must consist of at least five duly appointed
voting members who possess varying backgrounds that
will promote complete and a dequate review of research activities
commonly conducted by KUMC. A voting member who is unable to
be present at the convened meeting may participate by video-conference
or conference telephone call, when the member has received
a copy of the documents that are to be reviewed at the meeting.
Such members may vote and be counted as part of the quorum.
Opinions of absent members that are transmitted by mail, telephone,
fax or e-mail may be considered by the attending HSC members
but may not be counted as votes or the quorum for convened
meetings.
- The HSC must include at least one member and one alternate
whose primary concern is in a scientific area. An
HSC member who is a physician or PhD-level physical or biological
scientist satisfies this requirement.
- The HSC must include at least one member and one alternate
whose primary concern is in a nonscientific area. The
FDA interprets the requirement for diversity of disciplines
to include members who had little or no scientific or medical
training and experience. Lawyers, clergy and ethicists have
been cited as examples of persons whose membership will fulfill
the regulatory requirement for representation of a non-scientific
member. The non-scientific member or alternate must
be present at each convened meeting in order to satisfy quorum
requirements.
- The HSC must include at least one member who is not
otherwise affiliated with KUMC and who is not part
of the immediate family of a person who is affiliated with
the institution. Although 21 CFR 56.108(c) does not specifically
require the presence of a member not otherwise affiliated with
the institution to satisfy quorum requirements, the FDA considers
the presence of such members an important element of diversity;
as such, frequent absence of a non-affiliated member is unacceptable. Acknowledging
their important role, KUMC shall appoint at least two HSC members
who are not otherwise affiliated with the institution.
If the HSC regularly reviews research involving a vulnerable category
of subjects (e.g., children, prisoners, pregnant women, or handicapped
or mentally disabled persons) one or more individuals who possess
knowledge of or experience in working with these subjects must
be included in the HSC membership.
- The HSC shall be sufficiently qualified through the experience
and expertise of its members, and the diversity of the members
(including consideration of race, sex and cultural backgrounds
and sensitivity to such issues as community attitudes) to promote
respect for its advice and counsel in safeguarding the rights
and welfare of human subjects.
- Every nondiscriminatory effort will be made to ensure that
the HSC does not consist entirely of men or entirely of women,
and that due consideration is given to qualified persons of both
sexes, so long as no selection is made solely on the basis of
sex.
- The HSC may not consist entirely of members of one profession.
- In addition to possessing the professional competence necessary
to review specific research activities, the HSC shall be able
to ascertain the acceptability of proposed research in terms
of institutional commitments and regulations, applicable law,
and standards of professional conduct and practice. Therefore,
KUMC shall include persons knowledgeable in these areas (e.g.,
representatives from related compliance units, conflict of interest
and data safety monitoring committees, and safety officers for
radiation and biochemicals) as ex-officio members of the HSC.
- The HSC may, at its discretion and with approval of the Institutional
Official, invite individuals with competence in special areas
to assist in the review of issues which require expertise beyond
or in addition to that available on the HSC. These individuals
may not vote.
Alternate HSC Member
Alternate HSC members:
- are identified, selected and seated with the same procedures
used for regular HSC members;
- must be formally appointed and listed in the HSC membership
roster; and
- hold qualifications comparable to the primary member(s) to
be replaced.
The HSC roster shall clearly identify the primary member(s) in
whose absence an alternate member may attend HSC meetings. The
HSC minutes will document when an alternate member replaces a primary
member. When an alternate member attends for a primary member,
the alternate member must have received and reviewed the same material
the regular member would have received.
Ad Hoc Substitutions for Regular HSC Members
Ad hoc substitutes for regular HSC members are not permissible.
However, with proper advance notice to the IRB Administrator, regular
members may request that ad hoc substitutes attend convened meetings
as consultants. The ad hoc substitute may gather information for
the absent member but may not be counted toward the quorum, participate
in HSC deliberations or vote. The HSC may ask questions of the
ad hoc substitute just as they could of any non-member consultant.
Conflict of Interest
No member of the HSC may participate in the initial or continuing
review of any project in which they have a conflicting interest,
except to provide information requested by the HSC.
Committee Roster
A current roster of HSC members is maintained by the KUMC Office
of Compliance (OC) and must be readily accessible to all interested
parties (e.g., posted on the HSC Web site or available in hard
copy informational packets). The roster must include the following
information:
- name and KUMC job title, if applicable;
- earned degrees;
- representative capacity (i.e., ex-officio, voting or non-voting,
regular member or alternate member, non-affiliated member, non-scientific
member, etc.);
- indications of experience, such as board certifications, licenses,
etc., sufficient to describe anticipated contributions to HSC
deliberations;
- any employment or other relationship between each member and
KUMC; for example: full-time employee, part-time employee, member
of governing panel or board, stockholder, paid or unpaid consultant;
and
- appointment dates (initial appointment dates, ending appointment
and any renewals approved by procedures listed below).
Changes in Composition of Committee
Changes in HSC membership shall be reported to the OHRP by the
Associate Vice Chancellor for Compliance (AVCC) who serves as KUMC's
Institutional Official.
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Identification
and Selection of Members
Responsibility for Ensuring Representation
Members of the committee shall be drawn from disciplines
and specialties representing the types of human research conducted
at KUMC. All unit heads are responsible for ensuring
adequate representation on the HSC, so that research proposals
from their investigators may be reviewed. The Executive
Vice Chancellor (EVC), in consultation with the Research Advisory
Council (RAC) and the AVCC, reserves the right to postpone reviews
from areas with inadequate representation on the HSC.
Identification and Selection of Ex-Officio
Members
Ex-officio members of the HSC are individuals
whose service is required by virtue of their KUMC employment,
and that service is reflected as a job duty in their position
descriptions. An ex-officio member may or may not have voting
privileges, depending on the restrictions noted below. Ex-officio
members who have voting privileges must be present at each convened
HSC meeting or ensure that a duly appointed and appropriately
qualified alternate attends meetings in their absence.
Ex-officio members of the HSC hold the following
positions:
- AVCC - non-voting member
- Director of Human Research Protection Program - non-voting
member
- Director of Safety - voting member (this is
the same individual as the Biosafety Officer and Radiation
Safety Officer)
- HIPAA Manager - voting member
- Research Institute - non-voting member
The determination to add or delete ex-officio
members shall be made by the EVC in consultation with the RAC
and the AVCC.
Identification/Selection of COIC and DSMB
Representatives
The Conflict of Interest Committee (COIC) and
the Data and Safety Monitoring Board (DSMB) shall be represented
on the HSC to ensure that institutional considerations regarding
conflicts of interest and data safety are efficiently incorporated
into the review of human research. Representation on the HSC
may be accomplished through shared membership between HSC, the
COIC and the DSMB; alternatively, the Compliance Program Manager
may serve in a non-voting, advisory capacity on behalf of the
COIC and DSMB.
Identification and Selection of All Other
HSC Members (including the Chair and Vice-Chair)
Voting or non-voting members and their alternates,
the HSC Chair and the HSC Vice-Chair are identified in one of
the following ways:
- Self-nomination by interested candidates;
- Term renewal requests by members whose appointment
term is ending;
- Nomination by department chairs, center directors
or school deans;
- Nomination by the Faculty Assembly Research
Committee, the AVCC, or any of the Vice Chancellors;
- Nomination by members of the HSC, DSMB, COIC,
Institutional Research Safety Committee (IRSC) or Radiation
Safety Committee.
Nominations and requests for re-appointment are
submitted in writing to the AVCC, and shall include the following:
- Description of the nominee's qualifications
for serving on the HSC;
- Description of the nominee's qualifications
for serving on the HSC;
- Additional support documentation if needed.
Nomination materials and re-appointment requests
are reviewed at regularly scheduled meetings of the RAC. The
RAC may solicit additional information at its discretion. After
evaluation of the individual's qualifications and consideration
of HSC needs, the RAC will submit written recommendations to
the EVC, which specify the type of appointment that should be
considered (i.e., voting, non-voting, Chair, Vice Chair), terms
of appointment (in cases of renewals) and a brief explanation
of the RAC's selection rationale.
The EVC is responsible for the final selection
of new members and for issuing re-appointments. Appointment letters,
which outline the HSC charge, member responsibilities and terms
of appointment, shall be issued by the EVC through the AVCC.
Identification and Selection of Consultants
When an uncommon, unusual or discipline-specific
knowledge is required for the review of a given proposal and
appropriate expertise is not represented on the HSC, the AVCC,
in consultation with the HSC Chair and the IRB Administrator,
shall identify and seat appropriate consultants who shall serve
in non-voting, advisory capacities on an as-needed basis.
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Roles and Responsibilities
of HSC Members
HSC Chair
The HSC Chair is appointed by the EVC, under recommendations
from the RAC and the AVCC. Responsibilities include, but are
not limited to:
- serve at least one year as Vice Chair of the
HSC;
- understand regulations and guidelines governing
the protection of human research participants, work closely
with the IRB Administrator to ensure that requirements are
consistently applied in the review process and that work of
the committee is accomplished in an effective and timely manner;
- in conjunction with the IRB Administrator,
help develop the agenda for each HSC meeting, chair HSC meetings,
ensure that the agenda is completed, facilitate adequate and
meaningful discussion during the meeting, review and edit minutes;
- ensure that committee members who have potential
conflicts of interest for a given project are recused during
discussions of that project;
- consolidate the HSC's comments and concerns
into concise and meaningful communications back to each investigator;
- serve as signatory authority for documentation
requiring HSC Chair approval;
- work cooperatively with investigators, committee
members and HSC support staff; foster dialogue between committee
members and manage disputes when necessary;
- provide leadership to the HSC, participate
in training and orienting new members, and give input on related
policies, procedures and educational materials governing the
protection of human subjects;
- conduct expedited reviews; in conjunction with
the IRB Administrator, develop and coordinate a team of experienced
reviewers to provide expedited review;
- serve as faculty spokesperson for the HSC and
uphold HSC decisions; and
- in conjunction with the IRB Administrator and
other committee members, serve as a resource to researchers
who are planning or conducting human research.
HSC Vice Chair
- understand principles and regulations governing
the protection of human research subjects; and
- act on behalf of the HSC Chair in his/her absence,
and serve as delegated signatory authority for the Chair as
needed
HSC members
Individuals who serve on the HSC are responsible
for understanding ethical, legal and regulatory issues related
to the protection of human research subjects. Specific responsibilities
include, but are not limited to:
- conduct reviews as assigned by the IRB Administrator
in time to present findings at the regularly convened HSC meeting;
- conduct reviews as assigned by the IRB Administrator
in time to present findings at the regularly convened HSC meeting;
- notify the IRB Administrator if a need is identified
for an outside consultant to provide additional expertise;
- attend every scheduled HSC meeting or provide
adequate notice to the IRB Administrator when absences will
be necessary; help determine whether alternate members must
be present on their behalf;
- fully participate in discussions regarding
each project reviewed by the HSC;
- maintain integrity of the HSC review process,
recuse themselves from board discussions or deliberations when
there is a conflict of interest, and avoid discussing HSC protocols
with investigators outside of convened HSC meetings;
- review and approve meeting minutes; and
- notify the HSC Chair or HRPP Director if members
experience undue influence related to the review of research
protocols
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