SUBJECT: IRB Membership, Roles, and Responsibilities
PURPOSE: To establish guidelines for the
IRB members, the IRB Chairperson, and other officials, to delineate the
principles, authority, and the responsibilities of the IRB. The
IRB’s primary responsibility is to ensure that the rights, safety, and welfare
of human subjects are protected under the facility’s Human Research Protection
Program (HRPP). The IRB ensures that
human subject research is conducted ethically, and in compliance with Federal regulations, the requirements of state law, the institution’s
policies, and the Federal Wide Assurance (FWA).
The IRB accomplishes prospective and continuing review of this
facility’s human subject research and this includes the review of protocols,
informed consent process, and procedures used to enroll subjects.
POLICY: To appoint the Chairperson and members in compliance with all
applicable federal regulations and to ensure the members are cognizant of the
rules and responsibilities for which they must abide.
SCOPE: The IRB must prospectively review and make decisions concerning all human
subject research conducted under the auspices of
PRINCIPLES:
The basic ethical
principles guiding research involving human subjects are provided in the
Nuremberg Code, the Declaration of Helsinki, and the Belmont Report. Three basic principles contained in The
Belmont Report (http://ohrp.osophs.dhhs.gov/humansubjects/guidance/belmont.htm) are central to the ethics of research
involving human research and guide the IRB in assuring that the rights and
welfare of subjects are protected. These
principles are:
a. Respect for persons, which is applied by obtaining informed
consent, consideration of privacy, confidentiality, and additional protections
for vulnerable populations.
b. Beneficence, which is applied so that
possible benefits are maximized and possible risks are minimized to the
persons, involved.
c.
Justice, which is evidenced in
the equitable selection of subjects.
Definitions:
a. Human Subject Research-Under this organization's policy Human Subject Research is defined as
1. Any activity that meets the DHHS definition of "research" and involves "human subjects" as defined by the DHHS regulations; OR
2. any activity that meets the FDA definition of "research" and involves "human subjects" as defined by the FDA regulations.
b. Research - the Department of Health and Human Services (HHS) and the FDA both have definitions of human subject research:
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(HHS) a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalized knowledge.
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(FDA) any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the Food and Drug Administration or whose data will be submitted to or held for inspection by FDA. There are two types of activities that must meet the requirements for prior submission to the Food and Drug Administration. These are:
1. Any use of a drug, other than the use of a marketed drug in the course of medical practice.
2. Any activity that evaluates the safety or effectiveness of the medical device.
c. Human subject - the Department of Health and Human Services (HHS) and the FDA both have definitions of a human subject:
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(HHS) a living individual about whom an investigator (whether professional or student) conducting research obtains: (1) data through intervention or interaction with the individual, or (2) identifiable private information.
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(FDA) human subject means an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy individual or a patient. In the case of research involving medical devices, a human subject includes an individual on whose specimen a medical device is used.
d. Research - a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalized knowledge, or a clinical investigation. Under FDA regulations research is defined as any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the Food and Drug Administration.
e. Human subject - living individual(s) about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual; or (2) identifiable private information [Federal Policy 46 CFR §46.102(f)]. Under FDA regulations a human subject is defined as [FDA regulations 21 CFR §50.3(g), 21 CFR §56.102(e), 21 CFR §812.3(p): An individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A participant may be either a healthy human or a patient. Or in the case of a medical device: A human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control. A participant may be in normal health or may have a medical condition or disease.
f. Physician is defined, in this document, as anyone with a doctorate-level health science degree (M.D., D.O., O.D., DMD, DPM, PhD., etc.).
g. Private information - information about behavior that occurs in a context which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record).
h. Identifiable means that the identity of the individual is or may readily be ascertained by the investigator or associated with the information.
i. Community Representative - a member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.
If the activity involves a drug other than the use of an approved drug in the course of medical practice, the evaluation of the safety or efficacy of a medical device, or data that will be submitted to or held for inspection by FDA and the activity involves a human subject as defined by FDA regulations, the FDA regulations apply.
The definition of human subject includes
investigators, technicians, and other assisting investigators when they serve
in “subject” roles by being observed, manipulated, or sampled.
RESPONSIBILITIES:
The ethical conduct of research is a shared responsibility among the
Institutional Official, IRB Chairperson, IRB members, the research investigators, and their staff.
Institutional Official (Assurance Signatory Official) – As the Institutional Official, the Vice
President for Research ultimately is responsible for overseeing the protection
of human subjects. He/she must ensure
that open channels of communication are maintained between the IRB, research
investigators, staff, and management. The
Director of the Office of Research Integrity serves as the conduit between the
VP for Research and the IRB. He/she meets at
least quarterly, and whenever necessary, to assure the Institutional Official
is kept abreast of all issues involving human subjects. The VP for Research has an open-door policy
that allows any IRB member, investigator or staff to contact him. He/she is responsible for assuring resources are
allocated appropriately. He/she is
responsible for completing the necessary educational requirements.
Director of the Office of Research Integrity – The Director, Office of Research Integrity,
is responsible for assuring the policies and procedures are accurate and are in
compliance with the federal guidelines.
He/she serves as a non-voting member of the IRB. He/she facilitates communication between the IRB
members, investigators and the VP for Research.
He/she meets with the Institutional Official at least quarterly to report on
the activities of the ORI. Annually, he/she
submits a report to the IO detailing the current human, financial, and physical
resources utilization and any future resource requirements. He/she is responsible for completing the
necessary educational requirements.
Chairperson - In addition to the responsibilities as a
member, the Chairperson has primary responsibility for conducting IRB meetings
and assuring the IRB operates within all applicable regulatory
requirements. The IRB Chairperson works
with the IRB members, institutional officials, and investigators to ensure that
the rights and welfare of research subjects are adequately protected. As a fair
and impartial committee head, the Chairperson functions as a role model for how
IRB business should be conducted. He/she
schedules and conducts the IRB meetings in accordance with Robert’s Rules. He/she assures that all IRB minutes are recorded
accurately and are kept in accordance with federal policy. He/she assures that members having
a conflict of interest on research activities are not allowed to be present to
vote on the research activity. He/she is
responsible for assuring a quorum is maintained when voting. He/she is responsible for completing the
necessary educational requirements. The
IRB Chairperson is protected from liability under the State of
Members/Alternate
Members – Members and
alternate members are responsible for reviewing and monitoring research
involving human subjects and to protect the rights and welfare of
subjects. Members are expected to attend
IRB meetings on a regular basis and alternate members are expected to attend
IRB meetings when possible or as needed.
Members and alternate members serve as primary or secondary reviewers as
assigned by the Chairperson for research within their areas of expertise, and
serve as general reviewers on all research discussed at convened meetings. Members and alternate members are also
expected to conduct expedited reviews on behalf of the IRB when so designated
by the IRB Chairperson. In addition, the
members may be asked to serve as designee to the Chairperson and to participate in
other subcommittees, audits, and education, as long as there is no conflict of
interest with their IRB responsibilities.
The IRB members and alternates are responsible for completing the
necessary educational requirements. IRB members
and alternates must make the ORI Director aware of any immediate family members
who are currently or become affiliated with the organization. The
IRB members and alternates are protected from liability under the State of
Ex-officio member – The IRB Coordinator serves as an ex-officio
(non-voting) member and is responsible for distributing the agenda and research
activity documents, taking minutes, maintaining the roster and quorum
requirements, and
that minutes are distributed, as appropriate, as well as all other duties
detailed in other IRB related standard operating procedures.
AUTHORITY and RELATIONSHIPS:
Authority - The Institutional Official is responsible for all research activities
conducted under the auspices of
Relationships: Although the IRB is a Board administered through the Office of Research
Integrity, neither the Director of ORI nor the VP for Research or other
University official can approve research involving human subjects that has not
been approved by the IRB. If in the
course of its review, a University department requires changes to the protocol
that may relate to the determination of the protection of the human subjects,
the department must refer those changes back to the IRB for its approval
before the research may commence. The
IRB may require that proposed research be reviewed and approved by other
appropriate University committees. The
IRB must report any serious unanticipated problems involving risks to subjects
or others to relevant University officials or committees, to any applicable
sponsors or agencies, and to OHRP. The
Director of the Office of Research Integrity may establish additional reporting
relationships between the IRB and other officials or other committees, as
deemed appropriate.
The IRB may be designated for research review under another
institution’s FWA (or other Assurance) only with the written agreement
of the Institutional Official and in accordance with applicable Office of Research
Oversight (ORO)
requirements. Any such designation must
be accompanied by a written agreement specifying the responsibilities of the
facility and its IRB under the other institution’s FWA (or other
Assurance). The IRB has no authority
over, or responsibility for, research conducted at other institutions in the absence
of such a written agreement.
PROCEDURE:
Chairperson. The
Director of the Office of Research Integrity appoints the Chairperson. Examples of criteria for selection of the
Chairman are: (1) Comprehensive knowledge of the Human Research Protection
Program, (2) Experienced researcher which
can be validated by publications, (3) Uses sound ethical judgment which can be
evidenced by past practices, and (4) Past experience as a chairman or
member of a patient care committee. The
Chairperson serves a 3-year term and may be reappointed. He/She schedules and conducts the IRB meetings
utilizing normal business practices.
He/she ensures a quorum of voting members are present prior to voting on
any agenda items, being especially aware of quorum requirements when
conflict-of-interests arise. The
Chairperson, or his designee, signs all official IRB correspondence unless
otherwise indicated.
Members. The
Director of the Office of Research Integrity appoints IRB members. Members serve 3-year staggered terms, and
are eligible for reappointment. Members
vote to approve, require modifications in, disapprove, or defer research
submitted to the IRB. A fifty-percent
quorum of voting members, including the Chairperson, must be represented at
each meeting to vote on any research activity.
Regular attendance at IRB meetings is essential; therefore, two
unexcused absences (A) or three excused absences (E) within a 12-month period
will be brought to the attention of the Director, ORI, for a determination as to
whether an alternate is necessary. Members who serve as
designee to the Chairman for the conduct of expedited and exempt reviews are
selected based on the following qualifications and experience: (1) Comprehensive knowledge of the Human
Research Protection Program (2) Knowledge and understanding of the criteria for
expedited and exempt review and (3) Experience in the particular field of
research.
The IRB Membership must satisfy the following requirements:
1.
Be
comprised of at least five members.
2.
Possess
varying professional backgrounds to promote complete and adequate review of research
activities commonly conducted at the institution.
3.
Be
sufficiently diverse relative to race, gender, cultural background, and
sensitivity to community attitudes so as to promote respect for the IRB’s
advice and counsel in safeguarding the rights and welfare of human subjects.
4.
Include
persons able to ascertain the acceptability of proposed research in terms of
institutional commitments, regulations, applicable law, and standards of
professional conduct and practice.
5.
Consist
of qualified persons of both genders.
6.
No IRB
will consist entirely of members of one profession.
7.
Include
at least one member whose primary concerns are in scientific areas.
8.
Have at
least one member whose primary concerns are in non-scientific areas. This person must always be present to have a quorum.
9. Include at least one member who is not otherwise affiliated with the VAMC and who is not part of the immediate family of a person who is affiliated with the VAMC. This person must always be present to have a quorum.
Each IRB that reviews VA research requires the inclusion as voting members of the IRB two or more VA employees (at least 5/8 time) who must be appointed as VA representatives by the VA Medical Center Director for a three year term. One of the VA representatives must have a scientific expertise. VA members serve as full members of the IRB and review non-VA research matters coming before the IRB. VA Research and Development administration officials including, but not limited to the Associated Chief of Staff for Research and Development and the Administrative Officer for Research and Development, are prohibited from serving as voting members of the IRB.
Alternate IRB Members. The Director of the Office of Research Integrity appoints, one or more
alternate members to replace regular IRB members who are, on occasion, unable
to attend convened meetings of the IRB.
Alternate members are listed on the IRB’s official membership roster,
which specifies which member (or members) the alternate is qualified to
replace. The backgrounds of alternate
members are similar to the member they are replacing or they should be able to
represent similar interests. Terms of
appointment, length of service, and duties are exactly the same as for regular
IRB members. An alternate may be qualified to replace more than one regular member,
but the alternate at any convened meeting may represent only one such member.
Consultants. On an as-needed basis, the IRB may invite individuals with competence in
special areas to assist in the review of issues that require expertise beyond
or in addition to that available on the IRB. The Director, ORI will identify and
obtain a consultant. The consultants can either provide a written report
to the IRB or attend a meeting. If a consultant provides a written report,
that report will be provided to all IRB members and maintained in IRB records.
If a consultant attends a meeting, the key information provided by consultants
will be documented in the minutes. These individuals may not vote
with the IRB. The IRB will be given the
curriculum vitae or qualifications of the consultant in order to evaluate the
weight to be given to the consultant’s recommendations during protocol review.
IRB Coordinator. The IRB Coordinator distributes the agenda and research documents at
least one week prior to the meeting, maintains the IRB membership roster and
quorum requirements, and takes minutes of the meeting. She/he assures that the minutes are approved
by the Chairman and forwarded to the Director of the Office of Research
Integrity for approval, and finally forwarded to the Vice president of Research
for his/her review. The approved minutes
are distributed to the members of the IRB.
IRB Staff. The Director, ORI is responsible for the selection and appointment of all IRB staff. He/she will determine the requirements to be an IRB staff. All IRB staff will complete the Comprehensive IRB Training Initiative (CITI) course, attend the annual Public Responsibility In Medicine and Research (PRIMR) Conference, and any available subsequent training. The performance of the IRB staff will be evaluated by the Director, ORI on an annual basis.
Quorum Requirements and Voting.
The IRB Coordinator is responsible to monitor the members present at convened meetings and determine that meetings are appropriately convened and remain so.
Quorum Requirements:
- A majority of the IRB members (or their
designated alternates), including at least one member whose primary
concerns are in nonscientific areas AND at least one member who is a
community representative, must be present to conduct a convened
meeting. In order for research to
be approved, it must receive the approval of a majority of those members
present at the meeting.
- Members may be present in person or
audio (telephone) or audio-visual teleconference. Members present via teleconference are
noted as such in the meeting minutes, which also indicates that the
members received all pertinent information prior to the meeting and were
able to actively and equally participate in all discussions.
- IRB minutes include documentation of
quorum and votes for each IRB action and determination by recording votes
as follows: Total Number Voting ( ); Number voting for ( ); Number voting
against ( ); Number abstaining ( )
- Members recusing themselves due to conflicts
of interest may not be counted toward quorum requirements (i.e., may not
be counted among those voting or abstaining) or be counted as among the
majority of members necessary to constitute a quorum.
- An individual who is not listed on the
official IRB membership roster may not vote with the IRB. Proxy votes are not allowed.
- Any ex-officio member of the IRB may not
vote with the IRB.
- Ad hoc consultants may not vote with the
IRB.
- A non-scientist member AND a member
who is not otherwise affiliated with
the institution and who is not part of the immediate family of a person who is
affiliated with the institution must
always be present for a vote to be taken.
- If research involving a FDA regulated article is involved, a licensed physician must be included in the quorum. If a quorum is not maintained, the proposal must be tabled or the meeting must be terminated.
- For research involving prisoners, a majority of the IRB (exclusive of prisoner members) must have no association with the prison involved. At least one member of the board present at the meeting will be a prisoner representative.
Should the quorum fail during the meeting
(e.g., loss of a majority through recusal of members with conflicting interests
or early departures, or absence of a nonscientist member), the IRB may not take further
actions or votes unless the quorum can be restored.
Conflict-of-Interest. No IRB member may
participate in the IRB’s initial or continuing review of any project in which
the member has a conflicting interest, except to provide information
requested by the IRB. The IRB members,
including the Chairperson, who have conflicting interests are required to
disclose such interests and to absent themselves from deliberations, quorum
counts, and votes on the relevant protocol.
Such absences are recorded in the meeting’s minutes as absences not as abstentions. The IRB
must maintain to keep a quorum if votes are taken during absences. For further information consult the standard
operating procedure entitled “Conflict of Interest”.
Confidentiality.
Local IRB Bylaws require an “IRB Member Non-Disclosure Agreement” to be signed
by each member. This agreement will be renewed annually to ensure that all
members are reminded that study materials provided to the IRB are proprietary
and confidential. Study materials may
not be discussed or distributed outside of official IRB business and upon the
conclusion of IRB business must be returned to the IRB Coordinator unless
otherwise instructed by the IRB Chairman.
Procedures for Removal of Members. The IRB has authority to suspend or terminate
the enrolment or ongoing involvement of human subjects in the facility’s
research as it determines necessary for the protection of those subjects. The IRB has the authority to observe or
monitor the institution’s human subject research to whatever extent it
considers necessary to protect human subjects.
Any IRB member may be removed for improper conduct, not acknowledging
conflict-of-interest, and not maintaining confidentiality of the
proceedings. In the event a member is
charged with violating any of the above, the IRB will review the charges and
the collected evidence and by a majority vote, not including the accused, will
result in the recommendation to retain or remove the member from the Board. The IRB Chairman of the results of the IRB
recommendation will notify the Director of the Office of Research Integrity in
writing, before he will make a final decision as to the removal. The accused member will be notified in
writing and a copy will be submitted to the IRB.
Follow Up Responsibility:
Director, Office of Research Integrity
References: Department of Health and Human Services
(DHHS) Regulations at 45 CFR 46;
Federal Policy (Common Rule) for the Protection
of Human Subjects;
Food and Drug Administration (FDA)
Regulations at 21 CFR 50;
38 CFR 16 and 38 CFR 17
Revised 5-1-2007
Guest
Non-Disclosure Agreement
