Human Research Protection
Program (HRPP)
DOMAIN II: RESEARCH COMPLIANCE
OFFICE, INCLUDING the IRB
Chapter 6:
Structure and Composition of the IRB
The structure and composition of the STANFORD* Institutional Review
Board (IRB) is appropriate to the amount and nature of the research reviewed.
(AAHRPP Standard II-1.)
6.1 Scope
of IRB Authority
The IRB derives its authority from both federal regulatory and
institutional sources. Institutional
authority is conveyed by the Vice Provost and Dean of Research (Dean of
Research) through approval of this chapter and other chapters of the HRPP
Manual. Additionally, the Dean of Research issues a direct, written delegation
of authority under an institutional Charge to IRB members upon their
appointment to the IRB (see Charge to IRB members (medical
and nonmedical). The Dean of Research in turn has the
authority delegated
to him or her from the President of Stanford University (President). On a day-to-day basis, the IRB reports to the
Dean of Research, through the RCO Director.
However, the IRB Chair, an IRB member, or the convened IRB may refer a
matter directly to the President on those extraordinary occasions when it may
be deemed warranted.
The IRB has the statutory and institutional authority to take any action
necessary to protect the rights and welfare of human research participants involved
in research. For example, the IRB assesses
suspected or alleged protocol deviations, participant complaints, or violations
of external regulations or STANFORD policies.
The IRB has the authority to suspend or terminate the enrolment or
ongoing involvement of research participants in research as it determines
necessary for the protection of those participants. The IRB also has the authority to observe or
monitor any human research to whatever extent it considers necessary to protect
research participants. (45 CFR 46.109,
46.112, and 46.113). See http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.
Upon request, the IRB shall review and comment on proposed external
regulations dealing with human research.
When appropriate, the IRB will formulate draft policies and procedures
for approval by the appropriate STANFORD bodies and promulgation by the Dean of
Research.
Decisions of the IRB
IRB approval is always necessary before a research project involving research
participants may begin. An IRB decision to not approve a human research project,
or require modifications as a condition for approval, cannot be overturned by
any STANFORD official or STANFORD committee.
The IRB must provide the investigator with a written statement of the reasons
for not approving proposed research and must give the investigator an
opportunity to respond in person or in writing.
The IRB must carefully and fairly evaluate the investigator’s response
in reaching a final determination.
If an investigator has
concerns with respect to procedures or decisions of the IRB, the investigator
may discuss his/her concerns with the Dean of Research with the understanding
that neither the Dean of Research, the Provost, nor
any other STANFORD official or committee may approve a protocol that has not
been approved by the decision of one of the Panels, nor apply undue pressure on
the Panel to reverse a decision. Investigators
must first put their concern(s) in writing to the Dean of Research, who may use
his or her sole discretion to determine the process for responding to an
investigator’s concern, including:
Reporting Obligations within
STANFORD
The IRB is administered by
the RCO and reports to the President through the Office of the Dean of
Research. The Dean of Research is the
institutional official responsible for assuring compliance with STANFORD
policies and external regulations on the use of human research participants,
and is the head of the STANFORD HRPP. IRB Chairs prepare annual reports to the
President, summarizing the nature and volume of the IRB activities.
Responsibilities
to Regulatory Agencies
The IRB must
comply with the requirements of all relevant federal regulatory and compliance
enforcement agencies or offices, including OHRP and FDA, as well as relevant
agencies of the State of
6.2 Relationships between the IRB and Others
The IRB is required at times to participate with other programs or
research compliance committees at STANFORD that also have responsibility for
the ethical oversight of research within the HRPP. In some cases, the approval of another STANFORD
body may be required prior to or in addition to IRB review. Such cases include:
Radiological Safety: If a study
involves any radioisotopes or radiation-producing machines, the protocol is
forwarded to the Radiation Safety Officer (or delegate). If review by the Administrative
Panel on Radiological Safety is required, the IRB will not issue approval until
that panel issues its approval.
Biosafety: Gene transfer
studies and human subject protocols using biological agents must be approved by
the Administrative Panel on Biosafety (APB) in addition to obtaining IRB
approval.
Conflict of Interest: Each protocol
event – initial review, modification, or continuing review – requires
disclosure of financial holdings for all personnel involved in the proposed
research. Investigator conflict of interest identified during protocol submission,
must be reviewed by the Conflict of Interest Committee, and as appropriate,
adequately dealt with so as to safeguard the rights, welfare, and safety of the
research participants prior to IRB approval of the research.
See Chapter 3.7 for policy on Investigator Conflict of Interest.
The
The
The Veterans Affairs Research and Development (R&D)
Committee: Human research involving
facilities or personnel of the Department of Veterans Affairs Palo Alto Health
Care System (VAPAHCS) must be approved by the IRB prior to being placed on the
agenda of the VAPAHCS R&D Committee (http://www.palo-alto.med.va.gov/research.asp)
for review and approval.
Stem Cell Research Oversight: Any human research involving human stem cells
must be reviewed by the Stem Cell Research Oversight Panel (SCRO) as well as the IRB. See RPH 10.7.
Relationships with Industry Sponsors
and Other
Unless specifically required by the FDA or requested by the sponsor, the
IRB will not routinely provide written notification of IRB decisions to industry
sponsors and other holders of INDs or IDEs (STANFORD sponsor-investigators
excepted). For FDA-regulated research,
clinical investigators generally serve as the link between the IRB and the
sponsor, and are required to do so by the FDA in compliance with their
obligations as clinical investigators. This
relationship is agreed to by investigators when they sign FDA Form 1572 (for
drug and biologic studies) or an investigator agreement for device studies.
There are occasions when direct communication between the IRB and the
sponsor may facilitate resolution of concerns about study procedures or
specific wording in an informed consent document. The IRB staff may engage in such direct
communication on behalf of the IRB when the IRB Chair or the RCO Director considers
it desirable. The clinical investigator
will be kept apprised of such communication.
The FDA indicates that direct communication between the sponsor and the
IRB may be appropriate when the IRB does not accept a sponsor’s Nonsignificant
Risk (NSR) designation of a medical device (21 CFR 812.66). Direct communication between the sponsor and
the IRB is required for the waiver of informed consent in planned emergency
research relative to (a) the public disclosures required under 21 CFR 56.109(a)(7)(ii),(iii);
or (b) disapproval of such a waiver under 21 CFR 50.24(e).
6.3 IRB Composition and
Membership
The IRB has a qualified Chair, members and staff whose membership and
composition are periodically reviewed. The IRB staff, Chair, and members have
the knowledge, skills and abilities appropriate to their respective roles. (AAHRPP Element II.1.D)
Each IRB has a qualified Chair, members and staff whose membership and
composition is reviewed and adjusted annually by the RCO Director and the Dean
of Research. This review ensures that
individual IRB Chairs and members have the knowledge, skills and abilities
appropriate to their respective roles and perform their responsibilities in an
acceptable manner.
Stanford policy requires that the IRB be constructed according to DHSS
regulations and FDA regulations (45 CFR 46.107 and 21 CFR 56.107).
Additionally,
Furthermore, in compliance with national VA research standards, the IRB
must satisfy the following requirements:
Appointment of Members and Alternates, Length of Service, and Duties
IRB members are nominated from a variety of sources, including previous
IRB members, division chiefs, department chairs, compliance administrators, faculty,
hospital pharmacy and nursing staff, research laboratories, Associated Students
of Stanford University (ASSU), and various public groups. Consideration is given to balancing race,
gender, expertise, and cultural backgrounds.
People with active licensure from various clinical disciplines are
sought. A background knowledge of and
current familiarity with affiliated institutional concerns (e.g., the VA, LPCH,
SHC) helps ensure that the local research context is brought to IRB deliberations. Sensitivity to issues such as community
attitudes and international dimensions is valued. During the three months prior to October 1st
(the start date for the IRB year) newly identified nominees are contacted by
the HRPP Associate Director (or delegate) about their willingness to voluntarily
serve on the IRB and their availability for the coming year. When a nominee agrees to serve on the IRB,
his or her CV and any relevant correspondence are reviewed by the RCO Director
and Dean of Research.
STANFORD recognizes that officials who administer research programs may
be in a position to influence programmatic and budgetary decisions and exert
undue influence on IRBs or individual IRB members. To avoid such influence on IRB
determinations, the Dean of Research, School Deans, and other Stanford
University officers will not serve as voting members of the IRBs, unless there
are compelling reasons to do so. Such
reasons must be justified in writing, approved by the President of Stanford
University, and include specific measures to manage any conflict of interest or
the possibility of undue influence.
After an extensive review of a potential member’s education, experience
and other characteristics that might add diversity to the IRB, a new IRB member
is formally appointed by the Dean of Research.
Members serve one-year renewable terms (from October 1 to September
30). At the conclusion of the IRB year
(and interim, if needed), members’ contributions are evaluated by the IRB Chair
with the IRB manager (See Chapter 4). If
their service is satisfactory, and continued membership is mutually desired, they
are eligible for reappointment.
Members are responsible for ensuring that the rights and welfare of
research subjects are protected. Members
vote to approve, require modifications in, disapprove, or defer research
submitted to the IRB. Members are
expected to attend IRB meetings on a regular basis, serve as primary reviewers
for research within their areas of expertise, and serve as general reviewers on
all research. Members may also be asked
to participate in subcommittees, audits, and education, as long as there is no
conflict of interest with their IRB responsibilities or their other personal or
professional roles.
Qualification
to Perform Expedited Review
An IRB member may perform
protocol review according to the expedited procedure when the IRB Chair, in
consultation with the IRB manager and IRB Training Specialist, determines that
the member is "experienced" with regard to this purpose. There are
several ways a member may achieve sufficient experience, including attendance
at IRB meetings, targeted education, working with a mentor, independent study,
and previous IRB service. See Chapter 7 for more information.
Appointment of IRB Chair, Length of Service, and Duties
IRB Chairs are nominated from a variety of sources, including previous
and current IRB members, division chiefs, senior deans, department chairs, and
compliance administrators. In addition
to the characteristics sought in an IRB member, these individuals possess
demonstrated skills in leadership and group process. Typically, they have served on an IRB
previously.
IRB Chairs are formally appointed by the Dean of Research. Chairs serve one-year
renewable terms (from October 1 to September 30). At the conclusion of the IRB year (and
interim, if needed) the IRB Chairs’ contributions are evaluated by the Dean of
Research with the RCO Director (See Chapter 4). If their service is satisfactory, and their
continued service is mutually desired, they are eligible for
reappointment.
In addition to the responsibilities of IRB membership, the Chair has
primary responsibility for conducting IRB meetings and working with staff to
ensure effective and efficient operation of the IRB within all applicable
regulatory requirements. The IRB Chair
works with IRB members, institutional officials, and investigators to ensure
that the rights and welfare of research participants are adequately protected.
Compensation of IRB Members
IRB Chairs' departments receive a percentage of their salaries to offset
the time dedicated to IRB duties. IRB members generally do not receive monetary
compensation for their service on the IRB.
However, it is recognized that service on the IRB requires a significant
investment of time for all members.
IRB members who are not otherwise affiliated with STANFORD or its
collaborating institutions are compensated for their service by the issuance of
an honorarium. As stated in OHRP
guidance at http://www.hhs.gov/ohrp/IRBfaq.html#q11,
compensating unaffiliated members in this way does not create an affiliation or
cause a conflict of interest.
Alternate IRB Members
Alternates replace regular IRB members who are unable to attend convened
meetings of the IRB. They are required
to have the same qualifications and characteristics of expertise and diversity
as the regular IRB members for whom they substitute. When an alternate substitutes for a regular member,
the IRB staff provides the alternate member the same material that the regular member
received or would have received.
IRB membership rosters specify which regular member each alternate
member is qualified to replace. The
expertise or qualifications of alternate members are similar to those of the regular
member they replace, and in some case, alternate members are able to represent
similar interests or a specific vulnerable population. Terms of appointment, length of service, and
duties are exactly as for regular IRB members.
Alternate members must adhere to the same conflict of interest standards
and documentation requirements as regular IRB members.
If an alternate member attends a convened meeting at which his or her regular
member is voting, the alternate member does not vote. Ad hoc substitutions for regular
or alternate IRB members are not permitted.
Ex Officio IRB Members
An ex officio member is designated as an IRB member by virtue of that
individual’s office. For example, if the chair of the Administrative Panel on Radiological
Safety changes hands, that ex officio IRB membership changes hands accordingly
and does not remain with the individual who has left that office. Some ex
officio members serve on other STANFORD compliance panels and may provide
expertise to IRB members. Ex officio members may participate in the IRB
deliberations to provide information and expertise as requested by the
IRB. Ex officio members are expected to
adhere to the same conflict of interest standards and documentation
requirements as are regular IRB members and alternates. Ex officio members may not vote on any IRB
action or determination, and for this reason are sometimes referred to as
“non-voting” members.
Medical IRBs accept permanent ex officio representatives from the
following areas:
Nonmedical IRBs accepts permanent ex officio representatives from the
following areas:
The IRB may accept additional permanent ex officio members with the
agreement of a majority of IRB members, the IRB Chair, and the RCO Director.
Liability Coverage for IRB members
Support of IRB Membership
The IRB has a qualified staff, dedicated to supporting the IRB in its
mission to protect human participants in research. The IRB staff teams are
reviewed at least annually by the RCO Director and the Dean of Research to
ensure they continue to provide sufficient resources to the IRB. The IRB staff has knowledge, skills and
abilities appropriate to their respective roles. The RCO Director oversees the RCO Deputy
Director, the HRPP Associate Director, and the CQI Associate Director, and is
responsible for the overall management of the RCO. See the RCO
Organization Chart
For policies on qualifications, education and periodic evaluation of RCO
staff, see Chapter
4.
6.4 Scientific and Scholarly Expertise of IRB Members
The IRB uses a “primary reviewer” system. The IRB manager, in consultation with the IRB
Chair where appropriate, assigns protocols to primary reviewers, based on each
individual’s scientific, scholarly, professional, or clinical expertise. Primary reviewers must have the relevant
expertise to conduct an in-depth review of the protocols to which they are
assigned. If the IRB manager cannot
identify a primary reviewer with the appropriate scientific or scholarly
expertise, the IRB manager arranges for expert consultation and will not place
the protocol on an agenda until appropriate expertise is made available. Primary reviewers are expected to conduct an in-depth
review, and it is the responsibility of primary reviewers to notify the IRB
Chair or IRB staff should they feel unqualified or unable to do so. In such cases, the IRB Chair will assign
primary review responsibilities to another member who is appropriately
qualified or obtain consultation from one or more experts outside the IRB (see
below).
When the IRB reviews research that involves categories of participants
vulnerable to coercion or undue influence, the review process includes one or
more individuals who are knowledgeable about or experienced in working with
these participants (children, pregnant women, adults unable to consent, students,
etc.). The IRB staff reviews each
application to determine whether it involves participants vulnerable to
coercion or undue influence, and considers the participant population when
assigning reviewers.
The IRB is constituted to possess and make use of collective knowledge
of applicable regulatory and legal requirements; knowledge of professional
standards and practices; knowledge of the local research context and research
sites, and their capabilities and limitations; knowledge of community standards
and attitudes; scientific, scholarly, clinical, and professional expertise;
racial, ethnic, and cultural diversity; and representation of participants’
perspectives.
6.5 Obtaining Additional Expertise
The STANFORD IRB has a process for obtaining additional specific expertise
when needed to review protocols. (AAHRPP
Element II.1.B)
The IRB Chair or IRB staff reviews the proposed convened meeting agenda
and determines whether the IRB has the required expertise to review upcoming research. If not, the IRB Chair will invite individuals
with competence in the specific areas needed to assist in evaluating issues
that require expertise beyond or in addition to that available on the IRB. On an as-needed basis, an IRB primary
reviewer may invite individuals with competence in special areas to assist in evaluating
specific issues
Reasons for seeking additional or special competence from outside
experts may include (but are not limited to) the need for additional
scientific, clinical, or scholarly expertise; the need for particular knowledge
and understanding about potentially vulnerable populations of subjects; the
desire to ensure appropriate consideration of race, gender, language, cultural
background, and sensitivity to such issues as community attitudes.
Additional expertise may be obtained through a member of another IRB, or
individuals from various Schools and Departments within
or from:
IRB staff or the IRB Chair makes initial contact with a proposed
consultant and notifies the consultant of the IRB member conflict
of interest policy (See Chapter 6.6).
When a consultant is used, that fact and the pertinent information gained from
the consultant’s assessment is documented at the time of the protocol
discussion and recorded in the IRB minutes. In some cases, a consultant may provide the
IRB with a written report of his or her assessment which is kept with the
protocol file. The IRB staff can assist
in making the consultation arrangements and in obtaining the required conflict
of interest documentation.
All consultants, internal or external to
The Guidance
for Obtaining Additional Expertise or an Expert Consultant addresses the
use of consultants in further detail.
6.6 IRB
Member and Consultant Conflicting Interest
The IRB has written
guidelines so that IRB members and consultants do not participate in the review
of protocols in which they have a potential conflict of interest, except to
provide information requested by the IRB.
(AAHRPP Element II.1.C) (45 CFR 46.107(e); 21 CFR 56.107(e))
Guidelines
for IRB Members on Conflicting Interest includes definitions of conflicting
interest and outlines procedures for
recusal.
This policy applies:
This policy applies to all
projects reviewed by the IRB, regardless of whether the project is exempt or
considered during full, expedited, or continuing review. This policy also
applies to reviews of non-compliance reports and unanticipated problems
involving risks to participants or others.
IRB Member’s Disclosure of a Conflicting Interest
IRB members who realize they
have a conflicting interest when they are first assigned a protocol or report for
review must notify the IRB staff or IRB Chair immediately so that the protocol can
be reassigned.
IRB members review the draft
Agenda List before a convened meeting with the issue of conflicts in mind. Any
conflicting interest for protocols to be voted on must be reported to the IRB
Chair or RCO Director before the meeting whenever possible.
The IRB Chair begins each
meeting with a reminder that proceedings are confidential. This is followed by
a reminder of the requirement that each member must disclose any conflicting
interest and recuse him or herself from the discussion of and vote on the
project by leaving the room, except if the member is providing information at
the IRB’s request. If an IRB member
realizes at a meeting that he or she may have a conflicting interest in a given
project, then that should be disclosed to the IRB Chair immediately, orally and
in writing on the IRB Member Conflict
of Interest Declaration.
Consultant’s Disclosure of a Conflicting Interest
The definition of conflicting interest as defined in the Guidelines
for IRB Members on Conflicting Interest extends to any consultant who may
be asked to review a protocol. The IRB Manager
who contacts a consultant to enquire about review of a project is responsible
for asking if the consultant has a conflicting interest in the project. If such an interest exists, then the protocol
will not be assigned to the consultant. If no COI is declared, the consultant is asked
to complete a Consultant
Conflict of Interest Declaration for inclusion with the minutes of
the meeting.
If a consultant with a
conflicting interest is the only appropriate resource for the IRB, (e.g., is
the only scientist with sufficient technical understanding of the project) and
if that consultant has been asked to provide information to the IRB, then the conflict
of interest must be disclosed to the IRB members reviewing the protocol or
present in the convened meeting where the information is presented. Such a consultant is excluded from discussion
except to provide information requested by the IRB, and must leave the meeting
room during discussion and voting.
6.7 Assessment and Evaluation
of the IRB
The composition and membership of each IRB is evaluated annually by the
RCO Director and the Vice Provost and Dean of Research and is adjusted as
needed to ensure appropriate knowledge of applicable regulatory and legal
requirements; knowledge of professional standards and practices; knowledge of
the local research context and research sites and their capabilities; knowledge
of community standards and attitudes; scientific, scholarly, clinical, and
professional expertise; racial, ethnic, and cultural diversity; and
representation of participants’ perspectives.
Due to the increased complexity of human research protocols submitted,
this often results in adding members.
The composition of each IRB may change annually as needed.
Education, training and periodic evaluation of IRB members, IRB Chairs,
and IRB staff is discussed in Chapter 4.
6.8 IRB Roster and Quorum Requirements
The IRB membership rosters include sufficient information about members
to permit appropriate representation at the meeting for each protocol under
review. One or more unaffiliated members are represented on the IRB and one or
more members can represent the general perspective of participants. (AAHRPP
Element II.1.E)
An IRB Member database is maintained by the RCO and used as the data
source for all IRB membership roster needs.
The IRB Member database includes all information required under FDA and
DHHS regulations and OHRP guidance (45 CFR 46.107 and 108; 21 CFR 56.107 and
108) including:
Representative capacity is presented in enough detail to indicate which
appropriate participants can be represented by each member (e.g., children,
pregnant women, prisoners, economically disadvantaged, educationally
disadvantaged, cognitively impaired adults, students, recent immigrants, Native
Americans, non-English speakers, international communities). When research
protocols include participants vulnerable to coercion or undue influence, a
member who is knowledgeable about that population, or who has experience
working with similar participants, should be assigned to the project.
Scientific status, (including the designation of “non-scientist” – see Chapter 6.3), is determined during recruitment and annually
upon evaluation of IRB members. Scientific
status and area of scientific expertise (e.g., pediatrician, radiologist, psychologist, anthropologist, pharmacist) are presented
in sufficient detail to allow appropriate protocol assignment and in-depth
protocol review.
Affiliation is determined during recruitment and annually upon
evaluation of IRB members. The role of unaffiliated
members is to represent the general perspective of participants, (see Checklist
for Determining if IRB Members are Unaffiliated.) An IRB
member is considered affiliated if he
or she, or any member of his or her immediate family, has any employment or
other relationship (e.g., current or former employee, consultant, Board of Directors,
volunteer, trainee or student) with any of the STANFORD affiliated entities:
Changes in IRB membership require reporting to OHRP. The HRPP Associate Director (or delegate)
submits a revised IRB membership list to OHRP whenever membership changes
occur, but at a minimum once a year and whenever a new IRB is formed.
The IRB has positions available for student members, filled when
nominated by the ASSU. Student members represent the perspective of
participants in much nonmedical research.
Quorum Requirements and Voting at IRB Meetings
Maintenance of quorum and voting at convened meetings is based on the
following standards:
1.
A majority of the (voting) members of the IRB (or
their designated alternates), including at least one member whose primary
concerns are in non-scientific areas, must be present to conduct a convened
meeting. In order for research to be
approved, it must receive the approval of a majority of such members
present at the meeting.
2.
Members may be present in person or through audio
(telephone) or audio-visual teleconference.
Members present via teleconference shall be noted as such in the meeting
minutes, which shall also indicate that the members received all pertinent
information prior to the meeting and were able to participate actively and
equally in all discussions.
3.
IRB minutes shall include documentation of quorum and
votes for each IRB action and determination by recording votes as follows:
·
Total number voting
·
Number for
·
Number opposed
·
Number abstaining
·
Names of those abstaining.
4.
Members leaving the meeting room due to a conflicting
interest, or for any other reason, will not be recorded as part of the quorum
for a particular protocol.
5.
An individual who is not listed on the official IRB
membership roster may not vote with the IRB.
6.
A non-voting ex-officio member of, or representative
to, a STANFORD IRB may not vote with the IRB.
7.
Ad hoc consultants may not vote with the IRB.
8.
A non-scientist must always be present for any
vote to be taken.
9.
When a member and his/her alternate both attend a
meeting, only one person (generally the individual who performed the pre-review
of protocols for that review cycle), may vote.
10. Voting by proxy is not permitted.
11. If the quorum
fails during a meeting, such as due to lack of a majority of IRB members
being present or an absence of a non-scientist member, the IRB cannot take any
further actions or vote until the quorum is restored.
12. The IRB Manager
is responsible for monitoring the members present at a convened IRB meeting
to ensure that at the beginning of the meeting and for each subsequent vote the
meeting is appropriately convened.
13. When the IRB
reviews research that involves participants vulnerable to coercion or undue
influence, at least one member must be present who is knowledgeable about
or experienced in working with these participants.
14. When the IRB
reviews research that involves prisoners, a majority must have no
association with the prison involved, apart from their membership on the IRB.
15. When the IRB
reviews research that involves prisoners, at least one voting member at
the IRB meeting must be a prisoner or a prisoner representative with
appropriate background and experience to serve in that capacity.
16. When the IRB
reviews VA research at least one of the VA members of the IRB must be
present during the review of VA research.
17. When the IRB
reviews VA research that involves an FDA-regulated article a
licensed physician must be present.
18. When the IRB
reviews VA research that involves mentally disabled persons or persons
with impaired decision-making capacity, an IRB member who is an expert in
the area of the research must be present.
See Chapter 8.3
for information about convened meeting minutes.
6.9 Meeting Times and Materials
The IRB meets regularly and members have sufficient time to review
materials prior to meeting. (AAHRPP Element II.1.F) The IRB meets each month according to a
regular schedule.
Some IRB members, who review protocols according to the expedited review
procedure and confirm exemptions meet on an ad hoc basis as needed.
Individual meetings may be
rescheduled, or additional meetings may be held, as needed by agreement of the
IRB Chair and the RCO Director. Permanent changes to the meeting schedule may
be made by agreement of a majority of IRB members, the IRB Chair, and the RCO
Director.
The deadline for receipt of research
proposals to the IRBs is the first working day of the month preceding an IRB
meeting. For example, the deadline for the March
meeting is February first. However, if
there is room on the agenda of an upcoming IRB meeting, and sufficient time
(generally, a minimum of 72 hours) for review of all relevant materials by the
IRB members, research protocols can be placed on an earlier agenda, as deemed
necessary by the IRB Chair or IRB staff.
Review Preparation Time
The RCO staff assigns protocols and delivers necessary protocol
materials to primary reviewers in sufficient time for them to be reviewed
before the meeting, generally two to four weeks, but not later than 72 hours
before an upcoming meeting. All non-primary reviewers and attending IRB members
receive the necessary protocol materials 5 days prior to the convened meeting. All IRB members receive the agenda and
minutes from the previous meeting approximately five days prior to the meeting.
Materials necessary for review may be presented to IRB members less than 72
hours prior to a meeting only where determined necessary by the IRB Chair or
HRPP Associate Director.
For materials provided to members, see Chapter 7.5 and 7.7.
The standard for members
participating by audio or video conferencing is the same for those attending in
person, giving all members the opportunity to participate fully in IRB
deliberations.