Last Revised: 10.2015
Prior Version: 7.2007
Board Meetings
Introduction
This policy outlines the operational activities and actions of the IRB of CWRU to comply with
federal regulations on IRB functions and operations in the review of research.
When is IRB approval required?
The responsibility for initial determination whether an activity constitutes research involving
human subjects rests with the investigator. The investigator should make this determination
based on the federal definitions of “human subject” and “research.” Investigators may request a
confirmation that an activity does not constitute human subjects research from the IRB Office.
All requests must include sufficient documentation of the activity to support the determination.
Determinations regarding activities that are either clearly or clearly not human subjects research,
may be made by the IRB Manager. Determinations regarding less clear-cut activities will be
referred to the IRB Chair, who may make the determination or refer the matter to the full IRB.
Documentation of all determinations made through the IRB Office will be recorded and
maintained.
If a study involves “research” and “human subjects” as defined by 45 CFR 46, then investigators
are required to submit an application to the CWRU IRB via the iRIS system for approval prior to
any study procedures beginning - including the recruitment of study participants and the
collection of data. Research studies involving human subjects for student theses and
dissertations always require prior IRB approval. Data collected before approval is obtained is in
non-compliance with University policy and cannot be used for research.
The IRB will review and ensure that non-exempt research involving human subjects meets all
required ethical and regulatory criteria for initial and continuing review and any modifications of
approved research. The IRB may conduct their review using the follow review methods:
 Expedited Review
 Review by Convened IRB
What are the roles of the IRB Office?
The IRB Manager and HRPP staff are responsible for making determinations of exemption,
screening protocols for necessary components before sending to IRB member(s), answering
investigator questions, facilitating IRB review of protocols, maintaining records, providing
required written documentation of IRB actions. The IRB Manager also serves as a member of the
IRB Advisory Committee (IAC). If there are any questions about human study participants’
research or Case IRB procedures, please contact the IRB Office at cwru-irb@cwru.edu or 216368-6925.
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The federal regulations at 45 CFR 46.103(b)(2) and the Common Rule require CWRU to provide
its IRB with sufficient meeting space and to support the IRB’s review and record-keeping
responsibilities. The IRB shall include the administrative personnel to manage the processing of
the application to the IRB and managers to establish operating procedures to promote
consistency and efficiency. The staff receives mentoring and training on the job. They also
participate in the CREC training program required of the IRB members and investigators.
Additionally the IRB staff attends national meetings/conferences. Staff receives periodic
performance evaluations at least on an annual basis by the Associate Vice President of Research
Administration.
Once an application has been submitted to the IRB office, when can research begin?
No research may be initiated until the Case IRB has given a protocol full approval with no
revisions. An investigator must wait to receive this approval in writing before initiating research.
Verbal approval is not acceptable. Any data collected before obtaining written approval is in
non-compliance with University policy and cannot be used for research purposes.
IRB Meetings
The CWRU social and behavioral IRB usually meets on the first Tuesday of each month. The
agenda, along with meeting materials, is sent to IRB members five to seven days in advance of
the meeting via iRIS. Once the agenda is finalized, an automated email is sent to the board
members to notify them that the materials are posted. Protocols may be submitted to the IRB at
any time via iRIS. Protocols that require Full Board review must be submitted to the IRB office
at least two weeks before the next meeting (i.e., approximately the middle of the month before
the meeting date). Deadline dates are listed on the CWRU IRB website. If an investigator does
not submit a protocol requiring full board review before the monthly deadline date, the review
will automatically be placed on the agenda for the following month’s meeting. It is important to
keep the deadline dates in mind in order to avoid delays.
Some protocols are delayed because they require multiple full board reviews due to protocols
that require substantial revision or additional information. The IRB cannot approve protocols
that are lacking required information or that are unclear. Careful preparation of the application
by the investigator helps to avoid such delays. Protocols are not reviewed unless the submission
is complete.
All research not falling into an expedited, exempt or not human subject research category require
full board review and approval (i.e., review and vote by a majority of members of the IRB at a
convened meeting). Research involving children, the cognitively impaired, pregnant women,
fetuses, and the educationally and economically disadvantaged may require full board review
and approval. Other areas requiring full board review include initial and continuing review of
research that is determined to involve greater than minimal risk, and any other continuing
review, change requests or adverse event that the Chair or expedited reviewer requests receive
full board review.
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Except for unusual circumstances, each IRB member receives a copy of all full board meeting
materials approximately five (5) days prior to the meeting. These materials include the complete
initial/continuing review application or change request, as well as all other materials submitted
with the application, which usually includes the following: attachments, correspondence with the
IRB office and/or members, previous change requests, adverse event reports, and reports of
unanticipated problems. The Case IRB Manager is responsible for tracking quorum and, in
conjunction with the IRB chair, determines whether meetings are appropriately convened.
Policy
To comply with the federal regulations regarding human study participants in research (45 CFR
46), the Case IRB must consist of at least five (5) members. These members are appointed by
the University’s Vice President of Research and Technology Management “…to promote
complete and adequate review of research activities commonly conducted” at the University. In
addition to faculty members with expertise in scientific areas, the IRB includes at least one
member whose primary concerns are in a nonscientific area. Also, at least one member must be
from the community, and must not be affiliated with the institution. The IRB Office is
responsible for ensuring that at each meeting at least one non-scientific member is present.
The IRB may, in its discretion, 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 IRB; these
consultants, however, do not vote with the IRB.
Reviewer System
The IRB staff will assign a primary reviewer to each protocol based upon expertise. The IRB
Office is responsible to ensure that at least one reviewer has the required scientific and scholarly
expertise required to review the protocol. If the research involves prisoners, the IRB staff will
assign a prisoner representative as the primary reviewer. If a primary or secondary reviewer with
the appropriate scientific, scholarly, or cultural expertise and background is not available, the
IRB office will seek out a reviewer within or outside of CWRU to serve as a consultant and
utilize that person as the appropriate reviewer.
The primary reviewer is responsible to review all materials in depth and present the research
proposal at the convened meeting of the IRB. A secondary reviewer is responsible to review all
materials in depth, substitutes for the primary reviewer if the latter is absent at the meeting, and
otherwise provides an additional level of review and discussion. After the primary and
secondary reviewers have presented their comments, all Board members discuss the documents
received for review and add their comments.
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Meeting Procedures
The IRB Chair (or Vice-chair in the Chair’s absence) calls the meeting to order, once it has been
determined that a quorum is in place (educational presentations may commence before a quorum
is established). The Chair will check for and remind IRB members to recuse themselves from
the discussion and vote by leaving the room where there is a conflict of interest. The IRB will
review and discuss the IRB Minutes from the prior meeting.
The IRB uses technology in its meetings to assist the Board in meeting regulatory requirements.
As each study is considered/presented, appropriate sections of the IRB application,
protocol/study design, consent forms and other documents are projected for members'
information and discussion. The IRB reviewers’ comments pertaining to the review of the IRB
submission can be viewed by the full board via the projected documents. The reviewers are also
able to review any necessary checklist pertaining to the review of the IRB submission.
The IRB reviews all submissions for initial and continuing review, as well as requests for
amendments. The Primary and Secondary Reviewer present an overview of the research and
lead the IRB through the completion of the regulatory criteria for approval in the “Institutional
Review Board - Protocol Review/Initial Review” checklist. In order for the research to be
approved, it must receive the approval of a majority of those voting members present at the
meeting. Before closing the meeting, the Chair will ensure that the members have the
opportunity to comment on the monthly report of the actions taken by the IRB using the
expedited review procedures, which includes a listing of the approved protocols (new studies;
continuing reviews; and amendments to approved protocols).
Quorum and Voting
A majority of IRB members including at least one member whose primary concerns are in
nonscientific areas must be present at a convened IRB meeting. A protocol must receive
approval of a majority of the IRB members present at a meeting for it to be approved. The IRB
Office staff is responsible for monitoring the members present at convened meetings to
determine that the meetings are appropriately assembled and remain appropriately convened.
When quorum is lost during a meeting, the IRB must not take further actions or votes until the
quorum is restored. If the quorum cannot be restored, the meeting adjourns. Abstentions count
toward the quorum but not toward the required voting majority. The Chair counts towards
meeting quorum.
Minutes of a Convened Board Meeting
It is the policy of IRB that the minutes of a convened Board meeting will contain the relevant
information as stipulated by federal regulations (45 CFR 46.115(a)(2)).
Procedures for Documentation of IRB meeting Minutes:
An IRB non-voting staff member will attend each committee meeting and will draft detailed
notes to document the discussions and determinations of the Board for each agenda item. The
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Minutes of each IRB meeting will document the separate deliberations, actions, and votes for
each protocol undergoing initial or continuing review by the convened IRB, and the vote on all
IRB actions including the number of members voting for, against, and abstaining. The minutes
must be sufficient in detail to demonstrate:
 The IRB Chair, with the assistance of the IRB Manager, will confirm that quorum is present
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before calling the meeting to order. The IRB Manager, will be responsible to ensure that the
IRB meeting remains appropriately convened. The IRB Manager will document the time of
arrival and departure for all IRB members and notify the IRB Chair if a quorum is not
present.
Minutes of IRB meetings will contain sufficient detail to show the presence of a quorum
throughout the meeting. The attendance list shall include those members present at the
beginning of the meeting. The minutes will indicate, by name, those members who enter or
leave the meeting. The vote on each action will reflect the numbers of members present for
the vote on that item. Members who recuse themselves because of conflict of interest are
listed by name and the reason documented.
Attendance at the meeting for each IRB action, to include:
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If an alternate is present and who they are representing.
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The initial and continued presence of a majority of members (quorum), including
at least one non-scientist.
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If a consultant is present for each protocol discussed, the minutes must document
his or her attendance and protocol comments.
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Attendance of unaffiliated member(s) is documented at convened meetings.
If a Committee Member is excused from the meeting due to a conflict of interest during
the discussion and vote on the study. The name of the committee member is also
recorded.
Actions taken by the IRB (e.g. approved; modifications required to secure approval;
deferred; and disapproved
The discussion of any controverted issues and their resolutions, and documentation of a
consultant’s findings.
If the IRB reviews research that involves categories of subjects vulnerable to coercion or
undue influence, one or more individuals who are knowledgeable about or experienced in
working with such subjects are present.
The basis for required changes in research.
The basis for disapproving research.
The level of risk involved in the research (i.e., minimal or greater than minimal risk).
The approval period for initial and continuing review.
Justification for any change in study design or risk level for amendments, including those
submitted with the continuing review.
The vote on the actions including the number of voting “for; against; and abstaining.” In
order to document the continued existence of a quorum, votes should be recorded in the
minutes using the following format: Total = xx, For: xx, Against: xx, and Abstained: xx.
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Determinations required by the regulations (e.g., waiver or alteration of informed
consent; research involving pregnant women, human fetuses, or neonates; research
involving prisoners; research involving children); and protocol specific findings
justifying those determinations.
Justification for deletion or substantive modification of information concerning risks or
alternative procedures contained in any DHHS-approved sample informed consent
document.
When the suspension of an approved protocol is considered, documentation of the
discussion on whether to allow for continued treatment of enrolled subjects must be
included.
Notice of Committee Reports
The Notice of Committee is a monthly report of the actions taken by the IRB using the expedited
review procedures; and includes a listing of the approved protocols (new studies; continuing
reviews; and changes to approved protocols). Each month, the report is generated by the IRB
staff and sent to all IRB members.
Distribution and Approval of the Minutes
Draft minutes will be prepared by the IRB staff and forwarded to the IRB for review. The Board
members will receive copies of the minutes electronically. The minutes will be reviewed at a
convened meeting of the Board. Any requested revisions will be discussed and incorporated in
the minutes. The approval of the finalized minutes will be documented in the minutes of the
meeting, along with documentation of the vote (i.e., the number of votes “for,” “against,” and
“abstaining”) if it is not unanimous.
Notification of Action and Review of Responses
The IRB office reviews exempted protocols and sends investigators exemption notices via the
electronic IRB system. However, the full IRB reviews all studies in need of full review and one
or more IRB members review all studies eligible for expedited review. When Full and Expedited
reviews involve major or minor modifications to secure approval, written notification of the
IRB’s action, together with the reason(s) for its decision are provided to the Principal
Investigator/Responsible Investigator. The results of IRB actions are conveyed in writing
usually within one week of a convened IRB meeting at which the protocol was considered.
Furthermore, when a primary reviewer (either through Full Board or expedited review)
determines that additional modifications or clarifications are required, these are also forwarded
in writing to the Responsible/Principal Investigator. All communications are sent by the IRB
Administrative staff.
The investigator must respond to all IRB requests and enquiries in writing or in person. When an
investigator responds to the IRB actions, these correspondences are reviewed by the IRB
members to determine whether the information provided satisfies the Board’s requests and the
criteria for IRB approval. The information can be reviewed by expedited review (when the
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investigator has agreed to the changes requested by the IRB or the protocol is eligible for review
using the expedited procedure). Otherwise, the modifications are reviewed by the convened IRB.
When the IRB disapproves a protocol, the Principal Investigator/Responsible Investigator is
provided with written notification for the reason(s) for the disapproval; however, a detailed
critique of the protocol is not provided. The investigator is instructed to contact the IRB office
with any questions and may attend an IRB meeting to discuss the study. An investigator may
rewrite and submit the study as a new protocol if they wish, but must take into account the
Board’s concerns and reason(s) for the disapproval of the protocol.
Investigators at IRB Meetings
IRB meetings are not usually open to investigators. The IRB, in rare cases, may invite an
investigator to attend during part of the discussion of his or her protocol to respond to questions
from members of the IRB or provide additional information. The investigator would not be
present during the final discussion about the protocol or the protocol vote.
Visitors at IRB Meetings
A visitor is anyone who is not a voting or non-voting member or the IRB, or an employee of the
IRB Office or Office of Research Administration. Visitors may attend an IRB meeting with the
approval of the IRB. The IRB reserves the right to allow a visitor to remain in the room during a
vote or not. Visitors who attend meetings of the IRB must sign a Confidentiality Agreement.
Copies of signed Confidentiality Agreements will be kept on file in the IRB Office.
Institutional Oversight of Federalwide Assurance
A complete copy of the current CWRU Federalwide Assurance (FWA) is maintained in the
Office of Research Administration, and is available at the CWRU Research Administration
website and office. The Vice President of the Office of Research and Technology Management
has the ultimate responsibility for the institutional commitment made in the institution’s Federal
Wide Assurance (FWA); and is the designated Signatory/Institutional Official (IO) for the
Institution and the HRPP. The Institutional Official is appointed by; and reports to the Provost
and President of CWRU. The IO is authorized to act for CWRU and, accordingly, the Vice
President of the Office of Research and Technology Management is authorized to assure that
CWRU complies with the terms of the FWA and is ultimately responsible for the review and
conduct of human subjects’ research conducted or supported by CWRU. The Office of Research
Administration possesses knowledge about the requirements of federal regulations, applicable
state law, the institution’s Assurance, and institutional policies and procedures for the protection
of human subjects. The CWRU Assurance is based on the following principles in order to
safeguard the rights and welfare of human participants in research and other research activities.

CWRU faculty, staff, and students, which comprise its schools, departments, divisions,
and facilities, are subject to the Assurance and this policy. This includes any research for
which an Assurance or another formal agreement (e.g., IRB Authorization Agreement)
identifies the CWRU IRB as the IRB of Record.
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CWRU agrees to uphold the ethical principles of The Belmont Report to all proposed
research involving human participants. The ethical principles set forth in The Belmont
Report are:
o
Respect for Persons: Recognition of the personal dignity and autonomy of
individuals and special protection for those persons with diminished autonomy.
o
Beneficence: Obligation to protect persons from harm by maximizing anticipated
benefits and minimizing possible risk of harm.
o
Justice: Fairness in the distribution of research benefits and burdens.
CWRU further agrees to apply equivalent regulations such as the DHHS regulations (45
CFR 46), and the Health Insurance Portability and Accountability Act of 1996 (HIPAA),
when applicable, to all research involving human participants regardless of funding.
CWRU prohibits anyone including CWRU officials, investigators, employees, and sponsors
from attempting to or using undue influence with the CWRU IRB, any of its members or staff, or
any other member of the research team to obtain a particular result, decision, or action. “Undue
influence” means attempting to interfere with the normal functioning and decision making of the
CWRU IRB or to influence a IRB member or staff, or any other member of the research team
outside of established processes or normal and accepted methods, in order to obtain a particular
result, decision, or IRB action.
If a CWRU IRB committee member, principal investigator, research participant, or other
individual feels that he/she has been unduly influenced (e.g., coerced to participate, approve a
study, or conduct a study), a report should be made to any HRPP staff member, who will ensure
that it is relayed to the Associate Vice President for Research. Such reports will be reviewed,
investigated, and, when appropriate, corrective actions will be taken. Appeals related to IRB
policies and procedures (including investigator concerns or suggestions regarding the review
process) may be reviewed by the CWRU IRB. [Element I.3.B]
Responsibilities of the IRB under the Federalwide Assurance
All information provided under the CWRU Assurance must be updated at least every 36 months,
even if no changes have occurred, in order to maintain an active Assurance approved by OHRP.
Amendments to the Assurance must be reported promptly (within 90 calendar days) to OHRP.
This includes changes to IRB rosters and the addition or deletion of an IRB Chair or legally
recognized entity related to CWRU. Changes in IRB membership are reported to OHRP by the
Office of Research Administration. An IRB member can only be designated as “non-affiliated”
if he/she and or his/her immediate family members do not have any affiliation (including past
employment) with institutions within the Case HRPP.
Institutional Review Board Advisory Committee (IAC)
The Office of Research Administration, in conjunction with the CWRU IRB Advisory
Committee (IAC) members, will identify new information that might affect the HRPP, including
laws, regulations, policies, procedures, and emerging ethical and scientific issues. CWRU IAC
members will disseminate this information to their HRPP administrators, investigators and their
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research staff, and the IRB members and staff through written communication (i.e., IRB
websites) or verbal presentations. The IAC will also determine whether the required Continuing
Research Education Credit (CREC) Program should be revised based on any new information.
Investigators are encouraged to monitor the IRB, CREC and HRPP Web sites for new postings.
References and/or Regulatory Citations:
45 CFR 46
Belmont Report
CWRU Website for Federalwide Assurance
OHRP Assurance Information
OHRP IRB Registration
OHRP Policy Guidance
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