Institutional Review Board (IRB)

The UConn Institutional Review Board is charged with reviewing all research involving human participants conducted by faculty, students or staff that is conducted at or makes use of the facilities of UConn.

Authority from the Institution

The ORC/IRB has the responsibility to review and the authority to approve, require amendments of or disapprove research involving human participants conducted by UConn faculty, students or staff, or such research involving the use of UConn facilities, in accordance with administrative policies and procedures established for this purpose. The IRB shall monitor and conduct continuing review of such research at intervals of at least once per year.

The IRB, or its staff acting on behalf of the IRB, has the authority to inspect research facilities and to obtain records and other relevant information relating to projects it has approved and to observe, or have a third party observe, the consent process and research. The IRB affords protections to participants, and may suspend or terminate approval of projects it has approved and take actions that it judges necessary to ensure compliance with regulations and internal policies. Review and approval must be obtained from the IRB prior to a research project being initiated.

Reliance on IRBs of Other Institutions

The IO at UConn may elect to rely on the IRB of other institutions for review and approval of a study. In order to do so, that IRB must be officially designated on UConn's Federalwide Assurance and a written agreement must be in place between the two institutions. This is generally used when a study involves UConn and a facility with which a close working relationship exists (e.g., Yale University, Hartford Hospital, or the UCHC). In such an event, the IRB of the other institution, referred to as the IRB of Record, holds the same rights, authority and responsibility as the IRB of UConn.

Authority of Institutional Individuals

The IO of UConn may not approve a project that has not received the review and approval of the IRB or which has been disapproved by the IRB. In addition to the IRB, the IO may require additional review of research and has the authority to disapprove, suspend or terminate research previously approved by the IRB.

Purpose of the IRB

The primary purpose of the IRB at UConn is to ensure that proposed research studies involving human participants encompass the ethical principles of the Belmont Report and the protections provided by regulations and internal policies. The IRB application solicits relevant information pertaining to study design, recruitment procedures, inclusion and exclusion criteria, risks to participants and the procedures used to minimize those risks, possible benefits, procedures used to protect privacy and confidentiality and to obtain informed consent. Initial review and approval must occur prior to study initiation. Subsequent reviews, for expedited and full board studies, occur at least on an annual basis.

Membership of the IRB

The membership of the IRB is constituted in accordance with 45 CFR 46.107 and 21 CFR 56.107. The IRB has at least five members at all times. The membership will satisfy the requirements of having a non-scientist, a non-affiliated member, and a prisoner representative (whose presence is required when the IRB is reviewing a study involving prisoners). The membership will consist of individuals from various areas of expertise and various ethnic backgrounds and will also be composed of both genders. The membership of the IRB is registered with the Office for Human Research Protections (OHRP). The IRB Administrator will report changes in IRB membership to OHRP in a timely manner.

    Appointment of IRB Members
    On an as needed basis, the VPRGE or AVPR will seek input from the IRB Chair, Vice-Chair, IRB members, and Department Heads regarding appointment of new members. Potential new members will be identified to fulfill the needs of the IRB. The Chair, in coordination with the AVPR and ADRC, will identify preferences from those recommended. The ADRC will discuss the issue of being appointed to the IRB with the potential member. If interested in serving on the IRB, the ADRC will verbally inform the VPRGE's office, and the VPRGE will issue the official appointment letter. Appointment periods are up to three years, but are determined in accordance with the availability of the new member.

    The VPRGE appoints the IRB Chair and Vice-Chair. Appointment periods are for one year. The Chair will be employed by UConn, have at least 2 years of previous IRB experience, have a social sciences or biological sciences background, be familiar with clinical and social research and have demonstrated ability to work in committee. A member selected by the Chair and AVPR will be invited to serve as Vice-Chair. The Vice-Chair must be a UConn employee, have at least one year of previous IRB experience, and have a social sciences or biological sciences background. Consideration will be given to length of time on the IRB, thoroughness of reviews and attendance at meetings when selecting a Chair and Vice-Chair. The VPRGE will issue an official appointment letter to the Chair and Vice-Chair.

    Exceptions to the appointment process may occur. For example, if an individual expresses an interest in becoming an IRB member, the AVPR in consultation with the Chair may choose to appoint the individual.

    Responsibilities of IRB Members
    The responsibilities of IRB members include attending regularly scheduled meetings, generally once every three to four weeks. Members must thoroughly review all materials to which they are assigned as a primary reviewer, be prepared to present and discuss the material at the meeting, review and have a familiarity with all other material to be presented at the convened meeting such that they can participate in the discussion of all studies, reviewing all materials prior to the convened meeting, possessing an understanding of the principles of the Belmont Report and regulations pertaining to human participant protections, applying those principles and regulations to the review process, reviewing IRB minutes, and providing input/feedback on new policies that relate to the IRB. Members are responsible for excusing themselves from the deliberation and vote on any study for which they have a conflict of interest.

    The amount of time required for review of each study will vary based on the complexity of the study. In general, a primary reviewer should expect to devote between 1 to 2 hours on each assigned review and 30 minutes for other reviews. A reviewer is typically assigned 1 to 2 studies per meeting. Therefore, members should expect to commit between five to fifteen hours per month to IRB-related duties.

    The Chair is responsible for reviewing and approving exempt and expedited applications, or delegating this responsibility to appropriate IRB members, making the final determination as to the type of review required and appropriate approval categories, running the convened IRB meetings, giving final approval to studies that had been approved with amendments required, and serving as a resource to investigators and IRB members and staff. The Chair should expect to commit approximately 2 to 3 additional hours per week to IRB related duties.

    The IRB staff, in consultation with the Chair, assigns reviewers for full board reviews, ensuring that the primary reviewer will have the appropriate experience and scholarly or scientific expertise. An experienced member is considered to be one who has completed the required training and attended at least 6 IRB meetings. For initial review of studies subject to FDA oversight, the primary reviewer will be an M.D. or Pharm.D. If the Chair determines that the IRB does not have the appropriate expertise, the study will be referred to an outside expert. Newly appointed members will not be assigned as a primary reviewer prior to attending at least one meeting and completing training requirements.

    Due to the absence or unavailability of the Chair, the Vice-Chair is authorized to perform all functions of the Chair. The Chair may also delegate some or all duties to another IRB member who is experienced and has the appropriate expertise. For example, if the Chair and Vice-Chair are unavailable on the date of a scheduled convened meeting, an experienced member may be asked to chair the meeting, conduct expedited reviews, sign documentation, etc. The IRB roster will be used to identify such members. If the delegation of tasks is to someone other than the Vice-Chair, it will be noted via memo (e-mail) from the Chair to the IRB member with a copy given to the IRB Administrator to be kept on file with the IRB meeting minutes. Note: reference to the Chair throughout this document refers to the Chair, Vice-Chair or delegated IRB member unless otherwise noted.

    The IRB must operate in an environment free from undue influence. Any member of the IRB or IRB staff who believes that undue pressure is being brought to bear on him/her or any other member of the IRB must report the concern to the AVPR. Reporting may occur through the Chair to the AVPR, or directly to the AVPR. The IRB member reporting the concern should provide the name(s) of the individual(s) who may be creating the undue influence, the name(s) of who may be being influenced, and a summary of the situation, e.g., an associate professor being pressured to vote for approval of a full professor's study. The IRB member may choose the method of communication. The AVPR will follow through with the appropriate action based on the significance of the information presented. (Refer to the section on reporting undue influence).

    A member not fulfilling his/her obligations may be asked to step down by the Chair, the VPRGE, or the AVPR. Any member of the IRB may express a concern related to the performance of another member to the Chair, AVPR, or ADRC. Based upon findings, the Chair and/or AVPR may take no action, hold a discussion with the member regarding expectations and performance, or require that the member step down.

    Liability of IRB Members
    Members of the IRB are either employees of or acting as agents of the UConn Storrs. When acting in the capacity of either employee or agent, and in accordance with IRB standard operating procedures, members are indemnified by the State of Connecticut. Employees are indemnified (for actions not willful, wanton or malicious) by virtue of their status as State employees. Community members are indemnified by receiving an appointment to the faculty of UConn. This appointment is an administrative acknowledgment only. The VPRGE will issue a letter of appointment for the community member.

    Voting by IRB Members
    All members present at a meeting are expected to vote on studies presented to the full board. If a member abstains from voting that abstention will be counted as a vote of no and the member's presence will count towards quorum.

    A member cannot review or vote on a study, whether it is for initial review, continuing review, a request for modification, or other action such as a vote on actions to take regarding unanticipated problems or noncompliance, if: 1) the member is involved with the study as an investigator or participant, 2) the member has a conflict of interest with the study (refer to Conflict of Interest section for definition.) and/or 3) the member arrived late to the meeting after discussion of the study was complete. Members who cannot vote on a specific study for reason number 1 or 2 may provide information to and/or answer questions from the committee but cannot be present for the deliberations and voting and cannot count towards quorum for that particular vote.

    A majority vote of the members present will be required to carry a motion. In general, the vote will be taken by a show of hands and the number for, against and abstaining will be reflected in the minutes. The Chair reserves the right to use an alternate method of voting, such as by ballot, if it is deemed necessary.

    The Chair may not review or approve an expedited or exempt study for which s/he has any conflict as noted above.

    All studies approved through the exempt or expedited review process, and amendments to full board studies approved through expedited review, are presented on the agenda of the next regularly scheduled meeting. Any member may request that a study or modification previously approved through expedited review require full board review. A majority vote of the members present will decide the issue. If the vote is in favor of full board review the Chair will contact the PI, or direct the IRB staff to do so, to withdraw the approval until full board review is conducted. Notification will be done via memo (e-mail). This is not considered a suspension or termination of approval that is reportable to the IO or agency heads.

    Decisions made at a full board meeting will supersede any decisions made through the expedited review process. Should the full board vote to negate approval previously granted, the withdrawal of approval is considered a termination of approval. The IRB will inform the VPRGE and AVPR of this decision, via a copy of the minutes, and the VPRGE will report to other institutional officials, as necessary, and agency heads, as required. The investigators will be informed via letter from the IRB Chair and instructed to inform any previously enrolled participants of the termination.

    Alternate IRB Members
    The VPRGE may appoint alternate IRB members using the official appointment process noted above. The VPRGE may elect to appoint an alternate member if the volume of studies requiring a specific expertise increases or for other reasons that the AVPR deems appropriate. For example, an increase in the number of studies involving prisoners may require the appointment of an alternate prisoner representative to cover those meetings for which the regular member cannot attend. If implemented, the IRB Administrator adds appointed alternate members to the official IRB roster, processes the registration with the OHRP and indicates on the roster and the registration form the identity of the member or class of members for whom the alternate may serve. An alternate member will have an area of expertise similar to the member for whom s/he is designated to serve as the alternate. Alternate members will be called upon on an as needed basis. Alternate members will have sufficient time for review of material prior to meetings and will receive the same material for review that the regular IRB member would have received.

    Ad-hoc Reviewer/Consultant
    At its discretion, the IRB may enlist the help of an internal or external reviewer who is not a member of the IRB. Such reviewers will be called upon when, in the opinion of the IRB, someone with a specific expertise is needed to conduct a thorough review of a study or to address specific questions related to a study. Such reviewers will have full access to that specific file. The reviewer, acting as a consultant to the IRB, may submit written comments to the IRB and/or participate in discussions and make recommendations to the IRB at a convened meeting but will be excused prior to deliberations and voting. Participation of an ad-hoc reviewer will be noted in the minutes of the IRB meeting. The Chair may determine that a consultant is required at the time of initially assigning reviewers, a reviewer may request that a consultant be called upon once assigned to a protocol, or the IRB may come to this conclusion at a meeting. Assigned reviewers may also contact colleagues directly for consultation. If a colleague is consulted, the reviewer must document 1) that s/he has affirmed that the consultant-colleague has no conflict of interest with the study or sponsor and 2) the name and comments of the consultant-colleague. This documentation will be included in the IRB study record. Conflict of interest for a consultant-colleague is defined in the same manner as a conflict of interest for an IRB member (refer to section title Conflicts of Interest).

    Ad-hoc reviewers/consultants will first be sought by the Chair from within the institution and asked to provide the review as a courtesy to the IRB. No UConn employee will be paid for conducting a review. If an individual cannot be identified within the institution, an external consultant will be sought. The operating budget of the ORC will pay for such consultation if payment is required. No consultant may have a conflict of interest with the study for which s/he is being asked to review. Conflict of interest for an ad-hoc review-consultant is defined in the same manner as a conflict of interest for an IRB member (refer to Conflicts of Interest section). The Chair or Vice Chair will determine that no conflict exists in the course of communication with the consultant and document that such determination was made.

    Compensation to IRB Members
    Members receive no direct monetary compensation. The operating budget of the ORC/IRB covers expenses associated with continuing education of members. For members who are also UConn employees, service on the IRB is recognized by the faculty promotions committee.

    IRB Member Evaluation
    In July of each year the performance of IRB members will be evaluated. Elements taken into consideration will include attendance, number of studies reviewed (new and continuing), the ability to apply ethical principles to the review process, the thoroughness and clarity of presentations, contributions to discussions, and participation in educational activities. The Chair will evaluate committee members and the AVPR will evaluate the Chair. The VPRGE will receive and review the forms.

    Hiring and Evaluation of IRB Support Staff
    The VPRGE and AVPR are responsible for hiring IRB staff. The hiring of staff is done in compliance with Human Resources and Union policies. Applicants may also be asked to interview with other individuals such as the Chair, Vice Chair or ADRC. Performance evaluations are done on an annual basis using the standard UConn employee evaluation form.

ORC/IRB Relationships

IRB/ Vice Provost for Research and Graduate Education (VPRGE): The VPRGE is the highest ranking individual charged with the responsibility of research compliance oversight and is the IO. The VPRGE receives copies of the approved IRB minutes and of correspondence related to 1) audit results; 2) issues of noncompliance; 3) unanticipated problems involving risks to participants or others and 4) suspensions or terminations of IRB approval.

IRB/ Assistant Vice Provost for Research/Director of Research Compliance (AVPR): The AVPR reports to the VPRGE and is responsible for the daily operations of the ORC and is in direct communication with the VPRGE regarding developments, policies and procedures related to all elements of the HRPP. The AVPR receives copies of the approved IRB minutes and of correspondence related to 1) audit results; 2) issues of noncompliance; 3) unanticipated problems involving risks to participants or others and 4) suspensions or terminations of IRB approval.

IRB/Office of the Attorney General: The IRB works with the Office of the Assistant Attorney General (AG) at the Storrs Campus on a range of significant legal issues, including litigation, contractual review, and responses to change in federal and state law. The IRB requests the AG's office to participate in certain relevant meetings when deemed appropriate to the discussion. The AG's office may provide the IRB with information that pertains to the protections of human participants in research such as information pertaining to Connecticut laws or revisions to or new federal regulations.

If the IRB or any component of the compliance staff learn of information that may pose risk to a participant's safety or to the safety of others, and that risk does not pertain directly to the topic of the research study, the IRB consults with the AG's office for legal advice on whether any action, and if so what action, should be taken.

IRB/Office of Audit, Compliance and Ethics: The mission of the office of Audit, Compliance and Ethics is to assist the University and the Health Center in achieving their financial, operational and strategic goals while maintaining compliance with all associated laws and/or regulations. The Office accomplishes this goal by identifying institutional risks, performing audits, reviews and investigations; augmenting institutional compliance through effective education and training programs; and fostering the values of knowledge, honesty, integrity, respect and professionalism outlined in the University's Code of Conduct.

IRB/Office for Sponsored Programs (OSP): The AVPR works closely with the Executive Director and Assistant Vice Provost for Research Administration to ensure that grant applications are reviewed by the IRB as required and that the Executive Director is informed of reportable instances of noncompliance, unanticipated problems or suspensions or terminations of IRB approvals for sponsored research. The AVPR and Executive Director meet at regular VPRGE staff meetings and raise any relevant issues.

IRB/Institutional Biosafety Committee (IBC): UConn Storrs established an IBC in accordance with the "NIH Guidelines for Research Involving Recombinant DNA Molecules". Additional guidelines are provided by the Center for Disease Control (CDC) in their "Biosafety in Microbiological and Biomedical Laboratories" handbook. The University also complies with other applicable state and federal regulations. The IBC reviews research and teaching activities that involve recombinant DNA (rDNA), potentially hazardous biological materials and/or biological toxins. The purpose of this review process is to ensure that University activities comply with government regulations and provide appropriate safeguards for human health and the environment. The IBC meets at least four times per year and consists of University faculty and community representatives as proscribed by the NIH. As part of the initial review process, the IRB ensures that protocols that are reviewed by the IBC that also involve human participants have been reviewed and approved by the IBC prior to IRB approval.

IRB/Conflict of Interest in Research Committee (COIC): The COIC serves as the resource with respect to matters involving individual conflicts of interest in research. Its responsibilities include the identification and management, or mitigation or elimination of specific conflicts of interest. The committee consists of not less than five faculty members with broad representation from the University, and one community member who is not a University employee. At the time of proposal submission to the Office for Sponsored Programs (OSP), all investigators and key personnel are required to submit a Significant Financial Interest Review Form to OSP. If any investigator listed on a protocol application was required to submit the follow-up form, "supplemental" Significant Financial Interest Review Form, a copy of the form must be submitted with the IRB application as part of the initial review process. (Refer to the Conflicts of Interest section for more information.)

IRB/Embryonic Stem Cell Research Oversight Committee (ESCRO): The ESCRO provides oversight of all issues related to the derivation and research use of human embryonic stem cell lines at all schools, colleges, campuses, and research arms of the University regardless of the source of funding. The ESCRO ensures that sensitive research is well-justified and that inappropriate research is not conducted. Review by the ESCRO supplements but does not replace the usual reviews for compliance with federal, state, and local regulations provided by the IACUC, the IBC and the IRB. As part of the initial review process, the IRB ensures that protocols that are reviewed by the ESCRO that also involve human participants have been reviewed and approved by the ESCRO prior to IRB approval.

IRB/Collaborating Institutions: The IRB application solicits information from the PI to determine where the research procedures are to take place and if a collaborating institution is involved in a research study. The IRB staff will assist the investigator in determining if an institution is merely a performance site or if it is "engaged in research covered by 45 CFR 46" and must therefore operate under a valid Federalwide Assurance. In making this determination, the IRB staff will follow the OHRP Guidance that institutions are so engaged when their employees or agents (1) intervene or interact with living individuals for federally supported research purposes or (2) obtain individually identifiable private information for federally supported research purposes. Institutions receiving federal awards are automatically considered to be engaged in covered research regardless of where the research activities are carried out.

If the information is not provided to the IRB, the PI will be asked to clarify the issue and provide supporting documentation to the IRB or to work with the IRB to ensure proper assurance is obtained through OHRP. In appropriate situations, the ADRC will facilitate the signing of a Collaboration Agreement between the institutions.

IRB/IRB of UConn Health Center (UCHC): An agreement is in place between the IRBs of UConn Storrs and the UConn Health Center whereby one institution may rely upon the IRB of the other institution for review, approval and oversight of a study. The IRB of record is generally determined by where the majority of participant enrollment and study procedures will occur. Unless one will accept a copy of the other's IRB application, each institution's protocol application must still be submitted to each site. The IRB Chairs at each institution will make the final determination as to which site will serve as the IRB of record. Investigators will be informed in writing by the UConn ORC/ IRB staff of the decision to serve as the IRB of record or to accept a UCHC panel as the IRB of record.

IRB/IRB of Hartford Hospital: An agreement is in place between the IRBs of UConn Storrs and Hartford Hospital whereby one institution may rely upon the IRB of the other institution for review, approval and oversight of a study. The IRB of record is generally determined by where the majority of participant enrollment and study procedures will occur. Both IRBs' protocol applications or, if the IRBs agree, a copy of one IRB's application must be submitted to each site. The IRB Chairs at each institution will make the final determination as to which site will serve as the IRB of record. Investigators will be informed in writing by the UConn IRB staff of the decision to serve as the IRB of record or to accept Hartford Hospital as the IRB of record.

IRB/IRB of Yale University: An agreement is in place between the IRBs of UConn Storrs and Yale University whereby one institution may rely upon the IRB of the other institution for review, approval and oversight of a study. The IRB of record is generally determined by where the majority of participant enrollment and study procedures will occur. Both IRBs' protocol applications or, if the IRBs agree, a copy of one IRB's application must be submitted to each site. The IRB Chairs or their designee(s) at each institution will make the final determination as to which site will serve as the IRB of record. Investigators will be informed in writing by the UConn IRB staff of the decision to serve as the IRB of record or to accept Yale University as the IRB of record.

IRB/Sponsor: In most cases, contact with sponsors is either through the Office of Sponsored Programs, while negotiating a contract, or through the PI. However the IRB reserves the right to contact the sponsor directly to clarify issues pertaining to the grant application. The IRB expects all sponsors to conduct research in accordance with federal regulations and the principles of the Belmont Report.

IRB/Principal Investigator and Key Personnel: The members and staff of the IRB work with investigators throughout the conduct of a study. The IRB staff is available to answer questions and assist in the preparation of materials for submission. Assigned reviewers may contact investigators directly to have questions addressed by the PI. The IRB reserves the right to invite principal investigators to attend meetings to explain a proposed study. The Chair will determine when it is appropriate for an investigator to attend. The investigator may be present to answer questions or provide explanations but must not be present during deliberations and voting. The IRB expectations of investigator responsibilities are described later in this document.

IRB/Independent Investigator: Any investigator not affiliated with UConn Storrs, with a collaborating institution with an approved FWA, or otherwise covered by a contract between UConn and a sponsor, will be required to submit an Independent Investigator Agreement form which will be modeled on the template provided by the OHRP. The form will commit the investigator to comply with all relevant IRB determinations, federal and state regulations, and local policies pertaining to the prospective review of studies and protection of human participants in conducting a study. Independent investigators will also be asked to complete the same disclosure of conflict of interest form that employees of the institution are required to complete. The conflict of interest committee will be asked to review such disclosures and determine if a conflict exists, if it is manageable and if so what actions must be implemented for that management.

IRB/Research Participants: Most contact with research participants will be through the PI or other study personnel. Direct contact between the IRB and a participant may occur if the participant calls to express a complaint or concern, if the IRB or its designee observes the consent process, or if the IRB solicits information regarding an individual's experience as a research participant for purposes of quality improvement.

IRB/IRB Support Staff: The support staff of the IRB is responsible for managing the review and approval process of studies. Responsibilities for administrative staff include, but are not limited to, the following:

  • Screening applications for completeness prior to review by Chair or the full board
  • Preparing the meeting agenda
  • Preparing and mailing packets for committee members prior to meetings
  • Assisting with taking minutes at convened meetings
  • Maintaining meeting files
  • Entering new studies into the data base
  • Tracking studies in the data base
  • Sending reminder notices for continuations and notices of protocol expiration
  • Reviewing submitted revisions to determine amendments were made, as requested, prior to IRB approval
  • Maintaining files for approved studies
Responsibilities for professional staff include, but are not limited to, the following:
  • Acting as a resource for investigators and other study personnel by answering questions related to preparing applications, completing forms, complying with regulations and internal policies
  • Acting as a resource for the IRB Chair and members by providing regulatory guidance, acting as liaison between investigators and the board, and assisting with the development of policies and procedures
  • Taking minutes at convened meetings
  • Preparing correspondence to PIs
  • Conducting preliminary reviews of expedited and exempt applications in preparation for the primary reviewer

IRB/IRB Education and Compliance Monitor (IRB Monitor): The IRB Monitor reports directly to the AVPR and works closely with the IRB Chair and staff. The IRB Monitor conducts audits of approved studies, including audits of the IRB review process. The Chair and Vice Chair receive copies of the audit correspondence that is prepared by the IRB Monitor and signed by the AVPR The correspondence may include oversights of the IRB during the review process, recommendations for corrective action, or requirements for suspension or termination of a study.

General Meeting Information

IRB meetings are not public meetings. Guests, including PIs, may attend only at the invitation of the Chair. The IRB reserves the right to invite investigators to attend meetings to explain a proposed study. Guests and PIs may partake in discussion, but will be excused at the time of deliberations and voting.

The meeting will be called to order when a quorum is reached. At least 50% plus 1 of members must be present, including a non-scientific member and a non-affiliated member. One member may fulfill both requirements. A non-scientific member's primary activity does not relate to the field of social sciences, medicine, dentistry, nursing, pharmacy, other biomedical health professions, or medical or dental research. A non-affiliated member is not employed by or retired from, or otherwise compensated by the institution, and is not involved on any other governing board of the institution. The IRB staff will ensure that a quorum is maintained throughout the convened meeting. If quorum is lost, the IRB may take no further action or vote until quorum is restored. However, members remaining in attendance may provide guidance about the protocol to the PI. Members may be considered present via video or teleconferencing that allows for two way communication. The IRB roster will be used for attendance at the meeting to ensure that a quorum has been met. IRB files will be available and accessible during convened meetings.

IRB Meeting Agendas

The IRB staff prepares the meeting agenda. The agenda includes:

  • conflict of interest statement
  • a list of studies approved during the previous month by the expedited review process
  • a list of studies approved during the previous month and determined to be exempt from continuing IRB review
  • a list of amendments to full board protocols that were approved during the previous month by expedited review process
  • a follow-up report on the status of protocols that were previously reviewed by the full board
  • minutes for review and approval
  • new studies submitted for full IRB review
  • studies to be reviewed for continuation
  • requests for approval of an amendment
  • adverse event report submissions
  • protocol deviation report submissions
  • miscellaneous discussion items

IRB Meeting Minutes

Minutes will be taken at all convened meetings. Minutes will reflect:

  • members, staff and guests present
  • date and start and stop time
  • minutes of the previous month's meeting for review and approval
  • new studies approved via exempt and expedited review during the previous month
  • amendments to full board protocols approved via expedited review during the previous month
  • protocol number, title, PI, primary reviewer, grant reviewer, and vulnerable population, if applicable
  • summary and findings of each project discussed,(new studies, continuing review, requests for amendments, amendments, or other)
  • vote to approve, request amendments, not approve, or abstain
  • interval of IRB approval, if less than one year
  • maintenance of quorum, and a notation of when a member leaves or joins a meeting
  • identity of any IRB member recused from deliberations and voting because of a conflict of interest
When applicable, minutes will also reflect:
  • attendance of any member who is serving as an alternate, and the identity of the member for whom they are the alternate
  • applicable regulations, e.g., under what category prisoner research funded by DHHS is allowable
  • protocol specific information for how criteria for vulnerable populations are satisfied
  • information justifying an alteration to or waiver of informed consent
  • the requirements that were met to grant a waiver of the requirement to document consent
  • the rationale for a determination of significant risk or non-significant risk for device studies
  • review of the grant application in addition to IRB application
  • review and approval of data safety monitoring plans/boards
  • discussion and determination regarding unanticipated problems involving risk to participant or others
  • discussion and determination regarding serious or continuing noncompliance
  • discussion and determination of any suspension or termination of IRB approval
  • other controverted issues and the outcome of those issues
  • other discussion items and the motion and vote of those discussions
  • a justification of any deletion or substantive modification of information concerning risks or alternative procedures contained in the DHHS-approved sample informed consent document
  • review and approval of economic considerations/participant payment.
The approved minutes are sent to the IO, AVPR, and IRB members by the IRB Administrator.

IRB Files

IRB files and documentation are considered privileged information. Every effort will be made to maintain confidentiality and non-disclosure of this information. The IRB staff will maintain a file (electronic and hard copy) containing the minutes and the agenda for each convened meeting, plus a report of expedited and exempt approvals and a protocol status report.

That IRB staff will also maintain study specific files. These files will contain all documentation submitted by the investigator for IRB review, (initial review, continuing review, amendments), correspondence from the IRB to the investigator, correspondence from the investigator to the IRB, adverse event reports, reports of injuries to participants, statements of significant new findings provided to participants, and when applicable investigator brochures, grant applications, results of scientific reviews and audit reports. The IRB staff will maintain study files by assigned protocol number, with the most recent activity being in the front of each folder within the file. Files will have a designated section for adverse event and protocol deviation reports.

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