1.0 Policy Purpose
The purpose of this Policy is to describe the authority, role, and procedures of the Brown University Institutional Review Board (IRB). The IRB ensures the protection of human participants in research conducted under the auspices of Brown University.
2.0 To Whom the Policy Applies
This Policy applies to individuals formally appointed as members of Brown University’s IRB and any individual consultant engaged by the IRB for the review of Human Subjects research.
3.0 Policy Statement
The Brown University IRB is appointed by the Vice President for Research. The IRB prospectively reviews and makes decisions concerning Human Subjects research conducted by individuals serving as a Principal Investigator (PI) on an IRB Application in accordance with the Human Subjects Research Principal Investigator Eligibility Policy (collectively, “Brown Human Subjects research studies”). The IRB discharges its duties in compliance with the requirements of the Federal Policy for Protection of Human Research Subjects (45 CFR Part 46), applicable State regulations, the Federalwide Assurance, and Brown University policies.
3.1 IRB Authority
The IRB is authorized to do the following:
- Approve, Contingently Approve, Defer, Disapprove, or Table Brown Human Subjects research studies;
- Review Reportable Events as set forth in the Institutional Review Board Policy on Reportable Events and Noncompliance;
- Suspend or Terminate Brown Human Subjects research studies being conducted in conflict with the Federal Policy for Protection of Human Research Subjects, applicable State regulations, the Federalwide Assurance, and/or Brown University policies;
- Observe, or arrange for a third party to observe, the consent process for research participants in Brown Human Subjects research studies; and
- Observe, or arrange for a third party to observe, the conduct of any Human Subjects research under its oversight.
3.1.1 Authority of the Institutional Official (IO)
The Vice President for Research is the Brown University Institutional Official for all Human Subjects research studies. Research Approved by the IRB may be subject to review and denial by the Vice President for Research or this individual’s designee(s). The Vice President for Research may not Approve Human Subjects research if it has been Disapproved by the IRB.
3.1.2 Additional Requirements or Conditions
Brown Human Subjects research studies may require review by other Brown University regulatory boards or committees (e.g., the Conflict of Interest Review Board, the Institutional Biosafety Committee, the Radiation Safety Committee) or may otherwise be subject to review in accordance with Brown University policies (e.g., Brown University’s Policy on Handling Allegations of Research Misconduct) or ancillary review processes (e.g., for data security or cultural consultancy). Any changes to previously Approved Human Subjects research studies and/or associated consent forms resulting from these reviews or otherwise must be re-Approved by the IRB before the research may be conducted.
3.2 Number of IRBs
There is one Brown University IRB. The IRB Chair and/or the IRB Chair’s designee(s) will review the activity of the IRB on at least an annual basis and make a recommendation to the IO regarding the appropriate number of IRBs that are needed for the institution. This recommendation will be based on the volume of IRB applications and related post-approval activities subject to its review (e.g., Reportable Events) and the scientific diversity and complexity of the Human Subjects research studies the IRB reviews (e.g., social behavioral research, clinical trials, biomedical research). If additional IRBs are formed, the Chairs of each IRB will work together to ensure cross-coordination across IRBs.
3.3 Roles and Responsibilities of IRB Members
3.3.1 Chair of the IRB
The IRB Chair must have an active appointment and/or employment at Brown University and be fully capable of managing the IRB and the matters brought before it with fairness and impartiality and in a timely manner. It is the primary responsibility of the IRB Chair to ensure the IRB is fair, impartial, and immune to pressure from the institution's administration, the PIs whose IRB applications it reviews, and other professional and nonprofessional sources.
The IRB Chair is responsible for conducting all Convened IRB meetings and for advising the IO and the Office of Research Integrity (ORI) leadership regarding individual IRB members’ performance. The IRB Chair may designate other IRB members to perform duties, as appropriate, related to review, signature authority, and other IRB functions.
The performance of the IRB Chair will be reviewed on an annual basis by ORI in consultation with the IO. If the IRB Chair is not acting in accordance with this individual’s IRB appointment letter or the individual’s conduct is otherwise in conflict with any Brown University policies, this individual may be removed from the position by the IO.
3.3.2 Vice Chair of the IRB
The IRB Vice Chair serves as the IRB Chair in the IRB Chair’s absence and must meet the same qualification criteria set forth for the IRB Chair in section 3.3.1. When acting as the IRB Chair, the IRB Vice Chair has the same authority and duties as the IRB Chair. If the IRB Vice Chair is not acting in accordance with this individual’s IRB appointment letter or the individual’s conduct is otherwise in conflict with any Brown University policies, this individual may be removed from the position by the IO.
3.3.3 All Brown University IRB Member Responsibilities
Regardless of appointment type, all IRB members must adhere to the following requirements:
- Execute their responsibilities in accordance with Brown University policies and applicable federal, state, and local laws;
- Complete human subjects protection training in the Collaborative Institute Training Initiative (CITI) system, including the CITI Basic Course and CITI IRB Member module, and additional training as assigned;
- Provide an updated Curriculum Vitae to the Human Research Protection Program (HRPP) upon request;
- Ensure that the criteria for IRB approval are met for all reviewed assignments;
- Complete any relevant review worksheets or checklists when assigned as a reviewer for a Human Subjects research study;
- Maintain confidentiality for all matters related to service on the IRB, including shredding or otherwise securely destroying any physical or electronic files following review completion; and
- Comply with the IRB Member and Consultant Conflict of Interest Policy.
3.3.4 Subcommittees of the IRB
The IRB Chair may designate one or more IRB members to serve on a subcommittee [or subcommittees] of the IRB to perform certain duties on behalf of the Convened IRB (e.g., conduct investigations, review policies, or develop guidance). Any subcommittee of the IRB will report its recommendations to the IRB Chair and/or the Convened IRB for consideration and approval.
3.4 Composition of the IRB
- The IRB must have at least five members with varying backgrounds (e.g., fields of expertise, understanding of research protocols and content) in order to conduct a complete and thorough review of research activities commonly conducted by the institution.
- The IRB must be sufficiently qualified through the experience, expertise, and diversity of its members to ensure its advice and counsel with respect to safeguarding the rights and welfare of human participants is well-informed.
- The IRB must include at least one member whose primary expertise is in scientific areas and at least one member whose primary expertise is in nonscientific areas.
- The IRB must include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.
- In addition to possessing the professional competence necessary to review specific research activities, the IRB must be able to ascertain the acceptability of proposed research in terms of institutional policies and regulations, applicable law, and standards of professional conduct and practice.
- If the IRB regularly reviews research that involves a Vulnerable Population, consideration will be given to the inclusion of one or more individuals on the IRB who are knowledgeable about and experienced in working with these populations, either as members of the IRB or as consultants.
- IRB membership will represent a diversity of backgrounds and not be limited by race, ethnicity, gender identity, or socioeconomic class.
- IRB membership should not, to the extent practicable, consist entirely of any sole sex or gender identity, so long as no selection is made to the IRB on the basis of either category.
- An IRB member may satisfy more than one membership category.
- The IRB shall not consist entirely of members of one profession.
- Members of ORI may be voting members of the IRB.
3.5 Appointment of Members to the IRB
The IO appoints in writing all members of the IRB. Any change in appointment, including reappointment or removal, requires written notification from the IO. Appointments are for a term of up to three years, with the option for term renewals thereafter.
The IRB Chair and/or ORI will review the composition of the IRB annually to determine if it continues to meet regulatory and institutional requirements.
3.6 Resignation or Removal of Members from the IRB
IRB members serve at will and any IRB member may resign from the IRB by written notification to the IRB Chair, ORI Senior Director, or the HRPP Associate Director. IRB members who are unable to fulfill their membership responsibilities are expected to initiate their resignation with sufficient advanced written notice to allow the IRB Chair and ORI to identify and appoint an appropriate replacement member.
An IRB member’s adherence to the responsibilities set forth in this Policy and further detailed in the member’s appointment letter will be reviewed annually by the IRB Chair in collaboration with ORI. In consultation with the IO, members who are not acting in accordance with their responsibilities may be removed from service on the IRB.
In consultation with the IRB Chair and IO, ORI may remove a member of the IRB at any time to restructure Board composition consistent with the evolving needs of the research community and the IRB’s charge.
3.7 Primary and Alternate IRB Members
Primary and alternate IRB members serve the same functions on the IRB, with differing attendance requirements as set forth in their respective appointment letters. Primary and alternate IRB members are voting members of the IRB; however, when the primary member and corresponding alternate member(s) are present at a Convened IRB meeting, only the primary IRB member’s vote is counted. If a primary member is recused from a vote at a Convened IRB meeting or is not present at a Convened IRB meeting, the alternate member’s vote will be counted. Both primary and alternate IRB members will receive and are expected to review all materials on the agenda prior to a Convened IRB meeting at which they will be in attendance.
The IRB roster identifies the primary member for whom each alternate member may substitute. The IRB minutes will document when an alternate member’s vote replaces that of a primary member. Alternate IRB members are matched to primary members with similar member roles (e.g., non-scientist, scientist) and, when applicable, with similar expertise.
3.8 Use of Consultants (Non-IRB Reviewers)
When necessary, the IRB Chair may solicit individuals from Brown University or outside Brown University with specialized knowledge in certain areas to assist in the review of Human Subjects research studies that require expertise beyond or in addition to that available among appointed IRB members. The need for a non-IRB reviewer is determined in advance of a Convened IRB meeting by the IRB Chair by reviewing the Human Subjects research studies scheduled to be reviewed at the Convened IRB meeting. Non-IRB reviewers will receive all materials relevant to their review prior to the Convened IRB meeting and will be bound by the same confidentiality obligations of IRB members. Any non-IRB reviewer will receive a copy of the IRB Member and Consultant Conflict of Interest Policy and be required to abide by the policy. Non-IRB reviewers are not voting members of the IRB and may not observe the Convened IRB’s vote.
The non-IRB reviewer will present recommendations to the Convened IRB for consideration either in person or in writing. These recommendations will be documented in the IRB meeting minutes. Written reviews provided by the non-IRB reviewer will be filed with the research protocol.
3.9 Convened IRB Meeting Attendance Requirements
Primary members are required to attend at least 75% of Convened IRB meetings on an annual basis. Alternate members must attend at least 50% of Convened IRB meetings on an annual basis.
The Chair is expected to attend and chair all scheduled IRB meetings, and in cases when the Chair’s attendance is not possible, ensure the Vice Chair or another qualified IRB member is appointed to run the meeting. The Vice Chair is expected to attend and vice chair as many scheduled IRB meetings as possible and no less than 75% of annual Convened IRB meetings.
All IRB members are expected to attend Convened IRB meetings for which they have indicated a positive response to the meeting invitation. Occasional attendance via teleconference at in-person meetings is permissible; however, IRB members are expected to be physically present at meetings conducted in-person.
If IRB members are unable to attend a scheduled meeting, they must inform an HRPP team member in advance of the Convened IRB meeting. IRB members assigned to complete a review for a Convened IRB meeting must attend the meeting; if an emergency arises that prohibits an assigned reviewer from attending the meeting, the assigned reviewer must inform the HRPP team immediately and in advance of the Convened IRB meeting.
If an IRB member plans to be absent for an extended period of time, such as for a sabbatical or other type of leave, the member must notify the HRPP at least 30 days in advance of the absence start date so that an appropriate replacement IRB member can be appointed, if necessary. If the IRB member has a designated alternate member, the alternate member is expected to attend as many Convened IRB meetings as feasible during the primary member’s absence.
3.10 Initial and Ongoing Education of IRB Members
A vital component of a comprehensive human research protection program is an education program for the IRB Chair and the IRB members. Brown University is committed to providing training and ongoing education for all IRB members related to ethical concerns and regulatory and institutional requirements for the protection of research participants.
New IRB members are required to do the following:
- Attend an in-person orientation session with the IRB Chair, Vice Chair, and/or HRPP staff. New members must complete the orientation requirement before they may serve as a primary reviewer.
- Promptly complete the following CITI modules:
- IRB Chairs and Vice Chairs (applicable for the IRB Chair and Vice Chair only);
- IRB Member Module; and
- One of the Initial Education Requirement courses for Human Subjects research described in the Institutional Review Board Policy on Education and Training in the Conduct of Human Subject Research.
To ensure that oversight of Human Subjects research is ethically grounded and the decisions made by the IRB are consistent with current regulatory and policy requirements, continuous training for IRB members is provided throughout their service on the IRB.
3.11 Review of IRB Member Adherence to Responsibilities
The IRB members’ adherence to their IRB member responsibilities set forth in this Policy and further detailed in their respective appointment letters will be reviewed annually by the IRB Chair in collaboration with ORI. The IRB Chair will provide written feedback to any IRB member who is not in compliance with the member’s IRB member responsibilities. In consultation with the IO, members who are not acting in accordance with their responsibilities may be removed from service on the IRB.
For the purpose of this policy, the terms below have the following definitions:
An IRB action taken when the required determinations are made that allow research involving Human Subjects to proceed consistent with federal regulations, state and local laws, and University policy.
- Contingently Approve:
An IRB action that specifies conditions under which research can be approved. Comments by IRB members must be directive and request simple concurrences or specific, non-substantive changes. Upon receipt of the required changes, the IRB Chair or another member designated by the Chair will verify that the appropriate additions/corrections were made and will either approve the study or return it to the Full Board for further review at a Convened Meeting.
- Convened IRB:
A meeting of the IRB at which a majority of IRB members are present.
An IRB action taken when the convened IRB cannot fully evaluate the research under review and make the determinations required for IRB approval without (1) modifications to the Application and/or informed consent document(s), or (2) submission of clarifications or additional materials prior to reconsideration of the research.
An IRB action taken when the determinations required for approval of research cannot be made, even with substantive clarifications or modifications to the Application and/or informed consent process/document(s).
- Federal Policy for Protection of Human Research Subjects (45 CFR Part 46):
The Department of Health and Human Services regulation and policy on the protection of human participants in research. This policy applies to all research involving Human Subjects conducted, supported, or otherwise subject to regulation by any Federal department or agency that takes appropriate administrative action to make the policy applicable to such research.
- Federalwide Assurance:
The Federalwide Assurance (FWA) is granted by the Department of Health and Human Service's (DHHS) Office for Human Research Protections (OHRP). It is the only type of assurance of compliance accepted and approved by OHRP for institutions engaged in non-Exempt human subjects research conducted or supported by DHHS. Under an FWA, an institution commits to DHHS that it will comply with the requirements set forth in 45 CFR Part 46, as well as the Terms of Assurance.
- Human Research Protection Program:
The Human Research Protection Program (HRPP) promotes high quality, ethical research. It does this by serving as the advocate for the rights and welfare of persons who participate in research programs conducted by faculty, staff, students, and researchers at Brown University. The HRPP has responsibility for review of research involving Human Subjects conducted at Brown University, and assists researchers in complying with federal, state, and Brown University policies regarding experimentation involving Human Subjects.
- Human Subject:
A living individual about whom an investigator (whether professional or student) conducting research (i) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
- Institutional Official:
The individual identified on Brown University’s Federalwide Assurance with the Office for Human Research Protections who is legally authorized to act for and on behalf of Brown University, and who obligates the University to the Terms of the Assurance. At Brown University, the IO is the Vice President for Research.
- Institutional Review Board:
A specially constituted review body established to protect the rights and welfare of Human Subjects recruited to participate in biomedical or social/behavioral research conducted under the auspices of its affiliated institution.
- Principal Investigator:
An individual with the appropriate scientific and/or scholarly training and expertise to assume direct responsibility for the ethical conduct of a study involving Human Subjects, to provide technical and administrative oversight of the research, and to make important study-related decisions. For purposes of HRPP policy, only one individual is designated as the Principal Investigator of a Human Subjects research study.
- Reportable Events:
A type of unanticipated event or occurrence related to a human subjects research study that requires review by the IRB as defined in the IRB Reportable Events Policy.
An action taken by the Convened IRB or the IRB Chair to temporarily stop some or all approved research activities in order to protect participants pending completion of an investigation. Suspended studies remain open until the convened IRB determines to (i) lift the suspension or (2) terminate the study or some activities of the study.
An IRB action that indicates that review was not initiated or was not completed, resulting in postponement of IRB review, usually due to loss of quorum or other administrative issue. Research Tabled at a Convened IRB will be reviewed at the next Convened IRB.
An action taken by the convened IRB or the IRB Chair to permanently stop all research activities in an approved research study.
- Vulnerable Population:
A group of participants that may have insufficient power or resources to protect their own interests, which may make them susceptible to undue influence and/or coercion depending on the situation, their condition, or the research. A population’s vulnerability may change depending on the nature of the research and may fluctuate over time. Investigators must take special care and consideration when recruiting, consenting, and conducting research activities with these populations.
All individuals to whom this policy applies are responsible for becoming familiar with and following this policy. University supervisors are responsible for promoting the understanding of this policy and for taking appropriate steps to help ensure compliance with it.
6.0 Consequences for Violating this Policy
Failure to comply with this and related policies is subject to disciplinary action, up to and including suspension without pay, or termination of employment or association with the University, in accordance with applicable (e.g., staff, faculty, student) disciplinary procedures.
7.0 Related Information
Brown University is a community in which employees are encouraged to share workplace concerns with University leadership. Additionally, Brown’s Anonymous Reporting Hotline allows anonymous and confidential reporting on matters of concern online or by phone (877-318-9184).
The following information complements and supplements this document. The information is intended to help explain this policy and is not an all-inclusive list of policies, procedures, laws and requirements.
7.1 Related Policies:
- Brown University’s Policy on Handling Allegations of Research Misconduct
- Human Subjects Research Principal Investigator Eligibility Policy
- Institutional Review Board Member and Consultant Conflict of Interest Policy
- Institutional Review Board Policy on Education and Training in the Conduct of Human Subjects Research
- Institutional Review Board Policy on Reportable Events and Noncompliance
7.2 Related Procedures:
7.3 Related Forms:
7.4 Frequently Asked Questions (FAQs):