Research

Human Research Protection Program Policy and Procedure Manual - Section 2

2 Institutional Review Board

2.1 Purpose
2.2 IRB Authority
2.3 Number of IRBs
2.4 Roles and Responsibilities

2.4.1 Chairperson of the IRB
2.4.2 Vice Chair of the IRB
2.4.3 Subcommittees of the IRB

2.5 IRB Membership
2.6 Composition of the IRB
2.7 Appointment of Members to the IRB
2.8 Alternate Members
2.9 Use of Consultants (Outside Reviewers)
2.10 Duties of IRB Members
2.11 Attendance Requirements
2.12 Training / Ongoing Education of Chair and IRB Members in Regulations, Procedures
2.13 Review of IRB Member Performance
2.14 Reporting and Investigation of Allegations of Undue Influence

 

2 Institutional Review Board

2.1 Purpose

The following describes the authority, role, and procedures of the Brown University Institutional Review Board (IRB).  The IRB is established to ensure the protection of human participants in research under the auspices of Brown University.

 

2.2    IRB Authority

Under University policy “Human Research Protection Program (HRPP),” the IRB is authorized to:

  1. approve, require modifications to secure approval, or disapprove all research activities overseen and conducted under the auspices of Brown University;
  2. suspend or terminate approval of research not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to participants; 
  3. observe, or have a third party observe, the consent process; and 
  4. observe, or have a third party observe, the conduct of the research.

 

Research that has been reviewed and approved by the IRB may be subject to review and disapproval by officials of the institution. However, those officials may NOT approve research if it has been disapproved by the IRB.  University officials may strengthen requirements and/or conditions, or add other modifications to secure University approval or approval by another University committee. Previously approved research protocols and/or consent forms must be re-approved by the IRB before initiating the changes or modifications. The IRB Chair or RPO Director makes the determination whether the changes require full IRB re-review or expedited review.

 

2.3 Number of IRBs

There is currently one institution-wide Institutional Review Board.  The IO, the RPO Director, and the Chair of the IRB will review the activity of the IRB on at least an annual basis and make a determination as to the appropriate number of IRBs that are needed for the institution.

 

2.4 Roles and Responsibilities

2.4.1 Chairperson of the IRB

The Brown University IO (Vice President for Research), in consultation with the IRB members and the RPO Director, appoints a Chair and Vice Chair of the IRB. Any change in appointment, including reappointment or removal, requires written notification.  Appointments may, or may not, have a specified term.

The IRB Chair should be a highly respected individual, from within the University, fully capable of managing the IRB and the matters brought before it with fairness and impartiality. The task of making the IRB a respected part of the institutional community will fall primarily on the shoulders of the Chair. The IRB must be perceived to be fair, impartial, and immune to pressure by the institution's administration, the investigators whose protocols are brought before it, and other professional and nonprofessional sources.

The IRB Chair is responsible for conducting the meetings and is a signatory for correspondence generated by the IRB, as is the Associate Vice President for Research, the Vice-Chair, and RPO Director.

The IRB Chair may designate other IRB members to perform duties, as appropriate, for review, signature authority, and other IRB functions, e.g., the Vice Chair and RPO Director.

The IRB Chair advises the IO and RPO Director about IRB member performance and competence.

The performance of the IRB Chair will be reviewed on an annual basis by the RPO Director in consultation with the IO. If the Chair is not acting in accordance with the IRB’s mission, not following these policies and procedures, has an undue number of absences, or is not fulfilling the responsibilities of the Chair, he/she will be removed.

 

2.4.2 Vice Chair of the IRB

The Vice Chair serves as the Chair of the IRB in the absence of the Chair and has the same qualifications, authority, and duties as Chair.

 

2.4.3 Subcommittees of the IRB

The Chair, in consultation with the RPO Director, may designate one or more other IRB members, i.e. a subcommittee, to perform duties, as appropriate, for review, signature authority, and other IRB functions.

Duties of a subcommittee may include the following:

  1. serve as designees by the IRB Chair for the expedited review of new or continuing protocols, and/or modifications of continuing protocols. The subcommittee must be experienced in terms of seniority on the IRB.
  2. review and approve the revisions requiring only simple concurrence submitted by investigators for a protocol given provisional approval by the convened IRB.
  3. conduct an inquiry. A subcommittee is appointed consisting of IRB members, and non-members, if appropriate, to conduct an inquiry into allegations of non-compliance The subcommittee is given a charge by the IRB, which can include any or all of the following:
    • review of protocol(s) in question;
    • review of audit reports of the investigator, if appropriate;
    •  review of any relevant documentation, including consent documents, case report forms, participants’ files, as they relate to the investigator's execution of her/his study involving human participants;
    • interview of appropriate personnel, if necessary;
    • preparation of either a written or oral report of the findings, which is presented to the full IRB at its next meeting;
    • recommend actions, if appropriate.
  4. Conduct on-site review. Determination is made by the IRB on a protocol-by-protocol basis of the review interval and the need for additional supervision and/or participation. For example, for an investigator who is performing particularly risky research, or for an investigator who has recently had a protocol suspended by the IRB due to regulatory concerns, an on-site review by an IRB subcommittee might occur or approval might be subject to an audit of study performance after a few months of enrollment or after enrollment of the first several participants.

 

2.5 IRB Membership

IRB members are selected based on appropriate diversity, including consideration of race, gender, cultural backgrounds, specific community concerns in addition to representation by multiple, diverse professions, knowledge and experience with vulnerable participants, and inclusion of both scientific and non-scientific members.  The structure and composition of the IRB must be appropriate to the amount and nature of the research that is reviewed.  Every effort is made to have member representation that has an understanding of the areas of specialty that encompass most of the research performed at Brown University.  The University has procedures (See Section 4) that specifically outline the requirements of protocol review by individuals with appropriate scientific or scholarly expertise.

 

In addition, the IRB will include members who are knowledgeable about, and experienced working with, vulnerable populations that typically participate in Brown University research or have ready access to consultants with appropriate knowledge and experience. 

 

The IRB must promote respect for its advice and counsel in safeguarding the rights and welfare of research participants and possess the professional competence necessary to review specific research activities.   A member of the IRB may fill multiple membership position requirements for the IRB.


2.6 Composition of the IRB

  1. The IRB will have at least five members with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution.
  2. The IRB will be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human participants.
  3. In addition to possessing the professional competence necessary to review specific research activities, the IRB will 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.
  4. If the IRB regularly reviews research that involves a vulnerable category of participants (e.g., children, prisoners, pregnant women, or handicapped or mentally disabled persons), 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 participants.   When protocols involve vulnerable populations, the review process will include one or more individuals who are knowledgeable about or experienced in working with these participants, either as members of the IRB or as consultants.
  5. Every nondiscriminatory effort will be made to ensure that the IRB does not consist entirely of men or entirely of women, including the institution's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. The IRB shall not consist entirely of members of one profession.
  6. The IRB includes at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas.
  7. The IRB includes 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.
  8. One member may satisfy more than one membership category.
  9. The RPO Director and administrators may be voting members of the IRB.

 

2.7 Appointment of Members to the IRB

The IRB Chair, Vice Chair, and/or the RPO Director, identifies a need for a new or replacement member, or alternate member. The IRB may nominate candidates and send the names of the nominees to RPO. Department Chairs and others may forward nominations to the IO, to RPO, or to an IRB Chair or Vice-Chair.

For faculty members, the RPO Director, contacts the nominee. If there are no nominees, then appropriate Department Chairs or Program Directors will be contacted concerning the vacancies and to solicit nominees.

The final decision in selecting a new member is made by the IO, the IRB Chair, and the RPO Director.

Appointments may, or may not, have a specified term.  Any change in appointment, including reappointment or removal, will be provided through written notification. Members may resign by written notification to the Chair or the RPO Director.

At appropriate intervals, the IRB Chair and the RPO Director review the membership and composition of the IRB to determine if they continue to meet regulatory and institutional requirements.


2.8 Alternate members

The appointment and function of alternate members is the same as that for primary IRB members, and the alternate's expertise and perspective are comparable to those of the primary member. The role of the alternate member is to serve as a voting member of the IRB when the regular member is unavailable to attend a convened meeting. When an alternate member substitutes for a primary member, the alternate member will receive and review the same materials prior to the IRB meeting that the primary member received or would have received.

The IRB roster identifies the primary member(s) for whom each alternate member may substitute. The IRB minutes will document when an alternate member replaces a primary member.  If both primary and alternate members are present at the meeting, it will be made clear at the outset which member is there in a voting capacity.


2.9 Use of Consultants (Outside Reviewers)

When necessary, the IRB Chair or the RPO Director may solicit individuals from the University or the community with competence in special areas to assist in the review of issues or protocols which require appropriate expertise beyond or in addition to that available on the IRB.  The need for an outside reviewer is determined in advance of the meeting by the Director or the Chair by reviewing the protocols scheduled to be reviewed at the convened meeting. RPO will ensure that all relevant materials are provided to the outside reviewer prior to the convened meeting.

Key information provided by consultants at meetings will be documented in the minutes. Written reviews provided by the outside reviewer, as necessary, will be filed with the protocol.

The RPO staff reviews the conflicting interest policy for IRB members (7.5.3) with consultants, and consultants must verbally confirm to the RPO Director that they do not have a conflict of interest prior to review. Individuals who have a conflicting interest or whose spouse or family members have a conflicting interest in the sponsor of the research will not be invited to provide consultation. 

The consultant’s findings will be presented to the full board for consideration either in person or in writing.  If in attendance, these individuals will provide consultation but may not participate in or observe the vote. 

Ad hoc or informal consultations requested by individual members (rather than the full board) will be requested in a manner that protects the researcher’s confidentiality and is in compliance with the IRB conflict of interest policy (unless the question raised is generic enough to protect the identity of the particular PI and research protocol).


2.10 Duties of IRB Members

The agenda, submission materials, protocols, proposed informed consent forms and other appropriate documents are distributed to members prior to the convened meetings at which the research is scheduled to be discussed.  In general, members receive the materials for review at least one week before each meeting, in order to participate fully in the review of each proposed project.  IRB members will treat the research proposals, protocols, and supporting data confidentially.  All copies of the protocols and supporting data are returned to the IRB staff at the conclusion of the review for professional document destruction.


2.11 Attendance Requirements

Members should attend all meetings for which they are scheduled.  If a member is unable to attend a scheduled meeting, they should inform the IRB Chair, Vice Chair, or an RPO staff member.  If the inability to attend will be prolonged, a request for an alternate to be assigned may be submitted to the Chair or the Director.

If an IRB member is to be absent for an extended period of time, such as for a sabbatical, it is anticipated that he or she will notify the IRB at least 30 days in advance so that an appropriate replacement can be obtained, if necessary.  The replacement can be temporary, for the period of absence, or permanent if the member is not returning to the IRB.  If the member has a designated alternate, the alternate can serve during the primary member’s absence.


2.12 Training / Ongoing Education of Chair and IRB Members in Regulations, Procedures

A vital component of a comprehensive human research protection program is an education program for IRB Chair and the IRB members. Brown University is committed to providing training and an on-going educational process for IRB members and the staff of RPO, related to ethical concerns and regulatory and institutional requirements for the protection of research participants.

Orientation
New IRB members, including alternate members will meet with the IRB Chair and RPO Director for an informal orientation session. At the session, the new member will be given materials that include:

  • Belmont Report;
  • Brown University HRPP Policy and Procedures Manual;
  • Federal regulations relevant to the IRB


New members are required to complete the initial education requirement for IRB members before they may serve as Primary Reviewer.

Initial Education
IRB members will complete the following web based training:   

  • Brown University CITI program; and the
  • IRB Member Module - "What Every New IRB Member Needs to Know” at the CITI site.


Continuing Education
To ensure that oversight of human research is ethically grounded and the decisions made by the IRB are consistent with current regulatory and policy requirements, training is continuous for IRB members throughout their service on the IRB. Educational activities may include, but are not limited to;

  • in-service training at IRB meetings;
  • training workshops and special issues meetings;
  • copies of appropriate publications;
  • identification and dissemination by the RPO Director of new information that might have affected the HRPP, including laws, regulations, policies, procedures, and emerging ethical and scientific issues to IRB members via email, mail, or during IRB meetings.


The RPO staff is required to complete the Brown University CITI program. Staff will attend PRIMR or OHRP training, whenever possible.

RPO staff is encouraged to seek certification in areas of expertise, such as Certified IRB Professional (CIP).


2.13 Review of IRB Member Performance

The IRB members’ performance will be reviewed at regular intervals by the RPO Director.  Members who are not acting in accordance with the IRB’s mission or policies and procedures or who have an undue number of absences will be removed.


2.14 Reporting and Investigation of Allegations of Undue Influence

If an IRB chair, member, or staff person feels that the IRB has been unduly influenced by any party, they shall make a confidential report to the IO and/or President, depending on the circumstances.  The official receiving the report will conduct a thorough investigation and corrective action will be taken to prevent additional occurrences.

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