Chapter 5: USC Institutional Review Boards (IRBs)

This chapter covers IRB membership, the roles and requirements of IRB members, Chairs, and reviewers at the University of Southern California (USC). Additionally, this chapter explains the use of consultants, the role of IRB staff, voting requirements, and IRB record keeping.

There are four Institutional Review Boards at the University of Southern California. The IRBs review and approve research in accordance with Department of Health and Human Services (DHHS) regulations in 45 CFR 46. For studies involving products regulated by the Food and Drug Administration (FDA), the University of Southern California IRBs review research and comply with the requirements set forth in 21 CFR 50 and 56, as well as 21 CFR 312 and 812. In addition, the IRBs comply with HIPAA and its regulations set forth in 45 CFR 160 and 164, California law as it pertains to human subjects research and other federal regulations as applicable.

At USC the Vice President of Research is designated the Institutional Official. USC IRBs have been delegated the following authority by the Institutional Official in his delegation memo dated 11/23/2005:

• USC IRBs have the authority to approve, disapprove, or suspend human subject research projects. No USC faculty, staff, or student may conduct human subjects research without obtaining approval the appropriate IRB.
• USC IRBs have the authority to observe, or have a third party observe, the consent process and the conduct of the research.

Number, Qualifications and Diversity of Members

Each IRB has a minimum of five members with varying backgrounds to adequately review the research activities conducted by the Institution. Major clinical and selected basic science departments are represented to provide the experience and expertise sufficient for review of the research activities conducted at the Institution. The IRB member with appropriate scientific expertise for each protocol will be designated to review the application. The IRB includes at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in non- scientific areas. Also, the IRB consists of at least one member not otherwise affiliated with the Institution and not part of the immediate family of a person who is affiliated with the Institution. To enable each IRB to ascertain the acceptability of proposed research in terms of institutional commitments, regulations, applicable law, and standards of professional conduct and practice, each IRB includes persons knowledgeable in these areas and may include representatives of administration. Each IRB is sufficiently qualified through the experience, expertise and diversity of its members – including consideration of race, gender, 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 subjects.

The IRBs may review research that involves subjects who are considered vulnerable. They include subjects vulnerable to coercion or undue influence such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons). Consideration shall be given to the inclusion of one or more IRB members or consultants who are knowledgeable about, and experienced in, working with these categories of subjects.

Alternate Members

When deemed necessary by the IRB Chair, and when requested by department Chairs or deans, alternates will be appointed for IRB members. Formally appointed alternate IRB members may represent IRB members, provided the alternate’s qualifications are comparable to the primary member to be replaced. The IRB membership rosters identify the primary member(s) for whom each alternate member substitutes. Prior to the IRB meeting, materials required for review are made available electronically through iStar to all members.

The IRB minutes document when an alternate member replaces a primary member. When an alternate member substitutes for a primary member, the alternate must receive and review the same material the primary member received or would have received. Members and their alternates may not both vote. Alternates are not counted as “members” in establishing the numerical quorum of the IRB, except when they substitute for members during the IRB meeting. Alternates are invited to attend all IRB meetings, whether they are eligible to participate as voting members or not, in order to assure familiarity with the IRB practices and continuing education.

Ex-Officio Members

The IRB may include ex-officio members depending on the relevance of their office and their expertise and experience. The positions they hold preclude full IRB membership and therefore ex-officio members are not voting members of the IRB.

Selection and Appointment

The formal appointments of IRB members are made by the Vice President of Research. Typically, individuals who are responsible for business development are not selected to serve as IRB members. Non-affiliate members not associated with the Institution are identified by interest and relevance and are recommended for appointment by members of the IRB, IRB staff, Departments or Schools. IRB committee membership lists can be found on the HRPP website.

Length of Service

Appointments to the IRBs are for a period of 1 year. Expertise and diverse membership are expectations for both campus IRBs. Continued tenure on the IRB is at the discretion of the HRPP Director, IRB Associate Directors in consultation with the IRB Chairs.

Evaluations of IRB composition and formal evaluation of individual members are conducted at the end of the fiscal year at the time of IRB budget review/approval. Appointment letters indicating satisfactory evaluation of returning members are sent to IRB members at the end of one fiscal year for the next fiscal year. The duties and responsibilities of IRB members are stated in appointment letters from the Vice President of Research. Members who fail to meet IRB expectations, as outlined in the IRB appointment letters, are sent correspondence informing them that their service is no longer needed.

Duties

Members of each IRB or their designated alternates are required to:

• Participate in agreed upon number of convened IRB meetings
• Review the IRB application and informed consent form for research proposals
• Pre-review and complete a written critique of research proposals including review of clinical trial protocol, , questionnaire(s), advertisement(s), investigator’s drug brochure, and informed consent form when assigned as a reviewer by the Chair or IRB staff
• Review expedited actions of the Chair and IRB designee
• Review and promptly inform the Chair of corrections or additions to Full Board
  meeting minutes
• If substantive changes have been requested to a study, members, at a convened meeting, must review and verify that contingencies have been satisfied.
• Selected IRB members may be appointed as expedited reviewers and can review changes to previously approved research during the period covered by the original approval. Changes that may be reviewed by an expedited reviewer are those that do not alter the original approval criteria. Additional training is provided to IRB members who are appointed to be expedited reviewers.

The IRB Chair will designate experienced reviewers from among members of the IRB to perform review via expedited procedure to ensure that “When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.” (406.111(a)(7). All studies that meet criteria for “Limited IRB Review” as defined and described in the Common Rule effective January 21, 2019, will be reviewed via the expedited procedure.

“Limited IRB Review” is a provision of the Common Rule that allows for certain research with specific criteria to be categorized as exempt research, even when the identifiable information might be sensitive or potentially harmful if disclosed. USC will not conduct limited IRB review . Research meeting the criteria for limited IRB review will be reviewed via the expedited procedure, that is, by the Chair or an experienced IRB member designated by the Chair (although it can be conducted by the full IRB). Continuing review is required.

When an IRB member has a conflicting interest, the IRB prohibits their participation in IRB review of the project, except to provide information requested by the IRB. Refer to Section 4.5 – IRB Members and IRB Consultants Conflict of Interest for more information.

Attendance Requirements

Members and alternates serve at the discretion of the Institutional Official. Members who do not attend meetings will be removed from the IRB. If a member is unable to attend a meeting, the IRB office must be informed sufficiently in advance so that an alternate can be invited to attend. Frequent absences will be cause for removal.

Honorarium to Non-Affiliate IRB Members

An honorarium is paid to non-affiliate IRB members based on meeting attendance. Faculty members are not paid to attend meetings.

Training of the Chair and Members

Chairs are expected to attend professional conferences (including PRIM&R conferences) to enhance their education and IRB expertise. IRB members and alternates are initially trained as guests (non-voting capacity) of the IRBs. They are provided with IRB member education, USC specific guidance materials, and offered support to attend local or national meetings, if possible. Ongoing education of the IRB membership includes an education session preceding an IRB meeting approximately once per month. In addition, access to educational materials is provided to all IRB members (such as “IRB: A Review of Human Subjects Research”). IRB members and alternates are required to take the Protection of Human Subjects education modules provided online through the CITI website.

Evaluation of IRB Members

The duties and responsibilities of IRB members will be stated in appointment letters from the Vice President of Research. At any time, at the discretion of the Vice President of Research a member may be removed and replaced with the need to ensure that the board includes the expertise and representation required. Expectations and subsequent evaluation of IRB members follow:   

• IRB members will be re-appointed annually if expectations are met. Expectations are outlined in the document: USC IRB Members Standards and Responsibilities.  This document may be used as a self-evaluation tool and serves as a review guide for the annual formal evaluation processes of each IRB member. The re-appointment letter will acknowledge that the IRB member has been evaluated and satisfied the membership criteria.  
• If a board member is removed/replaced in order to ensure that the board maintains required expertise and representation, or if a member fails to meet the expectations outlined in USC IRB Members Standards and Responsibilities, correspondence will be sent informing them their service is no longer needed.

IRB members are evaluated on an ongoing basis by the IRB Associate Directors, Chairs, and the Director of HRPP. However, formal evaluations occur annually with the IRB Associate Directors and/or Director of HRPP. Performance is assessed according to the criteria outlined in USC IRB Member Standards and Responsibilities. Member evaluation also includes determining whether a member should be designated to conduct IRB reviews using the expedited procedure. Written feedback is provided to all members about their performance annually

Chairs are evaluated on an ongoing basis and undergo a formal evaluation annually by the Director of HRPP and IRB Associate Directors in coordination with the Vice President of Research. Performance is assessed according to the same standards as members along with review of their additional responsibilities. Chairs are assessed according to leadership ability, meeting management, engagement in the expedited review process, and effectiveness as representatives of the IRBs. Written feedback is provided to the Chairs annually.

Each IRB may, at its discretion, invite individuals with competence in issues that require expertise beyond, or in addition to, that available on the IRB. The consultants will be provided with the same information that the primary and secondary reviewers receive. Consultants are not counted as “members” in establishing the quorum for each IRB and shall not vote with the IRB. An honorarium for consultants may be provided.

The IRB member Conflict of Interest policy also applies to consultants. The IRB prohibits the participation in IRB review of any project in which the member has a conflicting interest, except to provide information requested by the IRB. Refer to Section 4.5 – IRB Members and IRB Consultants Conflict of Interest for more information.

The consultant may appear in person or provide a written review to the IRB members. Consultant(s) may be asked to attend the meeting for further clarification, if deemed necessary by the IRB Chair. Key information from the consultant will be included in the IRB meeting minutes and a copy of all documentation will be kept in the study file.

The IRB support staff assists the Chair in IRB activities. The support staff is responsible for submitting written correspondence to investigators regarding IRB actions. IRB staff shall document meeting minutes in accordance with federal regulations and guidance. Required documents are listed in Section 5.8 – IRB Records. IRB staff may be trained to perform exempt reviews and designated to conduct expedited reviews.

IRB staff training may be provided. Staff member training includes taking the CITI education courses, reading the Human Subjects Newsletter/listserv, and learning federal, state, and local regulations, and institutional the policies and procedures. A Bachelor’s Degree or prior IRB experience is required. Annual reviews are conducted to evaluate IRB staff.

The IRB staff will be evaluated annually, at the time of budget reviews, by the IRB Chair/Director. The following criteria will be measured: knowledge of the IRB process and regulations, continuing training, work attendance, and, overall ability to function as an asset to the IRB. If a staff member is found to be deficient in a particular area or areas, they will be further educated on the IRB process. The evaluation will be reflected in the annual salary determination.

IRB Support Staff Duties:

• Screen submissions before IRB review
• Prepare IRB meeting agenda
• Prepare meeting minutes (see “Meeting Minutes” in Section 5.8 – IRB Records)
• Prepare correspondence
• Facilitate review of IRB applications
• Customer service
• Database and information management
• Mentor new IRB staff and IRB Student Mentor
• Respond to subject concerns
• Follow office procedures
• Follow IRB policy and procedures and make suggestions/recommendations
• Undertake and provide education and training
• Intra-institutional relationships
• Handle meeting logistics
• Review and approve non-material contingencies such as those related to personnel changes (excluding change of PI), punctuation and wording or verification that something missing has been supplied
• Preliminary review of initial/continuing review documents (confirm all required documents have been submitted by the investigator, confirm the consent document submitted by investigator matches the one on file, identify issues and concerns for IRB consideration)

Selected IRB staff may be appointed as IRB members, alternate members, or designated reviewers. Additional training is provided to IRB staff who are also IRB members.

Chairperson

• • Selection and Appointment

    The Chair is selected from among the faculty of the Institution and appointed by the Institutional Official. The Chair should have previously served as a member of the IRB.

  • Selection Criteria

    The criteria used to select a Chair include experience with, and knowledge of, applicable federal regulations, state laws, and Institutional policies.  They must be willing to commit their service to the IRB; must have experience as an IRB member; and must demonstrate excellent communication skills, along with an understanding of clinical research.  They must also demonstrate a thorough understanding of ethical issues involved in clinical/social behavioral research.

  • Duties

    The Chair of the IRB convenes and runs the meetings of the IRB. The Director of OPRS will be assigned to Chair an IRB meeting when the Chair is unable to conduct the meeting. The Chair may conduct, or delegate expedited review of research as eligible, review investigators responses to contingencies in expedited studies or studies that qualify for the expedited procedure. The Chair/ IRB designee reviews and approves expeditable amendments in previously approved research, unless the change affects the approval criteria. The Chair may approve a Waiver of HIPAA Authorization for research that meets specific criteria outlined in USC Administrative and Business Practices Policy » Compliance » HIPAA.

  • Project Referrals

    The Chair may, at their discretion, refer the review of a research project to the IRB of the other campus if it is determined that more appropriate expertise lies in the other IRB.

Reviews of proposed research are conducted at a convened IRB meeting at which a majority of the members are present. At least one IRB member whose primary concerns are in non-scientific areas, one member whose primary concerns are in scientific areas, and one non-affiliate member must be present. In the event a majority of members are not present, or there is no member whose primary concerns are non-scientific, or a non- affiliate member is not present, the meeting will not be called to order (or if any of these circumstances arises after the meeting has been called to order, it will be adjourned or suspended until quorum is reestablished) and will be rescheduled. The IRB staff will monitor the members that are present at the meeting and determine that the meetings are appropriately convened and remain so.

In order for the research to be approved at the convened meeting it must receive the approval of a majority of the members present at the meeting. The IRB roster will show which members are in attendance for each vote taken during an IRB meeting.

Votes submitted prior to a convened meeting by mail, telephone, fax or e-mail are not permissible. Comments of the absent members may be submitted and considered by the attending IRB members.

IRB Membership Roster

The IRB maintains rosters of IRB membership including: name, earned degrees, representative capacity, experience (such as board certifications and licenses) sufficient to describe each member’s chief anticipated contributions to IRB deliberations, and any employment or other relationship between each member and the Institution.

Written Procedures and Guidelines

The IRB maintains written procedures as required by 45 CFR 46.103(b)(4), (5).

• Meeting Minutes

  For each IRB, an IRB analyst will maintain detailed records of meeting minutes that will specify which members were present, that a quorum was maintained for each action, the number of votes for each action during the meeting, and documentation of a non-scientist member for each vote. IRB minutes will document when an IRB member knowledgeable about or experienced in working with specific/vulnerable populations was assigned as a reviewer and/or was present for the vote. IRB minutes will document the uses of a consultant present at a convened meeting and include a brief description of the consultant’s expertise. When a convened IRB meeting includes non-members and or guests, the minutes will record the name(s) of all such attendees.

  Each IRB will keep a roster of all members and, for each action, record which members voted. This document will be kept separate from the distributed minutes.

  Additionally, IRB staff shall document all meeting minutes according to federal regulations and the requirements listed below.

  The IRB meeting minutes include:

  • Confirmation that quorum was maintained for each vote
  • Attendance for each action
  • Summary of discussion of controversial issues (if any) and their resolution
  • Record of IRB decisions (actions taken by the IRB)
  • Record of voting (including the number of members voting for, against, and abstaining) for each action
  • The basis for requiring changes in or disapproving research
  • Names of IRB member(s) recused and not present during the discussion or vote in any research protocol under review and of those who abstain due to conflicts of interest
  • Description of the materials reviewed for both new and continuing review proposals. Such materials might include the IRB application, clinical protocol, investigators brochure, informed consent form documents, continuing review form, primary reviewer’s evaluation (for continuing review) and any other materials submitted for review
  • All applicable waivers are discussed and documented (with justification) in the IRB minutes including, waiver or alteration of informed consent and written informed consent
  • Protocol specific determinations on studies involving vulnerable populations (45CFR46 Subparts B, C, D) are documented and justified according to the regulations
  • Approval period for initial and continuing reviews
  • Rationale for significant risk/non-significant risk device determinations
  • If an IRB member has a Conflict of Interest regarding a study being reviewed, they will recuse themselves from the review of the study. The name and reason for absence will be included in the minutes
  • When an alternate member replaced a primary member and reason for substitution

  Minutes from each IRB meeting are distributed to all IRB members, to the Vice President of Research and relevant institutional administration for review according to the Federalwide Assurance. IRB members are required to review the minutes and note any corrections or additions at the first meeting following distribution of the minutes.

• Records Retained in the IRB Files

  IRB files contain the following documents and information for each study (45 CFR 46.115(b)):

  • iStar application
  • Draft/Approved consent documents
  • Clinical protocol, including amendments/revisions
  • Investigators brochure(s)
  • Scientific evaluations, if any, that accompany the proposals
  • Funding information
  • Recruitment materials
  • Staff and designated reviewer reviews
  • Amendments
  • Reportable events
  • Category of approval for exempt, expedited, Full Board (when necessary), and continuing review submissions
  • Progress reports submitted by investigators
  • All continuing review activities
  • Reports of injuries to subjects
  • Statements of significant new information/findings provided to subjects
  • Emergency use reports
  • IRB minutes
  • Correspondence between the IRBs and investigator

• Record Retention Requirements

  Documentation relating to IRB review is kept indefinitely, even when a project is cancelled without subject enrollment.

  However, research records are maintained for a minimum of three years after completion of the research or as determined by the University’s policy or sponsor requirements and records. Records containing protected health information are retained for at least six years after completion of the research. However, USC, like many institutions, retains IRB records indefinitely.

  For additional information, refer to the USC Record Retention Schedule.

• Access to Files

  IRB records are accessible for inspection and copying by authorized representatives of federal agencies or departments at reasonable times and in a reasonable manner.

The USC Human Research Protection Program (HRPP)/IRB Policies and Procedures are written and applied according to federal regulations, state laws, university policies, funding agencies and accrediting bodies. To assure continued compliance, the following will be conducted:

• USC HRPP/IRB policies and procedures are to be reviewed every three years and when changes in regulations, laws, and institutional policies necessitate revision
• USC HRPP/IRB policies and procedures are developed and maintained by the Office of the Protection for Research Subjects
• The Human Research Protection Program is charged with the appropriate implementation and enforcement of HRPP/IRB policies and procedures consistent with other University policies and procedures

Investigator Responsibilities with Respect to Policies

The investigator will review the USC Human Research Protection Program (HRPP) policies and procedures as part of the required initial training for conducting human subjects’ research at the University of Southern California.  Current policies and procedures are located on the OPRS website and the Office of Research website. It is the responsibility of the investigator to stay informed of  new and revised HRPP/IRB policies and procedures. Updates are provided via the listservs and the OPRS website. The investigator should contact IRB staff for clarification of policies and procedures, when necessary.

IRB Staff Responsibilities with Respect to Policies

OHRP and FDA guidance documents, changes in regulations, and determination letters are resources that IRB staff are encouraged to review. On behalf of the Human Research Protection Program (HRPP) OPRS will contact the Office of General Counsel and Office of Compliance, when necessary, to discuss changes and assist in the interpretation of federal, state and local regulations affecting the HRPP/IRB policies and procedures. The IRB and OPRS offices will provide updates, revisions and educational sessions to IRB members and staff.

The IRB staff will use the HRPP/IRB policies and procedures posted on the OPRS website when reviewing IRB applications. The IRB staff may consult with other IRB officials for guidance in applying  policies and procedures. If the IRB staff notices that a policy or procedure is inaccurate or out of date, he/she should bring it to the attention of the IRB Directors who will communicate with the OPRS office. It is the responsibility of all IRB staff to assist in keeping the HRPP/IRB policies and procedures current and applicable to the daily processes of the HRPP/IRB offices and to follow the policies as stated.