Chapter 6. IRB Membership

The University of Notre Dame’s IRB will have sufficient expertise to review the broad variety of human subject research in which the university commonly becomes involved, will be knowledgeable about all relevant regulatory requirements, and will remain impartial and objective in its reviews.

A. Appointment of IRB Members, Length of Service, and Duties. The President of the university formally appoints IRB committee members. Members serve three-year terms, and are eligible for reappointment at the discretion of the Vice President for Research. Members vote to approve, require modifications in, disapprove, or defer human subject protocols research submitted to the IRB. Members are expected to attend IRB meetings on a regular basis, serve as primary reviewers for research within their areas of expertise, and serve as general reviewers on all research discussed at convened meetings. Members are also expected to conduct expedited or facilitated reviews on behalf of the IRB when so designated by the IRB Chairperson.

The Director of Research Compliance, the IRB Chair, and the Associate Vice President for Research will review the performance of IRB members on an annual and as needed basis. Members who do not perform in accordance with the IRB’s mission, follow these policies and procedures, have an undue number of absences (at least 3), or are not fulfilling the responsibilities of an IRB member may be removed by the Vice President for Research.

B. Appointment of IRB Chairperson, Length of Service, and Duties. The Vice President for Research formally appoints the IRB Chairperson. Chairpersons serve three-year terms and may serve no more than three consecutive terms as Chairperson. The Vice President of Research has the discretionary authority to remove the Chair. In addition to the responsibilities of IRB membership, the Chairperson has primary responsibility for conducting IRB meetings and directing IRB staff so that the IRB operates within all applicable regulatory requirements. The IRB Chairperson works with IRB members and staff, institutional officials, and investigators to protect the rights and welfare of research subjects. As a fair and impartial committee head, the Chairperson functions as a role model for how IRB business should be conducted. The Chairperson reviews and approves all official IRB correspondence for study deferrals and disapprovals. The Chair of the IRB has the following responsibilities:

• To assure that all research under the jurisdiction of the IRB complies with the Belmont Report, Federal Assurance document, and the Department of Health and Human Services (DHHS) regulations set forth in 45 CFR 45;
• Completion of the requisite IRB Certification in Human Subjects Research training prior to serving as a member of the board, reviewing, or voting on any human subject research proposal;
• Facilitate the ongoing education of research investigators and board members.
• Make every effort to maintain an appreciation of the regulatory changes relevant to the use of human subjects in research and participate in continuing education opportunities on an ongoing basis to maintain the professional qualifications and experience necessary to oversee the review activities of the IRB;
• Review and authorize the approval of proposed expedited or full board Human Subject research activities in a timely fashion. This is a delegable duty whereby this task is shared: with the IRB on exempt or expedited matters; or with other IRB members on exempt or expedited matters.
• Review all proposals presented to the full board committee to provide oversight and facilitate comprehensive discussions and deliberations;
• Collaborate with the Director of Research Compliance to maintain adequate oversight for the campus IRB operations;
• Report relevant information either to the Director of Research Compliance and Vice President for Research to assure the safety of human subject participants;
• Be responsive to all issues that arise between IRB meetings and provide leadership in establishing and implementing IRB standard operating procedures.
• The Chair is expected to attend and chair all IRB committee meetings and IRB initiated seminars on the campus of Notre Dame. If he/she is unable attend, the Chair is responsible for locating a suitable replacement.

C. Alternate IRB Members. The Vice President for Research also may appoint one or more alternate members to replace regular IRB members who are, on occasion, unable to attend convened meetings of the IRB.

Alternate members must be listed on the IRB’s official membership roster. Terms of appointment, length of service, and duties are exactly as for regular IRB members. Each alternate IRB member who replaces a primary member at any given meeting should have the experience, expertise, background, professional competence, and knowledge equivalent to that of the primary IRB member whom the alternate will replace.

Non­Voting IRB Attendees. The OVPR may designate certain “non-voting” IRB attendees who may be present at IRB meetings to answer questions or pose issues for discussion, but who may not vote and whose presence does not count towards quorum.

D. Consultants. An IRB may, at its discretion, invite individuals with competence in special areas to assist in the review of issues that require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB. Consultants may assist the IRB on either a regular or an as-needed basis.

E. IRB Membership Requirements. In compliance with Federal regulations at 45 CFR 46.107, the University of Notre Dame’s IRB must satisfy the following requirements:

(i.) The IRB will have at least five members.

(ii.) IRB members will possess varying backgrounds to promote complete and adequate review of research activities commonly conducted at the University of Notre Dame.

(iii.) IRB members will be sufficiently diverse relative to race, gender, cultural background, and sensitivity to community attitudes so as to promote respect for the IRB’s advice and counsel in safeguarding the rights and welfare of human subjects.

(iv.) IRB members will include persons able to ascertain the acceptability of proposed research in terms of institutional commitments, regulations, applicable law, and standards of professional conduct and practice.

(v.) IRBs will consist of qualified persons of both sexes.

(vi.) No IRB will consist entirely of members of one profession.

(vii.) The IRB will include at least one member whose primary expertise is in a scientific area.

(viii.) The IRB will have at least one member whose primary concerns are in non-scientific areas.

(ix.) Each IRB will include at least one member who is not otherwise affiliated with the university and who is not part of the immediate family of a person who is affiliated with Notre Dame.

F. Conflict of Interest. No IRB member may participate in the IRB’s initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB. IRB members, including the Chairperson, who have conflicting interests are required to disclose such interests and to absent themselves from deliberations, quorum counts, and votes on the relevant protocol. Such absences are recorded in the meeting’s minutes. Since many IRB members also conduct research, it is their responsibility to adequately disclose any conflicting interests they may have. Each board member must sign an acknowledgment of the conflict of interest requirement.

G. Initial Training, Continuing Education, and Professional Development of IRB Members. Upon receiving an appointment to the IRB, a member receives comprehensive reference materials (including information on how to access these policies, procedures and operating instructions) necessary to review research from an ethical and regulatory perspective. At a minimum, all members must complete the CITI training or comparable training module available via the OVPR website.

H. Compensation of IRB Members. While it is acknowledged that service on the IRB requires a significant investment of time for all IRB members and for IRB Chairpersons, IRB members do not receive financial compensation. A small stipend may be provided to IRB Chairperson.

I. Liability Coverage. Liability protection is provided to individuals for actions within the scope of their IRB appointments.

Chapter 7. IRB Voting and Conduct of Meeting

IRB members may not vote by proxy (i.e., member not present at the convened meeting or participating in the tele/vidoconference call may not vote on an issue discussed during a convened meeting). However, members can provide written comments for IRB consideration.

A. Voting. Voting at a convened meeting takes place under the following conditions:

i. A majority of the members must be present (or connected via speakerphone/video) for all reviews/actions voted on at a convened meeting;

ii. A passing vote must consist of a majority of members present (or connected via speakerphone/video) voting in favor of the motion;

iii. An individual who is not listed on the Office for Human Research Protections membership roster may not vote with the IRB;

iv. Ex-officio members of the IRB may not participate in the vote;

v. Ad-hoc and cultural consultants may not participate in the vote;

vi. The non-scientist member must always be present for a vote;

vii. A physician must be present to vote on a FDA regulated research;

B. Conduct of Meeting. The University of Notre Dame IRB conducts convened meetings in accordance with applicable federal requirements for full review (i.e., 21 CFR 56.108, 45 CFR 46.108, and 38 CFR 16.108).

Chapter 8. IRB Administrative Support

DHHS regulations at 45 CFR 46.103(b)(2) require that the University of Notre Dame provides its IRB with sufficient meeting space and staff to support the IRBs’ review and recordkeeping responsibilities.

A. Resource Allocation. The Vice President for Research has ultimate responsibility as the Institutional Official for protecting human subjects in research conducted at the University of Notre Dame. To this end, the Vice President for Research will allocate on an annual basis sufficient resources to support the IRB’s review and recordkeeping responsibilities.

B. Reporting Lines and Supervision. All IRB administrative staff are appointed by the Associate Vice President for Research.

C. Director of Research Compliance Duties.

The Director of Research Compliance is responsible for the following:

• Direct, coordinate and supervise the IRB office staff;
• Assist in the recruitment and interview process of prospective IRB Chairs and members;
• Supervise training and orientation of new IRB members to the applicable technical and ethical literature, appropriate ND and federal policy, statutes and regulations;
• Provide technical consultation to the IRB Chairs/members concerning the review of ethically and scientifically complex research involving human subjects and/or vulnerable population;
• Monitor changes and recommend appropriate revisions in policy, procedures and operating instructions. Coordinate with University Counsel and other departments within the university regarding compliance with regulations and policies;
• Represent the IRB in audits and deliberations with local and/or federal agencies;
• Designee for approval of administrative modifications
• Audit the IRB files and assist the research community during FDA, OHRP or IRB audits (e.g. internal audit);
• Provide advice and assistance to researchers for the development of compliant protocols;

E. IRB Staff Duties. IRB staff support the function and operation of the IRBs at the direction and under the supervision of the Director of Research Compliance.

Chapter 9. IRB Recordkeeping & Required Documentation

Federal regulations require that the University of Notre Dame implement written policies and procedures to govern the operations and direct the activities of its IRB. This IRB Policies and Procedures document satisfies that requirement.

Staff in the Office for the President for Research is responsible for developing and implementing procedures for efficient document flow and maintenance of all IRB records.

A. Record Retention. In accordance with Federal regulations at 45 CFR 46.115(b), IRB records will be retained by the University of Notre Dame for no less than three years after the completion of the research with which they are associated.

B. Access to IRB Records. All IRB records will be kept secure in locked filing cabinets or locked storage rooms. Ordinarily, access to IRB records is limited to OVPR staff, the IRB Chairperson, IRB members, IRB staff, and officials of Federal and State regulatory agencies, including OHRP and FDA. Research investigators will be provided reasonable access to files related to their research. All other access to IRB records is limited to those who have legitimate need for access, as determined by the Director of Research Compliance.

C. IRB Records. IRB records include files organized into the following categories:

(i.) Written Operating Procedures

(ii.) IRB Membership Rosters

(iii.) Training Records

(iv.) IRB Correspondence (other than protocol-related)

(v.) IRB Research Application (Protocol) Files

(vi.) Research (Protocol) Tracking System

(vii.) Documentation of Exemptions and Exceptions

(viii.)Documentation of Expedited and Facilitated Reviews

(ix.) Documentation of Convened IRB Meetings – Minutes

(x.) Documentation of Review by Another Institution’s IRB

D. IRB Membership Rosters. Any changes in IRB membership will be reported promptly to OHRP. All IRB membership rosters will include the following information:

(i.) Names of IRB members.

(ii.) Names of alternate members.

(iii.) Earned degrees and specialties of each member and alternate, if applicable, sufficient to describe each member’s chief anticipated contribution to IRB deliberations.

(iv.) The representative capacity of each member or alternate.

E. Education and Training Records. The University of Notre Dame is required to have a plan to provide education about human subject protections for research investigators and IRB members and staff.

At a minimum, all research investigators, the IRB members and IRB staff must complete the CITI training or comparable training module available via the OVPR’s website.

The Director of Research Compliance will maintain accurate records listing research investigators, IRB members, and IRB staff who have fulfilled ND’s human subject protection training requirements.

F. IRB Research Application (Protocol) Files. The IRB will maintain a separate file for each research application (protocol) that it receives for review. Protocols will be numbered sequentially by calendar year, in the order in which they are initially received (i.e., the first application received in calendar year 2002 = 02-001; the second = 02-002; etc.).

Each IRB research application (protocol) file will contain the following materials:

i. The IRB Research Application (Protocol) Form (included in Appendix II).

ii. Documentation of type of IRB review.

iii. The IRB-approved informed consent document, with the beginning and ending dates of the current approval period clearly displayed on at least the first page.

iv. Scientific evaluations of the proposed research, if any.

v. Applications for Federal support, if any.

vi. Sponsor or cooperative group protocols and sample informed consent documents, if any.

vii. Advertising or recruiting materials, if any.

viii. Applications for protocol amendments or modifications.

ix. Continuing review progress reports and related information.

x. Reports of serious adverse events and/or unanticipated problems involving risks to subjects or others.

xi. All IRB correspondence to and from research investigators.

xii. All other IRB correspondence related to the research.

xiii. Documentation of all IRB review and approval actions, including initial and continuing convened (full) IRB review.

xiv. Documentation of type of IRB review.

xv. Documentation of Project Closeout.

G. IRB Database. The University will maintain a research (protocol) tracking database.

i. At a minimum, the database will include the following information:

ii. Title of the Research (Protocol)

iii. Name of Principal Investigator

iv. Funding Source (if any)

v. Date of Initial Approval

vi. Date of Most Recent Continuing Approval

vii. End of Current Approval Period

viii. Type of Review (Expedited or Convened Review)

ix. Current Status (Pending, Active, Inactive, Suspended, Exempt)

H. Documentation of Exemptions. The Director of Research Compliance or the IRB Chairperson is responsible for reviewing and verifying whether activities are exempt from the human subject regulations.

Documentation of verified exemptions consists of the reviewer’s written concurrence in the IRB Research Application File that the activity described in the investigator’s Application for Exempt Research satisfies the conditions of the cited exemption category.

Categories of exempt research are stipulated in Federal regulations at 45 CFR 46.101(b)(1-6) as follows:

i. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

ii. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, (iii) employability, or reputation

iii. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt if: (i) The human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

iv. Research, involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

v. Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.

vi. Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

I. Documentation of Expedited Reviews. Expedited IRB review procedures may be employed for (i) minor changes in previously approved research during the specified approval period, or (ii) initial or continuing review of research falling with specific categories published in the Federal Register. Expedited reviews are conducted by the IRB Chairperson or a qualified IRB member designated by the Chairperson.

J. Documentation of Convened IRB Meetings—Minutes. IRB staff will compile the minutes of IRB meetings. The following specific information will be recorded in the meeting minutes:

i. Attendance.

ii. Quorum requirements.

iii. Actions taken by the IRB on the initial or continuing review of research; review of protocol modifications or amendments; review of informed consent process and document; risks and potential benefits; vulnerable populations; subject recruitment; serious adverse events and/or unanticipated problems involving risks to subjects or others; reports from sponsors, cooperative groups, or DSMBs; interval of IRB approval; reports of continuing noncompliance with the human subject regulations or IRB determinations; suspensions or terminations of research; and other actions.

iv. Votes on these actions.

v. The basis for requiring changes in or disapproving research.

vi. Summary of controverted issues.

vii. Required IRB findings and determinations.

viii. A list of research protocols approved since the last meeting utilizing expedited review procedures.

ix. IRB minutes for meetings in which an alternate member participates shall indicate the participation of the alternate and the member who the alternate replaces.

K. Attendance at IRB Meetings. IRB minutes will list attendance as follows:

i. Names of members present.

ii. Names of absent members.

iii. Names of alternates attending.

iv. Names of consultants present.

v. Name of investigators present.

vi. Names of guests present.

L. Quorum Requirements and Voting at IRB Meetings. IRB minutes will include a statement of Quorum Requirements based on the following standards:

i. A majority of the IRB members (or their designated alternate), including at least one member whose primary concerns are in nonscientific areas, must be present in order to conduct a convened meeting. In order for research to be approved, it must receive the approval of a majority of those members present at the meeting.

ii. Members may be present in person or audio (telephone) or audio-visual teleconference. Members present via teleconference will be noted as such in the meeting minutes, which will also indicate that the members received all pertinent information prior to the meeting and were able to actively and equally participate in all discussions.

iii. IRB minutes will include documentation of quorum and votes for each IRB action and determination by recording votes as follows: Total Number Voting ( ); Number voting for ( ); Number voting against ( ); Number abstaining ( ).

iv. Members absenting themselves due to conflicting interests may not be counted toward quorum requirements (i.e., may not be counted among those voting or abstaining).

v. No individual who is not listed on the official IRB membership roster may vote with the IRB.

vi. Each alternate IRB member who replaces a primary member at any given meeting should have the experience, expertise, background, professional competence, and knowledge equivalent to that of the primary IRB member whom the alternate will replace. Whenever an alternate member substitutes for a primary member of the IRB, the combined requirements of §46.107 and 46.108(b) shall remain satisfied. Whenever this occurs, the minutes of the IRB meeting should indicate clearly that the alternate IRB member has replaced the designated primary IRB member, and include the identity of the replaced primary and the alternate members. If multiple alternate members serve at an IRB meeting, the pairing of primary and alternate members should be indicated.

M. Actions Taken by the Convened IRB. IRB minutes will include all actions taken by the convened IRB and the votes underlying those actions. IRB actions for initial or continuing review of research include the following.

These actions will also be provided in writing to investigators:

i. Approved with no changes (or no additional changes). The research may proceed.

ii. Approvable with minor changes to be reviewed by a designated IRB member. Such minor changes must be clearly delineated by the IRB so the investigator may simply concur with the IRB’s stipulations. The research may proceed after the required changes are verified and the designated reviewer approves the protocol.

iii. Deferred pending receipt of additional substantive information. The IRB determines that it lacks sufficient information about the research to proceed with its review. The research may not proceed until the convened IRB has approved a revised application incorporating all necessary information.

iv. Disapproved. The IRB has determined that the research cannot be approved.

N. The Basis for Requiring Changes in or Disapproving Research. The minutes of IRB meetings will include the basis for requiring changes in or disapproving research. This information will also be provided in writing to the investigator, who will be given an opportunity to respond in person or in writing.

O. Summary of Controverted Issues at Convened Meetings. The minutes of IRB meetings will include a summary of the discussion of all controverted issues and their resolution.

P. Required IRB Findings and Determinations. The following specific IRB findings and determinations will be documented in IRB meeting minutes:

i. The level of risk of the research.

ii. The approval period for the research, including identification of research that warrants review more often than annually.

iii. Identification of any research for which there is need for verification from sources other than the investigator that no material changes are made in the research.

iv. Justification for waiver or alteration of informed consent, addressing each of the 4 criteria at 45 CFR 46.116(d). Briefly, the criteria that the IRB must find and document are: (1) the research involves no more than minimal risk to subjects; (2) the waiver or alteration will not adversely affect the rights and welfare of subjects; (3) the research could not practicably be carried out without the waiver or alteration; and (4) whenever appropriate, the subjects will be provided with additional pertinent information after participation.

v. Justification for waiver of the requirement for written documentation of consent in accordance with the criteria at 45 CFR 46.117(c).

vi. Special protections warranted in specific research projects for groups of subjects who are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, regardless of source of support for the research.

vii. Justification for approval of research planned for an emergency setting, with specific reference to the criteria specified under the special 45 CFR 46.101(i) DHHS waiver (see Appendix V) or the FDA exception at 21 CFR 50.24.