CHAPTER 2

2.0 Organization of the IRB

The Institutional Review Board (IRB) is responsible for conducting initial and continuing reviews and providing oversight for all research activities involving the use of human subjects performed by agents or employees of the University. The scope of research reviewed by the IRB is not limited and the IRB reviews all types of research submitted.

The Institutional Official (IO) formally grants the IRB the following authority related to the protection of human subjects:

• To approve, require modifications to secure approval, or disapprove all research activities overseen and conducted by the agents of the organization and involving human subjects, based on its consideration of the risks and potential benefits of the research and whether the rights and welfare of the subjects are adequately protected.
• To require reports for protocol continuing review.
• To continuously monitor the conduct of research on human subjects.
• To suspend or terminate approval of research that is not being conducted in accordance with IRB requirements or that has been associated with unexpected serious risk to subjects.
• To place restrictions on a study, if necessary, to protect human research subjects.
• To observe, or have a third party observe, the consent process.
• To observe, or have a third party observe, the conduct of the research.

No official within the organization may approve of a protocol or human subject research activity that has not been approved by the IRB. However, the IO may disapprove of a protocol or research activity that has been approved by the IRB.

2.1 Composition and Appointment of the IRB

The IRB is a committee formally appointed by the IO, with input and membership nominations coming from the IRB Chair and IRB members, University department chairs, and self-nominations, and is composed of a minimum of 5 members to ensure complete and adequate review of activities commonly conducted at the University. The composition of the IRB will exceed the minimum regulatory requirements and is sufficiently qualified through the maturity, experience, and expertise of their members and diversity (experience, professional expertise, racial, cultural, and gender) of membership to ensure respect for their advice and counsel specific to safeguarding the rights and welfare of human subjects. In addition to possessing the professional competence necessary to review specific activities, the IRB can ascertain the acceptability of proposals in terms of organizational commitments, regulations, applicable law, standards of professional conduct and practice, and community attitudes and are constituted to meet those requirements.

The IRB will include at least one scientific member, one member whose primary concerns are in nonscientific areas, 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 the organization, and one member who represents the perspective of research participants. The role of nonscientist and the person representing perspectives of research participants may be fulfilled by a single member. Scientific members of the IRB generally will have experience in research involving human subjects and will be recruited from among active research members (e.g., faculty) of the University. Nonscientific members will often be recruited from the University at large and will reflect professional expertise in a non-scientific area, such as law, ethics, human or patient rights, etc. The appointment of non-affiliated (community) members and a prisoner representative will also be done by the IO but the Research Compliance Manager is responsible for determining whether the nominees are truly unaffiliated and/or have appropriate expertise to serve as prisoner representatives.

Alternates are appointed and function in the same manner as the primary IRB members. The alternate’s expertise is comparable to those of a primary member. The role of the alternate member is to serve as a voting member of the IRB when a regular member is unable to attend a full board 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 alternate member will not be counted as a voting member unless they are acting in a voting member capacity. The IRB minutes will document when an alternate member acts as a voting member.

At times, the IRB may not have the necessary expertise to judge the scientific soundness of a research protocol and may be unable to make a fair and accurate determination of the risk-benefit ratio. For these protocols the IRB Chair, or the primary reviewer after consultation with the IRB Chair, may call upon an ad hoc consultant for assistance in review for scientific merit or to perform an in-depth review of the study. Ad hoc consultants are not considered to be members of the IRB, are utilized only for expert scientific review, have no voting rights and must disclose whether he/she has any conflicts of interest with the protocol. Subject matter experts who are conflicted with a study may not serve as a consultant to the IRB. The consultants will submit a written report, and copies of the report will be distributed to all IRB members. The consultant may also attend a convened IRB meeting and provide a verbal report to the IRB. The report and recommendations will be documented in the IRB minutes for the meeting.

The IO may appoint administrative staff and/or faculty (e.g., legal counsel) at the University to serve as non-voting members of the IRB should the IO, the IRB Chair, or the Research Compliance Manager decide that such people would be of assistance to the IRB in conducting its duties. Individuals involved in the business function or in research development do not serve in any capacity on the IRB and are not involved in the day-to-day operations of the review process. A non-voting member cannot be counted in the quorum and cannot vote but can participate in discussions. In addition, funding agencies may have additional IRB membership requirements. For example, the National Institute on Disability and Rehabilitation Research (NIDRR) specifies that when an IRB reviews an NIDRR-funded research project that purposefully includes children with disabilities as research subjects, the IRB must include at least one person whose primary interest is the welfare of children with disabilities. When reviewing these types of research projects, the IRB may use ad hoc reviewers with specific expertise in treating children with disabilities.

IRB staff will report changes in IRB membership to OHRP as required.

2.2 Terms of Appointment

IRB members are appointed to renewable terms, with no term limit. Members may resign at any time by submitting a letter or resignation to the IRB Administrator. The IRB leadership may remove members from the committee if the member is unable to complete their responsibilities as an IRB member. The IRB Chair and Vice Chair are expected to hold their positions for several years. Upon appointment and periodically throughout their appointment, each IRB member is queried to determine roster information such as affiliation status, relationship of the member to the University, indications of experience, and other relevant information. The IRB will be evaluated annually via surveys of membership, and results are reported back to the committee.

2.3 Committee Officers

The IRB will have a Chair, and optionally a Vice Chair, chosen from IRB members and will typically be faculty members of the University knowledgeable in human subject research, including the federal and state regulations, University policies, and ethics relevant to such research. The IRB Chair shall preside over and be authorized to speak for the IRB. Whenever the Chair is not available, optionally the Vice Chair will assume the responsibilities of the IRB Chair during the period of their absence.

2.4 Committee Meetings

To conduct IRB business at a full board meeting, IRB staff determine a quorum (majority) of members are present, including a non-scientist. When studies involving prisoners are reviewed, a prisoner representative must participate to have quorum. If quorum is lost, votes are not taken until it is restored. To be approved, a protocol must receive a majority of votes of members present at the meeting. The IRB shall hold regular meetings at a time and place to be determined by the IRB and posted electronically. Researchers are invited to attend to address specific concerns regarding research protocols but will be asked to leave the meeting during all deliberations and votes.

Prior to each full board meeting, the IRB staff or the IRB Chair will review the agenda of protocols and will assign primary reviewer(s) knowledgeable about or experienced in working with these types of studies. When research involves vulnerable populations, an IRB member or consultant with corresponding expertise is present or has provided feedback to the IRB. The IRB staff ensures that either the Primary or Secondary Reviewer is present at the meeting or available by teleconference during the full board meeting.

2.5 Confidentiality of the Review Process

Materials provided to the IRB for review are considered privileged information, and the IRB shall assure the confidentiality of the data contained therein.

2.6 IRB Meeting Minutes

Meeting minutes are recorded, may undergo quality assurance review, and are retained. IRB staff members monitor quorum at each meeting and record IRB discussion points for the minutes. Meeting minutes are provided each month to IRB members, the Associate Vice President, Research Compliance and Regulatory Services (AVP of RCRS), and the IRB staff via the electronic protocol system with a request for comments and/or suggested changes regarding the document’s accuracy. A vote for approval of the final version of the minutes occurs at the next full board meeting.

Minutes shall include:

• A record of deliberations for each protocol reviewed, resulting IRB actions, and a summary of the discussions.
• The approval period for each initial review, continuing review and amendment.
• A record of attendance for each protocol including the names of members who left the meeting due to a conflict of interest and a notation of such.
• The voting record for each protocol and the previous meeting’s minutes reflect the number of members for, against or abstaining from the vote and when alternate members replaced a primary member.
• The basis for requiring changes to a protocol, tabling/deferring, suspending, or disapproving research.
• A written summary of the discussion and resolution of controverted issues.
• Determinations for waiver or alteration of the consent process; research involving pregnant women, fetuses, and neonates; research involving prisoners; research involving children; and research involving participants with diminished capacity.
• Justification of deletions or substantive modifications of information concerning risks or alternative procedures contained in an HHS approved consent form.
• If applicable, the determination for significant risk/non-significant risk device determinations (rationale for determination documented in IRB submission materials and IRB reviewer checklist).
• A list of all actions that were taken administratively during the previous month.

Protocol-specific findings for justifying determinations for waiver or alteration of the consent process; research involving pregnant women, fetuses, and neonates; research involving prisoners; research involving children; and research involving participants with diminished capacity are documented in the IRB submission documents (e.g., proposal) and IRB checklists, as appropriate.

2.7 Reviewers Designated for Expedited Review

IRB members (including experienced IRB staff members) who have been designated by the IRB Chair as reviewers for initial or continuing review of research protocols, reports of non-compliance, protocol deviations, unanticipated problems, and amendment requests that qualify for expedited review will self-identify any Conflict of Interest (COI) that they may have with the research or Principal Investigator (PI). In such cases, the review responsibility will be reassigned to another experienced IRB member.

2.8 Interaction With Other UTEP Components

Some reviews are accomplished by other standing committees or offices. The success of the University’s intent to protect human research subjects is dependent upon open communication among these various institutional components. These committees and offices exchange information when necessary to ensure that, in addition to IRB review, human subject research receives all appropriate review prior to implementation of the research activities. Human subject research is not allowed to begin until all applicable reviews are complete and notification of approval is received by the IRB.

2.9 Types of Research Conducted at UTEP

UTEP supports a range of human subject research that includes social behavioral and education research, biomedical, clinical trials, vulnerable populations and international research.

2.10 Categories of Research Subjects

UTEP’s faculty, staff, and students perform research on diverse groups of participants. Whether from the local community, across the United States, or globally, research participants may represent different racial, ethnic and cultural backgrounds. They may not speak English as their first language. They may be considered healthy adults. They may belong to specifically identified and protected populations (children, pregnant women or prisoners) or be entitled to special safeguards (UTEP employees or students, educational, economic, or social disadvantage or decisional- impaired).

2.11 Determining if IRB Review is Required

Usually, this question is obvious. There are times that IRB staff (consulting the AVP of RCRS, IRB Administrator or Chair if needed) need to determine if the proposed activity engages in human subject research. The two questions below must be answered.

2.11.1 Is it Human Subject Research?

2.11.1.1 Is it research (HHS supported) or clinical investigation (FDA regulated)?

2.11.1.2 Are human subjects involved?

IRB staff will perform an initial review if a PI requests project review by phone or email. Descriptions of the activity, data collection and setting are required. Other information may be requested for clarification.

If the PI needs an official determination letter related to projects believed to be Not Human Subjects Research (NHSR), the appropriate form/application (located on the forms page) must be completed and submitted for review.  The NHSR application will be evaluated according to the applicable standards, and an official determination letter will be provided when appropriate.

2.11.2 Class Projects

Class projects typically do not meet the definition of human subject research. IRB review may not be required. For guidance regarding institutional policy regarding the review of class projects, visit the IRB Office or email IRB@utep.edu .

2.11.3 Oral History

Researchers are advised to consult with IRB staff to determine if an oral history project requires IRB review and approval.

Deciding whether oral history, or other activities solely consisting of open-ended qualitative type interviews, are subject to IRB review is based on the prospective intent of the PI and the definition of “research” under HHS regulations at 45 CFR 46.102(d). Specifically, to be subject to IRB review, the activity must meet the following standards and general principles for evaluating Oral History type activities:

• The activity involves a prospective research plan which incorporates data collection, including qualitative data, and data analysis to answer a research question; and
• The activity is designed to draw general conclusions (i.e., knowledge gained from a study may be applied to populations outside of the specific study population), inform policy, or generalize findings.
• Systematic investigations involving open-ended interviews that are designed to develop or contribute to generalizable knowledge (e.g., designed to draw conclusions, inform policy, or generalize findings) would constitute “research” as defined by 45 CFR 46.
• An open-ended interview of surviving Gulf War veterans to document their experiences and to draw conclusions about their experiences, inform policy, or generalize findings would require IRB review and approval.
• Oral historians and qualitative investigators may want to create an archival resource for others to do research. Creating this archive would constitute research under 45 CFR 46 because the intent is to create the archive so other investigators may conduct research as defined by 45 CFR 46.
• Open ended interviews are conducted with surviving Negro League Baseball players to create an archive for future research. The creation of such an archive would constitute research under 45 CFR 46 since the intent is to collect data for future research.
• Conversely, oral history activities that only document a specific historical event or the experiences of individuals without intent to draw conclusions or generalize findings would not constitute “research” as defined by 45 CFR 46.
• An oral history video recording of interviews with Holocaust survivors is created for viewing in the Holocaust Museum. The creation of the video does not intend to draw conclusions, inform policy, or generalize findings. The sole purpose is to create a historical record of specific personal events and experiences related to the Holocaust and provide a venue for Holocaust survivors to tell their story.

2.11.4 Coded Private Information as it Relates to Human Subject Research

OHRP does not consider obtaining coded private information or human biological specimens human subject research if the provider of that information retains the code and meets one of the following conditions:

• The key to decipher the code is destroyed before the investigator gets the coded information.
• The investigator and the holder of the key agree that the key will not be released under any circumstances.
• The releasing institution has IRB-approved policies and procedures applicable to the project that prohibit the release of the key.
• There are other legal requirements that prohibit the release of the key.

OHRP also does not consider authorship as a factor in determining if an institution is engaged in human subject research. Analysis of unidentifiable or coded information and/or publication of conclusions based on analysis of the information does not constitute being engaged in human subject research.

2.11.5 Undue Influence Over the IRB or IRB Staff

Individual members of the IRB, whether employed by UTEP or community members, and IRB staff have the right and obligation to report any undue pressure to make decisions that would favor an individual PI over participant protection. The Board or staff member will be asked to provide written documentation to the AVP of RCRS and IO to open a formal report. The IO will review the information and may obtain additional information as needed to determine findings. The AVP of RCRS will keep the IRB appraised. The IO may consult with the IRB to take corrective action.