50thAnniversary

Chapter 4 – Institutional Review Board (IRB)

Union Institution & University’s IRB reviews and approves applications and is responsible for developing and communicating IRB guidelines and procedures. The authority of the university’s IRB extends to all research involving human participants as subjects conducted under university auspices, conducted by any individual or groups of individuals who are affiliated with the university, including:

  • Students: Full-time, part-time, and casual or transient/visiting students enrolled in academic programs or courses offered by Union Institute & University are required to obtain IRB approval for any research involving human subjects that is a component of the student’s academic program or course.
  • Full-Time Faculty and Staff: Full-time Union Institute & University employees (faculty and staff) must obtain IRB approval for any proposed research involving human subjects to be conducted under university auspices, including research conducted while on approved (paid or unpaid) personal or sabbatical leave. The policy for ownership of intellectual property will apply. (See the UI&U Intellectual Property policy.)
  • Affiliated and Part-Time Faculty and Staff: Less-than-full-time Union Institute & University employees (faculty and staff) must obtain IRB approval for any research involving human subjects to be conducted under university auspices or for which the researcher will use her/ his affiliation with the university to obtain external funding. The policy for ownership of intellectual property will apply.

Researchers who are not Union Institute & University employees or learners, but who propose to conduct research on behalf of the university (e.g., consultants, members of the Board of Trustees, alumni/ae board members) will be required to obtain approval from the university’s IRB only if, at the conclusion of the research, the university will own the resulting data. If the researcher retains ownership of the data, approval from the university’s IRB is not required. (See the UI&U Intellectual Property policy.)

Researchers who are unclear as to whether their studies need IRB review may contact the IRB Director.

4.A. IRB Authority

Union Institute & University’s Board of Trustees has empowered the IRB as the university’s decision-making body with regard to research with human subjects. IRB determinations regarding proposed research are final—they may not be overridden or reversed by any individual or group. Researchers are obligated to abide by the IRB’s decisions about their proposed studies. Researchers may appeal an IRB decision to the IRB. (See “Appeals of IRB Decisions.”)

Union Institute & University will not condone, support, or accept any research involving human subjects that:

  • Does not have the prior authorization of Union Institute & University’s IRB, unless the requirement for such authorization has been waived by the IRB. (See “Waiver of Requirement for IRB Approval.”)
  • Has been approved by another institution’s IRB but has not been approved by Union Institute & University’s IRB;
  • Has been denied approval by any officially constituted IRB (Union Institute & University’s IRB or another IRB).

See “Failure to Submit an IRB Application“ for information regarding consequences of engaging in research without IRB approval.

4.B. IRB Structure and Membership

Union Institute & University’s IRB is registered with the Office of Human Research Protections (OHRP) of the U.S. Department of Health and Human Services. Committee composition is in compliance with 45 CFR 46.107. Members have appropriate expertise and diversity in ethnic backgrounds, gender, and cultural backgrounds. All members have completed the CITI Course in the Protection of Human Subjects Research, and they have knowledge of research methods and professional practices appropriate for determining the acceptability of proposed research.

Members of the IRB are appointed by the Provost, based on recommendations from Deans of the academic units. The committee includes members with interests in scientific and nonscientific disciplines as well as an unaffiliated, community member. Members serve two- or three-year renewable terms. The IRB operates independently of the university’s academic programs. Administratively, the IRB operates within the Office of Institutional Effectiveness.

The IRB is cross-institutional, not program- or college-specific. Most members are Union Institute & University faculty, although qualified administrators may also be appointed. In most instances, IRB members hold an earned doctoral degree. The IRB may (but is not required to) have one member who is a learner or an alumni/ae. The IRB Director, a voting member, is responsible for IRB operations and for providing assistance and advice to applicants.

4.C. Quality of Proposed Research

The IRB considers the quality of proposed research or the merit of a proposed study only in so far as it is related to ensuring the protection of the rights and well-being of human subjects. However, research design quality and merit are important in IRB members’ analysis of a study’s potential risks and likely benefits.

A poorly designed research project poses inherent risks to subjects. Studies that have little or no merit are unlikely to result in any benefit. An uninformed researcher may also pose a risk to subjects. During the evaluative review, IRB members consider evidence of the researcher’s knowledge of research design, research methods, research ethics, and/or data analysis, and familiarity with the work of other researchers in the field or topic. Researchers should keep IRB criteria in mind throughout the development and implementation of their projects.

Students may submit applications to the IRB only after the proposed study has been approved through applicable academic review and approval processes. Following IRB review, if substantive changes to a project are required in order to meet IRB criteria for approval, the learner may need to obtain academic approvals for planned revisions to the study.

IRB members are members of the community of scholars. The IRB may choose to make recommendations to improve a research project separate from its requirements for approval. Although researchers are not required to follow these recommendations—they will be clearly communicated as such—they should certainly be considered.

4.D. IRB Confidentiality

IRB members may not discuss a proposed research study outside the IRB review process. The IRB review process may, however, extend to consultation with individuals external to the IRB such as a learner’s faculty advisor or dean, or an employee’s supervisor. The IRB may also, if necessary, engage a consultant to provide additional expertise needed to make a decision about a proposed study.

When IRB approval is requested for externally funded research or for research to be conducted in collaboration with another institution, the IRB may also communicate with those parties about the study. Such communication will typically be limited to sending copies of official IRB correspondence (e.g., approval letters).

4.E. IRB Conflict of Interest

To avoid conflict of interest or the appearance of conflict of interest, an IRB member who is affiliated with a research project submitted to the IRB for review and approval is recused from the discussion about and the decision on the project. Such member may answer questions only and will not vote on approval of the research proposal.

4.F. Advice vs. Assessment

Each IRB member is available to provide general advice and information on IRB policies and criteria for research involving human subjects. An IRB member may not assess an IRB application prior to submission for consideration. Doing so would create a prior relationship or affiliation to the project that would require the individual to recuse her or himself from consideration of the research project.

4.G. IRB Records

The IRB maintains documentation of IRB activities and copies of all research proposals reviewed, reviews that accompany the proposals, approved sample consent documents, progress reports submitted by researchers, and reports of injuries, if any, to subjects.

Minutes of IRB meetings include attendance, actions taken, the vote on these actions; the basis for requiring changes in or disapproving research; and a written summary of the discussion of issues and their resolution.

Records of continuing review activities, modifications of research studies, official IRB approvals, all correspondence between the IRB and investigators, and statements of significant new findings provided to subjects are also maintained.

All IRB records, including records relating to research conducted, are retained for at least three years after completion of the research. IRB application and research proposal records are destroyed by shredding three years after the research has been completed or after the researchers have graduated, withdrawn, or are no longer registered and pursuing a degree program at UI&U.
Unless otherwise noted, “IRB” refers to the full IRB.

Recognizing that some university employees may have other employment, these guidelines apply only to research projects related to employment by, or relationship to, Union Institute & University.

OHRP guidelines allow the nonaffiliated member to be a graduate of the university, as long as the graduate has no other official relationship with the university such as membership on the Alumni Board.

Including, but not limited to, a member who is the principal researcher or co-researcher, the faculty advisor, dissertation chair, or supervisor of the researcher, a member of the researcher’s academic committee, etc.
IRB records are maintained in accordance with 45CFR46.115.