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IRB reviews may be conducted by the IRB Director, by another IRB member, or by the full IRB. The type of review will depend on the study. Researchers should become familiar with the types of IRB review to ensure that their applications are appropriately designed. The requirement for including an informed consent process applies when human subject interaction occurs during a research study, regardless of the type of review. Applications and research proposals undergo one of three types of reviews: (1) exempt, which includes theoretical and creative studies (2) expedited, or (3) full. The IRB may decline to consider a research study that was completed without IRB review and approval.
All research projects eligible for exempt review must be submitted to the IRB for review and approval. Researchers must submit either the Exempt Research Study Checklist – Application or the IRB Notification for Theoretical & Creative Research Projects form along with summary of the proposed research, including data sources and data collection and analysis methods. Any studies that the IRB determines are not eligible for exempt review must undergo expedited or full IRB reviews as described in this chapter and Chapter 7.
The following examples are of studies that could be eligible for exempt review. Studies of the types discussed in Categories 1 through 4 are often used in social and behavioral research.
Researchers must submit a summary of their research study and a Exempt Research Study Checklist – Application form or a IRB Notification for Theoretical-Creative Research form to the IRB. The IRB Director will notify the researcher via e-mail regarding whether the study is exempt from IRB review.
An expedited review process is used for certain kinds of research that involve no more than minimal risk but do not qualify for exemption and for relatively minor changes to previously approved research. To qualify for expedited review, the study must fit one or more of the following criteria. Studies that may qualify for expedited review include:
Other types of medical and clinical studies also eligible for expedited review include:
The expedited review process may not be used when identification of subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to subjects’ financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.
Studies must include procedures consistent with sound research design. The IRB will consider only risks and benefits that may result from participation in the study—distinguished from risks and benefits subjects might encounter if not participating. Finally, the IRB will not consider possible long-range effects of applying knowledge gained in the research (e.g., possible effects of the research on public policy) as among those risks/ benefits that fall within its responsibility. (See “Criteria for Approval.”)
Researchers must submit the IRB Application and Research Proposaland the Expedited Review Checklist form to the IRB Director. An expedited review may be carried out by the IRB Chair or by one or more experienced reviewers designated by the Chair from among voting members of the IRB. The expedited review is not available for federally classified research involving human subjects. Federally classified research is restricted to individuals with United States government security clearances.
Full IRB review is required for proposed research (or proposed changes to previously approved research) that might reasonably be regarded to pose some degree of risk (i.e., greater than minimal. (See “IRB Application Preparation and Submission.”) If the answer is yes to any one of the following five questions, the research requires full review.
The IRB conducts systematic reviews of previously approved, ongoing research with human subjects. As a condition of approval, the IRB may require the researcher to provide progress reports and/or a concluding report. If the IRB requires a progress report, the approval letter will include a submission date and an outline of the information the researcher is required to provide. The IRB may also decide, subsequent to approval, to require a progress report and/or concluding report.
Researchers are responsible for submitting required progress and/or concluding reports on or before the date established by the IRB. If a researcher fails to do so, the IRB may suspend or terminate approval for the study. The IRB may also suspend or terminate approval if a progress or concluding report describes a study that is substantively different from what was approved by the IRB and/or unanticipated or adverse events were not reported to the IRB. (See “Modifications to Previously Approved Research” and “Suspension or Termination of IRB Approval.”)
Twelve (12) months is the maximum length of time granted for initial IRB approval of a research study involving human subjects. IRB approval is intended to cover recruitment and data collection. If these phases are not completed within the approved twelve (12) months, obtaining a renewal of IRB approval is required. IRB approval may be renewed/ continued for an additional six (6) or twelve (12) months. Researchers are responsible for supplying information necessary for obtaining a renewal of IRB approval of their research studies.
The IRB uses full IRB review procedures unless the research meets the expedited review criteria for continuing review. To approve the research, the full IRB will determine whether all requirements for the initial approval continue to be met. (See “Criteria for Approval.”) Continued IRB approval for higher-risk studies may be limited to a maximum of six (6) months. If researchers do not obtain official IRB renewal, they are required to suspend their studies until they have received a renewal. If the IRB determines that a research study has continued beyond its approval ending date, the IRB will require the researcher to suspend the study until he/she has applied for and received and IRB renewal to continue. Studies continued beyond the original approval period, without IRB renewal, are unapproved studies. Researchers who do not obtain renewals but continue their studies will be in violation of UI&U and IRB ethical requirements.
An expedited review procedure may be used for the continuing review of research previously approved by the full IRB as follows:
To avoid interruptions to a study, a researcher should provide information needed to obtain a renewal at least two months in advance of the need for continued IRB approval. In most cases, the IRB Director can approve continuation of previously approved research. Continued review by the full IRB is required for studies originally reviewed and approved by the full IRB that do not meet the expedited review criteria for continuing review. (See Continuing Review/ Renewal Request form.)
IRB approval is required for substantive changes in the research model, informed consent form(s), survey instrument(s), or nature of subjects. IRB approval of the research with the proposed changes will extend no more than twelve (12) months from the date the researcher proposes to implement the changes.
If a subject experiences an adverse or unexpected reaction or side effect, the researcher will be required to make changes to the study to avoid future, similar situations. When an adverse event occurs, proposed changes to avoid additional adverse events require full IRB review.
The request for approval of proposed changes to a previously approved study should include the following:
Submit the revised documents, the Modification Request Form, and the Continuing Review/ Renewal Request form to the faculty advisor, dissertation chair, or supervisor for review and signature before sending it to the IRB Director; it will not be accepted for consideration without these approvals.
A collaborative research project involves more than one researcher and may involve researchers affiliated with different institutions. Participating researchers and institutions share the responsibility for safeguarding the rights and welfare of human subjects and compliance with applicable regulations.
External funding for a research study may require IRB certification of the project, even when no human subjects are involved. The IRB certifies projects through formal notification to the Office of Human Research Protections (OHRP) of the U.S. Department of Health and Human Services or to the applicable nongovernmental funding department / agency. For collaborative research involving more than one institution, only the IRB at the lead institution may file for certification with the OHRP. Proposed research for which the principal researcher requests IRB certification must be reviewed and approved by the full IRB, even when it qualifies for exempt review.
The IRB has the authority to suspend or terminate IRB approval of research involving human subjects for any of the reasons listed below. Researchers are obligated to halt their research immediately if they receive a notice of IRB suspension or termination of IRB approval.
The decision to suspend or terminate IRB approval of a research project may stem from the IRB’s charge from the university’s Board of Trustees, from the IRB’s responsibilities to human subjects, from the obligations of an OHRP-registered IRB, from our commitment to the protection of human research subjects evidenced by a Federalwide Assurance, or from IRB policies and procedures. The IRB is required to and will suspend or terminate IRB approval for research if it determines that:
The IRB may suspend IRB approval of a research study based on information provided by someone other than the researcher. In fact, as a member of the academic community, researchers are obligated to notify the IRB Director immediately if they have a concern about the conduct of research involving human subjects or the safety of those subjects. Notices of suspension or termination of IRB approval will be sent to other interested parties such as a faculty advisor, dissertation chair, dean, or funding agencies, if any. In emergency situations, such as when a subject has been harmed, the IRB Chair has the authority to suspend research. The IRB is not required to investigate or consult with the researcher prior to suspending IRB approval of a research study. In fact, in many cases, it will not do so. In emergency situations, notice of suspension of IRB approval may be made by telephone or e-mail.
This list is based on Title 45 CFR Part 46.101.
“Categories of Research that May Be Reviewed by the Institutional Review Board (IRB) Through an Expedited Review.” Available from http://www.hhs.gov/ohrp/policy/exprev.html.
Extracted from 45CFR46.110. Available from http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html.
The IRB may approve internal assessment research projects conducted by or on behalf of university administrative or academic units for up to 24 months. See “Class-Related and Other Research Activities.”
Source: Guidance on Continuing Review, dated January 15, 2007, available at http://www.hhs.gov/ohrp.