50thAnniversary

Chapter 8 – The IRB Review Process

The full IRB committee reviews research proposals involving more than minimal risk to human subjects. Individual IRB members and the IRB Director review proposals for exempt and expedited reviews. Centralization of IRB records and operations, with a designated IRB administrator and staff support, ensures that the IRB is able to fulfill its responsibility for tracking and oversight of ongoing research.

8.A. Application Submission Process

Complete basic modules of the CITI Course for the Protection of Human Research Subjects before submitting an IRB application and research proposal. The CITI Course program will automatically generate a completion report and send it to the IRB Director via e-mail. A CITI Course completion report is a requirement for acceptance of an IRB application for IRB review.

All applications should be submitted to the IRB Director. The Director will conduct a desk review to determine whether the application meets general IRB criteria with regard to format and content and that the applicant has completed the CITI Course. Full IRB review is not scheduled until an application is accepted by the Director.

If an application is not acceptable, the Director will contact the researcher (usually by e-mail), outlining the requirements for acceptance. These requirements range from simple clarifications or additions to a total revision of the proposal and/or attachments. All revisions should be highlighted to facilitate the review process.

8.B. IRB Meetings and Meeting Procedures

IRB committee meetings are held monthly, by teleconference. Additional meetings may be called by the Chair if necessary. A quorum is required for every meeting: A majority of IRB members constitutes a quorum, which includes a nonscientific member. Agreement of the majority of the quorum is required for official determinations on issues requiring full IRB approval. A maximum of three applications are considered at a committee meeting.

The IRB Director reviews each application received. Once accepted for review, the Director places acceptable applications requiring full review onto the next available IRB meeting agenda, and sends the applications to IRB members.

Applications for studies that qualify for review for exemption or expedited review are assigned to an individual IRB member. The IRB Chair has delegated responsibility for conducting exemption and expedited reviews to the IRB Director. Reviews for exemption and expedited reviews are conducted in the order received and accepted. The Director provides a monthly summary of all expedited reviews to the IRB.

8.C. Time Frame for IRB Review

No application submission deadlines apply to IRB applications. Applications requiring full IRB review will be scheduled for the next available meeting. Applications for full review should be submitted at least one month prior to the convened IRB meeting to allow for the Director’s review. Applications are sent to IRB members two weeks before the monthly meeting. The maximum number of applications reviewed at a convened full IRB meeting is three, which may result in an application being reviewed at a later date.

Within 3 to 10 working days after an application is received, the Director (or Director’s designee) will complete a desk review to determine whether the application is acceptable (i.e., meets format and general content criteria; all attchments are included). The following table shows typical timelines for completion of an IRB review. These times will vary, depending on IRB meeting agendas.

Type of IRB Review Typical Time Frame for Completing Initial Review
Acceptance of Application (Initial Review) Within 3-10 working days of receipt by IRB Director
Exempt Review Within 10-20 working days of acceptance by IRB Director (13-25 working days of receipt by IRB  Director)
Expedited Review Within 10-20 working days of acceptance by IRB Director (13-25 working days of receipt by IRB Director)
Full IRB Review Within 15-25 working days of acceptance by IRB Director (18-30 working days of receipt by IRB Director)

8.D. Official Notification

Informal notifications of IRB decisions may be made by e-mail. However, researchers may not begin their projects, including recruitment, until they have received the official approval/ notification letter from the IRB Director.

Official, written notice of all IRB decisions will be made within 3 to 7 working days of the decision. All official notices will be sent by the IRB Direcgtor (or Director’s designee), in the form of a letter on university letterhead. See “IRB Determinations” for the range of decisions available to the IRB.

8.E. IRB Determinations

A research proposal may be approved, conditionally approved (revisions, corrections, or changes may be required), deferred for revision (the proposal is not ready for IRB review or needs additional work), referred for review by an expert in the research area (if such expertise is not available on the IRB), or denied.

8.F. Approval

Applications that meet all IRB criteria will be approved. The researcher will receive an official notification letter on letterhead from the Director for exempt, expedited, and full review projects, which will stipulate the duration of IRB approval—typically twelve (12) months from the proposed or approved start date of the study—and any required progress or concluding reports. The researcher may begin the research project after receiving the official approval letter. Official approval for theoretical-creative projects is sent via e-mail.

Criteria for Approval

  1. Risks to subjects are minimized: (i) By using procedures consistent with sound research design that do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
  2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB will consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB will consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
  3. Subject selection is equitable. The IRB will take into account the purposes of the research and the setting in which it will be conducted and will pay particular attention to special problems of research involving vulnerable populations such as children, prisoners, pregnant women, mentally disabled persons, or economically or educational disadvantaged persons.
  4. Informed consent must be obtained for each prospective subject or the subject’s guardian / legally authorized representative, or waived, in accordance with IRB guidelines.
  5. Informed consent must be appropriately documented in accordance with IRB guidelines.
  6. Proposed research procedures should make adequate provisions to protect the privacy of subjects and maintain the confidentiality of data.
  7. When some or all subjects 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, additional steps must be included to protect the rights and welfare of these subjects.

Approval Time Frames
The approval time frame for expedited and exempt studies is one year (12 months) from the date of approval. For research studies reviewed by the full IRB, the approval period starts on the date the IRB approved the study or on the date the IRB Director determined that explicit conditions required by the IRB were approved. The expiration date is defined as the first day on which the study is no longer approved without renewal of IRB approval. The expiration date is calculated as the date that the IRB approved the study or approved the study with explicit conditions, plus the interval of approval (maximum of one year). The approval period ends the day before the expiration date. For example, if the full IRB approved a study with explicit conditions on 10/15/2011, and the Director confirmed that the conditions were met on 10/22/2011, the approval period is 10/22/2011 to 10/20/2012, and the expiration date is 10/21/2012.

Expiration Notices
The IRB Director sends researchers e-mail notices 60 days prior to the expiration of IRB approval of their studies. Notices list the study title, IRB ID number, approval expiration date, and the Continuing Review / Request to Renew Form is attached. Researchers are required to submit responses on this form regardless of whether they have completed or will complete all recruitment of subjects and all data collection prior to the expiration of IRB approval. If IRB approval for a research study expires, all research activities are to cease, including recruitment, acceptance of participants, interventions and interactions with current participants.

8.G. Conditional Approval

If the IRB agrees that a project is generally acceptable but needs minor modifications to meet all criteria for approval, it will be conditionally approved. Conditional approval is given when the IRB requires minor changes, such as clarification of a specific item or minor changes to the informed consent process (e.g., modification of language, correction of typographic or grammatic errors). The official notification letter or e-mail message from the IRB Director will stipulate conditions of approval.

Researchers may not begin their research projects until they have met those conditions and have received official notification of IRB approval. Conditional approval will also result if a study meets all IRB criteria but requires review by another IRB. Full approval will not be made until the researcher has furnished documentation of approval by the other IRB. Responses to a vote of conditional approval are reviewed by the IRB Director.

If an application is conditionally approved, the researcher must meet the conditions for approval within the time frame stipulated by the IRB Director in the notification letter, typically 30-90 days. If the researcher does not respond within that time frame, the Director may place the application on inactive status. The researcher must request reactivation if he/she wants further consideration of the application.

If a researcher’s revision does not respond appropriately to the IRB’s conditions for approval, the Director will  explain the remaining conditions to be met and indicate a time frame for response. If the second revision does not meet conditions for approval, the Director will refer the application for review by the full IRB with a recommendation for denial.

8.H. Deferral of Approval for Revision

The IRB will defer approval when the committee determines that it needs more information before it can review the study adequately. The committee may request substantive changes or additions in order for an application and research proposal to meet criteria for approval. The official notification letter from the IRB Director will stipulate all conditions for eventual approval. The notification letter may also include a deadline for submission of the revised application, typically 30-90 days. If the researcher does not meet the deadline, the Director may place the application on inactive status. After the application is placed on inactive status, the researcher must submit a new IRB Application and Research Proposal to obtain IRB approval for the research study.

If an application is deferred, the researcher has two options: (1) respond to the IRB’s requirements and resubmit it, or (2) withdraw the application. The researcher should notify the Director immediately when choosing to withdraw the application.

The researcher’s response to deferred approval will first be reviewed by the IRB Director to determine whether responses were made to all IRB requirements. The Director will then forward the response to the same IRB member who conducted the initial review or to the full IRB if the initial application was reviewed by the full IRB.

This second review may result in any of the following determinations: approval, conditional approval, deferral for revision, or denial. If approval is deferred for revision a second time, the next review will have only two possible determinations: approval or denial (or referral with a recommendation for denial).

8.I. Referral of Review

The IRB may refer the review of some research proposals for the following purposes:

  1. Review for expertise, or
  2. Review for denial of IRB approval.

Referral of Review for Expertise
An individual IRB reviewer will refer review to the full IRB when related expertise is needed to make an informed decision about a proposed study. All referred reviews are made by the full IRB. If an application is referred for review for expertise, the notification letter from the IRB Director will explain the reason for referral. The review will not occur until an appropriate reviewer has been identified.

Referral of Review for Denial of IRB Approval
An individual IRB reviewer must refer review to the full IRB if he/she believes approval should be denied, as only the full IRB has the authority to deny approval. If an application is referred for review with a recommendation for denial, the notification letter from the IRB Director will outline the reasons for the recommendation. The researcher will then have the option to officially withdraw the application, revise it, and resubmit it as a new application. If a researcher chooses to withdraw the application, he/she should notify the Director immediately.

8.J. Withdrawal of an Application

A researcher may choose to withdraw an application if he/she receives a decision of conditional approval, deferral of approval for revision, or referral for denial. (Researchers may also withdraw their applications for other reasons such as a decision to make substantive changes, or to postpone the start of the study.) The IRB Director may place an application on inactive status if a researcher fails to meet submission deadlines established through either conditional approval or deferral of approval for revision.

8.K. Denial of IRB Approval

Only the full IRB may deny approval. Denial of approval will occur only after due and careful consideration. The IRB will deny approval if any one of the following situations apply:

  1. The proposed study places subjects at risks that appear to outweigh the likely benefits and/or value of the knowledge to be gained.
  2. The proposed research raises serious ethical questions.
  3. The proposed study is insufficiently developed or articulated for the IRB to determine the level of possible risk to human subjects.

If the IRB denies approval of a proposed research project for any reason, the researcher may design a new project or redesign the project so that it will meet IRB criteria for approval of research with human subjects. IRB review of new or revised applications following denial may include consideration of the previously denied project.

8.L. Researcher Participation in Reviews

Researchers may interact with the IRB only through the IRB Director. Researchers should not initiate contact with individual IRB members about their projects. Although the IRB Chair may contact researchers, individual IRB members should not contact a researcher regarding submitted IRB applications and research proposals. Communications between the IRB Director and a researcher will be documented and placed into the researcher’s IRB file.

If an application will be reviewed by the full IRB, the Chair may choose to ask the researcher to join the teleconference meeting to respond to questions about the application. Although researchers are strongly encouraged to agree, because their involvement may help the IRB in its evaluation of their projects, their participation is not a requirement for approval. If a researcher is invited to join an IRB meeting, he/she is expected to abide by the meeting rules and to leave the meeting when asked to do so.

8.M. IRB Consultants/ Advisors

In rare circumstances, the IRB Chair will bring in a temporary member or engage a consultant/ advisor to inform its decisions. The Chair’s decision, which may have financial implications, will be made only in consultation with the IRB Director, and it may require approval from the university’s chief academic officer.

An IRB member may refer review for expertise. If appropriate expertise does not exist among IRB members, this option allows the IRB Chair to locate a reviewer with expertise appropriate to a proposed project. In such cases, the individual would serve as a temporary, nonvoting consultant / advisor to the IRB.

In most cases, consultant/ advisors will be chosen from UI&U faculty and administration. However, if an appropriate consultant/ advisor is not among the university’s faculty or staff, the IRB Chair may (1) recommend that an external consultant/ advisor be engaged, or (2) refer the application to the full IRB with a recommendation for denial. In the latter case, the IRB’s denial would be made on the basis that the university lacks the expertise to provide appropriate academic support and assessment of the proposed study.

If a project submitted for review involves the participation of prisoners as subjects and for which federal funding will be sought, the IRB is required, under federal regulations, to have a voting member who is either a prisoner or prisoner representative by reason of background or experience. Because arranging for this temporary IRB member may take some time, researchers planning such projects should notify the IRB Director well in advance. (See “Informed Consent Documentation.”)

Financial considerations related to engaging an external temporary voting member or consultant/ advisor can have an effect on the IRB’s decision. To prevent the appearance of conflict of interest, any costs related to engagement of an external member of consultant are the responsibility of the IRB. Consultants / Advisors may not be paid by the researcher.

8.N. Appeals of IRB Decisions

Researchers may appeal conditional approvals, deferrals of approval for revision, and denials if they disagree with the conditions or reasons stipulated by the IRB for the decision. Appeals must be submitted to the IRB Director, in writing, within thirty (30) working days of the date of the official notification letter from the Director. Appeals will be considered by the full IRB at a regularly scheduled meeting. An appeal is not considered justification for calling an emergency IRB meeting.

Appeals will be considered only if they include substantive revisions to the original application and/or significant clarification or additional information. The researcher must respond directly (item by item) to the reasons for the IRB’s decision—conditional approval, deferral of approval, or denial of approval. The IRB will not consider appeals submitted on the basis of resulting delay in completing degree requirements, nor will it accept disagreement with the IRB’s findings as a valid ground for appeal.

If an appeal is denied by the IRB, the researcher may not appeal to the IRB again. The researcher may choose to pursue other published formal university grievance or appeal options. Researchers should keep in mind, however, that decisions made by the IRB, as a Board of Trustees-mandated body, may not be overridden by academic or institutional officials.

This information is based on 45 CFR 46.111.