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IRB members refrain from participating in reviews where they may have a conflict of interest.

     » Declaration of Commitment to Avoid Conflict of Interest

Only IRB members serve as reviewers for non-exempt research. Only voting IRB members can conduct expedited reviews. In conducting an expedited review, an IRB member may ask the IRB Chair to appoint, as needed, a consultant with specialized expertise.

NON-EXEMPT RESEARCH

Unless the principal investigator formally seeks exemption, all human subjects research under the Alverno IRB jurisdiction formally begins with completion of the New Study Application for IRB Reviewand the Research Protocol.

New Studies

Submission

Standard Submission (Outside RRC Context): The principal investigator submits all application materials to the IRB Administrator. After determining the submission is complete, the IRB Administrator forwards a copy to the IRB Chair. The IRB Chair may make a determination that the new study application is eligible for an expedited review or requires a full IRB review. If the chair, determines the submission appears eligible for review, he or she may:

  • Conduct an expedited review him/herself
  • or assign one or more IRB members to conduct an expedited review.  (In some cases, the IRB Chair may make formal standing appointments for expedited reviewers for particular kinds of research.)

RRC Supported Submission (If IRB member has RRC Standing Appointment to do Expedited Reviews): Although submission may sometimes proceed directly through a RRC, a principal investigator, at the same time, routes a copy of all application materials to the IRB Administrator. This begins a process of documentation parallel to the standard submission.

Note that a researcher may directly submit an application for a new study to an RRC for an expedited review if and only if:

  • the RRC supports expedited reviews,
  • the RRC includes, as a reviewer, an IRB member authorized by a standing appointment from the IRB Chair to review proposals in that field,
  • an authorized RRC/IRB member agrees to conduct the expedited review (based on expertise and lack of conflict of interest), and
  • the researcher also submits at that same time two copies of all application materials (to the IRB Administrator).

Conducting the Review

When conducting an expedited review, the IRB reviewer(s) completes a checklist in support of that review. The IRB reviewer may request from the researcher additional materials and changes. We encourage a collaborative process.

Review Determination

In all expedited review contexts, an expedited reviewer must determine whether a research proposal meets criteria for an expedited review. See Section VIII of the New Study Application for IRS Review entitled New Study Application for IRB Review form. If it is not eligible for expedited review, the reviewer recommends full IRB review (see "d" below). The full array of possible determinations are noted on the bottom of the New Study Expedited: Reviewer Checklist and Action Determination form. These are:

  1. approve the research in expedited review,
  2. stipulate changes required for approval in expedited review,
  3. request a consultant or another reviewer with additional expertise prior to making a determination, or
  4. recommend that the study go forward to a full IRB review (Note, a study may be disapproved in a full IRB review, but not in an expedited review.)

Completing the Review

The expedited reviewer forwards his or her determination to the IRB Chair. The review is not complete unless it includes:

  • the completed application signed by the researcher,
  • documentation of any and all required revisions,
    • copy sent to IRB Chair
    • researcher and IRB Reviewer keep copy
  • the final approved consent form,
  • the reviewer's completed and signed New Study Expedited: Reviewer Checklist and Action Determination, and
  • a written letter from the chair to the researcher on the disposition of the review.

Note, the IRB Chair then routes all application materials and updates to IRB Administrator.

EXEMPT RESEARCH

IRB members who are affiliated with Alverno also sometimes serve as reviewers for exempt research. Among the occasions when an Alverno affiliated IRB member may conduct a decentral determination of exemption from IRB review are the following.

  • The IRB member serves as an RRC Decentral Reviewer (is assigned as RRC Reviewer to a review and receives and completes review through RRC)
  • The IRB member serves as an IRB Direct-Certified Decentral Reviewer:
    • for a streamlined determination of an educational research exemption for an Alverno educator:
      • Receipt of Submission: A researcher who is an Alverno educator may directly approach any IRB Direct-Certified Decentral Reviewer with a Streamlined Alverno Educator Request for Educational Research Exemption form. The certified reviewer accepts after he or she makes an initial determination of (a) no conflict of interest, (b) expertise, and (c) personal availability.
      • Special Preparation: IRB Direct Certified Decentral reviewers need to be ready to assist in (a) determining what is research, (b) what is educational research, (c) eligibility for streamlined review, and (d) particular specifications for informed consent appropriate to the educational research context.
      • Reviewer Action: (a) sign determined exempt, (b) sign determined exempt with required revisions, or (c) do not sign and recommend alternative submission.
      • Routing: If not in RRC review context, all completed application materials are directly routed to IRB administrator (reviewer and researcher keep copies). If in RRC-supported context, route to RRC Chair.
    • for a General Request for Exemption Determination:
      • Receipt of Submission: Only a researcher who is an Alverno educator may directly approach an IRB Direct-Certified Decentral Reviewer with a request to serve as a decentral reviewer for an exemption request.
        • Students must have been either assigned to an RRC Decentral Reviewer or have first submitted through the IRB Administrator.
        • A Principal Investigator not affiliated with the College must submit through the IRB Administrator.
      • Special Preparation: An IRB Direct-Certified Decentral Reviewer must be ready to address any needed request to waive/alter informed consent and/or its documentation. See associated researcher form and reviewer checklist. Also consult chapter 6.6 in Bankert and Amdur (2000).
      • Reviewer Action: (a) sign determined exempt, (b) sign determined exempt with required revisions, which includes copy of final consent form, or (c) do not sign and recommend alternative submission.
      • Routing: If not in RRC review context, all completed application materials are directly routed to IRB Administrator (reviewer and researcher keep copies). If RRC-supported context, route to RRC Chair.

DECENTRALIZED REVIEW: A formal process for determination of exemption from IRB review that the Alverno IRB has explicitly delegated to a particular individual or Research Review Committee.
EXPEDITED REVIEW: Review of proposed research by the IRB chair or a designated voting member or group of voting members rather than by the entire IRB. Federal rules permit expedited review for certain kinds of research involving no more than minimal risk and for minor changes in approved research. [Federal Policy 45 CFR 46.110]
RESEARCH REVIEW COMMITTEE: A standing committee at Alverno delegated by the Alverno IRB to conduct determinations of exemption of research from IRB review. When located within a School at Alverno (e.g., School of Nursing), the Committee also ensures that student research conforms to the School’s educational policy for protecting human subjects. {Alverno}
EXPEDITED REVIEW: Review of proposed research by the IRB chair or a designated voting member or group of voting members rather than by the entire IRB. Federal rules permit expedited review for certain kinds of research involving no more than minimal risk and for minor changes in approved research. [Federal Policy 45 CFR 46.110]
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