Continuing Review: Submission and Review
This document describes the policies and procedures UW–Madison IRBs use for conducting continuing reviews of research involving human participants.
- Continuing review includes a reassessment of the totality of the project to assure that, among other things, risks to participants are being minimized and are still reasonable in relation to anticipated benefits, if any, to the participants and the knowledge that is expected to result.
- Review of changes of protocol, unanticipated problems, noncompliance, or new information after initial approval does not constitute continuing review.
- UW-Madison IRBs conduct continuing review for studies that have been determined to present more than minimal risk to participants unless:
- Study activities are limited to data and/or biospecimen analysis (including analysis of identifiable private information or identifiable biospecimens) or accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care; and
- Applicable federal regulations permit the IRBs to excuse the study from continuing review.
- UW-Madison IRBs may excuse some studies from continuing review or may extend the continuing review period (e.g., to 2 years), if all of the following apply:
- In the case of federally funded or regulated research, applicable regulations permit an extension of the continuing review period or recusal from continuing review.
- The research meets one of the following criteria:
- Is eligible for expedited review;
- Has progressed to the point that the study involves only data or biospecimen analysis (including analysis of identifiable private information or identifiable biospecimens) or accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.
- If UW-Madison IRBs require continuing review for studies that could be excused from continuing review under institutional or applicable federal policies, the IRBs will document the reasons for the continued oversight.
- Federal regulations allow for expedited review by the IRB chair or an experienced IRB member designated by the IRB chair under certain circumstances.
- The definition of an experienced IRB member is the same as for initial review.
- A continuing review that appears to meet the criteria for expedited review can still be referred for review by the convened IRB at the discretion of the expedited reviewer.
- Some circumstances under which referral to the convened IRB may occur include:
- Federally-funded studies that enroll prisoners when study activities are not limited to data analysis or long-term follow-up.
- When the continuing review application suggests a compliance concern.
- When a participant complaint has been received that could not be resolved by the study team.
- A continuing review that did not qualify for expedited review at the time of initial review only qualifies for expedited review under the circumstances outlined in expedited review categories (8) and (9) in the list of research eligible for expedited review published by OHRP and the FDA.
- For any research approved under an expedited review procedure at the time of continuing review, all IRB members are advised of such approvals.
- IRB members shall be provided access to the IRB files for any research study in which they may have a concern.
- When continuing review for a study is required, the IRBs conduct continuing review of human participants research at intervals appropriate to the degree of risk, as defined in the initial review policy,
- The IRBs grant approval periods no greater than one year.
- The IRB might require continuing review if the study team’s conduct in prior studies suggests that closer monitoring by the IRB is warranted.
- The IRB determines on a study-specific basis whether the research requires more frequent than annual review.
- Common reasons for reviewing research studies more frequently than annually may include:
- A study poses high risk to participants;
- The study involves novel interventions;
- The study poses more than minimal risk to participants and would be expected to be completed in less than a year;
- The study involves vulnerable participants;
- The study team’s conduct of prior studies suggests that closer monitoring by the IRB is warranted.
- The IRB may require a new initial review application instead of a continuing review application if the IRB determines that a new assessment of the research study is warranted. Examples of when a new application may be requested include when the IRB determines the need for a re-evaluation of the study is appropriate because an amendment or an accumulation of revisions across the life of the study appear to require a substantive re-assessment of prior determinations in regard to the research or substantive revisions to applicable regulations and laws suggest the need for a re-evaluation of the research in light of such changes.
- When continuing review is required, UW-Madison IRBs must assess whether the research continues to fulfill the same criteria for IRB approval as at initial review and the determinations that the convened IRB or expedited reviewers make are the same as at initial review.
- When reviewing the current informed consent documents and/or process at continuing review, the IRB ensures the following:
- The applicable consent documents are accurate and complete.
- The consent process or any previously approved waivers or alterations of informed consent are still appropriate.
- Any significant new findings that may relate to the participant's willingness to continue participation are provided to the participant in accordance with regulations.
- The IRB also evaluates the following as part of continuing review, when appropriate:
- Investigator and institutional issues, such as:
- Changes in the investigator’s situation or qualifications (e.g., suspension of hospital privileges, change in medical license status, or increase in number of research studies conducted by the investigator);
- Evaluation, investigation, and resolution of any complaints related to the conduct of the research; or
- Changes in the acceptability of the proposed research in terms of institutional commitments (e.g., personnel and financial resources, adequacy of facilities) and applicable regulations, State and local law, or standards of professional conduct or practice.
- Research progress, including whether:
- Information provided at the time of continuing review is consistent with the application previously approved by the IRB.
- Enrollment is consistent with the planned number of participants described in the IRB-approved study.
- Any participant withdrawals suggest any problems with study conduct.
- Continuing review of prisoner research must meet the following criteria as appropriate.
- Research involving prisoners may be excused from continuing review or reviewed under expedited procedures. For ongoing studies involving prisoners, if no problems have been reported with the study at its next continuing review, the research may be excused from continuing review going forward.
- In the case of federally funded prisoner research, the IRB prisoner representative must be one of the designated reviewers for that study unless the study is permanently closed to enrollment and open solely for data or biospecimen analysis. This applies to both convened and expedited reviews.
- In non-federally funded research, if it is known that a prisoner will be involved but only incidentally in the research (e.g. an observational study involving participants with cancer not directed at the prison population), a prisoner representative need not be present at a convened meeting or one of the designated reviewers for that study.
- The prisoner representative may serve as a consultant for the review of non-federally funded prisoner research at the discretion of the designated reviewer or IRB.
Adopted By: All Campus IRB
Adoption Date: November 10, 2005
Revised: April 12, 2007
Revised: January 22, 2009
Revised: November 5 and December 3, 2009
Revised: March 1, 2012
Revised By: Cross-Campus HRPP Committee
Revision Date: July 7, 2015
Revision Date: May 31, 2017
Revision Date: February 5, 2018
Revision Date: April 26, 2018
Revision Date: August 15, 2018
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