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 of human participants research at intervals appropriate to the degree of risk, as defined in the initial review policy, but generally not less than once per year.
- 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.
- Continuing IRB review may be required when the research remains active only for long-term follow-up of participants or the remaining research activities are limited to analysis of identifiable data.
- In accordance with UW-Madison’s Five Year Renewal Policy, the IRB may require a new initial review application instead of a continuing review application after five years.
- [Coming Fall 2017] IRBs may decide not to require continuing review or may extend the continuing review timeline, if the study meets all of the following criteria:
- involves only one site,
- does not involve a drug, biologic, and/or medical device,
- is not VA regulated,
- is not federally funded,
- does not enroll prisoners,
- and meets one of the following criteria:
- Is eligible for expedited review;
- Has progressed to the point that the study involves only data 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.
- 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.
- The federal regulations allow for expedited review by the IRB chair or an experienced IRB member designated by the IRB chair under certain circumstances. All other continuing reviews require review by the full IRB.
- 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 full IRB at the discretion of the expedited reviewer.
- Some circumstances under which referral to the full 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.
- Continuing review of prisoner research must meet the following criteria as appropriate.
- Continuing review of research involving prisoners may be expedited if no problems have been reported with the study.
- 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 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
Copyright © 2017 University of Wisconsin System Board of Regents
- Protocol Closure Guidance
- End of a Study
- Initial Review: Submission and Review Policy
- IRB Analysis of Risks and Benefits of Research Guidance
- Equitable Selection of Research Participants Guidance
- Obtaining and Documenting Informed Consent
- Review of Data and Safety Monitoring in Research
- Protecting Research Participants Privacy Interests and Confidentiality of Data
- Review of Research Involving Vulnerable Participants
- Five Year Replacement/Renewal
- OHRP & FDA Expedited Review Guidance
- OHRP Continuing Review Guidance
- Additional Requirements When Conducting Human Subjects Research with Department of Defense (DOD) Support
- Additional Requirements When Conducting Human Subjects Research with Department of Justice (DOJ) Support
- Additional Requirements When Conducting Human Subjects Research with Department of Energy (DOE) Support
- Additional Requirements When Conducting Human Subjects Research with Department of Education (ED) Support
- Additional Requirements When Conducting Human Subjects Research with Environmental Protection Agency (EPA) Support