Changes in Research Activities: Submission and Review
This document describes the policies and procedures UW-Madison IRBs use to ensure prompt reporting of changes to the IRB and for the review of changes in research activities. Changes in research activities are frequently referred to as changes of study or amendments.
- The only changes in research activities that may be implemented prior to IRB approval are those necessary to eliminate apparent immediate hazards to the human participants.
- Changes in approved research initiated without prior IRB approval to eliminate apparent immediate hazards to a participant are considered unanticipated problems and must be reported to the IRB within fourteen (14) business days of implementation.
- When a change is planned it should be submitted to the IRB for review promptly.
- Each UW-Madison IRB may have specific required time frames for reporting changes in research activities.
- If changes are the result of new information, such as identification of unanticipated risks or findings that may affect a participant’s willingness to take part in the study, the research team must report this new information to the IRB independent of the change of study as a possible unanticipated problem.
- Possible unanticipated problems must be reported to the IRB within 14 business days after their discovery (or by the next business day if the new information suggests a problem that is immediately life-threatening to other participants).
- The criteria for approval of a change in research activity and the determinations that the convened IRB or expedited reviewers make are the same as at initial review.
- UW-Madison IRBs must determine whether the modified research continues to fulfill the criteria for approval of human participants research and if any additional federal, state, or institutional requirements apply (e.g. federally funded research involving pregnant women, fetuses or neonates; prisoners; or children).
- The federal regulations allow for expedited review by the IRB chair or an experienced IRB member(s) designated by the IRB chair of minor changes in research activities. All other changes require review by the convened IRB.
- The definition of an experienced IRB member is the same as for initial review.
- Changes can be reviewed under expedited procedures in the following cases:
- The study was reviewed under expedited procedures at the time of initial review and the change does not affect the risk level of the study such that it would required review by the convened IRB.
- For studies that were reviewed and approved by the convened IRB, changes are considered to be minor if they present minimal risk to participants or are administrative in nature and meet all of the following criteria:
- Represent minor clarifications of study procedures previously approved by the convened IRB.
- Do not significantly change the study design.
- Do not alter the risk/benefit ratio of the study.
- Generally, changes in personnel are considered minor changes.
- Changes to research involving prisoners may be expedited if the change fits the definition of minor changes as described above.
- In the case of federally funded prisoner research, the IRB Prisoner Representative must be one of the designated reviewers for the change if it affects the determinations required to be made under 45 CFR Part 46, Subpart C.
- A change that appears to meet the criteria for a minor change can still be referred for review by the convened IRB in any one of the following circumstances:
- The change requires assessment by one or more reviewers with relevant expertise.
- The change is for a study that enrolls prisoners and the change could affect that study population.
- The change requires input from other committees on campus (e.g., conflict of interest, Radioactive Drug Research Committee) or consultants (e.g., legal services).
- The change involves multiple revisions to research activities that may individually qualify for expedited review but collectively represent a substantial change to the study.
- Numerous changes have been made to a study such that reassessment of the full scope and purpose of the study may be warranted.
- For any changes in research activities approved under an expedited review procedure, 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.
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
Copyright © 2015 University of Wisconsin System Board of Regents
- Changes to Eliminate Immediate Hazards to Subjects Guidance
- Unanticipated Problems
- 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
- VA Research - Overview
- Expedited Change of Protocol Guidance
- Timeframe for Submission of Changes of Protocol to the IRB
- Personnel Change Guidance
- Common Rule (45 CFR 46)
- OHRP & FDA Expedited 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