This month in the IRB Corner we discuss what sort of study changes require the researcher to notify the IRB Office. We address what a researcher must do when a study requires changes or modifications after it has received an IRB approval or exempt determination. The IRB may refer to a change of study as an “amendment” or “modification” to a research project.
When must you notify the IRB of a change to your study?
The IRB reviews all materials associated with a project PRIOR to the researcher conducting the study. When the IRB Office approves a study or determines a study exempt, the decision is based on an assessment of the risk to human subjects in the project as it is presented on the IRB application and supplemental materials. After the IRB approval or exempt determination, ANY change to the study must be reviewed by the IRB Office PRIOR to the implementation of the proposed change of study.
What is meant by a “change of study”?
A change of study is ANY modification to a previously reviewed research plan that has been approved or determined exempt by the IRB Office.
Examples of changes to previously reviewed research plans include changes to:
- the study population,
- recruitment procedures,
- data collection instruments;
- any aspect of the informed consent documents and/or procedures,
- archival data used in the study,
- the study intervention,
- the study location, or
- the study personnel.
In short, the IRB Office must review a change of study for any population/sample, recruitment, data collection, consent document/procedure, type of data, study intervention, location, or personnel component of the study that is added, revised, or removed from the research plan following the review and approval, or exempt determination, of the project. Keep in mind the IRB has approved, or determined a project exempt, based on the project description and details presented on the IRB application and supplemental materials initially reviewed. Therefore, changes are in reference to the plans that the IRB had previously reviewed and approved or determined exempt.
Are there any exceptions? Must the IRB be notified PRIOR to ANY study change?
There is only one exception to this rule. A researcher can change a study without prior IRB review if that modification is needed to protect the human subjects during the data collection phase. In this case, the researcher deviates from the original study plan to reduce risk to study participants and then notifies the IRB immediately following about the deviation. For more about identifying unanticipated problems and adverse events, see the Office for Human Research Protections (OHRP) guidance (http://www.hhs.gov/ohrp/policy/advevntguid.html) and the University of Phoenix IRB GUIDANCE – Unanticipated Events.
How do I notify the IRB of proposed changes to my study?
Please use IRBNet and submit a resubmission (new package) associated with the previously approved or exempt project. Your submission type is “amendment” and you should include a completed copy of the FORMS - Change of Study Template with your resubmission. Include a revised copy of your IRB application form that reflects the changes. Describe the proposed changes to the research plan on the Change of Study form. Include appropriate modified supplemental documents and/or new permissions as needed based on the proposed changes. Note: Changes of study that involve minimal risk to subjects qualify for an expedited or exempt review depending on the initial IRB review and decision on the study. Proposed changes that involve higher risk studies will be reviewed by the full IRB committee. If the initial application required full IRB committee approval, the change of study may also require full IRB committee approval. You will be notified if the study has to be referred to the full IRB committee for review.