All amendments (also known as revisions) to an approved study must be reviewed and approved by the IRB prior to initiating the change(s). Examples of amendments include changes to advertisements, study team members, survey questions, methods and procedures, or an increase in subject enrollment.
Some amendments may necessitate changes to the consent forms. All amendments described on the project amendment form must be incorporated into the appropriate study documents and submitted for review utilizing track-changes in the Mentor IRB system.
Minor changes can often be reviewed faster than major changes. A minor change is one which, in the judgment of the IRB, makes no substantial alteration in:
Certain amendments to exempt studies can be made without review.
Please see the Project Amendments for Exempt Studies Guidance for information on when to submit project amendments.
Studies approved as Exempt or Expedited no longer require continuing review.
Projects approved as expedited after January 20, 2019 will no longer require continuing review. The investigator must still submit amendments prior to initiating any changes to these studies and close out the study when the study ends. The IRB may require continuing review if needed. Reasons to require continuing review include but are not limited to the following:
Studies approved Full Board or approved as Expedited before January 21, 2019 must be reviewed and re-approved prior to the expiration date.
It is the responsibility of each investigator to know when their study expires and submit a continuing review application (or termination) through Mentor IRB at least 30 days prior to the expiration date.
How to Submit a Continuing Review
Click here for instructions on how to submit a continuing review.
I didn’t submit my continuing review before the expiration date. What now?
Per federal regulations, all study related activities, including data analysis, must stop after the expiration date has passed.
If you are within 30 days of the expiration date:
If a PI wants to continue a research study but has failed to submit a continuing review prior to the expiration date and it is within 30 days of the study expiration, the PI must submit an adverse event by following the NKU IRB SOP for Reporting Unanticipated Problems or Adverse Events.
For studies approved as expedited or full board, the adverse event must be submitted in Mentor IRB using the NKU IRB Note to File – Unanticipated Problem or Adverse Event Memo.
If you are more than 30 days past the study expiration:
If a PI wants to continue a research study but has failed to submit a continuing review prior to the expiration date and it is more than 30 days past the study expiration, the PI must terminate the current study (See NKU IRB SOP #15 Terminating a Protocol) and submit a new study (See NKU IRB SOP #12 Submitting a New Protocol).
The phrase “unanticipated problems involving risks to subjects or others” is found but not defined in the HHS regulations at 45 CFR part 46. OHRP considers unanticipated problems, in general, to include any incident, experience, or outcome that meets all of the following criteria:
Taken from OHRP 06/29/2017
The HHS regulations at 45 CFR part 46 do not define or use the term adverse event, nor is there a common definition of this term across government and non-government entities. In this guidance document, the term adverse event in general is used very broadly and includes any event meeting the following definition:
Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research (modified from the definition of adverse events in the 1996 International Conference on Harmonization E-6 Guidelines for Good Clinical Practice).
Adverse events encompass both physical and psychological harms. They occur most commonly in the context of biomedical research, although on occasion, they can occur in the context of social and behavioral research.
Taken from OHRP 06/29/2017
Unanticipated problems and adverse events for studies approved as expedited or full board must be reported through Mentor IRB.
Click here for instructions on how to submit an unanticipated problem or adverse event.
Click here for the NKU IRB Note to File/Adverse Event Memo.