IRB Mythbusters: Over-Enrollment and Study Expirations
The VCU Human Research Protection Program presents IRB Mythbusters — a periodic newsletter clarifying common misconceptions about conducting human research and the IRB!
In this issue, “myths” surrounding over-enrollment of research participants and study expirations are addressed.
MYTH #1:
Enrolling more participants in a study than the IRB approved in my research plan is okay; the number I put in my submission was just an estimate.
FACT: An amendment must be submitted AND approved in order to increase your enrollment limit before you can enroll participants in excess of the enrollment limit that was initially approved by the IRB. While the number of anticipated enrolled participants that an investigator puts in an IRB submission may be an estimate, that estimate is still binding.
Federal regulations require that amendments (modifications) to research activities not be initiated without prior IRB review and approval except when necessary to eliminate apparent immediate hazards to subjects (in which case the investigator must promptly report the modification to the IRB).
Think of the IRB submission as a legal contract with the IRB: anything put in the submission is binding, unless you go through a process to formally change the agreement.
For research reviewed at the expedited or full board level, this includes any planned changes to the research protocol, including the number of participants to be enrolled.
For research reviewed at the exempt level, there is more flexibility for what changes need to be submitted and approved in amendments prior to implementation. A list of the types of changes that require approval for exempt studies can be found in the “Conditions of Approval” section in your approval letter from the IRB.
TIP: Submit an amendment to your study to increase your enrollment goal when you are approaching your enrollment limit, rather than waiting until you have already met the limit. It’s usually better to overestimate your enrollment goal than to underestimate it.
To submit an amendment to your study, follow the instructions outlined beginning on page 10 of the RAMS-IRB for Researchers Guide.
MYTH #2:
If a participant consents to my research study, but later is found ineligible, withdraws, or otherwise doesn’t complete the study, they don’t count towards my total enrollment limit.
FACT: A participant counts towards your enrollment limit if they meet the definition of “human subject” at any point in their involvement. This includes when someone is screened for eligibility, signs the consent document, or completes any study procedures, regardless of whether they complete the study. It also includes when you receive/collect identifiable information/biospecimens about/from an individual, even if you do not interact directly with the individual.
The initial IRB submission asks for the investigator to estimate the maximum number of individuals that:
- May participate in any study interaction or intervention (Including screening, consenting, and study activities)
AND/OR - You obtain any data/specimens about (regardless of identifiability)
This is why it is the case that withdrawals do not detract from your overall enrollment, because your overall enrollment still includes people who may not necessarily complete the study.
TIP: Keep track of all participants who are screened, consented, and/or complete any study procedures, regardless of whether they complete the study. Also keep track of anyone whose identifiable information/biospecimens you receive/collect. When you approach your enrollment limit (but before meeting or exceeding it), submit an amendment to increase your enrollment limit.
To submit an amendment to your study, follow the instructions outlined beginning on page 10 of the RAMS-IRB for Researchers Guide.
VCU also has a clinical trials management system, OnCore. This system may help investigators track overall enrollment, if it is configured appropriately. For more information on OnCore and to learn how to get training and access, contact [email protected]
MYTH #3:
If I have completed a study that is coming up for continuing review, I can just let the study expire to close out the study with the IRB.
FACT: Studies are not closed with the IRB until a closure request is submitted AND acknowledged by the IRB. Letting a study expire is not an acceptable alternative to submitting a closure request to the IRB.
IRB oversight of a research protocol is required as long as the research activities conducted involve human subjects. VCU IRB-approved research studies that have been completed or terminated and meet the criteria for closure … are considered to no longer involve human subjects, and therefore, no longer require VCU IRB oversight.
In order to confirm that a study meets the criteria for closure and that IRB oversight can end, an investigator must submit a closure request in RAMS-IRB so that the IRB can review and acknowledge it.
Allowing a study to expire is therefore not an acceptable alternative to submitting a closure request in RAMS-IRB.
Keep in mind, when continuing review of a research protocol does not occur prior to the end of the approval period specified by the IRB, the study’s IRB approval expires automatically, and all research activities must cease (including recruitment, enrollment, data collection, interactions and interventions with current participants, and data analysis).
Investigators who believe that current participants will be placed at risk by stopping research procedures should immediately contact the IRB chairperson and/or prepare a written justification for continuation, whichever is the most necessary immediate action based upon the research schedule. The IRB chairperson (or designee) will review the justification to determine whether it is acceptable, and notify the investigator in writing whether current participants may continue
In addition, investigators with outstanding expired studies will not be allowed to submit new research studies for IRB review until the expired study is addressed appropriately through the submission of a continuing review or a closure request, as appropriate.
TIP: Pay attention to your email in the months leading up to your continuing review due date. RAMS-IRB will send you automatic reminders to complete a continuing review or closure request. Always remember that investigators who have outstanding expired studies will not be permitted to submit new studies for review!
To submit a closure request for your study, follow the instructions outlined beginning on page 18 of the RAMS-IRB for Researchers Guide. For instructions on how to complete a continuing review, see the instructions beginning on page 14 of the same document.
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