Eligibility screening & Recruitment numbers

When submitting a new study for IRB review, PIs must state the inclusion and exclusion criteria (i.e. eligibility criteria) for participation. Based on these criteria, all participants should be screened to determine their eligibility before proceeding with the study procedures. This process is called Eligibility screening.

  • Participants who fail the screening should not be subjected to further procedures or data collection.
  • Only information pertaining to the participant’s study eligibility should be collected during the eligibility screening process and must not involve any study procedures. The data collected should not be used for research purposes.

Eligibility screening can be performed before obtaining informed consent (Pre-screening) or after (Screening).

  Pre-screening Screening
Definition Participants are screened before obtaining informed consent.
  		Participants are screened after obtaining informed consent.
When to employ? For non-interventional screening procedures e.g. written screening checklists, verbal questioning.

If participants are subjected to an intervention as part of the screening process (e.g. cognitive tests, physiological measurements), informed consent should be obtained first.
  		Applicable for both interventional and non-interventional screening procedures.
Participant confidentiality To protect participants’ confidentiality, it is recommended not to collect identifiable data as part of the pre-screening process, where possible.

If identifiable data is collected, the data should be deleted or anonymised once the participant is deemed to fail the screening process.
 
Non-identifiable data (e.g. screening logs, anonymous checklists) may be retained by the study team.
  		Participants who have provided consent are considered enrolled in the study and their data obtained as part of screening procedures (including identifiable data) should be retained as per NTU's Research Data Policy.
Recruitment number Participants who failed the pre-screening process and did not provide consent to participate in the study are not considered ‘enrolled’ and should not be included in the study recruitment number. Participants are considered recruited into the study once consent is taken and are considered ‘withdrawn’ if they subsequently fail the screening process.
 
In your IRB application, remember to factor in screen failures in the maximum recruitment number.

 

Note: Both Pre-screening and Screening procedures are considered part of the recruitment process and must be adequately described in the IRB protocol for review and approval.

References:
- UC Berkeley
- University of Maryland