Eligibility screening or “pre-screening” is used to describe an activity where researchers determine whether potential participants are eligible to participate in their research study (based on exclusion and inclusion criteria). Eligibility screeners often take the form of a survey or an interview prior to the main study activities. A screener may be conducted via phone, Zoom, or in survey format via Qualtrics. Eligibility screening is considered part of the recruitment process. For studies that meet the federal definition of Human Subjects Research, eligibility screeners should be reviewed and approved by the Teachers College Institutional Review Board (TC IRB). TC IRB will determine if the screener aligns with the researcher's study aims and stated study inclusion and exclusion criteria.

Data Collection in Eligibility Screeners

Eligibility screeners should only collect data that is related to the screening process and should not be used for research purposes or analysis. Screeners typically do not collect private, identifiable information that can be linked back to the potential participant. Instead, they are used to ensure that individuals meet inclusion criteria and identify whether there are any qualities that might exclude their participation from the research activities. Contact information for individuals who are not eligible to participate in the research should be promptly destroyed or deleted. Screeners that collect private identifiable information may be required to collect consent (Eligibility Screener Consent Template).

There are times when potential participants must disclose a medical diagnosis or stage of severity of a medical condition in order to qualify to be part of the main research study. For example, a researcher may administer a mental health screener to potential participants when determining whether they qualify for a therapeutic intervention. HIPAA authorization forms are only required if a medical provider must disclose a disorder to the researcher as part of the screening process. The HIPAA authorization form, screener, and others can be found in TC Mentor IRB/Documentation. 

Eligibility Screener Consent 

In cases when the self-disclosed eligibility screener may collect and retain personal or sensitive information, informed consent may be needed. The consent should inform potential participants about the purpose of the eligibility screener, how the information will be used and stored, confidentiality protections, and if applicable, obtain permission to contact the eligible individual with future study opportunities. 

The IRB may apply the criteria to waive documentation of informed consent (i.e., signature) as commonly done with online minimal risk surveys. TC IRB has developed an Eligibility Screener Consent Template for investigators who use a study subject eligibility screener, including a mechanism for individuals who may qualify for the study but choose to opt-out of their own free will. 

The different sections may include:

Screening Activities: Describe what the individual will be asked to do during the eligibility screener and how long it will take. 

  • For example: “You will be asked to complete a 10-minute survey about your mental health. You can complete this screener on a computer or your phone.” 
  • Or for an interview: “I am going to go through a list of questions with you to determine whether you are eligible to participate in the main study. This will take about 30 minutes of your time.”
  • Individuals should be allowed to leave the screening at any time, skip questions, and stop or pause the screener as needed. Researchers should clearly convey to individuals that their participation in the eligibility screener does not mean they are required to participate in the main study. They still have a choice to participate, even if they qualify for the main study. 

Confidentiality: Describe how collected information will be protected and the duration for which this information will be stored. Specify what will happen to the potential participant’s identifiable data, including their name and contact information.

  • For example: “Your survey responses on this eligibility screener will be stored in a password-protected digital file in the researcher’s Teachers College secure Google Drive account for 7 business days. If you are not eligible to participate in the study, all of your survey responses including your name and contact information will be deleted. You will be notified by a researcher that you are (or not) eligible to participate in the main study.”

Risks and Benefits: Potential participants may not understand that the risks and benefits associated with the eligibility screener are not the same as those that may be encountered during the study. Clearly describe the risks and benefits that may occur from participating in the eligibility screener and as applicable in the main study. 

  • For example: “The risks of taking part in this eligibility interview is minimal. You may feel uncomfortable answering some of the questions about your health. There are no benefits to completing the eligibility screener; however, you will learn whether you are eligible to participate in this study based on an established set of inclusion and exclusion criteria.”

Compensation: In cases where compensation is offered to study participants, clarify in the introduction whether the potential participant may receive compensation for completing the eligibility screener. Oftentimes, this is not the case, but researchers should strive to provide clear communication that individuals will not be compensated for completing the eligibility screener. 

  • For example: “You will not be compensated for participating in this interview as it is only to determine whether you are eligible to be in the study.”

Agree to Participate: Ask the potential participant whether they agree to participate in the eligibility screener. Describe what will happen if the person is not eligible or if they are eligible to participate in the survey.

If the eligibility screener does not collect personal or identifiable information, a formal consent form may not be required. Researchers should still ensure the individual is informed about the screener activities and duration, and whether they are eligible to participate (or when they will find out). Researchers can adapt the Eligibility Screener Consent Template to be a shorter version (about a paragraph). It should include information to help the potential participant understand what will be required of them. 

Whether you are preparing an eligibility screener consent or providing a short paragraph, the information should be clearly communicated, at a level that the target population can understand. For more information, please review our Writing for an IRB Review and Prepare, Present & Polish pages.