A script briefly describing the eligibility screening requirement should include the following information:
- That screening data are being collected to find out if the person meets basic eligibility requirements for the research study
- Whether any sensitive information will be collected
- What will be done with the person’s information, including:
- How long the data will kept
- Who will receive any identifiable data
- How information collected in the screening questionnaire will be kept confidential
- How any risks of breach of confidentially will be minimized
- What will happen to the person’s information if the person chooses not to take part in or is not eligible for the study
Note that screening scripts and questionnaires should be structured so that identifying information is recorded only from individuals who meet the basic eligibility criteria and continue to be interested in participation.
Consent and HIPAA authorization requirements will also apply if screening results will be retained in identifiable format from ineligible subjects. In that case a request for waiver of signed consent and alteration of elements of informed consent should be requested in the ARROW application including a rationale for retaining the data in identifiable format. A request for altered HIPAA authorization should also be requested, if applicable. The retention of screen fail data that cannot be linked to identifiers does not require consent or authorization.