• Collection of identifiable private information to determine study eligibility is considered a research procedure. Obtaining oral permission prior to the research screening interview is usually acceptable.
  • For HIPAA Privacy Rule purposes, screening may constitute a preparatory to research activity. See Preparatory to Research Activities in this manual. However, the VA interprets preparatory to research differently than the UW-Madison. Screening for VA research studies requires a partial waiver or alteration of authorization.
  • In most cases, screening information from individuals who take part in the study is kept as part of study records, while screening information from individuals who are not eligible or choose not to participate is destroyed. Researchers proposing to retain contact information and/or identifiable data collected during screening for future recruitment or other purposes should specify what information will be retained, and how long, how the information will be stored, how the information will be used, and who will have access to the information. In addition, researchers will need to either obtain informed consent and authorization (for studies that fall under HIPAA regulations) from subjects to retain the identifiable screening data or request waivers of informed consent and authorization from the IRB.
  • Retention of sensitive screening information from subjects who are ineligible (e.g., data about illicit or stigmatizing behavior; social security numbers) is discouraged.
  • The IRB may approve a research proposal in which an investigator will obtain information or biospecimens for the purpose of screening, recruiting, or determining the eligibility of prospective subjects without the informed consent of the prospective subject or the subject’s legally authorized representative, if either of the following conditions are met:
    1. The investigator will obtain information through oral or written communication with the prospective subject or legally authorized representative, OR
    2. The investigator will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.
      • The research protocol should include information about how potential subjects will be identified and recruited in order for the IRB to be able to determine whether informed consent for these activities is required.
      • Contact the IRB Office with additional questions or for further guidance regarding the requirement to obtain HIPAA authorization or a waiver to obtain HIPAA authorization for recruitment purpose.