Screening is a process by which an investigator determines whether or not a potential subject is eligible to participate in a particular research study. Eligibility is determined by a set of criteria, established by the investigator or the research team, that is specific to a particular research study. Requirements for obtaining informed consent for conducting screening procedures vary depending on whether the research is subject to FDA regulations, and, for non FDA-regulated research, whether screening data will be used for research purposes.
1. Screening consent requirements for non FDA-regulated research.
For non FDA-regulated research, investigators may choose to retain screening information for purposes of research analysis, or, if not pertinent to the research, discard or destroy screening information once eligibility is determined. Whether or not screening information will be retained determines informed consent requirements.
(a). When is informed consent required for screening research subjects?
Whenever investigators will store, retain, and/or use screening information for research purposes, they are required to obtain the informed consent of subjects prior to conducting screening procedures. With regard to screening consent, investigators have two options:
- Create a consent form specifically for screening procedures, separate from the consent form for the “main” study; OR,
Include screening information within the body of the consent
form for the “main” study.
Investigators who opt to create a separate consent form specifically for screening (option i) may use either the biomedical or social-behavioral CPHS screening consent template as a guide, whichever is more germane to the research:
- Template Screening Consent Form – Biomedical Study
- Template Screening Consent Form – Social-Behavioral Study
- Template Screening Parent Permission Form – Social-Behavioral Study
Investigators who choose to include screening information within the body of the “main” consent form (option ii) should refer to the “Study Procedures” section of the biomedical or social-behavioral CPHS informed consent template for suggested language:
Informed consent for screening must be obtained from subjects prior to the investigators commencing with any screening procedures.
(b). When is informed consent not required for screening research subjects?
According to the federal regulations at 45 CFR 46.116(g), for non FDA-regulated research, informed consent is not required for screening when information/biospecimens are obtained for the sole purpose of screening, recruiting, or determining the eligibility of prospective subjects, the data will not be stored or used for research purposes, and one of the following conditions are met:
- The investigator will obtain information through oral or written communication with the prospective subject or legally authorized representative; OR,
- The investigator will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens
Investigators are not required to obtain consent from subjects prior to screening when screening data will be used for the sole purpose of determining eligibility, and screening data will not be stored, retained, and/or used for research purposes. However, investigators must confirm in their eProtocol application, under part 7b-Screening (for non-exempt applications) or part 4a-Study Procedures (for exempt applications), that screening data will not be used for research purposes and that screening data will be destroyed as soon as possible after study eligibility has been determined.
2. Screening consent requirements for FDA-regulated research.
Per FDA guidance, informed consent for screening is not required when procedures are being performed as part of standard clinical care (e.g., the procedures would be done anyway to diagnose or treat a medical condition) and the subsequent results are used for determining study eligibility. However, if clinical screening procedures (e.g., laboratory and/or diagnostic tests) will be done solely for the purpose of determining study eligibility, informed consent must first be obtained. When consent for screening is required, options for obtaining screening consent for FDA-regulated research are the same as for non FDA-regulated research (see above, under 1(a), When is informed consent required for screening research subjects? for non FDA-regulated research). For FDA-regulated research, screening data must be retained in accordance with FDA regulations.