Informed consent is an ongoing process to ensure the participant has an initial and ongoing understanding of the research and its risks. The participant must also sign the informed consent form (ICF), indicating his/her understanding of the research and its risks prior to the researchers initiating any study-related activities; this includes conducting procedures solely for the purpose of determining a potential participant’s eligibility for research participation, with the exception of procedures that would be done anyway for standard clinical practice.
In this blog, we’ll take a look at a unique type of ICF known as the study-specific screening consent. Note that these are different from the general screening protocols and consents often used in Phase I research. In Phase I, this is often referred to as “pre-screening,” and the pre-screening consent is not specific to a particular study.
Often, consent for screening procedures is incorporated into the main study ICF. This kind of inclusive single ICF is generally the IRB’s preference. However, situations may arise where a separate ICF for screening procedures is necessary or more appropriate. For example, if the study is very complicated and described in an already lengthy ICF, it may be simpler to have a separate screening consent to only assess whether an individual is an appropriate candidate for the research study. The main ICF would subsequently place all of the attention on the actual research study.
While screening consent forms may have a somewhat limited purpose, they are still considered consent forms as defined by the regulations. As such, they should include all of the required elements of informed consent. See 21 CFR 50.25 and 45 CFR 46.116 for details on these requirements.
FDA provides some helpful guidance on screening tests prior to study enrollment. According to this guidance, the IRB should receive a written outline of the screening procedures to be followed. The screening consent should focus on describing the study screening procedures. Complete details about the main study do not generally need to be included in the screening consent. However, a brief summary of the main study must be included so that participants understand the procedures they will undergo if they are screened into the study. This summary helps explain to potential participants why the screening procedures are being performed, so they can make an informed decision about whether to agree to the screening procedures.
Need help drafting content for your screening consent? Here are a few examples from Advarra’s IRB guidance:
Participating in the screening procedures will determine whether you are eligible for the study. There is no other direct benefit to you from participating in the screening procedures. If these procedures show that you are eligible and you are considering participating in the main study, then a comprehensive review of the experimental procedures, risks, and potential benefits of the main study will be discussed with you at that time.
The only alternative to participating in the screening procedures is not to participate. If the procedures show that you are eligible and you are considering participating in the study, alternatives to participating in the study will be discussed with you at that time.
Still not sure how to proceed with a screening consent? Contact Business Development for support.