Some Points to Consider in Screening

Screening is something that can occur at one or more points in the process of approach, recruitment and consent. It can also occur as a stage of study activities after consent has been given and subjects have enrolled.

From the point of view of human subjects review, screening procedures are connected not only with the issue of informed consent, but also with the issue of risk or burden. The following list describes matters typically addressed in review of screening procedures.

• It is useful to make it possible for subjects to screen themselves out whenever possible, by being clear about study requirements in flyers, advertisements, or other preliminary approach and recruitment material. Doing this means that prospective subjects do not have to go through (and researchers do not have to conduct) unnecessary screening interviews.
  For example, if one wants only male or only female subjects, or subjects over or under a certain age, it makes sense to say so in the recruitment flyer.
• To avoid obtaining sensitive, identifiable information about people in the course of screening them out, it can be useful to "chunk" exclusion criteria. In this way one can know that a particular prospective subject is ineligible for the study, without knowing specific, potentially sensitive, things about that person.
  For example, if having had any one of several herpes infections woud disqualify subjects from a study, one could ask, "Have you ever had one or more of the following illnesses?" A "yes" answer would be enough to screen the prospective subject out, without having to collect any more specific information. When using such a procedure, it can be useful to explain it beforehand, when describing the kinds of questions one is proposing to ask.
• All things being equal, it is better not to give prospective subjects who have been screened out the impression that they have been screened out because of some defect on their part, but rather to put the burden on the study (by saying, e.g., "whether the study is a good fit for you"). Another benefit of avoiding talk of "eligibility" is that one also avoids encouraging prospective subjects to stretch a point to try to qualify for interesting or desirable studies or study conditions.
  Recruitment and screening materials should indicate that exclusion from the study is a matter of study design and not of a defect, or a failure to perform, on the part of the prospective subject.
• If prospective subjects will be screened before giving consent to be in the study, they should know what they are being asked to do, and be given a chance to decide whether or not to do it. This would includes the following elements.
  • a statement that, before it is possible to tell whether the study is right for the prospective subject, it is necessary to ask some questions;
  • a description or examples of the range, as well as of the most personal and sensitive kinds, of questions a prospective subject can expect to be asked, followed by a statement that they are free not to answer any questions they do not wish to answer;
  • a statement about how long data obtained in screening will be retained in identifiable form, for those who do not go on to participate in the study, and
  • a request for permission to proceed with the screening
• If it is possible that some subjects will be screened out after they have signed the consent form, the Procedures section of the consent form should describe the screening procedures clearly, to let subjects know the point by which they can be sure whether or not they have been accepted into the study. The consent form should also state how long screening data from those who do not go on to the rest of the study will be retained in identifiable form.
• If screening involves access to confidential information (such as educational records, or protected health information prior to obtaining consent, the application should explain (and document) how access to this information is to be obtained. For example, to use protected health information, a Confidentiality Agreement and waiver of authorization may be necessary.

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