Human subject research sometimes involves having potential participants engage in some type of screening activity to determine their eligibility for participation in a study. Collecting data directly from subjects or prospective subjects such as through written screening tools or oral responses to questionnaires, or accessing private information, i.e., grades, medical test results, legal records, or any other non-public information linked to a potential subject, for purposes of eligibility screening constitutes a research intervention or interaction that is part of the research activity and therefore requires IRB review.
Although screening activities do not necessarily result in data that are used to evaluate study outcomes, such procedures occur because of the research and are, therefore, reviewed by the IRB during consideration of proposed protocols. Screening activities are reviewed as part of the overall recruitment and consent process and evaluated with respect to the protection of privacy and confidentiality of those who are screened.
Screening procedures may include:
- Any interaction or intervention with the subjects to determine eligibility that would not otherwise have been performed if not for the study, or
- Accessing the results of interventions that were performed for purposes other than the study.
IMPORTANT NOTE: In order to protect the privacy of potential participants, only the minimal information necessary for screening is to be collected.
The Kuali application should include the following information with respect to screening procedures:
- The screening materials to be used
- Data, if any, that will be acquired from the screening activities
- A separate screening consent
- When and how the screening data will be destroyed
In those instances where the screening activities involve no more than minimal risk or involve procedures for which written consent is not normally required outside the research context, the investigator may request, and the IRB may find, that it is appropriate to waive documentation of consent for screening activities (i.e. prospective subjects need not sign the screening consent) and the scope of the screening consent can be limited to:
- A description of the screening tests (see for e.g. PAR-Q Screening Consent)
- The reasons for performing the tests
- A brief summary of the description of the study in which the individual may be asked to participate
Additional considerations:
- Participants determined eligible to participate: If the screening indicates that the prospective subject is eligible for participation, the informed consent procedures for the study, as approved by the IRB, would then be followed.
- Keeping information confidential: Often the greatest risk with obtaining information during a screening process is the loss of confidentiality. The investigator must consider and describe how the confidentiality of this data will be maintained. Whenever possible, information obtained during this process should not be connected with subject identifiers. As noted above, the amount of data collected should be limited. Once collected it should be kept secure or destroyed as appropriate.
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A screening script for research may be needed in lieu of the normal documented informed consent process.
- If such screening activities will take place prior to the prospective participant providing informed consent for participation in the research, the investigator may request a waiver of documentation of informed consent (i.e. signed consent) for screening activities.
- If screening activities will take place only after the subject has provided informed consent for participation in the research, then the waivers described above are unnecessary.
- HIPAA regulations apply to the screening process if it involves review of medical records. Investigators must obtain prospective HIPAA authorization or apply for a waiver of HIPAA authorization and informed consent.
- Telephone Scripts: In telephone surveys, the initial recruitment call sometimes leads directly into the consent process. In such studies, the script should include, at least, a statement that the study involves research, the names of the persons responsible for the research, reference to UMass Amherst, a description of the types of questions that will be asked, an estimate of the time it will take to complete the interview, and the direct question of whether or not a person wishes to participate. The interviewers also should have available an investigator's telephone number and email address in case the prospective subjects have questions about the study that the interviewer cannot answer, and the IRB phone number if there are questions about a research subject’s rights.
