Study screening procedures are frequently confused with study recruitment. The two activities may overlap but are distinctly different. Recruitment includes all activities where information is provided to the prospective participant while screening includes obtaining information from prospective participants. Recruitment does not require the consent of the prospective subject whereas screening does.
Recruitment can include all of the following:
- Word of mouth solicitation;
- Distribution of informed consent forms to prospective participants;
- Review of CHOP medical records (by CHOP physicians);
- Review of certain admission or clinic logs that contain identifiable private information;
- Other methods of distributing information about a research study to prospective participants.
Recruitment in Person:
Recruitment often takes place when the prospective participant comes for a clinic visit, is scheduled for surgery or is an inpatient in the hospital. Subjects may be approached and informed about the study as part of the informed consent process. The consent form should serve as a guide for the discussion including:
Recruitment over the Telephone:
For many studies, subjects telephone the study team after an email, telephone, advertisements, or other forms of solicitation to learn more about the study. Provided that the study team member provides information about the study and doesn't solicit information about the subject or their medical history to ascertain eligibility, this activity is considered recruitment and not screening.
What does the IRB require for telephone recruitment?
The CHOP IRB does not require a written recruitment script. By analogy, the IRB does not require a recruitment script for in-person solicitation because it is assumed that the consent document is serving as the template for the discussion. The same holds true for recruitment over the telephone. Recruitment should be a back-and-forth conversation between a member of the investigative team and the prospective subject, involving the provision of information to the individual and then questions and answers. That process fundamentally does not adhere to a fixed script.
The following information, based on what is in the consent form, should be provided to the prospective participant:
- Purpose of research
- Reason for approaching the subject - this may include a listing of important eligibility criteria
- Study procedures
- Risks and Benefits of participation
- Reimbursement for expenses and compensation payments
Information should not be solicited from the subject without obtaining their consent.
If the investigator submits a recruitment script, the IRB will review the information to ensure that it matches the information in the consent document and is presented in language appropriate to prospective participants.
Screening activities start the moment the investigator obtains information about the prospective participant to determine if they are eligible for the research. Screening individuals to obtain and record information to determine eligibility involves obtaining identifiable private information and is considered human subjects research for research subject to 45 CFR 46. OHRP's FAQ on Review of Records Without Informed Consent states that "OHRP expects that IRBs routinely will waive the requirement for informed consent for such activities." Screening activities might include:
- Review of CHOP or non-CHOP medical records;
- Asking individuals questions or taking a medical history to see if they meet study enrollment criteria;
- Performing laboratory tests to see if the results are within the required range.
Research procedures may not take place unless one of the following has taken place:
- the informed consent and (when applicable) HIPAA Authorization of the participant; or
- a waiver of consent and HIPAA Authorization issued by the IRB.
The consent process and information can be limited to consent just for screening or it could include consent for the entire study.
The FDA's definition of human subject's research differs from 45 CFR 46 and it therefore allows more latitude on what may be performed as part of screening. Records review and continued performance of clinically indicated lab tests would be permitted without consent. The FDA's Information Sheet is available on their website and below.