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 may.
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 may be solicited from the subject without obtaining their informed consent first, provided certain conditions are met as outlined below. However, even if these conditions are met, HIPAA Authorization may still need to be obtained.
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 and is subject to 45 CFR 46.
Per the regulations, the IRB may approve screening procedures without obtaining the prior informed consent of the prospective subject or the subject’s legally authorized representative only if the solicited information is limited to the minimum necessary for screening/determining eligibility for the main study AND if these procedures are limited to: (a) obtaining information through oral or written communication with the prospective subject or legally authorized representative, or (b) obtaining identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.
To qualify, these screening procedures must be brief in duration and limited in nature to focus solely on determining eligibility for the research. Therefore, administration of questionnaires/surveys that increase the potential risk to subjects (e.g. lengthy standardized questionnaires that make a new, or refute an existing, diagnosis; surveys/questionnaires where subjects' responses may place them at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, insurability, reputation, or be stigmatizing; etc.) would require prior informed consent. Creation of new data through means other than oral/written communication with the subject or collection of biospecimens solely for research purposes would also require prior informed consent.
If the information or biospecimens used for the purpose of screening, recruiting, or determining the eligibility of subjects include protected health information (PHI), HIPAA applies and HIPAA Authorization may still need to be obtained prior to conducting these screening activities. The IRB's responsibilities related to HIPAA are described in more detail in the IRB's Role in HIPAA.
Screening activities to establish eligibility might include:
- Review of CHOP or non-CHOP medical records, including certain admission or clinic logs that contain identifiable private information (consent not required; a waiver of HIPAA Authorization may be requested);
- Asking individuals questions or taking a medical history (consent is not required; HIPAA Authorization [when applicable] may be required);
- Performing laboratory tests on stored samples, to see if the results are within the required range (consent is not required; HIPAA Authorization may be required);
- Performing laboratory tests on samples obtained solely for the research, to see if the results are within the required range (consent and HIPAA Authorization will be required).
Research procedures, including screening, may not take place unless one of the following has taken place:
- informed consent and (when applicable) HIPAA Authorization have been obtained from the participant; or
- the IRB has determined that consent is not required and either HIPAA does not apply, HIPAA Authorization has been obtained from the participant, or a waiver of HIPAA Authorization has been issued by the IRB; or
- waivers of consent and HIPAA Authorization have been 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.