PRE-SCREENING OF POTENTIAL SUBJECTS
Pre-screening of potential subjects over the telephone or in person to determine their initial eligibility for and interest in a study is a common strategy in the recruitment process. When using this strategy, investigators must adhere to important guidelines to protect the privacy of the potential subject and the confidentiality of information collected about the subject.
Obtaining Potential Subject's Permission to be Contacted
The potential subject's permission to be contacted must be obtained prior to direct contact by study staff. Those subjects who respond to advertisements or recruitment letters have implicitly given their permission to be contacted. Refer to UVA’s Recruitment of Human Research Study Subjects for other acceptable methods to contact potential subjects, particularly those who have been identified through their private medical information such as medical records or patient databases.
Acceptable Information to Gather During Pre-screening
Questions appropriate for pre-screening address the specific inclusion/exclusion criteria for the study and other issues of suitability, for example, an individual's ability to come to the research site multiple times. It is not appropriate at this point in the process (prior to obtaining informed consent) to gather information that is not directly related to assessing eligibility and suitability (e.g. obtaining complete medical histories). Also refer to Conducting Pre-screening in Person below for guidance on performing very limited routine clinical procedures as part of pre-screening.
Methods for Conducting Pre-screening
A. Conducting Pre-screening over the Telephone
At the beginning of a phone pre-screening conversation, potential subjects should be informed of the nature and sensitivity of the questions, asked whether this is an appropriate time for them to answer these questions, and told how long the phone call is expected to take. The pre-sreening document that will be used must be submitted to the IRB-HSR for review and approval. , A script of what will be said by study staff should also be submitted for review and approval. Subjects should be offered the option of completing the pre-screening in person, if they wish and if it is feasible.
The subject should be told that s/he will be asked a set of questions to determine eligibility and that at the end, only if s/he appears to be eligible and is interested in pursuing the study, will s/he be asked to provide contact/identifying information (e.g. last name, address, birth date, telephone #, hospital medical record number, email address). By following this procedure, identifiable healthcare information is only created for those persons who likely meet eligibility criteria. And for those persons who do not meet entry criteria, only non-identifiable health information is created.
Collection of Non-identifiable and Identifiable Health Information:
The researcher may maintain identifying information at the end of the pre-screening conversation until the subject meets with study staff to discuss the study further and sign the consent form. It is acceptable to retain non-identifying information about individuals who are pre-screened for a study, but do not actually pursue the study or enroll. In fact, this is often desirable or even requested by industrial or academic sponsors to obtain information about the entire pool of individuals interested or potentially eligible for the study. Pre-screening documents from individuals who did not provide identifying information can be retained with no further action. Pre-screening documents with identifying information gathered to obtain consent and prior to enrollment may also be retained in research files, but must have segments containing identifiable information blacked out or cut off as soon as it is clear that the individual will not be enrolled.
B. Conducting Pre-screening in Person
Researchers may choose to conduct pre-screening in person, for example, if potential subjects are finding out about the research during routine clinical care or while visiting the hospital. Complete medical histories and screening physical exams are not considered acceptable pre-screening activities but rather part of actual research procedures, and should be conducted only after an individual has signed a consent form. It is, however, acceptable to perform very limited routine clinical procedures as part of a pre-screen if they directly relate to eligibility determinations and an individual verbally consents to have them performed before signing a consent form for a study. For example, it would be acceptable to weigh an individual in order to ascertain whether s/he qualifies for a dietary study, or acceptable to briefly view a pigmented lesion or a subject's skin type to see whether s/he qualifies for a dermatology study. Such exceptions are made in the interest of the convenience of the research subject, if s/he agrees. Complete physical exams, full body skin exams and any sample collection or laboratory testing must not be undertaken until a subject has given informed consent and has signed the consent form.
Example of Prescreening Process:
Before you begin the pre-screening process, ensure that the process and forms you plan to use are submitted and approved by the IRB-HSR.
The following is an example of a pre-screen process:
- Individuals respond to flyers, ads, and/or may be referred to the research staff for eligibility evaluation.
- The researchers will complete the IRB approved pre-screening document with that individual to determine if the participant is interested in the study. This may be done over the telephone or in-person.
- The research staff will ask the participant if he/she would be willing to answer some questions to determine eligibility. If the participant is on the phone and prefers to meet in person, the research staff should make an appointment for the participant based on the participant’s convenience.
- The research staff will ask the participant questions from the IRB approved pre-screening document. If the participant does not meet initial eligibility or the person is not interested in participating in the study, then that document will be destroyed or any identifiable information will be removed as discussed above and those participants will be referred appropriately.
- Only if the participant appears to be eligible and is interested in pursuing the study, will s/he be asked to provide contact/identifying information (e.g. last name, address, birth date, telephone #, hospital medical record number).
- When an individual qualifies for the research study and are interested in participating they need to be instructed to come in person to sign the consent. In some instances, the subject will be asked to sign the consent and mail or fax the document to the study team.
- If the participant qualifies for the study based on responses noted on the prescreening document and signs the informed consent, then the pre-screening document may be kept in the participant’s research chart.
SCREENING LOG FOR POTENTIAL SUBJECTS
A Screening Log is a helpful tool/tracking ledger that the research team can utilize to track why individuals are not eligible for a research study. It allows for easy identification of the specific criteria that may be negatively impacting participant enrollment. Many sponsors require a site to maintain a screening log.
When a potential participant is identified, the study team should record the status of all potential participants on the Screening Log. It is important to note that the consent must be signed prior to the initiation of any research specific testing/procedure or completion of study specific questionnaires that may qualify as participation in the research study. In other words, informed consent must be obtained before anything is done to a potential participant that is not deemed standard of care for the patient diagnosis and only done for the purposes of determining participant eligibility for enrollment in the research study.
The only identifier the screening log should list is the Date of Screening. A screening log provided by an outside sponsor may include additional identifiers such as DOB, or initials. These are not permitted on the UVA IRB approved screening log. Please discuss this with your sponsor if necessary.
ENROLLMENT LOG FOR CONSENTED SUBJECTS
A Subject Enrollment Log documents, tracks and follows the progress and status of each enrolled subject through the study process. The Enrollment Log is a running list of all potential participants who sign consent and agree to participate in the study. The enrollment log is unique to the study site and may contain information that can directly identify the subject (names, unique identifiers, date of birth or perhaps their home address and phone #). It is recommended that the enrollment log only be maintained at the investigative site. Sponsored-studies may require investigators to maintain a Subject Enrollment Log, in which case sponsors should specify what information to capture and/or provide the log prior to study start. If a sponsor provides the Subject Enrollment Log, file as instructed. Otherwise, the log may be filed in a location easily accessible and available for the research staff to reference and update as needed.
The Subject Enrollment Log offers a snapshot of the study progress of all enrolled subjects, as well as documents the reasons for early subject withdrawals/termination. The reasons for early subject withdrawals/termination can provide the investigator with information that may be useful when designing future studies, or in future recruitment efforts (e.g. if subject was non-compliant, they can be taken off future recruitment contact lists). Typical information collected on the enrollment log may include the following:
Includes the following information Optional information as deemed helpful (not inclusive)
▪ Subject ID ▪ Notes/Comments
▪ Date of 1st and Last Study Visit ▪ Dates of all study visits and required correspondence
▪ Date Informed Consent Signed ▪ How and where was subject recruited
▪ Documentation copy of consent given to subject ▪ Subject Demographics (Sex and Age)
▪ Reason for early withdrawal/exclusion ▪ Date Screened
It is recommended for all studies that an enrollment log be maintained especially studies with large subject enrollment goals and/or studies that will be long in duration. The study staff should consider whether a Subject Enrollment Log will help conduct the study in a more efficient and organized manner.
Create a log that includes all the information that the research staff agrees will be useful throughout the study. Create the log prior to the start of the study, and update when each subject is enrolled into the study.