What is an Enrollment Note?
An enrollment note is legal documentation of a properly conducted informed consent. Once the investigator presents a brief overview of the research study and answers any questions, they must have subjects and any other relevant parties sign the informed consent form. The enrollment note is essentially verification of this process to ensure that the subject’s voluntary participation is properly documented and any special considerations have been taken into account. The enrollment note is signed on by investigators, sponsors, and even physicians to attest that the subject is certified to participate in the investigation.
Benefits and Importance of an Enrollment Note
An enrollment is necessary because it documents that the informed consent process took place in a legal, properly conducted capacity. Furthermore, it solidifies an understanding between the investigator and participant about the research protocol. It facilitates a cohesive interaction among all the people involved in the study including participants, investigators, researchers, and even the IRB (Institutional Review Board). It also creates a resource for investigators to refer to throughout the study in order to modify the study protocol if needed. The enrollment note also ensures that the process itself is not rushed and forces investigators to adequately document all aspects of the study to ensure a safe, authorized research protocol.
Elements of an Enrollment Note
The following elements should be taken into consideration when filling out an enrollment note:
- Date and time the enrollment note is written.
- Date and time the informed consent is conducted.
- Statement that the subject meets the inclusion criteria and none of the exclusion criteria.
- Statement that the informed consent was obtained prior to starting any of the research procedures.
- Statement that the subject or legal representative had the opportunity to ask questions throughout the process.
- Informed consent and/or HIPAAAuthorization was obtained prior to starting any procedure
- Statement that the subject was given a copy of the signed informed consent form.
- Signature and date of IRB approved investigator.
Additional elements that may be present on an enrollment note when applicable include:
- Location/setting of consent process
- Consent tiers or quiz
- Assessment or capacity of participant’s comprehension
- Legally authorized representative consent or assent attained
- Assessment of minor’s ability to provide consent
- Specific requirements fulfilled for consent process requested by IRB committee or protocol
- For LEP (limited english proficient) subjects consent must be obtained thru IRB approved short form that can only be used a limited number of times. Certified translator may also be required.