Consent Process
Although Federal Regulations specify the information that must be given to potential subjects prior to participation in research studies andrequire that informed consent be documented by the use of a written consent form approved by the IRB and signed by the subjects, the form itself does not provide information pertaining to the informed consent process. ICH Guidelines for Good Clinical Practice (GCP) define informed consent as a process by which an individual voluntarily expresses his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the decision to participate. As part of the ICH Guidelines for GCP, before consent is obtained from a potential subject, the investigator or person designated by the investigator should provide the subject or the subject’s Legally Authorized Representative (LAR) with ample time and opportunity to inquire about the details of the study and to decide whether or not to participate. All questions about the study should be answered to the satisfaction of the subject or subject’s LAR. As with the Federal Regulation, GCP Guidelines require that prior to participation in the study, the written informed consent form should be signed and personally dated by the subject or the subject’s LAR and by the person who conducted the informed consent discussion, and a copy given to the subject.
Source data, as defined by GCP, include all information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial and are contained in source documents (or original records), which may include, but are not limited to, hospital records, clinical and office charts, lab notes, memoranda, subjects’ diaries and evaluation check lists, etc). Documenting the consent process, in the medical record (in the case of a therapeutic study), or a research record (for studies involving non-therapeutic research), provides information pertaining to the events and interpersonal exchanges of information about the research leading up to, surrounding, and after the consent form is signed. If the study is high risk, complex, or if subjects may be vulnerable, multiple interactions may be necessary in the period preceding the signing of the consent document and start of study interventions, and should be documented accordingly.
Although not all research is a clinical trial, ICH Guidelines for GCP provide guidance for designing, conducting, recording, and reporting trials that involve participation of human subjects and may be applied to other clinical investigations that may impact the safety and well-being of human subjects.
Example of Consent Process Note To Be Dictated or Placed In Medical Record
Study Title:
IRB #:
Principal Investigator:
Dr. (or named designee) has spoken with Mr./Ms./Mrs.about participating in the study. The study was explained and the consent form reviewed with (potential subject and ). The ICF was left with the subject to consider and discuss with his family. The subject (or the subject’s LAR) was provided the opportunity to ask questions about the study and have them answered. The subject has agreed to take part in the study and signed the consent prior to the start of study interventions (or participation in the study). A copy of the consent was placed in the MR (research record) and a copy was given to the subject. An original signed Informed Consent is on file with the investigator.
IRB Version: 2/1/2018Page 1 of 2