Responsibility for Obtaining Consent
The principal investigator of the research study is ultimately accountable for assuring that all aspects of the study are at all times in compliance with applicable research regulations and IRB policies. This includes the entire informed consent process and the instruction and oversight of individuals who may be involved in this process. The IRB application must include a detailed plan for informed consent process and include the individuals who will actually be conducting the consent process.
Studies Involving Drug, Device, or Surgical Procedures
The University requires that the PI or a Co-Investigator who is a licensed physician obtain informed consent. This does not mean the study coordinator cannot introduce the study and answer preliminary questions about the research. The final process of obtaining the written informed consent must be conducted by a physician investigator who must sign the Investigator's Certification statement at the time of this involvement.
There are circumstances when the IRB may permit, with an appropriate justification, that the consent process to be conducted by a licensed health care professional who is listed as a Co-Investigator. This individual must have the appropriate expertise and credentials to perform this duty.
Greater Than Minimal Risk Study
For greater than minimal risk research studies which do not involve the use of a drug, device, or surgical procedure; the PI or listed Co-Investigator must be involved in the informed consent process and must sign the Investigator's Certification statement at the time of this involvement.
Minimal Risk Study
The IRB may approve an exception to the rule requiring the PI or Co-Investigator’s to obtain consent with appropriate justification. If a waiver is requested, the individual who will be involved in the informed consent process and who will sign the Investigator’s Certification must be identified by name or position.
Informed Consent Process
Note that verbal or telephone consent is not acceptable unless the IRB has specifically waived the requirement for a signed consent form. Deferred consent (i.e., obtaining consent after the initiation of study procedures) is also prohibited.
The investigator must seek informed consent under circumstances that give the individual sufficient opportunity to consider whether to participate in the research study, and that minimize possible coercion or undue influence.
Informed consent to participate in a research study should be sought at a time separate from obtaining informed consent for procedures performed for the medical management of the patient (i.e., non-research procedures).For certain research studies (e.g., studies involving questionnaires, surveys) it may be practical and acceptable to mail the informed consent document to the potential subject and to have the signed document returned by mail. If this approach is taken, there must also be provisions for a telephone interaction between the potential subject and investigators to ensure that the informed consent process has been appropriately addressed. The cover letter accompanying the mailed informed consent document and survey or questionnaire materials must clearly address this telephone interaction. The procedures for ensuring an appropriate informed consent process when the consent form is mailed to potential research subjects should be addressed in the Questions 4.11, 4.12, and 4.13 of the OSIRIS application.
The Principal Investigator must retain the original signed informed consent document in his/her research records. A copy of the informed consent document must be provided to the subject. For hospital inpatients, a separate copy of the informed consent document should be incorporated into the patient’s medical record.
In addition to obtaining the signed, written informed consent document, it is recommended that a narrative note be written in the subject’s research records documenting the informed consent process. This documentation may depend on the risk of the study and could include information such as:
- Who was present during the informed consent discussion;
- The fact that risks were presented;
- A notation, if applicable, that significant issues of concern to the subject were addressed;
- A statement that all questions were answered to the satisfaction of the subject.
The narrative note should also indicate the date and time that the subject signed the informed consent document and be signed by individual responsible for the documentation. Noting the time of consent, in addition to the date, is especially important if any research procedures will be performed on the same day that informed consent was obtained. Note that this is a requirement for any research study involving the evaluation of a research intervention which falls under the jurisdiction of the FDA.