Responsibility for Obtaining Consent
The Principal Investigator (PI) or a Co-Investigator (Co-I) is responsible to obtain informed consent from subjects prior to initiation of research activities even though study coordinators or study staff may be involved in the consent process.
Below lists the personnel who are required to obtain consent for each type of study. Wherever permitted, and if desired, the study team can request and justify an exception to the informed consent requirement under Consent Process #5 of the PittPRO application. Additional information study personnel requirements for obtaining consent and permitted exceptions, refer to Obtaining Informed Consent for Human Subject Research.
Minimal Risk Study Not Involving Drug, Device, or Surgical Procedure
An exception may be granted to have an individual who is not the PI or a listed Co-I obtain consent with appropriate justification. If an exception 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. The exception request should describe the training and qualification of the individual.
Greater Than Minimal Risk Study Not Involving Drug, Device, or Surgical Procedure
The PI or listed Co-I must obtain consent and sign the Investigator’s Certification statement at the time of this involvement. No exception can be granted.
Study Involving Drug, Device, or Surgical Procedure
A licensed physician investigator must obtain consent and sign the Investigator’s Certification statement at the time of this involvement.
There are circumstances when the IRB may permit, with an appropriate justification, an exception to that requirement. Under Pennsylvania Act 61, an amendment to the Pennsylvania Medical Care Availability and Reduction of Error (MCare) Act, a licensed physician may fulfill their duty to obtain a patient’s or the patient’s authorized representative’s consent by delegating the task to a qualified practitioner prior to conducting surgery or administering radiation or chemotherapy, blood transfusions, or medications and devices. A physician or qualified practitioner performing a procedure may rely on information provided by another qualified practitioner to obtain informed consent. Qualified practitioners include 1) medical residents and fellows with a training license and 2) licensed advanced practice providers. In accordance to Act 61, the IRB may permit an exception to have the consent process be conducted by a qualified practitioner, licensed health care provider (e.g., optometrist, physical therapist), or other doctoral professionals as a listed Co-I. In addition to being within his or her scope of practice, this individual must have the appropriate expertise and credentials to perform this duty as determined by the IRB.
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 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 an 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 including time on the consent document is a requirement for any research study involving the evaluation of a research intervention which falls under the jurisdiction of the FDA.