Obtaining Informed Consent for Human Subject Research

Definitions:

  1. Licensed physician:  A physician with an unrestricted Pennsylvania medical license
  2. Qualified practitioner: Medical residents and fellows functioning under a training license, and licensed advanced practice providers (i.e. PAs, CRNPs, CRNAs, and nurse midwifes)
  3. Licensed health care providers: Other health care providers with an unrestricted health professional license such as RN, radiology technician, physical therapist, optometrist, etc.

University policy (Chapter 13, Obtaining Informed Consent) requires the Principal Investigator (PI) or a Co-Investigator (Co-I) of a research study to obtain informed consent from subjects prior to initiation of research activities. This policy anticipates that study coordinators or study staff may assist in the consent process.  This policy also requires that a physician with an unrestricted Pennsylvania medical license and listed as Principal or Co-investigator to obtain consent for a study involving a drug, device or surgical procedure. Medical residents and fellows operating under a Pennsylvania training license are not considered to be licensed physicians for this purpose.

The Pennsylvania General Assembly in June 2021 approved and the Governor signed Senate Bill 425 as Act 61 to amend the Medical Care Availability and Reduction of Error (MCare) Act.   This amendment permits a licensed physician to 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.

The list below details the personnel required to obtain consent for each type of study pursuant to University Policy and the current state of Pennsylvania law.  Wherever permitted and if desired, the study team can request, with justification, an exception to the above-stated informed consent requirement under Consent Process #5 of their PittPRO application. Exceptions will be evaluated on a case-by-case basis, taking into consideration the nature of the research, the qualifications of the individual on whose behalf the exception is being requested, and the involved interventions in a specific protocol.

Minimal Risk Study Not Involving Drug, Device, or Surgical Procedure

The IRB may grant an exception to permit an individual who is not the PI or a Co-I to obtain consent with appropriate justification. If an exception is requested, the request needs to identify by name or position the individual who will be involved in the informed consent process and who will sign the Investigator’s.  The exception request should describe the training and qualification of the individual.  The exception can be requested under Consent Process #5 in PittPRO.

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

University policy dictates that a licensed physician investigator must obtain consent and sign the Investigator’s Certification statement at the time of this involvement.  However, there are circumstances when the IRB may permit, with an appropriate justification, an exception to have the consent process be conducted by a qualified practitioner or a licensed health care provider as 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 for that particular study as determined by University IRB.  Medical residents and fellows in the role of co-investigator require appropriate training and supervision in order to conduct the informed consent process.

The following chart provides specific examples of circumstances where the IRB may consider granting an exception to the requirement that a licensed physician investigator obtain informed consent.

Example Consent Requirement Additional Information

Study involving anesthesia, radiation therapy, radiopharmaceuticals, or chemotherapy

Licensed physician investigator must obtain consent. An exception may be granted to a qualified practitioner investigator in the specialty.

 

Study involving the use of, but not evaluating the effectiveness and/or safety of an approved drug

Investigator must obtain consent.  Based on the details of the study, the IRB may require a licensed physician or qualified practitioner investigator to obtain consent. Prescription and administration of medication must comply with state and federal licensing statutes

Examples include:

  1. On-label use of prophylactic or rescue medications for research purposes
  2. Administration of drug to induce a physiologic state required for the study (e.g., administering nitric oxide to induce vasodilation in order to evaluate biomarkers related to vasodilation
  3. Bronchodilator for research PFTs or gadolinium for research MRIs

Study evaluating the effectiveness and/or safety of on-label use of an approved drug

Licensed physician investigator must obtain consent. An exception may be granted to a qualified practitioner investigator or licensed health care practitioner investigator.  
Study evaluating the effectiveness and/or safety of an unapproved drug or off-label use of an approved drug Licensed physician investigator must obtain consent. An exception may be granted to a qualified practitioner investigator for a study evaluating the effectiveness and/or safety of 1) an off-label use of an approved drug or 2) alternative formulation of a drug with well-known safety profile.  
Study involving but not evaluating the effectiveness and/or safety of a device (e.g., use of a device to collect study data) Investigator must obtain consent.  Based on the details of the study, the IRB may require the consent be obtained by a licensed physician, qualified practitioner, or licensed health care provider investigator.  
Study evaluating the effectiveness and/or safety of an on-label use of an approved device Licensed physician investigator must obtain consent. An exception may be granted to a qualified practitioner or licensed health care provider investigator  
Study evaluating the effectiveness and/or safety of an unapproved non-significant risk device or off-label use of an approved non-significant risk device Licensed physician investigator must obtain consent. An exception may be granted to a qualified practitioner or licensed health care provider investigator who would normally use that type of device in their scope of practice. Examples include a Physical Therapist for assistive devices, Optometrist for contact lenses, etc.
Study evaluating the effectiveness and/or safety of an unapproved significant risk device or off-label use of an approved significant risk device Licensed physician investigator must obtain consent.  An exception may be granted to a qualified practitioner or licensed health care provider investigator for a study evaluating off-label use of an approved significant risk device if they would normally use that type of device in their scope of practice.  
Study involving surgical procedures (including biopsies) Licensed physician investigator must obtain consent. An exception may be granted to a fellow in the applicable specialty, or advanced practice provider investigator with independent hospital privilege to perform that procedure.  Exception may also be granted to a resident with sufficient experience to obtain consent for minor procedures such as a skin biopsy.  

1/27/2022