Definitions:
- Licensed physician: A physician with an unrestricted Pennsylvania medical license
- Qualified practitioner: Medical residents and fellows functioning under a training license, and licensed advanced practice providers (i.e. PAs, CRNPs, CRNAs, and certified nurse midwifes)
- Licensed health care providers: Other health care providers with an unrestricted health professional license such as RN, radiology technician, physical therapist, optometrist, etc.
HRP policy 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 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 licensed physicians.
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 HRP 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 protocol. 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 Certification in absence of any approved waiver or alteration of the consent process. 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
HRP policy dictates that a licensed physician investigator must obtain consent and sign the Investigator’s Certification statement at the time of this involvement or as soon as possible thereafter. However, there are circumstances when the IRB may permit an exception to have the consent process be conducted by a qualified practitioner or a licensed health care provider as Co-I with an appropriate justification. In addition to being within their scope of practice, this individual must have the appropriate expertise and credentials to perform this duty for that 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 |
|---|---|---|
|
1. 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. |
|
|
2. Study involving the use of, but not evaluating the effectiveness and/or safety of an approved drug according to established medical practice |
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:
|
|
3. 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. | |
| 4. 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. | |
| 5. Study involving but not evaluating the effectiveness and/or safety of a not cleared/approved device (e.g., use of a device to collect study data) | Investigator must obtain consent. Exception to have investigator obtain consent may be granted if the use of the device qualifies as minimal risk. Based on the details of the study, the IRB may require the consent be obtained by a licensed physician, qualified practitioner, licensed health care provider, or non-health doctoral investigator. | |
| 6. Study evaluating the effectiveness and/or safety of an on-label use of a cleared/approved device | Licensed physician investigator must obtain consent. An exception may be granted to a qualified practitioner investigator, licensed health care provider investigator, or non-health doctoral investigator with special expertise. | |
| 7. Study evaluating the effectiveness and/or safety of a not cleared/approved non-significant risk or IDE exempt device or off-label use of a cleared/approved non-significant risk or IDE exempt device | Licensed physician investigator must obtain consent. An exception may be granted to a qualified practitioner, licensed health care provider investigator who would normally use that type of device in their scope of practice, or non-health doctoral investigator with special expertise. | Examples include a Physical Therapist for assistive devices, Optometrist for contact lenses, etc. |
| 8. Study evaluating the effectiveness and/or safety of a not cleared/approved significant risk device or off-label use of a cleared/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. | |
| 9. 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. |
In addition, an exception to have any listed investigator with appropriate training and expertise to obtain consent may be appropriate for minimal risk studies that evaluate the safety and/or effectiveness of medical devices in one of the following circumstances:
- IDE exempt software functions where the software function will not influence subject management or care
- IDE exempt or non-significant risk consumer device, e.g. VR headsets, Fitbits
- IDE exempt diagnostic assays with noninvasive sample collections, e.g. blood draws, vaginal swabs, etc.
- IDE exempt or nonsignificant risk devices where the only human subject involvement is noninvasive collection of data and/ samples for development of the device, i.e. the device will not be used on the subjects
11/11/2025