March 2021

Policy:

In Maryland and in many other states, a physician has a legal duty to provide all information material to a reasonable patient’s decision to undergo a clinical therapy or procedure. This physician duty is non-delegable. It is the policy of the Organization that when a research participant will receive a drug, device, or clinical procedure in a therapeutic clinical research study, a qualified physician-investigator must participate in the consent discussion with the research participant except as described herein. If the investigational therapy or procedure is within the scope of practice at Hopkins for an Advanced Practice Provider (APP) these individuals may obtain consent in lieu of the physician/investigator. The physician-investigator or APP-investigator must have privileges to practice in the facility where the study will be conducted and be an IRB approved study team member to be considered a qualified physician-investigator or an APP-investigator.

The material information that a physician-investigator or APP-investigator must discuss with the participant includes the risks and benefits of the drug, therapy, or procedure, as well as alternatives that a reasonable participant might consider (including non-participation). The physician/APP must also be satisfied that the participant understands this information, is competent to consent, and has no remaining questions. Although adult patients are presumed competent, in cases of temporary or permanently-diminished capacity (e.g., trauma, extreme pain, stroke, cognitive impairment) the physician-investigator or APP-investigator may need to assess and document competence prior to obtaining consent from the participant.

Definitions:

Advanced Practice Provider: An individual who has been trained and certified to provide basic medical services under the supervision of a  Maryland State licensed physician or independently when allowed. Advanced Practice Providers include: Nurse Practitioner; Physician Assistant; Registered Nurse First Assistant; Clinical Nurse Specialist; Certified Nurse Midwife; Certified Registered Nurse Anesthetist.

Therapeutic clinical research study: As defined by Center for Medicare and Medicaid Services, the principal purpose of a therapeutic trial is to test whether the intervention potentially improves the participant’s health outcomes and is not exclusively designed to test toxicity or disease pathophysiology.

Drug: Includes any drug, biological, botanical, or other substance used in the clinical investigation as named in the protocol, as further described in Organization Policy 103.19(a).

Principles and Procedures:

A physician-investigator or an APP-investigator must participate in the consent process for therapeutic clinical research studies involving any of the following:

• A study drug or medication that is (i) not approved for over-the-counter (OTC) use, or (ii) is approved for OTC use but is not used according to its labeled instructions;
• A device that is being studied under an (Investigational Device Exemption) IDE (does not apply to studies that are IDE exempt or non-significant risk, unless clinical consent for the device would be required);
• A clinical procedure (e.g., surgical procedure) for which clinical consent by a physician would be required.

Waivers and exceptions: 

• Supplements: For studies using a drug that may be obtained without a prescription (e.g., over-the-counter supplement) that is being studied under an IND, the physician-investigator or APP-investigator may request a waiver of the requirement for physician-investigator or APP-investigator consent from the IRB.
• Non-therapeutic studies using a drug or device: Physician/APP consent is not required for non-therapeutic drug studies provided that (i) medical screening for the study is signed off by a physician/APP, participants are informed they can ask to meet a physician/midlevel provider, (ii) documentation of the medical screening is included in the electronic medical record, and (iii) the non-physician PI or co-investigator discusses the risks and benefits of the study with the participant and signs the consent form.
• International Research: For studies being conducted outside of the United States, investigators must adhere to any requirement for obtaining physician-investigator or APP-investigator consent according to local law and custom as determined by the local IRB or Ethics Board governing the study’s conduct there.  The JHM IRBs will not impose any additional requirement.

IRB requirements: 

The eIRB application includes questions on whether the physician/APP consent policy applies to a study and, when it does, additional questions on which study team members will be obtaining consent under this policy. The IRB has the authority to require physician/APP consent when it determines the risks of the study procedures require physician consent, even if not otherwise required under this policy.

1. The physician-investigator or APP-investigator must discuss the risks and benefits of the study procedures and alternatives, including non-participation. The physician-investigator or APP-investigator must also be satisfied that the participant understands the study procedures and is competent to consent, and answers any questions about the procedures, risks, benefits and alternative treatments.
2. The physician-investigator or APP-investigator is not required to review and discuss the entire consent form with the participant. Non-physician/APP consent designees listed on the IRB application may conduct the balance of the consent discussion (e.g., protocol components, confidentiality, payments), either before or after the physician-investigator or APP-investigator discusses the risks, benefits and alternative treatments. If a non-physician/APP consent designee conducts part of the consent discussion, he or she should also sign the consent form as a consent designee.
3. For approved studies that are enrolling new patients and have an existing approved informed consent document issued prior to the implementation of this policy, the physician-investigator or the APP-investigator will use the stand-alone “Documentation of Physician Consent” form available on the JHM IRB website. For New Applications and Changes in Research that include a revised consent form, the most recent JHM IRB Informed Consent Template includes a separate page to confirm documentation of physician-investigator or APP-investigator consent. The physician-investigator or APP-investigator’s signature confirms that he or she has met the obligations described in this policy.
4. If screening is included in the consent form, minimal risk screening procedures (e.g., blood draws, certain radiographs) may be conducted after the participant and non-physician consent designee have signed the consent form, but the physician-investigator or APP-investigator must discuss the risks, benefits, and alternatives with the participant and sign the consent form prior to starting the study intervention. If the consent process will be conducted by the physician-investigator or an APP-investigator and a non-physician consent designee, the participant should sign the consent form twice (at the time the consent discussion is conducted with each of the consenters).
5. The study team may determine the method, timing and sequence of the consent discussions. For example, (i) the physician-investigator may conduct the entire consent discussion, (ii) the physician-investigator and the consent designee may jointly conduct the consent discussion in one meeting with the participant, or (iii) the physician-investigator and non-physician consent designee may have separate meetings with the participant.
6. The physician-investigator or APP-investigator should sign the main (initial) consent page. In this scenario, the “documentation of physician consent” signature section may be left blank as the discussion was incorporated into the main consent conversation. It is important that the physician-investigator or APP-investigator performing the entire consent process are designated as consenters in the eIRB application.  It is also advised that the physician-consenters and/or APP consenter be listed in the Delegation of Authority log. Important: The entire consent document should always be retained even if the physician or APP has signed as the investigator or consent designee.
7. If the IRB or a study sponsor requires re-consent on a Change in Research submission with a revised consent form, a physician-investigator or an APP-investigator is not required to participate in the re-consent process unless there are substantial changes to the risks/benefits of the study, or there are new alternative treatments.
8. An APP  listed as a consent designee on the IRB application may obtain consent in place of the physician-investigator if all of the study procedures are within the scope of the APP’s practice.
9. This policy applies to all JHM IRB-approved studies, including those whose conduct is already underway at the time of its issuance.

For additional information, please see the applicable JHM IRB guidance on Physician Consent.