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Pursuant to Organization Policy 111.14, a qualified physician-investigator or Advanced Practice Provider (APP) must participate in the informed consent process for research studies involving certain drugs, devices, or clinical procedures.
What studies are covered by the policy?
- A study drug or medication that is not approved for (i) over-the-counter (OTC) use, or (ii) is approved for OTC use but is not used according to its labeled instructions. This includes most drugs whose use is under an IND (Investigational New Drug) application;
- A device whose use is under an IDE (Investigational Device Exemption); and/or,
- Clinical procedures for which clinical consent by a physician would be required (e.g., surgical procedures) in the clinical setting.
This policy does not apply to low risk studies that do not fall into the categories listed above.
Waiver and Exceptions:
1. Exempt/NSR Devices: Physician consent is not required for studies of devices that are either exempt from IDE requirements or have been determined by the IRB or FDA to be non-significant risk (qualifying for an abbreviated IDE
2. Non-Therapeutic Studies Involving Drugs: Physician consent is not required for non-therapeutic drug studies where:
- Medical screening for the study is signed off by a physician/APP, participants are informed they can ask to meet a physician/APP;
- Documentation of the medical screening is included in the electronic medical record; and,
- The non-physician/non-APP PI or co-investigator discusses the risks and benefits of the study with the participant and signs the consent form.
In order to meet this exception, investigators should describe this process for the IRB in their description of the consent process in the eIRB application.
3. International Research: This policy applies to studies being conducted outside of the United States only to the extent required by local law or custom. Investigators must adhere to these requirements as necessary. The JHM IRBs defer to the local IRBs or Ethics Boards governing the research’s conduct in the respective host countries and will not impose any additional requirements.
4. Supplements: For IND studies involving drugs or supplements which can be obtained without a prescription outside of the research setting, the investigator may request that the IRB waive the physician consent requirement for the study. Investigators should make this request for waiver with the submission of their eIRB application.
Who must obtain consent under the policy?
A JHM IRB approved physician-investigator or APP, as a member of the study team named in the eIRB application, will be responsible to discuss the risks, benefits, and alternatives to participation. A non-physician consent designee may conduct the rest of the consent discussion (e.g., schedule, compensation, HIPAA privacy authorization, certain minimal risk screening procedures). In addition:
If the study will be conducted in regulated space, the physician-investigator or APP-investigator must be licensed in the State of Maryland and have privileges to practice in the facility where the study will be conducted.
- If the study will be conducted in non-regulated space, the physician-investigator’s or APP-investigator’s privileges to practice at any of the Hopkins facilities are sufficient
- The physician investigator’s or APP-investigator’s privileges must include the specific clinical procedure used in the protocol.
How is the physician consent documented?
On the JHM IRB website, on the Forms page, under Consent Forms, there is a form titled “Documentation of Physician Consent”. This form should be completed to include the study number, study title and PI, and signed and dated by the physician-investigator or APP-investigator and the participant. In the most recent version of the JHM IRB consent form template, this form has been included as the last page of the template. If a non-physician or non-APP consent designee conducts part of the consent discussion, the consent designee and participant should also sign and date on the standard signature page of the consent form.
Can anyone other than a physician obtain consent if this policy applies to the study?
- An APP (e.g., nurse practitioner, physician assistant) listed as consent designees in the eIRB application may obtain consent instead of the physician-investigator if the study therapy or procedure is within the scope of practice for their credentials at Johns Hopkins.
- In addition, individuals who are licensed providers in the State of Maryland and allowed by Johns Hopkins policy to perform a clinical procedure or test may obtain research consent for that procedure, provided it is within the individuals’ scope of practice, credentialing, and they are listed as consent designees in the eIRB application.
Must consent be obtained in a certain order?
No, the study team may determine the method, timing and sequence of consent discussions. For example, (i) the physician-investigator or APP-investigator may conduct the entire consent discussion, (ii) the physician-investigator or APP-investigator and non-physician consent designee may jointly conduct the consent discussion in one meeting with the participant, or (iii) the physician-investigator or APP-investigator and non-physician consent designee may have separate meetings* with the participant.
* If there are separate consent sessions (i.e. one with a non-physician consent designee and a later one with a physician-investigator/APP-investigator) which will involve a significant time lapse between the sessions, the investigator should detail and justify this process in the eIRB application for the IRB’s consideration.
How should consent be documented when the physician-investigator or APP-investigator conducts the entirety of the consent discussion?
- 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 i the Delegation of Authority log.
- The entire consent document should always be retained even if the physician or APP has signed as the investigator or consent designee.
If the IRB or a study sponsor requires re-consent on a Change in Research submission with a revised consent form, is the physician-investigator or APP-investigator required to participate in the re-consent process?
The physician-investigator or APP-investigator is required to participate only where there are substantial changes to the risks/benefits of the study, or if new alternative treatments have been identified.
Can any study procedures start before the physician-investigator/APP-investigator obtains consent?
If screening is included in the consent form, minimal risk screening procedures (e.g., blood draws, radiographs) may be conducted after the non-physician consent designee and participant have signed the consent form, but the physician-investigator or APP-investigator must explain the risks, benefits and alternatives prior to starting the study intervention or the use of the investigational drug/device.
Can any study procedures start before the physician-investigator obtains consent?
If screening is included in the consent form, minimal risk screening procedures (e.g., blood draws, radiographs) may be conducted after the non-physician consent designee and participant have signed the consent form, but the physician-investigator must explain the risks, benefits and alternatives prior to starting the study intervention or the use of the investigational drug/device.
What procedures are considered “clinical procedures for which consent by a physician/APP would be required”?
- Surgical procedures
- Glucose clamp studies
- Cardiac catheterization
- Arterial line insertion
Procedures that would not require physician consent under this policy include, x-rays, CT scans or MRIs. For these imaging tests, imaging staff should be following the same processes that they do for clinical imaging.
Is it possible to obtain a waiver from the requirements of this policy (other than those that can be granted by the IRB as defined above)?
In limited cases, a waiver may be granted for circumstances not contemplated by this guidance. PIs should email the JHM IRB Help Desk at firstname.lastname@example.org with request for waiver and justification. The request will be forwarded to the Vice Dean for Clinical Investigation and Risk Management for review.