New FDA Guidance In Effect During COVID-19 Public Health Emergency

For IRBs 

When reviewing single patient expanded access requests, IRBs face four challenges:

  • To speed up the review process for patients who truly are almost out of time.
  • To ensure that the investigational product will not cause undue harm to the patients involved.
  • To ensure that patients make informed decisions about using the investigational product.
  • To avoid jeopardizing marketing approval process for the investigational product.

Clinical Research Pathways has identified the following four-step process to support IRBs and desperately ill patients.  A PDF version can be downloaded here.

Streamlining Procedures for Single Patient Expanded Access Requests

Step 1: Revise IRB application procedures so that the treating physician may submit as the application:
  • FDA Form 3926 when the treatment use involves an investigational drug or biologic or a treatment plan for investigational medical devices that includes the same type of information required in the FDA Form 3926.
  • Investigator brochure or another source describing risks and potential benefits of the treatment.
  • Draft consent document.
Step 2: Revise procedures to ensure that your IRB is able to handle requests in a timely fashion.
  • As of October 3, 2017, FDA permits the IRB chair or designee to review and concur with the expanded access request involving an investigational drug or biologic.
  • FDA guidance permits the IRB chair to review and concur with an expanded access/compassionate use request involving an investigational medical device.  Note: FDA guidance does not permit a designee to conduct the review.
Step 3: Provide recommendations or similar guidance to your IRB members about how to review single patient expanded access requests.
  • Confirm the medical evaluation of the patient’s condition based on the information provided by the treating physician. This individual must be able to confirm or deny the claim that there is no comparable or satisfactory alternative available.
  • Ensure that informed consent or appropriate permissions will be obtained and documented. Given the compassionate nature of the request and FDA’s involvement, consent documents should meet the requirements listed in 21 CFR 50.25, using plain language that is specifically aimed at “patients” who expect direct benefit, as opposed to “subjects” who may not expect benefit.
  • Receive documentation that FDA has made its determinations regarding safety and effectiveness and has given clearance for the use.  Request the IND or IDE number and any documentation from FDA.
  • Review the physician’s treatment plan (or sponsor-provided treatment protocol) and determine that it makes adequate provision for ensuring the safety of the patient including adequate monitoring (timing and type of tests/exams, etc.) and appropriate plans for collecting and reporting the data.
Step 4: Publish procedures so that they are available to treating physicians and IRB members.

Assistance with IRB Procedures

We encourage all IRBs to streamline the review process so that every patient request for expanded access is approved quickly. For more information, including assistance with your IRB procedures, please contact Clinical Research Pathways at Together, we can make a difficult time a little easier for desperately ill patients and their families.

Additional Resources

From Clinical Research Pathways

FDA Expanded Access