How to Identify an Institutional Review Board
Once the pharmaceutical company has agreed to provide the investigational treatment and you have submitted Form FDA 3926 to the FDA, you must submit an expanded access treatment protocol and informed consent document to an Institutional Review Board (IRB). IRBs monitor all research involving human subjects, including clinical trials. Treatment via single-patient EA falls under their purview because of the investigational status of the treatment, but updated FDA Guidance now allows a waiver of the requirement of a convened IRB meeting with a majority of members present. With this waiver, review and approval by the IRB chairperson or another designated IRB member before treatment use begins is enough.
Many academic medical centers have their own IRBs, which can be used by the physicians who practice there. Alternatively, treating physicians can find an IRB through the HHS's OHRP Database of IRBs. There are several independent IRBs that are familiar with reviewing EA requests, including: Western IRB, Quorum Review IRB, Advarra, and Sterling IRB. For more information, questions or assistance with IRB procedures, visit Clinical Research Pathways. Also, the Department of Health and Human Services' Office for Human Research Protections maintains a database of registered IRBs. Go to this site and click on "Advanced Search," then enter your state to find registered IRBs in your area.
The Role of an IRB in Reviewing an EA Treatment Request
The role of an IRB is to protect and monitor patients receiving investigational treatments to ensure ethical treatment of patients. The IRB reviews informed consent documents to ensure that the patient is provided all the information about a protocol, including possible outcomes and risks. An explanation of procedures, potential benefits, possible risks, alternative treatments (if they exist), confidentiality of records, and what the patient’s rights are form the basis of a well-written informed consent.
Most IRB’s will request to also review Form FDA 3926 and the pharmaceutical company’s required documentation. At the onset of the IRB review process, you may want to ask the IRB about possible review fees and the anticipated timeline for review.
What the IRB will Consider During the Review
Approval from the IRB must be attained before the EA treatment can begin. During the review process an IRB will look for:
- Assurance that informed consent and appropriate permissions from the patient will be obtained and documented
- Assurance that the physician’s treatment plan makes adequate provisions for ensuring the safety of the patient, including monitoring and appropriate plans for collecting and reporting data
- Confirmation that HIPAA requirements will be followed to ensure confidentiality of the medical record
- Confirmation that the treating physician will follow standard medical practice to protect the privacy interests of the patient
- Confirmation that additional safeguards are included in the treatment plan where the therapy may require special monitoring or other safeguards
After reviewing the request, the IRB will notify the physician as soon as possible in writing if the request is approved, requires more information, or is rejected.
The IRB approval letter also will stipulate requirements for reporting serious adverse events, any changes in the treatment plan, and a summary when the treatment ends.