Information Sheet Guidance for Sponsors, Clinical Investigators, and Institutional Review Boards (IRBs). Waiver of IRB Requirements

Name of Guidance:
Information Sheet Guidance for Sponsors, Clinical Investigators, and Institutional Review Boards (IRBs). Waiver of IRB Requirements for Drug and Biological Products Studies.

Status of Guidance:
Final

Date of Guidance:
January 2006

Name of Organization:
United States Food and Drug Administration (FDA)

Target Audience:
Clinical trial sponsors and clinical trial investigators

Laws and Regulations Referenced:

• 21 Code of Federal Regulations (CFR) 10.115 – The FDA’s administrative practices and procedures regarding the use of good guidance practices. The guidance under review cites that it is in line with FDA’s regulations.
• 21 CFR 50 – This regulation addresses the need to protect human subjects that participate in clinical trials. The guidance under review does not apply to the informed consent section of 21 CFR 50.
• 21 CFR 56 – Institutional Review Board (IRB) requirements in clinical trials. The guidance under review is an addition to the waiver in section 21 CFR 56.
• FDA section 505 (i) – FDA Regulatory information regarding exemptions for research of new drugs. The guidance under review states that it remains under the discretion of the FDA to grant IRB exemptions.

Definitions:

Agency – When referring to pharmaceuticals, the agency is the government entity overseeing the development of medications. In the United States, the Agency refers to the Food and Drug Administration.

Clinical trial or clinical study– Process by which the efficacy and safety of a medication is tested in humans.

Clinical trial investigator or investigator – Medical doctor overseeing the clinical trial

Clinical trial sponsor or sponsor– Company paying for all expenses of the clinical trial

Code of Federal Regulations – Laws created by congress.

Guidance – When referring to pharmaceuticals, these are recommendations from the FDA.

Independent Ethics Committee (IEC) – Committee that approves, monitors, and reviews all aspects of a clinical trial involving humans. They are normally found in Europe and they comply with most FDA requirements.

Informed consent – Information given to the patient regarding a treatment or procedure. After receiving the information, the patient decides whether he or she would like to undergo the treatment or procedure.

Institutional Review Board (IRB) – Performs similar functions to the IEC. They are normally found in the United States.

Study protocol, trial protocol, or protocol – Document that describes all aspects of a clinical trial. It gives the background of the product or procedure being tested. It describes what the sponsors hope to accomplish the trial and how they will go about it.

Background:
Clinical trials are conducted all over the world. In the United States, a physician needs to obtain approval from an IRB before he or she is able to participate in a clinical trial. All of the details of a clinical trial are outlined in the study’s protocol. However, when the company sponsoring the clinical trial is located outside the United States, the protocol might call for an IEC instead of an IRB. This guidance was created to address this issue.

Summary:
This guidance provides information to a sponsor on what is needed to obtain an IRB waiver. In order to grant the request, the agency has two main requirements:

1. Reason why a waiver is necessary
2. Description of alternative methods of guaranteeing the safety of all participants in the study

Most requests received by the agency are from sponsors utilizing IECs instead of IRBs.

The sponsor must submit the request in writing to the appropriate division of the FDA. A written response will be sent to the sponsor regarding the waiver’s request decision. A copy of all communications must remain in the investigator’s files.

Rationale:
This guidance was created because under the Federal Law of the United States, IRB approval is necessary before a study can begin for an investigational new drug. This requirement is in place for the safety of all study participants. However, in some countries, IRBs do not exist. Instead, IECs are used for the protection of study participants.

Resulting Recommendations:
Sponsors are able to use IECs to conduct a clinical trial but they must obtain a waiver from regulatory authorities prior to starting the study.

Impact:
Obtaining this waiver may delay the starting of a study.