Since the origin of CPT nearly a half-century ago, consumer well-being and high standards for integrity have been our guiding principles. Indeed, our fundamental purpose is to conduct relevant trials that provide accurate data in support of our clients’ efforts to market products that truly improve lives. And that, we believe, begins with respect for clinical trial panelists’ rights, safety, and well-being.

Protecting Human Trial Panelists

The institutional review board (IRB) was introduced in 1974 as an essential step in developing and conducting human clinical trials. An IRB is a formal committee charged with the duty of ensuring that clinical trials are conducted ethically and with respect to human rights. IRBs may be known by different names (e.g., IEC) in different settings, but all are bound to support the rights of human subjects in research.

Every clinical trial is carried out according to a detailed study protocol, developed to answer an individual client’s specific research questions. The protocol describes the study’s goals, testing methods, data collection methods, risk mitigation (including informed consent), inclusion and exclusion criteria, and timing.  Most, but not all, clinical trials in the United States must be approved and monitored by an IRB to ensure that protocols are developed and implemented to minimize risk to human panelists.

In some cases, a research facility will have its own institutional review board.  (CPT does not have its own IRB to maintain a respectful distance between the IRB and the scientific staff.)  Federal regulations require that the board be comprised of at least five members of diverse background and without conflicts of interest. Of the minimum five members:  at least one must be a scientist and at least one not a scientist (such as a lawyer or member of the clergy), and at least one must have no other affiliation with the testing organization. The IRB may also call on consulting experts when needed, but these consultants may only offer information to the board and may not vote with the board.

The IRB in Action

In general, an IRB has the authority to approve, reject, or require modifications in the research protocol, as well as the authority to monitor the trial for protocol compliance.  The IRB review process encourages open, thorough, interdisciplinary discussion about planned trials before the trials begin – again, strictly for the purpose of protecting the rights and well-being of human trial subjects.

Each IRB member reviews trial materials before meeting to discuss that trial. The review package includes a summary of the study protocol, a proposed informed consent document, and other supporting materials to provide sufficient information for active and constructive discussion. The U.S Food and Drug Administration (FDA) requires that IRBs review all ongoing trials at least annually, and the IRB must keep meticulous records of its activities. IRBs also play an important role in pharmacovigilance programs, as all adverse events during a trial must be reported to the IRB.

Required or Optional

With very few exceptions (e.g., cosmetic trials), an IRB review is required whenever a clinical trial is designed to gather data from human test subjects.  Clinical trials approved by the IRB place it under the regulations developed by FDA to provide guidance for research related to FDA-regulated products.  FDA carefully monitors IRB activities and requires that IRBs under its authority register with the U.S. Department of Health and Human Services (HHS).

Regulatory authorities in other disciplines have specific IRB requirements as well. Sometimes there is overlap, such as in the case of an HHS-funded trial of an FDA-regulated product (in which case the IRB must follow HHS regulations). The research professionals at CPTC can help you navigate the regulatory labyrinth to ensure that all legal requirements are satisfied for your clinical trial.

Another reason for IRB review and approval of clinical trials is publication.  The International Association of Medical Journal Editors has agreed that no publication of clinical trials can be accepted unless the clinical trial has been approved by an IRB.  There have been some published scientific articles that have been retracted because the clinical trial did not have IRB approval.

CPT works successfully with a variety of IRBs.  To learn more about Institutional Review Boards, regulatory requirements for human clinical trials, and how requirements for IRB review apply to your planned research, please contact our Account Managers at sales@cptclabs.com.

 

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