A position statement released by the Endocrine Society supports the use of central institutional review boards to encourage progress in clinical research and streamline regulatory review in multicenter trials.
According to the statement, “Interdisciplinary research is critical to elucidate the mechanisms of a wide spectrum of endocrine disorders and diseases and to identify the effective treatments for them. Increased acceptance, accessibility and use of central [institutional review boards] could facilitate progress in clinical studies without reducing patient protection.”
The review process is currently slowed by regulations requiring clinical investigators to secure approval from multiple institutional review boards before they can begin studies that span several research centers. Waiting periods for approval can last a year or more as each individual institution conducts its own reviews and interviews researchers. Local biases and institutional demands can also hamper the process.
The safety of patients is still of utmost importance in conducting research. The Endocrine Society stated that it supports the following positions:
- Central institutional review boards should be accredited through a certification process, similar to the one offered by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).
- Central institutional review boards should establish written agreements and encourage their use by investigators who are conducting studies across multiple research sites.
- The Office of Human Research Protections should ensure the protection of those using central institutional review boards and offer information on the implications of using those review boards.
- Professional organizations should encourage and promote the use of these central institutional review boards.
- The NIH should advocate for researchers to consider the use of central institutional review boards in proposals for investigator-initiated studies that will utilize multiple sites. Central institutional review boards should be required for use in studies solicited by the NIH and involving multiple research sites; this requirement should apply to all grant solicitations in the future.
“The number of approvals necessary to proceed with a multisite study that utilizes each site’s [institutional review board] may involve waiting periods of a year or more,” stated Janet E. Hall, MD, president of The Endocrine Society, in a press release. “This process delays the progress of the study, discourages the investigators involved and is highly cost-ineffective. The Endocrine Society strongly encourages the utilization of [central institutional review boards] for multicenter clinical studies in order to advance clinical research and improve patient care while maintaining the highest patient safety standards.”
The Endocrine Society was founded in 1916, then known as the Association for the Study of Internal Secretions. The organization studies endocrinology and metabolism, publishing four leading journals in its fields, including Endocrinology, Endocrine Review, Journal of Clinical Endocrinology and Metabolism, and Molecular Endocrinology. The Society’s mission is “to advance excellence in endocrinology and promote its essential and integrative role in scientific discovery, medical practice, and human health.”
Over 14,000 members belong to the Society, from 85 countries around the world. It holds an annual post-graduate assembly called the Clinical Endocrinology Update, speaking to members about the importance of endocrinology and its implications for medicine as a whole.
The Endocrine Society also sponsors Sister Societies whose members correspond via the Endocrine Society. Sister societies include the American Diabetes Association, the American Association of Clinical Endocrinologists, the American Thyroid Association, and the Obesity Society.
For more information on the Endocrine Society, visit http://www.endo-society.org.
