This article is more than 5 years old. Information may no longer be current.
Endocrine Society backs use of central institutional review boards to advance clinical research
Click Here to Manage Email Alerts
The Endocrine Society recently released a position statement supporting the utilization of central institutional review boards to facilitate the progress of clinical research and consolidate regulatory review in multicenter trials.
“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,” according to the statement. “Increased acceptance, accessibility and use of central [institutional review boards] could facilitate progress in clinical studies without reducing patient protection.”
Currently, however, this process is hindered by the need for clinical investigators to obtain the approval of multiple institutional review boards before proceeding with studies involving several sites. The review process can be prolonged due to institutional demands or local biases, the statement said, or waiting periods for approval may last a year or more as each institution conducts its reviews and discusses concerns with the researchers.
Patient safety remains a top priority, and therefore, The Endocrine Society supports the following positions:
- Central institutional review boards should undergo a certification process, such as that offered by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).
- Written agreements should be established between certified central institutional review boards and facilitate their use for investigators conducting multicenter studies.
- The Office of Human Research Protections should issue guidance on the implications of using central institutional review boards and assure the protection of those using central review boards.
- Professional organizations should advocate use of central institutional review boards.
- NIH should encourage researchers to prospectively include the use of central institutional review boards in investigator-initiated proposals involving multisite studies. NIH should also require the use of central institutional review boards for multisite studies solicited by the NIH and include this requirement in all future grant solicitations.
“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,” Janet E. Hall, MD, president of The Endocrine Society, said 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.”
 |
Follow EndocrineToday.com on Twitter. |