The US government is looking at overhauling the regulation surrounding clinical trials in a bid to cut red tape and align it with current practice.
The news follows changes in the healthcare and clinical research environment over the past 20 years, which has forced the federal government to contemplate various ways of enhancing the regulations to protect human research subjects. The government is now calling for public input on an array of issues related to the ethics, safety and oversight of human research.
“This regulatory review effort is primarily about enhancing protections for human subjects,” said Howard Koh, The US Department of Health and Human Services assistant secretary for health. “The changes under consideration offer the promise of updating and enhancing those protections to keep pace with current challenges.”
Current regulations, often referred to as the Common Rule, have been in place since 1991 and were based on the fact that research, at the time, was predominantly conducted at universities, colleges and medical institutions and each study generally took place at only a single site.
Expansion of human subject research into many new scientific disciplines and venues and an increase in multi-site studies have highlighted ambiguities in the current rules and have lead to questions about whether the current regulatory framework is effectively keeping up with the needs of researchers and research subjects. However, the proposal is unclear whether trials financed by pharma would be completely covered by the changes.
Through public consultation, the government is seeking comment on: revising the existing risk-based framework to more accurately calibrate the level of review to the level of risk; using a single Institutional Review Board review for all domestic sites of multi-site studies; establishing mandatory data security and information protection standards for all studies involving identifiable or potentially identifiable data; implementing a systematic approach to the collection and analysis of data on unanticipated problems and adverse events across all trials to harmonise the complicated array of definitions and reporting requirements and to make the collection of data more efficient; extending federal regulatory protections to apply to all research conducted at US institutions receiving funding from the Common Rule agencies; and providing uniform guidance on federal regulations.
“The public’s input on these matters will be critically important to the government’s efforts to ensure that regulations keep up with today’s changing research environment and will be considered by HHS as it develops new proposed rules, which will also be made public for comment,” the HHS said in a statement.
For more information visit: 1.usa.gov/pxAZRD