On January 18, 2017, the final rule from the Department of Health and Human Services (HHS) and the National Institute of Health (NIH)’s corresponding policy on reporting to ClinicalTrials.gov will take effect. ClinicalTrials.gov, which is run by NIH, is a searchable registry of clinical trials. It is a federal requirement that sponsors of certain clinical studies that either have one American research site or are conducted under an investigational device exemption (IDE) or an investigational new drug (IND) application register and report the summary results on ClinicalTrials.gov. However, currently very few pharmaceutical companies, academic institutions, and government agencies are complying with the requirement. The regulatory changes taking effect will only have a meaningful impact if the incoming Administration chooses to enforce them. Read more
TAG ARCHIVES FOR NIH
In Case You Missed It (ICYMI): From time-to-time, PRIM&R will feature particularly well-received posts from the recent past. These posts remain timely as topics of discussion in the fields of research ethics, human subjects protections, or animal care and use. Highlighting them now enables readers who may have missed them a chance to read and comment. In this ICYMI, PRIM&R Executive Director Elisa Hurley explores the complex issue of clinical trial data sharing and its implications for the protection of human research subjects.
Though not a new issue, clinical trial data sharing has over the past several months taken center stage within the medical research community. In December 2015, a STAT [...] Read more
This week’s Research Ethics Roundup examines new findings from the FDA on juvenile animal studies for pediatric clinical development, the research community’s response to Apple’s ResearchKit, and why experts think more funding is needed for tuberculosis research. Read more
While many agree that increased data sharing is an ethical imperative given the risks that clinical trial participants are asked to undertake, the question many institutions are now struggling with is how they can meet that imperative with their current resources and while protecting the privacy of study subjects. Read more
[On December 11], Buzzfeed broke a story reporting on the planned phase-out of on-site housing of monkeys at one of the National Institutes of Health intramural laboratories, the National Institute of Child Health and Human Development (NICHD) Laboratory of Comparative Ethology in Poolesville, Maryland. As NICHD Director Constantine Stratakis outlined in an interview with Science News, the phase-out has been in the [...] Read more