Evaluating the Revised National Institutes of Health Clinical Trial Definition Impact on Recruitment Progress.

Background: The National Institutes of Health (NIH) announced a revised, expanded definition of "clinical trial" in 2014 to improve trial identification and administrative compliance. Some stakeholders voiced concerns that the policy added administrative burden potentially slowing research progress.

Methods: This quasi-experimental study examined the difference-in-differences impact of the new NIH clinical trial definition policy on participant recruitment progress in grants funded by the National Institute of Mental Health (NIMH).

Potential benefits and burdens of National Institutes of Health and National Institute of Mental Health clinical trial policies.

The National Institutes of Health (NIH) and the National Institute of Mental Health (NIMH) have implemented numerous clinical trial policies in recent years. These policies have well-intended goals but concerns of undue burden have been raised by professional societies. This study identified the new and revised NIH and NIMH clinical trial policies from 2005 to 2019 and summarized the publicly-identified potential benefits and burdens of those policies.

National Institute of Mental Health Recruitment Monitoring Policy and Clinical Trial Impact.

Background/aims: The National Institutes of Health (NIH) implemented a recruitment milestone and progress reporting policy in fiscal year 2019. While too recent to evaluate, the National Institute of Mental Health (NIMH) previously implemented a similar policy in fiscal year 2006 which may forecast likely effects of the NIH-wide policy.

Methods: An observational, single-group, pre/post evaluation of the association between the NIMH policy and the Relative Citation Ratio was conducted for non-fellowship, competing clinical trial grants funded from fiscal years 2004-2007.

Perspectives of IRB chairs on the informed consent process.

Background: Questions have been raised by researchers and ethics committees about whether human research subjects comprehend study participation when signing a research consent form.

Methods: To determine existing beliefs about the informed consent review process, impediments to shorter consent, and augmented/alternative consent methods, a survey of institutional review board (IRB) chairpersons was conducted.

Results: IRB chairs expressed concern with (but do not often assess) the length, complexity, and reading level of the consent form or participant comprehension.