The revised Common Rule requires that an IRB-approved version of an informed consent form be posted on a public federal website for all NIH-funded clinical trials. This must be done after enrollment ends and within 60 days of the last study visit. See Guide Notice NOT-OD-19-050.
A new Behavioral and Social Sciences Research Template is now available to guide investigators through the systematic development of a comprehensive clinical protocol. The new template, based on the previously released Phase 2 & 3 Clinical Trial Template, is fully integrated into the NIH’s Clinical e-Protocol Writing Tool, and can be used by behavioral and social science researchers to prepare research protocols for human studies measuring a behavioral or social outcome, or testing a behavioral or social science based intervention. This template may be especially helpful to investigators who are less familiar with the information and the level of detail that is required in a clinical protocol.
0 Comments
When conducting clinical trials, NIH funding recipients are required to register their study at ClinicalTrials.gov. To make registration easier, a new feature in the eRA Human Subjects System (HSS) allows applicants and recipients to export study record entries as an XML file, and upload fields that are captured in both systems directly into ClinicalTrials.gov’s Protocol Registration and Results System (PRS).
0 Comments
We have written several blogs and articles over the past two years about our efforts to enhance stewardship and transparency in clinical trial research. Indeed, earlier this year Congress applauded our efforts thus far and reaffirmed its commitment to ensuring public access to the results of the NIH-funded clinical trials through timely registration and results information reporting on ClinicalTrials.gov. However, we have heard concern about how the NIH’s Policy on the Dissemination of NIH-Funded Clinical Trial Information applies to fundamental studies involving human participants.
0 Comments
Well-conducted randomized trials are considered the best method of providing evidence about the safety and efficacy of treatments to improve health. Each year, NIH Institutes and Centers spend an estimated $3-4 billion supporting clinical trial activities. These activities require high-level understanding of human biology, of manufacturing and pre-clinical research, and of regulatory requirements. The process of translating a new therapeutic from discovery to practice can be robust, but … at the same time is long and expensive – and despite the challenges inherent in complex, multi-disciplinary research sometimes too long and too expensive.
1 Comments
I recently wrote an essay for the NIH’s Science, Health, and Public Trust series to encourage a healthy bit of skepticism about clinical studies that solely involve surrogate end-points (e.g. changes in “biomarkers” like blood cholesterol levels or findings on an electrocardiogram).
5 Comments
Last month, NIH announced a revision (NOT-OD-18-116) to a decades-old policy originally conceived in response to concerns that children were not appropriately included in clinical research. These changes broaden the policy to address inclusion of research participants of all ages, and as discussed at the last Advisory Committee to the NIH Director meeting, will apply beginning in 2019 to all NIH-supported research involving human subjects. Our goal is to ensure that the knowledge gained from NIH-funded research is applicable to all those affected by the conditions under study.
9 Comments
Much has been learned about how sex and race may contribute to differences in health outcomes and physiologic conditions (Clayton, 2014). We know that, for example, a specific drug used to treat insomnia requires different dosing for women and men. African Americans with hypertension are more susceptible to stroke than whites with the same blood pressure levels (Howard, 2013). But in many cases, findings from potentially informative stratified analyses may not be widely available. Less than a third of NIH studies required to analyze sex/gender and race/ethnicity have been found to publish sex-stratified results in peer-reviewed journals (Foulkes, 2011).
1 Comments
In August and September we released case studies and FAQs to help those of you doing human subjects research to determine whether your research study meets the NIH definition of a clinical trial. Correctly making this determination is important to ensure you are following the initiatives we have been implementing to improve the transparency of clinical trials, including the need to pick clinical trial -specific funding opportunity announcements for due dates of January 25, 2018 and beyond.
22 Comments
Recent policy changes requiring clinical trial applications to be submitted to FOAs that specifically allow clinical trials, first announced in fall of 2016, impact how all NIH applicants choose a FOA, whether you are submitting a clinical trial or not.
4 Comments
0 Comments