4 Questions For Researchers and Institutions Involved In Human Subjects Research

Last September, and in January of this year, we wrote about a suite of initiatives aimed at improving the quality and transparency of the NIH-supported research that most directly engages human participants – clinical trials. These initiatives include dedicated funding opportunity announcements for clinical trials, Good Clinical Practice training, enhanced registration and results reporting on ClinicalTrials.gov, and required use of single IRBs for multi-site studies. We are now entering the final phases of implementation of these initiatives – so, if you are contemplating research involving human subjects, please read on. We’ve received queries from members of the research community seeking clarity on whether their human subjects research will be affected by these new policies, and if so, how. So, we want to call your attention to four questions researchers involved in human s studies need to ask, and answer. These questions are: Does the study involve human participants? Are the participants prospectively assigned to an intervention? Is the study designed to evaluate the effect of the intervention on the participants? Is the effect that will be evaluated a health-related biomedical or behavioral outcome? If the answer to all four questions is yes, then we consider your research a clinical trial. The NIH definition of a clinical trial is “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include...
Source: NIH Extramural Nexus - Category: Research Authors: Tags: blog Open Mike Clinical Trials Clinicaltrials.gov Grants policy Source Type: funding