There are a number of important changes coming to NIH in 2017 which affect clinical trials and clinical research. Our office will be providing guidance and education in the coming months. In the meantime, we have provided a high-level summary below. Please contact email@example.com if you have additional questions or would like a presentation or update sooner.
|Notice Number||Title||Effective Date||High-Level Summary|
|NOT-OD-16-148||Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials||January 1, 2017||All research staff on NIH-funded clinical trials need to complete online GCP training, e.g., through UA CITI Program, every 3 years.|
|NOT-OD-16-149||NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information||January 18, 2017||All NIH-funded clinical trials must be registered in ClinicalTrials.gov by time of subject enrollment with results posted no later than one year after completion|
|NOT-OD-16-129||New Policy Eliminates Most Appendix Material for NIH/AHRQ/NIOSH Applications Submitted for Due Dates On or After January 25, 2017||January 25, 2017||Most appendix materials will be eliminated, except questionnaires and other FOA-specified items.|
|NOT-OD-16-130||Changes to the NIH/AHRQ/NIOSH Policy on Post-Submission Materials for Applications Submitted for Due Dates On or After January 25, 2017||January 25, 2017||Post-submission materials must meet specific criteria and must be submitted by Sponsored Projects to NIH/AHRQ/NIOSH.|
|NOT-OD-16-147||Policy on Funding Opportunity Announcements (FOA) for Clinical Trials||September 27, 2017||As of Sept. 2017, clinical trials cannot be applied for through generic parent FOAs. They must go through FOAs specifically designed to accept clinical trials.|
Clinical Research OR Clinical Trial?
NIH Definitions: http://grants.nih.gov/grants/glossary.htm#ClinicalTrial
Research with human subjects that is:
- Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. It includes: (a) mechanisms of human disease, (b), therapeutic interventions, (c) clinical trials, or (d) development of new technologies.
- Epidemiological and behavioral studies.
- Outcomes research and health services research
**Studies falling under 45 CFR 46.101(b) (4) (Exemption 4) are not considered clinical research by this definition.
A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
- The term "prospectively assigned" refers to a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo or other control) of the clinical trial.
- An intervention is defined as a manipulation of the subject or subject's environment for the purpose of modifying one or more health-related processes and/or endpoints. Examples include, but are not limited, to: drugs/small molecules/compounds, biologics, devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits); and, treatment, prevention, and diagnostic strategies.
- A health-related biomedical or behavioral outcome is defined as the pre-specified effect of an intervention on the study subjects. Examples include positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers; reading comprehension and/or information retention); disease processes; health-related behavior; and, well-being or quality of life.