NIH Good Clinical Practice Training Requirement
The National Institute of Health (NIH) has established a new directive regarding the training of investigators and staff involved in the conduct, oversight, or management of any NIH funded clinical trial. Anyone that is involved with NIH funded research, regardless of the nature of the research (biomedical or social science related) must be trained in Good Clinical Practice (GCP).
West Virginia University provides GCP courses through the CITI Program. Courses offered can be found under the Question 7 section of the ‘Add a Course’ area of your CITI account. Individuals needing to complete this training can take the course titled GCP (Good Clinical Practice) (Human Subject Research).
This training requirement is effective January 1, 2017. Therefore, any clinical research conducted under the auspices of WVU and funded by NIH, will not receive approval until the NIH GCP training requirement is met.
For more information concerning this requirement for NIH funded trials, please visit the following link: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-148.html
Conflict of Interest in ResearchTraining
Beginning January 1, 2017, all Key Personnel (Primary and Co-Investigators) listed on a submission must complete the Conflicts of Interest CITI Program course. This course can be found under Question 2 of the ‘Add a Course’ area of your CITI account. The completion of the conflict of interest training will be a requirement for WVU IRB protocol approval.
For more information regarding this requirement, please contact the Conflict of Interest in Research Officer, Joy Edwards at 304-293-5475.
Human Subject Research Participant Compensation Guidance
Office of Research Integrity and Compliance recommends investigators that compensates participants for research, in any form (e.g. gift, cash, or gift card), provide each participant with an information card regarding taxable income. Cards can be found in the Tax Compensation Template under the Additional Forms and Samples section at the following link: http://oric.research.wvu.edu/services/human-subjects/forms
This card gives the participant information regarding their obligation to report any financial compensation received from participating in research. It is not the investigators responsibility to report any information to tax services.