Clinical Trial Resources
The National Institutes of Health (NIH) has expanded their definition of a clinical trial and has added new requirements during the funding opportunity application process.
NIH Definition of a Clinical Trial
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 information below has been gathered to assist our investigators who are applying for NIH funding for studies that fit the definition of a clinical trial. Not sure if your research would be considered a clinical trial? Visit the NIH Clinical Trials Decision webpage.
The link above will take you to the general instructions for NIH Awards. Information related to the new clinical trial guidelines, Forms-E, can be found on page 223.
New Clinical Trial Form
This new form, created by the University of Michigan, is designed to help investigators complete the information required in NIH Forms-E. The School of Kinesiology Office of Research will request that researchers complete this form during the application process.
Certain boilerplate language has been developed, or is in the process of being developed, by the Medical School for specific pieces of Forms-E. The document link above will take you to a list of these items and include the recommended language. This list will be updated as new language is created.
The link above with take you to a sample showing the new clinical trial section completed.
Clinical Trial Contact
If you still have questions regarding whether your study will be deemed a clinical trial you can contact the medical school staff below for assistance.
Research Compliance Associate, Office of Research Compliance Review
Ethical issues in clinical settings: a reaction to ethics in teaching, advising, and clinical services
Berger, Bonnie G. (1993). Ethical issues in clinical settings: a reaction to ethics in teaching, advising, and clinical services. Quest, 45:106-119.
Ethics, codes and behavior
Drowatzky, John N. (1993). Ethics, codes and behavior. Quest, 45:22-31.
Ethical issues in human research
Kroll, Walter. (1993). Ethical issues in human research. Quest, 45:32-44.
Ethical considerations in human movement research
Olivier, Steve. (1995). Ethical considerations in human movement research. Quest, 47:135-143.
Ethics review of research projects involving human subjects
Olivier, Steve. (2002). Ethics review of research projects involving human subjects. Quest, 54:196-204.
Future directions of inquiry in adapted physical activity
Reid, Greg. (2000). Future directions of inquiry in adapted physical activity. Quest, 52:369-381.
Application of a scientific ethics approach to sport decisions
Zeigler, Earle F. (1980). Application of a scientific ethics approach to sport decisions. Quest, 32:8-21.
Funding Opportunities: Kinesiology
The Marie Hartwig Pilot Research Fund supports research by faculty members in the School of Kinesiology. This year there will be one competition with two categories of funding opportunities available.
- Category one will be for funding requests of up to $10,000; and
- Category two will consider proposals with funding requests up to $40,000.
Applications for the 2022 award are due on January 13, 2023. Applications should be sent electronically to the ADR in Kinesiology, Greg Cartee (email@example.com). Questions on the policies and process for applications may also be directed to Greg Cartee.