The U.S. Department of Health and Human Services (HHS) is the government’s principal agency for protecting the health of all Americans. It comprises several public health services agencies including the FDA (Food and Drug Administration), OHRP (Office of Human Research Protection), the NIH (National Institutes of Health), and the Centers for Medicare and Medicaid Services (CMS).
| Federal Agency | Key Regulations |
|---|---|
| Health and Human Services (HHS) | |
| Food and Drug Administration (FDA) | |
| Centers for Medicare and Medicaid Services (CMS) |
|
Food and Drug Administration is responsible for protecting and promoting public health through the regulations and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics. Understanding these rules is critical for any investigator who conducts human subject studies with drugs, devices or dietary supplements, whether already approved on the market, or still investigational.
Office of Human Research Protection provides leadership, guidance, and education in the protection of the rights, welfare, and well-being of subjects involved in research conducted or supported by the HHS. OHRP performs these services through providing clarification and guidance, developing educational programs and materials, maintaining regulatory oversight, and providing advice on ethical and regulatory issues in biomedical and social-behavioral research. Detailed regulations for human subject protection are listed on the OHRP website. OHRP rules guide the Institutional Review Boards (IRBs).
National Institutes of Health seeks to provide fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce the burdens of illness and disability. As part of this mission NIH provides leadership and direction to programs designed to improve health and provides support for research. As of December 2017 2017, the NIH funds 57 Clinical and Translational Science Centers across the country. Working together as a national consortium, Clinical Translational Science Award (CTSA) institutions share a common vision to improve human health by transforming the research and training environment to enhance the efficiency and quality of clinical and translational research. The CTSA program is supported by the National Center for Advancing Translational Science (NCATS), part of the National Institutes of Health. The CTSA program has the following overriding objectives:
- Provide a comprehensive array of essential tools and services to spark clinical and translational research.
- Ensure the training of a well-prepared workforce of trainees, staff, and investigators.
- Effectively communicate the many tools, services, and training opportunities to ensure innovative translational science advances that will improve human health.
Today, Penn State Clinical and Translational Science Institute offers resources that faculty, trainees and staff across the scientific and medical spectrum can use to enhance research and improve health and healthcare delivery.
Centers for Medicare and Medicaid Services is the federal agency which administers Medicare, Medicaid, and the Children’s Health Insurance Program. At this time, CMS requirements are only applicable at the College of Medicine.