Federal Guidelines and Resources
As of January 2010, the National Science Foundation (NSF) required that applicant institutions have in place a plan for providing “appropriate training and oversight in the responsible and ethical conduct of research to undergraduate students, graduate students and postdoctoral researchers.” (1) See Training Section for appropriate links.
DHHS is the U.S. government’s principal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. HHS works closely with state and local governments, and many HHS-funded services are provided at the local level by state or county agencies, or through private sector grantees. The Department’s programs are administered by (11) operating divisions, including eight agencies in the U.S. Public Health Service and three human services agencies. The department includes more than 300 programs, covering a wide spectrum of activities. In addition to the services they deliver, the HHS programs provide for equitable treatment of beneficiaries nationwide, and they enable the collection of national health and other data.
Information Sheet Guidance for Institutional Review Boards (IRBs), Clinical Investigators, and Sponsors (DHHS)
The Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS). OHRP helps ensure this by providing clarification and guidance, developing educational programs and materials, maintaining regulatory oversight, and providing advice on ethical and regulatory issues in biomedical and behavioral research.
“Protecting Human Subjects: Institutional Review Guidebook” (1993)
Office of Research Integrity (ORI)
The Office of Research Integrity (ORI) promotes integrity in biomedical and behavioral research supported by the U.S. Public Health Service (PHS) at about 4,000 institutions worldwide. ORI monitors institutional investigations of research misconduct and facilitates the responsible conduct of research (RCR) through educational, preventive, and regulatory activities.
Office of Human Subjects Research (OHSR)
The OHSR operates within the Office of the Deputy Director for Intramural Research (DDIR), National Institutes of Health (NIH). The NIH is part of the U.S. Public Health Service (PHS) which is, in turn, an agency within the Department of Health and Human Services (DHHS). The NIH's Intramural Research Program (IRP) is located on a 300-acre campus in Bethesda, Maryland. Researchers in the NIH's IRP conduct and collaborate in many different kinds of research activities including research involving people as subjects. The OHSR was established to help IRP investigators understand and comply with the ethical guidelines and regulatory requirements for research involving human subjects. OHSR's overall goal is to promote and support the IRP's efforts to conduct innovative research which protects the rights and promotes the welfare of human subjects.
OFFICE FOR EXTRAMURAL RESEARCH (NIH)
The Office for Extramural Research provides the corporate framework for NIH research administration, ensuring scientific integrity, public accountability, and Extramural grants account for approximately 83 percent of NIH's $30 billion budget. These are awarded to investigators throughout the U.S. and abroad. Approximately 10 percent of the NIH budget supports NIH intramural investigators, NIH staff who conduct research. OER supports extramural research by providing policy and guidance to the 24 NIH Institutes and Centers that award grants. OER serves as a vital interface between the NIH and the biomedical research community by guiding investigators through the process of attaining grants funding and helping them understand and navigate through federal policies and procedures.