|Policy & Guidance|
|Compliance & Oversight|
|Research Involving Human Subjects|
|Regulations, Policies & Guidance|
|Research w/Vulnerable Populations|
|Research Using Human Specimens, Cell Lines or Data|
|Human Subjects Protections Training|
|NIH Inclusion Policies and Procedures|
|Frequently Asked Questions|
|Office of Laboratory Animal Welfare (OLAW)|
|Animals in Research|
|Peer Review Policies & Practices|
|Intellectual Property Policy|
|Acknowledging NIH Funding|
|Invention Reporting (iEdison)|
|NIH Public Access|
|NIH Staff FAQs|
A. Who Must Comply with the Policy
Individuals who will be involved in the design or conduct of NIH-funded human subjects research must fulfill the education requirement. These individuals are considered to be "Key Personnel" on NIH awards and contracts that include research involving human subjects, this includes the Principal Investigator(s), all individuals responsible for the design or conduct of the study, and those individuals identified as key personnel of consortium participants or alternate performance sites.
No, but it is important for all investigators, even those working with tissues or specimens derived from human sources to understand when proposed research triggers regulatory and policy requirements.
Human subject as defined in 45 CFR part 46 means a living individual about whom an investigator (whether professional or student) conducting research obtains: (1) data through intervention or interaction with the individual, or (2) identifiable private information.
Research using human specimens, tissues, or data that are unidentifiable may not be considered human subjects research. See: http://www.hhs.gov/ohrp/policy/cdebiol.pdf (PDF - 24 KB).
Investigators who conduct studies with human specimens, tissues, or data that are determined not to involve human subjects are not required to fulfill the education requirement.
Yes. Investigators who conduct human subjects research that is exempt from Institutional Review Board (IRB) review and approval (six exempt categories defined in 45 CFR part 46.101(b)) must comply with the education requirement.
NOTE: From September, 2002 through March 9, 2005 NIH investigators conducting human subjects research meeting the criteria for Exemption 4 in the HHS regulations did not provide documentation of training. Effective January 10, 2005 all new, competing applications will require documentation of completion of the educational requirement for each investigator involved in the design and conduct of NIH-funded human subjects research prior to award (coincident with NIH implementation of the OHRP Guidance on Research Involving Coded Private Information or Biological Specimens, available at http://www.hhs.gov/ohrp/policy/cdebiol.pdf, PDF - 24 KB). As stated above, the requirement applies both to human subjects research and exempt human subjects research.
Yes. NIH expects that all Key Personnel will receive the required education before beginning research involving human subjects. If Key Personnel are added to an award in a non-competing year, documentation that they have received the required education should be included in the non-competing Progress Report.
No. Investigators who are identified as Key Personnel, but are not involved in the design and conduct of human subjects research do not need to comply with this requirement. For example, those involved solely in the analysis of de-identified data.
Yes. The education requirement applies to all individuals involved in the design and conduct of human subjects research supported by an NIH award whether or not they receive compensation from the award.
Yes. The education requirement applies to all investigators involved in the design or conduct of research involving human, including foreign awards and subcontracts. Foreign certification and documentation of the required education in languages other than English are acceptable.
If the grantee organization has difficulty obtaining documentation that Key Personnel on foreign subcontracts have received the required education, NIH staff may consider issuing awards that restrict third party participation until this documentation is provided to NIH. This will streamline issuing awards in situations where third party participation is not essential to the start of the project. See the September 5, 2001 NIH Guide Notice for additional information.
Yes. Third party Key Personnel and consultants must comply with the education requirement if they are involved in the design and conduct of research involving human subjects.
B. Human Subjects Protections Education Programs
No. The NIH does not endorse any specific educational programs. We believe that institutions are in the best position to determine what programs are appropriate for fulfilling the education requirement. Institutions may require a particular program or may choose to develop a program to meet the requirement. The NIH Bioethics Resources lists several courses that institutions may direct Key Personnel involved in human subjects research to complete.
As a public service, the NIH Office of Extramural Research offers a free tutorial on “Protecting Human Research Participants” that institutions may elect to use to meet the human subjects protections education requirement.
No. After completing the training module, the trainee may print out a certificate of completion that may be provided as documentation of compliance with the requirement. Should another copy of the certificate be required, the trainee may log in to the tutorial at any time to print the certificate associated with his or her account. NIH does not provide additional copies of the certificate.
The NIH policy is silent on the frequency of education. The intent of the education requirement is for investigators to keep abreast of development in human subjects protection. We believe that institutions are in the best position to determine when renewed or additional education is warranted.
Also see the NIH Guide Notice of June 5, 2000, September 5, 2001 and February 29, 2008 for additional information on the Requirement for Education on the Protection of Human Subjects.
C. Award Mechanisms
Yes. The education requirement applies to Research and Development Contract awards that include human subjects research. The contracting officer will request documentation that all Key Personnel involved in human subjects research have received the required education prior to the award of a new contract.
Yes. The education requirement applies to individual fellowship applications that describe human subjects research. For individual fellows, the Institute/Center that will be funding the fellowship application will request the necessary information prior to issuing the award (Just-In-Time).
Trainees on NRSA training grants are required to receive training in the responsible conduct of research (RCR), which may include the protection of human subjects as a topic. Trainees involved in the design or conduct of human subjects research only need to provide additional documentation of having received the required human subjects education if their required RCR training does not include the protection of human subjects as a topic.
Yes. The education requirement applies to all NIH awards that include human subjects research.
Yes. The award may be delayed in its entirety or NIH Staff may choose to issue an award restricting all human subjects research until documentation of completion of the education requirement has been received. If problems are encountered investigators should contact the program official or grants management specialist. Contractors and prospective contractors should consult with the project officer or contract officer.
Yes. The documentation must be signed by an institutional official. It is, however, not required that the Principal Investigator also sign the documentation (see the September 5, 2001 NIH Guide Notice).
Yes. Individuals involved in the design and conduct of human subjects research supported by more than one award must provide certification that they have received the required education once for each award.
Yes. The same certificate may be submitted to NIH to fulfill the human subjects education requirement for multiple applications and proposals.
Yes. Documentation of compliance with the education requirement must be provided for all Key Personnel involved in human subjects research once for each competing award. If Key Personnel are added to an award in a non-competing year, documentation that they have received the required education should be included in the next non-competing Progress Report.