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Frequently Asked Questions for the
Requirement for Education on the Protection of Human Subjects
(Updated: September 10, 2008)
Questions About Who Must Comply with the Policy:
- Who needs to receive required education on the protection of human subjects?
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" and include Principal Investigator(s) on NIH awards that include research involving human subjects, 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 if they are participating in research that involves human subjects.
- Does the education requirement apply to awards that do not involve human subjects?
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/humansubjects/guidance/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 receive the required education.
- Are investigators involved in human subjects research that is described by one or more of the exemptions in 45CFR46 required to comply with 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 (coincident with NIH implementation of the OHRP Guidance on Research Involving Coded Private Information or Biological Specimens, available at http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.pdf, PDF - 24 KB) 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. As stated above, the requirement applies both to human subjects research and exempt human subjects research.
- Does the education requirement apply to new Key Personnel involved in human subjects research whose names are added on non-competing Progress Reports?
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.
- Do individuals identified as Key Personnel who are not involved in the design and conduct of the human subjects portion of an award need to comply with the education requirement?
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.
- Does the education requirement apply to Key Personnel involved in human subjects research supported by an NIH award if they will not be compensated by the award?
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.
- Do Key Personnel on foreign awards or on foreign subcontracts have to comply with the education requirement?
Yes. The education requirement applies to all investigators involved in the design or conduct of research involving human subjects.
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.
- Do third party (subcontract) Key Personnel or consultants need to comply with the education requirement?
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.
Questions About Human Subjects Protections Education Programs:
- Does NIH specify which educational programs should be used to fulfill the protection of human subjects education requirement?
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.
- If the NIH tutorial “Protecting Human Research Participants” is taken to meet the education requirement, will NIH provide copies of the certificate of completion?
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. NIH does not provide additional copies of the certificate.
- How often do investigators involved in the design and conduct of human subjects research need to complete the education?
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 and investigators are in the best position to determine when 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.
Questions About Award Mechanisms:
- Does the education requirement apply to Research and Development contract awards?
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.
- Does the education requirement apply to NRSA research fellowship awards?
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).
- Does the education requirement apply to NRSA training grants?
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.
- Does the education requirement apply to responses to RFPs, RFAs and PAs as well as to investigator initiated grant applications?
Yes. The education requirement applies to all NIH awards that include human subjects research.
Questions About Documentation:
- When, in the award process, should documentation of the required human subjects education be provided to NIH?
The Institute/Center that would be funding the project will request documentation that all Key Personnel have received the required education prior to issuing the award. The information should be submitted to your Grants Management Official with other Just-In-Time requirements and must contain the signature of an authorized institutional official.
- Will an award be delayed until documentation of completion of the required education is provided?
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.
- Does the documentation that the required education has been received need to be a part of the document signed by an institutional official?
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).
- Do Key Personnel who have already submitted documentation of having received the required education for one award need to re-submit the documentation when involved in human subjects research supported by another award?
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.
- Can the same certificate of completion of the human subjects education be used on more than one application or contract proposal?
Yes. As long as the education is current, the same certificate may be submitted to NIH to fulfill the human subjects education requirement.
- How frequently do Key Personnel need to provide documentation of having received the required education?
Key Personnel only need to provide this documentation once for each competing award.
- If new Key Personnel involved in human subjects research are included in a non-competing Progress Report, does documentation of their compliance with the education requirement need to be provided?
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.
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