NIH REQUIRED EDUCATION IN THE PROTECTION OF HUMAN
As indicated in previous OSP communication and the Provost’s letters of June 28, 2000 and
August 29, 2000, NIH policy regarding education on the protection of human research became effective with applications submitted as of October 1, 2000.
For competitive proposals, i.e., new and competitive renewals, this training does not have to be completed prior to submission of the proposal. However, before funds are awarded for these applications investigators must provide a description of education completed for each individual responsible for the design and conduct of the research. For non-competitive proposals, the training must be completed prior to submission of the non-competing proposal.
We suggest that in addition to listing the names of the individuals dealing with human subjects the statement to be submitted to NIH should read something like “all the researchers on this application have received appropriate training in the use of humans as subjects. Specifically, each has received a copy of the booklet “Protecting Study Volunteers in Research” from the University of Rochester Medical Center and referenced as acceptable education materials by the NIH, and has taken and passed the examination provided with that material or has taken and passed the MIT web based online course administered by the MIT Committee on the Use of
Humans as Experimental Subjects.”
Attached are the frequently asked questions that NIH has prepared that should assist you in understanding this training requirement.
Frequently Asked Questions for the Requirement for Education
on the Protection of Human Subjects
1. Does the required education apply to research that does 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 the definition for human subjects as defined in 45 CFR part 46.
1A. Are investigators involved in exemption research required to complete this education?
Investigators who conduct research that is exempt from Institutional Review Board (IRB) review and approval (six exempt categories defined in 45 CFR part 46) must comply with this education requirement. Exemption from IRB review and approval is determined on the basis of the risks associated with the study. For example, research on the effectiveness of instructional strategies would not expose school children to risk and thus is considered exempt from IRB review but not from the NIH education requirement. It should be noted that research using human specimens, tissues, or data that are unidentifiable is not considered human subject research.
2. Does the required education apply to grant applications submitted before October 1, 2000 and scheduled to be awarded after that date?
Yes, it applies to all projects scheduled for funding in FY 2001 or later. The Institute/Center that would be funding the project will request documentation of the required education prior to issuing the award. The information should be submitted in writing and signed by an authorized institutional official.
3. Does the required education apply to Research and Development contract awards?
Yes, the contracting officer will request documentation of the required education prior to the award of a new contract. For ongoing contracts, the contractor must provide documentation of the required education in the first progress report it submits after October 1, 2000. (Although the Guide announcement stated that this information could be submitted with the annual report, NIH has determined that it isnecessary that the required education be completed as soon as possible, and that documentation of its completion be submitted to the NIH in a timely manner.)
4. Does the required education apply to non-competing continuation grant awards?
Yes, the required education applies to all projects involving human subjects, competing and non-competing, scheduled for funding in FY 2001 or later. Therefore, the information on required educational activities for all Key Personnel should be included in non-competingcontinuation applications
submitted for funding beginning Oct. 1, 2000. This information can be included in the progress report.
5. How will NRSA research fellowships awards be handled?
The required education applies to individual fellowship applications that involve human subjects in research but does NOT apply to trainees in institutional training grants who are already required to comply with a program on the responsible conduct in research which includes protection of human subjects as a topic. For individual fellowship, the Institute/Center that would be funding the fellowship will request the necessary information prior to issuing the award.
6. Will the policy apply to responses to RFAs and PAs as well as to investigator initiated grant applications?
Yes. the required education applies to all applications that will be funded in FY 2001 or later.
7. Do Key Personnel of foreign awards or on foreign subcontracts have to comply with this requirement?
Yes, this requirement applies to all investigators involved in the design or conduct of research involving human subjects.
8. Do third party (subcontract) Key Personnel have to comply with this requirement?
Yes, if they are involved in the design and conduct of research involving human subjects.
9. Do consultants have to comply with this requirement?
Yes, if they are identified as key Personnel in a project involving human subjects.
10. Do individuals identified as Key Personnel who are not involved with the human subjects portion of the project have to comply with this requirement?
11. Do Key Personnel need to document this requirement for each different grant or contract award?
Yes, required education applies to all key personnel involved in each different project that includes human subjects. This includes all individuals involved in the design and conduct of the study, whether or not they receive compensation from the award. This documentation should be provided to the NIH on a project-by-project basis for multi-component awards.
This specific requirement will be subsumed under the Office of Research Integrity (ORI) requirement for education on Responsible Conduct of Research. The ORI requirement is an assurance process that will operate at the institutional
level and take the place of this requirement for person-specific information on each award.
12. How frequently does the documentation of the required education need to be reported?
It needs to be reported only once for each grant or contract that the Key Personnel are involved in human subject research.
13. How are institutions to notify the NIH about new Key Personnel who are added to the project after the budget period begins or after the PI has submitted a progress report or letter?
We would expect them to be trained before undertaking the human subject research and documentation of the required education provided to the NIH at the time of the next progress report.
14. Does the documentation that the required education has been met need to be a part of the document signed by an institution official?
15. Will an award be delayed until the required education policy is met?
Yes. If problems are encountered you should contact your program officer or grants management specialist. Contractors and prospective contractors should consult with the project officer or contract officer.
For further Information, Please Contact Belinda Seto (firstname.lastname@example.org).