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. Human subject means a living individuals 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.

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.

Research using human specimens, tissues, or data that are unidentifiable is not considered human subject research and therefore investigators involved in research under exemption #4 are not required to complete this education.

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.

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 is necessary 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.)

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-competing continuation applications submitted for funding beginning Oct. 1, 2000. This information can be included in the progress report.

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.

Yes. the required education applies to all applications that will be funded in FY 2001 or later.

Yes, this requirement applies to all investigators involved in the design or conduct of research involving human subjects. If the grantee organization is having difficulty obtaining documentation, NIH staff may consider issuing awards that restrict the third party participation until the documentation is received by NIH. This will streamline issuing awards in situations where the third party participation is not essential to the start of the project. See the September 5, 2001 NIH Guide Notice for additional information.

Yes, if they are involved in the design and conduct of research involving human subjects.

Yes, if they are identified as key Personnel in a project involving human subjects.

No.

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.

It needs to be reported only once for each grant or contract that the Key Personnel are involved in human subject research.

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 subject protection. We believe that investigators are in the best position to make the determination of when they need additional education. For example, investigators involved in research with pregnant women or human fetuses should know that 45 CFR part 46 Subpart B has been revised recently. Another example would be international studies and the revisions with the Declaration of Helsinki and CIOMS guidelines.

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. The documentation can be included as part of the progress report without a separate letter.

Yes. It is not required that the principal investigator also sign the documentation (see the September 5, 2001 NIH Guide Notice).

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.