For CRC Investigators –NIH Requirement for Education in the Protection of Human Research Participants

The National Institutes of Health (NIH) requires education in the protection of human research participants for all investigators submitting NIH grant applications or receiving new or non-competing awards for research involving human subjects. The requirement applies to all NIH grant and contract mechanisms, including individual fellowships and institutional training grants when trainees are conducting human subjects research.

This education is also required of all Key Personnel (i.e., individuals responsible for the design and conduct of the study) on projects involving human subjects, including Key Personnel on subcontracts and consultants who are identified as Key Personnel. Key Personnel who are not involved in the human subjects portion of the project will not have to comply with the requirement.

Charles River Campus investigators and Key Personnel can meet this new requirement is by completing an on-line tutorial offered by the NIH. While designed for intramural researchers at NIH, this tutorial provides an informative overview of federal regulations governing the involvement of humans in research and the responsibilities of investigators and Institutional Review Boards in protecting human subjects.

The NIH on-line tutorial also has the capacity to generate a certificate for those who complete the tutorial. Instructions for obtaining a certificate are provided on the last page of the course. The certification instructions involve logging on to a web site and filling out an online form. Please note that Item 2 on the form asks that you identify the NIH component where you work. For non-NIH trainees, the only right answer is the “Other” choice in the second pulldown menu. Non-NIH trainees should also skip question 8 dealing with how long you have worked at NIH. Otherwise, fill out the form as requested and your certificate will be generated on the screen for you to print.

Boston University principal investigators who complete the on-line tutorial and obtain the certificate should include a copy of the certificate when they process their proposal for final University approval.

  • Click here to access the NIH tutorial. Please note that “Protecting Human Research Participants” is a NEW course, with new content. This course replaced the previous Protecting Human Research Participants (PHRP) course as of March 1, 2008. This new course does not recognize login information from the previous course. For information regarding the previous course and certification from that course, please email ncioesisupport@mail.nih.gov.