University at Buffalo - The State University of New York

Cerfitication of Training in Human Subjects Research

On June 5, 2000 the National Institutes of Health (NIH) promulgated new requirements on Investigator education and Investigator conflict-of-interest for studies involving human research subjects. Beginning on October 1, 2000, the NIH requires education on the protection of human research participants for all investigators submitting NIH applications for grants or proposals for contracts or receiving new or non-competing awards for research involving human subjects.

You must certify that you and your project staff have satisfied the training requirement by first having all key personnel complete the training and then including one of the two following statements in your annual progress report summary.

Cut and Paste the following text into your Progress Report:

All of the key personnel on this project have completed a training program in the protection of human research subjects by:

1. reading and understanding the Belmont Report-Ethical Principals and Guidelines for Protection of Human Research Subjects,
2. reading and understanding Part E: Responsibilities of the Research Investigator of the UB Multiple Project Assurance of Compliance with DHHS Regulations for the Protection of Human Research Subjects, and
3. completing the University of California at Irvine’s web based tutorial, Research with Experimental Subjects, Human Experimentation, on important aspects of protecting human research subjects.

OR

Cut and Paste the following text into your Progress Report:

All of the key personnel on this project have completed a training program in the protection of human research subjects by:

1. reading and understanding the Belmont Report-Ethical Principals and Guidelines for Protection of Human Research Subjects,
2. reading and understanding Part E: Responsibilities of the Research Investigator of the UB Multiple Project Assurance of Compliance with DHHS Regulations for the Protection of Human Research Subjects, and
3. completing the NIH’s web based tutorial, Protection of Human Research Subjects, on important aspects of protecting human research subjects.

Please refer to the following web sites for more information:

• NIH Notice OD-00-040 "Financial Conflict of Interest and Research Objectivity: Issues for Investigaotrs and Instiutional Review Boards"
• NIH Notice OD-00-039 "Required Education in the Protection of Human Research Participants"
• Protection of Human Research Subjects
• Request for Approval: Investigation Involving Human Subjects, Form OSPA-HS-1-A)