Brock University Procedures for compliance U.S. Public Health Service Financial Conflict of Interest Regulations OFFICE OF RESEARCH SERVICES INTERNAL PROCEDURES INTRODUCTION AND APPLICATION OF THESE PROCEDURES: These Procedures apply to all Brock University research funded by the U.S. Public Health Service (PHS), including the National Institutes of Health (NIH), and other granting agencies and components of the PHS. These Procedures may also apply to Brock University research funded by other sponsors who have adopted the PHS regulations and/or standards as a contractual or regulatory requirement of funding. These Procedures and the Investigator Procedures together implement 2 U.S. regulations regarding research that is funded by the PHS and its awarding components: the Regulation on and the Regulation on of the Regulations is to promote (the “Regulations”), both effective August 24, 2012. The purpose objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under PHS grants, cooperative agreements and contracts will be free from bias resulting from Investigator FCOIs. The Regulations provide that they apply to all institutions, both U.S. and foreign, applying for or receiving PHS research funding, including funding that is received as a sub-award from another institution, and to each Investigator participating (or planning to participate) in such research. All contracts and grants from PHS awarding components now require the University to agree to be bound by the Regulations as a condition of funding. In addition to the PHS and its components, some other U.S. sponsors of research, including some U.S. foundations, have adopted the Regulations. Where the terms of funding contracts or grants those sponsors’ require the University to adhere to the Regulations, these Procedures, as necessarily modified for context, will apply. One of the requirements of the Regulations is that the University must have a written enforced policy on FCOIs for PHS-funded research that complies with the Regulations. These Procedures and the Investigator Procedures together fulfill that requirement. DEFINITIONS:
Brock University Procedures for compliance U.S. Public Health Service Financial Conflict of Interest Regulations OFFICE OF RESEARCH SERVICES INTERNAL PROCEDURES INTRODUCTION AND APPLICATION OF THESE PROCEDURES: These Procedures apply to all Brock University research funded by the U.S. Public Health Service (PHS), including the National Institutes of Health (NIH), and other granting agencies and components of the PHS. These Procedures may also apply to Brock University research funded by other sponsors who have adopted the PHS regulations and/or standards as a contractual or regulatory requirement of funding. These Procedures and the Investigator Procedures together implement 2 U.S. regulations regarding research that is funded by the PHS and its awarding components: the Regulation on and the Regulation on (the “Regulations”), both effective August 24, 2012. The purpose of the Regulations is to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under PHS grants, cooperative agreements and contracts will be free from bias resulting from Investigator FCOIs. The Regulations provide that they apply to all institutions, both U.S. and foreign, applying for or receiving PHS research funding, including funding that is received as a sub-award from another institution, and to each Investigator participating (or planning to participate) in such research. All contracts and grants from PHS awarding components now require the University to agree to be bound by the Regulations as a condition of funding. In addition to the PHS and its components, some other U.S. sponsors of research, including some U.S. foundations, have adopted the Regulations. Where the terms of those sponsors’ funding contracts or grants require the University to adhere to the Regulations, these Procedures, as necessarily modified for context, will apply. One of the requirements of the Regulations is that the University must have a written enforced policy on FCOIs for PHS-funded research that complies with the Regulations. These Procedures and the Investigator Procedures together fulfill that requirement. DEFINITIONS:
PHS-COI-Procedures-Internal-4.docx