Clinical Research Protocols
Definition - Clinical Research Protocols (protocols) are research studies conducted by NIH staff. The protocol may test something for a specified condition or purpose, e.g., a drug or medical device, or may review previous studies or record the history of a disease or condition. Staff on a protocol consist of a Principal Investigator (PI), possibly a Co-Principal Investigator (Co-PI), one or several Associate Investigators (AI), a Medical Advisory Investigator (MAI), and a Research Contact (RC). There may also be consultants to the protocol, e.g., statistical or scientific consultants. Some of the investigators or consultants may not be NIH employees. To protect the integrity of the protocol and therefore the NIH in general, the financial interests of the NIH employees named on a protocol must be reviewed to confirm that no conflict of interest exists between investigators’ official duties on the protocol and their personal or imputed financial interests.
- IRB website
- HHS Form 717-1: Confidential Report of Financial Interests in Substantially Affected Organizations for Employees of the National Institutes of Health
Designated with authoring office and date.
- A Guide to Avoiding Financial and Non-Financial Conflicts or Perceived Conflicts of Interest in Clinical Research at NIH (OIR/CC, updated 10/14) (pdf, 6 pages)
- COI Certification For NIH Employees Who Do Not File Financial Disclosure Forms 717 or 450 (Attachment A) (10/14)
- COI Certification For Non-Federal Employees (Attachment B) (10/14)
- Conflict of Interest Requirements for Researchers and Research Staff (SOP 21)
- Desk-to-Desk Memorandum from Drs. Tabak and Gottesman (10/14)
- Implementation Memorandum from Dr. Lynette Nieman, OHSRP (10/14)
- Implementation PowerPoint Slides from Dr. Lynette Nieman, OHSRP (10/14)
- Personal Financial Holdings Clearance Form (NEO, 10/14) (PC fillable form)(MAC fillable form)