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.
- Procedures for review within NIEHS Ethics
- 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.
- Procedure for Ethics Review and Clearance of Clinical Protocols (NEO, 5/08)
- Approval of Expedited Review Memo (5/10)
- Protocol Review Flow Chart (8/10)
- Personal Financial Holdings Clearance Form (NEO, 7/10)
- Guide to Completing the Personal Financial Holdings Clearance Form (OIR/CC, 3/08)
- A Guide to Preventing Financial and Non-financial Conflicts of Interest in Human Subjects Research at NIH (OIR/CC, updated 5/08)
- Email from OIR/CC diseminating review forms and information (OIR/CC, 3/08) (see also its attachments)