Protocol Royalty Analysis Committee (PRAC) Review
This page explains that Protocol Royalty Analysis Committee (PRAC) review occurs when an NIH invention is the object of the study and the research team includes NIH investigators who are also identified as inventors of the intellectual property being studied. It provides instructions for study teams for completing the relevant portions of the IRB application in PROTECT.
This page explains that Protocol Royalty Analysis Committee (PRAC) review occurs when an NIH invention is the object of the study and the research team includes NIH investigators who are also identified as inventors of the intellectual property being studied. It provides instructions for study teams for completing the relevant portions of the IRB application in PROTECT.
All investigators, whether NIH or non-NIH employees, who are conducting research on behalf of the NIH Intramural Research Program (IRP), must follow the applicable federal laws and NIH policies that govern financial and other conflicts of interest (COI).
The NIH PI must disclose to the reviewing IRB in the electronic IRB system any investigator engaged in the research who is identified as an inventor of IP that is being evaluated in the research.
Background
Research conducted at the NIH can lead to the development of intellectual property (IP) (e.g., cell lines, assays, molecules, reagents, vaccines, or technology) that is or may be commercially developed and marketed.
Commercial development begins when an inventor files an Employee Invention Report (EIR) with their Institute or Center (IC) technology transfer office. The invention may subsequently be patented and/or licensed to commercial entities. These entities may then pay licensing fees or royalties to the NIH. When these are received, the NIH is obligated by law to share the monies with the inventors.
When investigators conduct research on their own inventions, study outcomes may affect the value of the invention and potentially alter payments to the NIH and to the inventors. Although this is not legally considered a financial conflict of interest, it creates an apparent conflict of interest that must be reviewed to determine if management strategies are needed to minimize risk to research participants, and to maintain public trust in the research enterprise.
Important Context Regarding Payment of Government Royalties
- Government royalty payments to NIH inventors are required by law.
- NIH investigators cannot be involved in licensing negotiations.
- NIH inventors do not receive direct royalty payments from the licensee.
- Payments are distributed to NIH inventors by the NIH as required by law. By federal law, this is not considered to be a financial conflict of interest (fCOI).
- Royalty payments to inventors are capped at a total of $150K per year per investigator, regardless of the number of royalty generating inventions an investigator may hold.
- Payment information to inventors does not include the source of funds.
Protocol Royalty Analysis Committee (PRAC)
The Protocol Royalty Analysis Committee (PRAC) reviews these situations and specifies any management strategies needed to ensure that human research participants are protected, and the integrity of the research is maintained.
PRAC review is required when an NIH investigator involved in the research is also an inventor of the intellectual property (IP) being evaluated in that study.
PRAC review occurs:
- When a new protocol is submitted to the NIH IRB, and it is disclosed in PROTECT that an investigator engaged in the research is identified as an inventor on intellectual property (IP) being evaluated in the research.
- At the time of modification if an inventor is added to the study team, or IP is being added to the study, and an inventor is a member of the study team.
- Annually when PRAC administrative staff conduct re-review of open studies with invention disclosures to determine if changes have occurred that may warrant additional mitigation strategies.
PRAC review can occur concurrently with IRB review.
The PROTECT study application asks about intellectual property to inform the IRB of potential apparent conflicts of interest. PRAC reviews invention disclosures and determines whether management strategies are needed.
PROTECT Questions
Question 10: Is any investigator engaged in this research listed as an inventor for any intellectual property (for example a drug, device, assay) that is the object of this investigation?
Options: Yes / No
If Yes:
Question 11: Indicate the name(s) of the person(s)
Question 12: Identify the IP being studied
How to Answer Question 10
Answer Yes if:
- An investigator is an inventor and listed on the Employee Invention Report, and
- The invention is the object of the research being submitted for review.
Answer No if:
No investigators are listed as inventors, or the invention is used in the study but is not the object being evaluated.
Some examples to help you answer Question 10:
- Example 1: A Principal Investigator (PI) invented a drug to treat lung cancer and is now conducting a clinical trial to test the safety and effectiveness of that drug. The answer should be Yes.
- Example 2: An investigator invented a new assay to diagnose a disease and is conducting a study to compare the sensitivity and specificity of this new assay to standard testing. The answer should be Yes.
- Example 3: An investigator who invented a widely used blood glucose assay is participating in a study on metabolic syndrome. The study uses the assay to measure blood glucose, but the assay itself is not the object of the investigation. The answer should be No.
If an invention is flagged in PROTECT:
- The IRB Analyst notifies PRAC support staff.
- PRAC contacts the IC technology transfer office to determine licensing status of the IP being studied.
- If licensed (or actively seeking license), additional information is gathered.
- The PRAC Chair or designee may meet with the inventor and/or PI.
PRAC administrative staff starts the review by consulting with IC Technology Transfer offices for details regarding patents, licensing arrangements, and royalty payments to the NIH inventors.
Then the committee or its designee reviews the research study and the nature of the potential conflict. For lower-risk situations, the PRAC Chair will conduct administrative review and make the determination. The full committee is convened to review studies that are determined by the IRB to be high-risk to participants or where the research could have a significant impact on the IP's financial value.
- Initial PRAC review - The IRB and the study team will be notified of the PRAC determination when a study level review comment is entered into PROTECT with the PRAC Outcome letter. Any specific mitigation strategies will be specified in the outcome letter.
- An email will be sent to the PI, the inventors and IC tech transfer staff that includes the PRAC outcome letter
- PRAC annual review - the study team will be informed of the result of annual review by adding a study level comment in PROTECT. An outcome letter will not be sent unless there is a change in the existing management strategies by the PRAC.
Related Resources
The What, When and Why of Investigator Financial Conflict of Interest Review
Presented by Tonia Smith Awoniyi, Heather Bridge and Jonathan Green