Step 4: Reporting a Cancer Prevention Clinical Trial
Published Results
Whenever a recipient's work is funded fully or partly by NIH, that activity is subject to the requirements of Bayh-Dole Act of 1980 (Public Law 96-517). This law:
- Gives grantee organizations/contractors title to inventions arising from federal funding agreements
- Allows the government to retain license to practice the invention
- Prescribes actions the Government may take to protect/retain rights
- Encourages commercialization of federally funded inventions
A Study Manuscript 'draft' or 'submission' manuscript shall be submitted within 60 days of the time that either 1) all participants have met the primary study endpoints, or 2) at least 80% of subjects are off study. All submitted manuscripts shall be clearly labeled on the cover page as either 1) draft or 2) submission version.
Contracts, with a few exceptions, that require data to be produced, furnished, acquired or specifically used in meeting contract performance requirements, must contain terms that delineate the respective rights of the Government and the contractor regarding the use, duplication and disclosure of such data.
The publishing/copyright rules for contractors (not grantees) are found in Part 27, Subpart 27.4, of the Federal Acquisition Regulations (FAR).
