Federal Regulations and Policies Overview

In addition, the federal government has policies that directly apply to the ownership and sharing of data from federally funded research. These include:

The "Bayh-Dole Act" (The Patent and Trademark Amendment, PL96-517) of 1980 governs the ownership and transfer of technology developed under Federally supported grants and encourages the commercialization of new technologies. See more information about Bayh-Dole.


Section 36 of the Office of Management and Budget (OMB) Circular A-110, Uniform Administrative Requirements for Grants and Agreements with Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations (Revised November 19, 1993, As Further Amended September 30, 1999) regulates the use, ownership, and sharing of data and other intellectual property developed under federal grants, including the rights of the public to gain access to research information under the Freedom of Information Act.

The Office of Research Integrity of the U.S. Department of Health and Human Services has developed and implemented a policy that governs how allegations of misconduct in research, (including fabrication and falsification of data) are handled.

Currently, this policy applies only to grants funded under the Public Health Services Act, but has been revised and its scope expanded to apply to research funded by all federal agencies. It is anticipated that the new policy will be implemented in 2002.