The Food and Drug Administration (FDA) is committed to supporting a safe and respectful work environment. To that end, FDA maintains requirements and recommendations for institutions and individuals supported by FDA-funded grant awards.
In supporting a safe and respectful work environment, FDA does not tolerate harassment of any kind, including sexual harassment at institutions that receive FDA grant funding, or anywhere that FDA-grant funded activities are conducted.
FDA’s Requirements and Recommendations
Consistent with HHS grants regulations (45 C.F.R. Part 75), and the HHS Grants Policy Statement (which is incorporated by reference as a term and condition of all FDA grant awards), FDA requires that every organization receiving FDA grant funds:
- Have policies and procedures in place to manage grant activities in accordance with Federal laws, regulations, and policies protecting the rights and safety of individuals working on FDA-grant funded projects.
- Notify FDA if an organization takes an administrative or disciplinary action against a principal investigator or other senior key personnel that affects their ability to continue in their capacity on an FDA grant award.
FDA grant recipients must also comply with applicable Federal civil rights laws prohibiting discrimination on the basis of sex, including Section 1557 of ACA, which prohibits discrimination by health programs and activities receiving Federal financial assistance (including health-related research), and Title IX of the Education Amendments Act, which prohibits discrimination on the basis of sex in educational programs and activities receiving Federal financial assistance. If sufficiently severe, sexual harassment is a type of sex discrimination that violates these laws. FDA grant recipients have also provided an assurance, when signing the HHS-690 form, that they will comply with these laws.
Consistent with the HHS Grants Policy Statement, which is incorporated by reference as a term and condition of all FDA grant awards, recipients of FDA funds must immediately notify FDA of changes in a principal investigator’s status, (e.g. modified employment or leave status during an investigation of alleged sexual misconduct.)
- The organization receiving FDA grant funding must notify FDA if it takes an administrative or disciplinary action against a principal investigator or other senior key personnel, e.g. limiting access to the institution’s facilities or resources, modifying employment or leave status during an investigation of alleged sexual misconduct, and anything else that affects the ability of the principal investigator or other senior key personnel on an FDA grant award to continue in their capacity.
FDA encourages organizations receiving FDA grant funds to have in place similarly rigorous policies and related procedures for employees, contractors, trainees, fellows, and any other personnel who engage in agency-funded activities.
FDA uses the compliance and oversight tools within its authority to support a safe, harassment-free work environment, while respecting the multitude of Federal, state, and local laws and policies that govern how sexual harassment allegations are adjudicated.
Outlined below are FDA policies and requirements that support these efforts: a description of the current reviews FDA conducts before an award is made and FDA post-award management and actions.
FDA Actions and Oversight
When an organization submits a grant application to FDA, its Authorized Organization Representative signs the application, certifying that the organization will comply with all applicable policies, assurances and/or certifications referenced in the application. Some of these stipulations require that a separate document be submitted to the appropriate Federal office, including submission of civil rights assurance to the Office of Civil Rights.
FDA conducts a pre-award risk assessment for every applicant organization by checking multiple Federal-wide systems used for management and oversight of Federal funding recipients. This includes, but is not limited to the Federal System for Award Management (SAM), among other resources, to determine if a recipient is eligible to receive an FDA grant award. FDA also queries the Federal Awardee Performance and Integrity Information System (FAPIIS) and the National External Audit Review center (NEAR) to determine if the applicant organization is eligible and qualified to receive an FDA grant award. FDA reports all information on non-compliance into these systems, including violations of the HHS Grants Policy Statement or violations of Federal laws and regulations, such as civil rights protections.
If FDA indirectly learns of an allegation of sexual harassment, we immediately alert the recipient institution to verify issues and take all appropriate actions. If senior/key personnel on an FDA-funded grant are not in compliance with applicable laws, and regulations, FDA can take several actions against the institution. These actions include requiring a change in senior personnel or remedies for noncompliance, such as suspension or termination of the grant award, consistent with applicable regulations, 45 C.F.R. Part 75, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards.
While FDA does not have jurisdiction to intervene in personnel matters at third-party organizations, FDA takes all allegations of sexual harassment very seriously and requires that grantee institutions foster work environments conducive to high-quality research, a term and condition of FDA award. FDA urges people to report allegations to the appropriate authorities.