FDA Ethics for Non-employee Scientists
FDA Ethics for Non-employee Scientists
As a Federal Agency, FDA must maintain the trust of the Nation in the way it conducts its operations by compliance with federal laws and avoiding conflicts of interest.
Federal employees share a responsibility to the United States and its citizens to uphold the Constitution, follow the laws, and adhere to ethical principles when discharging their official duties. Personal activities that have a nexus to federal employment must also be conducted with these considerations in mind.
Non-Employee Scientists are not federal employees, but similar considerations apply because they are placed within FDA and gain knowledge and exposure to FDA’s programs and operations as part of their training program.
If a Non-employee Scientist, to include their spouse and minor children, reports what is identified as a Significantly Regulated Organization (SRO) or prohibited investment fund financial interest in any amount, or a relationship with an SRO, except for spousal employment with an SRO, and the individual will not voluntarily divest the financial interest or terminate the relationship, then the individual is not placed at FDA.
HHS Supplemental Standards of Ethical Conduct define significantly regulated organization (SRO) as:
“an organization for which the sales of products regulated by the Food and Drug Administration (FDA) constitute ten percent or more of annual gross sales in the organization's previous fiscal year; where an organization does not have a record of sales of FDA-regulated products, it will be deemed to be significantly regulated if its operations are predominately in fields regulated by FDA, or if its research, development, or other business activities are reasonably expected to result in the development of products that are regulated by FDA."
The SRO List is publicly available and can be viewed at: https://www.accessdata.fda.gov/scripts/SDA/sdNavigation.cfm?sd=srolist&previewMode=true.
Note: the SRO lists only contain publicly-traded companies and funds. If you have a privately-held investment, or you are considering acquiring a privately-held investment, it will be important to ensure it would not be considered an SRO. Contact your Center Ethics Liaison for assistance.
During any non-employee scientist’s training placement at FDA, he or she will be obligated to comply with FDA ethics requirements for:
- Conflicts of Interest and Prohibited Holdings
- Outside Relationships and Interests
- Gifts from Outside Sources
- Gifts Between FDA Employees and Non-Employee Scientists
- Political Activity
- Seeking Employment
- Misuse of Position/Resources
Conflicts of Interests and Prohibited Holdings
Because of the FDA’s role as a unique consumer protection and regulatory agency, FDA Non-Employee Scientists must comply with a broad restriction that generally prohibits them as well as their spouse and minor child(ren) from holding financial interests, like stock, in “Significantly Regulated Organizations (SRO).”
Outside Relationships and Interests
While you are participating in the Non-employee FDA Fellowship or Traineeship program, you are prohibited from engaging in any employment, regardless of pay, with an SRO. This restriction includes business ownership, employment, service as an officer, director, trustee, contractor, and/or consultant.
You, your spouse, and/or minor child are prohibited from owning any proprietary interests in an FDA regulated product, including a patent, trademark, copyright, or licensing agreement.
Unless there is an exception, FDA Non-Employee Scientists may not accept gifts that come from “significantly regulated organizations.”
Gifts Between FDA Employees and Non-employee Scientists
Unless there is an exception, a non-employee scientist may not give, donate to, or ask for contributions for a gift to any FDA employee.
FDA non-employee scientists are prohibited from engaging in political activity while:
- On duty (including off-site training, for example);
- In a government room or building (including break rooms, conference rooms, gyms, and cafeterias);
- Wearing an official uniform or insignia; or
- Using a government vehicle.
Non-employee scientists are subject to further restrictions with respect to fundraising, use of official authority, candidacy, and business before HHS in relation to their political activities.
A non-employee scientist in an FDA training program is prohibited from seeking employment with an SRO while he or she is participating in the FDA training program. If you seek employment with an SRO, you must immediately notify your sponsor and may be removed from the program if you intend to continue seeking employment with the SRO.
- You may not use your title or non-employee scientists training position for any of the following purposes:
- For your own private gain, or the private gain of friends, relatives, or persons with whom you are affiliated in a nongovernmental capacity;
- To endorse any product, service, or enterprise;
- To coerce or induce someone, to provide any benefit, financial or otherwise, to you, anyone you know, or any group with which you are affiliated in a nongovernmental capacity;
- To imply that the Department endorses your personal activities or those of another;
- To disclose or use nonpublic information for your own private gain or that of another;
- To use federal time or property for unauthorized purposes, such as excessive personal use of computers, photocopiers, telephones, and fax machines; or
- To encourage the use of government time or resources to perform anything other than FDA official assignments, such as picking up your laundry.
You may contact your Center Ethics Liaison if you have questions about the ethics requirements that apply to you as a Non-employee Scientist at FDA.