Information contained in this publication is intended for informational purposes only and does not constitute legal advice or opinion, nor is it a substitute for the professional judgment of an attorney.
The National Institutes of Health (NIH) requires recipient institutions—i.e., any entity receiving funding from the NIH—to have policies that foster a harassment-free environment. Recipient institutions are required to establish and maintain a clear code of conduct, ensure employee awareness of all applicable laws, regulations, policies, and codes of conduct, provide user-friendly reporting processes, protect employees from retaliation, investigate all allegations promptly, and inform the NIH of administrative actions that remove Senior or other Key personnel1 on an NIH award.2
As part of the NIH’s reporting requirements, the NIH recently updated its rules requiring recipient institutions to notify the NIH when changes occur to certain Senior or other Key personnel due to concerns about harassment, bullying, retaliation, or hostile conditions.
Existing pre-July 9, 2022 reporting requirements: Under the current rules, the NIH requires proactive notification of changes in Program Director (PD), Principal Investigator (PI), or other Senior/Key personnel.3 However, under the current rules, there is no set timeframe for the notification requirement. Such notification should include mention of any safety and/or work environment concerns including harassment, bullying, retaliation, or hostile working conditions. Administrative or disciplinary action against an employee can include limiting access to the institution’s facilities or resources and/or modifying employment or leave status during an investigation. Additionally, the organization must notify the NIH and seek approval for replacement(s) of individuals.
Post-July 9, 2022 reporting requirements: As of July 9, 2022, NIH policies and requirements are changing regarding the notification process.4 Recipient institutions are now required to notify NIH when a PD/PI, or other Senior/Key personnel in an NIH notice of award are either removed from their position or are disciplined by the recipient institution due to concerns about harassment, bullying, retaliation, or hostile working conditions. The new policies require the Authorized Organization Representative notify NIH within 30 days of the removal or disciplinary action through this dedicated web form. All required notifications must include, at a minimum:
(1) The name of the Authorized Organization Representative submitting the notification,
(2) The name of the individual of concern,
(3) A description of the concern(s),
(4) The action(s) taken, and
(5) Any anticipated impact on the NIH-funded award(s).
Finally, if an institution determines that the concerns shared with the NIH will impact the PD/PI or Senior/Key personnel's ability to continue as the scientific lead of the project, the NIH will require approval for a replacement PD/PI or Senior/Key official.
It is important for all recipient institutions to maintain compliance with the new NIH reporting requirements, including the 30-day reporting deadline. For guidance regarding the NIH reporting requirements and notification requirements, please feel free to contact a Littler attorney.
1 Under applicable NIH guidance, Senior/Key personnel are defined as Program Director, Principal Investigators and other individuals who contribute to the scientific development or execution of a project in a substantive, measurable way, whether or not they receive salaries or compensation under the grant. These individuals usually have doctoral or professional degrees.
2 An NIH award is defined as “the provision of funds by NIH, based on an approved application and budget or progress report, to an organizational entity or an individual to carry out a project or activity.”
3 See NIH NOT-OD-20-124, Guidance Regarding Change in Status, Including Absence of PD/PI and Other Key Personnel Named in the Notice of Award, June 11, 2020.
4 See NIH NOT-OD-22-129, Updated Requirements for NIH Notification of Removal or Disciplinary Action Involving Program Directors/Principal Investigators or other Senior/Key Personnel, May 10, 2022.