NIH-funded institutions must report sexual misconduct cases within 30 days, effective July 9

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NIH is now required by law to direct grantee institutions to report senior personnel who are disciplined for misconduct, sexual or otherwise.

All organizations that “receive funds through a grant or cooperative agreement during fiscal year 2022 and in future years” are now required to notify NIH when principal investigators or key personnel are removed from their position or are disciplined due to concerns about harassment, bullying, retaliation, or hostile working conditions.

“While NIH has made progress toward our goal of ending harassment in biomedical research, NIH lacked clear authority to require funded institutions to report to NIH whether personnel changes to an NIH grant are related to harassment, only that they should report it,” Lawrence A. Tabak, acting director of NIH, said in a statement. “This limited NIH’s awareness of when harassment was affecting NIH-supported activities, and therefore NIH’s ability to take necessary action to ensure appropriate grant stewardship. That changes today.”

The relevant federal provision, codified in Section 239 of the Consolidated Appropriations Act for fiscal year 2022, gives NIH statutory power it didn’t have (The Cancer Letter, July 23, 2021).

“If an institution requests approval to remove a principal investigator (PI) or other senior key person named in the grant award due to concerns about safety and/or the work environments (e.g. due to concerns about harassment, bullying, retaliation, or hostile working conditions), NIH expects to be notified,” NIH officials said in a statement. “If an institution requests a change of recipient institution, and there are concerns about safety and/or work environment involving the PD/PI, NIH expects to be informed.

“The reason is clear—NIH does not tolerate sexual harassment. Period,” officials said. “The two situations we cited above are two critical loopholes identified by the Advisory Committee to the NIH Director’s (ACD) Working Group on Changing the Culture to End Sexual Harassment as needing more attention.”

Then-NIH Director Francis S. Collins lamented the reporting loophole in a May 2021 hearing before the Senate appropriations subcommittee on Labor, Health and Human Services, Education and Related Agencies.

I hope it would be a first step, but I don’t think this, in itself, will make a major difference because the culture is still such that women are penalized.

Shikha Jain

“I wish we were able to simply require—at the present time, legally, we are told we don’t have that authority,” Collins said at the time to Sen. Patty Murray (D-WA), chair of the Senate appropriations subcommittee. “We would have to go through a two-year rulemaking effort, or we would need statutory assistance.”

The Cancer Letter’s investigative report on Axel Grothey was published two days after Collins’s testimony, catalyzing a congressional inquiry that demanded answers from NIH on its “questionable handling” of sexual harassment complaints (The Cancer Letter, Aug. 10, 2021).

In NIH’s official response, Tabak said NIH was unable to conduct an inquiry into allegations of sexual misconduct because Grothey had left Mayo Clinic—an NIH-funded institution—in May 2018, a year before the complaints were filed with NIH, and was no longer “key personnel” on NIH grants (The Cancer Letter, Sept. 24, 2021).

Effective July 9, 2022, NIH-funded institutions that do not report relevant cases within one month would be considered to be in violation of NIH regulations and of federal law, pursuant to Sec. 239.

“Recipient institutions must report within 30 days … to our dedicated web form,” NIH officials said.

The following information should be reported:

  • Name of the Authorized Organization Representative submitting the notification
  • Name of the individual of concern
  • Description of the concerns
  • Action(s) taken
  • Anticipated impact on the NIH-funded award(s)

“We will then consult with the institution,” Michael S. Lauer, NIH deputy director of extramural research, and Marie A. Bernard, NIH chief officer for scientific workforce diversity, said in a statement. “If necessary, we may take additional actions ranging from changing personnel, restricting award funds, or suspending or terminating the grant as outlined in the NIH Grants Policy Statement.”

When a funded institution reports harassment to NIH, NIH will continue to work with the grantee organization, as well as other federal agencies as required, to determine appropriate action, Tabak said in a statement. 

“No one should ever have to endure harassment to contribute to biomedical research,” Tabak said.

Anti-harassment experts: NIH’s reporting rules are reactionary

Observers in oncology and anti-harassment organizations are cautiously optimistic about NIH’s new reporting requirements, but say that NIH needs to do more to provide an adequate or holistic framework for responding to incidents of misconduct.

“I hope it would be a first step, but I don’t think this, in itself, will make a major difference because the culture is still such that women are penalized,” said Shikha Jain, CEO and founder of Women in Medicine, assistant professor of medicine, Division of Hematology and Oncology, director of communication strategies in medicine at the University of Illinois Chicago, and associate director of oncology communication & digital innovation at the University of Illinois Cancer Center. 

“I think NIH needs to put some of the onus on systems and on leadership. And I think there needs to be real steps that need to be taken if someone brings up an allegation,” Jain said to The Cancer Letter.

“How do we make sure that there are standardized ways that we can support these women—so that, no matter what, the woman who comes with an allegation knows that, at least, certain steps will be followed, and certain procedures will be followed to investigate—as opposed to just sweeping it under the rug?”

In addition to the new reporting requirements, NIH needs to implement timely and corrective action in instances of substantiated misconduct, said Shea Holman, director of law and policy at the Purple Campaign, a nonprofit focused on ending sexual harassment in the workplace.

“Tying funding to safe, inclusive workplace conduct may act as an incentive for grantee-institutions and PI’s to be more conscious of and concerned about workplace misconduct,” Holman said to The Cancer Letter. “On the other hand, the NIH policy does not address what happens if an institution never follows up on the report and/or fails to complete an investigation. 

“Simply requiring NIH-funded institutions to report if they find that anyone funded by the grant proposal has committed sexual harassment is not enough.”

A conversation with Jain and Holman appears here.

NIH’s new rules would serve as a deterrent only when the procedures are made transparent and whistleblowers disclose safety in the process, said Pringl Miller, founder and executive director of Physician Just Equity, a nonprofit that provides peer support to physicians who experience harassment, discrimination, and retaliation.

“The presumption here is that it is safe to report—it’s not. That’s why the prevalence of this behavior is unknown,” Miller said to The Cancer Letter. “Senior key personnel are not removed or disciplined; complainants are.

“This is a defensive posture [on NIH’s part], not an offensive posture—reacting to harms that have already been experienced, rather than promoting a strong enough deterrent that any one would be afraid if they thought about behaving badly or committing a crime. Part of this requires the self awareness of even knowing you are behaving unlawfully.”

The lack of enforcement of misconduct regulations is another problem, Miller said.

“These actions by the NIH of having a trigger be removal or disciplinary action is downstream from the harms that have already taken place. There should also be strong and enforceable upstream deterrents to these behaviors—not just after the damage-has-been-done consequences.”

NIH needs to make the reporting processes transparent to the public and the complainants, Miller said.

For instance, NIH could produce semi-annual reports on “how the complainants have experienced it and publish metrics of case outcomes and satisfaction with subjects in the process, what has happened to the perpetrator and what has happened to the subject.” Miller said. “Subjects have to be seen to be safe and flourishing while perpetrators are punished and denied opportunity and privilege. The historical precedence of career impact must be shown to be inverted from what we know to be the current state of affairs. 

“The consequences should be proportional to the infraction or crime. Violators should be exposed—by name—and prevented from receiving further funding. Perpetrators, just like physicians with an adverse safety profile, must be flagged as a liability.”

Time will tell whether NIH’s reporting requirements will be effective, Miller said.

“Doubtful, based on historical lack of accountability and safety in reporting,” Miller said. “There should be external oversight that takes the burden of reporting out of the hands of the institution, and the investigation should be [handled] by an experienced neutral entity with transparency offered to the complainant. The culture does not demand fairness and protections for the complainant.

“Women should not have to be violated and [make a] report for this behavior to stop.”

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