How We Handle Allegations of Sexual Harassment

As we have discussed frequently over the past couple of years (see related statements), if there are concerns that sexual harassment is affecting an NIH-funded project, we want to know about it.

At the NIH Advisory Council to the Director (ACD) meeting on June 12 (see video for presentation, starting at 1hr 37sec), we mentioned that we would be posting our process for handling notifications of sexual harassment at the institutions we fund. Publishing these standard operating procedures aligns with our commitment to transparency. It is also one of the recommendations of the ACD Working Group on Changing the Culture to End Sexual Harassment. We have added a page on our Anti-Sexual Harassment: for NIH Awardee Organizations and Those Who Work There website that highlights the detailed steps NIH takes when we receive notification of a concern.

You will note that the flowcharts illustrate that NIH takes same rigorous approach to addressing allegations involving sexual harassment as we do other integrity issues.

We look forward to implementing additional ACD recommendations soon.

This blog was co-authored by Dr. Mike Lauer, the NIH Deputy Director for Extramural Research (OER). Dr. Lauer writes about NIH research funding policies and data at his blog, Open Mike.

Posted by Dr. Carrie D. Wolinetz, June 24, 2020

Dr. Mike Lauer
NIH Deputy Director for Extramural Research

New Steps to Help Ensure Safe Work Environments for NIH-Supported Research

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. 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. 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.

We are moving to close those gaps in our continued effort to address sexual harassment across NIH-funded research. Today, NIH has issued new guidance to grantees setting clear expectations that for awards (competing, non-competing and supplements) issued after today, NIH expects recipients requesting prior approval for changes in PI, key personnel, or recipient institution, to include mention as to whether these requests are related to concerns about the safety and/or work environment, including issues related to sexual harassment or bullying. (See NOT-OD-20-124).

 As of tomorrow, when requesting changes in either investigators (see NIH GPS Section or movement of a grant to a new recipient institution (see NIH GPS Section grantees are expected to mention if there are related concerns about the safety and/or work environments.

The new guidance marks critical progress in NIH’s efforts to foster a culture of safety and respect for all those working in science and sends a clear message that sexual harassment and other inappropriate behaviors are unacceptable and will not be tolerated.

We describe these steps in an editorial published today in Science. The new guidance builds upon previous steps NIH has taken to strengthen reporting sexual harassment and other professional misconduct taking place at grantee institutions in the context of NIH-funded research.

Our Anti-Sexual Harassment: for NIH Awardee Organizations and Those Who Work There website outlines NIH expectations, policies and requirements, and helps those concerned about sexual harassment at their institution find help. Among the resources on the site are a webform that allows for anonymous notification of concerns to NIH that sexual harassment is affecting an NIH-funded project.

While these first steps are critical, we recognize that we have a number of recommendations left to tackle to fulfill the ACD’s vision of a research culture free from sexual harassment. But our commitment remains strong, and we will get there. This is not just important for women in science. It is important for science. 

This blog was co-authored by Dr. Mike Lauer, the NIH Deputy Director for Extramural Research (OER).  Dr. Lauer writes about NIH research funding policies and data at his blog, Open Mike.

Posted by Dr. Carrie D. Wolinetz, June 11, 2020

Dr. Mike Lauer
NIH Deputy Director for Extramural Research

A Quick Word About Human Embryo Model Systems

Rapidly emerging areas of science can pose interesting challenges for policy frameworks intended to provide oversight of biomedical research or statutory limitations on NIH funding. A recent example, as described in this story on NPR, is an area of research in which scientists are hoping to gain insight on human development by creating structures that model certain aspects of embryonic development. The methods used to create these various model systems generally use human pluripotent stem cells, which are then differentiated into cell types with characteristics and/or organization similar to those seen in human embryos.

NIH has had a long-standing statutory limitation on funding research involving human embryos. The limitation, sometimes called the ‘Dickey-Wicker” amendment, is included annually in HHS appropriations language and has been incorporated into the NIH Grants Policy Statement (GPS). The GPS specifies that “NIH funds may not be used for (1) the creation of a human embryo or embryos for research purposes…”

You can probably anticipate the question I usually have to address. Can research involving various models of aspects of human embryo development be supported by NIH? The answer is “it depends.”

As a steward of taxpayer funds, NIH considers, on a case-by-case basis, whether we can support specific research proposals given the limitations set by the NIH GPS. NIH applies the same considerations to both research proposing the use of human embryos and research that aims to create or use experimental systems with human cells that model human embryos. We examine all experimental details specific to that experiment in order to make an informed decision about whether the research could be supported.

It is also important to note that even if NIH were to determine that proposed research is supportable under the limitation–NIH Institutes and Centers consider scientific merit, program priorities, their portfolio balance, and the availability of funds in making final funding decisions.

To help identify and better understand some of the unknowns associated with this nascent field of research, the National Academies of Science, Engineering, and Medicine will be holding a state of the science workshop on mammalian embryo model systems on Friday, January 17, 2020. I am looking forward to hearing more from the experts in the field about the opportunities and challenges that face this type of research.

Related Blog Post: Sharing Our Current Thinking: Models Containing Aspects of Human Embryos

Posted by Dr. Carrie D. Wolinetz, October 10, 2019

Carrie D. Wolinetz, PhD
Former Associate Director for Science Policy, NIH

Update on the “NIH Workshop on Optimizing Reproducibility in Nonhuman Primate Research Studies by Enhancing Rigor and Transparency”

I’ve received a lot of emails from folks asking why NIH announced and then subsequently postponed the “NIH Workshop on Optimizing Reproducibility in Nonhuman Primate Research Studies by Enhancing Rigor and Transparency.”  With everything going on in this space, NIH decided to pump the brakes on our NHP workshop to make sure we were putting together an agenda that moves the conversation forward and takes advantage of the expertise and groundwork already laid.

Over the past few years, NIH has been bolstering activities and policies focused on enhancing the rigor and reproducibility of the science it funds.  A notable example of this would be the work we have been doing to improve the quality and transparency of clinical trials. As discussed at the June meeting of the Advisory Committee to the NIH Director (ACD), the agency is now turning its attention to identifying gaps and opportunities to improve the rigor, reproducibility, translational validity, and transparency of studies involving animal models.

At that same meeting, NIH Director Francis Collins made it clear that nonhuman primate (NHP) research is essential to the NIH portfolio given the fundamental role it plays in both basic and translational research. In fact, the NIH Office of Research Infrastructure Programs (ORIP) recently released a two-part report on assessing nonhuman primate needs and resources for biomedical research, which projected an increased and unique need for NHP models, particularly in the areas of neuroscience and infectious disease.

While the NIH effort is focused rightfully on all species used in biomedical research, NHP research presents some unique opportunities and challenges. This has long been recognized in the animal welfare arena (for example, the Office of Laboratory Animal Welfare has six species-specific publications on enrichment for NHP) and has been well documented in considerations of scientific justification and oversight.  Moreover, the very qualities that make NHPs the best – and sometimes only – models for the study of human disease and translation of medical advancements also make them the subject of great public interest of which we, as a publicly funded research agency, are cognizant.

To help think through these unique issues, we will be convening a workshop of experts in the field of NHP models to discuss best practices for how these variables are assessed and taken into consideration. This includes thinking through how welfare considerations (such as housing enrichment, long-term care needs, social engagement, etc.) might clarify – or confound – research findings, as well as discussing whether the intersection of cutting-edge science, like neuroscience or gene editing, might present unique ethical considerations for NHP research.

An important thing to keep in mind is that NIH is not alone in thinking about these issues.  The National Academies recently hosted two workshops on the use of NHPs.  The first workshop focused on opportunities afforded by new NHPs models while the second focused on the care, use, and welfare of marmosets involved in gene-editing research. This mirrors the discussions arising in the scientific and bioethics communities about the intersection of NHP research, emerging technologies, and ethical issues.[1] [2] [3] Additionally, recognizing the value of NHP data and the need to share data efficiently, researchers are beginning to self-assemble to promote collaboration and open science. For instance, the PRIMatE Data Exchange is hosting a meeting in the fall at the Wellcome Trust to bring leading investigators from around the world to develop action plans related to activities in the field of NHP imaging. At the end of the day, all of these efforts have a common goal: assuring the best quality science adheres to commonsense ethical standards in order to improve human health.

We look forward to engaging with stakeholders to share best practices, consider new challenges, and offer pathways for improvement if needed. Stay tuned for further information…

[1] Sadato et al. (2019) Neuroethical issues of the Brain/MINDS project of Japan. Neuron, 101:385-389.

[2] Greely et al. (2016) Neuroethics in the age of brain projects. Neuron, 92(3): 637-641.

[3] Johnson, L.S. (2019) Neuroethics of the nonhuman. AJOB Neuroscience, 10(3):111-136.

Posted by Dr. Carrie D. Wolinetz, September 16, 2019

Carrie D. Wolinetz, PhD
Former Associate Director for Science Policy, NIH