Issue | march-2019



Uploading Studies to ClinicalTrials.gov Just Got Easier

When conducting clinical trials, NIH funding recipients are required to register their study at ClinicalTrials.gov. To make registration easier, a new feature in the eRA Human Subjects System (HSS) allows applicants and recipients to export study record entries as an XML file, and upload fields that are captured in both systems directly into ClinicalTrials.gov’s Protocol Registration and Results System (PRS). With just a few clicks, users will have a good start on completing ClinicalTrials.gov registration.

For step-by-step instructions and more information, see How to Upload Studies to ClinicalTrials.gov and the HSS: How to Export Study Record Data video.  

Keep Filenames in Grant Applications Short and Sweet

Attaching a file to your grant application? Make sure the filename is under 50 characters.

eRA systems now enforce the long-standing 50-character limit for filenames used for attachments in grant applications. The file name length will be checked by ASSIST and other solutions that use our validation service pre-submission, so remember to keep those file names short!

For more details, see eRA Submission Items of Interest.

NIH IRL: Join Us at the NIH Regional Seminar

I recently mentioned how much I enjoy starting a conversation through the blog with you, the investigators, grants administrators, research staff, and others in the research community. It’s a great way to help connect you with my perspective, and mine with yours.  

At the NIH Regional Seminar on Program Funding and Grants Administration, I hold “Open Mike” sessions where I have no slides and no prepared remarks – I let the audience determine the topics we discuss. I love the opportunity for frank conversations about whatever is on your mind. While I meet with people in the grants community at many different events, the NIH Regional Seminar is one of my favorites because of the opportunity to hear in a common setting the perspectives and challenges of investigators and research administrators.

I’m not the only one who feels this way. We bring close to 100 staff from across NIH and HHS who are interested in making connections with you. The 1:1 Meet the Experts is an invaluable chance to sit down face-to-face with NIH staff to get answers to your questions or to offer you further guidance, straight from the source. Our attendees have provided feedback that getting to know NIH staff on an individual basis during the 1:1 sessions is one of the best aspects of the seminar, and my NIH colleagues agree.

In addition to providing a face and voice to NIH and HHS, the NIH Regional Seminar creates a learning experience where you can share your information and experiences as well as bring back useful resources to your teams. Over the course of the two days, NIH & HHS review, grants, program, and policy officials will be providing sessions on over 50 different topics. There is more in-depth content during the optional pre-seminar workshops.

Whether you are a scientist, research administrator or in another important role that works with NIH grants, I encourage you to take a look at the seminar agenda to choose the right sessions for your needs.

General Registration rates for Baltimore end Friday, March 29. Unfortunately, we can only hold these twice a year, so if the spring seminar location or dates aren’t ideal for you, the only other dates in 2019 will be in Phoenix, Arizona, November 6-8.

Seeking Input on the Need to Enhance Access to NIH Grants Data

NIH has long been committed to transparency into who and what we fund. We have previously discussed the value of freely-available web tools that allow you to gain insight into NIH funding decisions. Award data available via RePORT and RePORTER, for instance, include non-sensitive information such as awardee institution, principal investigator, funding levels, research abstracts, as well as associated publications, patents, and other project outcomes. Better yet, if you want to see all of these data all at once, then ExPORTER allows you to download over 25 years’ worth of such non-sensitive NIH grant award data.

Researchers have used this grant information in creative and thought-provoking ways to explore NIH funding decisions. For example, both Fang, Bowen, and Casadevall as well as Li and Agha analyzed post-award research productivity according to pre-award peer review scores. Li, Azoulay, and Sampat linked publications resulting from NIH awards to patents. Boris et al used RePORTER data to verify self-reported awards in the dermatology field.  Cleary et al used RePORTER data to show that all recent new drug approvals were in some meaningful way linked to NIH funding.  And as I wrote in this 2017 post, Katz and Matter looked at some NIH data and described what they saw as inequality and stasis in the biomedical enterprise.

The data available through RePORT are quite powerful in their own right. However, compelling arguments exist for why researchers outside NIH should have access to even more information associated with the grants process. In addition to the non-sensitive data, NIH maintains sensitive information   collected via the grants process in its internal research administration systems. Such data includes information on peer review outcomes, progress reports, and demographics of individuals listed in NIH grant applications. 

As part of a Request for Information (RFI) described here and other future engagements, NIH is considering which categories of this sensitive data may be shared with researchers in compliance with applicable laws, while safeguarding sensitive, personally-identifiable, and confidential information (NOT-OD-19-085). NIH is beginning the process of exploring the costs and benefits of providing approved research organizations-controlled access to such structured, de-identifiable NIH administrative and scientific information in a formal and controlled way—through a secure data enclave.

Over the years, institutions, professional societies, advocates, and researchers interested in the science of science and innovation policy have requested access to more of these sensitive NIH data. Under certain circumstances, NIH allows researchers to enter into special data use agreements or other contractual arrangements to access these data for specific research purposes. As an example, NIH issued a contract that allowed Ginther et al to look at demographic information of researchers identified on applications, which they later used to compare with receipt of a major NIH award. It is important to remember though, that even when we permit such access, we remain dedicated to safeguarding your sensitive, personally-identifiable, and confidential information (please listen to the related NIH All About Grants podcast on this topic for more: MP3  / Transcript , 7 minutes).

Last December, the Advisory Committee to the NIH Director’s Next Generation Working Group recommended increased access to NIH administrative data. These administrative data have the capacity of “empowering career decision making through the availability of NIH data” and increasing accessibility of internal data for researchers studying the biomedical workforce” (see Theme 5.1 of the work group recommendations to NIH here).

Some federal agencies host unique environments allowing researchers access to agency information. The Centers for Medicare and Medicaid Services allows users to obtain research, data, and statistics on topics like actuary studies, compliance monitoring, and claims.Moreover, the Census Bureau makes certain administrative data available to reduce respondent burden and enhance analyses on changes in the U.S. population, demographics, economy, and social conditions. Though such avenues exist, concerns still remain around data security, personal privacy, affiliated costs to manage the platforms, how physical or virtual environments are controlled, and the overall need to know.

As noted earlier, we recently issued an RFI that seeks community input on considerations for securing these data, where they may be accessed, requirements for a research plan, and procedures for exporting information outside the enclave. Moreover, we hope to better understand what biomedical and/or behavioral research questions may be answered, if the enclave should be physical or virtual, how many seats an organization may be interested in using, what policies are needed to secure the information, and proposed steps to take in case of data breaches.

All RFI responses must be submitted electronically here by Wednesday, May 30, 2019.

This RFI is our attempt to gauge initial interest in a data enclave and identify issues that we will need to think through. This is your opportunity to tell us if this is something you would use, if you have concerns to share, and suggestions to improve the idea. If the response is positive, we fully expect to continue to engage the community to help us refine the idea.

Still Have Questions on the NIH Early Stage Investigator (ESI) Policy?

Looking for answers to your questions on our Early Stage Investigator (ESI) policy? Check out the following highlighted frequently asked questions (FAQ) for information on how NIH defines and reviews ESI applications to promote the growth and stability of the biomedical research workforce.  

How does NIH describe an Early Stage Investigator (ESI)?

An ESI, or Early Stage Investigator, is a Program Director / Principal Investigator (PD/PI) who has completed their terminal research degree or end of post-graduate clinical training, whichever date is later, within the past 10 years and who has not previously competed successfully as PD/PI for a substantial NIH independent research award.  A list of NIH grants that a PD/PI can hold and still be considered an ESI can be found at https://grants.nih.gov/policy/early-investigators/list-smaller-grants ESIs are encouraged to enter the date of their terminal research degree or the end date of their post-graduate clinical training in their eRA Commons profile to ensure their correct identification.  

 Will all my research grant applications receive special consideration?

No. Only R01-equivalent applications will be identified as applications from Early Stage, or Early Established Investigators so that they can receive special consideration.  

How are applications from ESIs identified in the review process?

The ESI status of the PD/PI(s), on any R01 Equivalent application will be determined at the time of submission. If the PD/PI(s) on the application is/are classified as ESI on the date the application is successfully submitted to Grants.gov, the application will be flagged as ESI and will receive special consideration during the review and funding process. 

What happens if I update my degree end date or my ESI extension request is approved after my application is submitted?

When NIH approves ESI extension requests or a PI updates their degree information in their eRA Commons personal profile after application submission, the ESI status for the application will be updated once the summary statement is released.

If I have two different applications under consideration as an ESI and one is awarded, will ESI consideration be given for the other?

No. Only one substantial NIH independent research application can be awarded as an ESI. When an ESI-eligible application is pending and the PD/PI has been awarded another R01 or R01-equivalent application, the ESI status of the pending application will be updated after release of the summary statement to indicate the application is no longer ESI-eligible.

See the Early Stage Investigators and Next Generation Researchers Initiative FAQ page for more information.

Update on NIH’s Efforts to Address Sexual Harassment in Science

Today we released a very important statement outlining actions NIH is taking to become part of the solution to address sexual harassment in science. I am including the full text of the statement below, as it speaks for itself. For additional information please visit our NIH Anti-Sexual Harassment: for NIH Awardee Organizations and Those Who Work There webpage.


As the NIH Director stated in September, sexual harassment is about power. The goal of the perpetrator, most commonly but not exclusively a man, is to objectify, exclude, demoralize, diminish, and coerce the victim, most commonly a woman, to exert power over her.  It’s morally indefensible, it’s unacceptable, and it presents a major obstacle that is keeping women from achieving their rightful place in science.

Victims of harassment know this all too well. Sexual harassment does not just damage the careers of those who have encountered it, it can leave deep scars and psychological effects that reverberate for a lifetime. The reports of scientists and students shared through the #MeTooSTEM movement portray a heartbreaking story of opportunities lost, pain suffered, and a systemic failure to protect and defend. To all those who have endured these experiences, we are sorry that it has taken so long to acknowledge and address the climate and culture that has caused such harm. The National Academies report on sexual harassment of women in science found that “federal agencies may be perpetuating the problem of sexual harassment.” We are concerned that NIH has been part of the problem.  We are determined to become part of the solution.

This month, the Working Group of the Advisory Council to the Director (ACD) on Changing the Culture to End Sexual Harassment met for the first time and heard from a wide-range of experts and perspectives, including Dr. BethAnn McLaughlin, whose leadership of the #MeTooSTEM movement has provided a voice for victims of harassment. We have heard similar, harrowing accounts from scientists in the NIH intramural program during meetings of the NIH Anti-Harassment Committee. These conversations have made it abundantly clear that NIH needs to do better in tackling the underlying culture that enables sexual harassment to take place, admit our contributions to perpetuating this culture, and elevate the seriousness with which the agency takes this issue through our actions.

The discussions of the ACD Working Group, who will report interim recommendations in June and provide a final report and recommendations to the ACD in December, centered around a number of themes that were similar to those identified by our internal Anti-Harassment Committee. As the senior leadership of NIH, we are taking  actions including those listed below, and we look forward to receiving the ACD recommendations and other input to strengthen our efforts:

Demonstrating accountability and transparency: We want to send a clear message to the institutions we fund and researchers who lead the research that sexual harassment is unacceptable. Discussions from both the NIH Anti-Harassment Committee and the ACD Working Group strongly endorsed an ethos of transparency and accountability to demonstrate the agency’s serious commitment to addressing harassment and deterring future inappropriate behavior. To bolster that transparency and accountability, we want to be clear that NIH has not and will not just look the other way when accusations come to our attention. In 2018, NIH followed up on sexual harassment-related concerns at more than two dozen institutions resulting in the replacement of 14 principal investigators named on NIH grant awards, disciplinary actions taken by awardee institutions against 21 principal investigators including termination of employment, and removal of 14 individuals from peer review. Over that same time period, NIH conducted administrative inquiries into 35 allegations of a sexual nature by NIH staff (both federal employees and government contractors). While some of these incidents remain under review, formal disciplinary actions ranging from reprimand to termination of employment were taken against 10 staff members, and informal disciplinary actions, including counseling/training and cease and desist warnings, were taken against another 10 staff members.

We recognize these numbers seem small compared to the disheartening incidence of sexual harassment described in the recent National Academies report, but we are continuing to expand our outreach to the extramural community to bring these concerns to our attention, and have enhanced our internal systems to act on all allegations of sexual harassment.

Clarifying expectations for institutions and investigators to ensure a safe workplace and inform the agency: If a principal investigator or other key personnel named on an NIH grant award is no longer able to fulfill their obligations to conduct research because they are under investigation or have been removed from the workplace because of sexual harassment concerns, NIH requires institutions to notify the agency of this change. The ACD Working Group discussions revealed that the requirement and appropriate timeline to notify NIH of changes in the status of key personnel named on an NIH grant award is unclear in the current guidance.

Those discussions, and ultimately the ACD’s recommendations, will help inform further actions, including clarifications in our guidance. In the meantime, NIH will provide written communication to the leaders of all NIH-funded and applicant institutions outlining NIH’s expectations relating to preventing and addressing sexual harassment, including the expectation that awarded institutions have implemented policies and practices that foster a harassment-free environment; maintain clear, unambiguous professional codes of conduct; ensure employees are fully aware and regularly reminded of applicable laws, regulations, policies, and codes of conduct; provide an accessible, effective, and easy process to report sexual harassment, and protection from retaliation; and respond promptly to allegations to ensure the immediate safety for all involved, investigate the allegations, and take appropriate sanctions.

Providing clear channels of communication to NIH: We can and will take action if there are concerns that sexual harassment is affecting NIH-funded research. For concerns related to NIH-funded research, an email can be sent to GranteeHarassment@od.nih.gov. We are working to create additional channels intended for confidential sharing of such information and hope to make those available in the next several weeks. While this communication does not constitute or substitute for a report of sexual harassment for legal action or investigation, NIH  will follow up with the relevant applicant/grantee institution on all concerns related to NIH-funded research. NIH also strongly encourages people to report allegations of sexual harassment or assault to the appropriate authorities, which may include your local police department or your organization/institution equal employment opportunity (EEO) or human resources offices.  Individuals may contact the HHS Office for Civil Rights (OCR) to obtain additional information and file a complaint. Please see NIH’s Anti-Sexual Harassment website for other information and resources.

Listening to victims and survivors of sexual harassment and incorporating their perspectives into future actions: Just as patients remind us every day why medical research is about real people, we cannot forget the intensely personal impact of sexual harassment. Those people whose careers or lives have been derailed by sexual harassment provide a critical voice in shaping the agency’s next steps in helping them re-enter the research workforce and reminding the entire research enterprise of the urgent need for culture change. NIH leadership, the NIH Anti-Harassment Committee, and the ACD Working Group are committed to working with scientists affected by sexual harassment and gender discrimination and will be planning listening sessions to provide a forum for input on proposed recommendations to the ACD.

These steps are only the beginning and are not meant to usurp the charge of the ACD Working Group, which will result in concrete recommendations to the ACD, or the continuing efforts of the internal NIH Anti-Harassment Committee. There is still a tremendous amount of work to be done, and we are confident that these two groups, with the input of all affected communities, will provide a roadmap for meaningful and sustainable culture change.  

We can do better. We must do better.


Francis S. Collins, M.D., Ph.D., Director

Lawrence A. Tabak, D.D.S., Ph.D., Principal Deputy Director and Chair, NIH Anti-Harassment Committee

Carrie D. Wolinetz, Ph.D., Acting Chief of Staff, Associate Director for Science Policy, and Co-Chair ACD WG on Changing the Culture to End Sexual Harassment

Michael S. Lauer, M.D., Deputy Director for Extramural Research

Michael M. Gottesman, M.D., Deputy Director for Intramural Research

Hannah A. Valantine, M.D., Chief Officer for Scientific Workforce Diversity

Alfred C. Johnson, Ph.D., Deputy Director for Management

National Institutes of Health

Welcome the New Director for the NIH Center for Scientific Review – Dr. Noni Byrnes

It gives me enormous pleasure to extend my warm congratulations to a friend and colleague, Noni H. Byrnes, Ph.D., for her recent selection as the new Director for the NIH Center for Scientific Review (CSR).   

CSR serves a vital role. Not only does CSR manage the receipt and referral of all grant applications for NIH and for other parts of the U.S. Department of Health and Human Services, dedicated CSR staff also oversee the peer review of approximately 75 percent of the more than 80,000 grant applications NIH receives each year. One can find more data on NIH peer review “in” the NIH Data Book

An analytical chemist by training, Dr. Byrnes first joined CSR in 2000 as a Scientific Review Officer.  Over the past 18 years, she has taken on increasing degrees of leadership and responsibility, most recently serving as Acting Director following Dr. Richard Nakamura’s retirement. Dr. Byrnes has led a number of high-profile efforts. She oversaw peer review activities related to American Reinvestment and Recovery Act Challenge Grants, the NIH Director’s Common Fund, and the All-of-Us program. She helped launch a new framework to increase collaborations with the scientific community and continuously evaluate all of CSR’s 178 study sections. She spurred on the creation of CSR’s Review Matters Blog, a Facebook page, and a Twitter account to communicate important issues around peer review.  She has an extraordinarily deep knowledge and understanding of peer review and the critical role it plays in the health and future of the extramural biomedical research enterprise.

Please join me and welcoming Dr. Byrnes to this new role. My colleagues within the NIH Office of Extramural Research and I are excited to work closely with her.