NIH Publishes Overview of COVID-19 Response for Applicants and Grantees
The NIH on April 6 published an overview Word document and overview presentation providing information for NIH applicants and grantees related to COVID-19 and research activities. Topics include patient care and researcher safety, NIH operating status, funding opportunities, donation of research supplies, and application deadlines. NIH has also established a COVID-19 “Updates History” webpage for applicants and grantees. Additionally, the NIH explained that Early Stage Investigator status can be extended due to disruptions from COVID-19.
Nature Reviews Drug Discovery: The COVID-19 Vaccine Development Landscape
Tung Thanh Le and colleagues from the Coalition for Epidemic Preparedness in Oslo reviewed in Nature the development landscape for the coronavirus vaccine. The landscape gives data on the pipeline to develop vaccine candidates by technology platform, the clinical phase of vaccines, and the numbers of vaccine developers by type and geographic location. Globally, they found 115 vaccine candidates, of which 78 investigations are confirmed “active,” mostly in an exploratory or preclinical stage. “The global vaccine R&D effort in response to the COVID-19 pandemic is unprecedented in terms of scale and speed,” they wrote, while calling for strong international coordination and mobilization among governments and health authorities. Spencer Bokat-Lindell in the New York Times examined coronavirus R&D, such as antivirals, and why even accelerated efforts take time, and AAMCNews explored how the process of producing a safe, effective vaccine is necessarily painstaking, as the risk of harm is real.
Advice on Safely Conducting Essential Research
A Viewpoint in the Journal of Clinical Investigation “addresses the major impact of the COVID-19 pandemic on biomedical research, the challenges created by the COVID-19 pandemic for research-intensive institutions, and what investigators can do to maintain some level of research activity while keeping their coworkers and trainees safe and engaged.” Also, an article in Nature discusses how scientists who must continue going into the lab during the coronavirus pandemic, including those performing COVID-19 research or maintaining animal facilities, can safely conduct their research. Beyond recommending that researchers follow institutional and COVID-19 specific safety precautions, suggestions include redesigning studies to be less labor-intensive, communicating constantly, collectively sacrificing to keep work going, and letting ethics guide which research to continue.
Reminder: NIH ICs Released NOSIs on Coronavirus Research
The NIH’s National Center for Advancing Translational Sciences (NCATS), National Institute of Allergy and Infectious Diseases (NIAID), and National Institute of General Medical Sciences (NIGMS) have released Notices of Special Interest (NOSIs) on Clinical and Translational Science Award (CTSA) program applications to address COVID-19 public health needs, repurposing existing therapeutics to address the COVID-19, the availability of emergency competitive revisions for research on coronavirus and COVID-19, and the availability of urgent competitive revisions for research on coronavirus and COVID-19. The NIH’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) also posted a new NOSI on the availability of urgent competitive revision supplements on COVID-19 related to HIV comorbidities, coinfections, and complications.
Hill and Regulation News
Lawmakers Introduce Bill to Remove Restrictions on Fetal Tissue Research
The Protecting Cures Act of 2020, which ensures all biomedical research tools — including fetal tissue — are available to develop treatments and vaccines against COVID-19, was introduced on April 1. The bill would remove restrictions imposed by the Department of Health and Human Services (HHS) on the use of human fetal tissue in NIH-funded research, including prohibiting the HHS secretary from withholding funds for NIH-funded fetal tissue research in cases of technical and scientific merit. The AAMC joined nearly 40 members of the higher education, research, and patient advocacy communities in support of the bill. The Hill covers the bill. Read more at AAMC Washington Highlights.
AAMC, Associations Urge Congress to Provide Funding to Support Researchers
Congressional leaders are discussing an “interim” emergency COVID-19 response package to supplement existing funding previously included in the CARES Act while they simultaneously begin negotiations on a larger “CARES 2” stimulus package. On April 9, AAMC President & CEO David Skorton, MD, sent a letter to Congressional leaders urging them to provide $26 billion in emergency appropriations to support the research workforce during the COVID-19 emergency.
The support for researchers and research infrastructure echoed an April 7 letter AAMC co-authored with APLU, AAU, and ACE urging this additional funding to support the major research agencies due to the impacts of COVID-19. The associations shared concerns about the research enterprise as many labs have shut down in-person activities to abide by social distancing measures. While the NIH has provided helpful guidance and administrative flexibilities related to grants management, institutions and the research community are incurring substantial expenses to support the research workforce as operations wind down temporarily, and will again when ramping projects and labs back up once the crisis subsides. Read more at AAMC Washington Highlights.
HHS Provides Information on All of its COVID-19 Grants
HHS is providing searchable information on all COVID-19 HHS grants and cooperative agreement awards under the CARES Act, including awards from NIH. The site includes details on the amounts awarded by state; the numbers of awards, amounts awarded by agency, and awards by program; and exportable data tables on awards made by HHS.
HHS OIG Examines NIH Protection of Peer Review from Foreign Influence
HHS’s Office of Inspector General (OIG) found that the NIH has effectively protected peer review from undue foreign influences by identifying reviewers who attempt to steal ideas from grant applications and other actions. The OIG report released last week also said that the NIH is “in the early stages of addressing this threat systematically” and “could do more.” Science covered the OIG’s critique and recommendations. Related, Mary Sue Coleman, PhD, president of the Association of American Universities, posted an essay on how AAU member universities are self-policing against security breaches by foreign governments.
NIH ICs Requesting Input on Strategic Plans
Three NIH Institutes and Centers are requesting input on their strategic planning. Comments to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) are due May 18, the National Institute of Neurological Disorders and Stroke (NINDS) continues to accept comments through this form, and Office of Behavioral and Social Sciences Research (OBSSR) has extended its deadline to April 30.
Open Mike: Some Thoughts on Cybersecurity – Part 1
NIH Deputy Director for Extramural Research Michael Lauer, MD, posted in his Open Mike blog the first in a series of essays describing cyberthreats. He thanked the professionals who protect NIH’s rapidly increasing IT assets. “On any given day, NIH’s automated email threat detection technology automatically blocks more than 23 million threatening emails that may be phishing attempts or could include malware,” he writes. Systems nationwide are increasingly vulnerable as personnel work remotely, and attacks can exploit the health emergency through messages designed to resemble COVID-19 maps or alerts. The post also reports usage trends for NIH’s electronic Research Administration (eRA) and other systems.
A Few NIH Notices
The NIH posted a notice explaining that it is moving ahead with the FORMS-F grant application form update and a reminder that eRA is moving to the cloud from April 17-20. NCATS published a NOSI on CTSA program administrative supplements to “add a dedicated quality assurance/quality control position to perform quality reviews of CTSA-related submissions.” The NIH posted another reminder about upcoming changes to forms and instructions for research training grant, fellowship, and career development award applications that are due on or after May 25. An NIGMS Feedback Loop blog post discusses the institute’s web resource on safety in the lab and other training environments. The NIH’s National Heart, Lung, and Blood Institute (NHLBI) posted an FAQ on its NOSI on COVID-19 administrative supplements. And, the Agency for Healthcare Research and Quality (AHRQ) posted a notice on flexibility available to AHRQ grant recipients and applicants impacted by COVID-19.
In Other Research News
IP Watchdog: The Evolution of University Technology Transfer
An article in IP Watchdog examined trends in university intellectual property using data from AUTM. Tracing the evolution of university intellectual property (IP) from early, one-off licensing ventures to the proliferation of start-ups, the authors, from the firm Ventech Solutions, predict that “the next frontier for university technology transfer will likely be in the transformation of data-rich sectors using artificial intelligence (AI) and machine learning technologies.”
AAMC Hosts Third Press Teleconference on the Front Lines of the Coronavirus
On April 3, the AAMC hosted its third press teleconference to provide the latest perspectives from the front lines of the coronavirus pandemic. Moderated by David Skorton, MD, AAMC president and CEO, the press conference featured AAMC experts who discussed pandemic preparedness and other breaking news related to teaching hospitals, patient care, medical research, and how medical schools are responding to the global health crisis.
Join the AAMC Twitter Conversation with #COVID19Wellbeing
The AAMC is exploring ways to create virtual community and solidarity to support those on the frontlines of the COVID-19 pandemic as well as those of you who are concerned about your colleagues and wish to share resources and ideas with them. Join in the AAMC Twitter conversation using the hashtag #COVID19Wellbeing. We hope to create an online community where physicians and researchers can share advice, knowledge, encouragement, and news; seek help; or just talk to someone who understands some of what they’re going through. The AAMC will monitor the ideas that come through and share them on the wellbeing page. Tweet chats will also be planned for people to gather virtually around the topic.
More News Links
- Office for Human Research Protections: Guidance on COVID-19
- NIH Director’s Blog: Dealing with Stress, Anxiety, and Grief during COVID-19
- NIH Director’s Blog: Can Smart Phone Apps Help Beat Pandemics?
- NCATS Director’s Corner: Practicing Physical Distancing and Bringing Our Science to Combat COVID-19
- Nature: Pick of the Coronavirus Papers
- Science: ‘These Are Answers We Need.’ WHO Plans Global Study to Discover True Extent of Coronavirus Infections
- Science: The $1 Billion Bet: Pharma Giant and US Government Team Up in All-out Coronavirus Vaccine Push
- HHMI: Repurposing Existing Drugs Could Offer Faster Path to COVID-19 Treatment
- WSJ: Scientists Rush to Find Coronavirus Cure—but It Still Isn’t Fast Enough
- STAT’s Guide to How Hospitals Are Using AI to Fight COVID-19
- STAT: New Research Examines Wastewater to Detect Community Spread of COVID-19
- FBR: Conquering Coronavirus Includes Animal Research (Infographic)
- Nature: Science-ing from home
- Science: Early-career Scientists at Critical Career Junctures Brace for Impact of COVID-19
- CHE: For Many Graduate Students, Covid-19 Pandemic Highlights Inequities
- IHE: What About Graduate Students (Dealing with Coronavirus)?
- Nature: Mentoring During the COVID-19 Pandemic
- Undark: In the Race to Crack Covid-19, Scientists Bypass Peer Review
- JAMA: Comparison of US Federal and Foundation Funding of Research for Sickle Cell Disease and Cystic Fibrosis and Factors Associated with Research Productivity
- PLOS Biology: What is Replication?
Perspectives for Research and Researchers
- Nature Index: What’s Wrong with the H-index, According to its Inventor
- Nature: How to Defend a PhD Remotely
- Undark: A Revolution in Science Publishing, or Business as Usual?
- Nature: Synchronized Editing: The Future of Collaborative Writing
For Your Interest