News and Media
by NIH Staff
Getting ready to apply for a grant and don’t know where to start? Set yourself up for success with tips from the experts at NIH. Quickly learn how to access application forms, ensure your application is a good fit for an announcement, and make an important final check of your application after submitting with new videos from the Office of Extramural Research (OER).
Check out these helpful quick tip videos on the How to Apply – Video Tutorials page to help you avoid common mistakes and position yourself for success:
NIH Seeks Public Comment on Proposed Provisions for a Future Draft Data Management and Sharing Policy
Resubmitted from: NIH Office of Science Policy
On October 10, 2018, the National Institutes of Health (NIH) issued a Request for Information (RFI) in the NIH Guide to Grants and Contracts to solicit public input on proposed key provisions that could serve as the foundation for a future NIH policy for data management and sharing. The feedback we obtain will help to inform the development of a draft NIH policy for data management and sharing, which is expected to be released for an additional public comment period upon its development.
Comments on the proposed key provisions will be accepted through December 10, 2018, and can be made electronically by visiting here.
To further engage stakeholders, NIH will also be hosting a webinar on the proposed key provisions on November 7, 2018, from 11:30 a.m. – 1:00 p.m. ET. Details about the webinar, including how to register can be found by clicking here.
For a perspective on the importance of obtaining robust stakeholder feedback on this topic, please see the latest Under the Poliscope by Dr. Carrie D. Wolinetz.
Questions about the proposed provisions may be sent to the NIH Office of Science Policy at SciencePolicy@od.nih.gov
When world famous cellist, Yo-Yo Ma, visited the NIH campus, he shared a story from the history of music, in which the peak of stringed instrument quality occurred in the late 17th century at a time of great collaboration and sharing of knowledge. When instrument makers began to compete, all of that changed: secrets of craftsmanship were held close and the quality of instruments plummeted. This decline lasted, according to Ma, until the 20th century, when again the free-flow of knowledge resumed. NIH Director Francis Collins noted, “There’s a lesson here about science.”
Data sharing is important. It is critical to continued progress in science, to maximize our investment in research, and to ensure the highest levels of transparency and rigor in science. But data sharing is a means to an end, not itself an end goal and, as such, needs to be done thoughtfully, in a way that fulfills the vision and mission of NIH and continues the advancement of treatments for disease and improvement of human health. NIH has long been on the forefront of making access to the results of our research accessible and has described our vision for expanding access to publications and data both in the 2015 NIH Plan for Increasing Access to Scientific Publications and Digital Scientific and in the 2018 Strategic Plan for Data Science.
The generation, analysis, and publication of data relates to the core function of NIH’s role as a biomedical research agency. Therefore, policies related to the management and sharing of data can have great impact across the agency and the research community. As such, it is critically important that we engage stakeholders on this complex topic. We began the conversation with the 2016 request for information on Strategies for NIH Data Management, Sharing, and Citation, and a 2017 joint workshop with the National Science Foundation that focused on the value of data sharing. Now we want to share with the community our current thinking about potential next steps in data management and sharing policy and seek your feedback on the best path forward.
Today, NIH released a notice in its Guide to Grants and Contracts that seeks public input on the key policy provisions that NIH is considering for inclusion in a future draft policy aimed at replacing NIH’s existing Data Sharing Policy. By obtaining robust stakeholder feedback we can help ensure that the future NIH policy will promote opportunities for data management and sharing while allowing flexibility for various data types, sharing platforms, and strategies. The information stakeholders provide can also assist us in developing streamlined approaches that could potentially reduce unnecessary administrative burdens.
While we appreciate and will consider any and all feedback our stakeholders provide, we are specifically interested in your thoughts on these key items:
- The definition of scientific data to be covered within these plans,
- The elements of required data management and sharing plans, and
- The optimal timing, including possible phased adoption, for NIH to consider in implementing various parts of a new data management and sharing policy, as well as how possible phasing could relate to needed improvements in data infrastructure, resources, and standards.
You can view our request for information (RFI), the key provisions and provide your comments by visiting https://osp.od.nih.gov/ provisions-data-managment- sharing/. Comments will be accepted until December 10, 2018. In addition, NIH will also be hosting a webinar on the proposed provisions on November 7, 2018. Interested participants can find more details and register for the webinar here.
I often hear that policies seem to emerge from NIH fully formed, with little opportunity for the expertise and thoughts of the research community to come to bear. This RFI represents an opportunity to join the conversation before policy decisions are made. In the spirit of collaboration, embodied by 17th century Italian instrument makers, let’s work together to get this right.
by NIH Staff
Curious about how NIH grant applications are reviewed? Get a front row seat to the peer review process in this video created by the NIH Center for Scientific Review (CSR). Investigators will get insights into how applications are reviewed so they can better enhance and advance their applications in the NIH peer review process.
Still have more questions? In this video, 10 experts from the NIH CSR answer the top 10 peer review questions applicants ask us. Be sure to also check out a list of the Top 100 NIH Peer Review Q&As for even more information and answers to questions you might not even know to ask.
by NIH Staff
Want to gain knowledge in clinical research and pharmacology? Start learning now through the FREE self-paced courses offered by the NIH Office of Clinical Research.
Introduction to the Principles and Practice of Clinical Research
This course trains participants on how to effectively and safely conduct clinical research.Topics covered in the course include: study design, measurement, statistics, ethical, legal, monitoring, and regulatory considerations, preparing and implementing clinical studies, additional study designs and more. Both the course and registration for the 2018-2019 course year are now open through June 30, 2019. Please visit the IPPCR website. (Note that this course is not intended to be a replacement for required training in the protection of human subjects.)
Principles of Clinical Pharmacology
This course covers the fundamentals of clinical pharmacology as a translational scientific discipline. The course consists of approximately 50 lectures by thought-leaders from around the world. Topics covered in the course include: pharmacokinetics, drug metabolism and transport, drug therapy in special populations, assessment of drug effects, drug discovery and development, pharmacogenomics and pharmacotherapy. Registration for the 2018-2019 course year is now open through June 30, 2019. Please visit the PCP website.
When preparing a new grant or setting up a study, it is important to know about the patient population through which the research will be conducted. With medical information being stored in electronic systems, data can become available to investigators for answering these important questions in new and simpler ways. However, searching through datasets can be intimidating and incredibly time consuming for those who are unfamiliar with computer languages or querying large datasets.
In collaboration with UW Medicine, ITHS has developed a new tool called Leaf which provides investigators with a user friendly self-service interface to scan data sets and generate reports which can provide essential information throughout the clinical research process. Tools like this help investigators understand the clinical landscape within which they are working to better frame research questions and design clinical research that will meet recruitment goals.
In providing data access, Leaf offers investigators insight into the electronic health records such as:
- Demographic data
- Cohort identification and research criteria
- Departmental statistics regarding visits and diagnoses
- Data visualization
- Abstraction of identified or de-identified data for quality improvement
Resubmitted from: ITHS | September 12, 2018 | URL: https://www.iths.org/blog/news/about-iths/iths-announces-new-data-access-tool-leaf/
The Clinical and Translational Science Award (CTSA) program has established a National Center for Data to Health to make research data more meaningful and accessible. Oregon Health & Science University, Northwestern University, the University of Washington, Johns Hopkins University School of Medicine, and Sage Bionetworks, together with The Scripps Research Institute, Washington University in St. Louis, the University of Iowa, and The Jackson Laboratory were funded by the National Institutes of Health to establish and manage this center known as the CD2H.
“The goal is to unlock the amazing wealth of technologies and innovation located within each individual CTSA and to create cohesive communities of practice founded on the fundamental premise that team science, data sharing, and collaborative innovation can advance patient care” said Dr. Melissa Handel, center director from Oregon Health & Sciences University.
The CD2H aims to advance biomedical research informatics and standards to support interoperability, collaborative innovation, and data science training by working alongside CTSA program hubs and other translational teams.
WAYS TO ENGAGE
- Join a Workgroup or Committee, meet up with other informaticians and data professionals at events and conferences
- Subscribe to the monthly newsletter for regular updates on activities and program developments
- Follow CD2H on twitter: @data2health
Resubmitted from: ITHS | September 5, 2018 | URL: https://www.iths.org/blog/news/about-iths/ncats/connect-with-the-national-center-for-data-to-health-cd2h/
Several months ago, we learned in the press that an NIH-supported investigator was banned from his university campus pending an ongoing investigation into allegations of sexual misconduct. The institution, which was the recipient of the awards in which this investigator was designated as principal investigator (PI), had not informed us of this situation. Once aware, we contacted senior institutional officials to discuss the need to ensure the effective stewardship of the award under these circumstances. We requested that the institution provide us with alternative plans for conducting the research given that this individual would no longer serve as PI and would have no other involvement in the NIH-funded research, and we reminded them (as we recently reminded the community and as reiterated below) that they are responsible for notifying NIH of any change in status that might affect the ability of an individual identified as key personnel to conduct NIH-supported research.
NIH takes sexual and gender harassment seriously. When harassment occurs, not only is it a personal violation, it can cause lasting damage to an individual’s professional development and training.
Unfortunately, sexual misconduct in the research setting is not uncommon. Too many people have described unacceptable experiences during the conduct of their scientific work. In a 2016 JAMA article, as an example, nearly one-third of women investigators on K08 and K23 career development awards reported experiencing sexist remarks or behavior, subtle bribery to engage in sexual behavior, unwanted or coercive advances, or threats.
In Nature that same year, my colleagues and I raised our concerns too. We highlighted an NIH Guide Notice, published in September 2015, reminding grantees of civil rights protections in NIH-supported activities and of our expectations for eliminating barriers and providing equal access to the opportunity to participate in NIH supported research, programs, conferences, and other activities. Consistent with Federal civil rights laws, organizers of NIH-supported conferences and scientific meetings are expected to maintain a safe and respectful environment for all attendees free from discrimination and harassment, sexual or otherwise.
In a National Academies study released in June, one fifth of women undergraduate and graduate students reported being harassed. This ranged from unwanted sexual attention, coercion, verbal or physical harassment, and offensive remarks about one’s sex or gender. Medical students also reported a strikingly high level of harassment, which may have origins stemming in part from the hierarchical nature and environment found in some of these schools and training programs.
At the Advisory Committee to the NIH Director meeting in June (go to 4 hours and 34 minutes in the recording), we discussed these reports, clarified NIH policies, and highlighted actions we are taking to address sexual and gender harassment both on our campus and in the extramural research community.
The NIH Grants Policy Statement (GPS), which is a term and condition of all awards, indicates that NIH intends to uphold “high ethical, health, and safety standards in both the conduct of the research we fund and the expenditure of public funds by our recipients” including adherence to civil rights assurances. For NIH-funded extramural science, the grant recipient, which nearly always is an institution, not a person, “is responsible for the actions of its employees and other research collaborators, including third parties involved in the project.” Thus, NIH expects that “recipient organizations have systems, policies, and procedures in place by which they manage funds and activities.” Further, “NIH recipients are expected to foster work environments conducive to high-quality research.”
The GPS states that failure to comply with the terms and conditions of award “may cause NIH to take one or more actions, depending on the severity and duration of noncompliance.” For example, NIH “may withdraw approval of the program director/principal investigator (PD/PI) or other senior/key personnel specifically referenced in the Notice of Award if a reasonable basis exists to conclude that the PD/PI and other such named senior/key personnel are no longer qualified or competent to perform the research objectives.” If a grantee takes administrative or disciplinary action against its employee(s) – for example, limiting access to the institution’s facilities or resources or modifying employment or leave status, etc. during an investigation of alleged sexual misconduct – that impacts the ability of the employee(s) to continue as “senior/key personnel” on an NIH award, NIH requires the grantee to notify NIH and seek NIH’s advance approval for replacement(s) of PD/PIs and senior/key personnel.
Also, as a term and condition of the award, the grantee certifies that it has on file with the HHS Office for Civil Rights (OCR) an Assurance of Compliance with the statutes described in the “Civil Rights Protections” provision at Subsection 4.1.2 of the NIH GPS. OCR, which is responsible for enforcing federal civil rights laws (among other laws), provides resources to agencies and to grantees, to address concerns regarding potential violations.
We will continue to partner with our grantees to actively address sexual and gender harassment in extramural research. As such, we also invite the community to consider the concrete actions that NIH is taking on our campus with our employees. In December 2017, NIH Director, Dr. Francis Collins, outlined NIH’s stance on this issue, provided resources for our employees, and highlighted future actions to be implemented. We will be improving our Civil Program’s process to better investigate and address allegations; providing information and resources in the NIH Manual to help eliminate workplace harassment; as well as encouraging staff to utilize the confidential consultation and short-term counseling, referral, and follow-up services through the Employment Assistance Program to enhance personal and professional well-being. A survey will also be administered to obtain baseline metrics of workplace interactions and effects of harassment. The findings will be used to effect change here at NIH. These steps will help us maintain a safe and civil organizational culture free from all forms of discrimination.
All people, regardless of their sex or gender, deserve to be valued and respected in their everyday personal and professional lives. NIH is, and will continue to be, committed to the well-being of all of those involved in our supported research endeavors. This conversation will continue here at NIH, because if new advances in public health are to be made, then they should be made by individuals working in a safe and productive environment conducive to learning, exploration, and engagement, while being free from harassment and harm.
For additional information, please see:
- NIH Office of Extramural Research Anti-Sexual Harassment webpage
- NIH Anti-Sexual Harassment website
- NIH Director’s Statement: Changing the Culture of Science to End Sexual Harassment (September 2018)
As stated in NOT-OD-15-152, individuals with questions, concerns or complaints related to any of the civil rights laws are encouraged to contact OCR. In addition, recipient institutions or organizations may have a designated official who is responsible for assisting individuals with civil rights concerns or questions and resources.
A new resource, RPPRs: Who Can Do What?, provides a quick look at the Annual, Interim, and Final Research Performance Progress Reports (RPPRs), including information such as due dates and how to access RPPR links. It also charts what happens to the Interim RPPR when a Type 2, Competing Renewal application is submitted.
by NIH Staff
Informed consent is a critical component of clinical research, but there are often challenges to making the process meaningful and effective. Explore these challenges with experts from diverse perspectives and learn innovative ways to address them at the “Meeting New Challenges in Informed Consent” installment of HHS Office for Human Research Protections (OHRP) Exploratory Workshop, a new initiative to provide a forum for the research community to exchange ideas on important issues related to human subjects protections.The workshop will include discussion on how to lay the groundwork for meaningful informed consent, effectively present information for high-quality decision making, and more!