NIH wants your input on their Strategic Plan for Data Science

In their latest Request for Information (RFI) notice, the National Institutes of Health recognize that "data science has increased in importance for biomedical research over the past decade" and they expect this trend will continue; because of this, they have created a draft strategic plan for data science which explains their goals, objectives and implementation tactics to keep the NIH on the cutting edge. The draft plan may be downloaded here: https://grants.nih.gov/grants/rfi/NIH-Strategic-Plan-for-Data-Science.pdf. Responses to this request for information must be received by April 2nd, and submitted electronically to: https://grants.nih.gov/grants/rfi/rfi.cfm?ID=73. Please see the complete RFI notice at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-134.html for more about what questions the NIH wants you, the stakeholder, to answer for them.

NIH's 'All of Us' is looking for research topics

The NIH's 'All of Us' program looks to create a diverse database of more than one million people across the country willing to share information about their health, habits and the conditions where they live. Anyone can sign up! And now the NIH is looking to researchers to provide them with ideas about what topics are most important to study. You can submit your research ideas and questions at the All of Us Research Priorities website: https://allofusresearchpriorities.ideascale.com/. What do YOU think is the most important medical research we should be using this database for? The submission window is open until February 9th, 2018.

NIH regional seminar on program funding and grants

NIH announces Early Registration rates for a May 2018 regional seminar on program funding and grants administration for researchers or administrators who want to learn more about NIH, talk to colleagues from the area, and speak with NIH personnel. The two-day seminar will be held May 2nd to 4th, at the Hyatt Regency Washington on Capitol Hill, Washington DC. Registration is open now and early bird rates are available until December 15th. There are also full and half-day workshops available.

Act FAST! NIH regional seminars sell out very quickly.

Should scientific presentations use emojis?

Last November, a team of scientists attended Emojicon in San Francisco and demanded that the Unicode Consortium approve a new set of scientific emojis that would better help them express themselves quickly. (See: Scientists call for emoji that represent the full spectrum of nerdom, Quartz, November 14, 2016.)

Now, the National Institute of Neurological Disorders and Stroke, after meeting with conference organizers to discuss efforts to increase transparency in the communication of scientific results, has released a Request for Information on developing emojis for scientific presentations such as conference posters. Use of an accepted emoji indicating, for example, randomized trials or a double-blind protocol, would allow someone viewing a poster to quickly assess the research method's rigor.

Responses are requested by December 15th. See NOT-NS-18-014, "Request for Information on Developing Experimental Design "Emoji" Symbols for Use in Scientific Presentations" for more information.

scientist emoji via Wikimedia Commons

NIH's Loan Repayment Program -- webinar coming up soon!

Interested in the NIH's Loan Repayment Program (see previous blog post here) but having some trouble figuring out how to apply? Register for the LRP Technical Assistance webinar at this link: NIH LRP Webinar.

Webinar Info:
Date and Time: Wednesday, September 27, 2017 3:00 pm, EST
Meeting number (access code): 620 964 208
Event password: LRPApp
Call-in toll-free number (US/Canada): 1-650-479-3208

Agenda:
1. Description of the Programs and Eligibility Requirements
2. Overview of Application Components
- Major Sections of the Application
- Research Activities and Personal Statement
- Recommendations
- Loan Information
3. Application Timeline
4. Applicant Checklist
5. Q&A

NIH's Next Generation Researchers initiative

As of August 31, 2017, the National Institutes of Health has implemented new procedures to better support early stage and early established investigators called the Next Generation Researchers Initiative. Early state investigators (ESI) are those who are within 10 years of their terminal research degree or the end of their post-graduate clinical training, who have not received a "substantial" NIH award yet. (For a list of smaller NIH grants that an investigator can hold, and still be considered early stage, click here.) An early established investigator (EEI) is within 10 years of receiving their first substantial NIH award as an early stage investigator. Both classes of investigator will be given priority, and NIH's goal is to award 200 more ESI and 200 more EEI awards this fiscal year than last year. Learn more about this initiative here: NOT-OD-17-101.

NIH Loan Repayment Program

The NIH Loan Repayment Programs (LRPs) are a set of programs established by Congress, designed to recruit and retain highly qualified health professionals into biomedical or biobehavioral research careers. The escalating costs of advanced education and training in medicine and clinical specialties are forcing some scientists to abandon their research careers for higher-paying private industry or private practice careers.

The LRPs counteract that financial pressure by repaying up to $35,000 annually of a researcher's qualified educational debt in return for a commitment to engage in NIH mission-relevant research. Awardees can receive up to $70,000 of qualified educational debt repayment with a two-year contract. This year's application cycle opens on Friday, September 1st. See the LRP website for more information: lrp.nih.gov.

Do you do research with human subjects?

Under the NIH's new definition of "clinical trial", your study might become one, soon.

Due to upcoming policy changes in the definition which broaden the requirements that qualify a study as a clinical trial, you may have to start checking "yes" to clinical trial on the Notice of Intent to Submit form and registering your studies on ClinicalTrials.gov, when you did not have to do so previously.

The NIH has created a helpful page at https://grants.nih.gov/policy/clinical-trials.htm that provides more information about the changes in policy, and the four questions which, if you answer "yes" to all, will define your human-subject study as a clinical trial.

Amid controversy, NIH backs down on grant limits

On June 8, Francis Collins posted on The NIH Director about the Grant Support Index (GSI), the method that was used to determine the advantage limiting NIH grants over a researcher's career had for beginning and mid-level researchers, as well as taxpayers, and the fact that "significant concerns" about the GSI's methodology have been expressed -- enough so that the NIH is now backing off that plan, and has come up with a new one called the Next Generation Researchers Initiative. While this plan also "place[s] greater emphasis on current NIH funding programs aimed at early-stage and mid-career investigators", some researchers feel it's not enough, and that the initial plan was perhaps abandoned because it was "shoved down quickly by a bunch of senior folks," as Gary S. McDowell states in The Chronicle of Higher Education. We'll have to wait and see how this all plays out for all our researchers, regardless of seniority.

NIH policy workshop on biosafety and emerging technology in July

On July 18-19, the NIH will be hosting a workshop entitled "NIH Guidelines: Honoring the Past, Charting the Future" in Rockville, MD. The workshop is designed for investigators, research administrators and biosafety professionals. More information about the event and how to register can be found here: https://tinyurl.com/ybpt2tm9

NIH looks to cap funding with the new Grant Support Index

On May 2, 2017, the National Institutes of Health announced a new approach to grant funding: the Grant Support Index (GSI). This index will assign points to individual researchers or labs based on the funding they receive from the NIH, with the aim to cap funding to one researcher or lab at 21 points. The purpose of this approach is to allow the NIH to fund more, and more diverse, researchers, and is based on a number of reports and findings, e.g., 40% of their funding is going to 10% of NIH-funded investigators and "greater degrees of funding may not generate as much additional scientific output as expected due to the impact of diminishing returns" (Mike Lauer, Open Mike blog). The NIH estimates that the new GSI may only affect about six percent of NIH-funded investigators.

For more information, please see the Open Mike blogpost, "Implementing Limits on Grant Support to Strengthen the Biomedical Research Workforce" and The NIH Director's website article, "New NIH Approach to Grant Funding Aimed at Optimizing Stewardship of Taxpayer Dollars".

Indirect costs and the "skinny" federal budget

Among the proposed cuts to federal grant funders, the NIH's budget is anticipated to be reduced by 18%, some of which could come out of indirect costs to universities, hospitals and other research institutions. Indirect costs are sometimes mistakenly thought of as "extra money" for a grant-holding institution rather than the reimbursement of expenses associated with doing research. Direct costs usually do not include essential items such as salaries for safety, compliance and grant management personnel, building upkeep, and utilities. These are all real costs to the research institution and must be paid for out of the indirect costs.

These misperceptions about indirect costs prompted COGR, the Council on Governmental Relations, an association of research institutions, to publish a three-page Talking Points document discussing what indirect costs are, how they are calculated, and how cutting indirect costs could affect research institutions like Fordham University. You can download it here: COGR Talking Points. Please feel free to share it.

A summary of new NIH policy changes

On the award side, the National Institutes of Health have made some changes to their policies on:

• final progress reports
• training for investigators involved in NIH-funded clinical trials, and
• reporting of NIH-funded clinical trials.

On the proposal side, there are changes in policy regarding:

• the items allowed to be included in appendices
• post-submission materials, and
• acceptable fonts/text color.

Finally, starting tomorrow you may submit an interim progress report rather than a final report if you are ending one grant cycle and waiting for the next cycle to begin. See this webpage for complete details and links to the Notices involved.

Upcoming NIH regional seminars

Registration for two Regional Seminars on Program Funding and Grants Administration will open in January. The first will be held in early May in New Orleans; the second in late October in Baltimore. There will also be pre-seminar workshops available on topics such as using eRA Commons, intellectual property issues, and human subject protocols.

Please see this notice for more information: NOT-OD-17-026.

NIH announces new appendix policy effective January 25th

The NIH will be updating application instructions by November 25th to reflect changes in their appendix policy for applications due on or after January 25, 2017. The only allowable appendix materials (unless specified in the FOA) will be:
For applications proposing clinical trials

Clinical trial protocols

Investigator's brochure from Investigational New Drug (IND), as appropriate

For all applications

Blank informed consent/assent forms

Blank surveys, questionnaires, data collection instruments

FOA-specified items

Note that the biggest change is the disallowance of any publications.

NIH peer review briefings for fellowships and R01 applicants

The National Institutes of Health will be providing three online video briefings in November and December regarding peer review at the NIH. On 11/2, they will concentrate on fellowship applications; on 12/1, R01 applications; and 12/2 a more general briefing for basic research applications. Registration is required, but free, and registrants will have the opportunity to submit questions before and during the webinars. Please see notice NOT-OD-16-152 for more information.

Upcoming research workshops: NIH and NSF

The NIH is holding a Regional Seminar in Chicago, at the Palmer House, October 26-28. General registration for this seminar ends September 1st.
Visit http://regionalseminars.od.nih.gov/chicago2016/ to view the agenda and register for this seminar, which has three tracks: administrators, new investigators, and all interests (you are not limited to staying within one track).

---

The NSF will be holding a Grants Conference in Pittsburgh at Carnegie Mellon University November 14 and 15. Visit http://www.nsfgrantsconferences.com/ehome/nsf/fall2016/ to view the conference site. Registration begins on September 8th. This conference is excellent for those who want to know more about the NSF's upcoming programs, the merit review process, and proposal preparation.

---

These research workshops are a great opportunity to meet NIH and NSF program officers and staff. In the past, for example, more than 100 NIH employees were available at one of their regional seminars. Don't miss out!

NIH's new Rigor and Reproducibility requirement in a handy chart

The NIH has come out with a resource chart to help you make sense of their Rigor and Reproducibility in NIH Applications requirement (see http://grants.nih.gov/reproducibility/index.htm).

Click here to download the PDF version of the chart.

Two upcoming research workshops

On May 11-13, the 2016 NIH Regional Seminar is being held in Baltimore, Maryland at the Renaissance Baltimore Harborplace Hotel. This workshop will cover all aspects of grant-making processes with the NIH for beginner, intermediate and advanced levels, from how to find a funding opportunity to how to comply with post award requirements such as the Public Access Policy. More information here: http://regionalseminars.od.nih.gov/baltimore2016/

---

The OHRP-sponsored Research Community Forum will take place June 21-22 at the Lowes Vanderbilt Hotel in Nashville, Tennessee. This year's theme is "The Changing Landscape of Research: Where do we go from here?" and will focus on recent and proposed changes to research as it pertains to human subjects. Everyone from physicians to students are invited to participate in this event. More information at this link.

NIH issues clarification on yet another new biosketch format

NOT-OD-16-080 clarifies the instructions for biosketches to be included with proposals that have application due dates on or after May 25, 2016.

Also, don't forget that for these applications, most will be using the new Forms D packages on Grants.gov. Be sure you download the correct version!