Final Report on Reducing Administrative Burdens Associated with Research Involving Laboratory Animals

NIH is pleased to announce that last month they worked with the Animal and Plant Health Inspection Service of the United States Department of Agriculture (USDA) and the Food and Drug Administration (FDA) to publish their final report on Reducing Administrative Burden for Researchers: Animal Care and Use in Research (NOT-OD-19-136).  This report, called for in the 21st Century Cures Act, is the culmination of more than two years of diligent work to address inconsistent and overlapping policies governing oversight of research involving animals, while ensuring research findings remain credible and research institutions safeguard animal welfare.

Regulations and policies overseeing federally-sponsored research help ensure NIH remains a responsible steward of public funds.  This extends to properly enforcing the public’s expectation on how laboratory animals will be used in biomedical research, teaching, and testing.  Many stakeholders have pointed out, rightfully so in some cases, that with federal regulations comes increasing reporting requirements which adversely affect research productivity without necessarily improving animal welfare.

Experts from the USDA, the FDA, and the NIH undertook much collaborative, thoughtful, and rigorous deliberation to get to this point.  More on their process can be found here, here, and here.  Their final report reflects, incorporates, and analyzes diverse perspectives of more than 1,300 researchers, animal welfare advocacy organizations, scientific professional societies, members of the public, and others who commented on an earlier draft version.  Investigators, generally speaking, supported the report’s recommendations to reduce various administrative hurdles.  But, importantly, they were also balanced with concerns raised by animal welfare organizations and the public to not lessen requirements in such a way that adversely effects the humane care and use of laboratory animals.

Below are some highlights.  You are encouraged to read the report for the full details and recommendations.

Opportunities exist to reduce duplicative regulations and policies.  These focus generally around areas such as inspections, animal protocol review, and institutional reporting.  For example, NIH will consider flexibilities in how and by whom semiannual inspections by Institutional Animal Care and Use Committees (IACUCs) are conducted.   It may be possible to streamline some IACUC animal protocol reviews, such as by using Designated Member Review for low-risk activities.  And, NIH and USDA will establish a process allowing annual reporting to both agencies on the same reporting schedule (such as through a streamlined data submission on a shared portal).

NIH recognizes the importance and value of better coordination across federal funders.  They will allow public comments for at least sixty days for all new significant policy guidances.  Building on that, guidances from NIH, USDA, and other federal funders will be harmonized as appropriate to reduce duplicative and inconsistent requirements.  NIH concurs with the suggestion to enhance training and resources across federal agencies.  One way to achieve this will be continuing to work with USDA colleagues to develop new industry-led training and web resources to strengthen IACUC activities that focus on reducing burden on investigators.

Keep an eye out for the next steps.  NIH is currently looking at all of the recommendations and thinking about possible ideas, guidance, and resources to address them.  Any planned changes will be implemented over the next couple years, along with a strategy that considers how effective they were. This time frame affords ample opportunity for your voice to still be heard along the way.

NIH would like to congratulate and thank colleagues Dr. Patricia Brown and Ms. Lori Hampton (both of the NIH Office of Laboratory Animal Welfare) for their leadership in helping to prepare the report and for their help in writing this summary.

Original post by NIH 9/25/2019

Don’t Forget to Link Your ORCID iD to Your eRA Commons Profile

Everybody from graduate students to senior scientists is encouraged to register for an ORCID account and link it to their eRA Commons personal profile. Starting October 1, 2019, ORCID identifiers will be required for individuals supported by institutional research training, career development, and other research education awards. xTrain appointments will not be accepted for agency review if potential appointees do not have an ORCID iD linked to their eRA personal profile. ORCID iDs will also be required for PD/PIs on individual fellowship and career development applications submitted for due dates on or after January 25, 2020.

For more details, see the full Guide Notice

Original post by NIH 9.4.2019

NSF: Writing Budget Justifications

A budget justification is the narrative that accompanies your NSF budget and can be up to 5 pages in length. This is where investigators validate and explain the dollar amounts they requested in their line-item budget. Justifications explain pay rates and outline equipment, materials, and supplies requests. Investigators should ask themselves if their budget justifications are answering these questions;

  1. Why are these requested funds needed?
  2. How does each item in the budget help meet the proposed deliverables?
  3. How were these requested funds estimated?

The first place to start before writing any budget justification is the PAPPG. In addition to all the picky details provided there, here are three general pieces of advice that typify budgets that meet little resistance when it comes time to fund your project. The best budget justifications tend to have these things in common:

Use of Parallel Formatting with the Budget Pages

The absolute best way to organize and format your budget justification is to use the same letter and number system used in the budget template. This also helps your Program Officer locate specific items and amounts.

Using Senior Personnel as an example, your budget template will look something like this;

budget just.png

Then your budget justification for this exciting, cross-disciplinary proposal should follow this order;

A. Senior Personnel

  1. Pomona Sprout- Principal Investigator, # months’ work/year, list specific responsibilities and explain how she arrived at this calculation.Year 1 $$$$, Year 2 $$$$, Year 3 $$$$, Year 4 $$$$
  2. Indiana Jones- Co-Principal Investigator, # months’ work/year, list specific responsibilities and explain how he arrived at this calculation.Year 1 $$$$, Year 2 $$$$, Year 3 $$$$, Year 4 $$$$

Salaries: Time and Rates

For all personnel, show what amounts you are asking for and state how you calculated those salary amounts. Give a monthly breakdown and include any fringe rates.

If you are requesting more than two months’ salary for any senior personnel, clearly justify that the rationale fits into one of these two categories:

  1. the person has a soft money position, or
  2. the project scope requires buying out of teaching time.

Section G. Other Direct Costs

Section G is often where confusion happens. The best way to avoid confusion is to start in the PAPPG. It clearly defines which costs should live in lines G1-G6. Some key points to keep in mind are;

  • Do not include funds for Materials and Supplies under Participant Support Costs (section F), even if those items will be used by students or other trainees. List them under G.1.
  • Section G.3 (Consultant Services): If you are using the consultant category, Program Officers may request additional information as to each individual’s expertise, primary organizational affiliation, normal daily compensation rate, and number of days of expected service.
  • Section G.5 (Subawards): For each subaward, a budget and budget narrative need to be prepared and submitted. Please make sure that the subaward budgets list the subawardee institution and PI (and not the information of the lead proposal again).
  • Section G.6 (Other Direct Costs – Other) is a catch-all category that will always attract scrutiny, so especially for this section be sure to be explicit about what you’re requesting, why, and how much it will cost. Also,
  • Graduate student tuition goes in G.6. Other.

In Conclusion

Justify everything. Assume nothing. If necessary, clarify the NSF budget guidelines with your Authorized Organizational Representative prior to submitting a proposal. This is especially important for rare or unusual expenditures, such as foreign subawards or consultancies or salary requests beyond two months for any senior personnel. It’s also important for normal expenditures like travel.

For example, don’t just write, “I need $8000 for international travel to go to two meetings in Europe.” PIs should use an airfare estimator and show the breakdown of costs.

Again, make sure your Program Officer understands how you came up with the total number you’re requesting in each category. There’s no harm in adding a table to show calculations. And this may seem obvious, but make sure the numbers in the budget justification match the numbers in the budget.

Finally, if most of your work is off-campus, check with your Authorized Organizational Representative about whether the off-campus indirect cost rate applies. Different institutions have different policies on when the off-campus rate is appropriate.

For additional tips on preparing an award budget, visit the MCB blog.

Original post by DEB Science Staff 8/23/19

How do I get an ORCHID iD?

If you are not familiar with the ORCID iD, ORCID stands for Open Researcher and Contributor ID.  This is a unique personal digital identifier that distinguishes every researcher and is a global effort for adoption by the scientific community.  Eventually the ID will allow you to link your eRA Commons account to various other resources to reduce your administrative burden. Currently for NIH, your ORCID iD will link to your eRA Commons account so that publications can be easily associated with your grants.

Starting in October 2019, ORCID iDs will be required for new appointees to institutional training grants and other awards who make appointments through xTrain.

When a 2271 appointment form is submitted for Training and Institutional K awards, eRA systems will check to ensure that the ORCID iD is present in the Personal Profile associated with the Commons IDs listed in the form.  Starting this month, a warning will be issued if the ORCID iD is not present.  This warning will be switched to an error in October of 2019 and must be cleared to successfully submit the new appointment.

How do you get an ORCID iD, you ask? Well, that is very easy.  Logging into eRA Commons, you can go to your Personal Profile. Just under your name and your listed eRA Commons roles, you will find a link to create your ORCID iD. Following that link to ORCID.org, you will be able to register and link your Commons account to your ID. See steps and screenshots in the ORCID topic in the eRA Commons online help.

For more information, see Guide Notice NOT-OD-19-109.

Original post on NIH eRA Items of Interest — July 2019

Project Summary/Abstract and Project Narrative: What’s the Difference and What to Include

When writing an NIH grant application, applicants are asked to develop a Project Summary/Abstract and a Project Narrative, two sections that, if funded, are made available on RePORTER to help the public understand the value of NIH-funded research. Check out the table below to see how they compare and what to include.

Project Summary/Abstract Project Narrative
A succinct and accurate description of the proposed work Communicates the public health relevance of the project to the public
30 lines of text or less No more than 2-3 sentences
Use plain language understandable by a general audience Use plain language understandable by a general audience
Include: the project’s broad, long-term objectives and specific aims, and a description of the research design and methods. Do not include: proprietary or confidential information, or descriptions of past accomplishments. Describe how, in the short or long term, the research would contribute to: the fundamental knowledge about the nature and behavior of living systems, and/or the application of that knowledge to enhance health, lengthen life, and reduce illness and disability.
If the application is funded, the summary/abstract will be available on RePORTER If the application is funded, the narrative will be available on RePORTER

For more guidance, see the Application Guide for Project Summary/Abstract and Project Narrative.

Original post on 6/28/2019 by NIH Staff

Clarifying Long-Standing NIH Policies on Disclosing Other Support

Who funds your current research?  Make sure to let NIH know.  It is required.

Institutions and investigators must disclose all forms of what is termed “other support” when applying for and receiving NIH grants.  Other support, as described in the NIH Grants Policy Statement (GPS) Section 2.5.1, includes all resources, regardless of whether or not they have monetary value, available in direct support of an individual’s research endeavors.

This is not new, but rather a long-standing requirement for those seeking NIH grants to be fully transparent regarding all of their research activities both domestic and foreign, which is critical for prudent fiscal management, accountability, and stewardship of U.S. taxpayer funds.

So, do you need to report those other NIH grants you have?  YES.  What about a contract from another federal agency?  YES.  Grants or contracts that go through another institution, including institutions in foreign countries?  YES.  Commercial funds?  YES.  Domestic or international positions held by senior/key personnel? YES.  In kind lab or office space?  YES.  Scientific materials?  YES.  Even if it has no monetary value?  YES. Affiliations (even if described as honorary or adjunct) with foreign entities or governments, including talents programs?  YES.

NIH uses this information to ensure that all resources made available to an investigator, including any foreign activities, are considered prior to making an award.  With this in hand, they will know that sufficient levels of effort are committed to the project, there is no scientific, budgetary, or commitment overlap, and only the funds necessary to the approved project are included in the grant award.

NIH recently published a Guide Notice to clarify what is meant by foreign activities as they relate to other support and what NIH expects to be disclosed.  As part of this notice, applicants are reminded they must also promptly notify NIH if previously submitted just-in-time information is substantively changed prior to award or at the time of the progress report, which could lead to budgetary, scientific, or commitment overlap.

Since institutions are the applicants for and recipients of NIH funding, they are responsible for ensuring that all materials submitted to NIH are complete and accurate.  This means they must also ensure individual investigators make all appropriate disclosures to them regarding other support, affiliations, and financial interests.  Sometimes NIH discovers potential issues involving institutions not accurately reporting other support, including foreign support through foreign institutions, associated with their NIH award.  Sometimes it’s because investigators don’t report their foreign research activities to their American institutions.  In such cases, we can take (and have taken) action.  Depending on the severity and duration of the noncompliance (see NIH GPS Section 8.5), NIH may contact the affected institutions, impose specific award conditions, disallow costs, withhold future awards for the project or program, suspend the award activities, make a referral for investigator suspension or debarment, or terminate the award.

NIH wants to be clear that they are focusing their efforts on enhancing research integrity across all their processes and systems.  The extraordinary contributions of foreign nationals to American science are indisputable.  As just one example, 24% of U.S. Nobel prizes have been awarded to foreign-born scientists.  The biomedical research workforce continues to be greatly enriched and strengthened by scientists who come to our shores from many parts of the world.  The overwhelming majority of researchers participating in NIH grants, whether U.S. or foreign-born, are honest contributors to the advancement of knowledge that benefits us all.  Driving away talented scientists from other countries would have a profoundly negative effect on American productivity.

NIH appreciates the efforts of recipient organizations to partner with them to improve reporting of all sources of research support and international collaborative research. These obligations are instrumental to protecting the integrity of biomedical research.  Working together, NIH along with you and your organization can be better assured that federal funding decisions are sound, proprietary information is protected, and compliance with grant terms is achieved.

If you have questions, please refer to the FAQs, the Guide Notice, or send an email to grantscompliance@od.nih.gov for additional assistance.

Original post on 7/11/19 by Mike Lauer/NIH

Now Available in Research.gov: Support for Collaborative Proposals with Subawards and New SPO/AOR Email Notification

Important message from NSF:

We are very pleased to announce that as of June 24, 2019, the research community can prepare and submit full, research collaborative proposals with subawards in Research.gov. This is in addition to the existing capability (since April 2018) to prepare and submit full, research non-collaborative proposals in Research.gov. Since that initial release just over a year ago, the National Science Foundation (NSF) has implemented several enhancements to the site, including additional flexibilities for PDF uploads, support for PDFs generated from LaTeX source documents, and compliance checks for fonts and font sizes. Future enhancements to the Research.gov proposal system will allow the preparation and submission of separately submitted collaborative proposals from multiple organizations.

Compared to FastLane, our grants management system launched in 1994, the Research.gov proposal system is much easier to use and provides proposers with faster document uploads and the ability to quickly create and update documents. We encourage you to try the new system, and we are confident that you will agree that this next generation grants management system is more efficient and less burdensome than FastLane.

Also, as of June 24, 2019, a new email notification functionality was implemented to generate Sponsored Project Office (SPO)/Authorized Organizational Representative (AOR) email notifications when Principal Investigators (PIs) enable proposal access to SPOs/AORs. A similar email notification is available in FastLane, and we are excited to add the capability in Research.gov.

Modernizing Proposal Preparation and Submission

NSF’s modernization of its FastLane system continues with the goal of improving the user experience to prepare and submit NSF proposals, while also reducing administrative burden for both proposers and NSF staff. As capabilities are migrated from FastLane to Research.gov, the system features will expand until it eventually replaces FastLane for proposal preparation and submission.

While proposers can still prepare and submit collaborative proposals with subawards as well as full, research non-collaborative proposals in FastLane, we encourage the research community to use the new Research.gov proposal system because as NSF continues to enhance the new system incrementally, your vital feedback is being incorporated during the development process.

Preparing and Submitting Proposals in Research.gov
Here’s some of the current Research.gov features that proposers are enjoying:

  • Integrated compliance checks for fonts, margins, and line spacing;
  • Real-time compliance feedback and alerts, so proposers know a proposal section is compliant before moving on to another section;
  • Specific checks on the budget screens and for Collaborators and Other Affiliations (COA) uploads;
  • A few seconds to upload documents versus 30-90 seconds for each document upload in FastLane; and
  • Embedded relevant sections of the Proposal & Award Policies & Procedures Guide (PAPPG) and video job aids, so proposers don’t have to go to multiple sites to access guidance and tools.

Initiating a Proposal in Research.gov
By answering a few questions in the five-step proposal wizard, Research.gov customizes the set-up process and compliance rules for the proposal being created. In addition, the proposal wizard dynamically drives the proposal sections that are required on subsequent screens.

If you have not done so already, we invite you to initiate a proposal in Research.gov by following the steps outlined below:

  • Open Research.gov and click “Sign In” located at the top right of the screen;
  • Enter your NSF ID and password and click “Sign In;”
  • From the Research.gov “My Desktop” page, click “New! Prepare Proposals (Limited proposal types)” in the “Prepare & Submit Proposals tile” or go to this option from the top navigation bar by selecting the “Prepare & Submit Proposals” tab and clicking on “New! Prepare Proposals (Limited proposal types);”
  • Select the “Prepare Proposal” option in the “Prepare New Proposal” tile on the left side of the Proposal Preparation page; and
  • Follow the five-step proposal wizard to set up the proposal.

After completing the initiation steps, you are ready to complete all required and optional sections

Submitting Feedback
NSF wants to hear from you! To submit feedback about the new Research.gov Proposal Preparation and Submission Site:

  • Go to the Research.gov Feedback page;
  • Choose “Other” under the Site Area dropdown menu;
  • Include your feedback in the Comments or Suggestions field; and
  • Click Submit when you are ready to send your feedback to NSF.

Training Resources and Additional Information

Please share this information with your colleagues. If you have IT system-related questions, please contact the NSF Help Desk at 1-800-381-1532 or rgov@nsf.gov. Policy-related questions should be directed to policy@nsf.gov.

Original post by NSF 6/26/2019

Hyperlinks in Grant Applications

The do’s and don’ts of hyperlinks in grant applications are simple:

  • Do include hyperlinks when explicitly requested in application guide, funding opportunity, or NIH Guide notice instructions
  • Do use hyperlinks in relevant citations and publications included in biosketches and publication list attachments
  • Don’t use hyperlinks anywhere else in your application

It would be hard to read more than a couple paragraphs on the internet these days without encountering a hyperlink to a definition or additional clarifying information. Hyperlinks are everywhere. So, why does NIH limit the use of hyperlinks in grant applications?

  • Fairness. Key sections of NIH grant applications – Specific Aims, Research Strategies, and Training Program Plans, to name a few – are page limited. Page limits promote fairness by ensuring all applicants have an equal opportunity to present their proposed project. Linking out to additional supporting information negates our page limits.
  • Reviewer Anonymity. We instruct reviewers to rely on the information contained in the grant application and caution them not to follow unrequested links to websites. Website access, especially access to sites controlled by the institution or PI, can be tracked and can compromise reviewer anonymity.
  • Security. Just like clicking on links in phishing emails, following links in grant applications can expose a reader to viruses, malware, or other security threats that can compromise our ability to protect application information.

At the end of the day, risk avoidance may be the most convincing reason to avoid unrequested hyperlinks. NIH may withdraw your application from consideration if you include them. Don’t risk it. Write a compelling, self-contained grant application and let it speak for itself.

Original post by NIH Staff 5/13/2019

Now Available in Research.gov: Support for Collaborative Proposals with Subawards and New SPO/AOR Email Notification

NSF is pleased to announce that as of June 24, 2019, the research community can prepare and submit full, research collaborative proposals with subawards in Research.gov.  This is in addition to the existing capability (since April 2018) to prepare and submit full, research non-collaborative proposals in Research.gov.  Since that initial release just over a year ago, the National Science Foundation (NSF) has implemented several enhancements to the site, including additional flexibilities for PDF uploads, support for PDFs generated from LaTeX source documents, and compliance checks for fonts and font sizes. Future enhancements to the Research.gov proposal system will allow the preparation and submission of separately submitted collaborative proposals from multiple organizations.

Compared to FastLane, our grants management system launched in 1994, the Research.gov proposal system is much easier to use and provides proposers with faster document uploads and the ability to quickly create and update documents. We encourage you to try the new system, and we are confident that you will agree that this next generation grants management system is more efficient and less burdensome than FastLane.

Also, as of June 24, 2019, a new email notification functionality was implemented to generate Sponsored Project Office (SPO)/Authorized Organizational Representative (AOR) email notifications when Principal Investigators (PIs) enable proposal access to SPOs/AORs. A similar email notification is available in FastLane, and we are excited to add the capability in Research.gov.

Modernizing Proposal Preparation and Submission

NSF’s modernization of its FastLane system continues with the goal of improving the user experience to prepare and submit NSF proposals, while also reducing administrative burden for both proposers and NSF staff. As capabilities are migrated from FastLane to Research.gov, the system features will expand until it eventually replaces FastLane for proposal preparation and submission.

 While proposers can still prepare and submit collaborative proposals with subawards as well as full, research non-collaborative proposals in FastLane, NSF encourages the research community to use the new Research.gov proposal system because as NSF continues to enhance the new system incrementally, your vital feedback is being incorporated during the development process.

Preparing and Submitting Proposals in Research.gov

Here’s some of the current Research.gov features that proposers are enjoying:

  • Integrated compliance checks for fonts, margins, and line spacing;
  • Real-time compliance feedback and alerts, so proposers know a proposal section is compliant before moving on to another section;
  • Specific checks on the budget screens and for Collaborators and Other Affiliations (COA) uploads;
  • A few seconds to upload documents versus 30-90 seconds for each document upload in FastLane; and
  • Embedded relevant sections of the Proposal & Award Policies & Procedures Guide (PAPPG) and video job aids, so proposers don’t have to go to multiple sites to access guidance and tools.

Initiating a Proposal in Research.gov

By answering a few questions in the five-step proposal wizard, Research.gov customizes the set-up process and compliance rules for the proposal being created. In addition, the proposal wizard dynamically drives the proposal sections that are required on subsequent screens.

 If you have not done so already, we invite you to initiate a proposal in Research.gov by following the steps outlined below:

  • Open Research.gov and click “Sign In” located at the top right of the screen;
  • Enter your NSF ID and password and click “Sign In;”
  • From the Research.gov “My Desktop” page, click “New! Prepare Proposals (Limited proposal types)” in the “Prepare & Submit Proposals tile” or go to this option from the top navigation bar by selecting the “Prepare & Submit Proposals” tab and clicking on “New! Prepare Proposals (Limited proposal types);”
  • Select the “Prepare Proposal” option in the “Prepare New Proposal” tile on the left side of the Proposal Preparation page; and
  • Follow the five-step proposal wizard to set up the proposal.

 After completing the initiation steps, you are ready to complete all required and optional sections of your proposal and then submit it to NSF.

 Submitting Feedback

NSF wants to hear from you! To submit feedback about the new Research.gov Proposal Preparation and Submission Site:

  • Go to the Research.gov Feedback page;
  • Choose “Other” under the Site Area dropdown menu;
  • Include your feedback in the Comments or Suggestions field; and
  • Click Submit when you are ready to send your feedback to NSF.

 Training Resources and Additional Information

NSF encourages you to share this information with your colleagues. If you have IT system-related questions, please contact the NSF Help Desk at 1-800-381-1532 or rgov@nsf.gov. Policy-related questions should be directed to policy@nsf.gov.

Original post by NSF on 6/24/2019

NSF-approved Biographical Sketch Format

Please be advised that the National Science Foundation (NSF) has designated the National Institutes of Health’s SciENcv (Science Experts Network Curriculum Vitae) as an NSF-approved format for submission of biographical sketch(es) and is encouraging its use to prepare a biographical sketch for inclusion in proposals to NSF.

In accordance with the current Proposal & Award Policies & Procedures Guide (PAPPG) (NSF 19-1), a biographical sketch (limited to two pages) is required for each individual identified as senior personnel on a proposal, and a separate biographical sketch PDF file, or other NSF-approved format, must be uploaded in FastLane for each designated individual (see PAPPG Chapter II.C.2.f.). These biographical sketch and file format requirements also apply to NSF proposals submitted through Research.gov and Grants.gov.

Use of an NSF-approved format aims to reduce administrative burden and improve efficiencies by providing proposers with a compliant and reusable way to maintain this information for subsequent proposal submissions to NSF, while also ensuring that the information is submitted in a searchable composition.

Beginning with the next iteration of the PAPPG (expected to be implemented in January 2020), NSF will only accept PDFs for biographical sketches that are generated through use of an NSF-approved format. A description of NSF-approved format(s) will be posted on the NSF website when the PAPPG is issued. A draft version of the PAPPG was published in the Federal Register for public comment. The deadline for submitting comments is COB July 29, 2019.

Multiple training resources are available on the SciENcv website. The following website resources may be of assistance to proposers preparing a biographical sketch using the SciENcv format:

You are encouraged to share this information with your colleagues. If you have IT system-related questions, please contact the NSF Help Desk at 1-800-381-1532 or rgov@nsf.gov. Policy-related questions should be directed to policy@nsf.gov.

Original post by NSF 6/17/2019