Nexus September 2012
Dr. Sally Rockey

Rock Talk

Celebrating Science

Earlier this month, I had the opportunity to participate in A Celebration of Science, where more than 1,000 leaders from across the scientific research and policy communities participated in a three-day event led by FasterCures and the Milken Institute. This celebration was held to reaffirm the importance of biomedical research and showcase the outcomes of research on people’s lives. The event took many forms, ranging from panels and presentations to a special concert event at the Kennedy Center.

NIH's "rock docs" performing at A Celebration of Science

Rocking out at the Kennedy Center in support of science, with Francis Collins and yours truly

The event came to NIH for a full day, where speakers and attendees convened at our Natcher Conference Center, not only to show the positive results of biomedical research on people’s lives, but also to engage in frank discussions of how to move forward.

These discussions included a topic my office is closely familiar with: supporting science in times of constrained budgets. It was promising to see Congressional representatives from both sides of the aisle—Representative Eric Cantor, the House majority leader, and Representative Steny Hoyer, the House minority whip—share the stage and acknowledge NIH’s vital role in supporting biomedical research.

But I was especially moved by the presentations from the individuals and families that have benefited from biomedical research progress. Dawn Averitt Bridge, an HIV-positive woman that later developed AIDS, spoke about how healthcare advances not only allowed her to survive, but also thrive in life, and become the mother of two non-HIV-infected children. Retta and Joe Beery, joined by their three children, described how whole genome sequencing changed their family’s life when it pinpointed the movement disorder affecting two of their children since birth—a treatable form of dystonia. It was extraordinarily meaningful to have patients share their personal stories and demonstrate the true value of NIH research—its ability to improve lives.

The day was inspiring and makes me proud to work at NIH and especially proud of the research you do as part of our incredible mission: to improve the health of the nation and the world. I encourage you to watch the highlight video below, or the full NIH Day morning session and evening session online. I hope it inspires you too.

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What’s Next?—Reviewing Your Summary Statement and Thinking About Resubmitting

So you’re wearing your lucky shoes and are ready to take a first look at the results of your grant review. Whether you are anticipating doing a victory dance or getting ready to head out to the nearest kickboxing class, it’s a good time to think about what comes next.

Some of you have noticed that the summary statements now include a link to a new online resource to address just this question. Especially if you are new to NIH funding, I encourage you to check out this “Next Steps” page, which was put together to help NIH grant applicants with the “What’s next?” questions following receipt of the summary statement.

If you aren’t in the position to be preparing  Just-in-Time information for an award, but  instead are considering resubmission, you may want to consider some of the data that have appeared in my previous blog posts, in addition to the resources available on grants.nih.gov. For example, in the post “Correlation Between Overall Impact Scores and Criterion Scores”, I show how approach, innovation, and significance factor heavily into the overall impact scores. As you look at your summary statement, talk to your NIH program official, and discuss your ideas with colleagues, it might be useful to keep this in mind.

Additionally our podcast series, All About Grants, includes conversations with NIH staff to help you understand how your grant is reviewed, such as these two episodes on summary statement basics and resubmission advice.

Whether you’re new to the grant application process or an experienced applicant, we hope you find these resources useful.

Posted in Application Submission, New Resources, Peer Review, Rock Talk | Tagged , | 3 Comments

Partnering with FDA to Support Research to Inform Tobacco Regulation

I am excited to tell you about a collaboration we have launched with the FDA to support research to inform the development and evaluation of regulations on the manufacturing, distribution, and marketing of tobacco products. FDA was granted authority to regulate tobacco products by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), which was signed into law in 2009.

FDA has identified 56 research priorities among 7 research areas related to tobacco use and public health. In collaboration with the FDA Center for Tobacco Products (CTP), which oversees implementation of the Tobacco Control Act, we have recently announced several funding opportunities to support scientific research that will inform CTP in carrying out its regulatory authorities. These include a research center program (P50) and ongoing support of a variety of research project grants (R01, R03, and R21). The awards made under these funding announcements will be administered by NIH using designated funds from the FDA CTP for tobacco regulatory science.

This collaboration is a great benefit for both agencies. Several NIH institutes and centers have long supported tobacco-related research. In fiscal year 2011, approximately $362 million was awarded by NIH to support research projects related to tobacco use.

We’re looking forward to helping the FDA CTP in achieving their goals—preventing tobacco use, especially among youth, encouraging current users trying to quit, and decreasing the harms from tobacco product use. We hope researchers are also looking forward to contributing their expertise to this interdisciplinary effort.

For more information about this collaboration, as well as links to research resources and contact information for further questions, check out the “Tobacco Control Regulatory Science: Understanding the Family Smoking Prevention and Tobacco Control Act” website at http://www.cancercontrol.cancer.gov/nih-fda/.

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NIH RePORT up for a People’s Choice Award from HHSinnovates—Voting Is Now Open!

Collage of RePORT screenshots I’m excited to let you know that NIH RePORT (Research Portfolio Online Reporting Tools) is a finalist for the HHSinnovates program, and for the first time ever the public will have the opportunity to vote on RePORT and the other finalists. We have often heard from you about the value that RePORT provides to the biomedical community, so now is the time to show your appreciation through your vote.

HHSinnovates is a program run by the Department of Health and Human Services (HHS) to highlight innovations in programs and processes developed by HHS staff. HHS Secretary Kathleen Sebelius launched the program in 2010, but this year marks the first “People’s Choice Award” where the public can vote and rate the HHS projects they deem most innovative.

Out of the initial 60 projects submitted in this round, RePORT is one of six finalists. I’m especially proud of the advances RePORT has made – and continues to make – in increasing transparency and accessibility to information on the NIH research portfolio.

As I’ve discussed in previous blog posts, RePORT’s innovative interface gives you access to comprehensive information about NIH funding, and the website continues to grow. One of the newest features links RePORTER with EurekAlert!, the international science news service operated by the American Association for the Advancement of Science (AAAS). When looking up an NIH award in RePORTER, you can view the news releases published in EurekAlert! that describe research supported by that particular award.

To demonstrate this tool, let’s build upon an example from my most recent blog post on RePORT, the search for active projects related to obesity. You’ll see in the screenshot below that the project search results page contains a “News & More” tab. At the time of writing this post, the tab shows that there are 30 press releases related to projects in the search results, along with 6 stories associated with projects funded through the Recovery Act. (The “News & More” feature is new. We expect the number of releases to increase quickly!)

Screenshot of project search results from RePORT

Clicking on the press release link will expand the list of 30, and you can sort by date to find the most recent news, for example, this August 15th release from the University of Maryland Medical Center.

Screenshots of RePORT and news and press release results

So how does RePORTER identify these press releases? NIH notices of grant award require acknowledgement of federal funding in press releases and research manuscripts. When press offices of the NIH grantee institutions use EurekAlert! to publish their releases, they now have the ability to tag their press releases with relevant NIH grant numbers, similar to how PIs include their NIH grant numbers in the acknowledgements of published research manuscripts. If an institution does not use EurekaAlert! they can work with the communications office of the funding NIH institute or center to get the release linked to the grant record in RePORTER.

(Note: At the current time RePORTER does not link press releases to specific subprojects of multi-project grants. As a result, RePORTER search results containing subprojects will retrieve all news associated with the parent grant award and all of its other subprojects, including those in diverse areas of research.)

Congratulations to all the finalists, and I hope you will consider voting for NIH RePORT!

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Top Stories

NIH Revises the NIH Guidelines for Research Involving Recombinant DNA Molecules

The NIH Office of Biotechnology Activities (OBA) has finalized updates to the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) to explicitly cover certain types of basic and clinical research with nucleic acid molecules created solely by synthetic means. The updated guidelines, which go into full effect in March 2013 and will be known as the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, address the need for appropriate biosafety containment of an agent regardless of whether the technique used to create the organisms is recombinant or synthetic. These guidelines also address a National Science Advisory Board for Biosecurity (NSABB) recommendation to ensure that federal  biosafety guidelines are appropriate, adequate, and easily understood with respect to working with synthetic nucleic acids. The revisions also clarify the criteria for selection of certain experiments that involve the introduction of drug resistance into microorganisms for NIH review (see Section III-A-1 and III-B of the NIH Guidelines).

The updated NIH Guidelines will go into effect in March 2013. The changes were announced in the Federal Register (volume 77, no. 172, p.54584-97) on September 5, and published in the NIH Guide (NOT-OD-12-150) on September 11. Additionally, a copy of the revised NIH Guidelines can be found on the Office of Biotechnology Activities website, together with answers to frequently asked questions regarding the changes related to synthetic nucleic acid research and addressing experiments involving the introduction of drug resistance into microorganisms.

For any specific questions not addressed by the Guide notice and OBA website, please contact the NIH Office of Biotechnology Activities by e-mail (oba@od.nih.gov), telephone (301-496-9838), or fax (301-496-9839).

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New Resources

NIH Pilots Electronic Submission for Relinquishing Statement, Type 6 & 7 Applications

As part of the continuing effort to move to electronic processes, NIH is now piloting a new eRA Commons module, which allows submission of relinquishing statements.  NIH is also piloting the electronic submission of applications through Grants.gov for post-award changes in grantee organization or grantee organizational status.  The following will be accepted electronically:

  • The Official Statement Relinquishing Interests and Rights in a Public Health Service Research Grant (PHS 3734 Form) (relinquishing statement). For more information see the Guide Notice.
  • Change in Grantee Organizational Status: Successor-in-Interest Applications for Existing NIH Grants (Type 6). For more information see the Guide Notice or Parent Announcement.
  • Post-award Change of Grantee Institution (Type 7) requests. For more information see the Guide Notice or Parent Announcement.

During this open pilot, grantees may electronically submit a relinquishing statement even if the corresponding application is submitted on paper.  You may also follow the current paper process as  described in the NIH Grants Policy Statement.  However, we encourage grantees to participate in this pilot. This is will allow you to become familiar with the electronic processes before they are required.

Posted in Application Submission, Award Management, New Resources | 2 Comments

What’s Next?—Reviewing Your Summary Statement and Thinking About Resubmitting

So you’re wearing your lucky shoes and are ready to take a first look at the results of your grant review. Whether you are anticipating doing a victory dance or getting ready to head out to the nearest kickboxing class, it’s a good time to think about what comes next.

Some of you have noticed that the summary statements now include a link to a new online resource to address just this question. Especially if you are new to NIH funding, I encourage you to check out this “Next Steps” page, which was put together to help NIH grant applicants with the “What’s next?” questions following receipt of the summary statement.

If you aren’t in the position to be preparing  Just-in-Time information for an award, but  instead are considering resubmission, you may want to consider some of the data that have appeared in my previous blog posts, in addition to the resources available on grants.nih.gov. For example, in the post “Correlation Between Overall Impact Scores and Criterion Scores”, I show how approach, innovation, and significance factor heavily into the overall impact scores. As you look at your summary statement, talk to your NIH program official, and discuss your ideas with colleagues, it might be useful to keep this in mind.

Additionally our podcast series, All About Grants, includes conversations with NIH staff to help you understand how your grant is reviewed, such as these two episodes on summary statement basics and resubmission advice.

Whether you’re new to the grant application process or an experienced applicant, we hope you find these resources useful.

Posted in Application Submission, New Resources, Peer Review, Rock Talk | Tagged , | 3 Comments

You Ask, We Answer

May I Still Use Forms Which Are Past the Expiration Date?

NIH recently issued a Notice on the availability of newly revised forms and instructions for post-award documents, including interim and final progress reports. Revised Ruth L. Kirschstein National Research Service Award (NRSA) forms are also now available. Revised competing applications and instructions are expected to be implemented in the summer of 2013, following electronic development of applicable forms. Until that time, continue to use the existing forms.

Posted in Application Submission, Award Management, You Ask, We Answer | 2 Comments

How Often Do I Need to Update My System of Awards Management (SAM) Registration?

Your SAM registration (formerly CCR registration) needs to be renewed at least annually. Remember, all registrations and renewals must be complete to submit an application to NIH.

NOTE: Once you update your record in SAM, it will take 48 to 72 hours to complete just like it did in CCR. You will be notified via email when the process is complete. SAM cannot expedite this process.

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If the Instructions in the Funding Opportunity Differ from the Application Guide, Which Do I Follow?

Instructions in the funding opportunity announcement (FOA) always supersede the instructions in the application guides. So when in doubt, follow the instructions in the FOA.

Posted in Grant Writing, You Ask, We Answer | Leave a comment

Calendar

October 17, 2012: New NIH RPPR Training Webinar

Are you familiar with the new NIH Research Performance Progress Report (RPPR)?  The RPPR is a Federal-wide initiative to standardize reporting by creating a uniform format for all interim reporting of research and research-related activities.  The result of this initiative is the RPPR Final Format.

As of October 19, all grantee institutions will have access to the new NIH RPPR for most Streamlined Non-competing Award Process (SNAP) and fellowship awards.  NIH expects to require the new RPPR format for all grantees with SNAP and fellowship awards in the spring of 2013.  The RPPR webpage includes a full list of Activity Codes for which the RPPR format will be available in October.

The NIH Office of Extramural Research will host a training webinar on the use of the new NIH RPPR eRA module on October 17 from 1:30-3:00pm. Space is limited to 1,000 log-ins, so register today at https://www3.gotomeeting.com/register/647997446. If you are unable to attend the webinar, the event recording will be made available at a later date.

For more information about the RPPR implementation plan, see the Guide Notice.

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October 8 (Monday) 2012 NIH Closed: Federal Holiday

NIH (including help desks) will be closed October 8 (Monday), 2012.

If a standard postmark/submission date falls on this federal holiday, the application deadline is automatically extended to the next business day.

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