Nexus November 2012
Dr. Sally Rockey

Rock Talk

Apply Now to Take Advantage of Unique Resources at the NIH Clinical Center

In August I let you know about an upcoming collaboration opportunity allowing extramural researchers to use the amazing resources of the NIH Clinical Center and collaborate with intramural researchers here at NIH. I’m happy to announce that the official funding opportunity announcement (FOA) was published Wednesday: Opportunities for Collaborative Research at the NIH Clinical Center (PAR-13-029). Twelve NIH institutes will participate in this cooperative agreement program, as will two NIH director’s offices. The FOA goes into detail about the specific research priorities of the program, but start planning now. The first submission date is February 20, 2013 and extramural investigators must have a collaborating investigator in the NIH intramural research program.

The NIH Clinical Center has also put together a great website for you to learn more about what’s going on at the Clinical Center that may be of interest to you. The “Collaborator’s Toolkit” on the right side of the page contains several notably helpful tools – a guide on how to find a collaborator and initiate a collaboration, a directory of available resources (e.g., biomedical specimens, equipment, unique data sets) and more.

We hope you find this opportunity as exciting as we do. I’m looking forward to seeing the creative ideas and outstanding scientific research that results when extramural researchers and intramural researchers join forces!

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The A2 Resubmission Policy Continues: A Closer Look at Recent Data

We have heard from many of you about the policy to sunset A2 applications. As you may remember, this policy was developed as part of NIH efforts to enhance peer review. There were concerns that applications were piling up in a “queue” and subject to a holding pattern that delayed funding until the resubmission (A1 and A2) stages, and as a consequence highly meritorious science proposed in original (A0) applications was made to wait additional months for funding. The policy was published in the Federal Register on October 8, 2008, and implementation began on January 25, 2009. In March 2011 I posted some early data showing that the number of applications funded as A0s was increasing and there was no queue at the A1 level.

More time has elapsed since the policy was implemented and this has allowed us to gather a substantial amount of data and conduct more in-depth analyses of the effects of allowing only one resubmission for each application.

First, as can be seen in figure 1, which looks at new (type 1) competing R01 and equivalent awards, the early analysis was confirmed – a higher proportion of A0 applications are being awarded compared to A1s and the “queuing” of original applications and revisions has been eliminated. In addition, the average time to award from submission of A0 applications has been reduced from 93 weeks to 56 weeks (figure 2). Although it is unsurprising that the time to award has decreased since the elimination of the A2, the increase in the proportion of funded A0 applications versus A1 applications was not an obvious outcome. Figure 1 shows the distribution of new competing R01 awards by submission number for fiscal years 1998 through 2011

Based on these analyses, the policy is achieving its goal of funding a higher proportion of original applications more rapidly. But we realize that these data alone do not address some major concerns, such as whether the new policy disadvantages new investigator applicants who may find it more difficult to craft new applications. One indication that this is not the case is the fact that the time to award for new investigators is not appreciably longer than the entire population (figure 2).

This graph shows Time-to-Award for New, Unsolicited R01  Applications by Fiscal Year of Original Submission, spanning fiscal years 2006

These results notwithstanding, we are well aware that a lot of great science goes unfunded because paylines have decreased. Some have suggested that to deal with this issue we modify the policy to allow A2 submissions for a specific subset of applications (e.g. those with scores just outside the payline). We have modeled the potential impact of changing the policy in such a way.

We looked at this issue using data from fiscal year (FY) 2011. If A1 applications with percentile scores below 25% were allowed to submit an A2 application in FY2011, it would have resulted in 764 unsolicited A2 R01 applications. 165 of the new applications were from new investigators. In addition, only a small minority of eligible applications (37 of 218 renewals) were from investigators trying to renew a previous new investigator award.

Assuming the most extreme case – that all 764 of these A2 applications would have been funded, NIH would have been able to fund 21% fewer A0 applications and 19% fewer A1 applications in FY2011 (figure 3). These displaced A0 and A1 applications would be highly likely to come back as A1s and A2s (as most displaced A1s would become eligible under the modified policy) and the average time to award would increase.

Figure 3 shows the estimated effect of a limited A2 policy on A0 and A1 award levels

Overall, these data indicate that the policy to sunset A2 applications continues to achieve the stated goals of enabling NIH to fund as much meritorious science as possible in as short a time period as possible. Any revision to the policy to allow additional resubmissions of all or a subset of A2 applications will displace equally meritorious A0 and A1 applications, and increase the time to award for many applications. For these reasons, we have decided to continue the policy in its current form.

We greatly appreciate the community’s input on this issue and the thoughtful deliberations we had here with NIH leadership, all culminating in the decision to keep the policy. Please know that we will continue to monitor the policy and its impact on time to award.

Update from the Rock Talk Blog Team (November 28, 2012 at 2:10 pm): Data tables corresponding to the figures shown in this blog post are available at: http://report.nih.gov/special_reports_and_current_issues/index.aspx

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Integrating Our Substance Use, Abuse, and Addiction Research Efforts

Today NIH Director Francis Collins announced an important decision on how to optimize substance use, abuse, and addiction research at NIH through organizational change. Two years ago, NIH’s Scientific Management Review Board (SMRB) and its substance use, abuse, and addiction (SUAA) working group issued recommendations on organizational changes to improve SUAA research and the health of people affected by SUAA-related problems. As many of you know, they recommended that NIH establish a new institute focused on these research areas, and also strongly considered an alternative option of functionally integrating existing research resources, rather than creating a new institute.

You may remember that we published a request for information on the proposed reorganization. After subsequent review and input from all of NIH’s constituents – patients and researchers alike – NIH will move ahead with functional integration of these research areas. The NIH institutes that fund these research areas – National Institute on Drug Abuse (NIDA) and the National Institute on Alcohol Abuse and Alcoholism (NIAAA) – will keep their institutional identities rather than organizationally merging into one institute. These institutes, and all the NIH institutes and centers that support related research, will continue to their ongoing efforts to work more closely with each other. We’re confident that we can achieve the SMRB recommendations with a functional merger, thus the important science of these two institutes will continue to flourish.

Update from the Rock Talk Blog Team (November 19, 2012, at 11:20 am): For more information, check out the NIH Feedback post on this announcement, which links to a draft strategic plan, details on the functional integration, and more.

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Improving Public Access to Research Results

Most researchers are familiar with our public access policy which is central to the NIH mission. It ensures NIH-funded research is accessible to everyone so that, collectively, we can advance science and improve human health. You’ve provided access at an impressive rate which has allowed many people to see the publications that result from NIH-funded research. For example, on a typical weekday over 700,000 users retrieve more than 1.5 million papers on PubMed Central, the host archive for the public access policy.

When we put the policy into place in 2008 it was an adjustment for all of us. Since that time, NIH has focused much of our attention on outreach. We’ve helped you understand your obligations and provided reminders when we found papers that were out of compliance. This strategy, along with the research community’s shared commitment to making the results of NIH-supported research public, has resulted in a high level of compliance with the policy. But our work is not done as there are still publications — and as a consequence, NIH awards — that are not in compliance. Thus, as of spring 2013 at the earliest, we will begin to hold processing of non-competing continuation awards if publications arising from grant awards are not in compliance with the public access policy. Once publications are in compliance, awards will go forward. For more details, see NIH Guide notice NOT-OD-12-160.

We are committed to doing all we can to help our grantees ensure they comply with the policy. This summer we made it easier for project leaders and the authors they support to collaborate in the paper submission process through enhancements to My NCBI. We are giving funded organizations at least five months to prepare for our new process, and we hope you use this time to assure that publications are in compliance with the policy long before this change in process begins.

The challenge is that publication occurs throughout the year, and progress reporting occurs once a year. So I encourage principal investigators to start thinking about public access compliance when papers are planned. Discuss with your co-authors how the paper will be submitted to PubMed Central, and who will do so, along with all the other tasks of paper writing. The easiest thing to do, perhaps even today, is to take a couple of minutes to enter the NIH-supported papers you have published in the last year into My NCBI to ensure you meet the requirements of the policy regardless of when your non-competing continuation is due. This will help you avoid a last minute scramble that could delay your funding.

We appreciate the partnership we have with the biomedical research community to allow the highest level of access to the great research resulting from our funding. Keep those publications coming!

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Getting Ready to ASSIST You with Multi-project Electronic Grant Submissions

I’m delighted to announce that this week NIH has posted the first funding opportunity announcement (FOA) that will use electronic submission for multi-project applications. This is no small achievement for NIH.

NIH has been fully electronic for R01 grant submission since 2007, and electronic for all but our multi-project grant applications since 2010. Our goal was always to have 100% of our applications submitted electronically, but our most complex applications did not fit with current submission methods.

To address this situation NIH developed ASSIST (Application Submission System and Interface for Submission Tracking) working in close partnership with Grants.gov. ASSIST is a web-based system designed to accommodate the complexities of NIH’s multi-project applications and, I am happy to say, incorporates many features that have been requested by applicants for years. The system provides pre-population of application forms using information from NIH’s eRA Commons, it accommodates multiple people working on an application concurrently, and it provides the capability for the signing official from the applicant organization to control access to various parts of the application. ASSIST also allows users to view the assembled application before submission the same way it will be seen by NIH reviewers. Additionally applications can be run against NIH and Grants.gov business rules before submission. Finally, applicants will be able to prepare their multi-project applications, submit them to Grants.gov, and view the final assembled application image from within a single system.

During the design and development of ASSIST, NIH’s eRA (electronic Research Administration) technical team worked closely with Grants.gov staff, NIH extramural staff from across NIH institutes, and dozens of applicants from a wide variety of institution types. We couldn’t have done it without everyone’s contributions. The input from all these stakeholders has allowed us to ensure the system accommodates the workflow of our applicant organizations, takes advantage of existing Grants.gov services, and meets the needs of the NIH staff and reviewers who work with these multi-project applications after submission.

We also recognize that many institutions have made large investments in their own system-to-system solutions that send application data directly to Grants.gov. We designed ASSIST to work with Grants.gov in such a way that those institutions, should they choose to extend the capabilities of their own systems to include submission of multi-project applications directly to Grants.gov in lieu of using ASSIST, may do so.

ASSIST can only accept multi-project applications, currently (e.g. P01s). I hope eventually it will be able to expand to include other types of applications as well. I am thrilled to hear that the Grants.gov program management is looking to leverage this collaborative effort to potentially develop an online forms capability for the entire federal grants community.

Initially, we are piloting ASSIST with a few FOAs that have receipt dates between January and September. If everything goes as planned, all of our multi-project applications will use electronic submission by January 2014 and we’ll be 100% electronic. You can find the transition timeline in NIH Guide notice NOT-OD-12-161. As pilot FOAs are published, we will add them to the transition timeline.

We’re delighted that our users will soon be able to submit all their applications to NIH electronically! It’s a large step into the 21st century.

 

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New Blog on the Block

I want to let Rock Talk readers know about a new NIH voice in the science blogosphere – NIH Director Francis Collins! He’ll be blogging at directorsblog.nih.gov, discussing science, medicine, and public health news, and sharing biomedical research discoveries that are, in his words, “game changers, noteworthy, or just plain cool”.

I really enjoy blogging here at Rock Talk and I know Francis will too. I’m looking forward to his posts and the discussions to come.

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When Disaster Strikes

My thoughts are with everyone affected by Hurricane Sandy, and I am deeply sympathetic to the struggles of those who continue to feel the aftermath of this destructive storm. The immediate and long term economic and emotional costs of natural disasters such as Sandy can be overwhelming.

Among the many groups affected by these types of events are the people and animals supported by NIH funding. Undoubtedly the loss of lives is of greatest concern, but the loss of years of research materials and data can be devastating and severely set back research progress.

NIH leadership understands that no amount of planning can fully prepare researchers for losses due to natural disasters, and we are committed to doing what we can to help the research community pick up the pieces after catastrophic events. We regularly work with other divisions within the Department of Health and Human Services (HHS) and other federal agencies (such as FEMA and the Office of Management and Budget) to coordinate a response. We take into consideration issues such as whether a federal disaster is declared; the severity of damage inflicted; the length of time an institution may be required to close or that is required for recovery; the impact on investigators, human research subjects, and animal subjects; and the overall impact on the community. Actions are taken on a case by case basis.

You may have seen the notice that NIH issued last Friday in advance of the storm that describes how NIH handles grant application submissions that are delayed due to the hurricane. Although we often issue a notice for major weather incidents, please know this policy is always in effect whether or not we issue a specific Guide notice.

NIH will be keeping on top of any impact of the hurricane on NIH supported research to assure that ongoing projects can be successfully completed. I advise grantees whose research is impacted by the storm to contact the NIH grants management or program official listed in their Notice of Award (NoA) to let them know your status.

My office maintains a website on  NIH extramural response to disasters and emergencies that you may find to be a valuable resource. Relevant NIH Guide notices are posted and archived on this page, and other resources, such as emergency contact information and links to disaster and preparedness websites of other science-funding agencies, can be found here as well. I hope you never have any reason to visit this page, but if crisis strikes, I want you to know where to find information that can help you.

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New Resources

A New Look to Grants.nih.gov

We have refreshed the look of Grants.nih.gov, NIH’s home page for grants and funding information. We expect to undertake a larger redesign of the website in the next year or so following a usability study that will engage users like you. In the meantime, feedback on the website refresh is always welcome: leave a comment or send us an email and let us know what you think!

Screenshot of grants.nih.gov home page

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You Ask, We Answer

If the Paper PHS 398 Form Was Used to Submit the Original Application, Then Which Application Do I Use For a Resubmission?

Even though the original application was submitted using the paper PHS 398 format, once a grant program/mechanism transitions to electronic submission, all future (new, renewal, resubmission or revision) applications submissions must use the electronic SF 424 (R&R) application.


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How Do I Know If My Software Is Compatible with Grants.gov?

Before starting the grant application process, do not assume that the latest release of any particular software will be the best one to use. When vendors make updates, it takes time to test and certify if a new release will work with the current programs. So before you start to fill out an application, check the software compatibility information at Grants.gov to make sure you are not using something newer than what has been tested and certified. You may also want to check out technical alerts at Grants.gov for current system updates.

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Calendar

January 1 (Tuesday), 2013: NIH Closed for Federal Holiday

NIH (including help desks) will be closed January 1 (Tuesday), 2013.

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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December 25 (Tuesday), 2012: NIH Closed for Federal Holiday

NIH (including help desks) will be closed December 25 (Tuesday), 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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Other NIH Happenings

OER Welcomes Michelle Bulls

Photo of OER/OPERA director Ms. Michelle BullsOn November 4, Ms. Michelle Bulls began her position as director of the Office of Policy for Extramural Research Administration, also known as OPERA, within the Office of Extramural Research. Ms. Bulls had served as acting director of OPERA for the past six months and is well respected throughout federal government agencies for her grants policy expertise. As OPERA director, Ms. Bulls provides trans-NIH direction regarding grants policy and compliance monitoring for the grants management offices of the 24 NIH institutes and centers that support extramural research. (Read more about OPERA’s mission and responsibilities on the OPERA homepage on grants.nih.gov.)

Ms. Bulls has over 20 years of grants administration (policy and operations) experience, She started her career as a grants technical assistant, grants management specialist, and grants management officer in the in the National Heart, Lung, and Blood Institute at NIH. She has since served in several high-level postiions within the Department of Health and Human Services (HHS), including director of grants management for the Indian Health Service, and director of grants policy oversight and evaluation in the HHS Office of the Secretary.

In her short time back at NIH, Ms. Bulls has already demonstrated her keen leadership skills both within NIH and across the extramural community. She also continues to lead Federal-wide efforts in drafting and implementing financial assistance regulations and policies, and is a leader in collaborative efforts to promote grants management efficiency and efficacy not just at HHS but across the Federal government.

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