Nexus Issue | NIH Extramural Nexus
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NEXUS AUGUST 2013
Rock Talk
Keeping Up With the Biomedical Research
Workforce Initiative
Posted on August 30, 2013 by Sally Rockey
Over the past two years I’ve frequently discussed the recommendations from the NIH Advisory Committee to the
NIH Director (ACD) on the Biomedical Research Workforce. I know there’s been loads of information coming from
us about how we are implementing these recommendations. I’m happy to share our new website that compiles all
of this biomedical workforce initiative information.
You can read about the background of the task force, and track progress for the seven main implementation areas.
We include links to the relevant NIH Guide policy notices and funding opportunities for the activities resulting from
task force recommendations, and timelines so that you can see when changes or new programs were announced,
or are expected to take place.
On the background page we’ve also included reports summarizing the two Requests for Information (RFI) we
posted to seek research community input on implementation activities. Most recently we’ve published the summary
of responses from the February call for comments. Below is a word cloud of the summary of responses so you can
get a flavor of the content and sentiment of the feedback, and I’m happy the community has been so responsive to
the issues we have raised.
You’ll see
from the
new
website
how your
suggestions are incorporated into our implementation plans. To give you a quick review of the many things we have
done in such a short time, implementation includes the BEST program, encouragement of IDPs, all NIH institutes
participating in F30s and F31s, extending Commons IDs to students, and further down the road using SciENcv
(whew!).
We’ll continue to update biomedicalresearchworkforce.nih.gov as workforce activities unfold, so check it out and
stay tuned.
Posted in Rock Talk | Tagged Biomedical Workforce, Resources | 6 Comments
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Reporting to NIH on Race and Ethnicity of Clinical
Research Participants
Posted on August 21, 2013 by Sally Rockey
The inclusion of women, different racial and ethnic groups, and children is extremely important in clinical research
to understand who is affected by a given disease or condition and to develop the appropriate treatments. To that
end, we have long-standing inclusion policies to assure that research participant demographics — sex/gender,
race, ethnicity and representation of those under age 21 — appropriately address the scientific question at hand. As
in the past, this policy continues to apply to all projects meeting the NIH definition for clinical research, not just
clinical trials. However, I’m bringing this topic to your attention because there has been some confusion about the
distinction between race and ethnicity and how to report this information to the NIH.
Researchers are asked to report to NIH on the planned and actual enrollment of clinical research participants by
sex/gender, race, and ethnicity. The racial and ethnic standards we use are set by the Office of Management and
Budget (OMB). When enrolling research participants, researchers should ask participants to self-identify both their
ethnicity and their race. The participant should also be given the option to select more than one racial category, or
to decline providing their sex/gender, race, and ethnicity. When reporting on actual enrollment to NIH, researchers
use the participants’ data to complete our forms. In an effort to clarify this policy and streamline our implementation,
we’ve recently modified the layout of the reporting forms to clarify the need for collecting race and ethnicity
information separately (for more on the distinction between race and ethnicity, check out this recent All About
Grants podcast). We’ve also added the ability for researchers to indicate how many individuals identifying with more
than one racial category they plan to enroll.
Note that these changes are to the forms researchers use in reporting to NIH. These forms should not be used for
data collection from the research participants themselves.
We have created additional resources to help researchers report inclusion information to NIH including a new
frequently asked questions page and narrated slide deck on race and ethnicity reporting — visit this recentlyupdated NIH inclusion policy website for these resources and more information about the inclusion policy and
reporting.
We’re transitioning to the modified layout in phases, starting with competing applications that have receipt dates on
or after September 25, 2013. We will be transitioning the progress reports for non-competing awards in the near
future — see this NIH Guide Notice for more details.
We are continuing to make our policies clearer and make it easier for the community to report on their clinical
studies, so that we can see this important research reach successful conclusions and provide the information
needed to reduce illness and disability.
Posted in Rock Talk | Tagged Grants policy, Inclusion | Leave a comment
New Data, New Data Book Updates
Posted on August 9, 2013 by Sally Rockey
Besides our data and analyses here on Rock Talk, the NIH Data Book on RePORT.NIH.gov should be your first
stop when looking for longitudinal and historical data on budget, funding rates, and other facts about NIH funding.
The NIH Data Book also contains national biomedical workforce data such as statistics on graduate students and
postdocs in the biomedical, behavioral, social and clinical sciences using data from the NSF-NIH Survey of
Graduate Students and Postdoctorates in Science and Engineering. The latest data from this survey (2011) are
available and reflected in the national graduate student and postdoc statistics sections of the Data Book. I wanted
to point to this resource because biomedical research workforce issues are of interest to many Rock Talk readers.
This survey is conducted each year by the National Science Foundation’s National Center for Science and
Engineering Statistics (NCSES). As described in the America COMPETES Act, NCSES serves as a central
Federal clearinghouse for the collection of data on science, engineering, technology, and research and
development, including statistical data on the scientific workforce, collected through several surveys.
It’s interesting to note that the total enrollment of graduate students in all areas NIH funds (the biomedical,
behavioral, social, and clinical sciences) has not been increasing in recent years.
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But looking a little deeper into the sub-field data, there’s no flattening of graduate enrollment in biomedical sciences
specifically, as you can see from the chart below. The leveling off of total graduate enrollment shown in the first
graph is due to the trends of graduate student enrollment in the behavioral and clinical sciences. For more
information on how the survey classifies these areas, see this chart.
It is too early to draw conclusions about the reasons behind this and what the future trend will look like, but it’s
worth watching as we continue to gather data on NIH-supported trainees and take on the challenge of improved
data and a better understanding of the biomedical research workforce.
Posted in Rock Talk | Tagged Biomedical Workforce, Funding data, RePORT | 2 Comments
NIH and the Lacks Family Announce a HeLa
Genome Data Sharing and Use Agreement
Posted on August 8, 2013 by Sally Rockey
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In 1951, biomedical research took a leap forward when it was announced that cancer cells taken from a patient,
Henrietta Lacks, could not only be grown in a lab, but also grown in perpetuity, creating the first immortal human
cell line. This cell line – “HeLa” – is the most widely used human cell line to this day. However, at the time this cell
line was created, there were no rules about research involving tissues available after clinical procedures, and the
cells were obtained without consent from Henrietta.
As described by NIH Director Francis Collins on his blog and in the journal Nature, he and deputy director Kathy
Hudson have been working with Henrietta’s family to discuss how biomedical researchers could access the HeLa
cell genomic sequence, but still protect the family’s privacy since this genomic data has the potential to reveal
personal information about her descendants.
Yesterday, NIH and the Lacks family announced an agreement that will allow HeLa-derived genomic data to be
deposited into NIH’s existing dbGap database while addressing the privacy concerns of the Lacks family.
Researchers will be able to apply for controlled access to whole genome HeLa cell data, and these requests will be
rapidly reviewed by a new HeLa Genome Data Access working group consisting of physicians, scientists, a
bioethicist, and two members of the Lacks family. We will only grant access if the terms and conditions of our data
use agreement are met, such as only using the data for biomedical research, reporting back to the NIH working
group with emerging results, and agreeing that the Lacks family will not be sought out individually and contacted.
Additionally, NIH will expect supported researchers to deposit DNA sequences derived from HeLa cells into dbGAP,
and acknowledge Henrietta and her family’s contribution in any publications or presentations resulting from use of
HeLa cells.
We’ll be publishing an NIH Guide notice with more information on both the acknowledgement of HeLa cell use and
how researchers who propose generating HeLa cell whole genome sequence data should address their dbGAP
data submission as part of the “Research Sharing Plan” included in each application. More information on the
access procedures and data use agreement can be found on the dbGAP HeLa page.
It’s important to also note that this is not a widespread change in existing consent or data-sharing policies for all
immortalized cell lines. This is especially unique to HeLa cell use, as Henrietta’s identity, and her family’s identity, is
well known.
I encourage you to read Dr. Collins’ blog and the article he co-authored with Dr. Hudson. Thank you to the Lacks
family for working with us on this agreement, and for Henrietta and her family members’ significant contributions to
biomedical research. Their generosity has boundless potential in improving the life of many, many people as a
result of research using the HeLa cell line.
Posted in Rock Talk | Tagged Data sharing, Grants policy | Leave a comment
Using eRA Commons to Improve Data on the
Biomedical Research Workforce
Posted on August 2, 2013 by Sally Rockey
In April I blogged about the various ways NIH is taking on the challenge of improving data on the biomedical
research workforce, particularly those who receive training support from NIH. In 2009 we began requiring eRA
Commons accounts for all postdocs listed in the grantees’ annual progress report and over the next year we’ll be
extending this requirement to capture data on NIH-supported graduate students and undergraduate students as
well. It is our attempt, with your help, to automate tracking of biomedical research careers from the onset of training
and beyond. As you will see, although we are instituting this as a requirement, we hope it will reduce burden in the
long run by pre-populating some reporting fields and forms. Although this change stems from requirements in the
NIH Reform Act of 2007, it was also supported by the Advisory Committee to the NIH Director (ACD) working group
on the biomedical research workforce. Respondents to a request for information issued in February also were
supportive of NIH identification and tracking of trainees.
We’ll be rolling this out in phases to give grantees and trainees time to register in eRA Commons and create a
profile. Beginning August 15, 2013, undergrads and grad students will be able to create a personal profile in eRA
Commons. Beginning October 18, 2013, grantees submitting progress reports using the Research Performance
Progress Report (RPPR) will be prompted to enter eRA Commons IDs for undergrads and graduate students listed
in their Participant List, though these IDs will not be required at that time. However, by October 1, 2014, these
Commons IDs will be required, and RPPR progress reports without these IDs will not be accepted.
We encourage all institutions to have trainees register for a Commons ID and create a personal profile as soon as
possible. The eRA Commons will accept graduate student and undergraduate student profiles beginning August 15.
Any undergrad or graduate student participating in an NIH-supported project for at least one month of full-time work
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(known as a “person month”) should be included on the progress report submitted to NIH and have a Commons ID.
We are leaving it up to the supported institutions to figure out the easiest way to have their trainees register —
whether all at once, when they enter a graduate department, or at the time of the RPPR submission. Whatever
works best for you
Another profile-related change we’ll be rolling out is that all students and postdocs completing an NIH Commons
profile will be required to answer certain questions such as date of birth, gender, race and ethnicity, disabilities, US
citizenship status and country of citizenship. Note that questions on gender, disabilities, race and ethnicity must be
completed, but one of the acceptable responses is: “Do Not Wish to Provide”. This information will help us better
understand the diversity of the biomedical workforce receiving NIH-support. The Commons profile also will include,
where applicable, information on the individual’s highest educational degree, and where and when it was earned.
We realize that many people besides Principal Investigators, postdocs, and trainees are part of the biomedical
workforce and make significant contributions to NIH-supported projects. Thus, we are encouraging institutions to
have other individuals who are supported with NIH support and listed in the progress report participant list to create
an NIH Commons account. This could include technicians, staff scientists or others. Basically, anyone supported by
NIH funds should have a Commons ID, but we are only requiring it for the three aforementioned categories.
Entering an individuals’ Commons ID will simplify the completion of the Participant section of the RPPR by prepopulating much of the requested information.
It is important to remember that all eRA Commons information is and will continue to be stored in a database
protected by the Privacy Act so we will protect personal information of trainees in the same way we do with all
others registered in the Commons. In addition, to reduce responders’ reporting burden, we’ve also revamped the
look and ease of creating and editing the NIH Commons Profile, making it much more user-friendly. My staff has
created a video demonstration of the new look and new features to help you along. Finally, a completed eRA
Commons Profile will help users develop their SciENcv and therefore the biosketches that can be submitted with
future grant applications and progress reports. I’ll be blogging more on SciENcv in the future.
I encourage you to read the NIH Guide notice announcing these changes, and share this Notice, blog post, and
personal profile tutorial with your colleagues. While it seems like there has been an almost overwhelming whirlwind
of activity resulting from the recommendations of the Biomedical Research Workforce working group, I am happy to
see that the community continues to embrace these recommendations, and want to thank you for your
understanding the urgency and speed at which we are implementing them.
Posted in Rock Talk | Tagged Biomedical Workforce, eRA Commons, Grants policy | 3 Comments
Top Stories
Multi-project Applications Moving Ahead With
eSubmission
Posted on August 30, 2013 by NIH Staff
Are you ready for electronic submission for all P01, P20, P50, U19, P2C and UC2 applications intended for due
dates on or after September 25, 2013? That milestone is just around the corner! We recently held a webinar to help
potential applicants get acquainted with ASSIST, NIH’s system for electronic submission of multi-project
applications. A recording of this webinar, along with slides and a transcript, are now available online.
In addition to checking out the full transition timeline for the electronic transition of NIH’s multi-project applications,
and the ASSIST webinar, we recommend the following links and resources to help you with the transition:
◾ ASSIST Online help
◾ Application Guide - Be sure to check out the new section in the application guide on Multi-project applications.
◾ Applying Electronically Website for Multi-project Applications
◾ Annotated forms - field-by-field tips on the multi-project application form set
◾ Overview of how your multi-project application image will be assembled
◾ Multi-project Application Demonstration Resources – to “play” with ASSIST and familiarize yourself with a
sample multi-project FOA
Posted in Top Stories | Leave a comment
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NIH Updates Electronic Application Forms (FORMS
-C)
Posted on August 30, 2013 by NIH Staff
We’ve been busy preparing for our transition to updated application forms for most grant programs, as described in
our May NIH Guide Notice and in the Nexus. Our funding opportunity announcements (FOAs) now have the new
FORMS-C application packages added, and the old packages (B1 and B2) are set to expire.
Here are some updated resources you may want to check out:
◾ Updated Frequently Asked Questions for Application Forms Updates and Choosing the Correct Forms
◾ Pay special attention to the FAQs on choosing the appropriate forms for applications submitted for the
September 9 AIDS deadline and under the continuous submission policy
◾ New Application Guides for Forms Version C in both Word and PDF format
◾ Annotated Form resources with field-by-field tips for Forms applications
If you are submitting to one of the few NIH programs (Fellowship (Fs),Career Development (Ks), Training (Ts) and
Small Business) that aren’t moving to FORMS-C yet, use the B package available with your FOA. For all other
programs use B application packages for due dates before September 25, 2013 and FORMS-C packages for due
dates on/after September 25, 2013.
Posted in Top Stories | Leave a comment
You Ask,W e Answ er
I’m Submitting an Application for the September 9,
2013 AIDS Due Date: Which Forms Should I Use?
Posted on August 31, 2013 by NIH Staff
If you are submitting an application for the September 9, 2013 AIDS due date (Sept. 7 falls on a Saturday this year),
you should use the B Series application form packages.
Note: The R01 and R21 Parent funding opportunity announcements (FOAs) were recently reissued.
Activity CodeOld Parent FOAReissued Parent FOA
R01
PA-11-260
PA-13-302
R03
PA-11-262
PA-13-304
R21
PA-11-261
PA-13-303
The B Series application packages associated with the old parent FOAs should be used for the AIDS due date. The
old parent FOAs indicate that they expire September 8, 2013 (since the September 7 AIDS deadline is the last
official due date). However, since September 7 falls on a Saturday, the due date moves to September 9. The FOAs
are set up with a grace period behind the scenes to allow applications to continue to be accepted beyond the
expiration date which accomodates the September 9 due date.
Posted in You Ask, We Answer | Leave a comment
How Can I Test-drive the New Multi-project
Electronic Submission System?
Posted on August 31, 2013 by NIH Staff
We’ve created a test environment so that applicants can try out the new multi-project electronic submission system,
ASSIST. To get familiar with a multi-project funding opportunity announcement (FOA), you can download a mock
FOA, and then follow the instructions here to learn how to “play” in the ASSIST sandbox.
More questions? Check out the list of resources here for help!
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