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May 7, 2014

Feature Articles

Opportunities and Resources

In The News

Advice Corner

New Funding Opportunities

Header: Feature Articles. 

Perspectives From NIAID's Experiences With Open Data Sharing

You may be aware of several efforts to improve transparency and access to research data.

For example, Public Library of Science (PLOS) recently required authors to make research data publicly available immediately upon publication of their articles. Also, the Institute of Medicine is holding workshops to review practices for sharing clinical trial data and recommend a new framework.

Other journals, scientific organizations, foundations, and government agencies, including NIH, are working on new policies designed to improve data sharing.

NIAID supports those efforts. We believe more open data sharing will make it easier to analyze, interpret, validate, and replicate research.

In fact, we provide research data through several Web sites.

As you prepare for a future where you may be expected to share more data—and have immediate access to others' data—consider our experience, starting with two of these sites: ImmPort and TrialShare.

Sharing Data Through ImmPort and TrialShare

Some details:

  • ImmPort is a long-term curated archive of basic and clinical trial data, metadata, and associated laboratory studies. ImmPort also provides tools for visualization and flow cytometry analysis (FLOCK).
    • Includes data from 95 NIAID studies involving more than 18,000 subjects, with new studies being added continually.
    • Exceeds 200 downloads of datasets each month.
    • Datasets contain immunology and disease phenotypes captured by many experimental measurements (including microarray and flow cytometry), and are packaged in MySQL database format as well as tab-delimited format.
      • MySQL scripts allow users to build a local database from ImmPort datasets.
      • Data collection and deposition is supported by 45 data standards and templates.
    • Data providers can submit data any time, before publication, after publication, or even without publication in a journal.
    • Enables private workspaces within ImmPort that allow scientists within one lab to share data or collaborate with any number of specified labs.
  • TrialShare is a Web portal for open access to clinical and mechanistic data from NIAID's Immune Tolerance Network (ITN) clinical trials. It also links to the ITN biorepository, which houses more than 120,000 specimens.
    • Includes data from 35 clinical trials involving 3,200 patients and 72,000 study visits.
    • Employs data visualization, filtering, and analysis tools.
    • Provides exact R scripts and other code underlying published figures.
    • Allows users to link directly to TrialShare from online journal publications.

While TrialShare data come exclusively from ITN studies, ImmPort data come from any research program that conforms to ImmPort's data deposition formats and NIAID's data sharing requirements.

For both platforms, data are deidentified, checked for accuracy and completeness, and formatted for immediate download and analysis.

We don't ask for proposals to use the collected data for research. TrialShare data providers know that others may use their data without the need to obtain permission.

Results So Far

Though our data sharing platforms differ from each other, our experiences have been similar: growth in registrants, usage, data volume, and diversity of users.

In the last nine months, TrialShare has opened almost 350 user accounts and contributed to two publications.

ImmPort has more than 3,000 registered users since 2009.

Several ImmPort tools, such as FLOCK and HLA analysis tools, have been used or cited in publications.

Some institutions have built training and educational programs where trainees practice data analysis and generate hypotheses using ImmPort's tools.

And, our ImmPort Data Submission Templates have standardized data collection across institutions as dozens of NIAID grantees have adopted them for their own local use. Developed in partnership with grantees, the templates provide a uniform submission process that facilitates integrated data analysis.

Looking to the Future

NIAID's approach is just one of many, but we anticipate that biomedical researchers will continue to make data more widely and immediately accessible, and we expect to see more emphasis on sharing of raw data.

Look for new sharing policies from NIH within the next calendar year, and stay tuned to this newsletter for any updates relevant to NIAID's research community.

We'll highlight more examples of open data sharing opportunities and programs supported by NIAID in future issues.

Related Links

TrialShare

Examples of manuscripts that link to TrialShare:

ImmPort

Institute of Medicine

Data Access for the Open Access Literature: PLOS's Data Policy

Header: Opportunities and Resources.

Apply to Be a Lasker Clinical Research Scholar

It may be worthwhile to check out a recent funding opportunity announcement (FOA) for the Lasker Clinical Research Scholars Program, which provides a unique combination of NIH funding for up to 12 years.

How the Program Works

The Program offers early-career clinical researchers* a chance to obtain an independent research position in the NIH Intramural Research Program (IRP) with the possibility of later staying in the IRP or moving to an extramural research institution. It has two phases:

  • Phase 1—work five to possibly seven years as a tenure-track investigator in a participating NIH institute or center.
  • Phase 2—after completing the first phase, choose one of two options:
    1. Remain in the IRP with continued intramural funding and potential progression to tenured senior investigator status.
    2. Continue research at an extramural institution by competing for a Lasker Scholars Grant, which provides direct costs of up to $500,000 each year (plus applicable facilities and administrative costs) for up to five years.

*To be eligible, you must be a physician or dentist who is licensed to practice clinically in the U.S. and no more than 10 years from completing core residency training.

Get a Letter of Support

Each participating institute or center has preferred areas of clinical research interest. For NIAID, they are hepatitis, food allergy, and antimicrobial resistance (in Gram-negative bacteria).

To ensure that your proposed research meets the goals of the NIH IRP, you must obtain a Letter of Support that will be part of your application.

For the Letter of Support, you'll need to submit a Biosketch and other required information by June 2, 2014. To learn more, go to Submission of Requests for a Letter of Support for the Lasker Scholar Program.

Application Info

As the project director or principal investigator, you—not your organization—will submit a paper PHS 398 Grant Application to NIH's Center for Scientific Review. Be sure to carefully read the Application and Submission Information in the FOA.

Your application, which must include the Letter of Support, is due by July 29, 2014.

For complete details, read the April 24, 2014, Guide notice, and go to Lasker Clinical Research Scholars Web site.

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A New Stepping Stone Toward HIV/AIDS Clinical Trials

Investigators who anticipate initiating future clinical trials to develop interventions and services that treat or prevent HIV should check out the new HIV/AIDS-specific clinical trial planning grant (R34).

Unlike the basic R34 that NIAID already supports (announced in this March 22, 2013, Guide notice), this new funding opportunity announcement (FOA) provides up to three years of funding and allows for feasibility testing in the context of a pilot study.

Specific areas of interest include:

  • Behavioral programs that initiate, sustain, or restore patient adherence to HIV care or regimens.
  • Challenges of simultaneous implementation of multiple prevention methods (for example, microbicide plus PrEP plus vaccine).
  • Approaches that sustain engagement in HIV care among people living with comorbidities or coinfections.

For a full list of priority research topics, as well as a list of activities supported by this FOA, see the April 17, 2014, Guide notice.

We strongly encourage you to request a consultation with staff at NIAID or the National Institute of Mental Health at least 10 weeks before the application due date. You can then obtain a summary letter to use as your application’s cover letter.

Submission deadlines for this FOA follow the Standard AIDS dates.

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An Opportunity to Support DAIT's Clinical Research Programs

A recent funding opportunity announcement (FOA) could be for you if you're interested in leading a Statistical and Clinical Coordinating Center (SACCC) for NIAID's Division of Allergy, Immunology, and Transplantation (DAIT).

This article provides an overview of the Center's multiple components, functions, and responsibilities, but we encourage you to read the FOA for complete details.

While we always advise reading the FOA, doing so is particularly important in this case because the FOA uses the activity code UM2-Program Project or Center with Complex Structure Cooperative Agreement. This should give you some indication as to how involved the opportunity is and why it's necessary to read all the information in the March 26, 2014, Guide notice.

Center's Functions

The purpose of the Center is to support clinical research programs in three disease areas—asthma and allergic diseases, autoimmune diseases, and transplantation—by performing functions such as statistical design and analysis; protocol development; study initiation and management; clinical site monitoring; data management; and safety oversight and reporting.

You may be familiar with the research programs the Center will support, such as the Asthma and Allergic Diseases Cooperative Research Centers, Autoimmunity Centers of Excellence, and Clinical Trials in Organ Transplantation, as well as the Collaborative Network for Clinical Research on Immune Tolerance, which conducts clinical research in all three disease areas.

To learn more about DAIT's clinical programs, go to Supporting Information for DAIT-Funded Clinical Research Programs.

Center Structure

To best accommodate the needs of the research programs, the Center will consist of nine functional entities:

  • Leadership Group—responsible for planning, directing, coordinating, managing, and evaluating the Center’s activities, as well as performing certain technical, operational, administrative, and fiscal functions for the project as a whole.
  • Disease-Specific Groups—responsible for providing support in three functional areas: 1) statistical design and analysis, 2) protocol development, and 3) study initiation and management.
    • Asthma and Allergic Diseases Group
    • Autoimmune Diseases Group
    • Transplantation Group
  • Centralized Groups—provide support for clinical research programs for all three disease areas.
    • Clinical Site Monitoring Group
    • Data Management and Reporting Group
    • Safety Oversight and Reporting Group
    • Ancillary Services Group
    • Bioinformatics Group

Project Director/Principal Investigator Responsibilities

Working closely with Group leaders and staff to promote efficient cooperation, communication, and coordination, the project director(s)/principal investigator(s) will have several responsibilities, including:

  • Directing the activities of the Center's Leadership Group.
  • Providing the full scope of statistical and clinical coordination support through the Disease-Specific and Centralized Groups.
  • Ensuring that support functions are performed in compliance with all federal and country-specific regulatory requirements and guidelines, as well as NIH and NIAID policies and procedures, for conducting human subjects research.
  • Ensuring that Center staff designated to provide statistical and clinical coordination support receive the appropriate training or certification.

Deadlines and Other Information

Optional letters of intent are due June 18, 2014. The application deadline is a month later on July 18.

For advice on writing an effective multiproject application, see Guidance for Preparing a Multiproject Research Application.

If you have questions about the FOA, direct them to Leighton Thomas, NIAID's scientific/research contact.

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Funding for Big Data Training Programs

If you're looking to beef up your institution's training program or start a new one, take note of three new funding opportunity announcements (FOAs) intended to develop a new cohort of scientists who have the knowledge and skills to develop "big data" tools and methods.

For this latest set of funding opportunities, your program will have to combine three disciplines—computer science (and informatics), biomedical research, and statistics—into a multifaceted, collaborative training experience with an emphasis on team science.

Read the following Guide notices for details and application instructions:

The first deadline for these applications is July 28, 2014, with an optional letter of intent due June 28, 2014.

These opportunities come out of the Big Data to Knowledge (BD2K) program, NIH's effort to develop new approaches, standards, methods, tools, software, and competencies to improve scientific use of big data.

Read below for two notes from NIAID to help your application succeed.

Competing for a Competing Supplement (Known as a Revision)

Two of the FOAs are revisions (formerly called competing supplements)—meaning, you must already be principal investigator (PI) of an active training grant for which you'll expand the scope to include a separate track that encompasses big data elements described in the notices.

If you're not PI of a training grant, don't be discouraged. Your institution may have somebody who is eligible to apply.

Reach out to your colleagues, search NIH's RePORTER database, or contact your business office to find out, then ask if you can join as part of a multiple PI application.

Three Opportunities, One Goal—What's Your Strategy?

While your institution may respond to each FOA (although the T15 is for NLM grantees only), we suggest you combine your efforts on one application that includes the best of what your institution has to offer.

Since all three FOAs serve one primary goal, NIH will make approximately 18 awards from the combined pool of applications for all three FOAs.

Your best bet to stand apart from the crowd is to focus your attention on one application, make it great, and then apply to the FOA that fits it best.

Header: Other News. 

Important Info for Small Businesses

Any small business that plans on submitting an application to NIH should be checking the SBIR/STTR News Flash Page regularly. It's a great resource for news and advice.

Be sure to read the post from April 21, 2014, which explains how NIH's new submission policy, announced in the April 17, 2014, Guide notice, affects small businesses. Examples for Phase I, Fast-Track, Phase II/Phase IIB, and Direct Phase II applicants are all covered. Also see How does NIH’s current resubmission policy affect SBIR/STTR Applicants? on NIH's SBIR/STTR Frequently Asked Questions page.

Another recent news flash, from March 24, 2014, reviews the top five eRA Commons grant submission errors for small business applicants. Follow the tips and solutions provided to avoid unnecessary delays in your application's submission.

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Attention Career Development Applicants: Foreign Components Are Allowed

We have good news for those interested in submitting a career development award (K) application with a foreign component. NIH has revised eligibility requirements to allow foreign components in applications from U.S. institutions. Read the May 02, 2014, Guide notice for details.

This change applies to the following K grants that NIAID supports:

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News Briefs

May Webinar to Discuss High-Priority Areas of HIV Cure Research. On Wednesday, May 28, 2014, NIH will present feedback from the recent Request for Information: Areas of Research Aimed at a Cure or Lifelong Remission of HIV Infection. The Webinar will include an interactive Q&A session. To participate, Register Now.

Patent Holders Can Apply for Humanitarian Recognition. The United States Patent and Trademark Office has renewed the Patents for Humanity program, a competition that gives public recognition and an acceleration certificate to 10 winners working to solve major global challenges. Applications are sought in several categories, including medical technology—medicines, vaccines, diagnostics, and medical devices are eligible. Apply by September 15, 2014.

Improvements to Financial Conflict of Interest Module in eRA Commons. NIH has upgraded several features of the FCOI module that investigators use to submit FCOI reports, as detailed in the April 18, 2014, Guide notice. Changes include more timely deadline warnings, new email reminders, and a simplified error correction process.

Header: Advice Corner.

Know What to Look for When Choosing a Mentor

If you're interested in applying for a fellowship or mentored career development (K) award, you'll need to find a principal investigator (PI) to serve as your mentor. Choosing one is among the most important decisions you'll make in your research career, so it's worth careful thought.

To help you pick the right person, here are some points to consider. This is by no means an exhaustive list, so we recommend you check the Related Links below and find other resources, e.g., people at your institution that can help you select a mentor who's right for you.

Note: We use mentor in the singular, but you are not limited to having just one. In fact, if you can't find one person who can meet all your needs, you may want to consider creating a mentoring team.

First Things First: What Is a Mentor?

A mentor is someone who makes a long-term commitment to your career. He or she wears many hats—adviser, advocate, critic, instructor—to guide your research and help you with your professional development and advancement.

As for what a mentor does, NIH's Office of Intramural Training and Education offers a good summary:

A good mentor will help you define your research goals, and then support you in your quest to achieve them. He or she will share knowledge, provide encouragement, and hopefully inspire you. In addition to promoting your research, your mentor should help you to develop your career goals and construct a scientific network. Above all, your mentor should be someone you trust to always keep your best interest in mind.—from Thoughts on Choosing a Research Mentor (linked below)

Qualities of a Good Mentor

Ideally, a mentor should be well known and well respected in your selected field and have essential qualities like being knowledgeable, open-minded, supportive, motivating, and a good listener.

He or she must be able to communicate clearly, give you appropriate projects to pursue, teach you to analyze and interpret results, as well as determine alternative paths.

Additionally, a good mentor should:

  • Foster collaboration.
  • Ensure you're making progress towards goals.
  • Give you feedback on your scientific work in a constructive and timely manner.
  • Support your participation in career-building activities, e.g., retreats, grant writing.
  • Encourage you to be independent, for example, in designing and conducting experiments.
  • Introduce you to researchers in your field at meetings or conferences.
  • Acknowledge your contribution to the research, for example, through authorship on publications.
  • Help you with grant applications and review them before you submit.

Keep in mind that a PI doesn't have to meet all the criteria above to be a good mentor.

Do Your Homework

You probably won't know whether a potential mentor has the aforementioned traits until you start working together, which is why you'll want to do your homework before approaching someone to take on this important role.

Talk to other students, postdocs, or research assistants to get their feedback on whether the PI has the qualities listed above. Ask them if they receive enough direction, feedback, and advice, and if they find the PI accessible and available. This is key since one who is frequently away or too busy to answer questions or resolve issues won't be of much help to you.

As another part of your homework, search for papers that the PI has published. This way, you get an idea of whether your research interests match as well as a sense of his or her publication record, which should preferably show that the PI actively publishes in high-quality journals.

In addition to the PI's publication record, ask about his or her training record, e.g., the number of people mentored, what positions past trainees hold currently. When evaluating your fellowship or career development grant application, reviewers will look at the training record, so be sure you examine it before they do.

Another key element to consider: the PI's funding situation. Since a fellowship or K award doesn't provide a substantial amount of money for research supplies, your mentor should be well-funded.

Final Thoughts

Selecting a mentor is a personal choice. Only you can get a sense of whether someone will meet your expectations and be able to guide your development as an independent researcher.

As we mentioned at the outset, we encourage you to find resources of your own and talk to others about potential mentors you have in mind. The more legwork you do, the better your chances of finding the right fit.

Related Links

NIH

NIAID

Career Toolkit: Mentoring

The "Right" Postdoc Mentor

How to Get the Mentoring You Want: A Guide for Graduate Students at a Diverse University

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Highlighting Synergy in Multiproject Applications

When reviewers score your multiproject application’s overall program, they consider the synergy among your projects. To improve your likelihood of success, you should address synergy directly.

Synergy doesn’t simply mean that discoveries made in the various projects of the program are thematically aligned. Instead, synergy means that discoveries made in one project of the program should substantively impact the research objectives in one or more of the other projects in the program. Success in one project should act as a catalyst for success in the others.

In short, synergy encapsulates the idea that a multiproject program should be greater than the sum of its parts.

To create synergy, projects may share or combine preliminary data, samples, technologies, research approaches, data management/analytical tools, reagents, pathogens, human subject populations, and model organisms.

For example, the NIAID Investigator-Initiated Program Project (P01) grants support integrated, multiproject research programs that have a well-defined, central research focus or objective. The P01 is a confederation of interrelated research projects, each capable of standing on its own scientific merit but complementing one another.

When scoring synergy, NIAID reviewers assess the scientific knowledge, ideas, and outcomes obtained through the cooperative interactions of the individual projects and cores. You should use the Overview section of your application to directly detail how components of the program will interact with one another.

NIAID has added guidance on how to address synergy. See Highlighting Synergy in the Guidance for Preparing a Multiproject Research Application.

For more information, contact program and scientific review officers listed in the June 28, 2013, Guide notice.

Header: Reader Questions. 

Feel free to send us a question at deaweb@niaid.nih.gov. After responding to you, we may include your question in the newsletter, incorporate it into the NIAID Research Funding site, or both.

"To renew a training grant, should I submit IRB and IACUC protocol approvals for mentors whose students are no longer being supported?"—anonymous reader

Yes, you should submit Institutional Review Board and Institutional Animal Care and Use Committee approvals for every mentor listed on the award. Contact your grants management specialist if you have further questions.

"How does the big grant policy apply to program project applications?"—anonymous reader

Investigator-initiated applications that request $500,000 or more in direct costs for any year require preapproval from an NIH institute or center. For a program project (P01) application, the policy applies even if none of the individual projects request $500,000 or more.

For more on big grants, go to NIAID's Big Grants SOP and Big Grant Applications questions and answers.

Header: New Funding Opportunities.

See other announcements at NIAID Funding Opportunities List.

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Last Updated May 07, 2014

Last Reviewed May 07, 2014