A doctor takes the temperature of a patient.

PCORI supports comparative clinical effectiveness research

"The

The Patient-Centered Outcomes Research Institute (PCORI) was established in 2010 as an independent non-profit, non-governmental, special purpose corporation authorized by Congress.  PCORI’s Congressional mandate is to improve the quality and relevance of healthcare information to help patients and caregivers make informed decisions. Through contracts, PCORI funds comparative clinical effectiveness research (CER) while engaging patients and stakeholders in the research process.

Patients and stakeholders help PCORI  prioritize research questions, advising PCORI on what to fund.  Stakeholders are engaged in the review process and help PCORI share findings with the community at large.

Currently most of PCORI’s $200 million budget supports clinical trial research, with the remainder funding general and targeted areas such as cancer, cardiovascular health, mental/behavioral disorders, and rare diseases.

PCORI supports applications from for- and non-profit entities as well as from entities not located in the U.S. Individuals may not apply.  Applications to PCORI are typically for 3-5 year projects and applications are often invited through a Letter of Intent (LOI) process.  Because PCORI is commitment to working with all stakeholders PCORI staff will work with researchers who did not get funded to strengthen their proposals to better align with the target solicitation.

PCORI funds comparative clinical effectiveness research (CER), so all questions must be comparative in nature.

For more information on PCORI and the types of research they fund, visit their website, pcori.org.


Written by Tricia Callahah, Director of Proposal development, Office for the Advancement of Research & Scholarship, Miami University.

Doctor and patient photo by Amanda Mills, U.S. Centers of Disease Control & Prevention, public domain. Culture photo by Carlotte Raymond Photography for International AIDS Vaccine Initiative (IAVI) via Flickr, used under Creative Commons license.

Large analog clock on outside of building. The business name -- Time -- is on a neon sign above the clock.

Changes to Federal labor rules will affect some research personnel

A blank IRS W-2 Wage and Tax Statement form.

UPDATE: On November 30, Miami University announced that in response to the federal judge’s injunction it will suspend, indefinitely,  changes it  planned to comply with the new FLSA overtime eligibility rules.
UPDATE: On November 22, a federal judge in Texas issued an injunction agains the FLSA action described below. It is likely these changes will not take effect December 1 as planned.

Recently the U.S. Department of Labor announced changes to the Fair Labor Standards Act (FLSA). This post summarizes those changes, discusses how they are being implemented at Miami University, and explains how those changes might affect researchers’ grant budgets.

What is FLSA?

The FLSA is a law that contains overtime pay provisions for U.S. workers. Currently, U.S. workers earning an annual salary of less than $23,660 are entitled to overtime compensation if they worked greater than 40 hours per week. U.S. workers who are paid an annual salary of at least $23,660 and are engaged in executive, administrative, or professional duties are exempt from this provision.

What changes are being made to the FLSA?

The changes made to the FLSA relate to the salary level that determines if an employee is exempt from the FLSA provisions for overtime (such as is the case for unclassified staff at Miami) or non-exempt from those provisions. In other words, the new FLSA provisions affect which employees are overtime eligible.

Effective December 1, 2016, the minimum annual salary threshold for exemption from overtime provisions will be set at $47,476 and will increase every three years thereafter.

What does this mean for grant budgets and for grant-funded employees?

In general, this means that  full-time employees who earn less than the $47,476 threshold will be required to track their work hours and must be paid overtime if they work greater than 40 hours a week. Researchers cannot allow or expect these non-exempt employees to work more than 40 hours per week without paying overtime.

Which grant-funded positions are most likely to be affected?

Postdoctoral researchers are the most likely to be affected by these changes. Postdoctoral candidates currently making under the threshold will be overtime eligible. Grantees may be able to raise the postdoc salary above the exemption threshold if there is room in the budget and if budget revisions are allowed by the sponsor. Alternatively, researchers who oversee grant-funded employees must monitor employees’ work hours and compensate them for any overtime beyond 40 hours per week.

How should I plan for future grant budgets?

For all new proposals, researchers are encouraged to budget their postdoc compensation at a minimum of $48,000, with 3% increases yearly.

What are some of the Federal-granting agencies doing to help researchers compensate for the increased threshold for exemption?

The National Institutes of Health (NIH) will increase postdoctoral stipends to levels at or above the proposed FLSA revisions. Projected postdoctoral stipends for Federal FY2017 can be found here. Look for the NIH to post guidance in the NIH Guide to Grants and Contracts regarding re-budgeting for current postdocs and employees over the new exemption threshold.

The National Science Foundation (NSF) postdoctoral fellowship programs already includes a stipend in excess of the FLSA final threshold. For grant-supported postdoctoral researchers making under the new threshold, NSF is leaving it up to principal investigators (PIs) and their institution to re-budget existing awards to comply with the new federal overtime rule. If additional funds are needed to cover any overages, grantees should contact their NSF Program Officer to discuss supplemental funding. See the NSF FLSA FAQs for additional information.

What is Miami doing about reclassification of impacted positions?

Definitions of unclassified and classified service can be found in the Miami University Policy Library. Specific questions regarding FLSA and employment at Miami University should be directed to Human Resources or Academic Personnel, as appropriate.

Starting August 1, 2016, Miami is centrally funding any increase in postdoctoral salary necessary to bring an individual above the new FLSA minimum so that all postdoctoral associates will be exempt from overtime. Because it is funded centrally, the salary increase will not affect current grants this fiscal year. However, central university funding will not be available indefinitely, so PIs affected by this increase are expected to seek supplements from their funding agencies during the upcoming year.


Updated November 28 to include information about the Federal court injunction. Updated November 30 to include information about Miami University’s response to the federal judge’s injunction. 

Written by Tricia Callahan, Director of Proposal Development, Office for the Advancement of Research & Scholarship, Miami University.

W-2 photo by 401(K) 2012 via Flickr. Time photo by Thomas Hawk via Flickr. Both used under Creative Commons license.

A student researcher takes blood from the finger of a research participant who is walking on a treadmill. The students mentor supervises.

Changes to NSF and NIH policies and procedures are forthcoming

A researcher holds a bird that will be banded.
Researchers working with vertebrate animals need to be aware of recently increased scrutiny by the NIH.

 

Below is a summary of changes in policy and procedure being implemented at the National Science Foundation (NSF) and the National Institutes of Health (NIH).

National Science Foundation (NSF)

The NSF Policy Office has a long history of being responsive to the grant community. In response to comments from investigators and research administrators, the NSF is making a number of changes in its policies pertaining to preparation and award administration. Full details can be found in the Proposal and Award Policies and Procedures Guide (PAPPG)but the changes that will have the most impact Miami University researchers are summarized below:

New proposal types and clarification on proposal types

  • Letters of Intent, preliminary proposals, full proposals, and invited proposals, oh my! Guidance on what to include in these different types of NSF proposals will now be outlined in the revised PAPPG. Special attention is given to what needs to be included in the new, separate section on Collaborator & Other Affiliation Information.
  • Look for two new proposal types to be implemented:
    • Research Advanced by Interdisciplinary Science (RAIS): RAIS will replace NSF INSPIRES to promote interdisciplinary science and education.
    • Grant Opportunities for Academic Liaison with Industry (GOALI): The GOALI program is expanding beyond Engineering to promote university-industry partnerships focused on solving basic research questions. Look for this cross-cutting program in many of the NSF Directorates.
  • Historically travel grants have supported international travel for students supported by NSF funds, while supplements — such as those for Research Experiences for Undergraduates (REUs) — have been used for domestic travel. Going forward, however, NSF travel grants will cover both foreign and domestic travel for students.

Defining participants

According to NSF policy, it is up to the institution, not the NSF program officer, to classify participant support. At Miami, we use the NSF definition of participant support recently adopted by the Office of Management and Budget (OMB): “Participant support costs are direct costs for items such as stipends or subsistence allowances, travel allowances, and registration fees paid to or on behalf of participants or trainees (but not employees) in connection with meetings, conferences, symposia or training projects” (PAPPG).

The revised PAPPG will aid in clarifying the difference between an undergraduate participant (such as an REU student) and an undergraduate researcher. However, if you are uncertain how to classify any student, please contact your OARS representative for assistance.

Finally, just a note on food for participants. If a participant receives funds for individual meal compensation, those funds should be budgeted under “Participant Support.” Funds for meals provided for conferences/workshops, should be budgeted under “Other.” Contact your OARS representative if you need assistance making this distinction.

Changes to NSF forms

  • The 4,600 character limit will be removed from the Project Summary. Instead, the Project Summary will be limited to one printed page using appropriate font size and type.
  • Guidance on “Collaborator & Other Affiliation information” will be updated in the revised PAPPG.

Financial considerations

  • NSF has adopted a 10% de minimis facilities and administration (F&A) rate for foreign subcontractors. Domestic subcontractors may used their Federally-negotiated F&A rate or may use the 10% de minimis rate, if they do not have a negotiated rate.
  • Use of an F&A rate less than the institution’s negotiated rate is considered by NSF to be cost share, which is unallowable for a majority of NSF programs. Using the NSF budget template provided by OARS will ensure you are using the correct F&A and fringe benefit rates.
  • NSF guidance on implementation of the Department of Labor’s Fair Labor Standards Act (FLSA) can be found in their list of frequently asked questions (FAQs).

Additional information

A final draft of the revised PAPPG will be posted to the NSF website in October 2016, with changes to be implemented January 2017.

If you’d like to learn more about NSF grant administration and programs, consider registering to attend the upcoming NSF Grants Conference being held November 14-15 in Pittsburgh, PA.

National Institutes of Health (NIH)

A number of changes have recently come out of the NIH Office of Extramural Research. Many of these changes have an impact on post-award accounting and reporting. The most helpful things for grant writers are the new NIH Guide to Grants and Contracts and the General Application Guide for NIH. These new guides offer streamlined overviews of NIH programs, open solicitations, and step-by-step instructions on preparing NIH proposals and reports.

Other changes to NIH policy and programs include:

New funding programs

The Precision Medicine Initiative (PMI) program was announced by President Obama during his 2015 State of the Union address. The focus of this initiative is to take fundamental research and apply it to a specific cohort of individuals to produce individualized care. Funding programs for PMI can be found here.

Form updates

  • The new Forms D are in effect for proposals submitted on or after May 25, 2016. The new forms include:
    • A new section on authentication of key biological and/or chemical resources in order to meet requirements for rigor and reproducibility.
    • New questions regarding enrollment of human participants (enrollment type, dataset source, participant location, etc.)
    • A PHS Assignment Request Form to help determine under which institute or center a proposal should be reviewed
  • Newly specified font types including Arial, Garamond, Georgia, Helvetica, Palatino Linotype, Times New Roman, and Verdana. All font types should be 11 points or larger.

Compliance issues

eRA Commons and technical/financial reporting

  • As of June 12, 2016, eRA Commons usernames are required for primary mentors on Mentored Career Development proposals. If you need to register a PI, co-PI, investigator, sponsor, or mentor with eRA Commons, please contact your OARS representative.
  • While registration is not required for undergraduate students, graduate students, and postdoctoral candidates at the proposal stage,  once a project is funded and work by those personnel is supported by NIH funding, they must be registered with eRA Commons so that PIs can complete technical (annual and close-out) reports. Contact your OARS representative to register individuals with eRA Commons.
  • New guidance on completing the Research Performance Program Report (RPPR) will be published this October. The new guidance will cover completing and submitting the Final Progress Report (FPR), the Final Invention Statement & Certification (FIS), and the Final Federal Financial Report (FFR). Please remember that all financial reports must be submitted by Miami’s Grants & Contracts office, and should not be submitted by the PI.

Additional information

If you’d like to learn more about NIH grant administration and programs, consider registering to attend the upcoming NIH Regional Seminar being held October 26-28 in Chicago, IL.


Written by Tricia Callahan, Director of Proposal Development, Office for the Advancement of Research & Scholarship, Miami University.

Treadmill research photo by Scott Kisssell, Miami University Photo Services. Bird photo also by Miami University Photo Services.

Looking up at several stories of office windows from inside a building. There is a round, black circle-shaped sculpture suspended from the glass ceiling of the building.

Director of Proposal Development offers updates on NIH and NSF policies

Skyline of Baltimore's Inner Harbor.
Baltimore, Maryland, is the site of an NIH Regional Seminar being held this week. Another Regional Seminar will be held in Chicago this fall.

Below are  updates on policies recently put into action at NIH and NSF, as well as a look ahead to some upcoming changes.


NIH

General

The NIH budget for FY16 is $32.3 billion, up $2M over FY15.

Proposal submission

  • All documents submitted to NIH (proposals, award documents, and post-award documents) must contain a signature from an Authorized Organizational Representative (AOR) or Signing Official (SO). At Miami, only Jim Oris, Anne Schauer, and Tricia Callahan can sign as AORs or SOs. Contact your OARS representative if you are uncertain who should sign your NIH documents prior to submission.
  • NIH has updated and streamlined its forms and instructions page. For applications due May 25, 2016 and later, Version D forms must be used.
  • Effective January 10, 2016, the NIH salary cap (Executive Level II) went to $185,100. NIH encourages investigators to propose using their base salary. If base salary exceeds the NIH salary cap, then adjustments will be made at the time of award.
  • For proposals that involve the use of vertebrate animals, the section on euthanasia is now a separate document in order to assure compliance with American Veterinary Medical Association (AVMA) guidelines. The NIH Office of Laboratory Animal Welfare (OLAW) offers policy, guidance, and education related to the use of vertebrate animals in research. Look for resources, FAQs, and quarterly webinars on the OLAW site.
  • The new NIH biosketch allows for up to five pages, one page more than the previous limit. Publications in progress can be mentioned in the Personal Statement, but should not be cited in the publications listing.
  • NIH created ASSIST (Application Submission System & Interface for Submission Tracking) for the preparation and submission of multi-project applications. Miami University will continue to submit and track applications through eSPA, so Miami applicants should not use ASSIST for their proposal submissions.
  • For NRSA and K awards, primary mentors must have an eRA Commons ID affiliated with Miami University. Contact your OARS representative to create an eRA Commons ID or to affiliate an existing ID with Miami.
  • If you plan to work with a foreign collaborator, OARS requests advance notice of 25 working days. However, you should be aware that it may take foreign entities eight to ten weeks to register with eRA Commons and the other systems, and that those registrations must be in place before contracting with the Federal government. Contact your OARS representative for assistance.

Reporting

  • All financial and technical reports must be submitted 120 days following the award end date. We’d like to take this opportunity to remind investigators that while they are responsible for their technical reports, all financial reporting must be done by Miami University’s Grants & Contracts Office. Information about the types of NIH reports and the content they require is available here. All invention disclosures should be processed through iEdison.
  • Find out what’s currently being funded at the NIH and discover trends using NIH RePORTER.

Continuing education

  • Thanks to everyone who joined us for our recent day-long series of NIH workshops, led by Dr. Norm Braveman, former member of the senior NIH staff.
  • NIH will hold two NIH Regional Seminars on program funding and grants administration in 2016:
    • May 11-13, in Baltimore
    • October 26-28, in Chicago

NSF

General

  • The NSF budget request for FY16 is $6.5 billion for research and development. Current funding rates average around 22-23%.
  • A notice will be posted this summer in the Federal Register describing changes proposed for the NSF Proposal and Award Policies & Procedures Guide (PAPPG), with time allowed for public comment before changes are finalized. Final changes will be posted in October and the grants community will be given 90 days to become familiar prior to implementation in January 2017.

Proposal submission

The following are reflected in the current PAPPG:

  • All proposals are due by 5:00pm local time of the submitting institution. Permission to submit after a deadline in the event of a natural disaster must come from the Program Officer in writing. The communication should be included as a Single Copy Document in the application and a box must be checked on the NSF Cover Page for special exceptions to the NSF deadline policy.
  • Collaborative and Other Affiliation information has been removed from the NSF Biosketch and is now submitted as a Single Copy Document (which differs from Supplemental Material). This change is to help researchers who have long lists of collaborations keep to the two-page limit for biosketches.
  • Information on Results from Prior NSF Submission has been clarified in the most recent version of the PAPPG.
  • Information on internal, institutional funds that require dedicated effort must now be shown on the NSF Current & Pending form.
  • Biosketches and Current & Pending forms can no longer be submitted as a single PDF. Each senior/key personnel should have a separate biosketch and separate Current & Pending forms. Biosketch information for other personnel, such as equipment users, should be uploaded as Supplemental Material documents, and do not have to follow the NSF biosketch format.
  • Clarity has been provided on the use of vertebrate animals in research, which follows NIH OLAW policies.
  • FastLane auto-checks for compliance with page limits and submission deadlines.

Post-award and reporting

  • All financial and technical reports must be submitted 120 days following the award end date. We’d like to take this opportunity to remind investigators that while they are responsible for their technical reports, all financial reporting must be done by Miami University’s Grants & Contracts Office.
  • All post-award communications, such as notifications and requests, must be signed and submitted by the institution’s Authorized Organizational Representative (AOR). Contact your OARS representative if you are uncertain who should sign your NSF requests.

Editor’s note 05/13/2016: The original post mistakenly indicated that NSF biosketches are limited to three pages. We regret the error and have updated the post with the correct limit, which is two pages.

Written by Tricia Callahan, Director of Proposal Development, Office for the Advancement of Research & Scholarship, Miami University.

Photo of Baltimore’s Inner Harbor by Ron Cogswell, via Flickr. NSF lobby photo by Luke Faraone, via Flickr. Both used under Creative Commons license.

Lauren Fussner stands beside a poster describing her research on adolescent depression, sensitivity to social feedback, and social functioning.

Project takes flight on HawksNest

Lauren Fussner and another person sit at a table reviewing paper documents and consulting a laptop.
Lauren Fussner, left, is lead investigator of the first project successfully funded through HawksNest, a new crowdfunding platform at Miami University.

Lauren Fussner, a graduate student in clinical psychology at Miami University, is lead investigator on the first project successfully funded through Miami’s new crowdfunding site, HawksNest.

Fussner says she was excited about using HawksNest to raise funds for her project because she had previously had difficulty obtaining funds from national funding sources to support her project. HawksNest allowed her reach people who had a personal interest in her project, which seeks to identify shared or common risk factors contributing to depression and eating disorders in adolescent females.

“Instead of competing broadly, on a larger scale, I was able to network through my personal contacts, as well as reach out to individuals who may have a personal interest in helping teens with depression and eating disorders,” Fussner says.

Crowdfunding allows researchers who, like Fussner, are conducting meaningful research and have a compelling story to tell, to raise funds by leveraging personal networks. This requires both initial generation of excitement about the project, as well as continuous promotion throughout the campaign (learn more here).

Fussner posted information about her project on her personal Facebook account and encouraged others in her lab to do the same. She also used contacts from her Notre Dame undergraduate Facebook alumni group and clinical psychology alumni group to help spread the word about her project.

Fussner further attributes her fundraising success to setting a realistic, attainable goal.

“With a modest goal of just over $500, we were able to raise our funds quickly. After the first donation was made, others quickly followed,” she says.

HawksNest was created to help Miami University students, faculty, and staff engage the Miami community to help fund student-centered projects.


Written by Tricia Callahan, Director for Proposal Development, Office for the Advancement of Research & Scholarship, Miami University.

Images courtesy of Lauren Fussner.

Closeup of a ball of multi-colored string

Grants come with strings attached

A row of marionettes.
Like marionettes, grants come with strings attached.

In the words of Ben Parker (Spiderman’s “Uncle Ben”),  “With great power, comes great responsibility.” The same can be said for grant funds. With the acceptance of a grant award, the Principal Investigator (PI) or Project Director (PD) agrees to try to meet the objectives laid out in the grant proposal. In addition to financial details, which are reported to the sponsor by Miami’s Office of  Grants and Contracts, the PI must report on progress made toward proposed goals and objectives.

Federal grant-making agencies, like the NSF and NIH, typically have project reporting systems through which annual and final outcome reports must be posted. These systems often require that PIs submit their annual reports no later than 90 days before the end of the current budget period and final reports no later than 120 days following the expiration of an award. Additionally, most Federal granting agencies require a non-technical report, understandable by the general public, to be submitted within 120 days post-award. (Learn more about the NSF’s and NIH’s technical reporting requirements.)

Even non-Federal granting agencies, like local foundations, often have reporting requirements. Take the Oxford Community Foundation (OCF) as an example. As a condition of accepting OCF funds, the PI must agree to submit a fiscal* summary and project evaluation within 60 days of project completion. Failure to do so may jeopardize future OCF funding.

When a report is overdue, things get messy. Overdue reports:

  • Will prevent the release of on-going funds for multi-year projects
  • Will keep the PI from submitting a no-cost extension
  • May affect future funding for the PI and all of the Co-PIs listed on the award with the overdue report

Therefore it is important to submit technical reports in a timely manner.

Don’t be afraid to communicate with your sponsor if you have setbacks in your grant activities. Often the sponsor can assist by granting additional time in the form of a no-cost extension or by allowing budget adjustments. Sponsors recognize that when conducting research, delays happen and problems arise. You don’t have to be Superman, but you do have to be a good steward of funds.

We encourage Miami researchers to let us know how we can help.

*All financial information should be reported by Miami’s Grants and Contracts office, not by the PI.


Written by Tricia Callahan, Director of Proposal Development, Office for the Advancement of Research & Scholarship, Miami University.

Marionette photo by Antonio Rù via Flickr. String photo by Phoebe Baker via Flickr. Both used under Creative Commons license.

Four dice sit on the green felt surface of a gaming table.

Seminar recap offers advice to increase odds for NIH funding

Roulette wheel.

On Wednesday, January 13, Urban Venture Group Ltd. (UVG) consultant Burr Zimmerman offered advice to Miami faculty, staff, and students about understanding the mission and culture of the National Institutes of Health (NIH) in order to increase the odds of obtaining NIH funding. The seminar was sponsored by the Scripps Gerontology Center and OARS.

First and foremost, Zimmerman says, is to understand that the NIH is a social organization. Therefore, it is imperative that applicants be in communication with an NIH program officer well before submitting a grant application.

Applicants should begin by exploring NIH’s various institutes, centers, funding mechanisms, programs, and study sections prior to submission. Zimmerman suggested the NIH RePORTER for researching the types of projects recently funded by the NIH. After this step, Zimmerman suggested applicants:

  • Assemble a research team comprised of partners skilled to meet project objectives;
  • Generate a “Specific Aims” document that outlines the significance of the project, introduces the team of experts, states a hypothesis, includes project aims, and details the impact that the project will have on the field;
  • Contact an NIH program officer to share the “Specific Aims” document and to ask questions to ensure the aims fit with the program’s objectives;
  • Revise aims based on program officer feedback;
  • Write the body of the proposal

Zimmerman emphasized that as with any proposal,  NIH proposals should be written to the review criteria. The NIH review criteria include significance, investigator(s), innovation, approach, environment, and additional review criteria.

NIH Review Criterion Criterion addresses …
Significance Impact on the field of study; why the proposed work should be carried out
Investigator(s) Experience, qualifications and training of investigators to conduct proposed work
Innovation(s) Novel concepts, approaches, methodologies, instruments, and interventions
Approach Experimental design including alternative plans for potential pitfalls
Environment Adequate resources such as equipment and facilities to carry out proposed work
Additional criteria Protections for human subjects; inclusions of women, minorities, and children; appropriate use of vertebrate animals; and management of biohazards

Finally, Zimmerman outlined the NIH review process and talked about how to decipher and respond to reviewer feedback. “Receiving a priority score and reviewer feedback equals success,” said Zimmerman. With funding rates of 20% and lower, the odds of being funded the first time an application is submitted are low. Keeping in mind Zimmerman’s opening statement about communication being the key to NIH success, attendees were encouraged to read and respond to reviewer feedback by revising and resubmitting following the initial steps of convening a comprehensive project team, sharing revised aims with the program officer, and then re-writing the proposal.

Zimmerman ended by directing participants to the proposal-writing resources available on the NIH website as well as resources available through OARS.

Learn more about increasing your odds for NIH funding by attending one of NIH’s 2016 Regional Seminars:

  • May 11-13 in Baltimore, Maryland
  • October 26-28 in Chicago, Illinois

Written by Tricia Callahan, Director of Proposal Development, Office for the Advancement of Research & Scholarship, Miami University.

Roulette wheel image by Zdenko Zivkovic via Flickr. Casino dice image by davidgsteadman via Flickr. Both used under Creative Commons license.

 

Shows the growth pattern of the SH-SY5Y neuroblastoma cell line.

New NIH guidance emphasizes rigor and reproducibility

A pair of hooded rats stands on a flat surface.

Recently the NIH published new guidance on rigor and reproducibility in the NIH application and review process.  This new guidance, which goes into effect for applications due January 25, 2016 and later, emphasizes rigor, reproducibility, and transparency in the NIH grant application process.  What does this mean for grant applicants?  Basically it means paying attention to details and making it clear to reviewers that you have done so.

The new guidance has little effect on the structure and content of the application. However, it does put the onus on the researcher to clearly communicate attention to rigor and reproducibility throughout the application.  Additionally, the guidance encourages a robust peer review and gives special consideration to the use of both males and females in biomedical research, as well as to authentication of key biological and chemical resources.

Outlined below are the areas most significantly affected by the new guidance:

Scientific premise of proposed research

While there has always been the expectation that researchers describe the strengths and weaknesses of prior research critical to the application, it is now expected that this description include attention to the rigor of the previous experimental designs as well as to consideration of appropriate biological variables (e.g., sex differences in subject pool) and authentication of key resources (e.g., cell lines, speciality chemicals).

Scientific rigor in experimental design

Not only should previous research be scrutinized for accuracy and precision, but the proposed research should also be robust and unbiased, including full transparency in detailing the experimental design.  As always, researchers in the field should be able to read and replicate the experimental design in order to extend the findings and advance the field.

Consideration of relevant biological variables in experimental design

Often overlooked in both animal and human subject study designs are biological differences between females and males.  Researchers must justify subject pool demographics and demonstrate understanding of potential sex-based differences in biological function, disease processes, and treatment responses. (Learn more about what it means to consider sex as a relevant biological variable in this post on the NIH blog, Extramural Nexus.)  In addition to sex-based differences, other crucial variables include age and weight, as well as current and previous health conditions.

Authentication of key biological and chemical resources

Key biological and chemical resources should be verified since resources can vary over time and between suppliers.  Researchers must demonstrate quality and quantity of resources, ensuring design replicability.

To learn more about enhancing rigor and reproducibility in the NIH grant application and review process, visit the NIH Office of Extramural Research.


Written by Tricia Callahan, Director of Proposal Development, Office for the Advancement of Research & Scholarship, Miami University.

Hooded rat photo by Jason Snyder via Wikimedia Commons. SH-SY5Y cell line photo by Reid Offringa via Wikimedia Commons. Both used under Creative Commons license.

 

James H. Shannon Building (Building One), NIH campus

Questions about NIH proposal evaluation answered

Three people site behind a table. The one in the middle holds up a card that says, "4. I like it."

While the process for proposal evaluation at the NIH is transparent and outlined on the NIH website, the steps and expectations can be overwhelming for those unfamiliar with NIH or its processes. A recent NIH webinar demystified the process as outlined below:

What happens to my application after it is submitted to NIH?
A majority of applications submitted to the NIH are assigned to the Center for Scientific Review (CSR). The CSR checks each application for completeness and assigns applications to a specific NIH Institute or Center (I/C). Applications are then assigned to a Scientific Review Group (SRG) or review committee that will evaluate the proposal based on NIH review criteria. Read more about application receipt and referral here.

On what criteria is my application evaluated?
Proposals are scored based on 5 core review criteria:

Significance– When ascertaining a proposal’s significance, reviewers ask questions such as, “Will the proposed work have a sustained and powerful impact on the field?” “Should this work be done and why?” and “Does the project address an important problem or barrier to progress within a certain filed?” and then assigns a score based on how well the proposal answers these questions.

Investigator(s)– What abilities, qualifications, and training do the investigators have to conduct the proposed work? There is an expectation that investigators demonstrate a record of success as evidenced by publications and prior funding. Some leeway is given for new and early stage investigators. New Investigators are those investigators who have never received an NIH R01 research grant, while early stage investigators (ESIs) are new investigators who have completed the terminal degree within the last 10 years. NIH is committed to accelerating the transition from new investigator to independent researcher, thus new investigators and ESIs do not have to demonstrate the same amount of prior success in order to receive NIH funding. If applicable be sure your NIH eRA Commons profile is up-to-date in order to reflect your status as a new investigator or ESI!

Innovation– The criterion of innovation addresses how well an application challenges or seeks to shift current research or procedures. Reviewers look to see if concepts, approaches, and methodologies are novel.

Approach– Is the proposed work appropriate in scope? Is it realistic? Are pitfalls and limitations anticipated, and if so, is an alternate plan laid out to address potential setbacks? It’s here that a sound evaluation plan becomes important to ensure the work is moving along in the proposed direction.

Environment– Are there adequate resources and institutional support for carrying out the proposed work?

Additional considerations include protections for human subjects; inclusion of women, minorities, and children; appropriate use of vertebrate animals; and management of biohazards.

What else do reviewers look for?
While all proposals are evaluated and scored on the five NIH core criteria, reviewers also look for: clear objectives with an obvious impact on the field; exciting ideas; realistic aims and timelines; brevity on obvious things; noted limitations; and a clear, well-written application that is free of grammatical errors.

How is my application scored?
Applications are scored on a scale from 1-9 as follows:

1- Exceptional
2- Outstanding
3- Excellent
4- Very Good
5- Good
6- Satisfactory
7- Fair
8- Marginal
9- Poor

After review, the scores of individual reviewers are averaged and that average is multiplied by 10 to give impact scores ranging between 10 (high impact) and 90 (low impact). Note: Only applications that are discussed are given impact scores. Reviewers may not discuss an application if they believe it is not meritorious enough to warrant discussion.

Where can I track my application status?
Grant status can be tracked via eRA Commons. eRA Commons contains the following: a PDF file of the submitted application; contact information for the Program Officer (PO), Scientific Review Officer (SRO), and Grants Management Specialist (GMS); council meeting dates; scientific review group; study roster; status history (including dates); funding outcome; summary statement; and award number, if applicable.

Who do I contact for assistance?

Before you submit your proposal: The Program Official (PO) is responsible for the programmatic, scientific, and technical aspects of a grant. If you have questions about the relevance of your work to the program, questions about the program not addressed in the announcement, or questions regarding the most appropriate study section for your application, contact your PO.

After you submit and prior to review: The Scientific Review Officer (SRO) is responsible for the scientific and technical review of proposals. The SRO is the point of contact for applicants during the review process.

After review (if funded): The Grants Management Specialist (GM) is responsible for the business management requirements of the award. You may also need to contact your Program Official if you need to request changes to your personnel, budget, or scope of work after an award has been issued.

After review (if not funded): After you’ve read your summary statement, you may want to talk to your PO about revising and resubmitting your application.

What is the typical timeline between submission and award?
For most applications, it takes about 9-10 months between proposal submission to receiving an NOA (Notice of Award).

If I am not funded, will I receive feedback regarding my application?
The NIH summary statement contains scores for each of the five review criteria, critiques from assigned reviewers, and a summary discussion of the overall review. For those proposals receiving an impact score, the summary statement will also show the overall impact score and percentile ranking. For those proposals not discussed, no overall impact score is given. Summary statements may also contain recommendations of the study section, a recommended budget, and additional administrative notes.

How can I learn more about the NIH Review Process?
Videos and information on the NIH review process are available on the NIH website. 
Additionally, depending on your accomplishments and expertise in a given area, you can become an NIH reviewer. Becoming a reviewer gives you valuable experience, as well as an insider’s perspective on the NIH review process. Learn more about becoming an NIH reviewer here.


Written by Tricia Callahan, Director of Proposal Development, Office for the Advancement of Research & Scholarship, Miami University.

Photo of James H. Shannon Building (Building One), NIH campus by Lydia Polimeni, National Institutes of Health, via Flickr. Score photo by uncoolbob via Flickr. Both used under Creative Commons license

 

Head-and-shoulders portrait of a woman.

First National Research Administrators Day observed this week

September 25, 2015 marks the first of what is planned to be an annual National Research Administrators Day. But just what is a research administrator and what does he or she do? Research administration of course!

Research administration is a profession that involves the “development, management, and implementation of research initiatives.” Research administration touches all aspects of planning for research programs, whether they are basic or applied programs, instructional programs, or public service programs. It also involves preparation and submission of proposals to secure funding for research, as well as project management, contract negotiation and management, financial management and oversight, and compliance with federal, state, and entity regulations and policies.

Thousands and thousands of people work in research administration across the globe. They may work in hospitals or institutions of higher education; they may work in not-for-profit agencies or in business and industry; or they may work in municipal, state, or Federal governmental agencies. Possible job titles in the profession include:

  • Vice President/Provost for Research
  • Sponsored Programs Director
  • Research/Proposal Development Coordinator
  • Program Manager/Coordinator
  • Contract Manager
  • Research Compliance Officer/Director
  • Research Integrity Officer
  • Export Controls Officer
  • Technology Transfer Officer/Director
  • Grants Accountant
  • Fiscal Administrator

The profession of research administration is supported by several organizations, including the National Council of University Research Administrators (NCURA) and the Society of Research Administrators International (SRA). According to NCURA, Research Administrators Day is “the day that will recognize the significant contributions made by administrators in support of research innovation, inquiry, and discovery.”

Research administrators can receive certification in their area of expertise through the Research Administrators Certification Council (RACC) and can earn their Master of Science in Research Administration through Johns Hopkins University, Rush University, or the University of Central Florida.

Written by Tricia Callahan, Director of Proposal Development, Office for the Advancement of Research & Scholarship, Miami University.

Video by NCURA via YouTube. Photo of research administrator Linda Manley (Miami University’s Grants & Contracts office) by Miami University Communications & Marketing.