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This is not recommended, however, if there was a good reason to include the same citation in both sections, this may be OK, although given that only 24 citations can be directly highlighted between the two sections it will probably be better to use the citations more selectively.
Not advised. The personal statement is the place you get to speak to your unique role, which will vary from project to project.
According to NIH policy, anyone submitting an application, proposal or report to the NIH must include the PMC reference number (PMCID) when citing applicable papers that they author or that arise from their NIH-funded research where funding was awarded after April 7, 2008. The NIH also provides specific guidance on how and when to use PMCIDs in citations.
For an individual, or couple of citations, the easiest way is to pull up the abstract in PubMED, i.e., click on the citation from the search list. If there is a PMCID, it will be there. There are converters that will take larger numbers of PMIDs and identify the PMCIDs if they exist. Read more here.
Biosketches should be tailored to address the specific aims of the grant in question. This is particularly true of the personal statement, which is your opportunity to demonstrate that your education and work experience make you uniquely qualified to perform the specific role (e.g., PI, co-investigator, consultant) on the project. For these reasons, biosketches should be revised for each funding submission.
The SF424 Application Guide for NIH and Other PHS Agencies stipulates that the NIH has a preference for biosketches to appear in alphabetical order. However, alphabetical order is not a requirement. As the PD/PI, it is important to keep in mind that peer-reviewers will see biosketches in the order they are presented within your submission. When determining the best order, you should give consideration to the role each individual has on the project and how their expertise contributes to the bigger picture you are trying to create, which is to demonstrate to reviewers that the research team’s collective strengths are uniquely suited to address the proposed problem.
According to NIH policy, anyone submitting an application, proposal or report to the NIH must include the PMC reference number (PMCID) when citing applicable papers that they author or that arise from their NIH-funded research where funding was awarded after April 7, 2008. The NIH also provides specific guidance on how and when to use PMCIDs in citations. Read more here.
NIH notice NOT-OD-16-004, released on October 13, 2015, clarified biosketch instructions. The notice stipulated that a URL for a publication list is optional and, if provided, must be to a government website (.gov) like My Bibliography.
The PMID is a unique number used by PubMed that is automatically assigned to each article when entered into PubMed. PubMed is an index of abstracts that indexes the literature within MEDLINE. PubMed only provides access to citations and abstracts – not full text articles. Because a PMID number only links to the abstract – and not the full article – in PubMed, it does not meet citation requirements of the NIH Public Access Policy. In contrast, the PMCID number is assigned by PubMed Central, the NIH-sponsored public-access database that contains the full text of peer-reviewed articles. Since its creation in 2000, PubMed Central has served as a free digital archive of full-text biomedical and life sciences journal literature at the NIH. Beginning in 2005, PubMed Central has also been the designated repository for papers submitted in accordance with the NIH Public Access Policy and for those that fall under similar policies from other funding agencies. The PMCID is a unique reference number that is assigned to every article that is accepted into PubMed Central. PMCIDs are listed below the abstract in a PubMed record. Learn how an article appears in PubMed Central.
Reviewers look at your biosketch to get a feel for who you are as a scientist – your background, training, and funding – and to assess the correctness of fit between your qualifications and your specific role on the project. The personal statement is your opportunity to demonstrate that your education and work experience make you uniquely qualified to perform the specified role (e.g., PI, co-investigator, consultant) on the project.
Biosketches are generally written in first person or third person. This is not mandated by NIH guidelines and is largely a matter of personal preference. That said, it should be noted that the NIH’s sample biosketch is written in the first person, which is a more intimate writing style because it tells a story from the author’s perspective (e.g., “I have expertise in…”). If an application will include multiple biosketches, the narrative voice selected should be the same for all biosketches.
The corresponding author is responsible for submitting the article to NIH. The article should be submitted only once, even though there may be multiple grants involved. Individual publishers may submit the “accepted version” to the NIH as a courtesy to the author. There are 4 methods to ensure that an article has been submitted to the NIH in compliance with the Public Access Policy. See a review of each submission method here.
Biosketches are required for all senior/key personnel and Other Significant Contributors (OSCs). The NIH defines senior/key personnel as “individuals who contribute to the scientific development or execution of a project both substantively and measurably.” Misidentifying personnel as senior/key creates unnecessary burden for application preparation, submission of Just-in-Time information, and annual reporting requirements. The NIH defines OSCs are individuals who will contribute to the scientific development or execution of the project, but will be contributing on an “as needed” basis and/or represented a “zero person months” in measurable effort. Consultants can be considered as OSCs if they meet this definition.
No. You may list four citations per contribution and each contribution is limited to one half page.
Yes. This section is your opportunity to share your scientific path and the impact that it has had. Early research experiences, particularly for junior faculty, should be included in Section C. Contributions to Science.
Career Development Awards (i.e. K Awards)
No. The NIH offers 2 types of K awards – mentored K awards and non-mentored K awards. Mentored K awards (i.e. K01, K03, K23, K25, and K99/R00) are primarily intended for new and early-stage investigators who need salary support and protected time to undertake intensive, supervised career development. They require the candidate to devote a minimum of nine person-months (75 percent of full-time professional effort) to the conduct of research for the duration of the award. Many institutes and centers (ICs) within the NIH participate in the mentored K award program. Fewer ICs within the NIH participate in non-mentored K awards (i.e., K02, K05, K07, K22, K24, K18), which are primarily utilized by more established investigators looking to acquire new research capabilities.
The NIH only permits applicants to receive one mentored K award. So, if you receive a mentored K award, you will not be able to apply for another mentored K award in the future. However, this does not preclude you from applying for a non-mentored K award (i.e., K02, K05, K07, K22, K24, and K18).
A good place to start your research is the NIH website, which provides an overview of all career development grant mechanisms and the currently active Funding Opportunity Announcements (FOAs).
Keep in mind that FOAs can be issued through either a Parent Announcement or an IC-specific FOA. What is the difference? NIH Parent Announcements are agency-wide FOAs that enable applicants to submit investigator-initiated applications to multiple ICs. ICs that participate in an NIH Parent Announcement may have supplemental requirements, so it is important to speak with the program officer at the IC whose research objectives most closely align with your research before submitting an application. Some ICs may choose not to participate in the NIH Parent Announcement in favor of issuing a targeted FOA that focuses on increasing research strength in a specific field of biomedical research or attracting researchers from underrepresented backgrounds.
Yes and no. By the time of award, a K grant applicant must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status). Individuals on temporary or student visas are not eligible to receive K awards with one exception – the K99/R00 (commonly referred to as the “kangaroo award”). The K99/R00 is the only category of K grant that does not have a citizenship requirement.
There is no easy way to answer this question. Because the majority of K grants are awarded through NIH parent announcements, which accept applications three times a year (January, May, September), it is generally understood that institutes will try to reserve some of their budget authority for each funding round. The only way to know, in general, how much they might award is to look at prior fiscal years. It can be insightful to examine the NIH Paylines and Success Rates for the IC you are considering for a K submission.
The K grants that receive the broadest participation from ICs across the NIH are the mentored K awards, specifically the Mentored Research Scientist Development Award (K01), the Mentored Clinical Scientist Development Award (K08), and the Mentored Patient-Oriented Research Career Development Award (K23), which provide doctoral-level researchers and health professionals with three to five years of support for a career development experience at critical stages in their research careers.
Current NIH policy does allow a K awardee to reduce effort on their K award, but only within the final two years of the award and only if the K awardee obtains funding as a PI on a research project grant (e.g., R01) or as a project leader on a program project grant (e.g., P01) or equivalent application. In turn, the requested budget for the research project grant or program project grant must request appropriate amounts for salary and associated costs for the K awardee, which will likely be reduced to 50 percent salary and associated costs on the K award if the concurrent application is awarded. In addition, throughout the duration of the K award, the total level of research commitment for the K awardee must remain at 75 percent of full-time professional effort (i.e., 9 person-months). During the first 3 years of a K award, K awardees can be included on research project grants, but work cannot detract from the career development program of the K award and the requested budget cannot commit professional effort (i.e., person-months) for the K awardee. To learn more, read NIH Policy Statement NOT-OD-08-065.
The NIH has offered career development (also known as “K” awards) since 1957 to help ensure that a diverse pool of highly trained scientists are available in adequate numbers and in the appropriate research areas to address the nation’s biomedical, behavioral, and clinical research needs. K awards are typically granted to individuals who have recently finished their doctoral and post-doctoral training and are transitioning to faculty positions. The awards provide salary support and limited research funds for a combination of intensive research and mentored training to advance participant careers to independent status. The expectation is that through this sustained period of protected research time and career development exposure, awardees will be able to accelerate their independent research careers and become competitive for new research project grant (e.g., R01) funding.
eRA Commons Accounts
No. PD/PIs should maintain a single eRA Commons account throughout their entire career. Why is this important? As a July 23, 2010, PIs can no longer enter publication information manually into their eRA Commons account. Users of eRA Commons are expected to create an NCBI account that uploads publication information from PubMed and to their NCBI account, which they must link to their eRA Commons account. Only those citations that appear in a user’s linked NCBI account will appear in the eRA Commons account. If you were to change institutions and create a new eRA Commons account, you would conceivably lose this publication history.
When you change institutions, it is important that your new institution affiliate with your eRA Commons account.
As the signing official for the College of Medicine, the Office of Research Affairs has the authority to affiliate with your eRA Commons account. To request that your eRA Commons account be affiliated with the College of Medicine, please contact Sarah Frey within the Office of Research Affairs at 717-531-0003, ext. 289443 or firstname.lastname@example.org.
Sarah can also help verify user ID and user roles in eRA Commons.
Yes. The personal profile associated with your eRA Commons account is utilized by the NIH to determine eligibility for Early Stage Investigator (ESI) and New Investigator (NI) status.
Investigators who plan to submit a funding application to the NIH or participate in an NIH-funded project need an eRA Commons account. The eRA Commons is an online interface where grant applicants, grantees and federal staff can access and share administrative information related to grant applications and awarded research grants. The eRA Commons account supports the pre- and post-award process associated with an NIH funding award. With an eRA Commons account, PIs can track the status of submitted applications, obtain their summary statement, submit just-in-time information, and annual progress reports.
If you do not have an eRA Commons account, the signing official for your institution must establish the account for you.
In addition, if you had an existing eRA Commons account when you joined the College of Medicine, you will need to affiliate your existing eRA Commons account with our institution.
Sarah can also help verify user ID and user roles in eRA Commons.
To request a new account, please be prepared to provide the following information:
- Last name
- First name
- Middle mame or initial (not mandatory)
- Email address
The National Center for Biotechnology Information (NCBI) partnered with eRA Commons to provide investigators access to the My NCBI tool several years ago. My NCBI is a tool for managing the list of publications that result from or are in support of NIH-funded research. In essence, the My NCBI account allows a user to create an association between their publications and NIH grant funding. When a user links their eRA Commons account to their My NCBI account, preferences saved in My Bibliography automatically appear in the user’s eRA Commons account. Maintaining a current account using the My NCBI tool is particularly important for investigators that are heavily funded by the NIH, which uses this documentation to track compliance with the NIH Public Access Policy.
F&A rates are applied to a direct cost “base” which varies according to project type, performance site, and sponsor requirements. As the PD/PI (Project Director/Principal Investigator), you should work closely with your assigned grants officer to make a determination on the applicable F&A rate. It is important to review the project scope early in the budget development process because the application of an F&A rate has direct bearing on the amount of funding available to us support all direct costs. The following is a hypothetical example of how an F&A rate could impact a project budget.
Not necessarily. It is standard practice for the NIH to request Just-In-Time information from all PD/PIs with grant applications that receive an overall impact score of 40 or less. Because all NIH Institutes and Centers (ICs) have different pay lines for determining which grants are funded, a standard NIH request for Just-In-Time information does not necessarily mean your proposal will be funded. However, if an IC is looking to make funding decisions an applicant’s Just-In-Time information will help to guide the decision-making process.
No. Letters of Intent (LOIs) that include institutional information (e.g. cost sharing) must be reviewed by the Office of Research Affairs (ORA) before being submitted to the sponsoring agency. For all other LOIs, the ORA should receive email notification from a Project Director/Principal Investigator (PD/PI) because if the sponsoring agency invites a full application, the ORA will be prepared to assist the PD/PI with the full application. For questions regarding your LOI, please contact ORA staff at 717-531-8495.
No. IRB and IACUC approval are not generally required at time of application submission. As a matter of policy, the IRB and the IACUC serving the College of Medicine limits its consideration of projects to those that have a reasonable expectation of receiving a funding award. Typically, a PD/PI will wait until he/she receives the overall impact score for their funding proposal, which is posted to their eRA Commons account within three to five days of the initial peer review (e.g. study section). The NIH utilizes a nine-point rating scale (1 = exceptional; 9 = poor) for all applications. If the overall impact score appears favorable, the PD/PI will initiate IRB and/or IACUC review in anticipation of receiving a request for Just-In-Time information from the sponsoring agency. Current IRB and IACUC approvals will be required as part of a Just-In-Time request.
Most institutions that undertake sponsored research have a federally negotiated Facilities and Administrative Rate (F&A rate) that must be used on funding proposals. The F&A rate helps the institution recover overhead costs that are commonly incurred to support research, but are costs that cannot be readily attributed to a specific research project or activity. These overhead costs include such things as:
- Depreciation and use allowances (e.g., buildings, capital improvements, equipment)
- Interest on debt associated with certain buildings, capital facilities, and equipment, operation and maintenance expenses (e.g., utilities, hazardous waste disposal, insurance)
- General administrative expenses, including wages and purchasing
The United States has three cognizant audit agencies that negotiate F&A rates – the Department of Defense (DOD), the Department of Education (DoED) and the Department of Health and Human Services (DHHS).
The federal agency that provides the bulk of an institution’s sponsored funding is the agency that negotiates its F&A rate, which is renegotiated every four to six years. For a complete definition of F&A rates, refer to OMB Circular A-21.
Penn State University’s cognizant audit agency is the DOD’s Office of Naval Research. The federal government determines the rates through a formal negotiation process with PSU using OMB Circular A-21.
In accordance with guidelines promulgated by the University’s Office of Sponsored Programs (OSP), all budgets should include F&A unless the funding source is 100 percent Commonwealth of Pennsylvania or it is a 501(c)(3) foundation with published guidelines prohibiting F&A. The F&A rate applied to a project is the same regardless if federal funds are awarded directly Penn State University or provided as flow-through funds from the Commonwealth, for-profit industries, or nonprofit organizations. Penn State University’s Office of Sponsored Programs (OSP) has a Frequently Asked Questions document and other materials that are a helpful for understanding the University’s policy on F&A.
To determine whether an individual should be identified as a consultant or collaborator, you must consider whether their role on the project is substantive. Consultants contribute expertise to a project by providing services with clearly defined deliverables, but they do not help shape the research strategy. In addition, their contribution to the project is generally less than $25,000 in costs.
As a matter of policy, University faculty and staff cannot be considered consultants. If they will be functioning in a consultant role on a federally funded project, they will have to be identified as unpaid collaborators within the project budget. If an individual will be integrally involved in the design and conduct of your research strategy, then their respective organization should probably be treated as a subaward. Consultants appear as a fee-based service within project budgets and are not required to report F&A rates.
In contrast, all subawards identified within a grant application must be accompanied by a budget, a budget justification, and executed letters of intent stipulating their willingness to enter into a consortium agreement with the project sponsor. Subawards are subject to federal F&A rates. As the PD/PI (Project Director/Principal Investigator), you must document all subaward (i.e. consortium) agreements within your application to ensure the sponsoring agency that the commitments are in place to conduct the proposed research.
Another important distinguishing factor to make note of is that subaward agreements may give collaborators the opportunity to co-author publications.
The Office of Research Affairs (ORA) recommends that the PD/PI (Project Director/Principal Investigator) have the subaward institution complete its own SF424 budget pages and budget justification. If a subaward institution is a Cayuse user, then their budget may be exported and linked to the College’s application. If a subaward institution is NOT a Cayuse user, then it is recommended that the PD/PI download the application package and email the budget as a PDF for completion by the subaward institution. The subaward institution will be providing substantive support to the project and will be required, by legal agreement, to provide financial information for periodic progress reports and close-out audits. If a grant is awarded, funding flows from the project sponsor to the subawardee (i.e. sub-recipient) to carry out specific components of the research strategy.
Because this responsibility lies with the sub-recipient, the ORA’s recommended best practice is for the sub-recipient institution to prepare their budget and budget justification under the direction of the PD/PI. It is important to keep in mind that when preparing a grant application that requires a detailed budget format, each sub-recipient organization must prepare a detailed budget, which includes a budget justification, for inclusion in the funding application.
The US Public Health Service (PHS) has regulations pertaining to Financial Conflict of Interest (FCOI) compliance. The regulation seeks to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under PHS grants or cooperative agreements will be free from bias resulting from investigator financial conflicts of interest. The FCOI regulations apply to all institutions that receive PHS grants or cooperative agreements and to any investigator, as defined by the regulation that plans to participate in PHS-funded research. As a PD/PI, this regulation applies to you if you intend to submit a funding proposal to one of the following PHS agencies:
- National Institutes of Health (NIH)
- Centers for Disease Control and Prevention (CDC)
- Health Resources and Services Administration (HRSA)
- Food and Drug Administration (FDA)
- Agency for Healthcare Research and Quality (AHRQ)
- Agency for Toxic Substances and Disease Registry (ATSDR)
- Indian Health Services (IHS)
- Substance Abuse and Mental Health Services Administration (SAMHSA)
It is a responsibility of the PD/PI to determine which members of the project team meet the PHS definition of an “investigator” and are therefore subject to the FCOI regulations.
In accordance with University policy RA20, an “investigator” means “…any individual, regardless of his or her title or position, whether faculty, staff, or student, who has the ability to make independent decisions related to the design, conduct or reporting of University Research, but not including individuals who perform only incidental or isolated tasks related to a University Research project.”
By this definition, an “investigator” generally includes anyone identified key personnel.
As soon as you have determined that you will be submitting a funding application to one of the aforementioned PHS agencies, you should contact the College of Medicine’s Office of Research Affairs (ORA) to discuss which institutions and individual “investigators” will be represented on your project team. An ORA grant specialist will first check the Federal Demonstration Partnership (FDP) Institutional Clearinghouse to verify compliance of the prospective subrecipient(s). If an institution is not currently registered through the FDP Clearinghouse, then the ORA grant specialist will reach out to the institution’s authorized organizational official to confirm that they have a PHS-compliant policy. If the prospective subrecipient cannot certify FCOI compliance, then the ORA must follow University policy RA20 and require the prospective subrecipient to follow Penn State’s FCOI policy.
FCOI requirements cannot be treated as a Just-In-Time requirement after your application has been submitted to the sponsoring agency. All FCOI requirements must be satisfied prior to application submission. If you have any questions about FCOI compliance, please contact the Office of Research Affairs.
Identifying Funding for Research
Research Development subscribes to multiple listservs and utilizes several funding databases to identify grants, contracts, and other types of funding opportunities. Relevant funding opportunities are distributed to faculty and research support staff. By request, Research Development works directly with individual investigators to identify potential sponsors for unique projects. For additional information or assistance contact Research Development at email@example.com.
Sponsors may limit the number of applications that an institution can submit in response to a specific Funding Opportunity Announcement (FOA). When a sponsor imposes such a limit, Research Development coordinates the process for selecting the applicant(s) that may submit an application to the sponsor. As applicable, Research Development coordinates limited submissions in conjunction with the University’s Office of Sponsored Programs (OSP). If you are interested in a limited submission FOA, it is your responsibility to contact Research Development. If it is determined that more than one PI/PD meets the eligibility requirements for a limited submission opportunity, Research Development will undertake an internal down-select process and/or coordinate the down-select process with OSP to determine which PI/PD will be permitted to submit a proposal.
For both New Investigator (NI) and Early Stage Investigator (ESI) applications, peer reviewers are instructed to focus more on the proposed approach than on the track record, and to expect less preliminary data than would be provided by established investigators. Institute staff members pay special attention to applications from NI and ESI investigators, as well. For many Institutes and Centers (ICs), the payline is typically more generous than the regular payline for established investigators.
The general answer is “yes.” There are many types of NIH grants a PD/PI can receive that do not disqualify him/her from being considered a New Investigator. For complete details, see the NIH Definition of New Investigator. Other circumstances that do not disqualify a PD/PI from being considered a New Investigator are:
- If you are assigned PI status to a project after an award is made.
- Being an investigator (listed as key personnel) on another PD/PI’s grant.
Yes. On April 17, 2014, the NIH announced a change in policy on application submissions (NOT-OD-14-074). For application due dates after April 16, 2014, applicants may submit the same idea as a new (A0) application for the next appropriate due date following an unsuccessful resubmission (A1) application. The NIH will not assess the similarity of the science in the new (A0) application to any previously reviewed submission when accepting an application for review. In addition, the new A0 application does not allow an Introduction or responses to the previous reviews. See details on the Resubmission Policy.
The NIH Public Access Policy ensures that the public has access to the peer-reviewed and published results of all NIH-funded research through PubMed Central. United States and/or foreign copyright laws protect most of the papers in PMC; PMC provides access to them at no cost, much like a library does, under the principles of Fair Use. Read more here.
The NIH permits one resubmission of an unfunded application (see NOT-OD-09-016). Current policy calls for applicants to outline substantial scientific changes within the Introduction to their resubmission. Introductions must include a summary of substantial additions, deletions, and changes to the application. They must also include a response to weaknesses raised in the Summary Statement. The NIH no longer requires applicants to identify substantial scientific changes within a resubmission application through the use of “bracketing, indenting, or change of typography.”
This policy became effective Dec. 4, 2014, with the issuance of NIH NOT-OD-15-030. The page limit for the Introduction may not exceed one page unless indicated otherwise in the Table of Page Limits.
A PD/PI qualifies as a New Investigator if they have not previously competed successfully as a PD/PI for a substantial NIH-supported research grant (e.g. R01 or equivalent). An Early Stage Investigator (ESI) is a New Investigator who is within 10 years of receiving their terminal research degree, end of medical residency, or equivalent. By definition, not all New Investigators will qualify for ESI status.
Software within the eRA Commons will check first for New Investigator (NI) status based on the PI’s previous award history. For individuals identified as NIs, the software will calculate the 10-year window of Early Stage Investigator (ESI) status based on the date of the terminal research degree or the residency end date entered in the investigator’s eRA Commons profile. To ensure that the NIH recognizes your ESI status, you must update your eRA Commons profile to reflect the date of completion of your terminal research degree or the end of your residency. The NIH will consider a request to extend the period of your ESI status if there has been a lapse in your post-degree training.
After a PD/PI is awarded their first R01 grant, they will lose New Investigator (NI) status.
No – the NIH does not currently require the use of SciENcv to generate the new NIH Biosketch. However, SciENcv is a cooperative project of multiple federal agencies (i.e. NIH, NSF, DOD, DOE, EPA, USDA, the Smithsonian), so there are many benefits to using SciENcv:
- Once an investigator creates a profile in SciENcv, that profile can be used to create multiple biosketches.
- Administrators can be provided “delegate access” to help maintain the biosketch information.
- When account holders link their eRA Commons account to their NCBI account, SciENcv will upload publications from their NCBI My Bibliography to populate their SciENcv profiles with information stored in their eRA Commons account. The same is true for ORCID account holders. The information transferred to SciENcv can be edited, hidden, augmented or deleted.
- Researchers can edit their profile as required, include or hide selected citations, add non-NIH research awards, or create multiple profiles customized for each new grant application.
Select “Create a New Profile” and “From an Existing Profile” to create a new biosketch from an existing master.
Linking your eRA Commons account with your My NCBI account allows SciENcv to pull your biographical information from eRA Commons (i.e. education, work experience, award history) to populate your biosketch. SciENcv creates a master profile from which you can create an untold number of NIH or NSF biosketches specific to any proposal that you are involved in. As a My NCBI account holder, you can invite other individuals to act as your delegate and grant them the ability to view and edit your My Bibliography collection (including Other Citations), as well as the ability to view, edit, and create profiles in your SciENcv.