Please note that the Department of Health and Human Services (HHS) is operating under a continuing resolution until November 21, 2019. As a result and in line with past practices, NIH will begin issuing non-competing research grant awards at a level below that indicated on the most recent Notice of Award. This generally amounts to 90% of the previously committed level. NIH will consider upward adjustments to awarded levels after the enactment of FY 2020 appropriations. For more information, please consult NOT-OD-20-003 or contact your OSP specialist.
Last year NIH announced changes to the effort reporting section of RPPRs that enabled the inclusion of decimals in Section D (Participants). This update also allowed for the inclusion of any key personnel with effort of less than one calendar month. OSP recently received a number of questions regarding this policy change. Although the RPPR instructions still state that effort should be rounded to the nearest whole month, OSP has reached out to the Office of Policy for Extramural Research Administration (OPERA) and confirmed that NOT-OD-18-202 supersedes the currently published instructions, though updates to the guide are in process. Please be sure to include decimals (where appropriate) and key personnel with effort of less than one month in Section D. For questions or concerns, please contact OSP. Related post: Annual, Interim, and Final RPPR Update: Use of Delegations for RPPR Initiation and Changes in Decimal Allowances for Effort Reporting
As a reminder, all applications for NIH institutional training grants must include a letter on institutional letterhead and signed by a key institutional leader that describes the applicant institution’s commitment to preventing occurrences of and responding to allegations of discriminatory harassment or other discriminatory practices. Please keep this in mind for the upcoming T32 deadline on May 25. Information related to VUMC’s compliance with this requirement can be found on OSP’s website (VUnetID required) under “Policies and Guidance.” For questions or concerns, please consult the relevant NOTs (NOT-OD-19-029 and NOT-OD-19-056) or contact your OSP specialist.
Section D of the RPPR requires grantees to report PI effort for a given period regardless of the level of effort, but what happens if a PI does not have effort in a given period (i.e., for an equipment or construction grant)? eRA Commons no longer allow PIs to report zero effort for an RPPR; as a result, NIH advises grantees to list ‘0.1’ in Section D if the PI did not devote any effort to the project. For questions or concerns, please contact your OSP specialist.
As you may know, a DUNS number is a unique, nine-digit number issued by Dun & Bradstreet that identifies an organization or business. Currently, many U.S. government agencies and other grant sponsors require that a grantee have both a DUNS number and U.S. Employer Identification Number (EIN) in order to accept any funding; however, in March 2019 the federal government announced it would be moving to a new, government-owned unique entity identification system—the SAM Managed Identifier (SAMMI)—as a replacement for the DUNS in all systems, including Grants.gov and eRA Commons. This change is slated to take effect by December 2020, when the System for Award Management (SAM) will become the central repository for the new SAMMI unique entity identifiers. Please note that OSP is aware of this upcoming change and will be working closely with our federal sponsors as additional information becomes available. For any questions or concerns, please contact your OSP specialist.
NIH prior approval is required for the transfer of legal and administrative responsibilities of a grant-supported project or activity from one legal entity to another before the expiration date of the approved project period. Outgoing transfers have three distinct requirements: Relinquishing Statement Final Invention Statement Final Financial Status Report OSP assists with two of these requirements: the relinquishing statement and final invention statement. Relinquishing Statement – PHS Form 3734 The department completes this form in collaboration with the PI. Please note that only the current year’s direct and indirect costs are to be included in the relinquishing statement. Carryforward will be captured in the final financial report. Once the department has submitted and received approval from VUMC Finance, the form will be submitted to OSP along with the Chair’s email approval of the relinquishment. OSP will then input and submit this information in Commons. Final Invention Statement and Certification This form is completed by the PI prior to his or
Things might look a little different on the eRA website starting this month. NIH recently announced that a newly designed website will be going live in April, and visitors can expect a few changes. NIH promises the new site will feature improved content, organization, and navigation, as well as better compliance with the Americans with Disabilities Act (ADA). Other changes are as follows: Updated instructions that incorporate screenshots of various processes Improved navigation, including hover-over functionality, breadcrumb hierarchy links, and scope notes Consolidated and better organized resources Enhanced mobile site presentation Please note that page URLs will change, so users will need to update any bookmarked or favorited pages accordingly.
Most sponsors require applicants to submit a list of all current awards and pending proposals (“Other Support”) for PI(s) and key personnel in order to demonstrate that there is no overlap within three main areas of concern: scientific, budgetary, or effort/commitment. Scientific – substantial similarities exist between the research proposed in more than one application or for an application submitted to two or more sponsors Budgetary – budgetary items already are covered by another funding source Commitment – personnel with time commitments exceed 100% or 12 person months Should Other Support indicate a potential issue, applicants must include a statement that specifically explains how the individual will address any perceived overlap (by adjusting the scope of work, revising project budgets, or modifying time commitments). It is not sufficient to merely state that any potential overlap will be resolved or that institutional policy prevents overlap. OSP recommends that these contingency plans both name the type of potential overlap and contain an explicit and specific
As a reminder, as of January 25, 2019, applicants utilizing human subjects (including those whose research is considered exempt) are required to include both a rationale for the age-range of study participants and justification for age-based exclusion. This new requirement seeks to ensure that NIH-funded research is applicable to all individuals affected by a condition and address concerns that certain groups (i.e., children and older adults) are disproportionately absent from clinical research. For VUMC applicants, this information will be captured in eCat as part of the FORMS-E PHS Human Subjects and Clinical Trials Information form. This information should be included in the attachment for “Inclusion of Women, Minorities, and Children (Section 2.4).” Please consult NIH’s detailed FAQ page regarding this policy, and do not hesitate to reach out to OSP with any questions or concerns.
If a proposed NIH project involves activities outside of the United States or involves partnerships with international collaborators (whether or not grant funds are expended), applicants are required to submit a foreign justification. Please note that the foreign justification requirement is in addition to the standard requirements of a budget justification, LOI, and SOW for foreign subcontracts. Activities that might meet this definition include the following: Human subject or vertebrate animal involvement at a foreign site Collaborations with investigators at a foreign site Use of facilities/equipment at a foreign site Extensive foreign travel by grantee project staff for data collection, surveying, sampling, etc. An activity of the grantee that may have an impact on U.S. foreign policy through involvement in affairs or environment of a foreign country Applicants should select “yes” in response to whether an applicant’s project has international collaborators or whether the project involves a foreign component. Upon answering “yes” on the questionnaire, NIH and other PHS applicants