F. INVESTIGATOR RESPONSIBILITIES
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1. Changes in Protocol or Scope
On most grants, the Principal Investigator or project director may make minor changes in methods, approach or other aspects of the project objectives. However, the prior approval of the sponsor is usually necessary for significant changes in aims, methods, key personnel, and budgets (see Sections V.B.3., V.C.1., and V.D.1.). Most contracts and cooperative agreements restrict the latitude of the investigator even further in this area.
2. Changes in Status or Absence of P.I. or other Key Personnel
Most sponsors require notification if there will be a significant change in the level of participation in the project by the Principal Investigator or other key personnel, i.e., when the individual devotes substantially less effort to the project than anticipated or when the project will continue without the active direction of the P.I. or program director during a continuous period of 3 months or more. Since awards are made partially on the basis of the qualifications and/or participation of the key personnel, most sponsors require as much advance notice as possible of proposed changes of this nature. Note that awarding office approval of revised effort for an awarded grant should precede submission of such revised effort in the Other Support pages for a different grant.
Principal Investigators are obligated to strictly observe the terms and conditions of their awards. In particular, the P.I. should review the Notice of Grant Award and pay specific attention to the grantee agency's policies governing the award.
The P.I. is responsible for initiation and authorization of University budget forms, for staying within the budget of the award, purchase requisitions, payroll, invoice approval, and other payment mechanisms which require authorization on a timely basis.
Additional P.I. responsibilities include resolving overexpenditures and incorrect charges on a monthly basis in order to prevent delays and inaccuracies in preparation of financial reports. The P.I. must also assure that funds are used for the purpose of the award, so as to avoid audit disallowances and criticisms of the University's stewardship.
- Salaries charged to the project should accurately represent the proportion of the individual's effort actually spent on the project.
- Prior approvals should be requested in a timely manner. Changes resulting from the FDP (Federal Demonstration Project) relieves investigators of some paperwork. At the same time, the new policies put an additional burden on the P.I. (and department) to take responsibility for fiscal actions which are still regulated. See the charts in Section V.B.3., V.C.1., and V.D.1. for a summary of federal agency prior approval requirements.
- JHU "Administrative Guides" defining policies and procedures pertinent to purchasing services, business travel/expense, equipment/space accounting, independent contractors/consultants, objects codes, and student tax obligations are available through the University's Human Resources Office. Faculty and staff can obtain copies of these guides by contacting the Office of Training and Development at Ext. 6-8114. Copies of Administrative Guides pertaining to salary administration and employment are available in the School of Medicine Human Resources Office (Ext. 5-2989).
- Fiscal grants management responsibilities may be delegated to administrative staff, but the P.I. should provide appropriate supervision and oversight of such delegated responsibilities by reviewing the expenditures no less often than monthly.
- The P.I. is also ultimately responsible for assuring that grant-related income (program income) is credited to the project. (Income generated by grant-supported activities, sale of assets or royalties/copyrights while the grant is still in effect may need to be reported as grant-related income. Contact the ORA to discuss further.)
a. Financial Reports:
For grants, the Principal Investigator is expected to review and approve all financial reports going to the sponsors. If there are any discrepancies in the figures, Research Accounting must be notified immediately.
For contracts, the P.I. is to review and approve final expenditure reports (the interim financial reports reflect only what appears on the Expenditure Statements). Certain contracts have provisions for special details which must be forwarded to Research Accounting by the P.I. for inclusion in the interim financial report. The P.I. is NOT to submit such additional financial reports directly to the sponsor.
b. Technical Reports:
The P.I. must complete invention statements and progress reports (generally, most grants require annual reports; more frequent reporting may be necessary for contracts). At the conclusion of federal agency grants, a final progress report and final invention statement must be submitted to the awarding agency. The investigator will also be asked to verify data on equipment reports for federal contracts. Failure to meet this obligations may preclude an investigator from receiving future awards. In extreme cases, agencies may initiate suspension and/or debarment procedures against a grantee institution who fails to meet these obligations.
c. Streamlined Process for Submission of NIH Continuation Applications
NIH has recently revised their requirements for noncompeting continuation applications. In the past, applications for continuation funding had to include a progress report, a detailed budget for the next period, and an estimated report of expenditures. Effective immediately, NIH now only requires a completed Form 2590 face page, a personnel and study subject page, a checklist page, and a brief, two-page progress report. It is no longer necessary to complete the indirect cost portion of the checklist page unless there is a change in the performance site. The simplified noncompeting continuation application instructions apply to R01, R03, R13, R15, R18, R21, R24, R25, R37, R42, R44 and all K Series mechanisms.
In addition, answers to the following questions must be inserted before the progress report.
Has there been a change in other support of key personnel since the last reporting period? If yes, form page 5 of the PHS 2590 appiication kit must be completed. If no, so state.
Will there be, in the next budget period, significant rebudgeting of funds and/or change in level of effort for key personnel from what was approved for this project? If yes, the budget page (form page 2) and the budget justification page (form page 3) of the PHS 2590 kit must be completed. If no, so state.
Is there any estimated unobligated balance (including prior year carryover) that is greater than 25 percent of the current year's total budget or more than $250,000? If so, it must be explained.
d. NSF Continuing Grants
In an effort to reduce paperwork, as well as processing time requirements, NSF no longer requires Grantees to submit formal requests and budgets to initiate continued support of grants planned for incremental funding. Provided satisfactory scientific progress is evidenced in the required annual progress report submitted by the P.I. and funds are available, NSF will award the annual increment at the level indicated in the original grant letter without a formal request. In order to ensure continuity of funding, the required progress report must be forwarded to the assigned NSF program officer at least 3 months prior to the expiration of the current support period.
Copies of The Johns Hopkins University School of Medicine Intellectual Property Guidelines can be obtained from the Office of Technology Licensing.
Investigators must cite inventions made under the previous years of a grant when submitting grant project renewal or continuation applications.
Inventions should be disclosed to the School of Medicine's Assistant Dean for Technology Licensing through the Office of Technology Licensing. Prompt and detailed disclosure is necessary to avoid loss of patent rights and to meet our responsibilities to federal and non-federal research sponsors. The best way to disclose an invention is to provide a Report of Invention to the Office of Technology Licensing (2024 East Monument Street, Suite 2-100) using the guidelines provided in Appendix P or contact the Office of Technology Licensing (Ext. 5-4666) for additional assistance.
The sponsor may require copies of reprints of publications resulting from the work sponsored and/or acknowledgment of sponsorship in such publications. The investigator bears direct responsibility for fulfilling these requirements.
Investigators should also review the School of Medicine policy on Responsible Conduct of Research (referenced in Section V.F.6) and the School of Medicine Intellectual Property Guidelines (Sections IV.C.3., IV.C.4., and VI) regarding investigator responsibilities associated with publication, confidentiality and conflict of interest disclosure.
5. Debarment (from eligibility for federal funds)
To ensure that public monies are appropriately used, DHHS grant administration regulations provide for termination and suspension of ongoing grants and contracts if there is a material failure to comply with the terms and conditions of the award. Such failure to comply also constitutes grounds for debarring the investigator and/or institution from future funding.
6. Responsible Conduct of Research
The rules and guidelines for responsible conduct of research at the School of Medicine are documented in the handbook, "Faculty Policies on Conflict of Commitment and Conflict of Interest, Responsible Conduct of Research, Procedures for Dealing with Allegations of Professional Misconduct, and Grievance Procedure for Faculty, Fellows and the Student Body." Investigators should be familiar with this policy, especially as it relates to supervision of staff and students, data gathering, authorship and publication.
The Office of the Registrar of the School of Medicine distributes to each new faculty member the booklet "Honor in Science," published by Sigma Xi. Faculty are required to sign an acknowledgement of receipt of this booklet when they respond to their initial letter of appointment from the Dean.
Applications for competitive new and/or renewal NRSA Institutional Research Training Grants submitted to NIH are now required to include, as an integral part of the proposed training program, the principles of scientific integrity and responsible conduct of research. The Registrar's Office also provides each new medical student and graduate student with a copy of the University procedures for "Dealing with Issues of Professional Misconduct" and the booklet "Honor in Science" published by Sigma Xi.
See Section III.B.2.a., Technical/Scientific, for additional information on training in responsible conduct of research.
7. Conflict of Commitment and Conflict of Interest
Faculty should consult the School of Medicine Faculty Policies Handbook, their Department Director or the Administrator of the Committee on Conflict of Interest and the sponsoring agency's policies for further details on their obligations for written disclosure and the School of Medicine's policy on conflict of commitment and conflict of interest at the proposal stage for ongoing research projects. The Johns Hopkins University School of Medicine Intellectual Property Guidelines describe those situations involving royalty and/or equity which also require written disclosure to and review by the Committee on Conflict of Interest. (See III.C.14.K, IV.A.2. and VI.)