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School of Medicine
Administrative Review and Special Clearances
IV. ADMINISTRATIVE REVIEW AND SPECIAL CLEARANCES
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A. CLEARANCES TO BE OBTAINED BEFORE ORA REVIEW
B. SUBMITTING SPONSORED PROJECT DOCUMENTS FOR INSTITUTIONAL SIGNATURE
C. OTHER UNIVERSITY POLICIES APPLICABLE TO SPONSORED PROJECTS
D. SITE VISITS
Once the appropriate preceding clearances have been obtained, the investigator should attach a completed electronic Information Sheet (eIS) and forward the proposal for signature to the ORA through the departmental offices.
The electronic Information Sheet should accompany all applications for funding (other than gifts), letters requesting budget revisions, and other correspondence to sponsor agencies (see below). The Information Sheet must be fully completed, front and back, and all necessary signatures must have been obtained. Principal Investigator's and Co-Investigators' Social Security numbers are now required on the Information Sheet for parallel data base tracking within Resource and CUFS.
It is the responsibility of the Principal Investigator to thoroughly answer the yes/no questions on the Information Sheet. By signing the Information Sheet, he/she is certifying the accuracy of the question responses and the corresponding details relating to the questions.
The electronic Information Sheet questions highlight relevant project issues which require compliance with other formal institutional review mechanisms, as well as University and governmental policies and regulations. Accurate responses enable the University, ORA and departmental administration to advise the Principal Investigator regarding compliance with institutional, sponsor, and government policies and regulations. Willfully false information in federal grants, cooperative agreements, and contract proposals is a criminal offense.
1. Departmental Review
a. Department Administrator:
The Administrator's signature on the electronic Information Sheet signifies that he/she has thoroughly reviewed the document, approved the project's impact on the Department, checked the budget and the forms for accuracy, and certified that the project is in compliance with the policies and guidelines of all institutions named in the proposal.
It is expected that the Departmental Administrator's review will include careful evaluation with respect to salary recovery, program income under the project, cost projections, patient care costs, other support declarations, redistribution of effort, resources and environment commitments, and use of human subjects or vertebrate animals.
Issues such as additional space, significant revisions to clinical practice, alterations/renovations to existing facilities, use of biohazards and highly toxic chemicals, etc., require resolution and appropriate institutional clearance prior to the application being submitted for review by ORA. Changes to PI effort on other projects may require concurrent prior approval of the other grant's awarding office.
b. Department Director:
Department Directors have the overall responsibility of determining the appropriateness of the project and project changes on behalf of the Department and the School. It is expected that investigators will have discussed the scope of the project and its implications with the Department Director before the proposal preparation has begun. The Director should be fully aware of the commitments entailed by the project (faculty appointments, personnel, space, facilities, etc.). The Director's signature on the electronic Information Sheet signifies that these obligations have been considered. "Per" signatures or signature of an individual other than the department director will be accepted only after written authorization by the department director.
2. Office of Research Administration
Grants, contracts and similar forms of funding assistance are legal agreements between the sponsor organization and the University. For the School of Medicine, they are formally approved only by an institutional official as listed here. Applications for funding and correspondence requiring institutional endorsement are reviewed to verify that University and sponsor requirements have been followed; to assure that the School has the resources and facilities to carry out the project; and to assess the potential impact of the research activity on the School and the University.
The Office of Research Administration reviews documents in preparation for institutional approval, including award and postaward documents. University budget accounts will not be established until this review and approval has occurred.
a. Timing: When to Submit the Paperwork to the ORA:
We request that you submit your documents for review at least five working days before you need to mail them. We will try to process your applications well in advance of the day they are due at the sponsor's office.
Feb. 1, Mar. 1, June 1, July 1, October 1, and Nov. 1 are major application deadlines. The volume of work being processed just prior to these dates is extremely heavy. Sufficient lead time is especially critical here. Errors and omissions which are not purged before the papers reach our office slow down the approval process for everyone. We will assist you in meeting genuine emergencies, but even genuine emergencies are not appropriate cause for complete disruption of the schedules of our Institutional Officials. Your patience will be appreciated.
b. What Paperwork to Submit:
(1) GRANT AND COOPERATIVE AGREEMENT APPLICATIONS
The ORA must review all grant applications for project funding other than gifts (regardless of source and amount). Generally, ORA requests one electronic Information Sheet and the original and one copy of the following:
- cover page/transmittal letter
- abstract or brief workscope description
- budget and budget justification pages
- all pages requiring institutional endorsement
- all pages specifying terms and conditions of award
- all other pages containing administrative detail, for example, the Resources and Environment, Other Support, and Checklist from NIH applications
- relevant animal portions of applications (e.g., Section f of a new or renewal NIH grant) if applicable. See Handbook Section IV.A.3.
- Copies of relevant correspondence with the sponsor
In summary, the ORA will want to review everything except the detailed research plan, bibliographical and biographical information from any given application.
(2) FELLOWSHIP APPLICATIONS
The ORA must review all fellowship applications in order to ensure compliance with institutional policies and guidelines. This includes both applications awarded to the Institution, as well as those which are awarded directly to the individual fellow applicant.
(3) SUBCONTRACT PROPOSALS
Furnish a completed electronic Information Sheet and the original and one copy of the cover letter, budget and workscope as described in Section III.A.1.c.
(4) CONTRACT PROPOSALS
The ORA is responsible for working with investigators on all aspects of contract negotiations. Therefore, investigators are asked to provide the following contract related items at the times indicated:
Notification of intent to enter into a contract and a copy of the RFP (Request for Proposal) - as soon as you have decided to apply.
The original and one copy of the final contract proposal, no less than five working days before you intend to mail the proposal, along with a completed and signed electronic Information Sheet.
The original and one copy of pre- or post-award correspondence with the Contracting Officer. This correspondence must be countersigned by our institutional official before it is mailed to the sponsor.
Should a contract be awarded, the P.I. is free to discuss the progress of the research with the Program or Project Officer, but neither the P.I. nor the Project Officer is authorized to negotiate any changes in the contract. Changes in research conduct or cost must be approved by the Contracting Officer and processed through the ORA for institutional endorsement.
(5) GRANT AND CONTRACT AWARDS AND AGREEMENTS
The ORA reviews all awards and agreements. In any agreement or award, the following elements are considered essential:
- The award is to the correct corporate entity, namely, "The Johns Hopkins University,"
- clear definitions of work scope, award period, and responsibilities are provided in the agreement itself or by reference to the proposal or protocol
- total costs or fees and budgets are correct, and rebudgeting restrictions are not excessive,
- payment terms are fair to the cash flow of the University,
- progress and financial reporting requirements are reasonable,
- confidentiality and publication restrictions do not violate University policy patent, licensing and copyright provisions comply with The Johns Hopkins University School of Medicine Intellectual Property Guidelines,
- general provisions refer to and comply with current laws and regulations,
- The University is granted approval on the use of its name, or any abbreviation thereof, or the name of the Principal Investigator(s), expressly or by implication, in any news, publicity release, advertisement or other public disclosure by the Sponsor.
Agreements which require Institutional acceptance may be signed only by the appropriate official, not by the P.I. (see Appendix M, "Institutional Official Signing Authority.") Where the sponsor requests P.I. endorsement in addition to institutional acceptance, the suggested heading is "I have read and agree to abide by the terms of this agreement."
(6) LETTERS OF REQUEST TO SPONSORS
The P.I. should author and sign post-award letters of request which need to be sent to sponsors (including NIH) on matters such as prior approval rebudgeting, extensions, supplemental funding, subcontracting, or transfers. Please leave space on the letter for institutional countersignature. The original and one copy of the correspondence should then be forwarded to ORA, along with written certification of Departmental approval.
(7) CONFIDENTIALITY/NON-DISCLOSURE AGREEMENTS
Commercial organizations may require that the University and/or Principal Investigator execute a confidentiality or nondisclosure agreement prior to disclosure of a potential sponsored project protocol that the outside organization considers proprietary or confidential. The Office of Research Administration is responsible for reviewing and approving such unidirectional confidentiality or nondisclosure agreements which are provided by commercial organizations as a precursor to sponsored research. (See Section VI.H. for a summary of other policies on Confidentiality/Non-Disclosure Agreements.)
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