Proposals Requiring Special Review (human & vertebrate animal subjects, radioactive material, clinical trials)
Proposal Deadlines (PI requirements for proposal submission to OGC)
University Review of Proposals
Submission of Proposals
Proposals Requiring Special Review
While preparing a proposal, it is important to note that certain proposals need special reviews and may need approvals which are necessary for insuring compliance with the University and sponsor requirements. University policy requires these reviews for all proposals which include the use of:
1. Human Subjects:
Proposal which call for the use of human subjects must be reviewed and approved by the University's Institutional Review Board (IRB). Faculty members are required to fill-out an "IRB Submission Form". For application to the IRB, faculty members should follow IRB's principles and procedures which can be found under the Instituional Review Board (IRB) website.
IRB reviews and approvals must be obtained either before the proposal is submitted or before a deadline set by the sponsoring agency. Please note that faculty members are required to include the IRB approval with their proposals, as no proposal will be processed by OGC unless the human subject protocol has been either submitted for review or has been already approved.
Some proposals may be exempted from IRB review; in this case an IRB Exemption Form must be submitted to the IRB in addition to the IRB Submission Form. The form lists the categories of research which qualify for exemption from IRB review. The chairperson of the IRB will either approve the granting of the exemption or request a modified submission.
2. Animal Subjects:
Proposals which call for the use of animal vertebrate subjects must be reviewed and approved by the Institutional Animal Care and Use Committee (IACUC) at the Faculty of Medicine. For application to the IACUC, faculty members should follow IACUC's principles and procedures. Faculty members are required to submit their proposals or protocols to the IACUC office for review by the Committee and by filling out an Animal Use Form.
3. Radioactive Material:
Research proposals that involve the use of radioactive material or radiation producing machines, or use of radiation in structural programs, and radiation medical applications must obtain the written approval of the University Radiation Safety Committee. This can be achieved by submitting an application for a license through the Department of Environmental Health, Safety, and Risk Management. The application must be approved by the Committee before the ordering of radioactive material or radiation producing devices.
For more information regarding the policies and practices of the University Radiation Safety Committee and the Health Physics Services of the Environmental Health, Safety & Risk Management Department, please refer to the Radiation Protection Handbook.
4. Infectious Agents
Research proposals that involve the use of potentially infectious agents including human blood or tissues, carcinogens, or mutagens or others are required to submit an abstract of their proposal to the Biosafety Officer at the Department of Environmental Health, Safety and Risk Management located in the Corporation Yard.
5. Clinical Trials:
Clinical trials are research studies to determine whether new drugs or treatments are safe and effective. These research programs are conducted with patients to evaluate a new medical treatment, drug or device, and their purpose is to find new and improved methods of treating different diseases and special conditions. Private companies such as pharmaceutical companies sponsor such trials. The scope of work known as the "Protocol" may be solely formulated by the sponsoring company or it may be designed by the principal investigator. In either case, clinical trials are considered sponsored projects and must be reviewed and approved as such.
The review of clinical trial differs from other projects because their proposals are different. As a start, it is often the case when the sponsor has had extensive discussions with the principal investigator and has in principal agreed to fund the trial. In addition, the clinical trial agreement that usually accompanies the protocol and other documents that make up the proposal usually coincide with the University policies and will have to be negotiated by OGC. An exception to this is the use of a previously negotiated standard agreement. Thus it is important for the principal investigator not to commit him/herself to any conditions prior of the University review as the OGC is the only office authorized to sign clinical trial agreements on behalf of the University. For more information on clinical trials see the pre-award and post-award management of clinical trials.
In order to assure that a proposal is processed in a timely manner, it should reach OGC well in advance (at least 7 working days) of any established submission deadline. Doing so guarantees PIs the full range of OGC services and the time needed to make any required changes. If a proposal arrives later than this deadline OGC cannot guarantee timely submission. Proposals are normally processed in order of receipt. Exceptions may be made for proposal with impending deadlines.
AUB faculty members are highly encouraged to keep the Office of Grants and Contracts informed of any initial contact with outside funding agencies, this will facilitate the application process and will ensure the smooth administration of the research once it is approved. When responding to a Request for Proposals or application (RFP/RFA) faculty members should forward a copy of the RFP or RFA to the Office of Grants and Contracts.
University Review of Proposals
The Office of Grants and Contracts is responsible for externally funded project/programs including proposal submission to funding agencies, award acceptance, award management and project closeout. All sponsored research proposals must be reviewed and approved by the university before the submission to external funding agencies. The reviews are needed to check for conformance to University policy as well as sponsor guidelines. Faculty members applying for external funding are required to channel their proposal to various campus administrators for review and approval before they are submitted to the Office of Grants and Contracts and the Office of the Provost for the final review and transmittal.
This routing process is done by filling out the" Proposal Transmittal and Approval Form" and attaching it to the proposal. The proposal is then routed to the Department Chairperson, Research Committee Chairperson, Dean/Director and then to the Office of Grants and Contracts. Upon review, the Office of Grants insures its routing to the Office of the Provost for his final signature; one should take into account that the Provost's signature may take a couple of days.
Review of Interdisciplinary or, Inter-Faculty and/or Collaborative Proposals
For proposals involving a group of faculty members from different faculties and Centers, approval from the appropriate Faculty(ies) Dean(s) and/or Center(s)' is needed before final approval of OGC and Provost's office. The Deans/Directors must approve the contribution of each member of their faculties for the proposed percent effort (time effort) to be spent on the project, and the salary recovery (if any) proposed. This can be done by obtaining the signatures of faculty(ies) Dean(s) and/or Center(s) Director(s)' on OGC's Proposal Transmittal and Approval Form.
Copyright Protection of Proposal Ideas/Topics of Research
To protect the intellectual property, in particular copyright, of AUB faculty members as individuals and/or as group of researchers, PIs submitting proposals with the same or similar objectives and goals of awarded projects or previous proposals already submitted by other faculty members, PIs should provide a letter to OGC indicating the acceptance/no-objection and/or approval of past and present collaborators for the submission.
For disputes between faculty members on the issue of copyright for proposals and/or publication authorship rights, the University Research Board (URB) will be responsible for resolving such disputes or differences. The URB will mediate and negotiate between the parties and is empowered to make a ruling which will be binding by all parties involved. The URB consists of two faculty representatives from FAS, and one from each of the other faculties elected by the faculty.
The reviews are concerned with:
1. The substance and merit of the proposal, including the academic appropriateness of proposed research or other sponsored activity.
2. The time commitments of faculty and staff and the possible effects on the teaching and other obligations of the personnel involved.
3. Salary arrangements, sabbatical leaves, buy-out time, provisions for summer salaries.
4. Requirements for space and facilities.
5. The budget. OGC verifies that all costs, including indirect cost are provided for, that all items are realistically estimated and that items included are not contrary to the policies of the University or the sponsor.
6. Availability of AUB funds for cost sharing if applicable and if cost sharing is a condition of the award and is included in the budget.
7. The identification of any special conditions requiring further review such as the use of human subjects, animal use, radioactive material, radioactive drugs, intellectual property rights, and patent rights.
8. Intellectual property rights, in particular copyrights, of proposal and project ideas.
9. The correctness of the filled out application and sponsor agency requirements.
Submission of Proposals
The Office of Grants and contracts is responsible for the formal transmittal of proposals. In this context, the Office prepares a transmittal letter and mails the proposal. Faculty members should alert the Office when responding to a call for proposals, grant announcements or any type of solicitation. Usually solicitations or "call for proposals" include the terms and conditions for any resulting award, however if the conditions are unacceptable to AUB the OGC must address these conditions and explain the University's position