OFFICE OF SCIENTIFIC AFFAIRS AND BIOTECHNOLOGY

RESEARCH RELATED POLICIES AND PROCEDURES

Pre-Award Policies and Procedures

WHO CAN BE A PRINCIPAL INVESTIGATOR / PROJECT DIRECTOR

Any staff member holding a paid or voluntary faculty appointment at Downstate Medical Center may be the Principal Investigator on a sponsored research, Institutional Review Board (human subjects), Animal Care and Use Committee or Institutional Biosafety Committee application. Students or other staff submitting training, fellowship or research proposals must identify a faculty member who will assume responsibility for the proposed project.

FINDING A SPONSOR

Sponsors (federal, state and local governments, philanthropic, industrial and other organizations) are the usual sources of support for faculty research, training and public service programs. However, since just about any type of organization can be a potential sponsor, identifying which sponsors fund specific types of programs can be a daunting task. There are a variety of resources available to identify potential sponsors. Printed or on-line materials are one way to learn about sponsors. Other means for understanding them include personal contacts, experiences of colleagues, and publications by other investigators on the results of their funded programs.

Identifying and learning about sponsors is a process initiated by an investigator's research interests. The Office of Scientific Affairs Division of Sponsored Programs (DSP), located in Room 2-71E Basic Science Building, is available to conduct searches of sponsors based on these interests. Funding possibilities, such as unsolicited proposals, grants competitions, and solicitations, then can be analyzed in the context of individual interests using materials such as program guides, past awards, etc. Using these aides will provide detailed information needed for making decisions on where to send your proposal and how to develop it.

Funding Resources

• NIH Guide – The NIH Guide for Grants and Contracts, issued weekly, is the official document for announcing the availability of NIH funds for biomedical and behavioral research and research training and disseminating policy and administrative information.
  
  The NIH Guide for Grants and Contracts is available on the the NIH Website, http://grants.nih.gov/grants/guide/index.html. The Table of Contents for the NIH Guide for Grants and Contracts is also available through listserv notification service [http://grants.nih.gov/grants/guide/listserv.htm].


• National Science Foundation (NSF) E-Bulletin – The NSF E-Bulletin is produced in a daily web-accessible electronic edition in order to provide the most accurate and timely information possible about NSF programs, deadline dates, publications, meetings, and sources for more information.

  The NSF E-Bulletin is available on the NSF website, http://www.nsf.gov/. Readers can sign up for the NSF Custom News Service [http://www.nsf.gov/mynsf/] to be notified when new issues of the E-Bulletin are available.

• Sponsored Programs Information Network (SPIN) – SPIN is an online telecommunications network of federal and non-federal funding opportunities, including private philanthropic organizations, voluntary health organizations, corporate-related foundations, and corporations. The SPIN Database can help you identify external support for research, education, and development projects, as well as for fellowships, sabbaticals, publications, and travel. SPIN supplies information about the type of research that potential sponsors fund, the amount of money available and specific details about the sponsor and eligibility. Information is updated on a regular basis. The network provides information on federal, non-federal and international sponsors. To request a SPIN search, obtain a search request form from the Division of Sponsored Programs (BSB 2-71E, Box 129), complete and return it. You will be asked to provide a synopsis of your training, experience, and ten keywords which best describe your research interests.
  
  The SPIN Database and search functions are also available through the DMC Research home page. Faculty who are able to access the internet, through the campus network only,may conduct their own searches (try it here).


• Reference Materials
  • Directory of Biomedical and Health Care Grants – This publication offers factual and concise descriptions of more than 8,600 research programs. These programs represent all areas of research, with a special emphasis placed on foundation and corporate sponsors as well as complete and up-to-date listings of federal and state programs.
  • The Foundation Directory – These two publications provide information on the finances and giving interests of the nation's largest grant awarding foundations. They also note limitations or restrictions on a foundation's giving program. These materials are available in the Division of Sponsored Programs.
  • NIH Reference Materials – A number of NIH reference materials and guidelines for the preparation of traditional research grant and fellowship applications are available in the Division of Sponsored Programs for perusal. Pamphlets include: "Helpful Hints on Preparing a Fellowship Application to the NIH," "Helpful Hints on Preparing a Research Grant Application to the NIH," "NIH Peer Review of Research Grant Applications," etc.
  
  
• Wherever possible, links to the full text of the sponsor's website, RFA, RFP, Program Announcement, etc. and application forms are provided.


• DMC Research Home Page (http://research.downstate.edu/) – Provides electronic access to many of the services and materials offered by the Division of Sponsored Programs including sponsor forms, DMC and Research Foundation policies and procedures, and other research related information.

PROPOSAL WRITING

The Division of Sponsored Programs staff assists Investigators in all aspects of the preparation and submission of applications for sponsored research grants and contracts, focusing on the development of the application's budget section and the review of the non-scientific aspects of the proposal. Investigators should allow at least two weeks prior to a sponsor deadline date for review by the DSP staff, especially prior to major PHS or NSF deadlines.

Writing a research proposal usually begins once a sponsor(s) has been identified. It is strongly recommended that the Investigator contact the sponsor to discuss the proposed research plan prior to writing the proposal. This will help insure that the proposal meets the current needs of and relates to the mission of the sponsor.

The clarity of all aspects of the research proposal is generally one of the most significant factors in its success. Investigators are urged to have proposals reviewed internally prior to submission to the sponsor. If desired, the DSP staff can identify other Medical Center investigators willing to provide this review assistance.

Based on the sponsor's application guidelines and application materials, obtained through the DSP, a proposal generally contains the information outlined below (see Forms for electronic copies of many sponsor forms and Standard Institutional Information and Identification Numbers for a listing of relevant institutional information required by many sponsors):

• Cover page – Most sponsors provide a specific application cover page. When one is not provided, basic institutional and Investigator information should be provided.
• Abstract – A concise statement, with a minimum of highly technical language, of the projects objectives, specific aims, research design and methodology. An abstract of the research activities should be prepared for any funded account, regardless of the sponsor.
• Budget and Budget Justification – See following sections on direct and indirect costs for specific types of costs to include and examples of completed budgets.
• Biographical Sketches – A brief c.v. should be provided for all key personnel (individuals who contribute in a substantive way to the scientific development or execution of the project, whether or not salaries are requested). Where no specific format is provided, information to be furnished should include present position, education/training and research/professional experience. Relevant publications from the past three years, including representative earlier publications pertinent to the application, should also be listed.
• Other Support – Principal Investigators and Co-Principal Investigators should provide relevant information on all (including industrial/pharmaceutical) current and pending support for their research activities regardless of the relationship, or lack thereof, to the proposed research. Where no specific format is provided, information to be furnished should include 1) project title, 2) sponsor, 3) project goals, 4) project period, 5) estimated costs and 6) effort. In addition, a statement describing any project overlap, if any, between proposals should also be included.
• Resources and Environment – Used to show that appropriate resources are available to successfully carry out the research project. Where no specific format is provided, information to be furnished should include a brief description of the capacities, capabilities and proximity of research laboratories, specialized equipment, clinical sites, animal and computer facilities and any other support service to be used in support of the proposed project.
• Research Plan – The research plan provides sufficient information necessary for the evaluation of the project, independent of any other documents and should include:
  • introduction
  • specific aims
  • background and significance
  • preliminary studies/progress report
  • research design and methods
  • human and/or animal subjects
  • literature cited
  • consortium/contractual arrangements and consultants
  • appendix

As many sponsors set limitations on the length of some or all of the above sections, care should be exercised in completing the proposal. Proposals may be returned un-reviewed if length limitations or other formatting requirements are not observed.

Multiple Submissions

Investigators may consider submitting proposals to more than one sponsor, unless one of the sponsors prohibits multiple submissions. While few sponsors object, all require that information be included in the proposal concerning the other sponsors to which a proposal has been submitted. Individual proposals must be prepared in accordance with the application format requirements of each sponsor.

Sponsor and Research Foundation policies generally prohibit the acceptance of more than one award for the same work. However, given the complexity of many areas of science, awards may be accepted from more than one sponsor for different aspects of a larger research program.

Commercial/Pharmaceutical Agreements

Projects funded by pharmaceutical firms and other industrial/commercial sponsors are generally based a formal contractual agreement which must submitted to and accepted by the Research Foundation. The purpose of this is to avoid problems concerning sponsor restrictions on proprietary information, publication of results, liability etc., and applies under any of the following circumstances:

• If the sponsor requires a formally signed document.
• If the sponsor requires testing of a drug or product.
• If the sponsor requires fiscal or technical reports.

When required, this agreement must be executed by both the sponsor and the Research Foundation (not the Investigator) before funding can be accepted and work begun. Faculty should not enter into contractual discussions with pharmaceutical companies without first notifying the Division of Sponsored Programs. All arrangements with pharmaceutical companies, including the proposed budget, must be processed through the department chair and the Division of Sponsored Programs. Copies of a sample agreement are available.

BUDGET DEVELOPMENT – DIRECT COSTS

The following information is provided to aid Investigators in the preparation of grant application budgets. The budget is intended to show the cost estimates for the total support required to carry out the proposed research project. The various cost items are listed in a manner similar to an NIH grant proposal. Changes in format may be required to meet the requirements of other sponsors. In addition, the allowability of certain types of costs will vary depending upon the sponsor. Sponsor specific guidelines should be reviewed, if necessary, with the Division of Sponsored Programs staff prior to completing the budget.

Some sponsors (i.e., New York State agencies) impose rigid expenditure restrictions based on an approved budget. Therefore, considerable thought should be given to types of expenses necessary to carry out the project. This will minimize the need to request budget modification approvals during the project period.

In addition to completing the detailed budget page, most sponsors require additional justification for the proposed project costs. Any items of an unusual nature or where, in a competing renewal proposal, there are significant increases (i.e., animal board rates) should be adequately described and justified. Do not assume that reviewers will make a connection between the research plan narrative and the proposed budget – it is preferable to provide more rather than less budget justification.

Reimbursement of SUNY Expenses in Support of Research Programs

To the extent allowed by the sponsor, all sponsored program proposal budgets must request full reimbursement of State expenses (laboratory technicians, graduate students and other State funded costs such as animal care, radiation waste disposal, telephones, etc.). All exceptions must be approved by the Senior Vice President for Biomedical Education and Research prior to submission to the sponsor.

Cost-Sharing

Some sponsors may require institutional commitments to fund a portion of the total project costs (mandatory cost-sharing) while others encourage, but not require, such commitments (voluntary cost-sharing). As current federal regulations require documentation of both mandatory and voluntary cost-sharing, Investigators are urged to be cautious when proposing such commitments, especially with voluntary cost-sharing. The extent to which the institution agrees to share in the project costs is generally not a major factor in the review and approval of a grant proposal.

Research Foundation personnel should not be used to meet a sponsor's cost sharing requirement. Only in very unusual circumstances will this be approved – prior approval must be received from the Office of Research Administration Personnel/Payroll Division.

In most cases, a cost sharing requirement can be met through the contribution of a portion of the Investigator's effort/salary devoted to the project. However, where actual cash commitments must be made, approval of such commitment must be received from appropriate individuals at the Health Science Center prior to submission of the proposal (see Grant Proposals Requiring a Commitment of Other Institutional Resources).

Salaries

Salaries requested for Research Foundation personnel must be consistent with current Research Foundation classification and compensation guidelines. Salaries requested for State employees at Downstate Medical Center, who are or will be working on the project, must be consistent with their current State salary. The proposed level of effort for each employee must be clearly stated and the amount of salary requested should equal the individual's base salary times their effort (i.e., $45,500/year base salary x 40% effort on the project = $18,200 salary request).

In projecting future years of support, it is recommended that salaries be increased by 3% per year to allow for increments. Supplies, travel, and other expenses should also be increased by this amount annually to allow for inflation.

Amounts listed on applications do not constitute entitlement of funds to the employee nor are they an institutional commitment to provide the amount shown.

If the research proposal is funded, the Investigator must submit the appropriate personnel requisition (P-10) and/or RF/IFR appointment forms to Office of Research Administration Payroll Office.

Fringe Benefit Rates

All research proposal budgets which include salary costs must provide for the recovery of fringe benefit costs based upon the current, federally approved Research Foundation fringe benefit rate. Fringe benefit costs may not be waived.

Separate rates, listed below, are developed for regular employees, graduate students and undergraduate students. The rates represent the ratio of the total cost of benefit programs to the total salary base of all employees in the category. In addition, the rates do not indicate the specific cost of benefits for any individual employee. A particular employee's benefits costs may be greater or less than the average.

As the current actual rate must be charged against all salary expenditures, it is strongly recommended that the proposal budget include an annual increase, for all future project years, of 1%.

• Regular Research Foundation employees only:

• Summer employees, for May 1st to September 30th appointments only (appointments extending beyond September 30th will be charged at the regular employee rate for the entire appointment period):

• SUNY/HSCB graduate students on RF regular payroll (rate for graduate students on RF/IFR payroll is 0%):

• SUNY/HSCB Undergraduate students on RF regular payroll (rate for undergraduate students on RF/IFR payroll is 0%):

• SUNY employees on RF/IFR payroll (rate based on actual NYS IFR fringe benefit rate):

Consultants/Independent Contractors

When the services of consultants/independent contractors are requested, the application must include evidence that the services to be provided are essential and cannot be provided by persons receiving salary support under the grant. There must be evidence that the charge is consistent with the qualifications of the consultant, his/her normal charge for the service, and the nature of the services rendered. Individuals who provide service for compensation may be classified as independent contractors only if they meet certain requirements established by the Internal Revenue Service. The IRS Right of Control criteria, focusing in large part on the manner in which the intended consultant's work is controlled and/or directed, is used to determine whether the individual is a project employee or an independent contractor.

Equipment and Equipment/Component Parts

For all federal sponsors, individual equipment items, or equipment fabricated from individually purchased parts, which cost more than $5,000 should be included in the Equipment section of the proposal budget. Equipment valued at less than $5,000 should be included in the Supplies section. Equipment valued at less than $5,000 should be included in the Equipment section only if required by the sponsor's budget guidelines.

Supplies

The following types of supplies, if applicable to the project, should be included in the proposal budget:

• equipment valued at less than $5,000
• chemicals
• glassware
• animals (animal board costs must also be included in the budget)
• books and periodicals
• radioactive materials (radioactive waste disposal costs must also be included in the budget)
• office supplies

Travel

Expenses for domestic travel, including for most sponsors travel to Canada, for project related activities. Specific cost estimates per trip should be itemized in the budget justification.

For foreign travel, federal sponsors require use of US air carriers.

Patient Care Costs

Patient care costs are generally not allowed on most research projects. Where these expenses are deemed allowable, based on the nature of the project, appropriate in-patient and/or out-patient charges should be obtained from University Hospital.

• University Hospital in-patient/out-patient costs –
• Clinical Laboratory costs –
• Pharmacy costs – It is the responsibility of the University Hospital Pharmacy to manage and control the drugs used in clinical drug trial protocols in accordance with the requirements of the various State and federal regulatory agencies. All new clinical trial study protocols should be reviewed with the Director of the University Hospital Pharmacy to determine the appropriate costs to be included in the final study budget. A Pharmacy pricing schedule is available which details the current charges for both oral and topical preparations and all parental preparations.

Alterations/Renovations/Installations

Investigators who anticipate requesting sponsor funds for alterations, renovations, installations, etc., should notify Facilities Management and Development prior to submission of the application. FM&D needs sufficient lead time to develop accurate cost estimates for inclusion in the proposal budget and to schedule approved work in order to accommodate requests from researchers on a timely basis.

Subcontracts/Consortium Agreements

Research proposals may include a collaborative arrangement with an investigator at another institution under which sponsor funds will be transferred to the other institution. In most cases, a subcontract is the appropriate mechanism. The Investigator should, when developing the proposal or subsequent to the award, prepare a detailed scope of work and budget (including allowable indirect costs) for the collaborative work to be included in the research proposal budget. In addition, this information will become the basis for a negotiated agreement with the other institution.

Other Expenses

The following types of expenses, if applicable to the project, should be included in the "Other/Miscellaneous" budget category:

• equipment insurance – Investigators who include items of equipment in their grant budgets may also include the cost of fire and theft insurance in the miscellaneous category. Equipment being used for a NIH project may be insured by that project even if it was purchased from another NIH grant. The Research Foundation does not carry fire and theft insurance for equipment but will make this coverage available upon request, provided that it is a sponsor allowable expense. The insurance cost is approximately $1 per $100. Research equipment that is taken off-campus must be insured.
• equipment maintenance costs / service contracts
• deposit and rental fees on gas cylinders
• computer usage
• subject payment fees
• medical illustration and photography
• animal board – Full animal care costs must be included in the proposal budget. DLAR staff can provide current rate schedules.
• publication costs and page charges
• printing and xeroxing
• telephone bills – Most sponsors will fund only telephone toll charges relating to the research activity but not for the basic monthly telephone service expense.
• recruitment advertisements for research personnel
• removal of radiation wastes – The Radiation Safety Office will provide cost estimates for the disposal costs based on the radioactive materials being used.
• postage (if large mailings, Express Mail, Certified Mail, etc. are anticipated)

Facility and Administrative (indirect or overhead) costs are those costs incurred by Downstate Medical Center which are not readily identifiable with particular projects or activities but nevertheless are absolutely necessary for the maintenance of the day-to-day operations of the Center and the conduct of the activities it performs. These costs generally include operation and maintenance of buildings and equipment, depreciation and use allowances, departmental and campus administrative expenses and library costs.

An indirect cost rate is simply a device for determining fairly and expeditiously, within the boundaries of current federal guidelines, that proportion of an institution's indirect costs applicable to its projects or activities. The Research Foundation develops individual campus indirect cost rates to enable the recovery of indirect costs incurred by the Downstate and the Research Foundation.

Policy

It is the policy of Downstate Medical Center to apply the full, applicable indirect cost rate, Federal or non-Federal as listed below, to all sponsored research, training and public service project awards. The only exceptions will be for:

• project awards from sponsors which, as a matter of policy and uniform application to all recipients, limit the allowable indirect cost recovery [for example, the March of Dimes or the American Cancer Society], or
• clinical trial awards funded by non-federal sponsors for which the rate will be 25% (effective January 1, 2005) of total direct costs, or
• project awards classified as gifts or for which no financial or technical reporting is required by the sponsor to which the current administrative rate will be applied [for example, Multiple Sponsor awards], or
• project awards for which a full or partial indirect cost waiver has been requested and approved.

Sponsored research accounts to which the applicable rate is not currently applied will be adjusted as follows:

• the full applicable rate will be assigned to the account and all future funding credited to the account will be charged at this rate.
• from current unexpended direct cost balances, an amount equivalent to 5% will be transferred from the direct cost category to indirect costs.

Indirect Cost Base

The direct cost base against which the indirect cost rate is applied varies depending on the budget guidelines and limitations of individual sponsors. There are generally two types of indirect cost bases:

Modified Total Direct Cost (MTDC)

For use with the federal indirect cost rate, the MTDC base includes all direct costs except equipment costing over $5,000, alterations/renovations, patient care costs and subcontract costs in excess of $25,000 (over the course of the full project period, i.e., 3 years).

For use with non-federal sponsor proposals, the MTDC base, depending on the sponsor limitations, may include or exclude additional cost categories. For example, the American Cancer Society excludes only equipment from their allowable indirect cost base.

Total Direct Cost (TDC)

For use with many non-federal sponsors, the TDC base includes all direct costs expended on a program regardless of the type of activity.

On- and Off-Campus Rates

The on-campus rate applies to projects performed in facilities owned or leased by SUNY.

The off-campus rate applies to projects performed in facilities not owned or leased by SUNY, or projects to which rent is directly charged.

Indirect Cost Rates

Federal -- Applicable to all awards funded directly or indirectly by the federal government.

The current indirect cost negotiation agreement date for indirect costs on federal research grants and contracts is March 11, 2008.

The rate for Res-DOD is only applicable to DOD research contracts.

Fed-IPA rate to be used for positions covered under the US Intergovernmental Personnel Act.

Non-federal -- Applicable to all sponsors who do not have a formal, written policy specifying allowable indirect cost rates.

Administrative -- Based on campus and system-wide administrative costs and is applicable to non-project type activities where a sponsor is providing general support with no expectation of financial and technical reports in return.

Indirect Cost Waiver

Exceptions to the above rates, absent a written sponsor indirect cost policy, require the approval of the President of Downstate Medical Center or his designee. Requests in writing, signed by the appropriate Department chair, for approval of a reduction must include the following:

• bona fide evidence that an attempt was made to request the appropriate full rate from the sponsor; or
• evidence that the sponsor is unwilling to fund the full indirect cost rate or will provide a specific level of funding (i.e., certain amount per patient for clinical trial agreement); or
• evidence that the application of the full rate would jeopardize the Principal Investigator's ability to carry out the project; and
• evidence that the project, if the indirect cost waiver is approved, will likely lead to future sponsored research funding that will include the full reimbursement of indirect costs; and
• a calculation of the amount of indirect costs to be waived, based on the appropriate full rate, the requested rate and the total project funding; and
• a defined period of time for which the exception is to apply.

Most sponsors require research proposals involving the use of animals, human subjects, recombinant DNA or radioactive materials to be reviewed by the appropriate institutional committee established in accordance with current federal regulations governing these areas. Outlined below are the basic requirements for each.

Laboratory Animals

Consistent with the new Public Health Service and revised U.S. Department of Agriculture guidelines in the "Humane Care and Use of Laboratory Animals," and Downstate Medical Center's Policies and Procedures for the Care and Use of Laboratory Animals in Biomedical and Behavioral Research and Education," all uses of animals for research, training, or other purposes within the Center must be approved by the Animal Care and Use Committee (ACUC). The ongoing cooperation of all investigators is vitally important in maintaining the Center's ability to continue to accommodate the wide variety of existing and planned research programs involving animals.

Effective January 1, 1987, the use of animals (of all species, mammalian, or sub-mammalian) in individual research and/or training activities at Downstate Medical Center will be suspended unless there has been a protocol submitted by the investigator of that particular research project to the ACUC for its review and approval. This requirement is applicable to all uses of animals regardless of the source (internal or external) of support, location of the animal, DLAR, or department. In addition, animals will not be ordered by the Division of Laboratory Animal Resources unless a protocol is submitted for the use of animals.

To obtain the necessary ACUC approval for the use of animals, a detailed protocol describing the aims and methods of the proposed procedure(s) must be submitted along with a completed copy of the ACUC Worksheet. This form is available in DLAR. If outside support is being requested, a copy of the grant proposal containing the detailed protocol should also be attached. The information to be provided should be as complete as possible in order to expedite ACUC review. The completed worksheet and protocol must be submitted to DLAR, Box 47.

Recombinant DNA and Infectious Agents

The Center's Institutional Biohazard Committee has established approval procedures for the use of recombinant molecules and infectious agents. Recombinant molecules includes DNA and RNA molecules whose sequences have been recombined deliberately by in vitro procedures, and also DNA or RNA copies of such molecules, or of parts of such molecules, produced by replication, transcription, or reverse transcription, regardless of whether or not such copying occurs in vitro or in vivo. Infectious agents include bacteria, mycobacteria, fungi viruses or others. Investigators whose research involves recombinant molecules and/or infectious agents must complete the appropriate certification form (available in the RDO) and return it to the Institutional Biohazard Committee, Box 129.

Human Subjects

Investigators whose research involves human subjects should submit their research protocols to the Institutional Review Board several months prior to the sponsor's deadline. Early submission of the protocol to the committee is advisable to allow time for any necessary clarification or revision. The Institutional Review Board meets the third Wednesday of every month. Protocols must be received by the established deadline dates to allow time for duplication and distribution of materials to the committee. IRB approval forms may be obtained in BSB 2-71E.

Radiation Safety

The use of radioactive materials at the Health Science Center is authorized by the Nuclear Regulatory Commission through the New York City Department of Health Bureau of Radiation Control which has issued a Broad Human Use and a Broad Non-Human Use License to the Center. Individuals who have been approved by the appropriate Radioisotope Committee (either Human Use or Non-Human Use) are permitted to store and use radioactive materials at the Center or at Kings County Medical Center. An institutional Radioactive Materials License is issued to individuals for specific radioisotopes, uses and locations. License application forms and information can be obtained from the Radiation Safety Office (BSB 7-26, x1424). Radioactive Materials Licenses are non-transferable, i.e., licenses from other institutions are not valid at the Health Science Center. There are specific requirements concerning the ordering, use and disposal of radioactive material which must be strictly adhered to. In addition, there are requirements for contamination checks, personnel monitoring and posting of warning signs. All of these requirements are provided to licensees by the Radiation Safety Office at the time of licensing.

APPLICATION REVIEW / APPROVAL PROCEDURE AND RESPONSIBILITIES

All sponsored research proposals, or acceptance of a sponsor award for which there was no initial proposal, must be reviewed and approved by the individuals listed below. The Research Proposal Application Review/Signature Worksheet is to be used to record these approvals.

In order to insure sufficient time to obtain the necessary approvals and signatures and to properly review and process proposals in time to meet deadline dates, applications must be brought to the Division of Sponsored Programs in final form at least five (5) working days prior to the sponsor's deadline. If it is not possible for the Investigator to have the entire application ready five working days prior to the deadline, the following sections will be accepted so that appropriate signatures may be obtained: the cover page, the application review/signature worksheet (with appropriate signatures), an abstract of the research plan, the budget pages and justification, the checklist page, the human subjects certification, the animal worksheet, and the Ethics Disclosure Form (if applicable). When the application is complete, the investigator should forward one (1) final, complete copy to the Division of Sponsored Programs (Box 129).

Principal Investigator

• If the research involves human subjects, complete and submit protocol forms to the Institutional Review Board (Box 129). If human subjects are not involved, indicate this on the internal signature page as well as on the cover page of the proposal and submit it with the application.
• If the research involves animals, complete and submit an animal worksheet and protocol to DLAR (Box 47). If animals are not involved, indicate this on the internal signature page.
• If the research involves recombinant molecules and/or infectious agents, complete the appropriate certification form and return it to the Institutional Biohazard Committee.
• A draft of the budget should be brought to the Division of Sponsored Programs for review at least two weeks before the sponsor deadline to allow time for any corrections and/or revisions. Draft budgets may be faxed (x3942) or submitted on computer disk in spreadsheet format for review and approval.
• All Investigators with State salaries above the statutory filing threshold submitting research proposals must file a SUNY-2 form annually with the Division of Sponsored Programs. All Investigators, regardless of salary, submitting proposals to the National Science Foundation or the U.S. Department of Health and Human Services (PHS, CDC, HRSA, etc.) must file a SUNY-2 form.
• Where there will be a significant involvement from another Investigator (as Co-Principal Investigator or Co-Investigator), it is strongly recommended that the other Investigator be given the opportunity to review the research proposal.
• The Investigator is responsible for mailing the application to the sponsor.

Department Chair

• Reviews the proposal to ensure that all applicable Downstate Medical Center policies have been followed.
• Reviews the proposal to evaluate the proposal's scientific merits and determine if such research is appropriate for the department.

Associate Vice President for Scientific Affairs (Investigators from the College of Health Related Professions and the College of Nursing must also obtain the signature of Dr. Joann Bradley, Vice President for Academic Affairs)

• Reviews the proposal to ensure that the research meets the scientific standards required by Downstate Medical Center and applicable federal and state agencies and that such research is appropriate for the Center.
• Reviews the proposal to ensure that all applicable Downstate Medical Center policies have been followed.

Division of Sponsored Programs – Research Foundation Endorsing Designee

• The Division of Sponsored Programs will review/process the application and check budgets. Any subsequent corrections must be made by the investigators. The signatures of the department chair and the Associate Vice President for Scientific Affairs must be obtained before the final proposal is submitted.
• Reviews proposal to ensures that the proposal's budget has been prepared in accordance with DMC and sponsor guidelines and policies. Ensures that the proposal meets all other requirements of the sponsor.
• Ensures that appropriate institutional review committee approvals have been obtained.

Approvals Required from Affiliate Institutions

All proposals for projects to be conducted at Kings County Hospital Center or any other DMC affiliated hospital should be approved by the affiliate prior to submission. For federally funded projects, space costs may be included as a direct cost to the grant. Ancillary costs (e.g. pulling charts, tests, etc.) must also be negotiated with the appropriate individuals at the affiliated hospitals.

If the proposed project requires additional office and/or laboratory space or renovations, it must undergo further review and approval.

It is essential that space needs, if any, be identified prior to submission of the proposal to the sponsor. Given the time required by most sponsors for the review and approval of proposals and the uncertainties of award, actual approval and assignment of space may not be appropriate or necessary until, or prior to, receipt of the project award.

The Investigator, through his/her Department Chair, should make every attempt to obtain departmental space. If departmental space is not available, the Department Chair will, in writing, submit a request for space to the Senior Vice President for Biomedical Education and Research (or the Vice President for Academic Affairs). The Senior Vice President, working in conjunction with the Facilities Management and Development Department (FM&D), review current space availability and make subsequent space assignments as necessary.

Space assignments for new research projects are generally made with the understanding that the space will revert back to the institution at the completion of the project, when sponsor funding is not longer available to support the project.

If space renovations are contemplated for which sponsor funds will not be available, the Investigator and Department Chair will obtain from FM&D an estimate of the costs required for the necessary renovation work. If departmental funding is available, the department must schedule the work with FM&D so that the renovations can be completed before the project is to start. If departmental funds are not available, the Department Chair will, in writing, submit a request to the Senior Vice President for Biomedical Education and Research (or Vice President for Academic Affairs) for institutional funding. The Senior Vice President must review the request and decide if the work is necessary and the funding can be made available.

It is understood that if space is not found, it may be necessary for the Division of Sponsored Programs to withdraw the proposal or not accept the award.

If the research proposal requires commitment of other non-space, institutional resources, an additional review process is required.

The Investigator must obtain, from the appropriate Department Chair/Director and/or Dean, written approval for the commitment prior to the submission of the proposal.

It is understood that if the commitment of institutional resources cannot be made, it may be necessary for the Division of Sponsored Programs to withdraw the proposal.

In certain cases, an Investigator may feel that some aspect of the handling or peer review of his/her grant application has been inappropriate, biased, or wrong. Summarized below are the National Institutes of Health (NIH) and the National Science Foundation (NSF) procedures for addressing Investigator concerns. As there have been successful appeals achieved through this process, Investigators are strongly encouraged to discuss these matters with relevant NIH/NSF staff.

NIH provides investigators with two sequential opportunities (respectively referred to as “rebuttals” and “appeals”) to have his/her concerns addressed. The first opportunity is after receipt of the summary statement that documents the results of the initial review of an application’s scientific and/or technical merit. If the applicant submits a letter rebutting the review to the program administrator who is responsible for the application, that letter will usually be made available to the National Advisory Council/Board of the relevant NIH ICD for consideration, if the ICD cannot handle the concerns administratively. The Council may recommend that the application be deferred and re-reviewed, it the applicant’s objections are deemed to have merit. However, should the Council not recommend deferral and re-review but concur with the initial review and deem that it should stand, then the applicant has a second opportunity to have his/her concerns heard, but submitting a formal appeal of the Council’s decision. (NIH Revised Peer Review Appeal Process / NIH Guide, Vol. 23, No. 39)

An investigator whose proposal for NSF support has been declined will receive information and an explanation of the reasons for declination from the cognizant Program Officer. If that explanation does not satisfy the investigator, he/she may request that the cognizant NSF Assistant Director reconsider the action to determine whether the proposal received review that was fair and reasonable, both substantively and procedurally. The request for reconsideration must be in writing and received within 90 days of the date of the declination letter. (NSF Grant Proposal Guide)