[AECOM Faculty Handbook (July, 2000, Section III, pp. 42-45]

Research Grants

AECOM encourages its faculty to engage in a broad range of scientific research projects. Research may involve human subjects, animals, the use of radioactive and other potentially hazardous materials including infectious agents, patients and records at affiliated and non-affiliated institutions, and access to national and international data bases

These activities, whether funded by outside agencies and organizations (governmental and private, commercial and not-for-profit) or internal sources, are closely regulated by rules that have been imposed by federal and local governments and AECOM itself. Clearly, all applications must be in conformity with the policies of the agency from which funding is being requested. Equally important are those regulations concerned with the responsible conduct of research including ethical performance, protection of human subjects, proper use of experimental animals, and conflict of interest in research.

The details of these regulations are too complex to be encompassed within this handbook. Therefore, you are referred to the following for guidance and specific instructions.

General Policy

A principal investigator on a grant application must be a member of the faculty at AECOM holding the rank of Instructor, Assistant Professor, Associate Professor, or Professor. All applications must be approved by the Dean's office before submission to a granting agency or private entity. To obtain such approval, the application must be reviewed and approved by the Department Chairperson, by the various departments or committees concerned with chemical and biological hazards, human subjects, animal use, College facilities, and relations with industry as indicated by the nature of the research, and by Finance. Such review and approval will indicate to the Dean that appropriate space and facilities are available to perform the proposed research and that the application conforms with governmental and College regulations. AECOM's Internal Grant Approval Form GA 6742 and related instructions are available from Grant Accounting in room 1108, Belfer, ext. 3712, from departmental administrators, and for downloading at www.aecom.yu.edu/home/finance/department_of_finance.htm. This form must accompany every grant application submitted for approval. Department administrators are familiar with this process and will assist the investigator with the preparation of a grant application.

Funding Sources

The office of Grant Support is available to help investigators identify possible funding sources, to provide information about funding agencies, and to assist investigators during the grant application process. Further information about the OGS is available on page IV-15 of this Handbook and at www.aecom.yu.edu/ogs.

Budgets

All applications for funding from outside sources must be approved by the Office of Grant Accounting, room 1108, Belfer, ext. 3712. The application budget should be prepared carefully and provide for sufficient funds to cover all costs required to carry out the research project. Special care should be taken to make certain that the percentage of an investigator's time and salary that is to be charged to the project is consistent with the percentage allotted to that project.

Human Subjects

All research involving human subjects conducted at an AECOM facility, funded through AECOM sources or involving patients or resources at Jacobi Medical Center or North Central Bronx Hospital, must be approved by the Committee on Clinical Investigations (CCI). All research involving human subjects conducted at any one of AECOM's other affiliated institutions must be approved by the appropriate Institutional Review Board (IRB) having jurisdiction over the particular patient population, i.e., Montefiore Medical Center, Bronx Lebanon Hospital, Long Island Jewish Hospital, Bronx Psychiatric Center, etc.

The Weiler Hospital, as a Division of Montefiore Medical Center, is under the jurisdiction of the Montefiore Medical Center Institutional Review Board (IRB); however, in the case of research conducted at Weiler under an Einstein grant, and/or by faculty on the AECOM payroll, the protocol must be submitted to the AECOM CCI. Blood or tissue obtained for research at AECOM from individuals at other institutions requires approval by the IRB at that institution and the AECOM CCI.

Use of an investigational drug or device for patient care must also be approved by the CCI or the appropriate IRB, as well as emergency/compassionate use of such drug or device.

Indemnification language and/or terms of contracts for clinical trials funded by pharmaceutical companies must also be approved by the University's counsel. This process is coordinated by the CCI Office.

CCI office staff are available for education and assistance with regard to protocol application and compliance matters. Participation in an educational program for investigators is a requirement for receiving CCI approval of research protocols. Forms, instructions and links to related sites can be accessed through the CCI website at www.aecom.yu.edu/home/cci.

Review by the CCI is very thorough, and applications coming before the full Committee must be submitted at least 12 working days prior to the meeting. Detailed information and applications for CCI approval with complete instructions are available from the CCI office at room 1002, Belfer, ext. 2237

Animals in Research

The care and use of animals is governed by the Guide for the Care and Use of Laboratory Animals (National Research Council) and Public Health Service policies, as well as New York State and New York City guidelines. The Animal Institute Committee (AIC) serves as the federally mandated Institutional Animal Care and Use Committee for the Albert Einstein College of Medicine. The AIC oversees use of vertebrate animals for research and teaching, establishes policies for ethical animal use, approves all protocols using experimental animals, investigates all reports of potential animal mistreatment, and oversees animal husbandry and veterinary care provided by the Institute for Animal Studies. Protocol forms for AIC review can be obtained in the AIC offices in 1105 Ullmann and should be submitted at least 30 days prior to the grant submission deadline. Protocol forms are available to be downloaded from the AIC website at http://www.aecom.yu.edu/home/mousehouse. The AIC oversees training of faculty, students and staff in the use of experimental animals, which is provided through small group training sessions, one-on-one training and through the AIC. Please contact the AIC Secretary at ext. 3572 regarding the schedule of training seminars.

The Institute for Animal Studies (IAS) provides housing, husbandry services and veterinary care for all living vertebrate animals used at AECOM. Veterinarians are available for consultation regarding design of experiments using animals and may, when appropriate, participate as collaborators in animal-based research. Veterinarians are available for consultation regarding issues of animal health and welfare 365 days per year and may be contacted after hours through AECOM security, 430-2019. Additional information may be obtained through the IAS office, room 1005 Ullmann, extension 430-3571, and through the website.

Chemical, Radioactive, Biological and Other Hazards in Research

The Environmental Health and Safety Department (EH&S), is responsible  for maintaining a safe work environment at the College. EH&S must approve all research applications that utilize hazardous materials (e.g., chemicals, biohazards, and radionuclides). The activities of EH&S are carefully supervised by four faculty committees. These are the Institutional Biohazards Committee, Chemical Hazards Committee, Non-Human Use Radiation Safety Committee and the Human Use Radiation Safety Committee. The EH&S department and the faculty safety committees insure that activities involving hazardous materials are conducted  safely and in conformance with Federal, State, and City regulations. For further information, including specific regulations and dates of workshops concerned with safety, contact EH&S in room 800, Forchheimer, ext. 4150, or consult the website at www.aecom.yu.edu/ehs.

Renovations and Structural Changes

All research projects that will require laboratory and office renovations or structural changes must be approved by the Department Chairman and by the Associate Dean for Scientific Operations, room 302 Belfer, ext. 3357, prior to submission. As it is not possible to make such alterations on short notice, advance planning and budgeting are essential.

Industry-Sponsored Research

Laboratory research funded by private industry must be approved by the Office of Industrial Liaison (OIL), room 302, Belfer. All agreements with industry must be negotiated by OIL and approved by the Dean. As research sponsored by industry incurs the same overhead costs as research funded by the National Institutes of Health, privately funded research budgets must bear the same overhead rates as specified in the Department of Health and Human Services agreement with AECOM. Exceptions may be made for small projects with limited budgets. The College's policy in this regard may be obtained from Grant Accounting or at www.aecom.yu.edu/home/finance/indirect_cost.htm. Faculty members are required to review such projects with the Director of OIL prior to any substantive discussion with an industrial firm. Clinical trials funded by pharmaceutical companies must be approved by the CCI and university counsel according to the principles described in the section on "Human Subjects."

Conflicts of Interest

To ensure that research at AECOM will not be influenced by a relationship between the College or the investigator and a commercial enterprise, AECOM has adopted a Conflict of Interest Policy that requires disclosure to the Dean by faculty of all such relationships. This policy can be found on page III-59.

Patents and Copyrights

All faculty members, trainees, students and staff are subject to the College's Policy on Patents and Licensing Agreements. Faculty members and trainees receive a copy of this Policy and are required to sign an agreement accepting its provisions. The Policy, which was written to conform to NIH regulations, mandates that all inventions that are related to work at the College must be disclosed to the Patent Committee and assigned to AECOM. If the Dean decides to patent and/or license the invention, two-thirds of the net income from such inventions are returned to the inventor in the form of both direct remuneration and research support. A copy of the Patent Policy can be found on page III-46. For additional information, consult the Patent Committee, room 302, Belfer, ext. 3357, or consult the website at http://www.aecom.yu.edu/home/biotechnology/