Office of Research Administration
Policies and Procedures Involving the Conduct of Research and Sponsored Programs
The following information is contained in the Annual Letter which is distributed to assist the faculty of the University in the preparation and submission of proposals for extramural funding of academic programs. Additionally, it advises faculty that approval through the Office of Research Administration, by a Digest of Terms or official letter is required prior to initiation of any research. The following are additional institutional requirements pertaining to research and to sponsored programs:
Institutional Endorsement Official institutional endorsement is required for all sponsored project applications or research proposals submitted for external funding regardless of whether informal contact with a potential sponsor has been established previously. All proposals, grant applications, and letters which describe a project and request funding must be reviewed and signed by this Office prior to submission. Preliminary letters which are intended only to ascertain an agency's interest in receiving a proposal in a particular area of activity may be sent directly by the faculty; it is advisable to forward a copy to this Office.
Applicant Institution New York Medical College is the sole designated applicant institution for all sponsored project applications submitted on behalf of its faculty. These applications are approved by and submitted through this Office.
Compliance Review and Approvals Government regulations require institutional review and approval of all research involving humans or animals. Additionally, College policies assure compliance with regulatory requirements including those pertinent to research misconduct and conflict of financial interest. Extramurally funded programs, in addition to intramural research, also must comply with the College's internal policies.
Internal protocol and budget review by this Office is necessary prior to submission of an application to the extramural funding agency. Your cooperation in meeting the internal deadline is therefore essential. In general, all applications, with College forms, are due in this Office two weeks prior to the funding agency deadline.
IRB Approval - To protect the rights and welfare of patients and volunteers in clinical research and investigations in the biomedical, behavioral and social sciences, projects involving the following require Committee for the Protection of Human Subjects (IRB) approval:
- Patient records
- Human materials
- New drugs, materials or devices
- New use of an approved drug or material
- Experimental treatments or surgical procedures
- Randomization, including the comparison of approved treatments
New York Medical College applications with study aspects at affiliated hospital sites will be reviewed by the Office of Research Administration to ensure that budgets contain funds to reimburse hospitals for their appropriate costs. For administrative review of requests involving hospital resources related to research, contact the appropriate affiliate office:
| Westchester Medical Center (914) 493-5244 |
Metropolitan Hospital Center (212) 423-6263 |
To expedite the approval process, investigators are encouraged to submit applications to these offices simultaneously with submission to the Office of Research Administration.
The AIDS virus or HIV-infected blood should be identified as "hazardous substances" on the College forms and a description of safety precautions attached for Biosafety Committee review. The same requirement pertains when other hazardous substances (recombinant DNA, pathogenic organisms, carcinogens, etc.) are used in research. HIV Containment Facility - An HIV containment laboratory is available for use in research involving the isolation and cultivation of the AIDS virus. The laboratory is also available for work with specimens containing the virus. Investigators currently preparing proposals that anticipate the use of this facility should contact Dr. Doris Bucher, Department of Microbiology and Immunology (914-594-4189).
Approval by the Animal Care and Use Committee is required before animals may be used in research or teaching; federal and other agencies require certification of this approval in applications. Completion of the vertebrate animal section of the College forms and preparation of a vertebrate animal statement is required before an application proposing the use of animals will be endorsed by the Office of Research Administration. Questions regarding PHS policy may be directed to Catharine Crea, Associate Dean, Director, Office of Research Administration (914-594-4480). Dr. Ellen Levee, Director, Comparative Medicine (914-594-4215), will assist investigators with preparing the vertebrate animal statement.
The vertebrate animal section of the College form reflects federal requirements, for example, information regarding an investigator's search for an alternative to live animals. Additionally, tumor-cell lines previously propagated in rodents must be certified free of contamination with infectious viruses or other agents before use in the central animal facility.
"Guidelines for Ethical Practices in Research and Policies for Dealing with Instances of Alleged Violations of Ethical Standards" is available from the Office of Research Administration. These guidelines meet the regulatory requirements and provide a framework for the College to respond to any allegations that might arise. Specifically, the purpose of these guidelines is to preclude the occurrences of all unethical scientific practices in research including: (1) deliberate falsification or misrepresentation in the proposal, conduct, or reporting of research, (2) pilfering of scientific data and plagiarism in scientific publications, and (3) misappropriations of research funds. The Guidelines also cite recommendations for investigating allegations of unethical scientific practices and outlines procedures for reporting and correcting the consequences of such unethical practices, while at the same time protecting the rights and reputation of investigators.
New York Medical College's policy on conflict of financial interest meets federal requirements and will be applied to all research and other academic activities. The policy requires that the principal investigator/program director and any other person who is responsible for the design, conduct or reporting of a project provide a listing of financial interests and those of his/her spouse and dependent children a) "that would reasonably appear to be affected by the research and b) in entities whose financial interests would reasonably appear to be affected by the research," i.e., does the research affect the value of your holdings or does the research affect the value of the company. Disclosures will be evaluated internally and, if it is determined that there is a potential for a significant conflict of financial interest, the investigator and the College will work to manage, reduce, or eliminate the conflict before the project is initiated. The New York Medical College Conflict of Financial Interest Policy and disclosure forms are available from the Office of Research Administration. Contact Catharine Crea, Associate Dean, and Director, Office of Research Administration (914-594-4480) for additional information.
The Office of Research Administration will continue to be a clearinghouse for all matters relating to the conduct of research or sponsored programs. Please visit this Office, located on the 2nd floor of the Administration Building or call 594-4480 if you need additional information or advice.
