OFFICE OF SCIENTIFIC AFFAIRS AND BIOTECHNOLOGY

RESEARCH RELATED POLICIES AND PROCEDURES

SUNY, DMC and RF Policies Relating to the Conduct of Research

The following is a summary of existing policies and procedures of the State University of New York, Downstate Medical Center and The Research Foundation of State University of New York that relate to and support the Center's research programs.

AFFIRMATIVE ACTION AND EQUAL EMPLOYMENT OPPORTUNITY

The Research Foundation of State University of New York and Downstate Medical Center have been and continue to be genuinely committed – in practice and spirit – to the principles of Equal Employment Opportunity and Affirmative Action. Affirmative Action requires the institution to conduct outreach activities to identify qualified candidates among minorities, women, the handicapped, special disabled veterans of the Vietnam era, so that they may be considered among other candidates for positions to be filled within the organization.

The Center's Affirmative Action program is a reaffirmation of that commitment to carry out recruiting, hiring, training, transfers, pSeptember 20, 2007o work practices without regard to race, color, religion, sex, age, or national origin except where sex is a bona fide occupational qualification. This program reflects the requirements as set forth in Federal and State statutes, guidelines, and regulations and assigns responsibility for their implementation.

Documents available in the Office of Opportunity and Diversity (ADMFAC 103):: HSCB Reaffirmation of Affirmative Action and EEO Policies (11/98); HSCB/RF Affirmative Action Plan

CONFLICT OF INTEREST

No officers or employees (including any person employed by, representing or acting on behalf of the Research Foundation, or who is in a significant decision making capacity with respect to the professional, technical or scientific aspects of a program or project conducted or administered through the Foundation) of the Research Foundation should have any interest, financial or otherwise, direct or indirect, or engage in any business or transaction or professional activity or incur any obligation of any nature, that is in substantial conflict with the proper discharge of their duties in the best interests of the Research Foundation. A conflict of interest is also any financial interest that will, or may be reasonably expected to, bias the design, conduct or reporting of sponsored programs.

All real, apparent or potential conflicts of interest as defined under the guidelines must be disclosed for review and determination as to whether a violation of this policy exists.

Faculty and staff of the State University of New York are encouraged to foster an atmosphere of academic freedom by promoting the open and timely exchange of scholarly knowledge independent of personal interests. In keeping with this obligation, they are also required to avoid conflicts of interest. In instances where potential or actual conflicts exist, faculty and staff are expected to consult with appropriate University officers and abide by the University policy. It is the responsibility of campus officials charged with implementing this policy to identify potential or actual conflicts of interest and take appropriate steps to manage, reduce or eliminate them.

SUNY faculty and staff:

may not engage in other employment which interferes with the performance of their professional obligations;
are expected to comply with the New York State Public Officers Law provisions on conflict of interest and ethical conduct;
to the extent required by law or regulation, shall disclose [go to: SUNY 2 Financial Disclosure Form] at minimum whether they (and their spouses and dependent children) have employment or financial interests or hold significant offices, in external organizations that may affect, or appear to affect, the discharge of professional obligations to the University.

Documents available in the Office of Scientific Affairs (BSB 2-71E):: RF Board of Directors Resolution 95-5; DMC Conflict of Interest Policy and Procedure (9/95); Policies of the SUNY Board of Trustees (Article XI, Title H, Section 4); Resolution of the SUNY Board of Trustees (6/27/95); NYS Public Officers Law (Section 73, 73-a, and 74)

FREEDOM OF PUBLICATION

State University of New York research investigators have the right to publish the results of their research. No research grants or contracts that prohibit or restrict this right to publish will be accepted by the Research Foundation on behalf of the University. Patent rights (especially in foreign countries) may be jeopardized by premature disclosure. Assistance regarding the timing of publication may be obtained from Downstate's Office of Scientific Affairs (BSB 2-71E / 270-2680) or the Foundation's Technology Transfer Office (518-434-7167).

Documents available in the Office of Scientific Affairs (BSB 2-71E):: SUNY Board of Trustees Resolution TR-66-258

MISCONDUCT OR FRAUD IN ACADEMIC RESEARCH

Scientific research must be carried out in accordance with the highest ethical standards. Impropriety of any type in the conduct of research is abhorrent to the inherent purpose of all scientific inquiry: the discovery and dissemination of truth. The academic community cannot condone plagiarism, fraud, lying, or other types of wrong-doing in the conduct of scientific research. Such activities seriously undermine the moral foundations of our institutions, the idea of scientific research, and the public's trust in the personal integrity of biomedical scientists. The faculty and administration of SUNY Downstate Medical Center are committed to sustaining and encouraging an environment of creativity commensurate with the highest ethical standards of scientific research.

Documents available in the Office of Scientific Affairs (BSB 2-71E):: DMC Institutional Guidelines for the Review of Alleged Scientific Misconduct (6/98)

PATENT & COPYRIGHT

In general, the Research Foundation on behalf of SUNY, reserves ownership of all inventions which are made using State University of New York facilities. Therefore, an investigator using University facilities who discovers an idea, process, or device which may be patentable is required to disclose that invention promptly through the campus research office, using forms provided. Assistance from the Research Foundation's Technology Transfer Office is available to the inventor in preparing necessary documentation and following appropriate procedures to protect patentable rights. Each invention is evaluated for patentability and marketability and a patent application is prepared when appropriate. Licensing and option agreements and research contracts are arranged with companies. These activities are carried out for both the University and the Research Foundation through the Research Foundation's Technology Transfer Office.

Generally, principal investigators retain all rights to copyright and publish works they have written. However, in cases in which researchers are employed, or directed within the scope of their employment, to produce specific work subject to copyright, the Research Foundation will have the right to publish such work without copyright or to copyright it in its own name. Copyrights will also be subject to any contractual arrangements contained in the sponsored agreement which supports the research program under which the material is prepared.

Documents available in the Office of Scientific Affairs (BSB 2-71E):: Policies of the SUNY Board of Trustees (Article XI, Title J)

USE OF HUMAN SUBJECTS

Downstate Medical Center is guided by the ethical principles regarding all research involving humans as subjects, as set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Ethical Principles and Guidelines for the Protection of Human Subjects of Research [the "Belmont Report"], regardless of whether the research is subject to Federal regulation or with whom conducted or source of sponsor support.

All requirements of Title 45, Part 46, of the Code of Federal Regulations (45 CFR 46) will be met for all applicable DHHS-supported research, and all other human subject research regardless of sponsorship, except as otherwise noted in the Center's Assurance. Federal (all departments and agencies bound by the Federal Policy) funds may not be expended for research involving human subjects unless the requirements of the Center's Assurance have been satisfied.

When a research project involves the use of human subjects, the Principal Investigator should submit their research protocols to the Chairman of the DMC 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, revision and reconsideration and final approval.

Documents available in the Office of Scientific Affairs (BSB 2-71E):: DMC Federal Wide Assurance of Compliance with DHHS Regulations for the Protection of Human Research Subjects; DMC Principal Investigator Guide for the Use of Human Subjects

USE OF LABORATORY ANIMALS

Consistent with the Public Health Service and U.S. Department of Agriculture guidelines on the Humane Care and Use of Laboratory Animals and the Downstate Medical Center 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 undertake the wide variety of existing and planned research programs involving animals. This requirement is applicable to all uses of animals regardless of the source, internal or external, of support, or the location of the animal, in the DLAR or departmental facilities.

Specifically, the PHS Policy requires that all applications submitted to PHS which involve the care and use of live vertebrate animals must contain the following information (Research Plan/Section-f of the PHS Grant Application Form 398):

identification of the species and approximate number of animals to be used
rationale for involving animals, and for the appropriateness of the species and numbers to be used
a complete description of the proposed use of the animals
assurance that discomfort and injury to animals will be limited to that which is unavoidable in the conduct of scientifically valuable research, and that analgesic anesthetic and tranquilizing drugs will be used when indicated and appropriate to minimize discomfort and pain to animals; and
a description of any euthanasia method to be used.

Documents available in the Office of Scientific Affairs (BSB 2-71E):: DMC Assurance of Compliance with PHS Policy on Humane Care and Use of Laboratory Animals (7/07); DMC Principal Investigator Guide for the Care and Use of Laboratory Animals

RECOMBINANT DNA/BIOHAZARDOUS MATERIALS

Consistent with the National Institutes of Health "Guidelines for Research Involving Recombinant DNA Molecules" and the Centers for Disease Control-National Institutes of Health "Guidelines for Biosafety in Microbiological and Biomedical Laboratories," all uses of recombinant DNA molecules, all organisms and viruses containing recombinant DNA and all microbiological and biomedical uses of the Human immunodeficiency Viruses and other pathogens at Downstate Medical Center must be approved by the Institutional Biosafety Committee.

When a research project involves the use of recombinant DNA molecules or other pathogens, the Principal Investigator should submit their research protocols to the Chairman of the DMC Institutional Biosafety Committee prior to the sponsor's deadline. Early submission of the protocol to the committee is advisable to allow time for any necessary clarification, revision and reconsideration and final approval.

Documents available in the Office of Scientific Affairs (BSB 2-71E):: HSCB Principal Investigator Guide for the Use of DNA and Infectious Materials (in preparation)