OFFICE OF SCIENTIFIC AFFAIRS AND BIOTECHNOLOGY

RESEARCH INTEGRITY AND COMPLIANCE

"State University of New York Downstate Medical Center (SUNY DMC) is proud of its long tradition of ethical and responsible conduct and is committed to continuing to conduct its business lawfully and ethically. Each member of SUNY DMC, including all employees, faculty and members of the College Council, is expected to adhere to this high standard whenever he or she acts on behalf of SUNY DMC. This includes, but is not limited to, when dealing with other employees, with patients and their families, with vendors, with government regulators, or with the general public. Violations of legal or ethical requirements jeopardize the welfare of SUNY DMC, its employees and patients, and the communities it serves." [HSCB Corporate Compliance Program]

Compliance with campus, State and Federal policies and regulations in the conduct of research is a major responsibility of all investigators and their staff as well as the institution itself. This involves a knowledge and understanding of these policies and regulations, through on-going investigator education programs, sufficient to ensure performance, in accordance with the highest ethical standards, of their responsibilities and activities.

The core areas of Downstate's research compliance program and the relevant campus policies include:

Use of Human Subjects in Research (Institutional Review Board)
Includes issues such as the definition of human subjects research, ethical principles for conducting human subjects research, informed consent, confidentiality and privacy of data and patient records, risks and benefits, preparation of a research protocol, institutional review boards, adherence to study protocol, proper conduct of the study, and special protections for targeted populations, e.g., children.

DHHS Office for Human Subject Protection
Other human subject protection resources

Use of Animals in Research (Institutional Animal Care and Use Committee)
Includes issues such as definition of research involving animals, ethical principals involving the use of animals in research, federal and state regulations governing such use, institutional animal care and use committees, and treatment of animals.

PHS Office of Laboratory Animal Welfare
Other animal subject protection resources

ALLEGATIONS OF RESEARCH MISCONDUCT
Includes issues such as fabrication, falsification and plagiarism, error vs. intentional misconduct, institutional misconduct policies, identifying misconduct, procedures for reporting misconduct, protection of whistleblowers, and possible outcomes of investigations.

Downstate Medical Center - Review of Alleged Scientific Misconduct Policy
DHHS Office of Research Integrity

CONFLICT OF INTEREST
Includes issues such as conflicts associated with collaborators, publication, financial conflicts, obligations to other constituencies, and other types of conflicts.

Downstate Medical Center Conflict of Interest Policy
NIH Conflict of Interest Policy
Downstate Financial Disclosure Form

U.S. EXPORT CONTROL LAWS and REGULATIONS
U.S. federal government laws and regulations require federal agency approval before the export of controlled items, commodities, technology, software or information to restricted foreign countries, persons and entities (including universities).

The federal definition of an export is any item (includes, but is not limited to, commodities, software or technology, retail software packages and technical information) that is sent from the U.S. to a foreign destination; to anyone outside the U.S., including U.S. citizens to foreign entities, individuals, embassies or affiliates at any location, including the U.S.

The Research Foundation's Technology Control Plan (TCP) outlines the procedures that will be used to prevent the unauthorized export of and/or access to controlled items, technology or data. This template should be used by principal investigators and staff to develop a Plan when it appears that there is a need to export a covered "item."

Please contact the DMC Office of Scientific Affairs for additional information, 718-270-2680.

Research Foundation's Export Controls Overview for Principal Investigators

U.S. SELECT Agent Laws and Regulations
Select Agents are pathogens or biological toxins which have been declared by the U.S. Department of Health and Human Services or by the U.S. Department of Agriculture to have the "potential to pose a severe threat to public health and safety". The Centers for Disease Control administers the Select Agent Program, which regulates the laboratories which may possess, use, or transfer select agents within the United States. The Select Agent Program was established to satisfy requirements of the USA PATRIOT Act and the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.

Select Agent Program requirements include:

1.The possession, transport and acquisition of Select Agent organisms and specified quantities of toxins requires registration with Health and Human Services (HHS) Centers for Disease Control (CDC) prior to possession. If you possess Select Agents OR intend to perform future research or work involving any Select Agent, you must immediately inform the DMC Institutional Biosafety Committee, or call 718-270-2680, so that appropriate arrangements can be made.
2.The US Patriot Act of 2001 established eligibility criteria for persons who have possession and/or access to the biological agents and toxins known as "Select Agents."
3.The intended use of all biological agents and Select Agents in particular, requires university registration with the Institutional Biosafety Committee (IBC). Registration with DMC's IBC assists the investigator in understanding these regulatory requirements, avoiding liability and fines and ensures the safe use of the agents.

National Select Agent Registry (DHHS/CDC & USDA/APHIS)
DHHS and USDA Select Agent and Toxin List

Data acquisition/management/sharing/ownership
Includes issues such as defining what constitutes data, keeping data notebooks or electronic files, data privacy and confidentiality, data as legal documents and intellectual property including copyright laws, and data selection, retention, sharing, ownership and analysis.

Mentor/trainee relationships
Includes the role of a mentor, responsibilities of a mentor, conflicts between mentor and trainee, collaboration and competition, selection of a mentor, and abusing the mentor/trainee relationship.

Publication practices and responsible authorship
Includes issues such as collaborative work and assigning appropriate credit, acknowledgements, appropriate citations, repetitive publications, fragmentary publication, corrections and retractions, conventions for deciding upon authors, author responsibilities, and the pressure to publish. Peer review Includes issues such as the definition of peer review, impartiality, how peer review works, editorial boards and ad hoc reviewers, responsibilities of the reviewers, privileged information and confidentiality.

Collaborative science
Includes issues such as setting ground rules early in the collaboration, avoiding authorship disputes, and the sharing of materials and information with internal and external collaborating investigators.

A comprehensive investigator education program for these and other possible areas, to include the dissemination of applicable materials, is being developed in conjunction with the School of Graduate Studies, the College of Medicine, the Office of Scientific Affairs, the Institutional Review Board and the Institutional Animal Care and Use Committee. Until this plan is complete, the investigator education programs currently in effect (see above links) will satisfy existing requirements. Questions regarding these should be directed to the Office of Scientific Affairs.

Frequently Asked Questions regarding research compliance / ethics issues

Helpful LINKS to other research compliance information sources