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
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
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.

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.

NIH Conflict of Interest Policy
SUNY II Financial Disclosure Form

Other Federal / State regulated activities

U.S. Export Control Laws and Regulations
U.S. SELECT Agent Laws and Regulations

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