Handbook for Research
Section II: Guidelines for the Conduct of Research
Special Research Concerns
1. Human Subjects
Conducting research involving patients or normal volunteers is a privilege. All human research at the Icahn School of Medicine, whether supported by federal, non-federal or intramural funds, is governed by federal and local government regulations and other ethical considerations that are encompassed in the policies of the Institutional Review Board (IRB). These policies, and the required consent forms, are incorporated into the IRB Policy Guide Manual. The manual is meant both to assist investigators in preparing research applications, and to serve as a guide to all individuals who participate in research on human subjects. An important requirement is that at least one member of the research team must be fully trained in the conduct of such research, and that this individual can and will assume full responsibility for the conduct of the research and mentorship of less experienced co-workers.
An essential aspect of clinical research is the safeguarding of subjects. It is the responsibility of all investigators who conduct research involving humans to familiarize themselves with and abide by all of the relevant guidelines. Copies of the relevant federal regulations and the IRB policy manual are available in the Grants and Contract Office. No research project involving human subjects can be initiated without written IRB approval. Failure to adhere to the regulations is considered scientific misconduct at the Icahn School of Medicine.
The Icahn School of Medicine has a longstanding program for ensuring that experimental animals are treated humanely, and maintained under conditions that keep them as healthy and comfortable as possible. The proper treatment of animals is both an expression of humane feelings and essential for the success of biomedical research. Use of animals that are ill, malnourished, stressed or in great pain can create variables that are not incorporated in the experimental design.
Under the Animal Welfare Act (AWA) and U.S. Public Health Service (PHS) policies, each institution is required to appoint an Institutional Animal Care and Use Committee (IACUC). Charged with assuring compliance with the AWA and with the PHS "Guide for the Care and Use of Laboratory Animals", the IACUC establishes institutional programs for good veterinary care and sets detailed policies for procedures (e.g., euthanasia, anesthesia, and surgery) that will minimize the discomfort or pain of laboratory animals. All research projects involving animals, whether supported by outside (federal, state, or private) agencies or internal funds, require prior IACUC approval and will be subjected to periodic checks. Researchers are encouraged to discuss problems and concerns with members of the IACUC. Non-compliance with the regulations constitutes scientific misconduct, and jeopardizes the use of animals throughout the institution.
It is the responsibility of the principal investigator or laboratory chief to educate, both explicitly and by good example, junior staff and trainees in the proper and humane use of animals. Trainees should also be made aware of sensitive issues involved in the use of animals in research.
3. Hazardous Materials
The rules and precautions that must be observed in the conduct of research involving biohazardous agents are outlined in manuals issued by the Mount Sinai Health System's Chemical Safety, Radiation Safety, and Infectious Control offices. These offices are responsible for developing and monitoring of institutional safety programs. In the day-to-day conduct of research, the principal investigator or laboratory supervisor is responsible for implementing the rules and practices necessary to protect the health of personnel and to avoid contamination of the environment with radioactivity, carcinogens, and other hazardous substances, including infectious agents or potentially harmful recombinant DNA molecules. A particularly important principle is that students, assistants, or inexperienced postdoctoral investigators should not be given tasks involving the use of potentially hazardous agents without explicit instruction about necessary precautions. Even after indoctrination in the proper use of such agents, the work of trainees should be carefully supervised.