Research Involving Humans, Animals and Biological Materials

Research

Humans

Animals | Biological Materials ]

What’s Essential

Federal regulations (Common Rule 45 CFR 46) and MIT policy require that the Committee on the Use of Humans as Experimental Subjects (COUHES) review and approve all research involving human subjects before any human studies are begun. This includes projects related to the investigation of new drugs; medical, radiological, engineering, physiological, behavioral, sociological, and nutritional studies; projects involving human tissues or blood; and images, questionnaires, interviews, and other procedures. All personnel who participate in studies involving human subjects must successfully complete a COUHES training course. In addition, all studies approved by COUHES require continuing review. If you fail to return the continuing review questionnaire by the deadline, your study will be terminated automatically and research grants related to the study will be suspended.

Why It’s Important

MIT has both legal and ethical obligations to ensure that human subjects used in research are treated  responsibly.

How To Comply

Prior to beginning the study:

  • Submit an application form to COUHES for approval. Although federal regulations permit certain research to be exempt from institutional review, all research involving human subjects at MIT, whether or not exempt under federal regulations, must by reviewed by COUHES
  • Complete the online human subjects training course approved by COUHES. This requirement applies to principal investigators, associate investigators, student investigators, study coordinators, visiting scientists, consultants, laboratory technicians, and assistants. PIs are responsible for ensuring that all staff they supervise on the project have completed the course. Training must be renewed every three years.

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Animals

[ HumansBiological Materials ]

What’s Essential

All research studies and teaching exercises involving the use of vertebrate animals or harvested tissues must be approved by MIT’s Committee on Animal Care (CAC) before activities are performed. The CAC will help you to comply with all applicable federal, state, local, and institutional regulations on animal care. All animal ordering is centrally managed by the Division of Comparative Medicine; a CAC-approved protocol is required prior to animal ordering. This includes off-site contract work such as polyclonal antibody production.

Why It’s Important

MIT has both legal and ethical obligations to ensure that animal subjects used in research are treated  responsibly.

How To Comply

Prior to beginning any study involving animals:

  • Submit a protocol for CAC’s approval. This requirement covers all projects regardless of funding source and includes animal work being conducted off campus
  • Complete the online CAC orientation. Regulations require the CAC to verify that all principal investigators, staff, and students who use animals in research or teaching have received appropriate training to use animals humanely
  • Contact the CAC at 253-9436 for further information

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Biological Materials

[ Humans | Animals ]

What’s Essential

All research studies and teaching exercises involving the use of biological materials including human cell lines, human embryonic stem cells, microorganisms, viruses, viral vectors, nanoparticle-based nucleic acid or drug delivery systems, and recombinant DNA technologies must be approved by MIT’s Committee on Assessment of Biohazards and Embryonic Stem Research Oversight (CAB/ESCRO). All studies involving biological materials must be registered with the CAB/ESCRO and require continuing review and approval. The registration process is centrally managed by the MIT Biosafety Program. The Biosafety Program and the CAB/ESCRO will help you comply with all applicable federal, state, local and institutional regulations and policies on the safe and responsible use of biological materials in research.

Why It’s Important

MIT has both legal and ethical obligations to ensure that all biological research is conducted in accordance with all federal, state, local and institutional regulations and policies.

How To Comply

Prior to beginning any study involving biological materials

  • Submit a Biological Research Registration form for CAB/ESCRO approval. This requirement covers all biological research projects regardless of funding source and includes research conducted off campus.
  • Complete all Laboratory Biosafety training requirements for Principal Investigators, associate investigators, post-doctoral fellows, and students. PIs are responsible for ensuring that all staff they supervise on the project complete all laboratory safety training courses as required. Training requirements are determined by the risks inherent in the proposed research project and materials. If the research project involves the use of human materials then the OSHA BloodBorne Pathogen course, including offer of HBV vaccinations, must be completed. The MIT Biosafety Program will work with investigators to ensure completion of all training requirements.

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