Gaining Approval for Animal or Human Studies

Prior to performing studies using human subjects, it is essential to first get permission from the MIT Institutional Review Board (IRB). Similarly, animal studies also require prior approval, which is granted by the MIT Committee for Animal Care (CAC).

It is essential that all experiments comply with the specific approved protocols for human and animal studies, even if it is a seemingly small change. It is of great importance to assure that all personnel working on these studies are approved participants.

The purpose of the IRB is to protect human subjects from harm. The review process ensures that prospective subjects fully understand the purpose of the experiment and their role in the experiment. IRBs are needed both for biomedical research and also for studies of psychology and other interactive research. The purpose of the animal protocol is to protect animal welfare.

Applying for an Animal Protocol

All animal studies must be assessed by a team of experts to evaluate the potential impact of the study, the design of the study, and the potential for discomfort of the animal subjects. Dr. Susan Erdman is a veterinarian and is the lead Translational Consultant for Animal studies. She can provide support for translating basic research toward animal studies (either directly or by providing connections to experts).

Applying for an IRB

You can find support for the process of moving from research to human studies from the Translational Consultants, listed above. In addition, Dr. Catherine Ricciardi (Board Certified Nurse Practitioner, Registered Nurse, and Faculty member at Massachusetts General Hospital) and has extensive experience supporting human subject research. Dr. Ricciardi has designed and supported translational research at MIT for over 10 years. Dr. Ricciardi can help you find a path from your research to an IRB, enrollment of human subjects, and sample collection if needed.

Getting Help with your IRB and with your human subjects research:
MIT IMES/Clinical Research Center

MIT’s Clinical Research Center (CRC) was established in 1964 to provide a facility in which the Institute’s expertise in science and engineering could be applied to the study of human physiology and, possibly, to the development of treatments for human diseases.

For the inexperienced, preparing an IRB proposal can be a challenge due to complexities of the proposal process and a need for advice on how to design human subjects experiments. The CRC provides support for all steps of the process, from initial conception of the research approach, to research design, and ultimately to the process of completing the IRB application.

In addition to providing support for IRBs, the IMES CRC also has a laboratory that can be used for simple medical procedures, such as phlebotomy.

Smart IRB for InterInstitute Collaborations

In the past, translational work being done at MIT in collaboration with Harvard required an IRB from MIT as well as an IRB from Harvard. This dual approval process has been a significant barrier to inter-institution collaborations for research on Human Subjects. The Harvard Catalyst developed “Smart IRB”, which enables one IRB to be used at other institutes across the nation. This new Nationally recognized IRB means that researchers who wish to collaborate with other institutes need only to apply for one IRB describing the collaborative work. This change removes a major barrier to studies of human subjects.

Collaborative Opportunities for Biomedical Research and Animal Studies at Tufts

MIT has recently entered into a collaborative agreement with Tufts University and their 32 other partners. Importantly, institutes who have partnered with Tufts are broadly dispersed and include Maine Medical, which is near to populations of Native Americans being helped by the CEHS and MIT Superfund Research Program.

Tufts has a Medical School, a Dental School, and a Veterinary School, making them a great choice for translational studies. In addition, MIT engineers and scientists have access to support from BURN, the biostatistics core at Tufts.

Rapid IRB for Disaster Preparedness

A major goal of the NIEHS is to provide valuable support to our community in cases of disasters. In particular, the NIEHS is supporting research that can be helpful either in immediate response to a disaster or after a disaster to learn about impact and interventions. Please visit the MIT-HSPH DR2 website.

A key barrier to responsiveness in the case of a disaster is the need for IRB approval to perform human studies. In order for a faculty member from MIT to apply their technology, they need permission within days to carry out appropriate research. A new system is under development to enable rapid IRB approval. This new approach involves having researchers develop a general IRB for human studies and to have this on file. Should an occasion arise where a researcher can contribute to response, an addendum can be filed and processed rapidly, on the order of a few days. This makes it possible for researches to contribute to the recovery process following a disaster.