Please know that a formal determination from CUHS is required before the research can begin, even with studies that are determined to be “exempt”. More information on how to submit a study may be found here.
So that you may properly prepare to conduct human subjects research, the IRB will offer three Spring 2016 training sessions for undergraduates. This training is designed to help you develop a proposal that minimizes risk and to guide you on completing templates for the protocol and informed consent documents. Training in the ethics of human subjects research is included. Click for dates and locations.
The Department of Health and Human Services and the National Institutes of Health (NIH) have released two proposals to increase the transparency of clinical trials via information submitted to ClinicalTrials.gov, a publicly accessible database operated by the National Library of Medicine (NLM), part of the NIH. Click here for more information.
IRB experts are available during these open information sessions to answer any questions about both the ESTR system and IRB review requirements. Please consider bringing a laptop to the session for more efficient assistance. Read more about Drop-In ESTR Training
If you are conducting human subjects research and your position at Harvard is one of the following, FAS policy requires you to have a PI-eligible faculty member sponsor your project*: Read more about Do You Need A Faculty Sponsor?