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If you are unsure whether a project meets the definition of human subjects research, please contact HARC for a determination. This Guidance for Determinations of Human Subjects Research can help you understand the process of making a determination. Not Human Subjects Research (NHSR) determination letters will be provided for researchers to use for publications, funding sources, or any other entity that requests one.
Changes needed for COVID-19?
What criteria does the HSC use to evaluate and approve protocols?
All research projects evaluated by the Human Subjects Committee are reviewed for compliance with applicable local, state, and federal regulations. For Expedited and Full Board categorized studies, at a minimum the Common Rule Regulations would be applied, which include the § 1c.111 Criteria for IRB approval of research. For Exempt categories of research, the HSC applies our institutional policy at a minimum. To find out if there are any other specific requirements for your research, ask the HSC administrator at [email protected] or during HARC Office HoursIf you currently have an active, HSC approved study involving human subjects and you find that to conduct your research in the near future you need to make modifications to the planned implementation of your study, please contact the HARC (Human and Animal Regulatory Committees) office at [email protected] to discuss this with the HSC administrator. All amendments will be fast tracked and can ideally be approved very quickly. If you need to completely halt the part of your study that involves human subject interaction, for the duration of the pandemic, there is no need to amend your protocol, although you might send an email to the HARC office to keep them informed. If you are considering studying the COVID-19 virus itself and its effect on the population, here is a link to some articles on the ethics of performing human subjects research among those experiencing a global health emergency that dwells on some special considerations for such situations.
What if you're working on COVID-19 and your group is completely new to research potentially involving human subjects/tissues/data?
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