Guide to the Updated Regulations for Human Subjects Research

  • Summary
    • The regulations for the protection of human subjects (45 CFR Part 46, known as the Common Rule) have been updated and the changes will go into effect on January 21, 2019
    • The full text of the changes is available online, but they are designed to reduce regulatory burden for minimal risk research. Although there will be several administrative changes “behind the scenes” in the IRB office, we do not anticipate many changes for investigators
  • Changes for Investigators
    • For projects approved prior to 1/21/19:
      • There is nothing to do now. Prior to the project expiration date indicated on your approval letter, submit a status report/renewal (as usual), and at that time we’ll review and transition your project to the updated Common Rule (see below)
    • For projects reviewed after 1/21/19:
      • You will no longer be required to submit annual reviews for minimal risk projects (i.e. you no longer need to submit an annual status update or “renew” your project). Instead, we’ll email you annually to check in and see whether the study is active, but there will no longer be an expiration date associated with your project
        • Note that any changes to approved research will still need to be reviewed/approved by the IRB prior to implementation (i.e. you still need to submit amendments)
        • Projects reviewed/approved by the full board will still need to be renewed annually
        • There will not be any changes to the IRB application
    • The informed consent template has been updated with some new required elements, including:
      • A section at the beginning with “key information” that will assist a potential subject in understanding the nature of the project and in determining participation
      • for identifiable information, a statement to indicate whether you will remove identifiers and whether de-identified information may or may not be used or shared for future research
  • If you have questions or concerns, please contact the IRB (irb@middlebury.edu; 443-3053) or stop by during office hours