COMIRB has posted two new decision tools to assist investigators in determining if their study requires an Investigational Device Exemption (IDE) or Investigational New Drug (IND) application.
Starting July 1, 2019, COMIRB will require that the Secondary Research Application be used for secondary research submissions, for improved consistency and clarity.
The 2018 Requirements for human subjects protections go into effect (finally!) on January 21, 2018. COMIRB will host a town hall to discuss changes we have made to comply with the new requirements.
We have updated the COMIRB template consent forms to remove lines for subjects' initials from each page and remove lines for an investigator signature.
COMIRB is piloting a new application form for research involving only the collection and analysis of data collected for another purpose, where a waiver of informed consent is requested.
The U.S. Department of Health and Human Services and 15 other federal departments and agencies have announced an Interim Final Rule (IFR) that delays by six months the effective date and general compliance date of the revisions to the “Federal Policy for the Protection of Human Subjects” (also known as the Common Rule) originally published in the Federal Register on January 19, 2017 (82 FR 7149). Most provisions in the revised Common Rule were scheduled to go into effect on January 19, 2018.
Effective Monday, September 5, 2017, COMIRB will only review and approve updates or changes to individuals in the roles of: Principal Investigator, Co-investigator, Primary Contact, or Faculty Mentor.
COMIRB no longer requires a signature line from the Principal Investigator or designated co-investigator on consent and assent forms. The regulations do not require that these lines be present