InfoEd no longer automatically sends emails reminding study personnel on COMIRB-approved protocols to recertify their human subjects training through CITI when their certification is close to expiring.
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.
The FDA updated Form 3629 (Individual Patient Expanded Access Investigational New Drug Application) and related guidance documents (e.g., Guidance on Expanded Access to Investigational Drugs for Treatment Use, June 2016) in October, 2017.
The U.S. Food & Drug Administration has released a new guidance document titled “IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects.”