The Office of Human Research Protections (OHRP) issues the regulations that govern informed consent for federally funded human subjects research, and the JHSPH IRB applies those standards to all human subjects research regardless of funding source. These regulations are referred to as the “Common Rule”.
The Common Rule (CR) became law in 1991. It provides basic elements of informed consent that should be in all consent documents, and additional elements appropriate for some, but not all, research studies. On January 21, 2019, a Revised Common Rule (RCR) becomes law, and it includes changes to the format of the consent form templates, the basic elements, and the additional elements. All elements, from the CR and the RCR, are listed on our Informed Consent Elements Guidance. All human subjects research applications approved after January 21, 2019, must conform to the new regulatory requirements. The JHSPH IRB will maintain two sets of consent templates: the CR templates, which studies approved before January 21, 2019 may use; and the RCR templates required for all studies approved after January 21, 2019.
New Applications submitted to the JHSPH after January 1, 2019 must use the RCR Templates. If you submit a new application on the CR templates, IRB staff will return the application to you so that you can submit your consent documents on the RCR Templates. Note: New Applications submitted before January 1, 2019, but are not approved before January 21, 2019, must submit consent forms on the new RCR templates before final approval.
Applications Approved Prior to January 21, 2019 (e.g., most likely to be currently approved research applications) may continue to use CR Templates for study amendments. We encourage researchers who submit amendments for currently approved studies to use the RCR Templates as well.