As of January 21, 2019, studies initiated on or after that date are expected to comply with all Revised Common Rule requirements for the remainder of the study including:
1) removal of the requirement for Institutional Review Boards (IRBs) to review grant applications and contract proposals related to research (see NOT-OD-19-055)
2) a new requirement for clinical trial informed consent documents to be posted on a public federal government website;
3) changes to categories of research that qualify for an exemption;
4) removal of the requirement for annual IRB reviews for certain categories of research.
Please see NOT-OD-19-050 for reference.
1) removal of the requirement for Institutional Review Boards (IRBs) to review grant applications and contract proposals related to research (see NOT-OD-19-055)
2) a new requirement for clinical trial informed consent documents to be posted on a public federal government website;
3) changes to categories of research that qualify for an exemption;
4) removal of the requirement for annual IRB reviews for certain categories of research.
Please see NOT-OD-19-050 for reference.