Office of Research and Development at The Queen's Medical Center

The revisions to the Federal Policy for the Protection of Human Subjects (also known as the “Common Rule”) that were originally to go into effect January 19, 2018, then delayed to July 19, 2018, will now be implemented on January 21, 2019 (with a potential for further delay). Studies approved on or after January 21, 2019 will generally be subject to the Revised Common Rule.

Significant Changes include:

Continuing Review

Informed Consent (See revised ICF Template)

Waivers of consent includes additional requirement (Revised RIRC Form 12):

Broad Consent and "Limited IRB Review"

Posting Clinical Trial Consent Forms