Announcement: Revised Common Rule

As of January 21, 2019, the Federal government has fully implemented revisions to The Common Rule (45 CFR 46) for the protection of human subjects. As a result, major updates to our IRB and ERC's policies and procedures, forms, and instructions were made.

There are now two versions of The Common Rule:

  • 2018 Requirements (Revised Common Rule) – Applies to studies approved on or after January 21, 2019.
  • Pre-2018 Requirements (Former Common Rule) – Applies to all studies approved prior to January 21, 2019.

Marywood University has not implemented all parts of the Revised Common Rule. For instance, exemptions involving the concepts of broad consent and limited IRB review are not being implemented, since no Federal guidance exists for these scenarios. See our Exempt Review policy for details.

NEW FORMSNew forms have been issued and must be used as of their publish dates, as shown below.

Form or Template Must Use On/After This Date
Translation or Interpreter Certifications Form 7/10/2020
Professional Review, Deviation, Determination Request and Adverse Event/Unanticipated Problem Forms 3/24/2020
Revision Request Form 3/6/2020
Closure Report Form 2/26/2020
Annual Check-In or Continuing Review Form 2/26/2020
ERC and IRB Informed Consent Form, Parent Permission, and Child Assent Templates 10/23/2019
ERC and IRB Application Forms 9/3/2019
IRB Member Reviewer Guide 9/3/2019

 

As of September 3, 2019, we have eliminated IRB six-month status reports and have updated eighteen polices which were affected by the Revised Common Rule. Each policy indicates the last revision date at the bottom of its web page.

CITI Training - Responsible Conduct of Research Change

The Policy Committee of the University had eliminated the requirement for all investigators and research advisors to complete CITI's Responsible Conduct of Research (RCR) training in May of 2018 (See the Institutional Policy and our Mandatory Training Policy). The RCR course is now only required of investigators and research advisors who will seek certain Federal funding (e.g. NIH, NSF, USDA, etc.). All investigators and research advisors will still need to complete a Human Research course appropriate for their discipline.