1. Understanding the Planned Changes to the Federal Policy on Protection of Human Subjects (the Common Rule)
Megan Kasimatis Singleton, JD, MBE, CIP
Assistant Dean for Human Research Protections
Director of the Human Research Protection Program
IRB Open House
May 11, 2018

2. History of Rule Development
Revisions to Common Rule were initiated in 2011 with an ANPRM
September 2015 NPRM was released
Generated large public response
Rule felt to be incomplete and confusing
Included provisions thought to have a negative impact on research
Final rule: Published January 19, 2017
Planned Effective Date: January 19, 2018
Planned Compliance Date for most provisions: January 19, 2018 [Exception: Single IRB review requirement for cooperative research: January 20, 2020]

3. Status of the Effective Date [Cont.]
January 17, 2018: Interim Final Rule published – extends both the effective and compliance date to 7/19/2018
human-subjects-delay-of-the-revisions-to-the-federal-policy-for.
Purpose of the Delay:
Provide additional time for guidance about the rule to be published
Provide organizations subject to the rule more time to prepare to implement the changes
**Note: There are plans to develop a new NPRM to seek comment on a proposal for further delay in the required implementation of the revised Common Rule. [e.g. to January 2019]

4. Status of the Effective Date (Cont.)
New Notice of Proposed Rulemaking released 4/20/2018 with a public comment period ending 5/21/2018
May delay implementation of the rule to January 2019 [or longer]
It is possible that implementation of select provisions would be permissible as early as July 2019

5. Key areas of change in the Final Rule
Key Changes outlined in the New Final Rule
Expansion of the definition of research to exclude certain types of activities [e.g. public health surveillance]
Expansion of research activities that qualify for exemption
Introduces concept of “limited IRB review” with certain exempt categories
Eliminates requirements for continuing review in certain cases
Eliminates requirement for grant vs. protocol review by the IRB
Requires posting of consent forms for clinical trials
Changes to required formatting of consent to require that “key information” be listed first
New required/optional elements of consent
Adds a new required element for consent waivers [when research involves identifiable data or biospecimens]
Allows for new broad consent option but the IRB may not grant a waiver if a participant says “no” – JHU will not utilize this option

6. Where are we now?
JHU IRBs have a preliminary plan to adhere to the new requirements
Much of the “work” in adhering will fall on the IRB offices
We are awaiting guidance from OHRP on several key areas of change
Over time there will be new/different questions in the eIRB application to gather information needed to apply the new rule & new language in IRB letters communicating the IRB’s decisions.
As new guidance is released, educational sessions will be offered

7. NEXT STEPS
JHU IRBs will work to revise policies, procedures, and submission systems to accommodate the rule changes
Please Note: New Rule will apply to all studies that are initially approved on/after the effective date [Currently July 19, 2018]
IRB websites will be updated with any new information
New Consent Template scheduled for release this summer
Currently the existing Common Rule remains in effect and must be applied to all research

8. DISCUSSION
Questions?