Updating Research Regulations: Common Rule Changes 2018-2019

1. Common Rule 2018 2019

2. Federal Regulations • First major change to the research regulations since 1981 • Released on January 19, 2017 • Effective and implementation date of January 18, 2018 21, 2019 • Intended outcomes are to increase efficiency and decrease burden on investigators

3. Common Rule 2017 OHRP FDA

4. Common Rule 2019 OHRP FDA

5. Additional Consent Form Requirements • Succinct summary of information that a reasonable person would want to make an informed decision about participation • A statement that identifiers might be removed from the identifiable private information or biospecimen, and that after such removal, the information or biospecimen could be used for future research studies or distributed to another investigator for future research studies without additional informed consent.

6. Additional Consent Form Requirements • If applicable, a statement that the subject’s biospecimen(even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit. • If applicable, a statement whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions. • If applicable, for research involving biospecimens, whether the research may include whole genome sequencing.

7. Continuing Review Changes

8. Use of Single IRB • Currently optional, but often encouraged • NIH policy will required single IRB after January 2018 • Other federal sponsored studies will require single IRB after January 2020 • Registration and acknowledgement required at Wake Forest.

9. Existing Studies • Discretion of the institution as to when/if existing studies will be modified • Current plan is to leave existing studies under the old regulations • Changes will only be applied to new studies going forward

10. Existing Studies • Some revisions are legal now, some must wait until the final rule takes effect • Revised consent form templates are available • Other changes to the online forms must wait until January 2019

11. Training Schedule • Many training events have been scheduled with department research staff starting in December • Working to schedule a brief presentation at departmental faculty meetings • Other announcements will be posted on the websites and other venues

12. Questions