1. Common Rule

2. Federal Regulations
First major change to the research regulations since 1981
Released on January 19, 2017
Effective and implementation date of January 18, , 2019
Intended outcomes are to increase efficiency and decrease burden on investigators
Common rule is a set of federal regulations agreed upon by 17 agencies to follow the same standards.
FDA is not part of the common rule.

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
Current Regulations
2019 Regulations
Continuing review is required for all non-exempt studies at a maximum of 12 months, no matter the risk level.
Full review of all criteria for renewal must be evaluated each year.
Certain projects qualify for an abbreviated continuing review.
Research originally approved as expedited.
Research approved with limited IRB review
Research that has progressed to the point that it involves one or both of the following
Data analysis only
Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.
For applicable studies, only the following information will be collected at continuing review: CITI certification, updated CV/biosketch, status of enrollment, minor deviations that have occurred, and any change in COI.

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