Common Rule 2018 2019

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 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.

Common Rule 2017 OHRP FDA

Common Rule 2019 OHRP FDA

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.

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.

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.

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.

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

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

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

Questions