Key Changes to the Common Rule – Regulations for …...Key Changes to the Common Rule – Regulations for the Protection of Human Subjects 45 CFR 46 December 2018 Jenna Brager, PhD,

Key Changes to the Common Rule –Regulations for the Protection of

Human Subjects45 CFR 46

December 2018Jenna Brager, PhD, RN - Director of Clinical Research

Jennifer Berkeley, MD, PhD - IRB Chair

Final Revisions to the Common RuleThe U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have issued final revisions to the Federal Policy for the Protections of Human Subjects (the Common Rule). The Final Rule was published in the Federal Register on January 19. 2017. It implements new steps to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.

~ HHS.gov website

Final revision available at: https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/pdf/2017-01058.pdf

Key Changes• Eliminates continuing review for most minimal risk research• Expands exemption categories and changes the review processes• Reframes informed consent information and adds required

elements• Requires single IRB review of federally-funded research involving

external collaborators (Effective 2020)

What’s not Changing?

Minimal change to IRB review of projects that involve:

• More than minimal risk

• Drugs/biologics/medical devices (FDA-regulated)

• Collection of biospecimens

• Children

• Prisoners

Changes to Continuing Review

• Requirement for continuing review is eliminated for studies approved via expedited review• The IRB can require continuing review for a study

• Also eliminated for full board projects once subject interaction is complete

• Amendments, Adverse Events/Unanticipated Problems must still be reported

• Investigators will receive annual reminders about submitting amendments, Adverse Events/Unanticipated problems and termination

reports

Exemption Changes

Changes to Exemption Review ProcessesProcess• Submit Exempt/QI/QA Applications to [email protected]• Exemption with “limited IRB review” (new regulatory category)

• For projects collecting sensitive, identifiable data, the IRB must review privacy/confidentiality protections (review by an IRB member)

• Standard exempt review by IRB staff member for certain types of exemptions

Exemption 1 – Educational Exemption

What’s new?• Now must consider “adverse affects” on student learning of required

educational content or on assessment of educators

Exemption 2 – Surveys/Interviews/Educational Tests/Public Observation ONLY

What’s new?

• Projects collecting sensitive and identifiable data may be exempt after

“limited IRB review” (for privacy/confidentiality protections)

• Clarifies that the exemption does not apply to projects involving:

• Interventions

• Collection of biospecimens

• Linking to additional personally-identifiable data

• Children (except for educational tests or some public observations)

Exemption 3 – Benign Behavioral Interventions

What’s new?• This exemption is completely new• Limited to research with adults

What is a benign behavioral intervention?• Brief in duration• Harmless and painless• Not physically invasive• Not likely to have a significant adverse impact on subjects• Not offensive or embarrassing

• Information is collected via • Verbal or written responses (surveys/interviews)• Data entry • Observation of subject (including audiovisual recording)

• Does not permit data collection via physical procedures• Physical sensors (e.g. blood pressure monitors, EEG, FitBits)• Minimally invasive procedures (e.g. blood draw or saliva collection)

Exemption 3 – Benign Behavioral Interventions

Exemption 3 – Benign Behavioral Interventions• Must obtain “prospective agreement to the intervention and

information collection” • No deception, except where the subject is told that they will be

unaware or misled about the nature or purposes of the research and they agree• Debriefing still encouraged

• “Limited IRB Review” required for projects collecting sensitive and identifiable data

Examples

• Solving puzzles under various noise conditions • Playing an economic game • Being exposed to stimuli such as color, light or sound (at safe

levels)• Performing cognitive tasks

Exemption 4 – Secondary Research Uses of Identifiable Private Information or Identifiable Biospecimens

What’s new?• No longer limited to retrospective data review• Permits secondary use of identifiable protected health information

(PHI) (with HIPAA waiver or privacy board review)

Exemption 5 – Public Benefit and Service Programs

Public benefit and service programs research and demonstration projects• Expanded to apply to such federally-supported research; no longer

limited to federally-conducted research• Added requirement that Federal agency publish a list of projects

covered by this exemption prior to commencing the research

Exemption 6 – Taste and Food Quality

No Change• Taste and food quality evaluation and consumer acceptance studies

Exemptions 7 & 8 – Storage and Secondary Use of Data/Biospecimens

• Related new exemptions• Exemption 7 covers the storage and maintenance of identifiable data

and/or biospecimens for future research collected under broad consent (i.e. creation of a repository). More on broad consent later…• “Limited IRB review” required to assess the terms of the broad consent

• Exemption 8 covers the use of data or biospecimens collected under broad consent • “Limited IRB review” required to confirm that the proposed use is consistent with

the broad consent and that privacy of subjects and confidentiality of data is appropriate

*At this time, the LBH IRB will not mandate nor implement the institutional use of Broad Consent, as the tracking requirements may be burdensome. This impacts Exemption categories 7 and 8, which rely on Broad Consent.

Informed Consent Changes

Informed Consent Changes

• Provide a “concise and focused presentation of key information” up front• Key information:

• Purpose• Summary of research procedures• Benefits/Risks• Alternative procedures or courses of treatment (if any)

• Brief social/behavioral consent documents may already meet this requirement• New templates will be available on IRBNet and the website

New Informed Consent Elements

• New required consent element • De-identified data or biospecimens may be shared for future research (or not)

• New consent elements (if applicable)• Biospecimens may be used for commercial profit (and whether the subject

will share in that profit) • Clinically relevant results will be returned (or not)• Research will involve whole genome sequencing

Broad Consent for Future Research using Identified Data or Biospecimens

• New provision to for future storage and research use of identified data or biospecimens • Not required for storage and secondary research use of de-identified

data or specimens or for uses consistent with the original informed consent

• New Exemption 7 covers the storage and maintenance of data/specimens collected with broad consent • New Exemption 8 covers the secondary use data/specimens collected with

broad consent

*At this time, the LBH IRB will not mandate nor implement the institutional use of Broad Consent for studies exempt from IRB review, as the tracking requirements may be burdensome. This impacts Exemption categories 7 and 8, which rely on Broad Consent.

Other Consent-Related Changes

• Waiver of informed consent (for secondary use of data)• Must validate why use of identified data is necessary to the research

• For federally-sponsored clinical trials, a copy of the consent form must be posted on a “Federal Web site that will be established as a repository for such informed consent forms.”• Two publicly available federal websites that will satisfy the consent form posting requirement, as

required by the Revised Common Rule, have been identified by OHRP as of August 28, 2018Link: https://www.hhs.gov/ohrp/news/announcements-and-news-releases/index.html

• ClinicalTrials.gov• A docket folder on Regulations.gov (Docket ID: HHS-OPHS-2018-0021).

OHRP defines a clinical trial as: “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effect of the interventions on biomedical or behavioral health-related outcomes.”

Single IRB Review Requirement

• Requires that all federally-sponsored research (not including NIH) with multi-institutional collaborators be reviewed by one designated IRB of Record• Not required until January 2020

Note: NIH Single IRB (sIRB) requirement was effective as of January 25, 2018

Timeline for Transition

• The new rule is effective January 21, 2019*

• Projects approved on or after January 21st must be compliant with new rules

• Projects approved before January 21st will be approved under current rule

• Guidance from OHRP and CITI indicate that studies already approved via full board or expedited procedures (or exempt) prior to the January 21st date are “grandfathered”, meaning that they will not be required to comply with the changes in the revised Common Rule.

Revised Common Rule Resources

Check your LBH email and website for updates• Send questions/comments to [email protected]• New informed consent templates and guidance will be posted to IRBNet and

the research website

OHRP and CITI Resources• https://about.citiprogram.org/wp-content/uploads/2018/07/Handout-3-

Comprehensive-Guide-to-Informed-Consent-Changes-presentation-slides.pdf

• https://www.hhs.gov/ohrp/education-and-outreach/revised-common-rule/revised-common-rule-q-and-a/index.html

Federal Common Rule Resources

• Federal Policy for the Protection of Human Subjects, Text of New Rulehttps://www.gpo.gov/fdsys/pkg/FR-2017-01-19/pdf/2017-01058.pdf

• Secretary’s Advisory Committee on Human Research Protections, August 2, 2017, Letter to the HHS Secretary and Attachments, including:• Attachment B, Recommendations on Benign Behavioral Intervention• Attachment C, Recommendations for Broad Consent Guidancehttps://www.hhs.gov/ohrp/sachrp-committee/recommendations/sachrp-recommendations/index.html

Other NIH Policy Changes and Initiatives –NIH Clinical Trials Initiative

• Intended to “enhance the accountability and transparency of clinical research” funded by the NIH• Registration of research and reporting of results on ClinicalTrials.gov

(effective 1/18/2017)• Good Clinical Practice training requirement (effective 1/1/2017)• Single IRB-of-Record requirement for multisite studies (effective 1/25/2018)

• Clinical trials are broadly defined and may include some basic behavioral studies that manipulate an independent variable to observe a hypothesized modification of a behavioral process• For more information, including FAQs and Case Studies, see:

https://grants.nih.gov/policy/clinical-trials.htm

Other NIH Policy Changes and Initiatives –New Certificate of Confidentiality Policy

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-109.html

• Now a provision for CoC as part of the terms and conditions of an NIH award

• Limits disclosure “identifiable, sensitive“ information

• Information/biospecimens are also considered to be identifiable if there is a very small risk of deductive disclosure

• Includes all identifiable human subjects data, biospecimens, individual level human genomic data, or other research data

• Effective October 1, 2017

• Applies to all NIH-funded research, beginning December 13, 2016 (part of the 21st Century Cures Act)

• NIH will continue to issue CoCs for other research falling under its mission

IRBContact Information

Patty LohinskiIRB Administrator

[email protected]

Jenna Brager, PhD, RNDirector of Clinical [email protected]

Jennifer Berkeley, MD, PhDIRB Chair

[email protected]