1. August 2018 Sandy Gibson Chair, IRB
Key Changes to the Common Rule – Regulations for the Protection of Human Subjects 45 CFR 46
August 2018
Sandy Gibson
Chair, IRB

2. Final Revisions to the Common Rule
The 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 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:

3. 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 research involving external collaborators

4. 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

5. Changes to Continuing Review
Continuing review is eliminated for studies reviewed via expedited review
The IRB can require continuing review for a study if there is cause
Also eliminated for full board projects once subject interaction is complete
Amendments and Adverse Event/ORIO reports are still required
Investigators will receive annual reminders about submitting amendments, AE/ORIOs and termination reports

6. Self-Determination
Researchers may be able to self-determine if their research is exempt from IRB review through the iMedris system.
TCNJ hopes to incorporate this self-determination in the near future.
Currently, when a researcher applies for self-deteremined exemption, there will still be IRB review to monitor and assess the accurate use of this new category.
Once review indicates accurate use of this designation, TCNJ will look towards allowing a formal, active self-determination category with auditing.

7. Exemption Changes

8. Exemption 1 – Educational Exemption
What’s new?
Now must consider “adverse affects” on student learning of required educational content or on assessment of educators
Self-exemption permitted, except where research involves access to student education records under FERPA

9. 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)
Self-exemption is permitted if information is not identifiable or not sensitive

10. 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

11. Exemption 3 – Benign Behavioral Interventions
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)

12. 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
Self-exemption permitted for projects that do not involve deception and where information collected is not identifiable or not sensitive
“Limited IRB Review” required for projects collecting sensitive and identifiable data

13. 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

14. 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 privacy board review)
No self-exemptions

15. 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

16. Exempt Human Subjects Research Decision Trees
Last Updated: 09/27/17
Exempt Human Subjects Research Decision Trees
Educational Exemption (#1)
Survey, Interview or Observation of Public Behavior (#2)
Benign Behavioral Intervention (#3)
Secondary Use, No Consent or Broad Consent (#4, 7 & 8)
Children
Yes No
Comprehensive IRB review
Children No
Yes
Educational tests or observation w/o interaction
Comprehensive IRB review
Identifiable data
Sensitive Data
IRB Limited Review
Surveys, interviews, tests, or observations
IRB Determined
Self-determined
PHI
Yes No
Not Regulated
Identifiable data
Only PHI
IRB Determined
Publicly available
Recorded w/o identifiers
Government collected data
Identifiable research data or non-research data
IRB Limited Review
Comprehensive IRB review
IRB Determined
Yes No
Self-determined
FERPA or PHI
Comprehensive IRB review
Adverse impacts on students or teachers
Normal education practices
Established education setting
Benign behavioral interventions No
Comprehensive IRB review
Yes No
Yes
Has deception
Deception Disclosed
Comprehensive IRB review
IRB Determined or
IRB Limited Review if identifiable, sensitive data
Identifiable data
Yes No
IRB Determined
Self-determined
PHI
Sensitive Data No
Yes
IRB Limited Review
IRB Determined
Self-determined
PHI
Has broad consent

17. Informed Consent Changes

18. Informed Consent Changes
Provide a “concise and focused presentation of key information” up front
Key information:
Voluntary participation
Summary of research procedures
Risks
Benefits
Brief social/behavioral consent documents may already meet this requirement
New templates will be available on the IRB website this fall

19. 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

20. Broad Consent for Future Research using Identified Data or Biospecimens
New provision 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

21. 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.”
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.”

22. Single IRB Review Requirement
Requires that all federally-sponsored research with multi-institutional collaborators be reviewed by one designated IRB of Record
Not required until January 2020 for federally funded research
TCNJ is adopting this now for all non-federally funded research
Note: NIH Single IRB (sIRB) requirement for federally funded research
is effective as of January 2019

23. Changes to eResearch Application
Change to iMedris questions
Addition of Exemption Screener page
Change to Exemption detail pages
Disqualifying response moves to next question in the full review path rather than sending back to select a new application type
New Secondary Use application path for all projects involving only secondary analysis of data/specimens
Changes to Informed Consent/Child Assent selections
Changes to Waiver of Informed Consent and Waiver of Documentation criteria

24. Timeline for Transition
The new rule is effective January 21, 2019* for federally funded research
Federally funded research approved on or after January 19 must be compliant with new rules
Federally funded projects approved before January 19 will be approved under current rule
TCNJ has decided to implement the new rule for all non-federally funded research starting August 27, 2018.

25. TCNJ Common Rule Resources
Check the HRPP Common Rule & Other Changes website for updates
Important dates
Changes to institutional policies and procedures
Send questions/comments to the IRB
Check the IRB website throughout the fall
Updated IRB guidance materials and case studies
New informed consent templates and guidance
Schedule of information sessions

26. Federal Common Rule Resources
Federal Policy for the Protection of Human Subjects, Text of New Rule
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 Guidance

27. 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 1/29/2019)
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:

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

29. IRB Contact Information
IRB Chair
Sandy Gibson
IRB Vice-Chair
Tamra Bireta
IRB Faculty Members
School of Education
Maureen Connolly
Tabitha Dell’Angelo
Sandy Gibson
School of Science
Danielle Guarracino
Steffen Marcus
School of Humanities & Social Sciences
Diane Bates
Tamra Bireta
HeLen Chung
School of Nursing , Health & Exercise Science
Avery Faigenbaum