The document provides an overview of the Institutional Review Board (IRB) and key changes to IRB regulations and processes taking effect in January 2018. It summarizes the purpose of the IRB in protecting human subjects, defines what constitutes research and human subjects, outlines categories of IRB review including exemptions and expedited review, and describes changes to the definitions and processes for determining exemption and requirements for informed consent.

1. IRB Overview
AIM Analytics
Cindy Shindledecker
Director, IRB-HSBS
November 20, 2017

2. Essential Questions
• What is the IRB?
• When is IRB review required?
• Regulatory Definitions
• “Not Regulated” Research Activities
• Types of IRB Review
• Regulatory and Institutional Changes January 2018
• FERPA and Research with Student Records

3. What is the IRB?
• The Institutional Review Board is responsible for the
protecting the rights and welfare of human subjects involved
in research
• In accordance with ethical principles
• In compliance with federal regulations (45 CFR 46/FERPA),
state law and institutional policies
• The IRB also supports the research mission of the institution
• Two IRBs on Ann Arbor Campus
• IRBMED – Michigan Medicine/FDA-regulated Research
• IRB-HSBS – Academic Campus

4. Key Definitions
(updated in 2018 Common Rule)

5. Research
_.102(l) Research means a systematic investigation, including
research development, testing, and evaluation, designed to
develop or contribute to generalizable knowledge

6. Human Subject
_.102 (e) (1) Human subject means a living individual about
whom an investigator [whether professional or student]
conducting research:
(i) Obtains information…through intervention or
interaction with the individual, or analyzes the
information…; or
(ii) Obtains, uses, studies, analyzes, or generates
identifiable private information…

7. Identifiable Private Information
_.102(e)(4) Private information includes information about
behavior that occurs in a context in which an individual can
reasonably expect that no observation or recording is taking
place, and information has been provided for specific
purposes by an individual and that the individual can
reasonably expect will not be made public
_.102(e)(5) Identifiable private information is private
information for which the identity of the subject is or may
readily be ascertained by the investigator…

8. Research Not Regulated by the IRB
• Program evaluation/quality assurance/quality improvement
• Intended ONLY to assess and improve practice internally rather than for
dissemination outside the institution (not generalizable)
• Secondary data analysis where study team has no access to
individually identified data
• Completely deidentified
• Coded but no one on study team has access to the key to coded identifiers
• IRB review not required but submission of eResearch “Not Regulated”
application suggested for those seeking a formal determination

9. Exempt Research
• Research with human subjects that falls within one or more specific
categories defined within the federal regulations or adopted by
institutional policy
• Presumption of no more than minimal risk
• Requires an eResearch application to validate exemption
• Major changes with new Common Rule
• New or revised exemption categories
• Changes to eResearch application
• Changes to exemption determination processes

10. Changes to Exemption Review Processes for
Interaction/Intervention Exemptions
• Self-determination – smart form questions will allow the investigator to issue a
self-determination letter for some exempt projects
Note – IRB-HSBS will implement a quality assurance process to validate all federal self-
determinations and a random selection of non-federally sponsored projects
• Submit to IRB –
• Standard exempt review by IRB staff member for certain types of
exemptions (e.g. research including access to student records) or by
investigator choice
• Exemption with “limited IRB review” (new regulatory category)
• For projects collecting sensitive, identifiable data, the IRB must review
privacy/confidentiality protections (review an IRB member)
The eResearch questions will direct the application to the correct review process

11. Exemption 1 – Educational Exemption
• Established or commonly accepted educational setting
• Normal educational practices (evaluation of instructional strategies, curriculum
evaluation, assessment of attitudes about learning)
• Does not include research that focuses on personal characteristics of students
or teachers (rather than on educational activity of interest)
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

12. Exemption 2 – Surveys/Interviews/Educational
Tests/Observation of Public Behavior
• Limited to projects that collect information via these methods only
• What’s new?
• Clarifies that the exemption does not apply to projects involving:
• Interventions
• Linking to additional personally-identifiable data
• Projects collecting sensitive and identifiable data may be exempt after
“limited IRB review” (for privacy/confidentiality protections)
• Self-exemption is permitted if information is not identifiable or not
sensitive

13. Exemption 3 – Benign Behavioral Interventions
What’s new?
• This exemption is completely new – similar to Michigan Exemption 2a but more
complex!
• 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

14. 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

15. New Application Type for All Research involving
Secondary Analysis of Data or Biospecimens
• All data/specimen only projects now use one application type (rather than
requiring the investigator to select the correct application type up front)
• Questions designed to route application to the correct IRB determination (not
regulated, exempt, comprehensive IRB review)
• Includes expanded exemption 4 for secondary research of data without informed
consent
• No longer limited to retrospective data review
• applies to projects where identifiable private information is accessed and
viewed but is not recorded
• Example – Student data including personal identifiers is screened but data
elements recorded for research analysis do not include identifiers.
• No self-exemptions

16. Comprehensive IRB Review
(Expedited)
• Research activities that do not qualify for exemption often will qualify for an
expedited review process meaning review by a single IRB member rather than
the full committee
• Expedited research must pose no more than minimal risk to subjects and meets
one or more of 9 federal categories of expedited research
• Category 5 - Research involving materials (data, documents, records, or
specimens) that have been collected, or will be collected solely for
nonresearch purposes.
• Category 6 - Collection of data from voice, video, digital, or image recordings
made for research purposes.
• Category 7 -Research on individual or group characteristics or behavior
• Expedited review categories currently being reevaluated by feds

17. Comprehensive IRB Review
(Expedited)
• One of two application types in eResearch (New):
• Interaction/intervention (combines old standard – for research involving data
collection from subjects
• Must include informed consent documents, recruitment materials,
survey/interviews
• Secondary Use – for research involving secondary data analysis and no direct
interaction with participants
• Section 24 – include description of specific data sets/data elements to be
analyzed as part of research
• Application is pre-reviewed by IRB staff and then by a single board member
• Turnaround typically 2-4 weeks

18. Comprehensive IRB Review
(Full Committee)
• Required for projects that may pose more than minimal risk to
participants, involve sensitive topics or complex research designs
• Reviewed by one of the full IRB committees
• Submitted via Interaction/Intervention or Secondary Use eResearch
application
• Applications must be submitted several weeks in advance of a
scheduled meeting for assignment to a meeting agenda
• 2 meetings per month
• Fewer than 5% of applications reviewed by IRB-HSBS go to full
committee

19. Comprehensive IRB Review
Key Common Rule Changes
• Eliminates continuing review for most project approved via
expedited review and all projects involving data analysis only
• Amendments and incident reporting still required
• Annual system reminder
• Reframes informed consent information and adds required elements
• Concise and focused summary upfront
• New element regarding data sharing
• Adds a requirement for approval of waiver of informed consent
• Must justify requirement for use of identified information

20. Changes to eResearch Application
• Change to Application Type page/path
• Interaction/Intervention
• Secondary Use
• Addition of Exemption and Secondary Use Screener pages
• 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
• Changes to Informed Consent/Child Assent selections to improve
understanding
• Changes to Waiver of Informed Consent and Waiver of Documentation criteria
based on regulatory requirements

21. Dates and Transition Planning
• Current effective/compliance date is January 19, 2018
• Projects approved prior to January 19 subject to old rules
• Projects approved on or after January 19 approved under new rules
• eResearch changes will be implemented over the weekend of January
20
• Recommend submitting applications in December for research to be
conducted in Jan/Feb 2018
• New Informed Consent templates in preparation – target release 12/1
• Guidance materials, including case study tips for exemptions in
preparation

22. Release of Student Data and the IRB
• The IRBs do not have jurisdiction over compliance with FERPA or the
release of student data. These are the responsibility of institutional
data stewards.
• IRB approval or determination of exemption does not mean that the
data steward approves the release of data.
• The IRB will advise researchers about the requirements of FERPA and
will ask to see documentation that institutional requirements for
release of data are met.

23. Resources
• Federal Policy for the Protection of Human Subjects, Text of New Rule
• https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/pdf/2017-01058.pdf
• HRPP Common Rule & Other Changes website
• http://research-compliance.umich.edu/human-subjects/common-rule-other-
changes
• IRB-HSBS website
• http://research-compliance.umich.edu/irb-health-sciences-and-behavioral-
sciences-hsbs
• eResearch Regulatory Management (IRB application):
• http://eresearch.umich.edu

24. IRB-HSBS
Contact Information
IRB-HSBS office
irbhsbs@umich.edu
734-936-0933
Cindy Shindledecker, Director,
IRB-HSBS
cshindle@umich.edu
734-615-9466