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CLINICAL RESEARCH BOOTCAMP: EMORY IRB OVERVIEW Clifford Gunthel, MD, IRB Co-Chair Rebecca Rousselle, CIP, IRB Director
CLINICAL RESEARCH BOOTCAMP: EMORY IRB OVERVIEW Clifford Gunthel, MD, IRB Co-Chair Rebecca Rousselle, CIP, IRB Director
Co-Chairs
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Cliff is Associate Professor of Infectious Disease at SOM, and
chairs Committee B1.
Aryeh is Professor of Global Health at RSPH and chairs Committee Q (compliance).
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Jill Perry-Smith, PhD Sociobehavioral VC
Larry Tune, MD Comedian, Psychiatrist
Susan Ray, MD Infect. Disease
Amy Langston, MD Hem/Onc
Ann Haight, MD Hem/Onc Peds
Carlton Dampier, MD Pediatric Hematology
How the IRB Staff Help • We know the regulations
• Q&A
• Do you need IRB review? We can tell you.
• Gets study in good shape for review
• Outreach/education, and quality assurance
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Because people do not always do the right thing; and it’s hard to know in the moment what the “right thing” is • Nazi Doctors: Obviously, pathologically, not right
• 1947 Nuremburg Code – required informed consent • Henry Beecher 1961 NEJM article:
• The physicians thought they were right – but weren’t in hindsight. “Science is not the highest value to which all other orders of values… should be subordinated” (Pope Pius IV, cited in Beecher)
• “Consent in any fully informed sense may not be obtainable. Nevertheless… it remains a goal toward which one must strive… There is no choice in the matter.”
• “An experiment is ethical or not at its inception. It cannot become ethical post-hoc – ends do not justify means.”
• 1971-1991: Tuskegee surfaces, Belmont Report’s Three Principles, national atonement for studies gone wrong. Led to IRB model for one-site studies, federal regulations
• 1990s – 2000s: Rise of multi-site studies, transnational research, shut-downs; more studies gone wrong
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Belmont Report Principles Respect for persons
Informed, comprehending consent assuming rational autonomy; safeguards for those with limited autonomy
Beneficence
Minimize risk, maximize benefit
Justice Ensure fairness of subject selection, balancing of burdens
and benefits
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Shared Oversight
HHS FDA
Cooperative trial group
Institution & IRB
PI
5 Points to Get an IRB Application Approved
Put yourself in the reviewer’s shoes. What is being
done with Human Subjects, and why? 1. The science must be sound 2. State the obvious: What is investigational about this
study? 3. Define the study population 4. The description of the risks must be complete 5. Have an appropriate data and safety monitoring plan
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IRB Triage Questions • Is it “research”? • Is it “human subjects”?
• Is it exempt human subjects research?
• Is it expeditable HSR?
• Must it go to a full board meeting?
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What is “Research”? • IRB jurisdiction is limited to “research” (with “human
subjects”) • Contact the IRB at [email protected] to talk with an analyst
about your project • Our first question is: is it “research”? • See handout • If it isn’t “research,” no IRB review needed • IRB will give you a letter for your records
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Research or Not? Generalizable knowledge is information gathered to draw general conclusions beyond the study population. The researcher approaches the project with the intention of extrapolating from the chosen sample to generate knowledge about a larger reference group.
By contrast, non-research projects gather information about a chosen sample to describe a local phenomenon, or draw conclusions that are intended to be used for the benefit of that local sample alone.
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“Research” or Not?
Not “Research” • Some education activities • Quality improvement, assurance, assessment studies
• <6 Case reports or case series • Public health practice, program evaluation • But… it always depends. CALL or EMAIL US!
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Research (45 CFR Section 46.102(d)): a systematic investigation designed to develop or contribute to generalizable knowledge.
“Human Subjects” or Not? A living individual about whom an investigator
conducting research obtains data through intervention or interaction with individuals or obtains identifiable private information
• About a living person (at time of collection) • Intervention/interaction – in person, phone, internet • Identifiers • Private vs public
45 CFR 46.102(F)
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Publishing I want to publish, so it’s research, right? • Common misconception
• One can publish works that meet - or do not meet - the IRB
definition of “research.”
• Publishing is simply sharing information with an external audience.
• The Emory IRB can give you email or letter with determination, for
publishers.
• If not research, publication should not attempt to generalize conclusions. Should report on what you did and how well it worked – “you’re mileage may vary.”
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What is “exempt”? Most common types of exempt research:
• Surveys, interviews and focus groups of adults • Public observation of adults and of children (but only if
investigators do not intervene at all) • Fewer approval criteria – based on Emory policy
• CITI training • General sniff-test • Adequate informed consent
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What is “expeditable”? Non-exempt HSR that is:
• Minimal risk AND • Falls in certain categories set by federal regs
Most common expeditable research:
• Medical record reviews • Blood, urine, hair, saliva samples • Non-invasive biometric measurements
More than minimal risk: goes to full board meeting.
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Create Study
Dept Review
CTRC review
(if cancer-related)
IRB staff screening • Change
request loop
IRB Review • Change request
loop • Ancillary reviews
Final Approval!
Protocol Amendments
Annual Renewal
Close Out
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Review Outcomes • Approved • Approved pending minor modifications • Deferred to another meeting (full board only)
• Major issues, or missing information Disapproved (very rare) – must be done by full
board Tabled (lack of quorum, immature application)
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How are ongoing studies reviewed? • Investigator/sponsor responsibilities
• Safety reports • Monitoring visits • DSMB reports • Document Document Document (subject binders, study
binders, logs, AE worksheets…) • IRB responsibilities
• Unanticipated problems • Noncompliance reviews and corrective/preventive
action plans • Review of study at least annually
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Visit our Website
irb.emory.edu
eIRB (eresearch.emory.edu/Emory)
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Time • What turnaround can you expect? Here are AVERAGES
(vary according to quality of submissions, staffing, novel issues, COIs, etc.)
• Full board new: app. 3-8 weeks til IRB meeting • FB Amendments: 3 weeks til IRB meeting • All Continuing reviews: before expiration if not submitted late
• Expedited new: app. 2-8 weeks • Expedited Amendments: 2-4 weeks
• “No review needed” and exemption determinations: 2-4 weeks
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The Stick • The IRB may:
• Suspend enrollment • Suspend approval of a study • Terminate a study • Bar an investigator from conducting HSR or certain kinds of HSR (e.g., more than minimal risk)
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Why we all do this…
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Community trust in research Willing subjects Continued funding
Contact the Emory IRB • Main email: [email protected]
• Rebecca Rousselle, CIP
• [email protected] • (404)712-0785
• Main line: (404) 712-0720
• IRB website: www.irb.emory.edu
• Dr. Gunthel
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