CLINICAL RESEARCH BOOTCAMP: EMORY IRB Presentations/IRB - Gunthel... · CLINICAL RESEARCH BOOTCAMP:…
Post on 04-Jun-2018
CLINICAL RESEARCH BOOTCAMP: EMORY IRB OVERVIEW Clifford Gunthel, MD, IRB Co-Chair Rebecca Rousselle, CIP, IRB Director
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).
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
Do you need IRB review? We can tell you.
Gets study in good shape for review
Outreach/education, and quality assurance
Because people do not always do the right thing; and its 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 werent 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 Reports 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
Belmont Report Principles Respect for persons
Informed, comprehending consent assuming rational autonomy; safeguards for those with limited autonomy
Minimize risk, maximize benefit
Justice Ensure fairness of subject selection, balancing of burdens
Cooperative trial group
Institution & IRB
5 Points to Get an IRB Application Approved
Put yourself in the reviewers 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
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?
What is Research? IRB jurisdiction is limited to research (with human
subjects) Contact the IRB at firstname.lastname@example.org to talk with an analyst
about your project Our first question is: is it research? See handout If it isnt research, no IRB review needed IRB will give you a letter for your records
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.
Research or Not?
Not Research Some education activities Quality improvement, assurance, assessment studies
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)
Publishing I want to publish, so its 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
If not research, publication should not attempt to generalize conclusions. Should report on what you did and how well it worked youre mileage may vary.
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
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.
IRB staff screening Change
IRB Review Change request
loop Ancillary reviews
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)
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
Visit our Website
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
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)
Why we all do this
Community trust in research Willing subjects Continued funding
Contact the Emory IRB Main email: IRB@emory.edu
Rebecca Rousselle, CIP
Main line: (404) 712-0720
IRB website: www.irb.emory.edu
Clinical Research Bootcamp:Emory IRB OverviewCo-ChairsSlide Number 3How the IRB Staff HelpBecause people do not always do the right thing; and its hard to know in the moment what the right thing isBelmont Report PrinciplesSlide Number 75 Points to Get an IRB Application ApprovedIRB Triage QuestionsWhat is Research?Research or Not?Research or Not?Human Subjects or Not?PublishingWhat is exempt?What is expeditable?The FlowReview OutcomesHow are ongoing studies reviewed?Visit our WebsiteTimeThe StickWhy we all do thisContact the Emory IRB