Title Slide

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Research Ethics / IRB Part III IRB Eric D. Z
emper, Ph.D. Statewide Campus System Michigan S
tate University College of Osteopathic
Medicine Department of Physical Medicine Reha
bilitation University of Michigan
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IRB
The Institutional Review Board (IRB)
Purpose To see that Risks to research partici
pants are minimized Risks are reasonable in rel
ation to benefits Selection of participants is
equitable Informed consent is obtained Confi
dentiality is adequately maintained
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IRB
HUMAN SUBJECT A living individual about whom an
investigator conducting research obtains
Data through intervention or interaction with the
individual, or (2) Identifiable private informati
on. 45 CFR 46.102 (f)
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IRB
RESEARCH A systematic investigation, including r
esearch development, testing and evaluation,
designed to develop or contribute to
generalizable knowledge - 45 CFR 46.102 (d)
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IRB
You cannot proceed with study (or even contact
participants) until IRB approves your project
Informed consent is necessary from all participa
nts in a research project The participants must
be completely informed and consent must be
uncoerced IRB must review and approve any chang
es You have to keep all IRB forms and signed co
nsent forms on file
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IRB
Things you have to do Tell the IRB about your
plan for human research After approval Tell th
e IRB about any changes Tell the IRB about the
problems you encounter Tell the IRB about the p
rogress of your research
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IRB
Tell the IRB about your plan for human research
Who are the potential subjects? What risks do
they take? What makes the research scien
tifically worthy of those risks? Is it s
ufficiently funded to reach its goals?
What is the justification for changing medical
care? Who is responsible for what? Back-up
plan?
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IRB
Tell the IRB about your plan for human research
What will be done to minimize risks? - Potent
ial physiological / medical harms
- Potential psychological / social harms
Who, besides the researchers, are providing
oversight? Is a DSMB (Data and Safety Mo
nitoring Board) needed?
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IRB
After approval Tell the IRB about any changes
Apply for IRB approval BEFORE implementing
changes in a protocol or consent
EXAMPLES - Eligibility criteria - Number of s
ubjects to be recruited - Adding or deleting a pr
ocedure or analysis - Adding or changing a recrui
tment method (letters, flyers, phone call
) - Change in investigators or facilities
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IRB
After approval Tell the IRB about any changes
Apply for IRB approval before implementing chan
ges EXCEPT when safety protections are necessary
to eliminate apparent immediate hazards to the
subject. Implement a safety change and report
IMMEDIATELY to IRB.
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IRB
Tell the IRB about the problems you encounter
Unanticipated Problems Unexpected and exp
ected Adverse Events (check IRB
policies/guidance) Protocol and consent
deviations
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IRB
Tell the IRB about the progress of your
research Report progress with renewal applic
ation (yearly) Report data about recruited subj
ects Report updates, significant developments
New information that may affect subjects
willingness to participate Summaries of
expected and unexpected adverse
events (see IRB policies)