1 Why does responsible conduct of research matter? Bernard Lo, M.D. August 18 and 26, 2010.
Practical issues in IRB review Bernard Lo, M.D. August 16 and 19, 2010 1.
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Transcript of Practical issues in IRB review Bernard Lo, M.D. August 16 and 19, 2010 1.
Practical issues in IRB review
Bernard Lo, M.D.
August 16 and 19, 2010
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Topics to cover
When is IRB review not necessary?
How to avoid delays in IRB review? IRB review of multisite trials Tips for IRB approval
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Infections related to central venous catheters
80,000 bacteremia episodes annually
Cost $45,000 per infection
28,000 deaths
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Reducing ICU catheter-related infections
Handwashing
Clorhexidine
Full-barrier precautions when inserting
central lines
Avoid femoral sites
Remove unnecessary catheters
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Reducing ICU catheter-related infections
Standard recommendations not
followed
Quality improvement project in 108
ICUS in 67 Michigan hospitals
Checklist
Monthly feedback
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Reducing ICU catheter-related infections
Catheter-related bloodstream infections /
1000 catheter-days (mean)
Baseline 7.7
After 16-18 months 1.4
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Reducing ICU catheter-related infections
After publication, OHRP investigation Project was research: grant, publication IRB review required Consent from subjects
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Is IRB review necessary?
No risk to patients Checklist procedures standard practice Efforts to improve adherence not harm
patients Researchers receive hospital infection rates,
no identifiable patient information
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Is IRB review necessary?
Primary goal of QI is to improve patient
care, not generate knowledge Intervention could be implemented as part
of clinical care Obligation to do QI Instituting interventions without analyzing
whether they work makes little sense
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Is IRB review necessary?
IRB review not feasible 45% of hospitals in project had no IRB HIPAA does not require consent for QI Review by clinical service directors
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When is IRB review not necessary?
1. Not research
2. Not human subjects research
3. Exempt from federal regulations Certain survey, interview research Certain research with existing data and
biological specimens
Definition of research
“Systemic investigation … designed to
develop or contribute to genralizable
knowledge”
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1. Not research(hence no IRB review)
Innovative clinical practice
Public health practice Surveillance, epidemiology, investigate
outbreaks May publish findings
Quality improvement?
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Infertility in cancer survivors
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Induced pluripotent stem cells (iPS cells)
Reproductive research with iPSC derivatives
Differentiate iPSCs into oocytes and
sperm
Carry out IVF, observe embryo to see if
normal development
Use iPSCs that are easy to work with
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Questions for audience
Do regulations permit using de-
identified somatic cells to derive iPSCs
and gametes and fertilize gametes in
vitro, without consent of somatic cell
donors? Yes /No / Unsure
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Questions for audience
Should regulations permit using de-
identified somatic cells to derive iPSCs
and gametes and fertilize gametes in
vitro, without consent of somatic cell
donors? Yes /No / Unsure
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Definition of human subjects
Living individuals about whom an
investigator obtains Data through intervention or interaction OR Identifiable private information
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What is human subjects research?
Interact with person OR
Use identifiable private information Not human subjects research if exisiting
data and materials cannot be identified Examples of tissue from cancer surgery
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What is identifiable?
None of 18 HIPAA identifiers
Data and materials are coded but
researcher cannot access keys to code Code may be retained by database or
biobank
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Ethical rationale for no IRB review
If no human subject, no one can be
harmed
Hence IRB review would not protect
participants But would pose administrative burdens
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2. Not human subjects research:Examples
Collect hospital-specific data on
infection rates
Reproductive research with de-
identified iPSCs
Coded neonatal spots
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Reproductive research with iPSC derivatives
Not human subjects research if de-
identified
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Reproductive research with iPSC derivatives: concerns
Reproduction very private
Some object if such reproductive
research done without their consent
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Reproductive research with iPSC derivatives: concerns
Deeply held beliefs about reproduction: Some believe that IVF is immoral Some believe that embryos have moral
status of persons, should not created or destroyed for research
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Reproductive research with iPSC derivatives: concerns
Such individuals object to use of their
biological materials in such research Even if de-identified Respect their values and preferences by
asking their consent
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Warning
Research permitted under federal
regulations may not meet ethical
standards Ultimately researcher is responsible
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3. Exempt from federal regulations
Most survey and interview research Unless subjects can be identified and
responses could put respondents at risk• Not if ask about illegal activities, sensitive or
private topics
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3. Exempt from federal regulations
Certain existing data or materials Publicly available Researcher records information in manner
than subjects cannot be identified• Can look at medical records
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3. Exempt from federal regulations
Much research in educational settings
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How can we avoid delays in IRB review?
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Expedited IRB review
Reviewed by chair or designate, not
full committee
Shorter time to approval
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When may IRB review be expedited?
1. Must be minimal risk
2. On list approved by DHHS
Definition of minimal risk
Probability and magnitude of harm or
discomfort
Not greater than encountered in daily
life or routine physical exam
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Examples of minimal risk
Answering (non-sensitive) questions
over telephone
Routine blood tests, EKG
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Significance of minimal risk
May be eligible for Expedited IRB review Waiver of informed consent
In pediatrics, different categories of
review and approval
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When may IRB review be expedited?
2. On list approved by DHHS Noninvasive collection of specimens
• Urine, buccal swabs
Noninvasive clinical procedures• EKG, ultrasound
• Not x-rays
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When may IRB review be expedited?
2. On list approved by DHHS Venipuncture Interview, focus group research Research with existing data, specimens
collected for nonresearch purposes Minor changes to approved protocol
• Changes in questionnaire, tests run
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Questions?
IRB review of multisite studies
Review at each site causes long
delays, requires great effort
Inconsistent requirements
May push clinical trials to clinical
research organizations, independent
IRB
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Review of multisite studies
Cooperative arrangements Defer review to other UC IRBs
Facilitated review by central IRB NCI sends detailed review to sites
• May be useful in other types of studies
Facilitated review by single IRB member
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Top 5 problems with IRB submissions
1. Study procedures not clear Reader should be able to replicate study
2. Recruitment and consent process
unclear Who, where, when, how? Vulnerable populations
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Top 5 problems with IRB submissions
3. Inconsistency within protocol Methods and consent sections not agree
4. Missing information
5. Undefined acronyms
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Tips for IRB submissions
Know what CHR requires Use correct templates and form Special regulations for children, prisoners
Anticipate IRB concerns Write for nonspecialists Reviewers do not want to re-read to figure
out what you are doing
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Tips for IRB submissions
Ask the IRB questions Find out what they are likely to have
concerns about
Get it right the first submission If difficult or sensitive issues, show that
you considered alternatives and give reasons for your approach
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Take home points
IRB review process will be easier for
you if You understand when expedited and waiver
are permitted Avoid common problems with IRB
submissions
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