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The IRB: Friend or Foe?

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The IRB: Friend or Foe? Margaret J. Neff, MD MSc Assistant Professor of Medicine Pulmonary & Critical Care Medicine – PowerPoint PPT presentation

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Title: The IRB: Friend or Foe?


1
The IRBFriend or Foe?
  • Margaret J. Neff, MD MSc
  • Assistant Professor of Medicine
  • Pulmonary Critical Care Medicine

2
Getting things through the IRB
  • Why does it matter?
  • Basic requirements
  • Lay-out of the UW IRB
  • Specific scenarios
  • Screening, consent, database reviews
  • Helpful tips

3
Past Research
  • 1930s-40s Nazi war
  • crimes experiments
  • 1971 Stanford Prison
  • Experiment
  • 1932-1972 Tuskegee
  • Syphilis Experiment

4
Recent Research
  • 1999 U Penn gene transfer study (Jesse
    Gelsinger) followed incl/excl criteria?, safety
    monitoring?, informed consent?, conflict of
    interest?
  • 2001 Johns Hopkins asthma study (Ellen Roche)
    hexamethonium who is responsible for researching
    safety?

5
Common Themes
  • Lack of informed consent
  • Risk gtgtgtgtgt benefit
  • Risk assessment not complete
  • Vulnerable populations
  • Students employees
  • Poor safety oversight
  • Conflict of interest

6
Troubled Waters
  • Penn
  • Duke
  • Johns Hopkins
  • U of Illinois-Chicago
  • U Colorado
  • West LA VA
  • Rush Presbyterian
  • Virginia
  • Not a list we want to join

7
Ethical Codes Guiding Clinical Research (Human
Research)
  • Nuremberg Code 1947
  • Declaration of Helsinki 1964
  • The Belmont Report 1979

8
Regulations Pertaining to Clinical Research
  • U.S. Code of Federal Regulations
  • Health and Human Services
  • 45 CFR 46 (protection of human subjects)
  • Food and Drug Administration
  • 21 CFR 50 (protection of human subjects)
  • 21 CFR 56 (institutional review boards)
  • State Law
  • Washington Administrative Code (WAC)
  • Institutional policies, sponsor

9
Criteria for approval of research
  • Risks minimized and reasonable in relation to
    anticipated benefits
  • Subject selection is equitable
  • Informed consent sought
  • Informed consent documented
  • Plan data safety monitoring
  • Provisions for privacy/ confidentiality
  • Additional safeguards for vulnerable populations

www.access.gpo.gov/nara/cfr
10
Design of IRB
  • At least 5 members
  • Varying backgrounds, gender
  • At least 1 scientist 1 non-scientist
  • At least 1 not affiliated with institution
  • No conflict of interest with study reviewing
  • May invite consultants to review

www.access.gpo.gov/nara/cfr
11
Univ. of Washington IRB
  • Multidisciplinary membership
  • MDs, RNs, pharmacists, lawyers, students,
    community members
  • 6500 protocols reviewed/year
  • 10 committees
  • 3 biomedical, 3 behavioral, 3 minimal risk, 1 VA
  • Full-time staff but other members are primarily
    volunteering their time
  • Western IRB now used for all industry-sponsored
    trials

12
When do you need IRB approval?
  • When youre conducting human subjects research
  • Any study where results are intended for
    dissemination as research (vs QI)
  • Patient info or patient samples
  • Waiver of consent possible in some instances
  • De-identified data
  • 18 specific data points removed
  • Limited data set
  • Meet specific criteria (emerg research records
    review, etc)

13
Types of Review
  • Full committee review
  • Most studies
  • Expedited review
  • Generally only for database/registry work
  • No patient contact, no interventions
  • Using data already available
  • May qualify for certificate of exemption

14
General Issues Prior to Review
  • Do you have the resources to do it?
  • Coordinator? Funds? Enough time?
  • Any financial conflict of interest?
  • Taken ethics/IRB training?
  • Required for NIH and VA studies soon for all UW
    studies
  • Clinical Research Budget Billing
  • Made contact

15
The IRB Submission Process
  • Complete application, get dept signatures
  • Submit application (include a cover letter with a
    howdy, heres what were doing and address any
    anticipated problem points brief)
  • Once at the IRB
  • Pre-screening
  • Full review with deferral or approval
  • Committee letter
  • Your response
  • Re-evaluated in sub-committee
  • Back to full committee, hopefully to approve

16
Who is it youre hearing from?
  • Each committee
  • Chair, members, administrator, and coordinators
  • The administrator pre-screens the study and often
    contacts you for clarifications prior to first
    review
  • Get to know this person
  • If complex study, go and meet
  • Offer to come to the committee meeting (or be
    available by phone) if anticipated
    questions/problems
  • Be nice and not defensive

17
Some common pitfalls
  • Application should be understandable to an
    educated, lay audience (the IRB members)
  • Avoid lots of cutting and pasting of text
  • Be organized! Be consistent.
  • Make it easy to read (not tiny font)
  • Think of it like a grant youre submitting
  • Be thorough and follow the instructions
  • Appropriate copies, answer all questions
  • If you dont know what they mean, ask!

18
Screening/Recruitment
  • Screening for potential subjects
  • Waiver of consent for screening
  • Confidentiality agreement
  • Need to report each time access chart
  • Recruitment
  • Include any flyers or website notices
  • Generally try to allow potential subjects to call
    you rather than cold calls.

19
Subject approach
  • Avoid any appearance of coercion
  • Initial introduction by non-research personnel
  • Ideally have clinical personnel separate from
    research personnel

20
Privacy/Confidentiality
  • Minimize identifiable information on data
    collection forms no names
  • No identifiable elements on screened,
    non-enrolled (non-consented) subjects
  • Describe mechanism for safeguarding data
  • Plan for destruction of any links and the data as
    soon as possible (but feasible)

21
Risks and Benefits
  • Dont exaggerate the benefits
  • Be honest about the risks
  • Usually death is always a risk in any
    intervention study
  • Often useful to group by common and rare risks
  • How youll deal with any adverse events
  • Who pays?
  • Who pays for research studies?
  • In most cases, its the sponsor
  • For NIH or investigator initiated UW
    Compensation plan

22
Consent
  • Utilize the consent template (some standard
    wording and sections)
  • Assent form for children as well
  • Language
  • 8th grade reading level
  • Subject not patient
  • Go through consent checklist

23
Obtaining Consent
  • Subject needs adequate time and information to
    make a decision
  • Competency must be assessed
  • If limited, at minimum need assent
  • Consent is invalid if subject is pressured or
    coerced
  • Ideally assess comprehension

24
Who Can Consent?
  • Subject him or herself
  • Legally authorized representative
  • This varies state-to-state whether allowed and
    what order is followed
  • In Washington, its based on WAC guiding clinical
    decision making, extrapolated to research
  • Guardian, Subject, DPOA-HC, spouse, adult
    children, parents, adult siblings
  • Who consents for clinical procedures may vary but
    for research, this order is strictly adhered to
  • Recent changes clinically for domestic partners

25
Waived Consent for Emergency Research
  • Should the needs of the many ever outweigh the
    needs of the one?
  • Waived consent (e.g. pre-hospital, MI, stroke)
  • Specific criteria must be met and documented
  • If criteria for waived consent are met
  • No more than minimal risk
  • Will not adversely affect rights of subjects
  • Research not practical without waiver
  • Provide info to subjects at later date
  • May require survey and notification of community

26
Other Issues
  • Federal Certificate of Confidentiality
  • If sensitive questions about drug and alcohol
    abuse
  • Vulnerable subjects
  • Prisoners, pregnant women, children
  • Registration of clinical trials

27
Tips for Interacting with the IRB
  • They are there to help you and to protect the
    subjects and the ability to do research here at
    all!
  • Research is a privilege, not a right
  • Be prompt in responses
  • Be cordial

28
  • May not be consistent committee to committee
  • Each is independent but this is improving moving
    towards sending all of 1 type of specialized
    study to 1 committee

29
  • There may be delays and lots of questions that
    seem not relevant
  • Theyre trying to best understand the study
  • If you dont understand what theyre getting at,
    call them. Maybe they didnt understand
    something youre trying to do.
  • Offer to meet the administrator or go to the
    meeting. Resolve the problems up front.
  • Try to explain your intent

30
Resources
  • IRB website
  • http//www.washington.edu/research/hsd/
  • Clinical Research Budget Billing
  • http//www.uwmedicine.org/Research/
    ResearchBudgetBilling/
  • HIPPA resources
  • http//privacyruleandresearch.nih.gov/
  • http//www.hhs.gov/ocr/hipaa/
  • Me mneff_at_u.washington.edu

31
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