protection of research subjects: the irb process · all human subjects research requires prior irb...
TRANSCRIPT
Protection of Research
Subjects: The IRB Process
Ethics in Patient-Oriented Research
October 13, 2010
Sharon Friend
Director, OHRPP
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Overview
Charge and Function of the IRB
Conducting Risk and Benefit
Assessments
Research Involving Collaborations with
Other Institutions
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What is an Institutional
Review Board (IRB)?
An independent internal review committee
Composed of institutional members (UCLA faculty) with relevant expertise and
at least one nonaffiliated member and
at least one nonscientific member
Reviews proposed human subjects in research conducted by UCLA faculty and students
regardless of funding source and
usually regardless of site
Based on federal criteria, IRB has the authority to approve,
require changes
or disapprove human research.
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What is the mission and
charge of UCLA IRBs?
Ensure ethical principles are applied to the conduct of research
Assure federal criteria for approval of human subjects research and institutional policies are met
Promote and facilitate the protection of the rights and welfare of human subjects in research
Support and facilitate the conduct of human research at UCLA
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What do both the IRB and the
PI consider in applying the
ethical principles?
Beneficence (Be nice!) – Design studies to
minimize risk to the extent possible
maximize benefit (both individual and societal)
Respect for Persons (Be respectful!)
Obtain informed consent before involving participants (or using private identifiable information) in research
Assure confidentiality provisions are in place.
Justice (Be fair!)
Select participants who are likely to benefit from research participation
Do not systematically include or exclude participants for convenience.
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Human Research Is…
any research or
clinical
investigation that
involves people
or identifiable
data from people.
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What is research?
Research‖ is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Systematic Investigation: a proposed research plan that incorporates data collection & analysis
Generalizable Knowledge: designed with intent to draw general conclusions (beyond population(s) studied), inform policy, and/or disseminate findings.
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What is a
Human Subject?
A living individual about whom an investigator (faculty or student) conducting research obtains data
Through an intervention or interaction with the individual, or
Access to identifiable, private information. 45 CFR 46.102(f)
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What is not Human
Research?
The following are types of studies that may not be considered human research at UCLA: Analysis of data or specimens that do not include private or
personally identifying information
Studies using public data sets
3 or fewer individual case studies
Quality improvement activities
Guidelines and decision tree on OHRPP website and short questionnaire in webIRB to assist investigators
IRB review may not be required
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When Is IRB Review
Required?
All human subjects research requires prior IRB
review and approval before initiation (New
Studies)
All modifications or changes made to an IRB-
approved study require IRB approval prior to
initiation (Amendments)
All continuation of an IRB-approved study
beyond its approval period (usually one year)
requires IRB approval (Continuing Review)
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What are the levels of
IRB Review?
There are three levels of IRB Review,
depending on level of risk:
Full Committee for more than minimal
risk
Expedited review for minimal risk
studies
Exempt certification for studies that fall
into one of six federal categories
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What is the Best News Ever
about the UCLA IRB Review
Process?
There is now a web-based on-line submission system: webIRB.
It’s much easier to submit an application.
The program uses a ―smart form‖ that walks you through the process and provides help text on the side or within links.
Approval times are much faster!
WebIRB submissions are even faster!
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What is webIRB?
Web-Based IRB Submission, Review
and Tracking System
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How does it support PIs and
Research Staff?
Homepage with access to information on all studies
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How does it support PIs and
Research Staff?
Track status of submissions
Receive feedback and approvals online
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What Were the IRB Turnaround
Times in July 2010?
From time of complete submission to time of full IRB approval:
Full Committee: 34 days
Expedited:
6 – no subject contact
12 – subject contact
Continuations:
9 – expedited
21 – full committee
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What is the focus of the IRB
Review?
Assessing Risks and Benefits: Risks associated with the research, as distinguished
from the risks of procedures the subjects would receive even if not participating in research
Determining that the risks are minimized to the extent possible
Identifying the probable benefits to be derived from the research
Determining that the risks are reasonable in relation to the benefits to subjects, if any, and the importance of the knowledge to be gained
Assuring that potential subjects are provided with an accurate and fair description of the risks or discomforts and the anticipated benefits
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How do you conduct a
risks assessment?
Identify risks associated with the research:
How are risks different than those risks the subject would encounter if not participating in the research?
Consider the subject population:
Are the research participants particularly sensitive or vulnerable to the risks posed by the research?
Do the risk(s) meet the definition of minimal risk?
Does research fit into an exempt or expedited category of review or does it require full committee review?
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Definition of Minimal Risk
―Minimal risk‖ means that the probability and magnitude of harm or discomfort
anticipated in the research
are not greater in and of themselves
than those ordinarily encountered in daily life
of the general population or
during the performance of routine physical or
psychological examinations or tests.
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Expedited Research
No more than minimal risk to subjects
―Expedited‖ protocols are reviewed by
an IRB subcommittee
Seven federally-defined categories
Informed consent or waiver of consent
or waiver of signed consent with
appropriate justification required
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Full Committee Research
Greater than minimal risk to subjects
Full committee protocols are reviewed at a convened IRB meeting
Informed consent required in almost all cases
Includes most clinical trials: studies involving non FDA-approved drugs and devices or medical interventions
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Which potential risks need to
be considered for all levels of
IRB review?
Loss of Confidentiality
Has to do with issues surrounding data
Data security needs to established and described—
seek IT help if needed
Primary source of complaints to IRBs (beyond why
didn’t I get paid on time)
Loss of Privacy
Has to do with personal privacy
Important in recruitment and screening as well as
practice
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What are the Special Issues for
Industry-Sponsored Clinical
Trials?
Need to coordinate IRB approval and contract
Sponsor pays IRB Review Fees
Consent form needs to be revised to Use UCLA standard requirements for indemnification
and ownership of tissue
Be in lay language and not overly legal
Data Safety Monitoring Boards usually required
IRB cannot require a major change in the science and expect the company to revise the protocol—it’s either thumbs up or thumbs down
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Examples of Expedited or Full
Committee Research or Research
Not Requiring IRB Review
Randomized double-blind study for the safety
and efficacy of investigational drug XYZ
Review of medical records of patients in hospital
from 1990 to present to study correlation of
Alzheimer’s and heart disease
Randomized double-blind study to compare two
approved surgical procedures (lumpectomy vs
mastectomy)
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More Examples
Analysis and comparison of UCLA medical
student socio-economic and educational
background and admission records to
evaluate predictors of ability to graduate
Questionnaires for parents of parents whose
children have recently died from cancer to
assess grief coping mechanisms
Phase IV (post marketing) Drug Study
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Examples continued
Comparison of psychotherapy vs medication
for the treatment of depression
Collection of saliva samples from people who
developed a cold and cough within the last 48
hours to study the genes related to asthma
Survey of physicians at UCLA to ask
their opinions about physician-assisted suicide
whether they have participated in physician-assisted
suicides
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Examples continued
Analysis of facial expressions of people who are lying
Analysis of facial expressions of children who are afraid of spiders
Study of elder abuse among caregivers
Skin samples collected via punch biopsy for SCNT (somatic cell nuclear transfer) study
Skin samples sent from UCSF with or without PHI (private health information)
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Waves of the Future
Continued push to rely on
other IRBs
OHRP
FDA
AAHRPP
CTSAs
Study Sponsors
Local Institutions
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What’s Currently in Place
at UCLA?
UC-Wide Memorandum of Understanding (MOU) to rely on each others IRBs 2011) Being used for Expedited and Exempt Studies
Used over 700 times since 2006
Plans for expanded use for Full Committee Studies in spring 2011
CTSA MOU for Cedars, LABioMed, Charles Drew and UCLA – limited implementation but plan for expanded use in spring of 2011
Use of Federal-wide IRBs –NCI, NIDA, NICHD, others
Western IRB – commercial, pay for review
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More Waves
Revised medical consent form templates (to
be used also for multi-site UC and CTSA
studies)
UCLA-wide guidance on the use of remnant
tissue and specimens for research
Expanded education including video-training
on advanced topics in human research
Expanded use of ability to rely on other IRBs (beyond UCs and CTSAs--longer term but in
planning)
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Last Minute Tips
#1 Refer to the OHRPP website for
webIRB online application
Links to application
Information about training (monthly Noontime Series and Learn at Lunch)
UCLA consent form templates
UCLA OHRP guidelines on various topics
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#2 Writing Musts
Consider the audience Not all IRB members are scientists
Avoid acronyms
Use lay language for recruitment and consent documents
Be consistent Within the application
Make sure that study aims, methods, risks, benefits and alternatives are consistent
Between application and consent documents
Between application and sponsor protocols or grants
Use the same name for the study drugs throughout the submission
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Final Tips
#3 Contact the OHRPP with any questions
before or during the application process
#4 Bonus Tips:
Do not group related full committee studies into a
complicated application. Submit a separate
application for each study or phase of study.
Do group data analysis or retrospective chart reviews
into one study when useful for your purposes.
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We’re Here to Help
OHRPP Website: www.research.ucla.edu/ohrpp
Medical IRBs Telephone: (310) 825-5344
E-mail: [email protected]
webIRB Help Desk 310-267-1887