Transcript Ethical Challenge & Solution in Social Behavioral Research

Ethical Challenge &
Solution in Social
Behavioral Research
Melody Lin
December 2012
Objectives
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Apply regulation & ethical principles
Develop review parameter
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Roles & responsibilities
Do actions protect human subjects
45 CFR 46
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Understand regulations’ flexibility and aplly to
SBER research
Ethical principles
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The 3 ethical principles are:
Respect
 Beneficence
 Justice
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EP are the basis for the regulations
Primary Ethical Concerns (SBER)
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Informed consent
Confidentiality
Privacy
Risk category
Psychological risk
 Social risk
 Economic risk
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Subject selection
Areas of IRB Review
Use regulations, ethical principles, institutional guidance and their expertise to
review research for:
 Respect
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Beneficence
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Recruitment
Informed consent
Confidentiality procedures
Subject compensation
Background literature
Investigator experience
Research design
Justice
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Risks and benefits
Subject selection practices
Application of the Regulation
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Do not provide direct guidance on each of these ethical
concerns
Ethical issues are briefly mentioned:
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Informed consent requirement (46.116)
Confidentiality
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Privacy
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In relation to informed consent (46.116(a)(5)
IRB approval criteria (46.111)
Risk
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IRB approval crietria (46.111)
Meeting or exceeding “minimal risk” (46.102)(i)
Review Challenges
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Regulations do not provide ethical guidance
IRBs are not experienced in application of the
regulations to non-medical research
A one-size fits all approach may not work
Lack of guidance creates confusion and tension
Regulations Allow for Flexibility
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Exempt status
Expedited review via subcommittee
Waiver of informed consent and documentation
General open-mindedness in consideration of
various research design choices
Exempt Review Examples
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Use of biological samples
Involvement of school children in educational
research
Survey gathering non-sensitive data
Expedited Review: Examples
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Effect of stride frequency on oxygen uptake
while running uphill
Knowledge and attitudes on contraception and
reproductive health in residents of a small
Mexican town
A comparison of standard vs. hearing aid
processing in cell phones for the hearing
impaired
Full Committee: Examples
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Interviews with law enforcement agents, armed
group leaders, drug users, and drug dealers on
the drug trade in several Asian Countries
Testing weight-reduction strategies for breast
cancer survivors
Study of social rejection and depression using
deception
So, We Understand
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IB member responsibilities are highly complex
Social and behavioral sciences studies are highly
complex
Each study must be reviewed case by case
Regulations allow for flexibility
IRB members and administrative staff should be
well-trained and supported by the institution
What to Do?
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Improve understanding and relevant application
Streamline process and compliance
Determine whether actions actually protect
subjects
Where to focus?
Where Do We Begin?
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PI creates a good protocol
Produces valid, worthwhile science
Responds ethically, not bureaucratically, to
regulations
Demonstrates sensitivity to the context, culture
and needs of subjects
Shows understanding of the consent process,
risk & benefit privacy & confidentiality, and the
consultative role fo the IRB
Demonstrate Ethical Practices
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Conduct valid research (using accepted scientific
methods)
Appropriate sampling (to get valid results)
Respect people and their communities
Protect research participants
Benefit individuals and society
Create a basis for socially beneficial polices
Disseminate findings effectively
Facilitate the application of finding
Stakeholders
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Regulatory
Institutions
Research subjects
Shared Responsibilities
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Stakeholders have complementary and
competing goals:
Legal concerns
 Academic freedom
 Human rights
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Perception of the IRB
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Supportive?
Controlling?
Inconsistent?
Fearful?
Restrictive?
Helpful?
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Powerful?
Arbitrary?
Facilitative?
One dimensional?
Mysterious?
Uninformed?
See JERHRE, March 2006 for results of study perceptions of iRBs
Opportunities or Challenges?
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Collaborate – us/them or team approach?
Communicate – challenge or Facilitate?
Cooperate – problem or solutions?
Collaboration, Communication and
Cooperation
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Increase collaboration
Minimize confrontation
Improve communications
Reduce barriers
Value added decisions
Shared visions and responsibility
Opportunities to partner in research endeavors
Tips for the IRB
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Organizational perception
IRB composition/support
Educate, guide and consult
Streamline
Meet the investigators
Appropriate flexibilty
Identify Challenge
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Protocol review/approval
Appropriate consent process/documentation
Appropriate risk assessment
Turn around time
Consent form details
Knowledge of research design
Use of exempt and expedited review
Providing education
The Review Process
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Does one size fit all?
Consider methodology
Disciplines involved
Risk assessment/management
Infomred consent
Proactive Site Visits
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Create an opportunity to see the research in
action
Create an environment where on-site monitoring is
accepted/valued
 Enhance IRB awareness of practical issues from the
investigator’s perspective
 Promote communication between researchers and
the IRB
 Increase opportunities for training of
ethical/responsible research practices
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Tip for Investigators
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Take RESPONSIBILITY become
EMPOWERED
Knowledge is power – know the Federal regulations,
institutional policy / guidance
 Opportunities to learn
 Protocol submission
 Communicate
 Ethical awareness
 Use resources
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Resources
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Both NIH and NSF have developed guidance
specific to SBER research
http://obssr.od.nih.gov
http://www.nsf.gov/bfa/dias/policy/hsfaqs/jsp
National listserve
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[email protected]