Transcript Human Subjects - Medical University of South Carolina

Institutional Review Board (IRB)
for Human Subject Protections:
Working with the IRB
Erin McClure, PhD
Department of Psychiatry and Behavioral Sciences
Previous Training
Previous Training
The Belmont Report
 3 Basic Principles for Protection of Human
Subjects:
– Respect
 voluntary informed consent
 privacy
 protections for vulnerable populations
– Beneficence
– Justice
Beneficence
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Persons treated in an ethical manner
 Protecting them from harm
 Helping to secure their well being
Justice
• Who ought to receive the benefits of
research and bear the burden of research?
• Equals ought to be treated equally
• Fairness in distribution
• What is deserved
Informed Consent
• Essential to ethical conduct of clinical
investigation
• Potential subject chooses whether or not
they will participate
• Obtained after full information is given and
understood
• Explanation of study objective, potential
benefits, risks, inconveniences, subject’s
rights and responsibilities
Valid Informed Consent
3 Key Components
1. Informed
2. Understood
3. Voluntary
Ensuring Adequate Informed
Consent
 Given the imperative to protect the rights of
participants, how can we be sure that our
informed consent process is sufficient?
 Ideas:
– Reading aloud
– Ask the participant questions
– Quiz
– Signatures and dates
Therapeutic Misconception
 Most studies are not designed to directly
benefit study participants
 Important to help participant understand that
research is not the same as clinical
treatment
 If participant does not understand the
difference, consent is not valid
IRB Purpose
 To protect the rights and welfare of human
research subjects
 Authority to approve, require modification
and disapprove any research involving
human subjects
Protecting Participants from Harm
 Does not mean study must be minimal risk
 Have appropriate selection criteria to
exclude individuals at greater risk of harm
 Have study procedures to evaluate
participants’ safety
 Have DSMB to monitor study progress
 Potentially stop study early / revise protocol
if there are significant risks or benefits
identified
Institutional Review Board
Responsible for verifying
1. Safety
2. Integrity
3. Human rights
4. Public reassurance
5. Scientific content
What information is reviewed?
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Protocol
Informed Consent Document(s)
Informed Consent process
HIPAA Authorizations/Waivers
Personnel-including who will obtain consent
Recruitment process/plan
Advertisements
Investigator’s brochure
Compensation
FDA information (if applicable)
Medical device information
Adverse events/DSMB
Recruitment Process
 How you recruit for your study must be
approved by the IRB:
– Advertisements
– Word of mouth
– Medical Record Review
– Asking medical providers to provide letter to
possible participants
– Directly approaching potential participant
– “Cold calling” is not allowed
Investigator Obligations
• Conducts a clinical investigation
• Responsible for
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All procedures conducted
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All data collected
• May delegate work in conducting
study but they retain responsibility
The Mountain of Responsibility
•Protecting Participants
•Implementing Study
•Reporting Accurately
OHRP Suspensions
 During the last 8-9 years, OHRP has
suspended all human research at the
following institutions:
– University of Illinois, Chicago Campus
– University of Colorado
– Duke University
– Johns Hopkins
– University of Pennsylvania
– And others
Submitting an IRB Application
 Pay attention to deadlines!
– http://academicdepartments.musc.edu/research/
ori/irb/deadlines.html
 Clearly articulate what you are doing for
research purposes
 Do a mental walk through of your study
– Where will it be done? By whom?
– What will participants do? In what order?
– What data do you need? How/where will data be
stored?
Working with the IRB
 Lessons learned
– They are doing their job! i.e., protecting
human subjects
– Support as much as you can with evidence
– Pick your battles
– Communicate frequently with IRB staff
– “Better to ask for forgiveness than
permission.” Well, sometimes….
Examples and Experiences
Informed consent while
under the influence
Examples and Experiences
Deception or withholding
information
Examples and Experiences
Pregnancy and urine drug
screens
“If you are or become pregnant and test positive for illegal drugs, it is a
law that the South Carolina Department of Social Services (DSS) must be
notified. You and your family will be evaluated by the agency. You could
be ordered to mandatory drug treatment, lose custody of your children, or
possibly be jailed.”
Examples and Experiences
Conducting research with
adolescents
Examples and Experiences
Conducting multi-site studies
Examples and Experiences
Use of “experimental” devices
Regulatory Support
Call the SUCCESS CENTER
At 792-8300
Useful Regulatory/Policy Material
 MUSC IRB
 http://academicdepartments.musc.edu/research
/ori/irb/
 http://academicdepartments.musc.edu/research
/ori/irb/deadlines.html
 Office for Human Research Protections
 http://www.hhs.gov/ohrp/
 Food & Drug Administration
 http://www.fda.gov/oc/ohrt/irbs/default.htm