“Human Subject Research” (E McClure)
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Transcript “Human Subject Research” (E McClure)
Institutional Review Board (IRB)
for Human Subject Protections:
Working with the IRB
Erin A McClure, PhD
Department of Psychiatry and Behavioral Sciences
Addiction Sciences Division
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
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 its burdens?”
• Equals ought to be treated equally
• Fairness in distribution
Informed Consent
• Essential to the 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
Advances in Informed Consent
Remote services (telehealth, etc.) and
research
– Doxy me (https://doxy.me)
Advances in Informed Consent
Apple ResearchKit
(http://www.apple.com/researchkit/)
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
Ongoing review of study procedures
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?
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
• Responsible for
All procedures conducted
All data collected
• May delegate work in conducting
study but they retain responsibility
OHRP Suspensions
During the last 10-15 years, OHRP has
suspended all human research at the
following institutions:
– University of Illinois, Chicago University of
Colorado
– Duke University
– University of Pennsylvania
– Johns Hopkins University (all federally funded research
was shut down; 2400 protocols)
– And others
Submitting an IRB Application
Pay attention to deadlines!
– http://academicdepartments.musc.edu/research/ori/irb/d
eadlines.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 your study and procedures 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
Remote collection of data
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
Use of experimental devices
or investigational drugs
Examples and Experiences
Conducting multi-site studies
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