Transcript Institutional Review Board

Human Participant Research
at JHU
"What You Need To Know To
Get Started“
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History, Ethics, and
Regulations
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History
• Nuremberg Code (1948)
• Tuskeegee Syphilis Study (1932-1972)
• Wichita Jury Case (1953)
• Miligram “Obedience to Authority” Study
(1963)
• Stanford “Zimbardo Simulated Prison” Study
(1973)
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Belmont Report (1979)
Respect for Persons
– Treat individuals as autonomous agents
– Protect persons with reduced autonomy
Beneficence
– Maximize potential benefits and minimize potential risks
– More than “do no harm”
Justice
– Potential risks of research should be born equally by the
members of our society that are likely to benefit from it
– Distribute the risks and potential benefits of research equally
among those who may benefit from the research
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DEFINITIONS
“Research”
– Research means a systematic investigation, including
research development, testing and evaluation,
designed to develop or contribute to generalizable
knowledge.
45CFR 46.102(d)
– Tests a hypothesis and draws conclusions.
– Research is described in a formal protocol and a set
of procedures designed to reach an objective.
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What is a Human Participant?
– A “human participant” (volunteer) is a living
individual about whom an investigator
conducting research obtains:
data through intervention or interaction
with the individual
or
identifiable private information
From: 45 Code of Federal Regulations (CFR) 46.102
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What is an Institutional
Review Board (IRB)?
The group or committee that is given the
responsibility by an institution to review research
projects involving human subjects.
Its primary purposes are
– to assure the protection of the safety, rights and
welfare of the human subjects.
– determine if benefit of the research (to the individual
or society) exceeds the risk to the participant (healthy
volunteer or patient)
By Federal law, the group contains both
scientific and non-scientific (community)
members
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All Human Subjects
Research (HSR) must be
submitted to the IRB for
review!
If you are unsure if your research
is considered HSR, please
contact the IRB Office for
assistance BEFORE beginning
your project!
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Functions of the HIRB Office
Review Protocol Transactions
– New, Amendments, Renewals, Deviations,
Exceptions, Unanticipated Problems, Serious
Adverse Events (SAEs)
Organize IRB meetings
Education for the the research community
Investigator and student support
Monitor and audit protocols to ensure
compliance with regulations
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Risk Levels
The Federal regulations only acknowledge
two risk levels:
Minimal Risk: 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 or during the performance of
routine physical or psychological examinations or
tests.*
Greater Than Minimal Risk
*45 CFR 46.102(i); 21 CFR 50.3(k)
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Levels of IRB Review
Exempt: for minimal risk research
Expedited: for minimal risk research that
does not meet exempt category
Full Board: for greater than minimal risk
research
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Exempt Research
The IRB, not the investigator, determines if
the research is “exempt”
The research is exempt from further IRB
review and from the Federal regulations
Six exempt categories
– Category 1 and 2 most common at
Homewood
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Categories 1 and 2
(1) Research conducted in established or commonly accepted
educational settings, involving normal educational practices,
such as (i) research on regular and special education
instructional strategies, or (ii) research on the effectiveness of
or the comparison among instructional techniques, curricula,
or classroom management methods.
(2) Research involving the use of educational tests (cognitive,
diagnostic, aptitude, achievement), survey procedures,
interview procedures or observation of public behavior, unless:
– (i) information obtained is recorded in such a manner that human subjects
can be identified, directly or through identifiers linked to the subjects; and
– (ii) any disclosure of the human subjects' responses outside the research
could reasonably place the subjects at risk of criminal or civil liability or be
damaging to the subjects' financial standing, employability, or reputation.
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Other Exempt Categories
(3) Research involving the use of educational tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures, or observation of public behavior
that is not exempt under paragraph (b)(2) of this section, if:
(i) the human subjects are elected or appointed public officials or candidates for public
office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the
personally identifiable information will be maintained throughout the research and
thereafter.
(4) Research involving the collection or study of existing data, documents, records,
pathological specimens, or diagnostic specimens, if these sources are publicly available or
if the information is recorded by the investigator in such a manner that subjects cannot be
identified, directly or through identifiers linked to the subjects.
(5) Research and demonstration projects which are conducted by or subject to the
approval of department or agency heads, and which are designed to study, evaluate, or
otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining
benefits or services under those programs; (iii) possible changes in or alternatives to
those programs or procedures; or (iv) possible changes in methods or levels of payment
for benefits or services under those programs.
(6) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome
foods without additives are consumed or (ii) if a food is consumed that contains a food
ingredient at or below the level and for a use found to be safe, or agricultural chemical or
environmental contaminant at or below the level found to be safe, by the Food and Drug
Administration or approved by the Environmental Protection Agency or the Food Safety
and Inspection Service of the U.S. Department of Agriculture.
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Expedited Review
Minimal risk studies that do not meet
exempt criteria
Does not have to be reviewed at fully
convened meeting
9 categories of expedited research
– Category 5, 6, and 7 are most common at
Homewood
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Expedited Categories
(5) Research involving materials (data, documents, records, or specimens)
that have been collected, or will be collected solely for nonresearch
purposes
(6) Collection of data from voice, video, digital, or image recordings made
for research purposes.
(7) Research on individual or group characteristics or behavior (including,
but not limited to, research on perception, cognition, motivation, identity,
language, communication, cultural beliefs or practices, and social behavior)
or research employing survey, interview, oral history, focus group, program
evaluation, human factors evaluation, or quality assurance methodologies.
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Full Board Review
Greater Than Minimal Risk Transactions
Protocols are pre-reviewed by a HIRB Office
Full Review conducted by IRB members at a convened
meeting
– Determination is made for each protocol:
Approved
Contingently Approved
Deferred
Disapproved
A full quorum of at least 5 members is assembled
– Non-scientists/unaffiliated members
Decision is rendered by a majority of the assembled quorum
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Examples of Research That
May be Minimal Risk
Survey
Interview
Focus groups
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IRB must determine that the following
requirements have been satisfied:
Criteria for IRB Approval of Research
45 CFR 46.111
1. Risk(s) to participants are minimized
2. Risk(s) to participants are reasonable in relation to
anticipated benefits and to the importance of the expected
knowledge.
3. Selection of participants is equitable
4. Informed consent will be sought and the consent form
includes all elements and in language understandable to
participants
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IRB Review Requirements
(cont.)
5. Provisions for obtaining and documenting informed
consent are appropriate
6. Privacy and confidentiality are adequately protected
If Applicable:
– 7. Research plan makes provisions for data safety
monitoring
– 8. Additional safeguards are included to protect the
rights and welfare of vulnerable participants.
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Vulnerable Populations
Pregnant Women, Human Fetuses and
Neonates (45 CFR 46, Subpart B)
Prisoners (45 CFR 46, Subpart C)
– (requires prison advocate review)
Children (45 CFR 46, Subpart D)
Cognitively impaired individuals
Students/employees
Elderly
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Principal Investigator (PI)
Must a faculty member or senior staff
member
The IRB recognizes only one PI for
each project
Students can not be PIs
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How to Get Started
with Your Research Study
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PI Responsibilities:
Investigators must have expertise in the area
Assures that the conduct of the study complies
with all ethical, scientific, and financial principles
of JHU and the Federal government
– Knows and follows applicable regulations (Federal,
state, institutional policies)
– Upholds ethical principles (Belmont Report)
Assures that there are adequate resources
(space, staff, funding) to accomplish the
research
Assures that all team members are adequately
trained
Responds to participant concerns/complaints
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Basic Educational Requirements for
Investigators and Research Staff
CITI Training (online)
– All individuals engaged in human participant research at
JHU Homewood are required to completed CITI training
every three years
https://www.citiprogram.org
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To make your application
process smoother…
Plan ahead!!
• Usually a few revisions of the protocol
are necessary
• Submit early!!!
• Exempt and expedited studies take up to a
month
• Full board studies take longer; usually at
least 2 months because the fully convened
IRB only meets once a month
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You study will likely take longer to
be reviewed if it involves:
Children
Cognitively Impaired
Prisoners
International Research
•You should call the IRB Office discuss your
research plans if your study will involve any
of these!
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For more information:
•Visit the HIRB website at
http://web.jhu.edu/HomewoodIRB/policies.html
•Contact the HIRB Office
• 101 Whitehead Hall
• 410-516-6580
• [email protected]
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Questions?
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