Transcript Mission of the IRB - University of Idaho

The University of Idaho
University of Idaho
Institutional Review Board (IRB)
Mission of the IRB
The IRB is charged with providing independent,
objective review of research involving humans
subject in order to:
• protect the rights and welfare of human
research subjects, and
• ensure compliance of human subject
research with established ethical standards
and federal, state, and local regulations and
policies.
History of Human Subject Research Regulation
Precursors of Modern Research Ethics
Hippocrates, “Hippocratic Oath:” “…I will do
no harm or injustice to [my patients].
Immanuel Kant, Metaphysics of Morals:
“Act in such a way that you treat humanity,
whether in your own person or in the person
of any other, always at the same time as an
end and never merely as a means to an end.”
History of Human Subject Research Regulation
Thomas Percival, Medical Ethics; or, a Code of
Institutes and Precepts Adapted to the Professional
Conduct of Physicians and Surgeons(1803)
 “[N]ew methods of chirurgical treatment should be devised
but … should be scrupulously and conscientiously governed
by sound reason, just analogy, or well-authenticated facts …
[N]o such trials should be instituted without a previous
consultation of the physicians or surgeons according to the
nature of the case.”
 Experimental treatments permissible when all else fails, and
when they can serve the public good.
History of Human Subject Research Regulation
William Beaumont (1833)
 There must be recognition of an area in which
experimentation in man is needed
 Some experimental studies in man are justified
when the information cannot otherwise be
obtained
 The investigator must be conscientious and
responsible…[A] well-considered, methodological
approach is required so that as much information
as possible will be obtained whenever a human
subject is used. No random studies are to be
made.
History of Human Subject Research Regulation
William Beaumont, cont.
 The voluntary consent of the subject is necessary
 The experiment is to be discontinued when it
causes distress to the subject
 The project must be abandoned when the subject
becomes dissatisfied
American Medical Association Code of
Ethics (1847)
History of Human Subject Research Regulation
Claude Bernard (“founder of experimental
medicine”), Introduction to the Study of Experimental
Medicine (1865)
 Permissible to save, cure, or gain personal benefit
for the subject
 “Those [experiments] that can only harm are
forbidden. Those that are innocent are
permissible, and those that may do good are
obligatory.”
History of Human Subject Research Regulation
Walter Reed (1900)
 Conducted a series of experiments on U.S.
soldiers and Spanish immigrants to Cuba to
determine whether mosquitoes served as
intermediate hosts for yellow fever.
 Coded names of participants to shield identities
 Used written informed consent for experiment
participants. (Oldest extant informed consent
documents)
History of Human Subject Research Regulation
Walter Reed (1900)
Informed Consent Elements
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Autonomy (respect for persons): “gives his consent…for the reasons and
under the conditions…”
Voluntary Participation : “being in the enjoyment and exercise of his own
free will”
Risks : “In case of the development of yellow fever in him, that he endangers
his life to a certain extent.”
Benefits : “He will receive from the said commissioner the greatest care and
the most skillful medical service.”
Compensation: “he will receive the sum of $100 in American gold . . .”
Study withdrawal conditions: “The undersigned binds himself not to leave
the bounds of this camp during the period of the experiments and will forfeit
all right to the benefits named in this contract if he breaks this agreement.”
History of Human Subject Research Regulation
The Nuremburg Code (1947)
• Principles enumerated by the Nuremburg
Military Tribunals during proceedings against
23 German physicians and administrators for
war crimes and crimes against humanity
• Charges arose from medical experimentation
on concentration camp prisoners
• First international document to advocate
voluntary participation and informed consent
History of Human Subject Research Regulation
1939-1944 Nazi Experimentation
Findings of the Tribunal:
In every single instance appearing in the record,
subjects were used who did not consent to the
experiments;…
In no case was the experimental subject at liberty of
his own free choice to withdraw from any experiment.…
History of Human Subject Research Regulation
1939-1944 Nazi Experimentation, cont.
All of the experiments were conducted with
unnecessary suffering and injury and but very little, if
any, precautions were taken to protect or safeguard the
human subjects from the possibilities of injury, disability,
or death.
In every one of the experiments the subjects
experienced extreme pain or torture, and in most of
them they suffered permanent injury, mutilation, or
death, either as a direct result of the experiments or
because of lack of adequate follow-up care.
History of Human Subject Research Regulation
Nuremburg Code and Voluntary Consent
 The duty and responsibility for ascertaining the
quality of the consent rests upon each individual who
initiates, directs or engages in the experiment. It is a
personal duty and responsibility which may not be
delegated to another with impunity
 This means that the person involved should:
 Have legal capacity to give consent
History of Human Subject Research Regulation
 Situated as to be able to exercise free power of choice, …;
and should have sufficient knowledge and comprehension of
the elements of the subject matter involved as to enable him
to make an understanding and enlightened decision.
 This latter element requires that before the acceptance of
an affirmative decision by the experimental subject there
should be made known to him the nature, duration, and
purpose of the experiment
 The method and means by which it is to be conducted
 All inconveniences and hazards reasonably to be
expected;
 The effects upon his health or person which may
possibly come from his participation in the experiment.
History of Human Subject Research Regulation
The Declaration of Helsinki (1964)
• Principles established by the World Medical
Association to guide physicians conducting
medical research involving humans subjects
Differentiated between therapeutic and nontherapeutic research:
• Therapeutic research gives patients the opportunity to receive
an experimental treatment that might have beneficial results.
• Non-therapeutic research is conducted to generate knowledge
for a discipline, and might have positive results in future
patients.
History of Human Subject Research Regulation
1966 NIH Policies for the Protection of Human
Subjects
 Established the IRB as one mechanism through which
human subjects would be protected.
1974 National Research Act (raised NIH policy to
regulation)
 Required regulations for protection of human subjects
 Informed consent
 Institutional Review Boards
 Created National Commission for the Protection of
Human Subjects of Biomedical and Behavioral
Research
History of Human Subject Research Regulation
The Belmont Report (1978)
Established three basic ethical principles:
Principle 1: Respect for persons
• Individuals should be treated as autonomous agents
• Persons with diminished autonomy are entitled to protection.
Application: Informed consent
– Subjects, to the degree that they are capable, must be given the opportunity
to choose what shall or shall not happen to them
– The consent process must include three elements:
• information,
• comprehension, and
• voluntariness.
History of Human Subject Research Regulation
The Belmont Report
Principle 2: Beneficence
• Human subjects should not be harmed
• Research should maximize possible benefits and minimize
possible harms
Application: Assessment of risks and benefits
– The nature and scope of risks and benefits must be assessed in a
systematic manner
History of Human Subject Research Regulation
The Belmont Report
Principle 3: Justice
• The benefits and risks of research must be distributed fairly.
Application: Selection of subjects
– There must be fair procedures and outcomes in the selection of research
subjects
IRB and Compliance
• Articulates ethical norms for “local” researchers
• Works with community stakeholders to fashion local norms and
practices for research
• Serves as “organizational conscience:” balances external
demands with organizational conditions and priorities
• Implements “enforced self-regulation:” establishes local ethical
codes within federal regulatory framework.
Federal Regulation of Human Subject Research
The Common Rule (Federal Policy for the
Protection of Human Subjects, 56 FR
28003, June 18, 1991) :
46 CFR 45 (HHS implementation of the
Common Rule)
The Common Rule
• Defines regulated research
• Provides regulatory authority for IRB review
• Establishes requirements for IRB review
• Identifies criteria for IRB approval of research
• Creates additional protections for children
Definition of Human Subject Research
(45 CFR 46.102(d) and (f))
Research – a systematic investigation including
research development, testing and evaluation,
designed to contribute to generalizable
knowledge
Human Subject – a living person about whom an
investigator conducting research obtains
1) data through an intervention or interaction with the
individual, or
2) identifiable private information
Three Types of Review under the Common Rule
Exempt (45 CFR 46.101)
• Limited categories of research exempt from Federal
regulation and IRB review and oversight.
Expedited Review (45 CFR 46.110)
• Review by one or more IRB members of research that
within certain prescribed categories and presents no
more than minimal risk. Full review standards are
applied.
Full Board Review
• Convened meeting of board, usually reserved for
protocols presenting more than minimal risk, research
that cannot be expedited, or projects presenting issues
not previously considered by HAC.
Exempt Research (45 CFR 46.101(b)(1)-(6))
Exemption 1: Normal Educational Practices and Settings
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 on the comparison among instructional techniques, curricula,
or classroom management methods.
Exempt Research, Cont.
Exemption 2: Anonymous Educational Tests, Surveys,
Interviews, or Observations
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 the human subjects can be identified,
directly or indirectly through identifiers linked to the
subjects; AND (ii) any disclosure of the subject's
responses outside the research could reasonably place
the subject at risk of criminal or civil liability, or be
damaging to the subject’s financial standing,
employability, or reputation.
Exempt Research, Cont.
Example: Web survey (Survey Monkey) that
allows for the anonymous completion of the
survey (provided that the subject matter is
not deemed “sensitive” and/or involves
children/minors).
Note: Exemption 2 (46.101(b)(2)) does not apply to
research on children, unless research is limited to
“observation of public behavior when the
investigator(s) do not participate in the activities
being observed.” (45 CFR 46.401(b))
Exempt Research, Cont.
Exemption 3: Identifiable Subjects in Special
Circumstances
Research involving the use of educational tests…, survey
procedures, or observations of public behavior that is not
exempt under (b)(2), if: (i) subjects are elected or
appointed public officials or candidates for public office; or
(ii) federal statutes require that the confidentiality of the
personally identifiable information will be maintained
throughout the research and thereafter.
• usually limited to senior public officials, such as school
superintendents and mayors, rather than covering public
employees such as teachers and policemen
Exempt Research, Cont.
Exemption 4: Collection and Study of Existing Data
Research involving the collection or study of existing data,
documents, records, pathological specimens, or
diagnostic specimens, if the sources are publicly available
or if the information is recorded by the investigator in such
a manner that subjects cannot be identified, directly,
indirectly, or through identifiers linked to the subjects.
Not appropriate for:
• de-identified data that can be linked through use of a code
to individuals
• research involving existing data in combination with data
collected after initiation of research.
Exempt Research, Cont.
Exemption 5: Public Benefit or Service Program
Research and demonstration projects that are conducted by or
subject to approval of department or agency heads, and which
are designed to study, evaluate, or otherwise examine: (i) public
benefits or service programs; (ii) procedures for obtaining
benefits; (iii) changes or alternatives to those programs; (iv)
possible changes in methods or levels of payment under those
programs.
Not appropriate for:
• research involving programs for vulnerable subjects
• research involving data compiled for the program that would
be considered private by the subjects.
Exempt Research, Cont.
Exemption 6: Taste and Food Evaluation and
Acceptance Studies
Taste and food quality evaluation and consumer acceptance
studies…
Not appropriate for:
• consumption of food by subjects that might pose physical
risks
Expedited Review
Two general categories of research available
for expedited review (46.110(b)):
1) Research activities presenting no more than
minimal risk and listed in NIH adjunct list of
categories qualifying for expedited review
2) “minor changes in previously approved
research during the period (1 year or less)
for which the approval is granted”
Expedited Review Categories
Category 1
Clinical studies of drugs and medical devices only when:
a) research on drugs that does not require an
investigational new drug application (21 C.F.R. 312).
b) research on medical devices that does not require an
investigational device exemptionapplication (21 C.F.R.
812).
Category 2
Collection of blood samples (finger stick, heel stick, ear stick,
or venipuncture), with constraints on amounts drawn and
draw frequency
Expedited Review Categories
Category 3
Prospective collection of biological samples for research
purposes by non-invasive means.
Category 4
Collection of data through noninvasive procedures (not
involving general anesthesia or sedation) routinely
employed in clinical practice, excluding procedures
involving x-rays or microwaves.
Expedited Review Categories
Category 5
Research involving materials (data, documents, records, or
specimens) that have been or will be collected solely for
nonresearch purposes.
Category 6
Collection of data from voice, video, digital, or image
recordings made for research purposes.
Category 7
Research on group characteristics or behavior…or research
employing survey, interviews, oral history, focus groups,
program evaluation, human factors evaluation, or quality
assurance methodologies.
HAC Expedited Review Process
Application Intake: receipt of application by
HAC coordinator and review for common
errors, with corrections requested as needed.
First Review: Evaluation by HAC member
(often HAC Chair), and identification of any
amendments necessary to meet regulations
Second Review: Evaluation by second HAC
member, and identification of any
amendments necessary
HAC Expedited Review Process
Review and Consolidation of HAC
Conditions: Review of HAC member
comments (by Chair) and communication of
HAC conditions for approval to applicant
Approval of Protocol: Approval of research
protocol, once investigator have provided
properly amended application or associated
materials.
Full Board Review
• Evaluation of application for protocol
presenting more than minimal risk to subjects
by HAC members.
• Investigator appears at convened HAC
meeting to answer questions regarding
proposed protocol.
Informed Consent
Informed consent (minimal risk) requires:
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Statement that study involves research
Explanation of the purpose of the research
Expected duration of subject’s participation
Identification of procedures that are experimental
Descriptions of benefits to subject and/or to others that
may reasonably be expected
6) Disclosure of appropriate alternative, beneficial
procedures or courses of treatment (if any)
7) Statement describing the extent, if any, to which
confidentiality of records will be maintained
Informed Consent
8) Statement describing the extent, if any, to which
confidentiality of records will be maintained
9) Explanation of whom to contact for pertinent answers to
questions about the research, research subject’s rights,
and in the event of a research related to injury to the
subject.
10) Statement that participation is voluntary, that refusal to
participate involves no penalty or loss of benefits to which
the subject is otherwise entitled, and that the subject may
discontinue participation at any time without penalty
Presumption that consent will be
documented in written form.
Informed Consent – Waiver of Documentation
An IRB may waive the requirement of a signed consent
form for all or some of the subjects, if:
1) The only record linking the subject and the research
would be the consent document and the principle
risk would be potential harm resulting from a breach
of confidentiality.
2) The research presents no more than minimal risk of
harm to the subjects and involves no procedures for
which written consent is normally required outside
the research context.
Informed Consent – Waiver of Documentation
If the IRB approves waiver of written documentation of
consent, it may still require:
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Statement at the beginning of the survey/interview
that incorporates the elements of informed consent
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Written consent statement at the initial screen or cover letter of a
survey (web/mail)
Consent elements in invitation to participate in survey (e-mail
communication/mailing)
Oral consent prior to initiating an interview (with subsequent written
statement)
Statement at the conclusion of survey/interview
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Oral consent prior to initiating an interview (with subsequent written
statement)
Documents to Submit with Application
• Survey instrument
• Interview Questions
• Consent Script (Oral Consent)
• Written consent statement/description of
research
Common Research Risks (Non-Medical)
• Disclosure of private/confidential information
• Psychological risks (insult, trauma)
• Social risks (embarrassment, rejection by
peers)
• Economic risks (loss of job, credit, insurance)
• Legal risks (subpoena, fine)
• Inconvenience/intrusiveness (boredom,
frustration)
Common Application Problems
Failure to identify potential risks:
• Do not assume that there will be no potential risks
• At minimum, the collection of confidential information (for
non-anonymous research) poses the risks of disclosure
• Address any potential psychological, social, economic, or
legal risks
Common Application Problems
Anonymity vs. Confidentiality
• Anonymity - Providing anonymity of information collected from
research participants means that either the project does not
collect identifying information of individual subjects (e.g., name,
address, Email address, etc.), or the project cannot link
individual responses with participants’ identities. A study should
not collect identifying information of research participants
unless it is essential to the study protocol.
• Confidentiality - Maintaining confidentiality of information
collected from research participants means that only the
investigator(s) or individuals of the research team can identify
the responses of individual subjects; however, the researchers
must make every effort to prevent anyone outside of the project
from connecting individual subjects with their responses.
Common Application Problems
“Children”
• Anyone under the age of 18 cannot consent to be a
participant in research.
• For individuals under 18, a researcher must obtain
legal consent from a parent or guardian and assent
from the child or minor (as required by the IRB).
• Assent - a child's affirmative agreement to participate
in research.
• Mere failure to object should not, absent affirmative agreement, be
construed as assent. (45 CFR 46.402(b))
The University of Idaho
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