Transcript Human Subjects Protection Program Appalachian State University

Human Subjects Protection Program
Appalachian State University
Robert R. Johnson
Graduate Studies and Research
Appalachian State University
From: Guidelines for the Review of Research Involving Human
Subjects
http://www.graduate.appstate.edu/rsp/irb/index.shtml
 If I asked you to participate in a study I was
conducting, what types of things would you like
to know?
Development of Protection of Human Subjects
 For much of its history, the norms for
involving human participants in research
were thought best left to the individual
investigators. Slowly, and largely in
response to revelations of specific abuses of
human subjects in research, consideration
was given to what constituted ethical
research and what type of oversight was
needed.
EVENTS
 Nazi Atrocities of World War II
1. Key task of the prosecutors was to distinguish
between Nazi experiments and U. S. wartime research, both of which used
human subjects.
2. AMA developed code of research ethics (1946)
3. Nuremberg Code – Judges presented 10 “basic
principles” for research using human subjects.
 Brooklyn Jewish Chronic Disease Hospital
1. This 1964 NIH funded study involved the injection of cancerous cells
into debilitated elderly patients.
2. The investigators claimed to have informed consent, but many of the
patients were incapacitated or did not speak English and those able to give
consent were not told that the cells to be injected were cancerous.
Events (cont.)
 Willowbrook State School for the Retarded
1. This study involved the injection of a mild strain of the hepatitis virus to
children entering the hospital.
2. Although parental consent was obtained, the consent form may have been
misleading, as desperate parents may have been unduly influenced by the availability
of preferential and later exclusively research-related admissions to the institution.
 Tuskegee Syphilis Study (circa 1932)
1. Although a formal protocol never existed, the study intended to trace the
natural history of syphilis in the poor, black males living in Macon County, Alabama.
2. Participants were not told the purpose of the study. They were led to believe
that they were being treated for syphilis.
3. Investigators continued the study even after penicillin became widely
available for the treatment of syphilis.
4. In exchange for participation, the men received some unrelated health care,
free meals and transportation, and later in the study, to encourage autopsy, a $50.00
burial stipend.
The Belmont Report
On September 30, 1978, the National
Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research
submitted its report entitled, “The Belmont
Report: Ethical Principles and Guidelines for the
Protection of Human Subjects in Research.”
This report set forth the basic ethical principles
underlying acceptable conduct of research
involving human subjects.
Belmont Report
RESPECT FOR PERSONS involves a recognition of the personal dignity and
autonomy of individuals, and special protection of those persons with
diminished autonomy.
This sets for the requirement for informed consent
-information
subjects must be given sufficient information on which to
decide whether or not to participate
-comprehension
subjects must be able to comprehend the information that is
given to them
-voluntariness
subjects’ consent to participate must be free from coercion and
undue influence
Belmont Report
BENEFICENCE entails an obligation to protect persons
from harm by maximizing anticipated benefits and
minimizing possible risks of harm.
This involves the concept of risk/benefit
assessment.
-all possible harms, not just physical and
mental must be considered
Belmont Report
Justice requires that the benefits and burdens of research be distributed fairly.
This principle mandates that the selection of research subjects must be
the result of fair selection procedures and must also result in fair selection
outcomes.
-subjects should not be selected either because they are favored
by the researcher or they are held in disdain
-care should be taken to avoid the injustice that arises from
social, racial, sexual, and cultural biases institutionalized in
society
-subjects should not be selected because they are readily
available or they are easily manipulated because of such things
as illness or economic condition
Appalachian State University
Institutional Review Board (IRB) Statement of Purpose
The IRB is responsible for protecting the rights
and welfare of human subjects participating in
research projects. The IRB acts according to
policies set forth the United States Department
of Health and Human Services Public Health
Service Act as amended (45 CFR 46).
Any research that involves human subjects,
whether funded internally or from extramural
sources, or not funded, that is undertaken by
ASU faculty, staff, or students, supported by or
conducted at ASU, must be reviewed and
approved by the IRB prior to soliciting subjects
or collecting any data from any human subjects.
Definitions
Research refers to a systematic investigation,
including research development, testing and
evaluation, designed to contribute to
generalizable knowledge.
Human subject refers to a living individual about
whom a researcher obtains either identifiable
private information, or data through intervention
and/or interaction with the individual.
Student Research
Research conducted by students, such as thesis research
and some class projects, requires the approval of the
IRB prior to execution.
Individual projects conducted primarily for instructional
purposes within the context of a formal class, and not
designed to contribute to generalizable knowledge, do
not meet the definition of “research” as defined in the
federal guidelines.
Review Process
Request for Review must be submitted to the IRB
(c/o Graduate Studies and Research)
http://www.graduate.appstate.edu/rsp/irb/reqforrev/index.shtml
Review Process (cont.)
In order for any research protocol to be approved, the IRB must determine that all
of the following requirements are satisfied:
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Risks to the subjects are minimized and are reasonable in relation to
anticipated benefits of the research,
selection of the subjects is equitable given the purposes and setting of the
research,
appropriate informed consent will be sought for each subject of the
subject’s legally authorized representative, and such consent will be
appropriately documented,
the research plan makes appropriate provision for monitoring the data
collected to insure the safety of subjects,
Appropriate provisions are made to protect the privacy of subjects and to
maintain the confidentiality of the data, and
where some or all of the subjects are likely to be vulnerable to coercion or
undue influence, appropriate additional safeguards have been included to
protect the rights and welfare of these subjects.
Categories of Review*
*NOTE: Only the IRB Administrator is authorized
to determine which protocols may be subject to
limited review or may be exempt from review by
the Board.
EXEMPT RESEARCH
EXPEDITED REVIEW
FULL BOARD REVIEW
Exempt Research - examples
 Research conducted in established or commonly accepted
educational settings, involving normal educational practices, such
as (a) research on regular and special education instructional
strategies, or (b) research on the effectiveness of or the
comparison among instructional techniques, curricula, or
classroom management methods.
NOTE: The Board interprets this provision to exempt from review those research
protocols in which subjects will consist exclusively of students in a faculty member’s
own classes. However, where the research requires using students in classes which are
the usual responsibility of other faculty or staff members, the research protocol will
require review and approval by the Board (unless the research is exempt under some
other provision of law or University policy.
The Board makes this interpretation based on its belief that the phrase “normal
educational practices” is intended to encompass only those situations in which a faculty
member, or a student under a faculty member’s supervision who is also an instructor,
conducts research in his or her own classroom.
Exempt Research (cont.)
 Research involving the use of educational tests (cognitive,
diagnostic, aptitude, achievement), surveys, interviews or
observation of public behavior, unless: (i) information obtained is
recorded in such a manner that participants can be identified,
directly, or though identifiers linked to the subjects; and (ii) any
disclosure of an individual’s response(s) outside of 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.
 Research involving the collection or analysis of existing data,
documents, records, pathological specimens, or diagnostic
specimens, if such sources are a matter of public record or if the
information is recorded in such a manner that subjects cannot be
identified, directly or though identifiers linked to the subjects.
Expedited Research*
*NOTE: Research activities present no more than minimal risk,
where minimal risk is defined as the probability and magnitude
of harm(s) or discomfort(s) anticipated in the research are not
greater than those ordinarily encountered in daily life or during
the performance of routine physical or psychological
examinations.
*NOTE: The expedited review procedure may not be used where
the identification of the subjects and/or their responses would
reasonably place them at risk of criminal or civil liability or be
damaging to the subjects’ financial standing, employability,
insurability, or reputation, or be stigmatizing, unless reasonable
and appropriate protections will be implemented so that risks
related to invasion of privacy and breach of confidentiality are no
greater than minimal.
Expedited Research - examples
 Collection of data from voice, video, digital, or
image recordings made for research purposes
 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.
Expedited Research - examples
 Collection of blood samples by finger stick, heel
stick, ear stick, or venipuncture as follows:
from healthy non-pregnant adults who weigh at least
110 pounds (there are limits to amount drawn).
from other adults and children, taking into
consideration the age, weight, and health of the
subjects (there are specifications on method of
collection, amount, etc…..)
Full Board Review
 All protocols that do not qualify as either
“Exempt” or “Expedited”
Protected Classes
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Children
Prisoners
Fetuses
Pregnant women
Human in-vitro fertilization
Review
Complete the Request for Review
http://www.graduate.appstate.edu/rsp/irb/reqforrev/index.shtm
NOTE: Review may take up to one month.
NOTE: Approval may be up to one year. Certain
protocols may be reviewed more often than yearly (e.g.
high risk/benefit ratio).
Procedures to Initiate Review
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Name(s) and department(s) of investigator(s)
Title of study
Signature of responsible faculty member
Whether or not external funding is proposed
Purpose of study
Description of subjects
Description of methodology, including a copy of instruments used
Potential benefits and risks to the subjects
Anticipated beneficial knowledge resulting from the study
Qualifications of investigator(s)
Description of any deception
A copy of any recruiting materials or scripts
Method for insuring informed consent, including a copy of the proposal
informed consent statement
Informed Consent
A copy of the Informed Consent must be submitted with the Request for Review. The
following elements must be present in each Informed Consent Document.
1)
the title of the study, information on the purpose(s) of the research, a description of
the method(s) and procedure(s) to be followed, including, the intention to publish or
disseminate the results of the study, and the amount of time the subject will spend in
actual project participation.
2)
a description of any reasonably foreseeable risks or discomforts to the subject,
including expected total time participation. If disguised of deceptive procedures are
to be used, a plan to debrief participants must be explained to the IRB.
3)
a description of any benefits to the subject or to any others as a result of the
information obtained from the research.
4)
A disclosure of appropriate alternative procedures that may be advantageous to the
subject when making an informed decision whether or not to participate in the
research (this pertains primarily to medical research and drug trials).
a description of the measures taken to insure the confidentiality of data and the
anonymity of individual subjects, if applicable, as well as any circumstances under
which confidentiality CANNOT be guaranteed.
5)
Informed Consent (cont.)
6.
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The name and phone number of a contact person(s) who will be available to
answer any questions the subject or his/her authorized representative may
have regarding the research. This third party is the IRB Administrator.
a clear explanation that the research is voluntary and that no penalty or loss
of benefits which the subject is otherwise entitled will occur should the
subject either refuse to participate or decide to discontinue participation (at
any time).
disclosure of costs to the subject, if any, because of his/her participation in
the research: disclosure of compensation/reward to the subject, if any, for
his/her participation in the research.
for projects of more that minimal risk to subjects, a statement must be
included that describes how the costs of medical care or other therapies
required as a result of injury of mishap while participating in the research
will be handled.
the approval and expiration date for the Consent Form
the Consent Form must not include a statement releasing the investigator,
sponsor, institution or its agents from liability or negligence.
Composition of IRB
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Scientist
Non-scientist
Ethicist
Non-affiliated
Associate Dean of Graduate School
NOTE: Each member is appointed by the
Chancellor for fixed term.