Research Ethics The Protection of Human Subjects

Research Ethics
The Protection of Human Subjects
Presented by
Carolyn Strong, CIM
Research Coordinator
Office of Sponsored
Programs Administration
JMAC Bldg 6, Suite 26
Phone: (540) 568-2318
Email: [email protected]
IRB Mission
• To oversee and review all research projects
that involve research with human subjects. It
is important to note that the IRB reviews all
projects, not just externally supported
activities. These reviews include faculty/
student research and classroom activities as
well.
• See IRB Policy for more details:
http://www.jmu.edu/JMUpolicy/1104.shtml
IRB Membership
•
•
•
•
At least 5 members
At least 1 scientist
At least 1 non-scientist
At least 1 person not affiliated with the
institution
• Members with varying backgrounds
• Diverse membership (gender, race, cultural
background)
IRB Responsibilities
SAFEGUARD THE RIGHTS AND
WELFARE OF HUMAN SUBJECTS
Authority of the IRB
• The IRB’s decision to deny approval of a
protocol (or to deny permission to recruit
subjects on-campus) cannot be overridden by
the president, any member of the
administration, or the Board of Trustees of
the institution.
**THE IRB’S DECISION IS FINAL!
Definitions
Research
• “a systematic investigation, including
research development, testing and
evaluation, designed to develop or
contribute to generalizable knowledge.”
Definitions
Human subjects
• “living individual(s) about whom an
investigator (whether professional or
student) conducting research obtains
(1) data through intervention or
interaction with the individual, or
(2) identifiable private information.”
Brief History
• 1947 – (26) Nazi physicians are tried at
Nuremberg, Germany, for research atrocities
performed on prisoners of war.
• This results in the Nuremberg Code, the first
internationally recognized code of research
ethics, issued by the Nazi War Crimes
Tribunal (a prototype for later codes of
ethics)
Brief History
• 1940s – A series of research abuses starts in
Tuskegee, Alabama.
• In one study on the natural history of
untreated syphilis, poor, black males are
uninformed of their disease and denied
treatment even after a treatment is found in
1947.
• The abuses were revealed in 1972.
Brief History
• 1960s: Milgram Studies of Obedience to
Authority
 Basic purpose – to understand why people follow the
directions of authority figures even when they are told
to do things that are cruel or unethical.
 Experiment – subjects deceived into thinking they were
helping with a study to evaluate the role of negative
reinforcement on learning. Subject was instructed to
deliver an electric shock when a person who was
playing the role of the “learner” answered a question
incorrectly.
 Results – many of the subjects experienced extreme
psychological distress after understanding the level of
cruelty of their actions.
What Research Must Be Reviewed?
• All research at James Madison University that
involves humans, human tissue, or records
gathered on human subjects requires IRB
review.
• This is true regardless of its funding source or
area of research.
Basic Principles
Autonomy
• Each person should be given
the respect, time, and
opportunity necessary to
make his or her own
decisions.
• Participants must be given the
information they need to
decide to enter a study or not
to participate.
• There should be NO pressure
to participate.
Basic Principles
Beneficence
• Obligates the researcher to secure the
well-being of all study participants.
• It is your responsibility to protect
participants from harm, as well as ensure
that they experience the possible benefits
of involvement.
**Maximize possible benefits and
minimize possible harms.
Basic Principles
Justice
• Distribute the risks and potential benefits
of the research equally among those who
may benefit from the research
• Selection of subjects not based on
convenience, subject availability,
compromised position of subjects, subject
manipulability, or language barrier.
IRB Review Criteria
The IRB uses the following criteria to
review your research:
1. Risks to subjects are minimized.
2. Risks to subjects are reasonable in
relation to anticipated benefits.
3. Selection of subjects is equitable.
IRB Review Criteria
4. Informed consent is:
a. Sought from each prospective participant or his or
her legally authorized representative, and
b. Properly documented.
5. Adequate preparation is taken to protect
the privacy and confidentiality of subjects.
6. Adequate provisions are made for the
ongoing monitoring of subjects’ welfare.
Categories of Review
Exempt Review
• Research activities in which the only
involvement of human subjects will be in
one or more of the listed categories found
at the following URL:
http://www.jmu.edu/sponsprog/irb/irbProtocolExemptionGuide.doc
Categories of Review
• Category 1 - 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.
• Category 2 - Research involving the use of educational tests
(cognitive, diagnostic, aptitude, achievement), survey procedures,
interview procedures, or observation of public behavior, unless: (a)
information obtained is recorded in such a manner that the human
participants can be identified, directly or through identifiers linked to
the participants; and (b) any disclosure of the human participants'
responses outside the research could reasonably place the participants
at risk of criminal or civil liability or be damaging to the participants'
financial standing, employability, or reputation.
• (Note: Exemption for survey and interview procedures does not apply
to research involving children. Exemption for observation of public
behavior does not apply to research involving children except when the
investigator does not participate in the activities being observed.)
Categories of Review
• Category 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 Category 2 above if: (a) the human participants are
elected or appointed public officials or candidates for public office; or
(b) federal statute requires without exception that the confidentiality of
the personally identifiable information will be maintained throughout
the research and thereafter.
• Category 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 participants
cannot be identified, directly or through identifiers linked to the
participants.
Categories of Review
• Category 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: (a) public benefit or service programs; (b) procedures for
obtaining benefits or services under those programs; (c) possible
changes in or alternatives to these programs or procedures; or (d)
possible changes in methods or levels of payment for benefits or
services under those programs.
• Category 6 - Taste and food quality evaluation and consumer
acceptance studies: (a) if wholesome foods without additives are
consumed; or (b) 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.
Categories of Review
Full Board Review
• Research activities conducted outside the classroom and/or
departmental research participant pool if they involve:
 minors (i.e., persons under the age of 18),
 external funding involved
 a targeted population of adults whose ability to freely give informed consent may
be compromised (i.e., persons who are socio-economically, educationally, or
linguistically disadvantaged, cognitively impaired, elderly, terminally ill, or
incarcerated),
 pregnant women and/or fetuses who may be put at risk of physical harm,
 a topic of a sensitive or personal nature, the examination or reporting of which
may place the research participant at more than minimal risk, or
 any type of activity that places research participants at more than minimal risk.
Categories of Review
The schedule for full board submission
deadlines and convened meetings can be
found at the following URL:
http://www.jmu.edu/sponsprog/irb/irbMtg-SubmDates.html
Categories of Review
Expedited Review
• All other research that does not qualify for
Exempt or require Full Board review (e.g., no
more than minimal risks & participants at
least 18 years of age or older)
Researcher’s Responsibilities
• Educate the participants about risks and
benefits
• Obtain consent before involving participants
in the research
• Keep participants informed
IRB Online Certification Training
• Since October 1, 2000, federal guidelines mandate
all investigators and key personnel directly
responsible for the design and conduct of the human
subjects part of a project be trained prior to working
with human subjects.
• To assist in preparing a protocol that is consistent
with IRB procedures and reviewer criteria, follow the
steps to complete the four training modules located
on the Office of Sponsored Programs’ web site:
http://www.jmu.edu/sponsprog/irb/irbtraining.html.
• IRB training for students is valid for up to 1 year.
IRB Forms
IRB Forms can be found at the following URL:
http://www.jmu.edu/sponsprog/irb/irbforms.html
Contact for IRB Assistance
CAROLYN STRONG, CIM
Research Coordinator
JMAC Bldg 6, Suite 26
Phone: (540) 568-2318
Email: [email protected]