Transcript Protection of Human Subjects in Research

Protection of Human Subjects
in Research
Whitworth University
Institutional Review Board
The Board
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Scientist
Non-scientist
Persons with expertise in the types of
special populations reviewed
Person with expertise in regulations
Community member
Whitworth’s IRB
We review
 behavioral and educational research
 faculty research
 student research when it is a requirement for
graduation such as the psychology research
projects or a master’s thesis.
 research from off campus which uses our
student body as subjects (occasionally)
Nuremberg Code 1947
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Voluntary consent
Anticipate scientific
benefits
Benefits outweigh
risks
Animal experiments
first
Avoid suffering
Jeremy Sugarman, MD, MPH, MA, copyright
Nuremberg Code 1947
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No intentional death
or disability
Protection from
harm
Subject free to stop
Qualified
investigators
Investigator will stop
if harm occurs
Jeremy Sugarman, MD, MPH, MA, copyright
Tuskegee Syphilis Study
Macon Co., AL 1932-1972
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400 AfricanAmerican men
Researchers tested
the men for latent
syphilis and studied
its natural course
Jeremy Sugarman, MD, MPH, MA, copyright
Tuskegee Syphilis Study
Spinal taps
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Recruited with
promise of “special
free treatment” for
“bad blood”
Actually spinal taps
without anesthesia,
called “spinal shots”
Enrolled without
consent
Jeremy Sugarman, MD, MPH, MA, copyright
Tuskegee Syphilis Study
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Denied antibiotic
therapy in the 1940s
and 1950s (although
safe and effective)
Study halted in
1972: 28-100 men
died from advanced
syphilis
Jeremy Sugarman, MD, MPH, MA, copyright
Willowbrook State School
Hepatitis Experiments
1963-1966
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Inoculation and
injection of hepatitis
Mentally retarded,
institutionalized
children
Admission through
the research unit
Jeremy Sugarman, MD, MPH, MA, copyright
Federal Regulations and IRBs
1974-Today
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Sets a minimum standard
Based on the Belmont Principles
Applies to ALL research
Puts the responsibility on the institution
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Through the establishment of a local IRB
to review research with human subjects
IRB=Institutional Review Board
The Belmont Principles 1979
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Beneficence
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Maximize benefit, minimize harm
Categories of Risk
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Minimal risk: The risks of harm are not
greater, considering probability and
magnitude, than those ordinarily encountered
in daily life or during the performance of
routine physical or psychological
examinations or tests
More than minimal risk: Risks exceed, either
in probability or magnitude, those ordinarily
encountered in daily life or during the
performance of routine physical or
psychological examinations or tests
Risks in Behavioral and Social
Research
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Invasion of privacy
Breach of confidentiality
Embarrassment
Stigma
Psychological Trauma
The Belmont Principles 1979
 Respect for persons: dignity
and autonomy
Participation is informed and
voluntary
 Special protection of vulnerable
subjects
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The Belmont Principles 1979
 Justice
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Fair and equitable selection of subjects
Benefits and burdens of research is
distributed fairly among populations
Special Populations found in
sub-parts of the regulation
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Vulnerable populations require a higher level of
oversight
Children
Mentally Handicapped
Prisoners
Minorities
Women
Fetuses in utero
The Elderly
Employees, Students.
Informed Consent
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May be coercive if
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Subjects are in a group when recruited and there
is an unspoken expectation that they should
participate because of their membership in the
group, e.g. students, racial affiliation
Compared to the study subjects, the investigator
has a position of socio-economic status and/or
expertise, e.g. doctor or professor
The technical jargon makes subjects feel
intimidated and/or prevents understanding
Elements of Written Consent
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Purpose
Procedures
Voluntary Participation
How the information will be used
How to opt out at any point
How to contact the researcher
Signatures
IRB Review of Projects in
Schools
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Any research which looks at normal
educational practices or educational
testing is exempt – Fill out the exempt
application, no parental consent is
required by the IRB – check your
schools’ policies and follow them
Projects in Schools
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When doing research in schools, follow
the individual school policy.
In many cases you do not need
parental approval if your research is on
regular educational practices
Protection of Pupil Rights
Amendment (PPRA)
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Parental consent is required for Qs about:
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Political affiliations
Mental and psychological problems potentially
embarrassing
Sex behavior and attitudes
Illegal, anti-social, self-incriminating and
demeaning behavior
Critical appraisals of others (close family)
Legally recognized privileged relationships such as
lawyers, doctors
Family income
Non-Exempt Educational
Research
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Those projects that would fall under
PPRA
Any other survey or interview projects
that are not part of the regular
classroom procedure can be reviewed
at the expedited level
Examples of when written
consent can be waived
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Phone interviews – keep a log
Surveys – introductory explanation
either verbal or written (tacit consent)
On-line surveys – introductory
explanation
What about my study? When is research
taking place with human subjects?
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Research means a systematic investigation,
including research development, testing and
evaluation, designed to develop or contribute
to generalizable knowledge. The knowledge is
published or presented in a public forum.
Human subject is a living individual about
whom an investigator (whether professional
or student) conducting research obtains 1)
data through intervention or interaction, or 2)
identifiable private information.
Activities that are not research
with human subjects
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Surveys or interviews done to inform institutional
practice that stay within the institution
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Journalism interviews for newspaper articles
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Quality control, quality assurance
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Classroom research at Whitworth required for
completion of a class UNLESS you are presenting that
research at the Spokane Intercollegiate Research
Conference
However . . .
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Even if your project is exempt, or not
considered research with human
subjects, you still have to follow ethical
and legal principles
When can research begin?
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Research can begin only after the
investigator receives a written approval from
the IRB.
If investigator is asked to make some
changes prior to approval, research may not
begin until the researcher submits a
Protocol Change form and receives written
approval from the IRB indicating that they
have met the conditions required.
Can Deceit be used in Human
Subjects Research?
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Yes, but . . . researcher must debrief subjects
afterwards
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In a school setting this would not be exempt
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A study without deceit may withhold some
non-risk related procedural or outcome
information if it might affect participant
behavior (not participation) and, therefore,
destroy or invalidate the results of the study
Categories of review
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Exempt –
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anonymous AND minimal risk
IRB decides if exempt
no special populations
Most education research fits here – regular classroom
procedures or educational tests
Reviewed by department representative on the IRB
Expedited – 2 reviewers
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1 reviewer
Oral history, interviews, surveys, focus groups
Minimal risk, but not anonymous
UNLESS children are involved
Full Board
What about my my study?
IRB Review Criteria
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There must be a benefit.
The protocol must minimize the risks.
There must be an equitable selection of
subjects.
Participation must be informed and voluntary.
No unfair inducements such as large cash
payments.
Privacy and confidentiality of subjects and
data must be protected.
Documentation of Informed
Consent
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It is a process, not just a document
Provide a written statement/script
whenever written consent is waived
Washington State requires written
consent if a conversation is to be taped
or recorded
Waiver of Written Consent
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Written consent can be waived by the IRB if:
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the only record linking the subject and the
research would be the consent, AND
If their name were discovered they would be at
risk of legal proceedings or their reputation, job or
financial status would be at risk OR
it presents no more than minimal risk and it is
anonymous
What a script should cover
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Purpose & subject matter
Procedure
Voluntary participation
How to opt out at any point w/out penalty
Your name, Lynn Noland’s info., and contact
information
A template is available on the Sponsored
Programs website
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Academicaffairs/sponsoredprograms/compliance
Street Kids
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Need to have an advocate who works
with street kids present
The board will also need to have an
advocate present during review
Requires full board review
Prisoners
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Research done with prisoners cannot be done
by students unless a faculty member who is
experienced in working with prisoners is
involved and present
Research with prisoners cannot be approved
by the IRB unless there is a prisoner
advocate present – full board review
Research with juvenile prisoners must have
approval from the court first
Navigating the Review Process
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Fill out application – Follow the directions
Exempt is first page only
Attach survey sample
Attach consent form, verbal consent script, or
written explanation
Attach letters of approval from outside
agencies whose clients you propose to use as
subjects
Common Problems
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Not enough detail to describe the study procedures
Letters from agencies outside Whitworth not
attached
Consent form in language that is difficult to
understand – should be at 5th grade reading level.
Unclear how to opt out once study begins
No script or information if written consent is waived
Did not read directions on the application
Studies which put students or the university at legal
risk, e.g. simulated shoplifting, carjacking
Autonomy of Board
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If the board approves a project, it can
be overturned by the Vice President for
Academic Affairs if it is decided that it is
not in the best interests of the college.
If the board disapproves a project, the
college cannot overturn that ruling.
Brief History
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WWII and Nazi experiments- Nuremberg Trials and
Nuremberg Code - unsigned
1960s, 1970s in US – Willowbrook, Tuskegee
1974 Code of Federal Regulations mandates IRB
review of research
1979 – Belmont Commission Report
1990s – tightening of the regs because of continued
abuse
2007 – loosening of some interpretations when
applied to social, behavioral and educational research