Promoting Integrity in the
Next Generation of Researchers
A Curriculum for Responsible Conduct of
Research in Occupational Therapy (2005)
Funded by the Office of Research Integrity through the
American Association of Medical Colleges
Protection of Human Subjects
Occupational therapy documents typically refer
to human subjects as participants. The terms
are used interchangeably in this PowerPoint
Objectives




Discuss the historical abuses of participants that
influenced guidelines for human subject research.
Describe the three Belmont Report principles that
guide ethical conduct of research.
Compare and contrast the goal of treatment to that of
research, and the rights of a patient to those of a
research participant.
Appreciate the role of institutional review boards
(IRBs), and the need for occupational therapists to
serve on these boards.
Objectives (continued)





Differentiate the process of informed consent from a
consent or assent document.
Describe the types of IRB reviews.
Describe the content required in a consent form.
Commit to being honorable in participant
recruitment and selection, gaining informed consent,
participant assessment and intervention, and
management and use of data and records.
Given case studies, recognize human subjects issues
and discuss ways to prevent and/or resolve these
problems.
Why Weren’t Research Ethics a Part of
Early Medical Doctors’ Training?




Medical research relies on human subjects.
Medical research was commonly performed by
MDs.
MDs were presumed ethical and were rarely
supervised in their assessment and intervention with
patients.
By association, it was assumed that research by MDs
was ethical, and medical researchers were rarely
supervised in their efforts to make discoveries about
diseases and treatment.
Abuse Led to Rules for Human Research

Questions about research arose because of failed
ethics:
 Nazi medical experiments in concentration camps
1930-1945
 Federally funded Tuskegee syphilis study 19321972
 Human Radiation Studies 1944-1974
 Examples from the news
Nazi Medical War Crimes

So-called medical experiments conducted on
uninformed and unwilling concentration camp
prisoners


After WWII, 20 MDs & 3 laypersons found guilty of
“crimes against humanity”.


Most carried through to death
7 sentenced to death, the others to 10 yrs to life
imprisonment
Resulted in the NUREMBERG CODE

First international code of medical research ethics
(United States Holocaust Memorial Museum, n.d.)
Tuskegee Syphilis Study (1932-1972)

A classic example of a slippery slope.

Initially a legitimate study conducted by
researchers with good intentions, it
becomes one that is horrifically
unethical.
Tuskegee Syphilis Study (continued)
The Ethical Beginning

1926 An estimated 35% of men of reproductive age
have syphilis. There is no effective and safe
treatment

1929 Drs. Clark and Vondelehr at Tuskegee begin
research on effects of topical Mercury and Bismith
on syphilis. Funding lost after Wall Street Crash
reduces foundation funds.

1931 Drs. Clark and Vondelehr continue to follow
participants to show need for treatment program
(Centers for Disease Control and Prevention, 2005)
Tuskegee Syphilis Study (continued)
The Slippery Slope

1932 US Public Health Services funds "Tuskegee Study
of Untreated Syphilis in the Negro Male” to document
natural course of syphilis in black men and possibly
justify treatment programs for African Americans.


At the time there is no safe effective treatment for syphilis
399 poor black sharecroppers with syphilis and 201 men
without (controls) agree to participate. They are falsely
told that some of the assessments being performed (e.g.
spinal taps) are treatment.
(Centers for Disease Control and Prevention, 2005)
Tuskegee Syphilis Study (continued)
The Slippery Slope (continued)

1934-36 Study begins publishing findings.
Infrequent concerns are raised about whether
the men are receiving any treatment. There is
no general outcry.

1940s Local black and white MDs agree not to
treat the study men for syphilis. Study is
widely known in Tuskegee and few questions
are raised.
(Centers for Disease Control and Prevention, 2005)
Tuskegee Syphilis Study (continued)
The Clear Unethical Turn

1945 Penicillin becomes known as an effective and
safe drug for syphilis.

1947 Penicillin readily available to the US poor via
federally funded Rapid Treatment Centers (RTCs)
established to treat poor people with syphilis.

Participants are denied access to Penicillin from all
controllable sources (e.g., RTCs, general public
clinics, local black and white MDs, Armed Forces).

Participants not given option to withdraw from
study.
(Centers for Disease Control and Prevention, 2005)
Tuskegee Syphilis Study (continued)
The Fallout







1968 Public concerns raised about ethics of the study
1969 Center for Disease Control and AMA defend study’s
continuation
1970 Newspaper and magazine articles condemn the study
1971 Congress holds hearings
1972 Front-page NY Times article causes large public outcry
1972 Per panel recommendation, the study is ended
1973 Class action suit - participants compensated with cash
and continued medical care for themselves and
their families.
(Centers for Disease Control and Prevention, 2005)
Tuskegee Syphilis Study (continued)
The Effect on US Policy

1974 National Research Act, creates the National
Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research


Requires that all researchers get voluntary informed
consent from all research participants in Dept. of Health,
Education and Welfare funded studies.
1997 President Bill Clinton apologizes to all
participants and their families on behalf of nation.
Reparations paid
(Centers for Disease Control and Prevention, 2005)
What Guides Responsible
Study of Humans?
Since the 1974 National Research Act, the Belmont
Report (the result of the National Commission for the
Protection of Human Subjects of Biomedical and
Behavioral Research) has been the dominant research
ethics statement
Belmont Report Principles



Autonomy/ Respect
Beneficence
Justice
Principle of Autonomy/Respect





Persons have a right to decide if they will or will
not participate in a study
Persons who cannot make a competent decision
(i.e., vulnerable individuals) must be protected by
outside decision makers and must be closely
monitored
Persons invited to participate must know &
understand risks and benefits, and be informed if
these change while in the study
Individuals may decline or withdraw without
penalty
Children must give assent before participating in
study
Principle of Beneficence




Research design and method should yield valid
results
If possible, do no harm
If harm in an inescapable risk, minimize it and
maximize direct benefits to study participants
Inform participants of risk and benefits.
Principle of Justice




Access to risk & benefit must be fairly
distributed in society.
Studies should not exclude by age, race, sex,
etc. without strong reason.
When possible, studies should randomly assign
participants to treatment groups to ensure that
risk and benefits are equally distributed
MDs should not be excluded or included
differently than others
The Unexpressed Belmont Principle
The researcher cannot decide whether she or he is
conducting reasonable research, meeting ethical
requirements, or has a conflict of interest
The Tuskegee studies (among others) show that
researchers can be myopic when it comes to their
own studies.
There must be external review and oversight by
individuals and groups not directly involved in the
study.
Differences Between Being a
Patient and Being a Research
Participant
Based on an idea presented at the 1999 American College of Rheumatology/
Association of Rheumatology Health Professionals Annual Conference - author
unknown
A Difference in Goals
Goal of
TREATMENT:
To improve
patient’s condition
or state
Goal of
RESEARCH:
To answer a
question
A Difference in Rights
PATIENTS
1) Must be provided
effective treatment, if
known; or the
treatment thought to be
most likely to be
effective in their case
PARTICIPANTS
1) May receive no
treatment (i.e., control)
or a treatment that is
purposely neutral (i.e.,
placebo)
A Difference in Rights (continued)
PATIENTS
2) Cannot be treated in a
manner that risks
harm, unless there is
high likelihood of
benefit
PARTICIPANTS
2) May be intentionally
treated in a manner that
carries risk if such risk
is monitored, all risk is
as low as possible, and
subject is informed of
risks. The likelihood of
benefit may be
unknown
A Difference in Rights (continued)
PATIENTS
3) Are responsible for
costs related to
treatment
PARTICIPANTS
3) Are generally NOT
expected to pay costs
associated with
experimental assessment
or intervention
A Difference in Rights (continued)
PATIENTS
4) Do not need to give
formal consent to the
process of occupational
therapy treatment. It is
implied.
PARTICIPANTS
4) Must give formal
consent to the process
of randomization and
experimental
assessment and
intervention –
regardless of group
assignment
A Difference in Rights (continued)
PATIENTS
5) Participation and results
are shared with
referring physician as
required by state rules
regarding
documentation
PARTICIPANTS
5) Results or status of
participation cannot be
shared with anyone
outside of study
without formal
permission of subject
A Difference in Rights (continued)
PATIENTS
6) Must be accurately
informed of the
treatment s/he is
receiving.
6)
PARTICIPANTS
May be intentionally
deceived if
a)
b)
c)
there is low risk of
injury,
persons are properly
debriefed at earliest
opportunity, and
persons are given right
to withdraw data postdebriefing.
A Difference in Rights (continued)
PATIENTS
PARTICIPANTS
7) Records are kept under 7) Records are private,
individual’s name and
kept under code, and
carry identifiable
may be reviewed only
elements. They may be
by those individuals
reviewed by anyone
described in the
with legitimate access
consent form or an
to charts, as permitted
examining body. MD
by state and federal
of participant may not
law.
automatically access
A Difference in Rights (continued)
PATIENTS
PARTICIPANTS
8) May or may not be fully 8) Must be fully informed
informed about
about alternatives to
alternative treatment
participation in
options.
research. This includes
the option to decline to
participate and
alternative treatments.
Occupational Therapist Researchers
Are Also Guided By…
AOTA Code of Ethics
Federal Rules/Regulations
Educational Institution’s Rules/Regulations
Hospital/Clinic/Center Rules/Regulations
AOTA Code of Ethics (Principle 3)
(American Occupational Therapy Association, 2000)
Occupational therapy personnel shall respect the recipient
and/or their surrogate(s) as well as the recipient's
rights. (autonomy, privacy, confidentiality)
Occupational therapy practitioners/personnel shall:
C. Obtain informed consent from participants involved in research
activities and indicate that they have fully informed and advised
the participants of potential risks and outcomes. …(and) ensure
that the participants comprehend these risks and outcomes.
D. Respect the individual's right to refuse professional services or
involvement in research or educational activities.
E. Protect all privileged confidential forms of written, verbal, &
electronic communication gained from educational, practice,
research, and investigational activities unless otherwise
mandated by local, state, or federal regulations.
Federal Rules and Regulations

Seventeen federal agencies have regulations
governing research involving humans.

Contracts and grants from these agencies
require that rights of participants be ensured
and overseen by both federal and institutional
bodies
Academic Institutions’ Rules and
Regulations

Educational institutions generally require that all faculty
& all students performing research have their studies
reviewed by the College or University Institutional
Review Board (IRB) or Human Subjects Protection
Office.

This is typical regardless of research locale, regardless
of whether faculty/students are being paid or conducting
the research gratis, and regardless of whether
faculty/student are conducting the research as part of
their faculty/student roles or as external jobs.
INSERT YOUR INSTITUION’S HUMAN
SUBJECTS REGULATIONS HERE
Hospital & Clinic Rules and Regulations
Generally include that :

Employees involved in research be trained
and approved

Employees involved in research gain IRB
approval, even if the research is not on-site.

If the institution does not have an IRB, it may
accept approval from another institution’s.
Institutional Review Board
(IRB)
IRB
Uses prospective review. Review and permission required
before any research takes place

 Assign
review type based on level of risk vs benefit, and
according to the Federal guidelines:


Exempt = public info, use of anonymous data, no subject contact

Expedited (quicker - single reviewer) = low risk, adults, typical
daily activities

Full committee (requires individual review followed by
discussion of committee) research on children, study of treatment
or assessment that have risk, sensitive topics
The IRB, not the researcher, makes category decision
IRB (continued)

The IRB must review each study:

Regardless of the type of study (qualitative vs.
quantitative; descriptive vs experimental; natural
history vs intervention), and

Regardless of the researcher (student vs faculty)
For IRB Process, Timeline or Forms Go To
Insert your institution’s IRB website here
After Initial Approval, IRB Monitors
Research Studies


Re-review at least annually
Audit a selection of studies to ensure all
processes being performed as promised.
The Consent Form





The Consent Form is only 1 part of the informed
consent process
Consent forms should be readable at <8th grade
reading level
Consent Forms are used for adults >18 years old
Assent Forms are used for subjects 8-17 years old
Verbal or nonverbal consent/assent can be accepted
for young children, non-competent persons & nonliterate adults

Nonverbal consent/assent may be documented by witness
or by videotape/ audiotape of explanation and participant
response
Contents of Consent Form
(Elements of Informed Consent, 21 C.F.R. § 50.25, 2000)

Purpose and details of the research study, including
description of drugs or devices (tools or pieces of
equipment) or procedures used in the research study and
type of assignment and odds of assignment to different
study groups.

Identification of the researching individuals and
affiliations. Students should be identified as students, but
should not indicate that the research is to complete degree
requirements

Explanation of research procedures, schedule and
timeline of the research study.

Costs of research procedures, drugs, devices, etc. and who
is responsible to pay. Differentiation of research expenses
from those of usual care.
Contents of Consent Form (continued)

Payment or non-payment to participant.

Risks, dangers, and discomforts of the study, and
means that will be used to control for these.

Benefits and advantages of participating in the
research study. Direct benefits, not payment or good
to society.

Alternatives to study participation.

Medical treatment available if participant is
injured by the research, and who will pay for this
treatment.
Contents of Consent Form (continued)

Who, if anyone, will have access to subject data, and
whether study results will identify participant

Will study create or use any Protected Health
Information (PHI), and if data will be part of chart.

Assurance that participation is voluntary and person
may quit without affecting future treatment or current
relationships. Description if treatment requires
withdrawal or monitoring after quitting.

Statement that data may be withdrawn from study or
why this is not possible.
Contents of Consent Form (continued)

Assurance that new information will be shared
with participants

Chance to ask questions about the research study.
Outside-of-study contact information.





Place to sign consent/assent form,
Notice that they will be given a copy of
signed/dated form for their records.
Place for investigator to sign, date form.
Place for witnesses signature/date, if witness is
needed
Consent Forms for Non-English Speakers

Download free generic Consent Short Forms in 11
languages (Arabic, Croatian, French, Hmong, Khmer, Lao,
Oromo, Russian, Somali, Spanish, and Vietnamese) from
http://www.research.umn.edu/irb/consent/downloadshortfor
ms.cfm

Generic forms may be used with more detailed oral
explanation, to obtain consent from occasional non-English
speaking participants.

Generic forms cannot substitute for properly translated
consent form in studies of primarily non-English speakers.
Adverse Events & Unexpected Experiences

Definitions

Adverse events are any experience that suggests a significant
hazard, contraindication, side effect, or precaution – even if it is
already listed as possible in IRB materials

Unexpected adverse experiences are any adverse experience whose
nature, severity, & incidence are not described in the information
provided for IRB review or in the consent form

Immediately report events/experiences to the IRB & change
procedure and consent accordingly.

If event/experience is significant, IRB may pause or stop
study
Unanticipated Problems or Events

Report unanticipated problems that might affect
subject




Risk/benefit analysis,
Confidentiality,
Participants’ willingness to continue
The IRB will consider the effect of the problem on
the study and on the participants already enrolled.
Events at Other Institutions

If a research project involves many
institutions and the event occurred at another
institution, inform your IRB of event,
severity, likelihood that it could occur at your
institution, and implications for your future
subjects.
Resources



American Occupational Therapy Association (2000).
Occupational Therapy Code of Ethics. Retrieved September
11, 2005, from http://www.aota.org/general/coe.asp.
Centers for Disease Control and Prevention (2005). The
Tuskegee Timeline. Retrieved September 11, 2005 from
http://www.cdc.gov/nchstp/od/tuskegee/time.htm.
Elements of Informed Consent, 21 C.F.R. § 50.25 (2000).
Retrieved August 20, 2005, from
http://frwebgate.access.gpo.gov/cgi-bin/getcfr.cgi?TITLE=21&PART=50&SECTION=25&YEAR=2000
&TYPE=TEXT.
Resources (continued)



Magnus, P.D., Kalichman, M. (September 2002).
Protection of Human Subjects. Retrieved September 11, 2005,
from RCR Educational Resources, Online Resource for RCR
Instructors:
http://www.rcrec.org/r/index.php?module=ContentExpress&f
unc=display&meid=74&ceid=33.
National Institutes of Health. (2000). Available from
http://cme.cancer.gov/c01/nih_reg.htm (Course Registration).
United States Holocaust Memorial Museum (n.d.) The
doctors trial: The medical case of the subsequent Nuremberg
proceedings.Retrieved September 11, 2005, from
http://www.ushmm.org/research/doctors/
This completes the presentation
on
Protection of Human Subjects
THANK YOU!