This document discusses ethical guidelines for conducting research with human subjects. It provides historical context of abuses that led to modern rules. The three principles from the Belmont Report - autonomy, beneficence, and justice - guide ethical research. Key differences between patients receiving treatment and research participants are reviewed, such as differing goals and rights. The roles of institutional review boards and ethics of the informed consent process are explained.

1. Protection of Human Subjects in
Therapeutic Recreation Research
in Canada
PROFESSOR PEIVAND PIROUZI, PH.D., M.B.A.
SENECA COLLEGE OF APPLIED ARTS AND
TECHNOLOGY
TORONTO, ONTARIO, CANADA
2015

2. Protection of Human Subjects
An approach to the Therapeutic
Recreation Research in Canada
THERAPEUTIC RECREATION RESEARCH DOCUMENTS
REFER TO HUMAN SUBJECTS AS PARTICIPANTS. THE
TERMS ARE USED INTERCHANGEABLY IN THIS
POWERPOINT

3. Objectives
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 Therapeutic
Recreation treatments 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 Therapeutic Recreation Specialists in
Ethics boards.

4. Objectives (continued)
The process of informed consent from a consent or
assent document.
Types of Ethics reviews.
Content of a consent form.
Subject recruitment and selection
Management and use of data and records.
Case studies, recognize human subjects issues and
discuss ways to prevent and/or resolve these problems.

5. Absence of Research Ethics Training as
Part of Early Medical Training
Clinical research relies on human subjects.
Clinical research was commonly performed by MDs.
MDs were presumed ethical and were rarely supervised
in their assessment and intervention with patients.

6. 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 1932-1972
◦ Human Radiation Studies 1944-1974
◦ Examples from the literature

7. Nazi Medical War Crimes
So-called medical experiments conducted on
uninformed and unwilling concentration camp prisoners
◦ Most carried through to death
After WWII, 20 MDs & 3 laypersons found guilty of
“crimes against humanity”.
◦ 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.)

8. Nazi Medical War Crimes
At the Nuremberg trials, the prosecuting attorney classified the Nazi
concentration camp experiments into 2 categories:
1) Those meant to determine the cheapest and easiest ways to kill
individuals or entire races/ethnicities (a pseudoscience termed
"thanatology“ by the prosecutor). This included experiments in
sterilization, experiments with carbon monoxide poison, experiments in
which prisoners under no specific condemnation of death were shot
with poisoned bullets to test their potential deadliness. These
experiments were separate from, but supportive of, the
contemporaneous efforts at genocide within the camps.
certainly should have raised some of the same issues in terms of
informed consent, coercion, and the responsibilities of medical doctors.

9. Nazi Medical War Crimes
2)Those meant to make war activities safer for Nazi troops. As
examples, some of these prisoners were exposed to deadly high altitude
pressures or freezing cold or forced to drink processed sea water to help
devise ways to avoid problems when flying high altitudes and to aid
rescue/treatment of Nazi armed forces who would be forced into frigid
waters when shot down or sunk. In addition, concentration camp
prisoners were exposed to mustard gas and phosphorous- both agents
that burn- to test the effects of sulfanilamide as a therapeutic agent,
and were injected with malaria, jaundice, and typhus to help Nazi
researchers understand the natural course of these diseases and to
study possible treatments of these diseases.

10. Nazi Medical War Crimes
In his opening statement before the Nuremberg court, the prosecuting
attorney Telford Taylor noted “None of the victims of the atrocities
perpetrated by these defendants were volunteers, and this is true
regardless of what these unfortunate people may have said or signed before
their tortures began. Most of the victims had not been condemned to
death, and those who had been were not criminals, unless it be a crime to
be a Jew, or a Pole, or a gypsy, or a Russian prisoner of war. …Whatever
book or treatise on medical ethics we may examine, and whatever expert
on forensic medicine we may question, will say that it is a fundamental and
inescapable obligation of every physician under any known system of law
not to perform a dangerous experiment without the subject's consent. In
the tyranny that was Nazi Germany, no one could give such a consent to the
medical agents of the State; everyone lived in fear and acted under duress. I
fervently hope that none of us here in the courtroom will have to suffer in
silence while it is said on the part of these defendants that the wretched
and helpless people whom they froze and drowned and burned and
poisoned were volunteers.” FROM THE OPENING STATEMENT BY TELFORD
TAYLOR [from Trials of War Criminals before the Nuremberg Military
Tribunals under Control Council Law No. 10. Nuremberg, October 1946–
April 1949. Washington, D.C.: U.S. G.P.O, 1949–1953.]:

11. Nazi Medical War Crimes
It is interesting to note that some of the Americans brought to
Nuremberg as expert witnesses on research ethics and methods were,
at the same time, themselves conducting research on Americans who
were in prison (i.e., criminals in prison).

12. 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.

13. 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)

14. 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)

15. 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)

16. 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)

17. 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)

18. 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)

19. Responsible Study
of Humans.
IN THE U.S.A., 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

20. Belmont Report Principles
Autonomy/ Respect
Beneficence
Justice

21. 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

22. 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.

23. 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

24. 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.

25. Differences Between Being a
Patient and Being a Research
Participant

26. A Difference in Goals
Goal of TREATMENT:
To improve patient’s condition or
state
Goal of
RESEARCH:
To answer a question

27. 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)

28. 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

29. 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

30. A Difference in Rights
(continued)
PATIENTS
4) Do not need to give
formal consent to the
process of therapeutic
recreation 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

31. A Difference in Rights
(continued)
PATIENTS
5) Participation and
results are shared with
referring physician as
required by provincial
rules regarding
documentation
PARTICIPANTS
5) Results or status of
participation cannot be
shared with anyone
outside of study without
formal permission of
subject

32. A Difference in Rights
(continued)
PATIENTS
6) Must be accurately
informed of the
treatment s/he is
receiving.
PARTICIPANTS
6) May be intentionally
deceived if
a) there is low risk of
injury,
b) persons are properly
debriefed at earliest
opportunity, and
c) persons are given
right to withdraw data
post-debriefing.

33. A Difference in Rights
(continued)
PATIENTS
7) Records are kept under
individual’s name and carry
identifiable elements.
They may be reviewed by
anyone with legitimate
access to charts, as
permitted by provincial
and federal law.
PARTICIPANTS
7) Records are private,
kept under code, and
may be reviewed only by
those individuals
described in the consent
form or an examining
body. MD of participant
may not automatically
have access.

34. A Difference in Rights
(continued)
PATIENTS
8) May or may not be fully
informed about alternative
treatment options.
PARTICIPANTS
8) Must be fully informed
about alternatives to
participation in research.
This includes the option
to decline to participate
and alternative
treatments.

35. Researchers Are Also Guided By…
TRI-COUNCIL POLICY STATEMENT, CANADA
CODE OF ETHICS
FEDERAL RULES/REGULATIONS
EDUCATIONAL INSTITUTION’S RULES/REGULATIONS
HOSPITAL/CLINIC/CENTER RULES/REGULATIONS

36. Federal Rules and Regulations
Contracts and grants from these agencies require that rights of
participants be ensured and overseen by both federal and institutional
bodies

37. 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.

38. Research Ethics Board at Seneca
When conducting research with human subjects, Seneca REB Approval
is required for the following:
Research activities are independent of a course and conducted by
Seneca students and/or faculty
Research activities are a part of a course and conducted by Seneca
students and/or faculty (Course-based student research - Form 2)
Information is collected directly from Seneca subjects or from existing
Seneca records
Data collected from participants will be published
A similar project has been approved by another REB

39. 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.

40. Institutional
Review Board
(IRB)

41. 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

42. 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)

43. 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.

44. 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 & non-literate
adults
Nonverbal consent/assent may be documented by witness or
by videotape/ audiotape of explanation and participant
response

45. 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.

46. 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.

47. 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.

48. 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

49. 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
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.

50. 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

51. 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.

52. 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.

53. Resources
1. Seneca College Research Ethics Board:
http://www.senecacollege.ca/research/ethics-board.html
2. Centers for Disease Control and Prevention (2005). The
Tuskegee Timeline. Retrieved September 11, 2005 from
http://www.cdc.gov/nchstp/od/tuskegee/time.htm.
3. Elements of Informed Consent, 21 C.F.R. § 50.25 (2000).
Retrieved August 20, 2005, from
http://frwebgate.access.gpo.gov/cgi-bin/get-
cfr.cgi?TITLE=21&PART=50&SECTION=25&YEAR=2000&TYPE=
TEXT.
4. National Institutes of Health website.
5. Tri-council Policy Statement, Canada (2014)