Protection of Human Subjects - S by pengtt


									  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
   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
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 were presumed ethical and were rarely
    supervised in their assessment and intervention with
   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
     Nazi medical experiments in concentration camps
     Federally funded Tuskegee syphilis study 1932-
     Human Radiation Studies 1944-1974
     Examples from the news
Nazi Medical War Crimes
   So-called medical experiments conducted on
    uninformed and unwilling concentration camp
       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
   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
Tuskegee Syphilis Study (continued)
The Ethical Beginning
   1926 An estimated 35% of men of reproductive age
    have syphilis. There is no effective and safe
   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
                     (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
   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
   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
   Children must give assent before participating in
Principle of Beneficence
   Research design and method should yield valid
   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
Differences Between Being a
Patient and Being a Research

Based on an idea presented at the 1999 American College of Rheumatology/
Association of Rheumatology Health Professionals Annual Conference - author
A Difference in Goals
 Goal of                 Goal of
   TREATMENT:              RESEARCH:
   To improve              To answer a
   patient’s condition       question
   or state
A Difference in Rights
       PATIENTS                   PARTICIPANTS
1) Must be provided          1) May receive no
   effective treatment, if      treatment (i.e., control)
   known; or the                or a treatment that is
   treatment thought to be      purposely neutral (i.e.,
   most likely to be            placebo)
   effective in their case
A Difference in Rights (continued)
      PATIENTS                   PARTICIPANTS
2) Cannot be treated in a   2) May be intentionally
   manner that risks           treated in a manner that
   harm, unless there is       carries risk if such risk
                               is monitored, all risk is
   high likelihood of          as low as possible, and
   benefit                     subject is informed of
                               risks. The likelihood of
                               benefit may be
A Difference in Rights (continued)
       PATIENTS              PARTICIPANTS
3) Are responsible for   3) Are generally NOT
   costs related to         expected to pay costs
   treatment                associated with
                            experimental assessment
                            or intervention
A Difference in Rights (continued)
       PATIENTS                   PARTICIPANTS
4) Do not need to give        4) Must give formal
   formal consent to the         consent to the process
   process of occupational       of randomization and
   therapy treatment. It is      experimental
   implied.                      assessment and
                                 intervention –
                                 regardless of group
A Difference in Rights (continued)
        PATIENTS                   PARTICIPANTS
5) Participation and results   5) Results or status of
   are shared with                participation cannot be
   referring physician as         shared with anyone
   required by state rules        outside of study
   regarding                      without formal
   documentation                  permission of subject
A Difference in Rights (continued)
       PATIENTS              PARTICIPANTS
6) Must be accurately   6)   May be intentionally
   informed of the           deceived if
   treatment s/he is         a)   there is low risk of
   receiving.                     injury,
                             b)   persons are properly
                                  debriefed at earliest
                                  opportunity, and
                             c)   persons are given right
                                  to withdraw data post-
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
Academic Institutions’ Rules and
    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

    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.
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
 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 & non-
    literate adults
       Nonverbal consent/assent may be documented by witness
        or by videotape/ audiotape of explanation and participant
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
   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
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
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.
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
Unanticipated Problems or Events
   Report unanticipated problems that might affect
       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
   American Occupational Therapy Association (2000).
    Occupational Therapy Code of Ethics. Retrieved September
    11, 2005, from
   Centers for Disease Control and Prevention (2005). The
    Tuskegee Timeline. Retrieved September 11, 2005 from
   Elements of Informed Consent, 21 C.F.R. § 50.25 (2000).
    Retrieved August 20, 2005, from
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:
   National Institutes of Health. (2000). Available from (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
This completes the presentation
Protection of Human Subjects


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