Protection of Human Subjects in Research by mikeholy


									Protection of Human Subjects
in Research

       Whitworth University
    Institutional Review Board
The Board
   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
                Voluntary consent
                Anticipate scientific
                Benefits outweigh
                Animal experiments
                Avoid suffering

                Jeremy Sugarman, MD, MPH, MA, copyright
Nuremberg Code 1947
              No intentional death
               or disability
              Protection from
              Subject free to stop
              Qualified
              Investigator will stop
               if harm occurs

            Jeremy Sugarman, MD, MPH, MA, copyright
Tuskegee Syphilis Study
Macon Co., AL 1932-1972
                  400 African-
                   American men
                  Researchers tested
                   the men for latent
                   syphilis and studied
                   its natural course

              Jeremy Sugarman, MD, MPH, MA, copyright
Tuskegee Syphilis Study
 Spinal taps
                 Recruited with
                  promise of “special
                  free treatment” for
                  “bad blood”
                 Actually spinal taps
                  without anesthesia,
                  called “spinal shots”
                 Enrolled without
               Jeremy Sugarman, MD, MPH, MA, copyright
Tuskegee Syphilis Study
                Denied antibiotic
                 therapy in the 1940s
                 and 1950s (although
                 safe and effective)
                 Study halted in
                 1972: 28-100 men
                 died from advanced

                   Jeremy Sugarman, MD, MPH, MA, copyright
Willowbrook State School
Hepatitis Experiments
                 Inoculation and
                  injection of hepatitis

                 Mentally retarded,

                 Admission through
                  the research unit

                   Jeremy Sugarman, MD, MPH, MA, copyright
Federal Regulations and IRBs
   Sets a minimum standard
   Based on the Belmont Principles
   Applies to ALL research
   Puts the responsibility on the institution
       Through the establishment of a local IRB
        to review research with human subjects
       IRB=Institutional Review Board
The Belmont Principles 1979
   Beneficence
       Maximize benefit, minimize harm
Categories of Risk
   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
   Invasion of privacy
   Breach of confidentiality
   Embarrassment
   Stigma
   Psychological Trauma
The Belmont Principles 1979
 Respect for persons: dignity
 and autonomy
   Participation is informed and
   Special protection of vulnerable

The Belmont Principles 1979
 Justice
     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
   Vulnerable populations require a higher level of
   Children
   Mentally Handicapped
   Prisoners
   Minorities
   Women
   Fetuses in utero
   The Elderly
   Employees, Students.
Informed Consent
   May be coercive if
       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
   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
   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
   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)
   Parental consent is required for Qs about:
       Political affiliations
       Mental and psychological problems potentially
       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
   Those projects that would fall under
   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
   Phone interviews – keep a log

   Surveys – introductory explanation
    either verbal or written (tacit consent)

   On-line surveys – introductory
What about my study? When is research
taking place with human subjects?

   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
   Surveys or interviews done to inform institutional
    practice that stay within the institution

   Journalism interviews for newspaper articles

   Quality control, quality assurance

   Classroom research at Whitworth required for
    completion of a class UNLESS you are presenting that
    research at the Spokane Intercollegiate Research
However . . .
   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?
   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?
   Yes, but . . . researcher must debrief subjects

   In a school setting this would not be exempt

   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
   Exempt –      1 reviewer
       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
        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
   There must be a benefit.
   The protocol must minimize the risks.
   There must be an equitable selection of
   Participation must be informed and voluntary.
    No unfair inducements such as large cash
   Privacy and confidentiality of subjects and
    data must be protected.
Documentation of Informed
   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
   Written consent can be waived by the IRB if:
        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
What a script should cover
   Purpose & subject matter
   Procedure
   Voluntary participation
   How to opt out at any point w/out penalty
   Your name, Lynn Noland’s info., and contact
   A template is available on the Sponsored
    Programs website
       Academicaffairs/sponsoredprograms/compliance
Street Kids
   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
   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
   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
Common Problems
   Not enough detail to describe the study procedures
   Letters from agencies outside Whitworth not
   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
   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
   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
   2007 – loosening of some interpretations when
    applied to social, behavioral and educational research

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