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Title: Ethical Issues Author: College of Health and Human Sciences Last modified by: College of Health and Human Sciences Created Date: 10/7/2005 5:47:17 PM – PowerPoint PPT presentation

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Title: Ethical%20Issues

Ethical Issues
  • NIH Training
  • BergChapter 3

NIH Course
  • National Institutes of Health. http//cme.cancer.g
  • Belmont Report, 1979
  • Respect for Participants (autonomy)
  • Informed consent
  • No pressure to agree or continue
  • Benificience
  • Potential benefit does not justify potential
  • Maximize benefit and minimize potential harm.
  • Justice
  • Participants should be a group that has potential

NIH Course
  • Tuskegee Syphilis Study1930s, Penicillin shown
    effective in 1940s, study continued until 1972.
  • Jewish Chronic Disease Hospital Study, 1963,
    injected live cancer cells in sick people to show
    they rejected it more slowly than health people,
    informed consent not documented.

NIH Course
  • The Willowbrook Study, 1963-66  To understand
    the natural history of infectious hepatitis,
    children were deliberately infected. Parents
    unable to admit their children to Willowbrook
    unless they agreed to their participation in the

NIH Course
  • The Nuremberg Code served as the first set of
    principles outlining professional ethics.  The
    ten points included the statement that "voluntary
    consent of the human subject is absolutely

NIH Course
  • The Declaration of Helsinki was developed by the
    World Medical Association for use by the medical
    community following dissemination of the
    Nuremberg Code.
  • Declaration made informed consent a central
    requirement while allowing for surrogate consent
    when the research participant is incompetent,
    physically or mentally incapable of giving
    consent, or a minor. Research with these groups
    should be conducted only when the research is
    necessary to promote the health of the population
    represented and when this research cannot be
    performed on legally competent persons.

NIH Course
  • Who
  • Living individual information through
    intervention or interaction with individual, or
  • Identifiable private information.
  • Third party (e.g., questions about parents)need
    3rd party approval.

NIH Course
  • Vulnerable Populations
  • Children.
  • Individuals with questionable capacity to
  • Prisoners.
  • Fetuses and pregnant women.
  • The terminally ill.
  • Students/employees.
  • Comatose patients.

NIH Course
  • The informed consent form must indicate the
    researcher's obligation to report certain
    observations, if such duty exists, as well as to
    offer assistance to participants in need
  • Where there is a particularly high risk of
    stigmatization based on participation in a
    research project, the IRB may waive the
    requirement that written informed consent
  • There are no clear rules or standards for payment
    other than a general prohibition against coercion
    or the exercise of undue influence. 

NIH Course
  • Privacy has also been defined as freedom from
    unwanted intrusion.  Privacy may mean the right
    not to know certain information, even about
    oneself, and the right to prevent others from
    obtaining or using personal information.
  • Breaches of confidentiality are disclosures to
    third parties, without patient consent or court

NIH Course
  • Confidentiality--following routine practices
  • Substituting codes for identifiers or encrypting
    identifiable data
  • Removing face sheets from survey instruments
    containing data
  • Properly disposing of computer sheets and other
  • Limiting access to identifiable data
  • Educating staff on the importance of
  • Storing paper records in locked cabinets or
    assigning security codes to computerized records

NIH Course
  • Under Federal law, and some state laws,
    researchers can obtain an advance Certificate of
    Confidentiality that will provide protection
    against a subpoena.
  • Certain information must be disclosed to third
    parties by law
  • Information indicating a risk of harm to others
    (usually homicidal thoughts)
  • Information indicating a risk of harm to self
    (usually suicidal thoughts)
  • Disclosures about child abuse
  • Disclosures about infectious diseases required to
    be reported to public health authorities

NIH CourseInformed Consent
  • Not all of these are needed for every study
  • A statement that the study involves research
  • An explanation of the purpose of the research, an
    invitation to participate and explanation of why
    the participant was selected, and the expected
    duration of the participant's participation

NIH CourseInformed Consent
  • A description of procedures and identification of
    which are investigational and which might be
    provided as standard care to the participant in
    another setting. 
  • Use of research methods such as randomization and
    placebo controls should be explained
  • A description of any foreseeable risks or
    discomforts to the participant, estimate of their
    likelihood, and a description of steps taken to
    prevent or minimize them. Acknowledgment of
    potentially unforeseeable risks

NIH CourseInformed Consent
  • A description of any benefits to the participant
    or to others that may reasonably be expected from
    the research, and an estimate of their likelihood
  • A disclosure of any appropriate alternative
    procedures or courses of treatment that might be
    advantageous to the participant
  • A statement describing to what extent records
    will be kept confidential, including examples of
    who may have access to research records

NIH CourseInformed Consent
  • For research involving more than minimal risk, an
    explanation of any compensation and any medical
    treatments that are available if participants are
    injured through participation where further
    information can be obtained, and whom to contact
    in the event of research-related injury
  • An explanation of whom to contact for answers to
    questions about the research and the research
    participant's rights (including the name and
    phone number of the Principal Investigator (PI))

NIH CourseInformed Consent
  • A statement that research is voluntary and that
    refusal to participate or a decision to withdraw
    at any time will involve no penalty or loss of
    benefits to which the participant is otherwise
  • A statement indicating that the participant is
    making a decision whether or not to participate,
    and that his/her signature indicates that he/she
    has decided to participate having read and
    discussed the information presented.

NIH Course--Exempted
  • Research conducted in established or commonly
    accepted educational settings, involving normal
    educational practicesthis class project is
  • Research involving the use of educational tests
    (cognitive, diagnostic, aptitude, achievement),
    survey procedures, interview procedures, or
    observation of public behavior, unless
  • Information obtained is recorded in such a manner
    that human participants can be identified,
    directly or through identifiers linked to them.
  • Any disclosure of the human participant's
    responses outside the research could reasonably
    place the participant at risk of criminal or
    civil liability or be damaging to the
    participant's financial standing, employability,
    or reputation.

NIH Course--Exempted
  • Research involving the use of educational tests
    (cognitive, diagnostic, aptitude, achievement),
    survey procedures, interview procedures, or
    observation of public behavior if
  • The participants are elected or appointed public
    officials or candidates for public office.

NIH Course--Exempted
  • Research involving the collection or study of
    existing data, documents, records, pathological
    specimens, or diagnostic specimens, if these
    sources are publicly available or if the
    information is recorded by the researcher in such
    a manner that participants cannot be identified,
    directly or through identifiers linked to them
  • Research and demonstration projects conducted by
    or subject to the approval of Federal department
    or agency heads and designed to study, evaluate,
    or otherwise examine public health benefit or
    service programs
  • Taste and food-quality evaluation and consumer
    acceptance studies

Passive vs. Active Consent
  • Passive consent. You have children take a form
    home and if it does not come back saying no, you
    include the child.
  • Active consent. You must exclude any child who
    does not return a form with the parents consent.
  • Now active consent is expected, but how do you
    exclude those who do not have it from
    participating in the experiment?

Anonymity vs. Confidentiality
  • Anonymous means there is no way to connect the
    participants name to their data.
  • Student evaluations in a large class
  • Small class if you check gender and expected
    grade, instructor could identify.
  • Confidential means that the name and data link
    are known only to research staff.

Written, Verbal, Implied Consent
  • We have focused on written consent. Difficult to
    do with telephone surveys.
  • Verbal consent involves reading informed consent
    document and asking for approval verbally.
  • Some say if you describe the study, risks, etc.
    and they do it, then you have implied consent.
    This does not go over well with IRBs.

Data Management
  • You want to keep the link between the name and
    the data as separate as possible.
  • Only keep an identification number with the
    stored data.
  • Destroy the link to the person after data is
    entered and validated.
  • Store link and original data in locked file in a
    locked room that has controlled access.

Web Based Surveys
  • Participants may presume they have anonymity.
  • Depending of software this may or may not be the