Ethical%20Issues

1
Ethical Issues

• NIH Training
• BergChapter 3

2
NIH Course

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

3
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.

4
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
  studies.

5
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
  essential." 

6
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.

7
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.

8
NIH Course

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

9
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. 

10
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
  order. 

11
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
  papers
• Limiting access to identifiable data
• Educating staff on the importance of
  confidentiality
• Storing paper records in locked cabinets or
  assigning security codes to computerized records

12
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

13
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

14
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

15
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

16
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))

17
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
  entitled
• 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.

18
NIH Course--Exempted

• Research conducted in established or commonly
  accepted educational settings, involving normal
  educational practicesthis class project is
  example
• 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.

19
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.

20
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

21
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?

22
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.

23
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.

24
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.

25
Web Based Surveys

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