The Ethics of Nursing Research

1
The Ethics of Nursing Research
2
Historical Perspectives/The Need for Ethical
Guidelines

• Care should be exercised in protecting the rights
  of human subjects.
• History has led us to the need for ethical
  concerns.
• The Tuskegee Syphilis Study (1932-1972) by the
  Public Health Service withheld medical treatment
  from 400 black men to see what the effects of
  tertiary syphilis would be.
• The Nazi medical experiments did not use consent
  or give folks the ability to refuse participation
• The Jewish Chronic Disease Hospital injected
  liver cancer cells into elderly patients without
  their knowledge or consent
• The use of the mentally ill or prisoners to study
  medical treatments or drug experiments.

3
Ethical Dilemmas

• These happen when the rights of the participants
  and the demands of the research project are in
  conflict.
• The goal is to advance knowledge using the best
  methods possible while adhering to ethical
  dictates/possibilities.
• For examplea dilemma could ensue when one wants
  to complete an unobstrusive observation of
  fathers behaviors in the delivery room.
• How would informed consent be obtained or would
  it?
• How would knowing one is being observed effect
  the persons reaction?
• Is this time too personal for someone for a third
  party to intrude?
• What are the mothers, health care staff, and
  infants rights and how would they be protected?

4
National Research Act of 1978

• Established the National Commission for the
  Protection of Human Subjects of Biomedical and
  Behavioral Research
• This commission issued a report that served as
  the basis for regulations affecting federally
  sponsored research.
• This report is known as the Belmont Report

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The Belmont Report

• This report articulated three primary ethical
  principles on which standards of ethical conduct
  in research are based
• Beneficence
• Respect for Human Dignity
• Justice

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Beneficence Doing good

• Includes the concept of non-maleficence (doing no
  harm).
• Includes freedom from harm
• Freedom from undue stress, death, disability or
  injury as well as psychological consequences
• Includes freedom from exploitation
• There should be no disadvantage to taking part in
  the research.
• Remember that exploitation can be overt, covert,
  or subtle
• Subjects should see the nurse role as researcher
  not as nurse care provider as it could then be
  considered coercive.

7
Beneficence Doing good

• Risk/Benefit Ratio
• Do the benefits outweigh the risks to the
  subjects?
• Do the benefits to society outweigh the risk to
  the participants?

8
Beneficence Doing good

• Major potential benefits
• Access to an intervention that might not have
  otherwise
• Gratification in being able to participate
• Increased knowledge about self or condition
• Excitement about being involved in a study
• Satisfaction that they be helping others
• Direct monetary or material gain through stipends
  or incentives

• Major potential risks
• Physical harm
• Physical discomfort, fatigue, boredom
• Psychological or emotional stress
• Loss of privacy
• Loss of time
• Monetary costs

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Respect for Human Dignity

• Respect for human dignity includes
• Right to Self-determination
• Right to Full-disclosure
• Informed Consent
• Respect

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Respect for Human Dignity Right to
Self-determination

• Humans should be autonomous, controlling their
  own activities and destinies.
• They should have the right to decide voluntary
  participation without penalty or prejudice.
• They should have the right to terminate their
  participation.
• There should be no coercion (explicit or implicit
  threats for failure to participate).

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Respect for Human Dignity Right to
Full-disclosure

• There should be full disclosure of
• The nature of the study
• The right to refuse participation
• The researchers responsibilities
• The risks and benefits

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Respect for Human Dignity Informed Consent

• Individuals need to be given adequate information
• They must be capable of making a decision
  (comprehending the information given)
• There must be the power of free choice
• Consent must be voluntary
• Qualitative studies may use a process consent
  where the researcher continually renegotiates the
  consent as the study evolves.

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Respect for Human Dignity Respect

• Sometimes full disclosure and right to
  self-determination can be problematic to the
  research purpose.
• Sometimes full disclosure may lead to biases
• Bias resulting from distorted information
• Bias resulting form being able to recruit a good
  sample

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Respect for Human Dignity Respect

• Therefore, some researchers will do the
  following
• Covert data collection
• Data is collected without the participants
  consent or knowledge
• Some believe this is acceptable if the risks are
  negligible and the right to privacy is not
  breached
• Deception
• Information is withheld or participants are
  misled with false information.

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Respect for Human Dignity Respect

• When deception or covert data collection occurs,
  the researcher should inform participants as soon
  as possible after the data collection, explain
  the nature of the study and why informed consent
  was not obtained. The researcher should then give
  the individual the right to decide if they agree
  to have their data included in the study.

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Justice

• Justice includes
• The right to fair treatment
• The right to privacy

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Justice The Right to Fair Treatment

• There must be nondiscriminatory subject selection
• There must be nonprejudicial treatment
• All agreements must be honored
• There must be access to researchers at any time
  to clarify
• There must be access to appropriate professional
  assistance in the event of injury, harm, etc.
• Debriefing with the participants should occur as
  needed
• There should be sensitivity to/respect for
  beliefs, habits, and lifestyles
• People should be treated with courtesy

18
Justice The Right to Privacy

• The research must not be more intrusive than it
  needs to be
• Data should be anonymous when possible (no one
  even the researcher can link the data to the
  participant).
• At a minimum there must be confidentiality
  (information that is held in confidence so no one
  other than the researcher can link the data to
  its source)

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Vulnerable Groups

• There are certain groups that the federal
  government considered vulnerable and unable to
  give full informed consent or may be at high risk
  of unintended side effects because of their
  circumstances. These groups are
• Children
• While children cannot legally give consent, their
  assent (agreement to participate) should be
  obtained
• Parents or guardians must give consent for
  participation
• Mentally/emotionally handicapped
• These folks are unable to weight the risks
  benefits and cannot legally or ethically give
  consent for themselves.
• Guardians must give consent
• Physically handicapped (e.g. deaf)
• Special procedures may be required for obtaining
  consent (e.g. interpreters for the deaf,
  alternative means of documenting consent for
  those who cannot write).

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Vulnerable Groups

• These groups are (continued)
• The institutionalized
• These folks may feel coerced into participation
  due to the circumstances of their
  institutionalization.
• Prisoners may feel they have no options or those
  institutionalized for health reasons may believe
  their care would be compromised if they fail to
  participate.
• Voluntary participation MUST be stressed.
• Pregnant women
• There is a desire to protect the woman from
  physical and psychological risk as well as the
  fetus who cannot give consent.
• Federal regulations stipulate a pregnant woman
  CANNOT be involved in a study unless the purpose
  of the study is to meet the needs of the woman
  and unless risks to her and the fetus are
  minimized.

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Protection of Human Subjects

• Researchers are often not the most appropriate
  individuals to oversee the protection of their
  participants due to their lack of objectivity.
• Due to the potential bias that exists in their
  evaluation of risk/benefits and ethical
  appropriateness of their studies, there is
  usually an external review.
• Committees that review proposed research for the
  protection of human subjects are often called
  Human Subjects Committees or Institutional Review
  Boards (IRB)

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Protection of Human Subjects (info quoted
directly from sections of the IU Human Subjects
Tutorial)

• IRBs review research projects to provide for the
  protection of subjects against
• undue or unnecessary invasion of privacy,
• disregard for human dignity,
• physical, psychological or social harm.
• In most cases, this involves approval of an
  informed consent document written in a language
  that is understandable to the research subject or
  representative. The informed consent document
  must provide sufficient information so that the
  subject is fully informed of the risks and
  benefits that might be reasonably expected.

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Protection of Human Subjects (info quoted
directly from sections of the IU Human Subjects
Tutorial)

• IRB review assures that
• risks to subjects are minimized
• risks to subjects are reasonable in relation to
  anticipated benefits, if any, to subjects, and
  the importance of the knowledge that may
  reasonably be expected to result
• selection of subjects is equitable and
• there is proper informed consent and
  documentation of informed consent.

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Protection of Human Subjects (info quoted
directly from sections of the IU Human Subjects
Tutorial)

• In some instances, IRB review can also require
  that
• the research plan makes adequate provision for
  monitoring the data collected to ensure the
  safety of subjects
• there are adequate provisions to protect the
  privacy of subjects and to maintain the
  confidentiality of data
• and
• additional safeguards are included to protect the
  rights and welfare of any subjects likely to be
  vulnerable to coercion or undue influence

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Protection of Human Subjects(info quoted
directly from sections of the IU Human Subjects
Tutorial)

• Once research is initiated, IRBs have continuing
  responsibilities. These include
• The conduct of continuing review at intervals
  appropriate to the degree of risk, and in any
  event, not less than once per year.
• Authority to observe or have a third party
  observe the informed consent process and the
  research.
• Receipt of prompt reports from investigators of
  any unanticipated problems involving risks to
  subjects or others, or any serious or continuing
  noncompliance with the IRBs requirements or
  determination, or with the regulations.
• Authority to suspend or terminate IRB approval of
  research that is not being conducted in accord
  with the IRBs requirements or that has been
  associated with unexpected serious harm to
  subjects.

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Protection of Human Subjects (info quoted
directly from sections of the IU Human Subjects
Tutorial)

• Research projects are reviewed at one of three
  levels, depending on the level of risk to the
  human subjects and the Federal regulations that
  define the categories of review, which are
• exempt from continuing IRB review,
• expedited IRB review, and
• full IRB review.

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Exempt Review (info quoted directly from sections
of the IU Human Subjects Tutorial)

• Types of research which may fit into exempt
  categories include, but are not limited to
• Research on instructional strategies conducted in
  established or commonly accepted educational
  settings.
• Research involving the use of educational tests
  (cognitive, diagnostic, aptitude, achievement),
  survey procedures, interview procedures or
  observation of public behavior.
• 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 investigator in
  such a manner that subjects cannot be identified
  (see Section 4.5.4 Existing Data).
• Research and demonstration projects, which are
  conducted by or subject to the approval of
  department or agency heads.
• Even if an investigator believes that a project
  is exempt, she or he must submit an application
  to the IRB for a final determination.

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Expedited Review (info quoted directly from
sections of the IU Human Subjects Tutorial)

• Research activities that present no more than
  minimal risk to human subjects, and involve only
  certain specified procedures may be reviewed by
  the IRB through the expedited review procedure.
• Minimal risk means that the probability and
  magnitude of harm or discomfort anticipated in
  the research are not greater in and of themselves
  than those ordinarily encountered in daily life
  or during the performance of routine physical or
  psychological examinations or tests.

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Expedited Review (info quoted directly from
sections of the IU Human Subjects Tutorial)

• Research protocols that fall under this category
  do not require review by the full IRB instead, a
  sub-committee reviews the protocols.
• Procedures approved in the Federal regulations
  for expedited review that are likely to be
  undertaken by researchers include, but are not
  limited to
• Recording of data from subjects using noninvasive
  procedures
• Voice recording
• Moderate exercise by healthy volunteers
• Study of identifiable existing data and
• Research on an individual or group behavior that
  involves no manipulation of the subjects and is
  not stressful.

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Full Review (info quoted directly from sections
of the IU Human Subjects Tutorial)

• Research that involves greater than minimal risk
  requires review and approval by a full IRB
  composed of members qualified to review research
  in that field. Risks to research subjects posed
  by participation in research should be justified
  by the anticipated benefits to the subjects or
  society. Research that requires full IRB review
  includes but is not limited to
• Certain types of research involving children or
  the cognitively impaired
• Most research involving prisoners
• Survey research that involves sensitive questions
  or is likely to be stressful for the subject and
• Any research project that does not fit into the
  exempt or expedited categories.

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Ethical Considerations in Research Literature

• In research reports/articles, the specifics of
  human subjects protection are often not
  mentioned.
• If it is mentioned in any manner, it is usually
  found in the methods section of the report or
  article.
• Usually IRB review is mentioned.
• A good article will not give specificity about
  the locale of the study in order to protect the
  confidentiality of research subjects/participants

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The Research Critique

• When evaluating research for usefulness and
  appropriateness in comparing the study you are
  reading to standards of good research, you
  should ask the following questions
• Were participants subject to any harm?
• Did the benefits outweigh the risks?
• Were any types of coercion used?
• Was participation voluntary?
• Was there an IRB or Human Subjects Committee
  review of the project?

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The Research Critique

• You should ask the following questions
  (continued)
• Were vulnerable subjects used? Who gave
  consent/assent? Was there a full IRB review?
• Was there deception?
• Were participants fully informed?
• Did participants sign an informed consent?
• Was privacy protected?