Informed Consent: Some Challenges to the Universal Validity

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Informed Consent Some Challenges to the
Universal Validity of the Western Model Robert
E. Levine
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INFORMED CONSENT

• The four attributes of patient consent, cited by
  Robert E. Levine, that the Nuremberg Code
  identifies as required for a person to
  participate in medical research are
• 1. Consent must be voluntary. The participant
  must choose freely to participate.
• 2. Consent must be legally competent. The
  patient must be legally authorized to consent to
  participate.
• 3. Consent must be informed. Researchers must
  inform potential participants of the nature of
  the research, and possible risks in addition to
  possible benefits.
• 4. Consent must be comprehending. The patient
  must understand the nature of the research and
  how the research might affect his or her health.

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RESPECT FOR PERSONS I

• Levine notes that the ethical principle of
  respect for persons incorporates two fundamental
  ethical convictions according to the National
  Commission.
• 1. Individuals should be treated as autonomous
  agents. self-governing beings able to make free
  choices for themselves
• 2. Persons with diminished autonomy who, because
  of that diminishment, are in need of protection,
  are entitled to that protection.

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RESPECT FOR PERSONS II

• Levine makes the following points about respect
  for persons in relation to recognition of their
  autonomy
• We are not to interfere with another such as in
  touching or encroaching upon his/her private
  space - unless the person consents to such
  interference.
• Persons are to be left alone then, even when they
  choose to do things that might hurt them, unless
  they agree to our intervention to prevent them
  from self-harm.
• We are not to obstruct their actions unless they
  are clearly detrimental to others.
• Our actions should be designed to affirm their
  autonomy and enhance their capacity to be
  self-determining.

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DISRESPECT FOR PERSONS

• Levine We show disrespect for autonomous
  persons when we either repudiate their considered
  judgments or deny them the freedom to act on
  those judgments in the absence of compelling
  reasons to do so.

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MORAL AGENTS

• The prevailing view of the nature of a moral
  agent in Western civilization, as cited by
  Levine, is
• 1. A moral agent can form a rational life plan.
• 2. A moral agent can rationally deliberate about
  possible plans of action to make choices that fit
  his or her life plan.
• 3. A moral agent and can assume responsibility
  for his or her decisions.

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RESPECT FOR PERSONS III

• Levine thinks that the National Commissions view
  of respect for persons was influenced by the
  German philosopher Immanuel Kant and by the
  American judge Benjamin Cardozo.
• Kant So act as to treat humanity, whether in
  thine own person or in that of any other, in
  every case as an end withal together with a
  means, if being treated as a means, never as
  means only.
• Cardozo Every human being of adult years and
  sound mind has the right to determine what will
  be done with his own body.

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INFORMED CONSENT AS A TWO STEP PROCESS

• The two-step process cited by Levine that
  characterizes informed consent of a prospective
  research patient as examined by Institutional
  Review Boards is
• 1. Information about the research is presented to
  the patient.
• 2. The potential research subject satisfies
  himself that he understands the information, and
  based on this understanding agrees or refuses to
  participate in the research.

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IS THE WESTERN VIEW UNIVERSAL?

• Levine says no.
• He thinks that, at this point in history, the
  Western view of the human moral agent and the
  relation of the individual to society is not the
  prevalent view in the world of what is person is
  and how a person relates to society.
• Levine says that, because it is not the case that
  all cultures have a similar notion of the nature
  of a person and the relation of that person to
  society, we do not now have a universally
  applicable definition of informed consent.

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UNIVERSALISTS AND PLURALISTS I

• Levine identifies views he calls universalist
  and pluralist as they pertain to the
  regulation of medical research that crosses
  national boundaries.
• A universalist says that all research should be
  conducted according to universally applicable
  standards one set of standards applies to all.
• A pluralist accepts some standards as universal,
  but thinks that other standards are relative to
  the mores of a particular society some standards
  apply to all, others do not.

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UNIVERSALISTS AND PLURALISTS II

• Universalists call their opponents ethical
  relativists.
• Pluralists refer to their opponents as ethical
  imperialists.
• Levine thinks that universalists correctly point
  out that most therapeutic innovations are
  developed in industrialized nations.
• Universalists say that the Declaration of
  Helsinki is widely accepted.
• Pluralists say that the Declaration of Helsinki
  reflects a view of the person that is uniquely
  Western.

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UNIVERSALISTS AND PLURALISTS III

• Universalists think that, as Marcia Angell puts
  it, force of local custom or law cannot justify
  abuses of certain fundamental rights such as the
  right of self-determination on which the concept
  of informed consent is based.
• Levine thinks that certain forms of cultural
  relativism should be tolerated, but he thinks
  that there are limits to how much cultural
  relativism ought to be tolerated.
• For Levine, respect for persons as stated by Kant
  is an example of a moral principle that should be
  universally applicable, and so in spite of
  differences between cultures.

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INTERNATIONAL STANDARDS FOR INFORMED CONSENT I

• Levine maintains that informed consent protects
  people by enabling them to pursue and protect
  their own interests, and it shows respect for
  persons in doing that.
• 1. All plans to conduct research involving human
  subjects should be reviewed and approved by a
  research ethics committee (REC) that, ideally,
  is based in the community in which the research
  is to be conducted.

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INTERNATIONAL STANDARDS FOR INFORMED CONSENT II

• 2. Proposals to employ consent procedures that
  do not conform to the international standard
  should be justified by the researcher and
  submitted for review and approval by a national
  ethical review body.
• The role of the national ethical review body is
  to authorize consent procedures that deviate from
  the international standard.

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INTERNATIONAL STANDARDS FOR INFORMED CONSENT III

• 3. There should be established an international
  ethical review body to provide advice,
  consultation and guidance to national ethical
  review bodies when such is requested by the
  latter.
• 4. In the case of externally sponsored research
  Ethical review should be conducted in the
  initiating country . . . consistent with the
  international standard.