Ethical Considerations in Clinical Research

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Ethical Considerations in Clinical Research

• Seton Healthcare Office of Research
  Administration
• Heather J. Gipson, JD, MA, CIM

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Finagles LawFinagle's Law of Dynamic Negatives
(also known as Finagle's Corollary to Murphy's
Law)

• If an experiment works, something has gone wrong
• No matter what result is anticipated, there is
  always someone willing to fake it
• No matter what the result, there is always
  someone eager to misinterpret it
• No matter what happens, there is always someone
  who believe it happened according to his pet
  theory
• In any collection of data, the figure most
  obviously correct, beyond all need of checking,
  is the mistake
• Once a job is fouled up, anything done to improve
  it only makes it worse

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Definition of Clinical Research

• Patient-oriented research - Research conducted
  with human subjects or on material of human
  origin for which an investigator directly
  interacts with human subjects. This area of
  research includes
• Mechanisms of human disease
• Therapeutic interventions
• Clinical trials
• Development of new technologies
• Epidemiologic psychosocial studies
• Outcomes research and health services research.

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Ethics Definition

• The branch of philosophy that investigates ideals
  in living (a good life) and morally correct
  conduct (right actions).
• Bioethics is the critical analysis of emerging
  moral issues in health.

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More Definitions

• Bioethics is the philosophical study of the
  ethical controversies brought about by advances
  in biology and medicine. Bioethicists are
  concerned with the ethical questions that arise
  in the relationships among life sciences,
  biotechnology, medicine, politics, law,
  philosophy, and theology.
• Wikipedia

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More Definitions

• Date 1971
• Bioethics a discipline dealing with the ethical
  implications of biological research and
  applications especially in medicine.
• Merriam-Webster Dictionary

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And More Definitions

• Bioethics branch of applied ethics that
  studies the philosophical, social, and legal
  issues arising in medicine and the life sciences.
  It is chiefly concerned with human life and
  well-being, though it sometimes also treats
  ethical questions relating to the nonhuman
  biological environment. (Such questions are
  studied primarily in the independent fields of
  environmental ethics see environmentalism and
  animal rights.)
• Encyclopedia Britannica

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Areas of health sciences that are the subject of
published, peer-reviewed bioethical analysis
include

• Abortion
• Animal rights
• Artificial insemination
• Artificial life
• Artificial womb
• Assisted suicide
• Biopiracy
• Blood/blood plasma (trade)
• Body modification
• Brain-computer interface
• Chimeras
• Circumcision
• Cloning
• Confidentiality (medical records)
• Consent
• Contraception (birth control)
• Cryonics

• Life support
• Lobotomy
• Medical malpractice
• Medical research
• Medical torture
• Moral obligation
• Nanomedicine
• Organ donation (fair allocation, class and race
  biases)
• Pain management
• Parthenogenesis
• Patients' Bill of Rights
• Placebo
• Population control
• Prescription drugs (prices in the US)
• Procreative beneficence
• Professional ethics

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Ethics Differs from Science in That

• Ethics fosters evaluation and prescribes the most
  correct action.
• Science describes, explains, and predicts
  phenomenon.

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Strengths

• Scientific inquiry gives more and more productive
  power.
• Philosophic inquiry gives better and better
  direction.

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Research and the Ethical and Religious Directives

• A Catholic health care institution, especially a
  teaching hospital, will promote medical research
  consistent with its mission of providing health
  care and with concern for the responsible
  stewardship of health care resources. Such
  medical research must adhere to Catholic moral
  principles.

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Legal and Ethical Foundations

• Nuremberg Code
• The Declaration of Helsinki
• The Belmont Report
• The Common Rule (45 CFR 46)
• International Ethical Guidelines for Biomedical
  Research Involving Human Subjects
• The ICH Harmonized Tripartite Guideline for Good
  Clinical Practice

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• How can we evaluate/think through research
  ethics in a paradigm?

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A Definition of Philosophy

• Love and pursuit of wisdom by intellectual means
  and moral self-discipline.
• Investigation of the nature, causes, or
  principles of reality, knowledge, or values,
  based on logical reasoning rather than empirical
  methods.
• A critical analysis of fundamental assumptions/
  beliefs.
• A set of ideas or beliefs relating to a
  particular field or activity
• A system of values by which one lives.
• (edited from Answers.com)

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Bioethics Must Ask

• "First, what kind of medicine and health care,
  and/or stance toward nature and our environment,
  do we need for the kind of society we want"
• "The second question reverses the first What
  kind of a society ought we want in order that the
  life sciences will be encouraged and helped to
  make their best contribution to human welfare?"
• Callahan, 1995

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Research Philosophy

• Logic (reasonable assertions)
• Metaphysics (what is truth, life, God?)
• Aesthetics (order, beauty)
• Ontology (our beingness)
• Existentialism (radical freedom)
• Epistemology (how do we know?)
• Phenomenology (being-in-the-world)
• Ethics (analysis of correct actions)

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Phenomenology

• Focuses on the description and interpretation of
  peoples lived experience
• Asks What is the essence of a phenomenon and
  what does it mean?
• Acknowledges peoples physical ties to their
  world Being-in-the-world

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Goals of Qualitative Inquiry

• Identify the meaning of a phenomenon, event or
  experience for an individual
• In-depth knowledge of a phenomenon that is
  difficult to express numerically

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What should be done? By whom? Under what
situation?
Influences on Ethical Thoughts
Parents, Society, Religion, God,
Intuition, Etc.
Ethically permissible action toward
patient(s)/subject(s) (Is the action itself is
wrong?)
Create Argument via Moral Strategies
Moral/patient or another person The most
happiness for the most individuals
Reflects/ Researches
Principles Theories Compassion Virtue
Ethicists Articles
Society or Audience
Moral Agent (inherent in who they/we are)
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• In a study of nurses opinions about informed
  consent in clinical trials, one nurse laments
  that the patient reported she would have signed
  anything.

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Informed Consent

• Philosophical Basis
• Hippocratic admonition to help, or at least,
  to do no harm
• Social Benefit (may contribute to producing the
  greatest good for the greatest number by
  reducing suspicion about research)
• Respect for Persons (In legal context Justice
  Benjamin Cardozo in 1914 stated that every human
  being of adult years and sound mind has a right
  to determine what shall be done with his own
  body.)
• No foundation can stand alone all are needed to
  justify concept of informed consent
• Ethical and Regulatory Aspects of Clinical
  Research
• Readings and Commentary

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Informed Consent

• Religious Basis
• Several fundamental tenets of the
  Judaeo-Christian tradition also provide grounding
  for the requirement to seek consent. This
  tradition affirms that each human life is a gift
  from God and is of infinite and immeasurable
  worth (the sanctity of life).
• The consent requirement can also be grounded
  explicitly in the notion of covenant. Seeking
  consent is an affirmation of the basic
  faithfulness or care required by the fundamental
  covenantal nature of human existence.
• Ethical and Regulatory Aspects of Clinical
  Research
• Readings and Commentary

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Informed Consent

• Legal Basis
• The legal grounding for the requirement for
  consent to research is based on the outcome of
  litigation of disputes arising almost exclusively
  in the context of medical practice. (Canadian
  case Halushka v. University of Saskatchewan)
• Ethical and Regulatory Aspects of Clinical
  Research
• Readings and Commentary

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Two Legal Foundations

• 1) failure to obtain proper consent was
  traditionally treated as a battery action. A
  priori (wrong) to touch, treat, or do research
  upon a person without the persons consent.
  Whether or not harm befalls the patient/subject
  is irrelevant (it is the unconsented-to touching
  that is wrong).
• Ethical and Regulatory Aspects of Clinical
  Research
• Readings and Commentary

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Two Legal Foundations

• 2) Modern trend is malpractice is to treat cases
  based upon failure to obtain proper consent as
  negligence rather than battery. A
  patient/subject must prove that the physician had
  a duty toward the patient that the duty was
  breached that damage occurred to the patient
  and that the damage was caused by the breach.
• Under both battery and negligence doctrines,
  consent is invalid if any information is withheld
  that might be considered material to the decision
  to give consent.
• Ethical and Regulatory Aspects of Clinical
  Research
• Readings and Commentary

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Research on the Informed Consent process Joffe,
Dana Farber

• subjects failed to recognize non-standard therapy
  (74)
• the potential for incremental risk from research
  participation (63)
• the unproven nature of the treatment under study
  (70)
• the uncertainty of benefits to self (29) and
• the trials' primary benefit for future patients
  (25).

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Other Issues to Consider

• Clinical Trial Design
• Recruitment
• Equipoise (equality) in Research
• Research on Special Populations
• Genetic Research
• Biological Specimens
• Conflicts of Interest
• Scientific Misconduct
• Challenges to the Institutional Review Board
  System

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• How can the rights of individual persons be
  reconciled with the demands of the scientific
  enterprise?

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• Good clinicians always maintain their
  orientation toward truthin humble recognition of
  their limited ability to know that truth.
• Dr. Daniel Sulmasy, The Healers Calling