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Ethical Considerations in Clinical Research

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Finagle's Law of Dynamic Negatives (also known as Finagle's Corollary to Murphy's Law) If an experiment works, something has gone wrong ... – PowerPoint PPT presentation

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Title: Ethical Considerations in Clinical Research


1
Ethical Considerations in Clinical Research
  • Seton Healthcare Office of Research
    Administration
  • Heather J. Gipson, JD, MA, CIM

2
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

3
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.

4
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.

5
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

6
More Definitions
  • Date 1971
  • Bioethics a discipline dealing with the ethical
    implications of biological research and
    applications especially in medicine.
  • Merriam-Webster Dictionary

7
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

8
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

9
Ethics Differs from Science in That
  • Ethics fosters evaluation and prescribes the most
    correct action.
  • Science describes, explains, and predicts
    phenomenon.

10
Strengths
  • Scientific inquiry gives more and more productive
    power.
  • Philosophic inquiry gives better and better
    direction.

11
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.

12
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

13
(No Transcript)
14
  • How can we evaluate/think through research
    ethics in a paradigm?

15
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)

16
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

17
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)

18
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

19
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

20
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)
21
  • In a study of nurses opinions about informed
    consent in clinical trials, one nurse laments
    that the patient reported she would have signed
    anything.

22
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

23
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

24
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

25
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

26
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

27
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).

28
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

29
  • How can the rights of individual persons be
    reconciled with the demands of the scientific
    enterprise?

30
  • Good clinicians always maintain their
    orientation toward truthin humble recognition of
    their limited ability to know that truth.
  • Dr. Daniel Sulmasy, The Healers Calling
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