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Professional & Research Ethics: Conflicting Roles & Expectations © PLEASE DO NOT REPRODUCE WITHOUT PERMISSION Rob Hall, Ph.D., J.D. Interim Vice-Provost for Research University of Missouri (Columbia) Professor, Entomology, University of Missouri (Columbia)

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Professional&Research Ethics:ConflictingRoles &Expectations © PLEASE DO NOT REPRODUCE WITHOUT PERMISSION

Rob Hall, Ph.D., J.D.

Interim Vice-Provost for Research

University of Missouri (Columbia)

Professor, Entomology, University of Missouri (Columbia)

James R. Thobaben, Ph.D., M.P.H.Visiting Ethics ScholarMolecular Biology Program, University of Missouri (Columbia)

Professor, Social & Medical Ethics, Asbury Theological Seminary


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Presentation Outline

  • Some History

  • Moral Language

  • Accountability

  • Specifics in the University of Missouri System

    * Human: IRB

    * Non-human Animal: ACQA/OAR

  • Closing Comments

  • Questions/Discussion


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A Quick Recent History for Understanding Research Ethics

  • Speculation as Science

  • Surreptitious and/or Pioneering

    • Jonathan Edwards (small-pox inoculation: 1758)

    • Benjamin Jesty (cow-pox on family: 1774)

    • Jeremy Bentham: utilitarian argument for considering non-human animals (1780)

    • Edward Jenner (small-pox/cow-pox vaccination on James Phipps “scientifically” recorded; 1796)

    • Louis Pasteur (anthrax, rabies:1885)

    • Charles Darwin: Origin of Species (1859)

    • “Resurrectionists” (19th century)

    • Vegetarianism associated with animal welfare and, especially, health “experiments”

    • Animal Welfare organizations: anti-vivisectionists/ SPCA-England (1824)/ ASPCA (1866)/ Cruelty to Animals Act [Britain] (1876)


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A Quick Recent History for Understanding Research Ethics

  • Controlled Controls

    • Nazi research: esp. disabled, twins (late 1930s – 1945)

    • Tuskegee (early through mid-20th century; natural course of syphilis )

    • Draize Tests (1944 - present; eyes in rabbits used to test cosmetic, etc. irritation)

    • Willowbrook (1956-1970; hepatitis infection of institutionalized children)

    • Jewish Chronic Disease Hospital (1963; live cancer injection of elderly)

    • Post- WWII transformation in understanding of animals: the “suburbanization” of animals as pets and “Bambi-ization” of nature


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A Quick Recent History for Understanding Research Ethics

  • Rights & Suspicion

    • Declaration of Helsinki (1964)

    • Milgram (Yale) psychology experiments (1960s)

    • Institutional Review Board (1970’s)

    • Laboratory Animal Welfare Act [USA] (1966; amended 1970)

    • Significant protests against use of animals in cosmetic testing

    • Popular scientific research on primates in wild

  • The Future ???

    • Central Function of Human Research Participant Protection Programs (HRPPPs)

    • Continued arguments for animal “rights” v. “welfare” v. “interests”

    • Inadequacy of scientific engagement


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Nuremberg Code Slide 1

  • Voluntary

  • Otherwise unprocurable data

  • Based on prior animal experimentation

  • Avoids unnecessary physical & mental suffering


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Nuremberg Code Slide 2

  • Avoid when a priori reason to expect death/disability (except perhaps if experimenter is subject)

  • Risk not exceed humanitarian importance

  • Proper preparation & facilities

  • Free to withdraw

  • Researcher free & willing to terminate if injury, disability, death likely


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COMPONENTS OF JUSTICE

(Deontologially Framed for Social Contract Society)

Retributive

Punishing

Wrong-Doers

Distributive

Allocating goods

& costs of society

Commutative

Exchanging

information

and goods

on basis

of fairness


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Some prima facie Rules for Commutative Justice:

  • Privacy Norms (Schoeman B&W 733ff)

    • Discretionless: strict (often shame-based) norms, for instance those surrounding bodily functions

    • Narrow: highly regulated, but with great discretion on application internal to relationship (e.g. parent-child; therapist-patient; priest-penitent)

    • Wide: restricted access to others, but as a matter of discretion and interpretation (e.g. who one dates)

  • Truth-telling

    • Imbalance of knowledge

    • Immediacy

    • “Reasonably” Complete

  • Consent

    • Imbalance of power

    • Access to guidance

    • Desperation

  • Selection criteria (boundary with distributive justice)


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    DISTRIBUTIVE JUSTICEThe Distribution of Risk Assumption by Subjects/ParticipantsWho gets picked? Who is control? Who benefits?

    • Lottery

    • ‘First-come, first-served

    • Social worth

    • Ability to pay

    • Medical criteria (best recipient)

    • Medical criteria (most needy recipient)

    • Stratification

    • Affirmative Action

    • Convenience

    • etc.


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    Research Subjects/Participants&the Assumption of Risk

    “...experimentation has always been conducted on those with little social standing and few champions.”

    (McNeill 369)

    Does this include non-human animals?


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    One more model of accountability...

    RTOTAL POPULATION RTOTAL RESEARCHER

    <

    BTOTAL POPULATION BTOTAL RESEARCHER

    WHEN:

    1) Expected R < B for both total population and for researcher;

    “disaster” is when R>B.

    2) 0 < R  1

    3) Risk for researcher = employment termination, humiliation/shame, loss of

    prestige, loss of grants, criminal sanction, lawsuit, injury/death, etc.

    4) Benefit for researcher = Grant funding, commercial profit, prestige, tenure,

    satisfaction, etc.

    5) Subject/Participant should have lower ratio than researcher.


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    Cost of Treating/Not Treating

    Risk of Not Treating Risk of Treating

    Optimum

    Dose/Exposure

    Based on: Kammen & Hassenzahl

    Optimum Choice in Balance of Risk & Benefit


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    Who is accountable

    for research “errors”

    ?

    • Scientists & other supportive academics with knowledge

    • Companies with economic clout

    • Physicians/Professors who control the use on specific subjects

    • IRBs

    • Institutions

    • Consumers/Patients/Students who have choices of the market

    • Government that protects members of social contract

    • Advocacy groups as protectors of the vulnerable & commons


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    Funding:

    (government and/or academic and/or corporate)

    Continued success: increased production & health benefits & profit & practitioner prestige

    Researcher interest

    Market distribution to other practitioners

    Internally objective research

    Accountability for Risk

    YES

    Researchers appropriate preparation and evaluation of research

    Peer-group approval

    (scientists)

    IRB present-ation

    Product

    Sales in “retail” market

    Consumer “purchase”

    Failed research or excessive marketing costs

    (termination by peers, institution, sponsor, scientist) OR

    Discontinue:

    Too expensive/

    too insignificant

    Outside Source suggests research

    NO: Naturalism/ Luddite(?)

    NO:

    Research Inappropriate

    (see below)

    Too small of market due to social/ cultural constraints

    Too expensive to produce/ use

    Unforeseen health consequences or ineffective by cost of “dose” or overall production


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    A model of accountability

    A = B + E + (I + P)

    A = accountability (  culpability)

    B = benefit accrued to agent (directly and/or indirectly)

    E = level of expertise by agent (what is known or what should be known)

    I = influence in act (usually a function of “earliness” in process)

    P = power to act (formal, bureaucratic, as function of social respect, etc.)

    Influence in act is usually a function of “earliness” in the process, which is also correlated with less knowledge about consequences.

    Benefit and risk may be concentrated or diluted; both level of concentration and total amount should be considered in that threshold effects may exist.

    Higher risk should (but often does not) provide more formal power over decision.

    Risk NEVER equals 0


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    Institutional

    Ethics

    Committee

    Mandated by

    accrediting

    organizations (esp. JCAHO)

    Institutional Institutional

    Review Animal

    Board Care & Use

    Committee

    MU: ACUC (ACQA/OAR)

    Mandated by Mandated by

    federal federal

    government government

    for sites with for sites with

    supported human animal

    investigation investigation

    (possibly to be replaced

    by “Human Research

    Participant Protection

    Programs” [HRPPPs])

    Response Has Been Ethical EvaluationWithin the Institution


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    Institutional Review Board Functions

    • To protect the rights and welfare of human subjects involved in research projects conducted at or sponsored by UMC.

    • To review, approve, require modification, or disapprove all research activities involving the use of human subjects.

    • To approve changes in previously approved research.

    • To provide continuing review all research activities.


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    Institutional Review Board (IRB)

    • All research involving human subjects at MU must be approved by the IRB priorto initiation of the project.

    • Anychanges in the protocol, consent form, or survey instruments must be approved by the IRB.


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    Definitions

    • HumanSubject

      • A living individual about whom an investigator (whether professional or student conducting research) obtains:

      • Data through intervention or interaction with the individual

      • Identifiable private information.

    • Research

      • A systematic investigation, including research development, testing & evaluation, designed to develop or contribute to generalizable knowledge.


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    Choosing the Appropriate Forum

    Guidelines for Investigators Applying for IRB Review


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    A Principal Investigator must apply to the Health Sciences Institutional Review Board (HS IRB) if any one of the following apply:

    • The Principal Investigator is employed at any of the following:

      • School of Medicine

      • University Hospitals and Clinics

      • Ellis Fischel Cancer Center

      • Rusk Rehabilitation Center

      • Truman Memorial Veterans Hospital

      • Charles & Josie Smith Sinclair School of Nursing

      • College of Veterinary Medicine

      • Missouri Institute of Mental Health

      • Missouri Rehabilitation Center

      • Columbia Regional Hospital


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    A Principal Investigator must apply to the Health Sciences Institutional Review Board (HS IRB) if any one of the following apply (cont’d):

    • The subject population includes patients (either in-patients or out-patients) in any of the institutions above.

    • The research involves physical stress to the subjects (e.g., exercise physiology projects)

    • The research involves any collection of human blood or tissue.

    • All other investigators must apply to the Campus IRB.


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    • All investigators must obtain an Education & Training Certificate prior to IRB approval.

    • The HS IRB and Campus IRB have different review processes and forms. General questions can be answered at our web page:

      • http://www.research.missouri.edu/

      • web_research/compliance/human_subjects.html

    • Internal and external funds can not be released until approval has been given by the appropriate IRB forum.

      CONTACT PERSONS

      HS IRB – Katarzyna Karelus @ 882-3182

      Campus IRB – Michele Reznicek @ 882-9585


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    Seven Categories of Experimental Use of Animals Certificate prior to IRB approval.(Instrumental Use in Science) (Rollin 414-415)

    • Basic biological

    • Applied basic biological/psychological

    • Development of drugs/therapeutic chemicals

    • Food & fiber research

    • Testing of consumer goods

    • Use in education

    • Extraction of drugs/biological products

      Do they have rights/Do we owe them welfare?


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    5 Basic Approaches to “Using” Animals (if at all) Certificate prior to IRB approval.

    • Animals as Interest Bearers (esp. as experiencers of physical/psychological “pain”)

    • Animals as Rights Holders

    • Animals as Object of Duty

    • Animals as Object of Compassion

    • Animals as Objects of No Distinct Moral Value


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    Modified to: Certificate prior to IRB approval.The Five R’s(1 -3 from William Russell & Rex Burch The Principles of Humane Experimental Technique; also Orlans 407; 4 & 5 Thobaben)

    • Refinement

      • to lessen degree of pain/distress

  • Reduction

    • of number to minimum scientifically required

  • Replacement

    • of animal models with non-animal when possible

  • Reproduction Protection

    • of species as part of ecosystem

  • Revise Downward

    • toward lower & more common animals when possible


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    Animal Care and Use - General Policy Certificate prior to IRB approval.

    • MU policy is to foster humane care and use of vertebrate animals and to adhere to laws, standards, and policies

    • Product of AWA and PHS mandates

    • Applicable to all vertebrate animals used in research or teaching (including rats, mice, birds)

    • MU policy applies regardless of funding source


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    Animal Care and Use - Structure Certificate prior to IRB approval.

    Office of Research

    Institutional Official (Dr. Rob Hall - Interim)

    Research Compliance Coordinator (Dr. Rob Hall)

    Animal Care Quality Assurance (ACQA)

    Office of Animal Resources (OAR)

    ACQA – Dr. Bill Dale (Director) 882-3681 WBC 106/107 in ASRC OAR – Dr. Lon Dixon (Director) 882-8485 M144 Med.Sci.Bldg.


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    Animal Care and Use – Certificate prior to IRB approval.Getting Started…

    • TRAINING – basic training is required

    • OHSP – enrollment is required

    • PROTOCOL APPLICATION – must be approved by ACUC before ordering animals


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    Other Institutional/Ethical Interactions Certificate prior to IRB approval.

    • Hazardous Materials Management

    • Biological Safety

    • Radiation Safety

    • Occupational Health & Safety

    • Conflict of Interest

      • Individual financial COI

      • Other individual COI

      • Institutional COI

    • Scientific Misconduct Policy (UM CRR)

    • Faculty Responsibility Committee


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    CONCLUSION: Certificate prior to IRB approval.Is there such a thing asa “virtuous” faculty member?

    • Duties as “contract”

      • W/ students

      • W/ UM

    • Duties as “covenant”

      • W/ students

      • W/ UM

      • W/ broader society


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    Professional Certificate prior to IRB approval.&Research Ethics:ConflictingRoles &Expectations © PLEASE DO NOT REPRODUCE WITHOUT PERMISSION

    Rob Hall, Ph.D., J.D.

    Interim Vice-Provost for Research

    University of Missouri (Columbia)

    Professor, Entomology, University of Missouri (Columbia)

    James R. Thobaben, Ph.D., M.P.H.Visiting Ethics ScholarMolecular Biology Program, University of Missouri (Columbia)

    Professor, Social & Medical Ethics, Asbury Theological Seminary


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