ProfessionalProfessional && Research Research Ethics:Ethics:

ConflictingConflicting Roles &Roles & ExpectationsExpectations

© PLEASE DO NOT REPRODUCE WITHOUT PERMISSION © PLEASE DO NOT REPRODUCE WITHOUT PERMISSION

Rob Hall, Ph.D., J.D.Interim Vice-Provost for ResearchUniversity of Missouri (Columbia)

Professor, Entomology, University of Missouri (Columbia)

James R. Thobaben, Ph.D., M.P.H.Visiting Ethics Scholar

Molecular Biology Program, University of Missouri (Columbia)

Professor, Social & Medical Ethics, Asbury Theological Seminary

Presentation OutlinePresentation OutlineI.I. Some HistorySome History

II.II. Moral LanguageMoral Language

III.III. AccountabilityAccountability

IV.IV. Specifics in the University of Missouri SystemSpecifics in the University of Missouri System* Human: IRB* Human: IRB* Non-human Animal: ACQA/OAR* Non-human Animal: ACQA/OAR

IV.IV. Closing CommentsClosing Comments

V.V. Questions/DiscussionQuestions/Discussion

A Quick Recent History A Quick Recent History for Understanding Research Ethicsfor Understanding Research Ethics

Speculation as ScienceSpeculation as Science Surreptitious and/or PioneeringSurreptitious 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)

A Quick Recent History A Quick Recent History for Understanding Research Ethicsfor Understanding Research Ethics

Controlled ControlsControlled 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

A Quick Recent History A Quick Recent History for Understanding Research Ethicsfor Understanding Research Ethics

Rights & SuspicionRights & 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 ???The Future ??? Central Function of Human Research Participant Protection

Programs (HRPPPs) Continued arguments for animal “rights” v. “welfare” v.

“interests” Inadequacy of scientific engagement

Nuremberg Code Nuremberg Code Slide 1

Voluntary Otherwise unprocurable data Based on prior animal

experimentation Avoids unnecessary physical &

mental suffering

Nuremberg Code 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

DistributiveAllocating goods& costs of society

RetributivePunishing

Wrong-Doers

COMPONENTS OF JUSTICECOMPONENTS OF JUSTICE(Deontologially Framed for Social Contract Society)(Deontologially Framed for Social Contract Society)

CommutativeExchanginginformation and goods on basis

of fairness

Some prima facie Rules for Commutative Justice:

Privacy Norms (Schoeman B&W 733ff)

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

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

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

Truth-telling Imbalance of knowledge Imbalance of knowledge ImmediacyImmediacy ““Reasonably” CompleteReasonably” Complete

Consent Imbalance of powerImbalance of power Access to guidanceAccess to guidance DesperationDesperation

Selection criteria (boundary with distributive justice)

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

Research Research Subjects/ParticipantsSubjects/Participants

&&the Assumption of Riskthe Assumption of Risk

““...experimentation has always been ...experimentation has always been conducted on those with little social conducted on those with little social

standing and few champions.”standing and few champions.” (McNeill 369)

Does this include non-human animals?Does this include non-human animals?

One more model of accountability...

R TOTAL POPULATION R TOTAL RESEARCHER

<

B TOTAL POPULATION B TOTAL RESEARCHER WHEN:1) Expected R < B for both total population and for researcher;

“disaster” is when R>B.2) 0 < R 13) 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.

Optimum Choice in Balance of Risk & Optimum Choice in Balance of Risk & BenefitBenefit

Cost

of

Tre

ati

ng

/Not

Tre

ati

ng Risk of Not Treating Risk of Treating

Optimum

Dose/ExposureBased on: Kammen & Hassenzahl

Who is accountableWho is accountable

for research “errors”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

Accountability for Risk

Researchers appropriate preparation and evaluation of research

YES

Funding:(government and/or academic and/or corporate)

NO: Naturalism/ Luddite(?)

Peer-group approval(scientists)

Internally objective research

Market distribution to other practitioners

Failed research or excessive marketing costs(termination by peers, institution, sponsor, scientist) ORDiscontinue:Too expensive/too insignificant

ProductSales in “retail” market

Too expensive to produce/ use

Too small of market due to social/ cultural constraints

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

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

IRB present-ation

Outside Source suggests research

Researcher interest

NO: Research Inappropriate(see below)

Consumer “purchase”

A model of accountabilityA 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

Response Has Been Ethical EvaluationResponse Has Been Ethical EvaluationWithin the InstitutionWithin the Institution

Institutional EthicsCommittee

Mandated byaccrediting

organizations (esp. JCAHO)

Institutional Institutional Review Animal Board Care & Use

CommitteeMU: ACUC (ACQA/OAR)

Mandated by Mandated byfederal federalgovernment governmentfor sites with for sites withsupported human animalinvestigation investigation(possibly to be replacedby “Human ResearchParticipant ProtectionPrograms” [HRPPPs])

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.

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

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

Institutional Review Board (IRB)

Definitions

Research A systematic

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

Human Subject 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.

Choosing the Appropriate Forum

Guidelines for Investigators Applying for IRB Review

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

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.

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

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 PERSONSCONTACT PERSONSHS IRB – Katarzyna Karelus @ 882-3182

Campus IRB – Michele Reznicek @ 882-9585

Seven Categories of Experimental Use of Seven Categories of Experimental Use of AnimalsAnimals

(Instrumental Use in Science) (Rollin 414-415)

Basic biologicalBasic biological Applied basic biological/psychologicalApplied basic biological/psychological Development of drugs/therapeutic chemicalsDevelopment of drugs/therapeutic chemicals Food & fiber researchFood & fiber research Testing of consumer goodsTesting of consumer goods Use in educationUse in education Extraction of drugs/biological productsExtraction of drugs/biological products

Do they have rights/Do we owe them welfare?Do they have rights/Do we owe them welfare?

5 Basic Approaches to 5 Basic Approaches to “Using” Animals (if at all)“Using” Animals (if at all)

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

Modified to:The Five R’s

(1 -3 from William Russell & Rex Burch The Principles of Humane Experimental Technique; also Orlans 407; 4 & 5 Thobaben)

RefinementRefinement to lessen degree of pain/distressto lessen degree of pain/distress

ReductionReduction of number to minimum scientifically requiredof number to minimum scientifically required

ReplacementReplacement of animal models with non-animal when possibleof animal models with non-animal when possible

Reproduction ProtectionReproduction Protection of species as part of ecosystem of species as part of ecosystem

Revise DownwardRevise Downward toward lower & more common animals when toward lower & more common animals when

possiblepossible

Animal Care and Use - General Policy

• 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

Animal Care and Use - Structure

Office of ResearchInstitutional 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.

Animal Care and Use – Getting Started…

• TRAINING – basic training is required

• OHSP – enrollment is required

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

Other Institutional/Ethical Interactions

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

CONCLUSION: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

ProfessionalProfessional && Research Research Ethics:Ethics:

ConflictingConflicting Roles &Roles & ExpectationsExpectations

© PLEASE DO NOT REPRODUCE WITHOUT PERMISSION © PLEASE DO NOT REPRODUCE WITHOUT PERMISSION

Rob Hall, Ph.D., J.D.Interim Vice-Provost for ResearchUniversity of Missouri (Columbia)

Professor, Entomology, University of Missouri (Columbia)

James R. Thobaben, Ph.D., M.P.H.Visiting Ethics Scholar

Molecular Biology Program, University of Missouri (Columbia)

Professor, Social & Medical Ethics, Asbury Theological Seminary