Responsible Conduct in ResearchResponsible Conduct in Research

Fred Lombardo, Pharm.D.,MS

Howard University

Basic BioethicsBasic Bioethics

Two predominate philosophies governing ethics in the Western world:– Deontological view-I. Kant (1724-1804)– Utilitarianism-John Locke (1632-1704) and

John Stuart Mill (1806-1873)

Deontology/UtilitarianismDeontology/Utilitarianism

Deontology– The study of duties

that persons have toward one another.

– The categorical imperative of Immanuel Kant

Utilitarianism– The view that actions

or policies are to be morally evaluated according to the extent to which they promote happiness or well-being

Clinical BioethicsClinical Bioethics

Principles:– Beneficence (To do Good)– Nonmaleficence (Primum non nocere)– Justice (Fairness)– Autonomy (Self-determination)– Veracity (Truth telling)– Utility (The greatest good for the greatest

number)

Oath of MaimonidesOath of Maimonides

Code of ethics for the pharmacy profession. Altruism….”May the love for my art

actuate me at all time…”May neither avarice nor miserliness, nor thirst for glory or for a great reputation engage my mind..”

Caring..”May I never see in the patient anything but a fellow creature in pain”

Code of Ethics for PharmacistsCode of Ethics for Pharmacists

Respect the values and abilities of colleagues and other health care professionals.

Service to individual, community, and societal needs

Seek justice in the distribution of health resources

Code of Ethics for PharmacistsCode of Ethics for Pharmacists

Respect for the covenantal relationship between patient and pharmacist.

Promotion of good for every patient in a caring, compassionate, and confidential manner.

Respect for the autonomy and dignity of patient. Act with honesty and integrity in professional

relationships Maintenance of professional competence

Elements of Informed ConsentElements of Informed Consent

Threshold requirement: competence Information requirements

– Information– Understanding

Consent requirements– Consent– Authorization

Informed ConsentInformed Consent

Benefits Risks Alternatives

Problems/Ethical DilemmasProblems/Ethical Dilemmas

Veracity- Truth Telling, is deception every justified?

Privacy/Confidentiality, is failure to protect the privacy of the patient every justified?

Differences between obligations for privacy and for confidentiality

Tuskegee Study (1932-1972)Tuskegee Study (1932-1972)

Reasons given for continuing study– Long-term benefits for African-Americans– Contribution to scientific knowledge– Benefits for subjects (would receive other

medical treatment)– Subjects were not harmed– Treatment might harm (Jarische-Herxheimer)– Should not waste data collected

Tuskegee Study (1932-1972)Tuskegee Study (1932-1972)

Reasons given for not telling subjects the truth:– Subjects incapable of understanding– Scientists better equipped to determine what

would benefit the subjects (paternalism)– Better to sacrifice a few for the greater good of

the whole (utilitarianism)

Tuskegee Study (1932-1972)Tuskegee Study (1932-1972)

Reasons for breach of veracity tenet continued:– Subjects in the study were better off than those

not selected to participate.– Long-term scientific goals were of greater

importance than rights of an individual (Kant’s Categorical Imperative is breached)

Egregious Examples of Egregious Examples of Unethical ResearchUnethical Research

Tuskegee Syphilis Study (1932-1972) Nazi Experiments on Prisoners-WW II Willow Brook Study-1960’s Human Radiation Experiments 1950-1970 LSD Experiments 1930s Serratia marcescens experiments Bacillus subtilis experiments

Belmont ReportBelmont Report

Principles:– Respect for persons’ consent, privacy,

confidentiality– Beneficence (Benefits versus Risks)– Justice/Equality

45 Code of Federal 45 Code of Federal Regulations 46.111Regulations 46.111

Risks to subjects minimized Risks reasonable in relation to anticipated

benefits. Selection of subjects equitable Provision for safety monitoring Informed consent documented

45 CFR Part 46.11145 CFR Part 46.111

There is adequate provisions to protect the privacy of subjects and to maintain confidentiality of data

Where any of the subjects are likely to be vulnerable to coercion (“susceptible to kindness”) or undue influence, additional safeguards are incorporated to protect the subjects.

The Nuremberg CodeThe Nuremberg Code

The voluntary consent of the human subject is absolutely essential.

The experiment should be such as to yield fruitful results for the good of society.

Experiment based on results of animal experiments and knowledge of the natural history of the disease or problem

The Nuremberg CodeThe Nuremberg Code

The experiment should be conducted as to avoid all unnecessary physical and mental suffering and injury.

No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur;except in those experiments where the investigators serve as subjects.

The Nuremberg CodeThe Nuremberg Code

The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.

Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.

The Nuremberg CodeThe Nuremberg Code

The experiment should be conducted only by scientifically qualified persons.

During the course of the experiment the human subject should be at liberty to bring the experiment to an end (Intention to Treat Precepts)

The Nuremberg CodeThe Nuremberg Code

During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he/she has probable cause to believe, in the exercise of good faith, superior skill, and careful judgment that the continuation of the experiment is likely to cause injury, disability or death (Stopping Rules)