Responsible Conduct in Research Fred Lombardo, Pharm.D.,MS Howard University

Basic Bioethics l Two predominate philosophies governing ethics in the Western world: –Deontological view-I. Kant ( ) –Utilitarianism-John Locke ( ) and John Stuart Mill ( )

Deontology/Utilitarianism l Deontology –The study of duties that persons have toward one another. –The categorical imperative of Immanuel Kant l 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 Bioethics l 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 Maimonides l Code of ethics for the pharmacy profession. l 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..” l Caring..”May I never see in the patient anything but a fellow creature in pain”

Code of Ethics for Pharmacists l Respect the values and abilities of colleagues and other health care professionals. l Service to individual, community, and societal needs l Seek justice in the distribution of health resources

Code of Ethics for Pharmacists l Respect for the covenantal relationship between patient and pharmacist. l Promotion of good for every patient in a caring, compassionate, and confidential manner. l Respect for the autonomy and dignity of patient. l Act with honesty and integrity in professional relationships l Maintenance of professional competence

Elements of Informed Consent l Threshold requirement: competence l Information requirements –Information –Understanding l Consent requirements –Consent –Authorization

Informed Consent l Benefits l Risks l Alternatives

Problems/Ethical Dilemmas l Veracity- Truth Telling, is deception every justified? l Privacy/Confidentiality, is failure to protect the privacy of the patient every justified? l Differences between obligations for privacy and for confidentiality

Tuskegee Study ( ) l 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 ( ) l 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 ( ) l 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 Unethical Research l Tuskegee Syphilis Study ( ) l Nazi Experiments on Prisoners-WW II l Willow Brook Study-1960’s l Human Radiation Experiments l LSD Experiments 1930s l Serratia marcescens experiments l Bacillus subtilis experiments

Belmont Report l Principles: –Respect for persons’ consent, privacy, confidentiality –Beneficence (Benefits versus Risks) –Justice/Equality

45 Code of Federal Regulations l Risks to subjects minimized l Risks reasonable in relation to anticipated benefits. l Selection of subjects equitable l Provision for safety monitoring l Informed consent documented

45 CFR Part l There is adequate provisions to protect the privacy of subjects and to maintain confidentiality of data l 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 Code l The voluntary consent of the human subject is absolutely essential. l The experiment should be such as to yield fruitful results for the good of society. l Experiment based on results of animal experiments and knowledge of the natural history of the disease or problem

The Nuremberg Code l The experiment should be conducted as to avoid all unnecessary physical and mental suffering and injury. l 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 Code l 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. l 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 Code l The experiment should be conducted only by scientifically qualified persons. l 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 Code l 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)