BIO ETHICS IN CLINICAL RESEARCH

Presented byShazia afreen To

Dr.Smitha

DISCLAIMER

Contents are drawn from various sources

I am not authority /expert on the topic

Bioethics is the application of ethics to the field if medicine and healthcare.

It is the way of understanding and examining what is right and what is wrong in biomedical research and practice.

Bio ehics was first coined in 1971 by Van Rensselaer potter of wiseosin university.

Introduction to Bioethics

History of Bioethics

• Started as concerns regarding research ethics• Nuremberg Doctors’ Trial -- 23 German physicians who either

participated in the Nazi program to euthanize persons deemed "unworthy of life“ or who conducted experiments on concentration camp prisoners without their consent were tried.  The trial lasted 140 days.  85 witnesses testified and almost 1,500 documents were introduced.  16 of the doctors charged were found guilty.  7 were executed.

What Were Founding Bioethicists Studying?• Normative ethics – formulation and defense of basic

principles, values, virtues, and ideals governing moral behaviour

• Descriptive ethics – factual descriptions of moral behaviour and belief systems

• Analytic approach – discerning meanings of life, concepts of rights/justice/fairness, etc.

• Balancing ethical principles• Shift from the greatest good to individual rights

❏ Respect for persons autonomy- informedvoluntory consent protection of volunerable persons❏ Beneficience/Non-Maleficience protection of rights Investigator – study design wellbeingnesof subjects more benifits than risks❏ Justice/Non-Exploitation fairness equitable recruitment of participants caring of volunerable group

Principles of Bioethics:

Players involved

-Ethics committees and review boards-Researchers and sponsers-Community and advocates

EVOLUTION OF BIOETHICS

Feminist critique– Social structure and power hierarchy– Concerns of medicalization– Significance of social relationships– Multiculturalism and perceived homogeneity among bioethicists– Care ethics justice reconfigured– Relational autonomy

Disability critique• Vulnerability and dependency as human conditions• Meanings of “normal” and a “good” life• Medical vs social model• Cure vs social acceptance• Social contexts affect individual decisions• Meaning of autonomy challenged

Current Focus in Bioethics

• Branches – biomedical/clinical ethics, research ethics, organizational ethics

• Genetics• Brain imaging technologies• Multiculturalism• End-of-life care• Aging• Health-care resource allocation

Systematic Approach in Resolving Dilemmas.Define and identify the ethical dilemma• Clarify the facts – what’s known and what’s not?

– Medical indications- patient profile.– Patient/Resident/Family (PRF) preferences.– Quality of life-subjective evaluation of his or her situation– Contextual factors-Social contexts, family situation,

cultural/religious values, financial situation, etc.– Analyze and balance the values involved– Make a recommendations shared decision making– Follow up and evaluation

• ensures accountability, consistency, and transparency, thereby promoting trust and integrity

Case Discussion

• As a result of an automobile explosion, 25 year-old Dax Cowart was badly burned over 65% of his body. Both eyes, both ears and both hands were damaged beyond repair. Large doses of narcotics were required for minimal pain relief. To control the many infected areas on his body, Cowart had to be submerged daily in a tank of highly chlorinated water to disinfect his wounds. The experience was excruciatingly painful, and Cowart protested and refused the “tankings.” He pleaded with his caregivers to be allowed to die, and stated several times that he wanted to kill himself. The physicians turned to his mother to obtain consent for all his treatments.

What Should the Clinicians Do?Moral Considerations Factual Considerations

Non-Maleficence Medical IndicationBeneficence PF PreferenceAutonomy Improving thequality of LifeJustice Contextual FactorsCareConfidentialityLoyaltyTruthfulness

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