BIOETHICS &

BIOSAFETY Anirban SahaM.Pharm (Pharmaceutics)Year- 2nd , Semester- 3Amity University .

AMITY INSTITUTE OF PHARMACY

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CONTENTS

INTRODUCTION ETHICS AND MORALS IMPORTANCE OF BIOETHICS HEALTH & MEDICAL ETHICS IMPORTANCE PRINCIPLES BIOETHICS IN PATIENT CARE PROFESSIONAL ATTRIBUTE BIOETHICS IN TEAMWORK UNESCO BIOETHICS PRINCIPLE

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INTRODUCTIONThe study of the ethical and moral implications of

new biological discoveries and biomedical advances, as in the fields of genetic engineering and drug research is bioethics.

The term “bioethics” was introduced in the 70’s by Van Rensselaer Potter for a study aiming at ensuring the preservation of the biosphere.

It was later used to refer a study of the ethical issues arising from health care, biological and medical sciences.

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ETHICSDiscipline concerned with right or wrong

conduct.Guides to moral behavior.Making choices or judgments.

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ETHICS vs MORALS

Morals are an individual frame work for decision making that includes personal values.

Ethics are a generalized conceptual frame work for decision making.

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IMPORTANCE OF BIOETHICS

Bioethics education for medical practice is essential in today’s complex world because: Medical policies and patient rights legislation are

ever-changing. Health care systems function differently than before. Clinical practice now involves decision-making

about many new issues.

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Health Ethics

The rules or standards governing the conduct of a person or the members of a profession relating to the study or practice of medicine.

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Patients are entitled to good standards of practice and care from

their doctors.

Essential elements of this are professional competence, good

relationships with patients and colleagues and observance of

professional ethical obligations.”

(From Good Medical Practice, GMP)

competences of Indonesian doctors” (SKDI, 2012)

Ethics in Medical Science (Medical Ethics)

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Nowadays, conflicts of interests between the government and medical institutions, between medical institutions and medical personnel, between physicians and patients are getting more and more serious and complex.

High technologies not only brought us hopes of cure but have also created a heavy economic burden.

The ethical dilemmas of prescribing high technology medicine, organ transplantation, and concerns about quality of life-have become increasingly prominent.

Why Bioethics has Become Important?

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There are 4 (four) principles of Bioethics

Autonomy- Right of self-determination

Beneficence – To do well and to promote well-being

Non-maleficence – To do no harm or to avoid doing

harm.

Justice – Treat everyone alike(Beauchamp and Childress, 2001.)

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BIOETHICS IN PATIENT CAREBioethics involves making the best possible health care decisions with attention to more than just medical factors - especially when there is disagreement about an appropriate course of action.

DecisionsMaking decisions can be difficult. Bioethics helps to consider life-sustaining treatments (including cardio-pulmonary resuscitation, artificial ventilation and artificial methods of providing food and fluids) and discusses aspects of their use.

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Ethical and Regulatory Aspects of Clinical Research Utilize a systematic framework for evaluating the ethics

of a clinical research protocol. Apply appropriate codes, regulations, and other

documents governing the ethical conduct of human subject research to their own research.

Discuss controversial issues relating to human subject research, including Phase 1 research, randomization, children in research, international research, etc.

Identify the critical elements of informed consent and strategies for implementing informed consent for clinical research.

Describe the purpose, function, and challenges of IRBs. Appreciate the experience of human subjects who have

participated in research protocols.

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PROFESSIONAL ATTRIBUTES & BIOETHICS

Displaying honesty and integrity• Never misrepresent or falsify information and/or actions (cheating).• Do not engage in other unethical behavior.Showing respect for patient's dignity and rights• Make appropriate attempt to establish rapport with patients or families.• Show sensitivity to the patients' or families' feelings, needs, or wishes.• Demonstrate appropriate empathy.• Show respect for patient autonomy.• Maintain confidentiality of patient information.

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CONTINUED..Maintaining a professional demeanor

• Maintain professional demeanor even when stressed; not verbally hostile, abusive, dismissive or inappropriately angry.• Never expresses anger physically.• Accept professionally accepted boundaries for patient relationships.• Not to be arrogant or insolent.•Proper Appearance, dress, professional behavior. Follow generally accepted professional norms.

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BIOETHICS IN TEAM WORKResponding to supervision• Accept and incorporates feedback in a non-resistant and non-defensive manner.• Accept responsibility for failure or errors.

Demonstrating dependability and appropriate initiative• Complete tasks in a timely fashion (papers, reports, examinations, appointments, patient notes, patient care tasks)• Do not need reminders about academic responsibilities, responsibilities to patients or to other health careprofessionals in order to complete them.• Appropriately available for professional responsibilities (ie required activities, available on clinical service)• Take on appropriate responsibilities willingly (not resistant or defensive)• Take on appropriate patient care activities (does not "turf" patients or responsibilities)

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CONTINUED..

Interacting with other members of the team

• Communicate with other members of the health care team in a timely manner

• Show sensitivity to the needs, feelings, wishes of health care team members

• Relate and cooperates well with members of the health care team

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UNESCO’s 15 Bioethical principles

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