BIOETHICS
Bioethics is the discipline dealing with the ethical implications of biological research and application, especially in medicine. It includes the study of what is right and wrong in new discoveries and techniques in biology, such as genetic engineering and organ transplantation. The term Bioethics (Greek bios = life; ethos = behavior) was coined in 1926 by Fritz Jahr.
HISTORY OF BIOETHICS – KEY EVENTS
- 1947: Nuremberg Doctors’ Trial and Nuremberg Code
- 1948: Universal Declaration of Human Rights (UN)
- 1953: Double helical structure of DNA
- 1962: Kefauver-Harris amendments to FD&C Act
- 1964: Declaration of Helsinki (WHO)
- 1967: First heart transplant
- 1973: Roe vs. Wade decision
- 1976: Karen Quinlan decision
- 1981: First reported cases of AIDS
- 1997: Birth of ‘Dolly’ (cloned sheep)
- 2000: Rough draft of Human Genome
- 2001: Terri Schiavo Case
- 1972: Tuskegee Syphilis Experiment revealed
- 1973: American Hospital Association – Patients’ Bill of Rights
- 1975: Asilomar meeting on recombinant DNA
- 1978: Belmont Report
- 1984: John Moore case
- 1994: Oregon Death with Dignity Act
- 2001: George W. Bush stem cell policy
- 2006: Launching of No Lie MRI
- 2007: Sperm sorting
- 2008: Health care access on election agenda
PRINCIPLES OF BIOETHICS
Respect for Autonomy
This principle highlights the need to honour autonomous people’s right to make their own decisions. It acknowledges their right to decide on their own treatment. Informed consent is essential in healthcare because it guarantees that patients are provided with the information they need to make decisions about their care.
Non-Maleficence
This principle is based on the concept “do no harm”. Healthcare providers have to refrain from hurting their patients. The two most important components of non-maleficence are ensuring patient safety and reducing hazards.
Beneficence
This principle involves giving patients advantages while balancing potential hazards. Doctors work to develop care plans that optimise advantages for patients. It focuses on encouraging the patient’s well-being and improving their health.
Justice
The principle emphasises fairness. It guarantees the equitable distribution of medical benefits. It guides the allocation of scarce resources (solid organs or costly tests). It is crucial to treat people equally who have comparable requirements and circumstances.
INDIAN COUNCIL OF MEDICAL RESEARCH (ICMR)
The Indian Council of Medical Research (ICMR), New Delhi, is the apex body in India for the formulation, coordination, and promotion of biomedical research. It is one of the oldest medical research bodies in the world.
Timeline of ICMR Ethical Guidelines
- 1980: Policy Statement on Ethical Considerations Involved in Research on Human Subjects
- 2000: Ethical Guidelines for Biomedical Research on Human Subjects
- 2006: Revised Ethical Guidelines for Biomedical Research on Human Participants
- 2017: National Ethical Guidelines for Biomedical and Health Research involving Human Participants
- 2017: National Ethical Guidelines for Biomedical Research Involving Children
Salient Features of ICMR
- Developed two national guidelines (2017) – for human participants and for children.
- Dissemination activities to raise awareness among physicians, researchers, ethics committee members, students, nurses, and academics.
- Ensures safety of participants, prevents exploitation, and protects rights, welfare, and safety.
- Leading in developing and periodically revising guidelines since 1980.
- Guidelines cover all biomedical and health research (clinical, basic sciences, epidemiological, socio-behavioural, public health, data/sample studies).
- Guidelines are thorough, user-friendly, and harmonised with national and international requirements.
ICMR – 21 ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN PARTICIPANTS
- Guided by respect for dignity and rights of participants.
- Clear scientific purpose in accordance with ethical principles.
- Welfare of individual over interests of science and society.
- Conducted only by individuals with appropriate training and expertise.
- Risks and benefits carefully weighed.
- Sufficient information for informed decision.
- Informed consent from all participants.
- Freedom to withdraw at any time without penalty.
- Protection from harm, discomfort, and exploitation.
- Respect for privacy and confidentiality.
- Disclose all potential conflicts of interest.
- Transparent and accountable manner.
- Subject to independent ethical review.
- Sensitive to cultural differences.
- Appropriate medical care and treatment, including access to beneficial interventions.
- Promotes welfare of society as a whole.
- Respect rights and interests of vulnerable populations.
- Minimise adverse effects on the environment.
- Comply with all relevant laws and regulations.
- Results disseminated in timely and responsible manner.
- Guided by honesty, integrity, and transparency in all aspects.
SUMMARY TABLE: FOUR PRINCIPLES OF BIOETHICS
| Principle | Key Concept | Application |
|---|---|---|
| Respect for Autonomy | Right to make own decisions | Informed consent |
| Non-Maleficence | “Do no harm” | Patient safety, hazard reduction |
| Beneficence | Giving advantages, balancing risks | Optimising patient benefits |
| Justice<｜｜point｜｜>Fairness, equitable distribution | Allocation of scarce resources |
Dr. Saint Paul is a pharmacy educator, Pharm.D graduate, and academic content creator from Jawaharlal Nehru Technological University Kakinada (JNTUK), where he completed his Doctor of Pharmacy (Pharm.D) degree between 2015 and 2021.
He has more than 7 years of experience creating pharmacy educational content, writing study materials, and reviewing academic articles for pharmacy students. He has also contributed guest articles to pharmacy education platforms, including PharmD Guru.
At D.PharmGuru, his work focuses on simplifying complex Diploma in Pharmacy (D.Pharmacy) subjects into easy-to-understand notes, practical explanations, and exam-oriented educational resources for students across India.
His areas of focus include Human Anatomy and Physiology, Pharmaceutics, Pharmacology, Pharmaceutical Chemistry, Hospital and Clinical Pharmacy, and other core D.Pharmacy subjects.
