Question

FUNDAMENTAL - 2
INDIVIDUAL ASSIGNMENT TOPIC: ETHICS OF CONDUCTING BIOMEDICAL RESEARCH
1. It should be hand writing.
2. Follow the key points and marks distribution
3. Submit on time and no delay submission.
  
The key Points are:

1. Introduction - 0.5 mark
2. Conducting Biomedical Research on Humans - 2.5 marks
3. Conducting Research and Experiments on Animals - 2.5 marks
4. Regulations for Accepting Scientific Research Grants - 2 marks
6. Regulations for Innovative Interventional Procedures - 2 marks
7. Neatness and Creativity - 0.5 mark

Answer 1

1. Introduction:-
Levels of moral response constitutes, Expressive level where the individual reacts with just a feeling of the conscience, second is the Pre- reflective Level in which the individual‘s reaction is justified via law and legislation, last is the Reflective level where the responses are the reasoned ethical arguments and defenses based on ethical principles. Bioethics is the study of the typically controversial ethical issues emerging from new situations and possibilities brought about by advances in biology and medicine. It is also a kind of moral discernment as it relates to medical policy, practice and research.

2. All research involving human subjects should be conducted in accordance with three basic ethical principles:-

(A) RESPECT FOR PERSONS includes at least two fundamental ethical considerations, namely
1. Respect for autonomy
2. Protection for those with impaired or diminished autonomy

(B) BENEFICENCE – includes the ethical obligation to maximize benefits and minimize harms and wrongs.

(C) JUSTICE – In the ethics of research involving human subjects the principle primarily refers to distributive justice, which means equitable distribution of both burden and the benefits of participation in research.

Other principles
Principle of Essentiality
Principle of voluntariness and Informed Consent
Principle of Non-exploitation
Principle of Privacy and Confidentiality
Principle of Precautions and Risks Minimisation
Principle of Professional Competence
Principle of Accountability and Transparency
Principle of Maximisation of Public Interest and of Distributive Justice
Principle of Institutional Arrangements

3. Animal research encompasses a wide range of biomedical and behavioral experiments. One field of behavioral research entails observing animals in colonies that simulate their natural environments. Other animals undergo medical procedures such as surgery to gauge the effectiveness of new techniques. Some are exposed to toxic substances until death or disability results. Others are killed immediately to obtain an essential organ or tissue for further studies. Although long-term survival is sometimes the goal of animal experimentation, most research animals are humanely killed at some point during the course of the research.

Benefits Derived from the Use of Animals:-

The use of animals in biomedical and behavioral research has greatly increased scientific knowledge and has had enormous benefits for human health. For example, in the United States, animal experimentation has contributed to an increase in average life expectancy of about 25 years since 1900.

4. six values that are most influential in shaping the norms that constitute research practices and relationships and the integrity of science:
Objectivity
Honesty
Openness
Accountability
Fairness
Stewardship

Scientific misconduct is the violation of the standard codes of scholarly conduct and ethical behaviour in professional research. The consequences of scientific misconduct can be damaging for both perpetrators and any individual who exposes it.
Forms of scientific misconduct includes Plagiarism which means claiming the ideas or data of another as one‘s own then using those ideas or data without appropriate credit or compensation thus presenting the research results of another as one‘s own (in whole or in part). A subset is Citation Plagiarism where the author fails to appropriately credit other or prior discoverers, so as to give an improper impression of priority.

5. Innovation in research encompasses new questions, drugs, devices, and protocols, but also new research methods and regulations. Whereas innovative new results receive most of the investigator and public attention, innovation in research regulation is critical to enabling and facilitating research conduct, and to reducing research cost, increasing efficiency, and ensuring the rights and protections of those patients and volunteers on which research depends, and for whose eventual benefit research is conducted.