Question

Several international and domestic documents have been written addressing ethical considerations when doing research and practicing medicine on human subjects. Provide one example of these documents and describe three of the founding principles within the document.

Answer 1

Ethical considerations when doing research & practicing medicine on human subjects

Ethics is also known as moral philosophy. It is an essential dimension of human research, and is considered both as discipline & practice. For clinical research there is requirement of ethically justified criteria for the design & review of clinical investigation to both the researcher as well as human subject.

Furthermore bioethics is the philosophical study of ethical controversies covering biology and medicine. Bioethics concerns ethical issues that arise in relationships among life Sciences, biotechnology, medicine, politics, law and philosophy.

There are following key elements of ethics in research:

• Informed consent
• Confidentiality
• Privacy
• Privileged communication
• Respect & responsibility.

In this chain Research ethics committees should promote better understanding of ethical issues on biomedical research.

Moreover these committees function for submission, consideration, evaluation as well as communication of findings.

And research ethics committees should review effectively application, research protocol, patient information leaflet & informed consent form for legal and moral safety, integrity & welfare of the research subjects.

There are Research ethic's declarations & treaties to control this research.

In this chain there are number of treaties & declarations which address fundamental principles of ethical conduct in biomedical research:

Following are some famous declarations & treaties:

• The Nuremberg Code
• The Declaration of Helsinki
• EU Convention on Human Rights and Biomedicine
• The ICH GCP Guideline

Out of these ICH GCP Guidelines is very crucial and detail is as such:

Good Clinical Practice (GCP) is an international ethical & scientific quality standard for designing, conducting, recording & reporting trials that involve the participation of human

subjects.

There should be compliance with this standard provides public declaration that the rights,

safety & well-being of trial subjects along with protection of trial data.

The guideline was developed with consideration of the current good clinical practices of the European Union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the World Health Organization (WHO).

This guideline should be followed when generating clinical trial data that are intended to be submitted to regulatory authorities.

That can also have an impact on the safety & well-being of human subjects.

The ICH GCP states: “A trial should be conducted in total compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC).