Justification of participation of human subjects in Phase 1 clinical trials: an ethical analysis.

Abstract: In the process of clinical trials, after ascertaining the safety of drugs or other therapeutic interventions in animals or in vivo, phase I clinical trials are conducted as initial step on healthy human volunteers (or patients with specific disease) to observe pharmacokinetics, safety and side effects associated with escalating doses of the drugs. Participation of human subjects having different biological system than animals is not without risks in these trials; this fact raises some important ethical issues. In the light of international research ethics guidelines, this paper analyses moral justification of use of humans as research subjects in phase I clinical trials, discusses what groups of participants should be involved, their economic status, questionable coercive effect of monetary remuneration on the subjects and soundness of informed consent obtained for the trials. These issues are also discussed in the perspective of four founding principles of bioethics i.e. autonomy, justice, beneficence and non-maleficence.

Organ Transplantation And Vulnerable Donors: Donation Under Emotional Compulsion.

Abstract: During last few decades advancements in medical knowledge and technologies have increased the practice of organ donation. Organ transplantation, on one hand gifts renewed life to the donors, while on the other hand unwanted ethical practices in the field exploit vulnerable donors, such as trend of ‘transplantation tourism’ involving non-related live donors. Beyond this, some delicate and intriguing situations bring the physicians at cross-roads in cases of live related donors’ transplantation. In this paper, I would like to discuss and analyze a case of live donor (un-married girl), where overtly consents to donate kidney to her brother who is breadearner of their joint family. By consenting to donate, the girl jeopardizes her matrimonial proposal as her fiancé is uncertain about her post-donation health status. The transplant clinician, aware of this fact faces ethical dilemma, whether to perform transplantation surgery so as save the life of ailing patient or to abandon it in order to save the future marriage of the girl from being broken. The case highlights multiple ethical issues in Asian socio-cultural context. I have attempted to disentangle the dilemma by applying Mc Donald and Rodney’s framework of ethical decision making.

Informed Consent: Protecting Patients Or Salvaging Physicians.

Abstract: History of tradition of following ethical code in medical practice is very ancient and it could be traced as back as 3500 year old document of Ebers Papyrus (Berdon 2000). Later Greek and Egyptian teachings also emphasized upon ethical practices in medicine. But the concept of formally taking consent (and informed consent) with emphasis on patients’ rights and his/her autonomy emerged in early 20th century when some law suits were filed in courts, particularly in USA. Later the well known infamous atrocities carried out by Nazi doctors on prisoners during Second World War and consequent verdict by Nuremberg tribunal and milestone declaration of Nuremberg made a land mark in the history of medical ethics and provided a ground on which the doctrine of ‘Informed Consent’ is built. This paper discusses and analyzes various ethical issues related to informed consent. How the obligation of taking informed consent was established in the clinical practice and biomedical research. Discusses whether informed consent is a moral obligation or legal necessity with reference to various historical cases and presentation of views by some authors. This paper also analyzes famous legal litigations that helped to provide foundations for the patients’ rights and autonomy in clinical, such as cases of Shoendorff v. New York Hospital of 1914; Prince v. Massachusetts litigation of 1944; Canterbury v. Spence lawsuit of 1972; Large v. Superior court of Arizona legal case of 1986 and Younts v. Francis Hospital suit of 1986. A discussion is also made regarding five universally accepted components of informed concept (disclosure to the patient/research subject, comprehension by the patient, his/her competency, voluntariness and willingness), which are variously and sometimes conflictingly interpreted in different contexts and situations. Situations are highlighted where these problems create ethical dilemmas and legal conflicts in clinical and research environment and a reference is made to ongoing discussion whether informed consent has been primarily devised for protection of the patients or it is a tool to rescue physicians when they are brought to courts to face law suits.