Meaningful research which can be applied in real life situations is based on ethical conduct of researchers. The researchers have a duty to protect the study participants and to maintain confidentiality. Considerations of ethical research include informed consent from the participants, privacy, confidentiality, anonymity, and beneficence (Fouka & Mantrozorou, 2011). This paper evaluates the case of Sarita Kudumula, 13, whose parents learned she was participating in a Human Papiloma Virus (HPV) vaccine clinical trial after she died.
HPV is a sexually transmitted virus that causes cervical cancer. Various vaccines have been developed against the virus and most are tested in India. Sarita participated in such a clinical trial for Gardasil, a drug developed by Merck which involved 300 girls. She collapsed and died a few days later. Despite being a minor, her parents were not asked to give consent for her to participate in the clinical trials (Buncombe & Lakhani, 2011). In this study, the ethical principle of informed consent was breached. Consent from parents and guardians must be given before a minor participates in the study. The consent should be given after proper education of the risks involved in the study. There has been an increase in clinical trials in which participants have not given consent and may not even be aware they are taking drugs which are on trial (Kulkarni, 2013). The cause of breach in obtaining consent is that clinical trials are largely conducted in the developing world where illiteracy and poverty levels are high. In some areas, it is a case of the drug on trial, or no drug at all making many people to participate without giving informed consent. To eliminate the ethical problem, especially where the participants are minors, it is mandatory to obtain parental consent before a participation. The researchers should educate the target participants on the planned study before seeking consent to participate.
References
Buncombe, A., & Lakhani, N. (14 Nov, 2011). Without consent: how drugs companies exploit
Indian 'guinea pigs' The Independent. Retrieved on 11 June 2013, from <http://www.independent.co.uk/news/world/asia/without-consent-how-drugs-companies-exploit-indian-guinea-pigs-6261919.html>
Fouka, G., & Mantzorou, M. (2011). What are the Major Ethical Issues in Conducting Research?
Is there a Conflict between the Research Ethics and the Nature of Nursing? Health Science Journal, 5(1): 3-14.
Kulkarni, P. S. (2013). Current topics in research ethics in vaccine studies. Perspectives in
Clinical Research, 4(1), 80.
