Health research methods and ethics
Chin and Lee (2008) explains that the ethical principle of respect for human participants in research studies involving human beings as the study subjects requires that the research participants be informed about the results of the study upon completion of the research. By doing so, the human subjects would feel respected and valued and not merely used or abused for the sake of achieving a particular medical objective. In application of the principle of respect, the ability of the individual to make own choices and decisions should be considered as Gallin and Ognibene (2012) corroborates. However, despite being an act of demonstration of respect to the research participants, such disclosure might affect the person to whom it is disclosed in a negative way. In this regard, as Devettere (2010) postulates, the participants should be informed about the consequences of such disclosure and be left to make own decisions as to be disclosed or not be disclosed to the study results based on information about the consequences. In light of this information, I would consider informing the women about the results of the study as it would be a demonstration of respect to them. This would be in consideration of the fact that the study does not change therapy that the patients are currently subjected to. Despite being a show of respect and enhancement of their self esteem, I would also have to establish their attitude towards the current therapy they are receiving so as to make decision as to the nature of psychological counseling to offer to the patients as regards to the consequences of disclosing to them the results of the study.
This question relates to giving feedback to the study participants about the contents of the study data. According to Childress, Meslin and Shapiro (2005), the ethical principle of privacy and confidentiality in medical research involving human subjects calls for protection of human participants with regard to access and dissemination of their personal information for purposes of safeguarding their psychological state. Considering that the research data contains confidential information that the participants would not want shared with other individuals in the study, it would be appropriate not to feed back the study data to the participants and to the clinicians. By sharing the data to the entire participants or with the clinicians, this will amount to the breach of ethical principle as regards to the privacy and confidentiality of the participants’ data.
Panicola (2007) argues that a research studies has the potential of contributing new scientific knowledge that would be of great benefit to the entire wider society. In such an instance, and as Emanuel (2008) explains, there should be proper balancing as regards to the benefits accruing to failing to disclose the data to the research participants versus the benefits that accrue to the wide community on disclosing such research data. The principle of justice in medical research demands that benefits and costs of a research be equitably distributed amongst all people who are directly or indirectly affected by the research as Marshall (2007) postulates. In light of this information, there are circumstances that would require the disclosure of the research data to the participants and to their clinicians. In determining whether or not to feed back the data to the participants and clinicians, the magnitude of the harm and the benefits from such disclosure to individual participants against to the wider society will have to be evaluated. Anne et al. (2014) explain that the value of a research study is usually known before the study commences. This has the implication that the research participants should be informed of the consequences as relates to disclosure of the study results and study data so as to make an informed consent about participating in the research study. If the research study requires the disclosure of the study data and results to a wider number of stakeholders, this information should be provided to the participants prior to making decisions about participation.
As has been evidenced in the essay, research activities involving human subjects are governed by ethical principles of dignity, respect, beneficence, justice, confidentiality and informed consent. Participants should be informed all the aspects of the study before making voluntary decision about participation. The results of the study should be communicated to the participants on the basis of the consequences of the disclosure and upon informing the participant about the consequences of knowing about the research results. This would be demonstration of ethical principle of respect and would enhance the participants’ feelings of self worth. The application of ethical principle of justice requires consideration of the effects that disclosure of the research study data and results would have to the wider interest groups in the research. The benefits and the costs involved in the disclosure of the results would have to be weighed in deciding about disclosing the results to the wider society.
Anne M, Lisa A. W, Kathy M., Margaret J., Paul R. C, Deborah H, Kathleen E. , 2014. Ethical Considerations in Human Subjects Research Original Research Article. Journal of Emergency Nursing, 40(1), Pages 92-94
Chin, R. & Lee, B. 2008. Principles and practice of clinical trial medicine. Amsterdam Boston: Elsevier/Academic Press.
Childress, J., Meslin, E. & Shapiro, H. 2005. Belmont revisited : ethical principles for research with human subjects. Washington, DC: Georgetown University Press.
Devettere, R. 2010. Practical decision making in health care ethics cases and concepts. Washington, D.C: Georgetown University Press.
Emanuel, E. 2008. The Oxford textbook of clinical research ethics. Oxford New York: Oxford University Press.
Gallin, J. & Ognibene, F. (2012). Principles and practice of clinical research. London: Elsevier/Academic Press.
Lavery, J. 2007. Ethical issues in international biomedical research : a casebook. Oxford New York: Oxford University Press.
Marshall, P. 2007. Ethical challenges in study design and informed consent for health research in resource-poor settings. Geneva, Switzerland: World Health Organization.
Panicola, M. 2007. An introduction to health care ethics : theological foundations, contemporary issues, and controversial cases. Winona, MN: Saint Mary's Press.
WHO, 2014. Research policy: Research ethics. Retrieved on 16th April 2014 from http://www.who.int/rpc/research_ethics/en/