Ethics Research in Modern History - Essay Example

? Ethics and IRB Historical Review of Ethics in Research with the Human s The current regulations in clinical research originated from a combination of history and ethical thoughts. The term ‘ethics’ is from ‘ethos’, which is a Greek word for character or custom. Ethics is contrasted with the term morality that frequently relates to how the way a person was raised and the values learned from the culture, parents or religion. Ethics refers to the systematic study of the basis of right or wrong decision. The regulations for protection of human subject in United States provide a minimum baseline through which every person must comply when operating the institutional review board, IRB, when obtaining consent from the research subjects, and when conducting the research. The ethical thought has shaped the regulations, though ethics require more conditions than what regulations require (Steinberg, 2007). Throughout the history of ethics, various theories have been formulated on what ethics ought to be. When these theories are critically examined, the procedure, rules and outlooks of ethics are justified. The major challenge in a practical environment, particularly in medical research, is the translation of the theoretical concepts of ethics into action. Regulations will thus come into place and help in accomplishing such tasks (Chamberlain, 2008). Development of the research ethics has evolved over time. Many tragedies have been reported through the research history involving the human subjects. Many people suffered as they participated in the research. The first research experiments on human subjects were the vaccination trial where physicians experimented with either their families, or themselves. Ethically, it is an injustice to abstract them from thinking on regulations away from the ethical context (Juritzen, Grimen & Heggen, 2011). In modern history, the discovery of atrocities by the Nazi physicians pioneered in human subject protection. Some of the experiments were considered inhumane and unethical. The voluntary consent is, therefore, essential when performing experiments on the human subjects and the research risks should be minimized so that it will benefit the society. Ethics Ethics refers to branch of study that deals with the most appropriate course of action for human beings. It involves systemizing, recommending and the defending concepts of right and wrong behavior. Ethics is a critical requirement in human life since it determines the course of action towards a certain goal or objective. When conducting the nursing research, the researchers should be aware of nursing and research ethics. The decision on what to study, participants, and termination of the interviews and documentation of the results of the case study, should be based on ethical deliberation (Melton, 2004). Ethics is crucial in nursing research since it helps to set the competence boundaries. All nurses conducting research should work within their competence boundaries. Also, ethics enable researchers make informed consent where the information has to be judged to avoid confusing the people. Valid consent for participation in research depends on understanding, and freedom from deception and coercion. The information to the participants should be presented in written form and orally (Chamberlain, 2008). Ethics helps the nurses maintain confidentiality during their research. Confidentiality is an extension for privacy and is controlled by the privacy Act. Participants should trust that confidentiality is maintained for the information they give. Ethics ensure that the participants are free from risks and injuries during the research. This should encompass physical and non-physical wellbeing. In questioning, the researcher is entitled to maintain what is ethical. Ethics also ensures quality where the review committee assesses the ethical implications of the research proposals. Also, honesty in reporting is enhanced where the researcher publishes the process and findings to allow for peer scrutiny (Steinberg, 2007). Institutional Review Board, IRB IRB refers to people who monitor the design of a research that is to be used to obtain information about the human subjects. The board approves monitors and reviews the biomedical and behavioral research using human subjects. The IRB members are from the community from which the research is conducted and the various research disciplines. The IRBs are critical in protecting the human subjects from psychological and physical harm, and are responsible for the critical oversight functions of ethical, regulatory and scientific research (Chamberlain, 2008). In ethical study, IRBs can approve a research protocol, define any modifications on the research protocol for it to be approved, disapprove the research, terminate or suspend the already approved research. The determination of the IRB should be communicated within a reasonable time and in writing to give certain recommendations on the changes required to secure approval and define the conditions for the approval of a research protocol (Chamberlain, 2008). The IRB applies the Nuremberg principles to evaluate the proposed research activity. This is to protect safety, rights, and the well-being of the participants. The staff in IRB assists the investigators to maintain the adherence to the regulatory mandates and the institutional policies. The IRB may invite a PI to present the research protocol as well as clarify any study-related issues (Chamberlain, 2008). IRB depends on the research protocol in deciding on the approval of the research. Based on the institutional requirements, the sponsor should submit one or more copies of the protocol used. The IRB thus uses the reviewer system that highlights key aspects of the trial, and investigator should inform the human subjects within the consent process, and should identify some relevant genetic variants (Chamberlain, 2008). Independent Ethics Committee, IEC, and Institutional Review Boards, IRB protects the safety and rights of the human participants in a clinical trial. The two independent boards formulate the regulations that guide in review, approval and conducting of the human research. IRB bases most of its decisions on review documents by the PI or the sponsor. The IB, inferred from the CFR 21.56.111, is an example of independent review in IRB used to assess the risks as well as determine the relationship between the risks and the anticipated benefits (Johnson, 1992). Article Review Ethical Principles of Clinical Research by David Perlman According to this research, Nazis have been described to mark the beginning of the atrocities. They used twins to perform their experiment; one was exposed to pathogen and autopsied and the other was used as a control to determine the differences. From a scientific perspective, this is commendable comparison. However, the experiment is unethical and inhumane. Therefore, IRB comes in to minimize such risks to human subjects and maximize benefits to the participants. The risks and benefits to the human subjects should be assessed before any research is conducted (Steinberg, 2007). The subjects should comprise of informed volunteers. Legally authorized representatives should consent for the participants if they cannot consent for themselves. The human subjects are entitled to the safeguarding of their integrity, and the informed consent should be documented. Obtaining informed consent is critical just as the documented information about the consent is. In this research, the participants did not have the informed consent. Henry Beecher, who was anesthesiologist in Harvard is described to have performed numerous unethical experiments with the intention of increasing the awareness on the ethical problems in human experimentation, and that the unethical human treatment is not only among the Nazis from German (Steinberg, 2007). Confidentiality entails the non-disclosure of confidential information about the participant by the clinical researcher. Confidentiality and anonymity are closely linked to the informed consent. Guarding against disclosure protects the basic principles of human dignity. Indirect invasion of peoples’ privacy, regardless of whether it is harmless, is unethical (Johnson, 1992). According to the ‘Threat of a Stranger’ research, the respondents are uneasy to disclose sensitive personal information, but the professionals conducting the research speak to the participants openly, and promising them that the information they give is confidential. However, trust and negotiation will build with time and the researcher should be authentic and should explain the purposes of research and the use of information that the participant will give (Steinberg, 2007). Review of articles Yeliz, A. and Nuran A. (2012) Improving the quality of life for multiple sclerosis patients Using the nurse-based home visiting model. Scandinavian Journal of Caring Sciences (26), 295–303 This journal describes the suffering experienced by Multiple Sclerosis patients who often lack optimal home that results to subsequent hospital readmissions. The journal investigated the nursing interventions based on North American Nursing Diagnosis Association (NANDA) for the different quality-of-life issues and several other challenges. The intervention helped in identifying the symptoms as well as training the people on recognition of referrals to medical professionals and other consulting services. The results indicated that they were still needed for increasing the quality of care and life for patients with multiple sclerosis. The healthcare in Turkey does not have the health programmes and the long term hospital care. Also, the support from the family members is inadequate. The nurses conducted the study at the home of the patients and could make a referral to other health professionals. There was no direct interaction of the nurse with other healthcare providers. Patients were instructed to collaborate with those who were doing the exercise. The ethics Committee of the Faculty of Medical sciences approved the study. The association’s representatives summoned the patients and their respective families to request for the study participation. The families and patients were visited, and written consent and study procedures were obtained. The criterion of voluntary participation of the patients was highly appreciated, and the unwilling participants were not compelled to do so. From the interview questions, anonymity of the participants was maintained where the participant was not supposed to give the name. The study helped to increase the health status of patients with MS who were unable to get the preventive healthcare services due to dependency condition. The results from the study indicate the importance of the homecare visits to enhance the accessibility of rehabilitation and healthcare services to patients without increased detriment of their health status. Michelle, P., Mark, W., Michelle, M., Anne K., Marshall, G. and Mark, S. (2012). The Path to Self-Management. A Qualitative Study Involving Older People with Multiple Sclerosis, 6-17. This article is on a qualitative study carried out on older people to determine their experience in ageing while with the Multiple Sclerosis. The study was approved by Human Investigations Committee from Memorial University, and Patient Research Committee from Eastern Health Authority. The participants were identified and contacted through telephone from their healthcare provider. Those who were interested were contacted by the research team members. Informed consent was gotten from all the participants. This study identified the facilitators, abilities, knowledge and inhibitors that surround experiences of ageing with the Multiple Sclerosis symptoms. This knowledge facilitated gaining of understanding on the diversity of the MS experiences that assisted in lessening fear and enhances the self determination, strong ability in problem solving, social support and maintenance of a collaborative relationship between the health professionals and the patients ageing with MS. From the interview questions, anonymity of the participants was maintained where the participant was not supposed to give the name. References Chamberlain, B. (2008). The Institutional Review Board. Clinical Nurse Specialist 22 (3), 124-25. Juritzen, T., Grimen, H., & Heggen, K. (2011). Protecting Vulnerable Research Participants: A Foucault-inspired Analysis of Ethics Committees. Nursing Ethics 18 (5), 640-50. Melton, P. (2004). Reviews in Medical Ethics. The Journal of Law, Medicine & Ethics 32 (4), 770-72. Steinberg, D. (2007). Biomedical Ethics: A Multidisciplinary Approach to Moral Issues in Medicine and Biology . Hanover: University of New England. Chamberlain, B. (2008). The Institutional Review Board. Clinical Nurse Specialist 22(3) , 124-25. Michelle, P., Mark, W., Michelle, M., K., A., Marshall, G., & Mark, S. (2012). The Path to Self-Management. A Qualitative Study Involving Older People with Multiple Sclerosis ,6-7. Yeliz, A., & Nuran, A. (2012). Improving the quality of life for multiple sclerosis patients Using the nurse-based home visiting model. Scandinavian Journal of Caring Sciences(26) , 295-303. Read More