Comparative analysis of Helsinki declaration October 2013 compared to the 1996 version
The Helsinki declaration 2013 compared to the one 1996 states that one of the reasons of biomedical research is to continuously evaluate medical interventions apart from the improvement of diagnosis and prevention of diseases which is also stated in the older version. In addition in the newest declaration the importance of final experimentation on human subjects is mentioned, whereas in the previous edition the experimentation in humans is mentioned only as a part of the final experimental design. Regarding the role of ethical committees and the approval of experimental protocol, there are some implementations in the 2013 declaration which give the ability to the committee to control the whole experimental procedure and the adverse effects during the study. In addition, the fact that changes cannot be made in the protocol during the study is mentioned clearly, this part was not mentioned in the 1995 declaration and the clear explanation of this fact does not leave any free space for different types of behavior. Finally, new considerations regarding the protocol have been added in the newest version of Helsinki declaration in which all the details including ethical aspects and compensation for the subjects should be included in the experimental protocol, which will be under consideration by the ethical committee.
Duties of physicians
In both editions of the Helsinki declaration the role of the physician in protecting the human subject involved in the study is stressed out. However in the 2013 declaration in a more detailed way all the parameters that should be protected by the health care professional are described and those include not on...
... middle of paper ...
... obtained regardless of being negative or positive should be published openly. Moreover liable for the ethical aspects of the study are not only the physicians but also the editors and the publishers. Increasing the liability in all individuals involved in the implementation and publication of the study decreases the possibility of a study that does not take into account all the ethical aspects will be conducted. Finally the 2013 declaration gives the ethical possibility to the physician to use an unproven method if he believes that this will be for the benefit of the patient and after the informed consent is given.
References
1. WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects, 2013
2. WMA Declaration of Helsinki, Recommendations guiding physicians in biomedical research involving human subjects, October 1996
The next stage is for the team to jointly develop an evidence-based practice standard based on the information compiled during the research process (Doody & Doody, 2011). An important concept of evidence-based practice as pointed out by Doody & Doody (2011) is the involvement of the patient in the development of new standards. The developed standard should apply to the research topic that is being addressed, however; it should also be modified from person to person based on morals and values for the standard to truly be evidence-based (Doody & Doody,
1. Capp, Marshall B. "Ethical and Legal Issues in Research Involving Human Subjects: Do You Want a Piece of Me? -- Kapp 59 (4): 335 -- Journal of Clinical Pathology." BMJ Journals. J Clin Pathol, 18 Jan. 2006. Web. 11 Feb. 2012.
The IRB is an administrative body which has been established to make sure research participants' rights are protected. IRBs review all aspects of the researchers' project: the study design, the recruitment process, the participant population, the informed consent document and process, the risk/benefit ratio, privacy and confidentiality, data storage and protection, and safeguards for vulnerable participants (University of St. Francis, n.d.). In this way, participants' rights are protected because the effort is made even before the research begins. The review process ensures that participants are chosen fairly and informed adequately and the information collected during research is safeguarded through collection, use, and storage. Research using human participants is such an important part of medicine that it is imperative it is performed in a way that its intrigue is not compromised.
Southam’s practice, beginning with the Code’s number 1 rule, “The voluntary consent of the human subject is absolutely essential.” Other rules under the Nuremberg Code were broken as well, however all of these egregious behaviors of researchers, more so than just Southam, have influenced the tight research protocols in place today. As Dr. Hardy shared information on research protocols, she consistently referred back to a strict system of regulations that, at times, may seem a little extreme. The alternative, a system permitting researchers like Southam, would be a far harder bullet to bite. In the end, I am glad these systems are in place to try to ensure a trust between patients and
The first article is entitled “of mice but not men: problems of randomized clinical trials,” is written by Samuel Hellman and Deborah S. Hellman discusses the issues of randomized medical testing and experiments on patients. The article describes the role of the personal physician and how the physician can take an ethical or unethical path of treating his/her patients. The relationship between the patient and physician is greatly emphasized because according to the article trust is very valuable in medicine especially when a patient’s life is at risk. A Kantian and a Utilitarian view of randomized clinical trials are debated but the authors clearly steers towards a Kantian point of view.
In evaluating the ethical issues in the study using most of the components of the evaluation checklist in Houser (2015, p. 69), there were several observations. First of all, in this study, all of the women were provided oral and written information about the voluntary participation of the study. And being that all the women are identified originally as being above the age of 18, and are cognitively intact, there was no evidence that there were vulnerable populations involved. Since the study was based on interviews, there was no intent to harm. The information provided to the women included that all information was coded therefore confidentiality was intact and anonymity maintained. It was noted that all of the women gave oral and written consent on their behalf to participate. Approval was obtained by the Regional Ethical Review Board at the Facility of Health Sciences, University of Linkoping 2005. The study followed the guidelines and was performed in accordance with the Declaration on Helsinki which was written by the World Medical Association (WMA). “The WMA was created to ensure the independence of physicians, promoting the highest possible standards of medical ethics, the WMA provides ethical guidance to physicians through its Declarations, Resolutions and Statements.” (WMA, 2014). There was no notation or evidence that the participants had any underlying motivation to be coerced into the study, for instance, no monetary reimbursement or promise of medications trials.
In the United States, the basis for ethical protection for human research subjects in clinical research trials are outlined by the Belmont Report developed in the late 1970’s. This document, published by the Nation Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, highlights three important basic principles that are to be considered when any clinical trial will involve human research subjects. They are; respect for persons, beneficence, and justice. (Chadwick & Gunn, 2004)
Coleman, C. (2005). The ethics and regulation of research with human subjects. 3–50.50 Code of Federal Regulations, 46(102).
Truog, Robert D., Walter Robinson, Adrienne Randolph, and Alan Morris. "Is Informed Consent Always Necessary For Randomized, Controlled Trials?" The New England Journal of Medicine 340, (March 1999): 804-807.
Steinbock, Bonnie, Alex J. London, and John D. Arras. "The Principles Approach." Ethical Issues in Modern Medicine. Contemporary Readings in Bioethics. 8th ed. New York: McGraw-Hill, 2013. 36-37. Print.
Looking beyond the Nuremberg Code and applying it to modern medical research ethics, there are many challenges that it poses. Many have argued that the Code tries to provide for all unforeseen events, which restricts the researcher by requiring him to anticipate every situation, demanding the impossible. The most important contribution of the Code is the first principle, which says that voluntary consent of the human subject is absolutely essential. The subject involved should have legal capacity to give consent, should have free power of choice, as well as sufficient knowledge and comprehension of the experiment. This restricts that populations upon which some experiment may be conducted, since many do not have “legal capacity”. For instance, studies of mental illness and children’s diseases have been curtailed because neither of these populations has the legal capacity to give consent. Another group of people, prisoners, are never really able to give voluntary consent since they might be enticed by financial rewards, special treatment, and the hope of early release in exchange for participating in the human experimentation projects. British biostatitcian Sir Austin Bradford Hill also questioned whether it was important to inform a research subject who was receiving a placebo since it does...
Tunis S., Stryer D., Clancy C. Increasing the Value of Clinical Research for Decision Making in Clinical and Health Policy. JAMA. 2003;290(12): 1624-1632
Following the ethical codes and getting approval from the Institutional Review Board (if the study has human subjects) can really decrease the possibility of any harm being done to the participants. A perfect example of a research study that had lots of things unethical practices was the Tuskegee Syphilis study:
Informed consent is a very serious decision a patient has to make when it comes to their health and consenting to procedures that are believed to cure or treat their current health status. It is important to address the effectiveness of the role a physician play in the informed consent process assuring that the patient has given truly informed consent and what safeguards can be put in place to assure the patient is exercising informed consent. Informed consent is based on the fact that the person consenting is a rational individual that is aware of the action to which he/she is consenting. Allen and McNamara (2011) notes that "On the standard understanding, the important elements of informed consent are the provision of information, the voluntariness of the choice and the competence of the chooser to make the choice— so the potential research participant should be provided with information relevant to the decision to participate, they should be able to choose freely about their participation and they should be competent to decide.
The article titled “Contemporary Ethical Analyses: A Shortfall in Scientific Knowledge” describes the ethics through the public’s eye. One of the major ethical issues brought up is informed consent.