Law assignment help:Ethical Issues for Human Subjects in Research
Although there are several rules which govern the human subjects but there are some tough choices like:
Informed Consent: The human subjects should be correctly and fully informed about the experiments in which they are going to participate and they should give their consent in writing before getting enrolled. However there are few subjects who cannot give their informed consent like some adults who have impaired decision-making capacity, some children and critically ill patients because either they are not old enough to realise the importance of information or they have lost their ability to understand the relevancy of information (Steneck, 2007).
Right to Withdraw: It is agreed that the research subjects should have the right to withdraw if they want to from the experiment anytime they want. But in some cases they cannot do so like in the final stages of development like mechanical hearts are being tested on the patient’s body whose original heart is just about to fail in such cases they can’t withdraw when they want. Because once the mechanical heart replaces the weakened heart the reverse cannot be done or is not possible (Steneck, 2007).
- Risk without benefits: In an experiment conducted recently researchers were trying to find out whether a common surgical method which has been used for arthritis pain relief is beneficial or not and in order to gather relevant information related to the benefits derived a clinical trial was being designed in which the patients in the control group had to undergo sham surgery. In this case an operation was being performed but the common surgical procedure was not performed. In this case the researchers complied with all the regulations which also covered thorough IRB review. But not a single patient had adverse effect and the research study gave the conclusion that the common surgical procedure did not provide any major benefits as desired. But surgery always involves risk so the subjects of control groups were put at risk and that too without any expectation that they will receive any benefit (Steneck, 2007).
Thus the researchers who deal with growing complexities of social, behavioural and biomedical research need to undergo special training. At the same time the researchers who use human subjects for research should also undergo some kind of formal training related to bioethics so that they can actively take part in the critical reasoning process which is required in order to give response to the complex and critical moral issues which are being raised due to use of human subjects for research.
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