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Informed consent is an authorization verbally or written agreement to participate in research. Basically, participant involves are voluntarily without compulsion and there are rational decision to participate. There is a common procedure to go through before starting any study or research. Informed consent document must be clearly written and must be understandable by the participant. The consent must use the easy language and should be define or explained in lay terms if the words are scientific or there is medical terms. The informed consent is an important agreement before register a participant.
Indeed, the informed consent is described an ethical codes and legal for human subjects research. The aim of informed consent process is to provide sufficient detailed information on the study. The participants are entitled to ask question and researcher must answer those question. Furthermore, allowing sufficient time for participant to make their decision. Therefore, the participant will make decision whether they are enroll or not to continue in the study. However, the participants have the right to refuse to participate in this study without penalty if they wish.
However, there are some issues relating research on human subject:
1. Potential risk to subject
Potential risk can be widely categorized in human research. Researcher need to take precaution to minimize potential of risk. The potential risk in human research included;
2. Deceptive practice
Deceptive happen when a researcher gives false information to the subject or deliberately misleads them about some of the key aspect of research. This may include feedback on the subject involving creating false beliefs about relationship or the manipulation of self-concept.
Confidentially needs to be maintained in order not to leak information. The subjects have the right to be protected from injury or unauthorized intrusions into their privacy and the preservation of their personal dignity. Benefits of maintaining confidentially will help to establish trust between the participant and researcher and participant feels more respected.
Research Ethics is essential to adhering to ethical principles and protecting the safety and wellness rights of research participants. Then, all human-involved research should be reviewed by ethical committees to ensure that appropriate ethical standards are maintained.
The existing research ethics source is the Belmont Report published in 1979. It is a major work on ethics in healthcare research. Its main purpose is to protect subjects and participants in clinical trials or research studies. The Belmont Report is written by a panel of experts and proposes three ethical research principles involving human subjects. The three key ethical principles quoted from Belmont’s report are autonomy, beneficence, and justice.
In general, autonomy can be defined as an individual’s right to determine the activities they want or not participate. In particular, autonomy requires an individual to understand what they are asking to do, making a reasonable decision about their entry and effect, and making the choice to freely participate in force. The principle of protecting autonomy is known as the consent process, in which a researcher provides potential research participants with complete disclosure of the types of research, risks, benefits and alternatives, and gives a chance to ask before deciding to take any part. Participants are considered as reduced autonomy, based on decreased cognitions such as children, cognitive disabilities or mental illness. Other conditions such as prisoners or people with severe illnesses are considered vulnerable populations. In some cases, children and inmates have certain protections to protect their autonomy as required by law.
Beneficence can be clearly defined is the benefit of research participants. Profitable principles are behind research efforts to minimize risk to participants and maximize benefits to participants and communities.
Justice requires careful selection of participants, preventing participants from being unfair participants to participate, such as prisoners and organized children. The principle of justice requires those who carry out the burden of inquiry to benefit from the investigation, and principles that are often violated by the export of clinical trials to less developed countries.
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