Ethical issues refer to the investigator’s moral, professional, and legal responsibilities in relation to the care of research participants. Many issues can arise such as deception, invasion of privacy, and informed consent. Each issue has its guidelines and requirements. For example, informed consent is a central issue that encompasses many ethical concerns and means of protecting participants in experimentation. Informed consent requires that the participant be capable of providing consent (competence), is aware of the procedures, risks, and benefits (knowledge), and willingly agrees to participate (volition). More generally, ethical issues are so critical that they usually need to be suitably addressed in a proposal or plan for research prior to running any subject. The many ethical issues raised in research have prompted guidelines and regulations designed to protect the rights of individual subjects. The guidelines apprise investigators of their obligations and the priority of ensuring protection of the subject at all times. Regulations are more demanding and put into policy, law, and federally mandated requirements to more strongly ensure that rights are protected. The concern over protection of participants is an international focus and international organizations as well individual countries have guidelines. Also, many guidelines span multiple countries (e.g., Declaration of Helsinki).
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