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3.3 Explain The Process For Gaining Informed Consent

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Three rights of subjects that need to be protected in research include the:
• Right to self-determination-incorporates the ethical conviction that a person should be treated as an autonomous agent. An autonomous person is an individual capable of making a voluntary decision as to whether or not to participate in a study or withdraw from a study, at any stage, for any reason, and without penalty. Coercion is one way in which the right to self determination could be violated. People can be coerced when they believe that their care will suffer if they refuse to participate in a study. For instance, a cancer patient without insurance may join a chemotherapy study to receive care that would otherwise be unavailable.
• Right to anonymity and confidentiality-incorporates …show more content…
Potential benefits included improving cancer pain and other serious problems related to pain such as fear, anxiety, depression, hopelessness, and desire to die.
In the end, the IRB had to ensure that the risks were reasonable in relation to the potential benefits and that all of the individual procedures have met their respective ethical criteria.
3. Explain the process for obtaining informed consent for participation in a study. Include the four essential elements of informed consent in your answer and the essential content to ensure compliance with HIPAA Privacy Rules.
The process of obtaining informed consent is build upon four elements:
• Disclosure of essential information-involves giving a subject adequate information concerning the study (i.e. purpose, procedures, risks, benefits, compensation, confidentiality, and alternatives to participation) and allowing the potential subject the opportunity to ask

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