Are there boundaries to informed consent

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Question: Research involving human subject participants must use valid and rigorous scientific methods, but first and foremost, it must be conducted in an ethical manner. This has not always been the case, as evidenced by the horrific breaches in human research ethics outlined in the Tuskegee and Belmont reports. Researchers have an ethical and legal obligation to protect the privacy and well-being of human subject participants by offering informed consent, especially to those in vulnerable populations such as children, prisoners, and individuals in mental health care settings.

According to the American Psychological Association (APA), informed consent typically entails describing the following eight study elements to participants: (1) purpose, (2) duration, (3) procedures, (4) right to decline or withdraw, (5) reasonably foreseeable factors pertinent to the decision to participate, (6) benefits or incentives, (7) confidentiality limits, and (8) contact information about rights (Walkup & Bock, 2009).

Not all studies have such clear ethical boundaries. Some studies may not seem to present as high stakes or be as involved as others. For example, when conducting a brief "person on the street" interview of just a few questions about health behaviors, is there as much need to detail all eight of the APA elements as there might be in a longitudinal study of individuals with a pernicious disease? This is a question that you, as a health professional, may need to consider and address in your daily work at various times in your career.

For this week's Discussion, read the article by Walkup and Bock regarding their study on informed consent. Reflect on the authors' assertions about what potential research participants want and need to know. How do these factors inform researchers in designing studies using human participants in terms of providing informed consent?

Post your answer to these questions: Are there boundaries to informed consent? Are there ever situations in which it is right to withhold information about a study from potential study participants? Justify your answer with specific examples.

Article: What potential research participants want to know about research: a systematic review (By Helen Michelle Kirkby, Melanie Calvert, Heather Draper, Thomas Keeley, Sue Wilson)

Reference no: EM132043512

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