Informed consent process in clinical research and practice

Informed Consent Process

In Walkup and Bock’s study (2009), the authors investigate what prospective research participants want to know when they are asked to join a study. Basically, they look at the conversational nuance of informed consent processes. Their findings indicate that participants often fail to ask about important elements of consent, such as voluntariness, risks, privacy, data maintenance, and so on, because they either assume they already know the answers or simply do not care about these aspects. For example, participants rarely inquired about their ability to withdraw from a study, possibly because they presumed such rights are inherent in research participation (Walkup & Bock, 2009). This assumption could reflect their pre-existing beliefs or the way the research was presented?.

When researchers design studies involving human participants, they have to recognize that participants do not always request or value all the information typically provided in formal consent documents. Walkup and Bock (2009) suggest that this could lead to confusion if redundant or overly detailed information is included, which may imply risks where none exist?. Researchers should try to balance disclosure with the clarity and relevance of the information that they provide so that aspects like voluntariness and risks are conveyed in ways participants are likely to appreciate.