Informed Consent In Research
Informed consent is a basic requirement for clinical studies. It gives people a choice to participate in the study while understanding what the research entails. Generally, the consent form should contain a statement of the research study in question, the purposes of the research and the overall experiences along with the benefits that subjects may encounter. It should also contain a disclosure of any proper alternate plans of action or courses of treatment. Information about a study must be presented in a way that enables people to make decisions on whether they want to participate as a research subject or not. Despite the concept being simple there are several issues with the way current consent forms are written which fail to register key
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The purpose of the study should be in lay mans terms and should clearly state the reasons as to why it is considered. This along with legible fonts will be more appropriate especially when it comes to elderly and visually impaired population. One challenge of informed consent today is that there are false expectations of the study as well as experimental outcome and understanding of study procedures since consent forms are not very transparent (as cited in Nijhawan, Janodia, Muddukrishna, Bhat, Bairy, Udupa, Prashant). Many people sign the consent form without being aware of the details as the information is not very clear. For example, as described in The Oxford Textbook of Clinical Research Ethics, 75% of people who participated in an oncology research in Boston assumed that the purpose of the cancer study was to improve future cancer patient’s treatment (as cited in Emanuel, E. Chapter 59 p 646). There was clearly a complexity of understanding research purposes since they most likely were not clear about the …show more content…
Some participants feel like they need to continue with their participation as they are not clearly explained the situation where they can withdraw their participation anytime. They could also be waiting for some form of verbal agreement allowing them to excuse themselves from the study. So another improvement I would consider is including a section making sure that participants know they are entitled to certain rights such as the freedom to withdraw their consent at any time if they choose not to participate in the
The purpose of the study should be in lay mans terms and should clearly state the reasons as to why it is considered. This along with legible fonts will be more appropriate especially when it comes to elderly and visually impaired population. One challenge of informed consent today is that there are false expectations of the study as well as experimental outcome and understanding of study procedures since consent forms are not very transparent (as cited in Nijhawan, Janodia, Muddukrishna, Bhat, Bairy, Udupa, Prashant). Many people sign the consent form without being aware of the details as the information is not very clear. For example, as described in The Oxford Textbook of Clinical Research Ethics, 75% of people who participated in an oncology research in Boston assumed that the purpose of the cancer study was to improve future cancer patient’s treatment (as cited in Emanuel, E. Chapter 59 p 646). There was clearly a complexity of understanding research purposes since they most likely were not clear about the …show more content…
Some participants feel like they need to continue with their participation as they are not clearly explained the situation where they can withdraw their participation anytime. They could also be waiting for some form of verbal agreement allowing them to excuse themselves from the study. So another improvement I would consider is including a section making sure that participants know they are entitled to certain rights such as the freedom to withdraw their consent at any time if they choose not to participate in the