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REVIEW ARTICLE
Year : 2017  |  Volume : 8  |  Issue : 3  |  Page : 107-112

Informed consent process: A step further towards making it meaningful!


Quality Assurance Manager, Chest Research Foundation, Pune, Maharashtra, India

Correspondence Address:
Rashmi Ashish Kadam
Chest Research Foundation, Marigold Premises, Kalyani Nagar, Pune - 411 014, Maharashtra
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/picr.PICR_147_16

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Informed consent process is the cornerstone of ethics in clinical research. Obtaining informed consent from patients participating in clinical research is an important legal and ethical imperative for clinical trial researchers. Although informed consent is an important process in clinical research, its effectiveness and validity are always a concern. Issues related to understanding, comprehension, competence, and voluntariness of clinical trial participants may adversely affect the informed consent process. Communication of highly technical, complex, and specialized clinical trial information to participants with limited literacy, diverse sociocultural background, diminished autonomy, and debilitating diseases is a difficult task for clinical researchers. It is therefore essential to investigate and adopt innovative communication strategies to enhance understanding of clinical trial information among participants. This review article visits the challenges that affect the informed consent process and explores various innovative strategies to enhance the consent process.


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