Bhupathi P Arun, Ravi G R
Assistant Professor, Department of Orthodontics, Vishnu Dental College, Kovvada Andhra Pradesh, India.
Reader, Department of Pedodontics and Preventive Dentistry, Drs Sudha and Nageswara Rao Siddhartha Institute of Dental Sciences, Allapuram, Andhra Pradesh, India.
Int J Clin Pediatr Dent. 2017 Jan-Mar;10(1):73-81. doi: 10.5005/jp-journals-10005-1411. Epub 2017 Feb 27.
Informed consent in research, clinical trial, and practice is a process in which a patient/participant consents to participate or undergo the proposed procedures after being informed of its procedures, risks, and benefits. Ideally, the patient/participant is expected to give his consent only after fully comprehending the information about the procedures, benefits, and risks involved in research/clinical trial/practice. Thus, many ethical issues are entwined in the process of obtaining a proper informed consent. Certain untoward events in the past led to propose guidelines to prevent exploitations and unhealthy practices in the field of life science. Eventually, the practice of obtaining informed consent was emphasized to make sure that a participant's rights were not in jeopardy. Yet, there are flaws in the practical application of obtaining consent due to lack of understanding, barriers in communication, culture, custom, and various other factors. The present article highlights the need for a complete and comprehensive format of recording informed consent without compromising the rights of an individual and the standards of research or practice on ethical and moral grounds.
Bhupathi PA, Ravi GR. Comprehensive Format of Informed Consent in Research and Practice: A Tool to uphold the Ethical and Moral Standards. Int J Clin Pediatr Dent 2017;10(1):73-81.
在研究、临床试验和实践中,知情同意是一个过程,即患者/参与者在被告知拟进行的程序、风险和益处后,同意参与或接受这些程序。理想情况下,患者/参与者应仅在充分理解有关研究/临床试验/实践中所涉及的程序、益处和风险的信息后才给予同意。因此,在获得适当知情同意的过程中交织着许多伦理问题。过去的某些不良事件促使人们提出指导方针,以防止生命科学领域中的剥削行为和不良做法。最终,强调了获得知情同意的做法,以确保参与者的权利不受损害。然而,由于缺乏理解、沟通障碍、文化、习俗以及各种其他因素,在实际应用中获取同意存在缺陷。本文强调需要一种完整且全面的记录知情同意的格式,同时在伦理和道德层面上不损害个人权利以及研究或实践标准。
布帕蒂·PA,拉维·GR。研究与实践中知情同意的综合格式:维护伦理和道德标准的工具。《国际临床儿科牙科学杂志》2017年;10(1):73 - 81。