https://imcjms.com/public Ibrahim Medical College Journal of Medical Science https://imcjms.com/public/registration/journal_full_text/338 Sat, 07 Mar 2020 01:01:59 +0000 Abstract Background and objectives: Informed consent is now accepted as the cornerstone of medical practice and research. Concept of consent is an endeavor by which the patient can take part in clinical judgment concerning their treatment and protects patient and doctors against any litigation. However, in research informed consent is not merely a form that is signed, but is a process in which the participant has an understanding of the research and its risks. In view of this, the objective of the study was to assess the knowledge regarding informed consent among the doctors pursuing postgraduate courses in a medical institute in Bangladesh. Methodology: A descriptive cross sectional study was carried out among 160 postgraduate medical students in Dhaka city. A self-administered structured questionnaire consisting of 36 questions was used to assess their knowledge regarding informed consent. The response format was based on a 3-point Likert scale. Frequency distribution was used for statistical analysis. Results: The age range of the participants was from 25-40 years. Of the total participants, 48% were males and 42% were females. Majority of the respondents acknowledged the importance of an informed consent and 86.3% of the doctors agreed that only verbal consent was not adequate. Only 66.2% agreed that consent for participation in research should always be voluntary and informed. Majority (76.9%) agreed not to recruit individuals with mental or behavioral disorders not capable of giving adequately informed consent. Only 27.5% were aware that assent should be taken from children participating in a research. Out of total participants, 71.2% and 81.2% agreed that the participants should be informed about the laboratory test results. Management/referral must be ensured in case of abnormal test results respectively. For genetic research, 88.1% and 81.3% agreed for pre- and post-counseling respectively. Conclusion: There is need to initiate further educational programs to aware the doctors of the importance of informed consent in research, clinical practice and patient care. IMC J Med Sci 2020; 14(1): 005. EPub date: 07 March 2020. DOI: https://doi.org/10.3329/imcjms.v14i1.47451 Address for Correspondence: Dr. Nabeela Mahboob, Assistant Professor, Department of Microbiology, Popular Medical College, Dhanmondi, Dhaka, Bangladesh. Email: nabeela.islam311@gmail.com, Contact no: 01769050442   Introduction Medical research has increased greatly in many developing countries during the recent decade, motivated by the need to improve health in these countries [1]. Since medical research involves human participants, such research needs to be guided by fundamental ethical principles to ensure the protection of their rights and welfare. Furthermore, international standards mandate the review of research by research ethics committees (RECs) [2,3]. Ethical code within medicine has evolved overtime. In the past, a “doctor knows best” attitude was adopted by patients before any procedure as universal acceptance of the physician’s procedure. It was in the last few centuries that pressure began to mount on physicians for information about diseases and treatment options by patients [7]. The Nuremberg Trials of 1947 are regarded as the basis for the development of medical consent [8]. The Nuremberg Code of 1948 laid out the principle that “voluntary consent of the human subject is absolutely essential” [9]. Informed consent eventually emerged as legal and a right in 1972. This was as a result of series of legal cases in California in the 1950s [10] and in response to public outcry concerning unethical practices in the Tuskegee research [7]. Informed consent is a legal term that is supported by jurisdiction and international laws. It is defined as “voluntary agreement given by a person or a patient’s responsible proxy for participation in a study, immunization program, treatment regimen, invasive procedure, etc., after being informed of the purpose, methods, procedures, benefits and risks’’ [11]. A descriptive cross-sectional study was conducted among postgraduate medical doctors over a three months’ period from January 2018 to March 2018. The study was conducted in a single Postgraduate Medical Institute. All doctors of different disciplines studying in 2nd year and thesis part of postgraduate courses were approached to take part in the present study. Only 160 doctors agreed to take part and after obtaining consent a self-administered structured questionnaire was distributed. The questionnaire was developed and tested among them, and interviewed to obtain feedback on the overall acceptability of the questionnaire in terms of length and language clarity. Based on their feedback, the questionnaire did not require any corrections. The questionnaire designed to obtain knowledge towards informed consent, consisted of four sections. Section I solicited general demographic and professional background information. Section II had integrated 24 questions to collect information about knowledge regarding informed consent, section III had integrated 8 questions about knowledge regarding informed assent and section IV had integrated 4 questions about knowledge towards genetic studies. Before giving the questionnaires the participants were clearly explained about the research procedure and purpose. The anonymity was maintained. They were approached individually and requested to complete the forms. The participant’s responses for all sections other than section I were recorded using a 3-point Likert scale. Questionnaires were coded and excel sheet was created for data entry. The data were analyzed using SPSS version 20 (SPSS Inc., Chicago, IL, USA). Frequency distribution was calculated for proportion. In the present study, more than 80% of the participants agreed that for genetic studies, participants should be informed about the nature, outcome and consequences of the study findings, test results must be revealed and clarified, provisions for pre- and post-counseling must be ensured. Because of the complex issues and implications surrounding genetic testing, genetic counseling is often provided in the way of education, guidance, and pre- and post-test information about the risks, benefits, limitations, and implications of tests, as well as data storage and data usage (e.g., use in quality control or research) [26,27]. This approach facilitates patient consent to genetic testing and is viewed as a positive ethical feature. Indeed, evidence suggests genetic counseling improves knowledge and decreases anxiety, distress and depression [28]. Even so, concern remains about the lack of feasibility, applicability, or benefit to patients of receiving all of this information during the consent process. This is true for genetic testing in general, but especially relevant to broader genome analysis [29,30]. Others have gone further, and argued that too much detailed information can overload patient understanding [31,32] and undermine autonomous choice [33]. Though in our study, only 88.1% and 81.3% agreed for pre- and post-counseling respectively, but all genetic research must have provision for proper pre- and post-counseling. This study has concluded that informed consent is deemed as an integral part of the doctor and patient rapport. Knowledge and attitude should always run in a parallel way; once knowledge gets better, attitude will automatically improve. Although there is fair knowledge among postgraduate students; there is further need to initiate educational events to increase knowledge, awareness and acceptance of principles of research ethics among researchers. Faculty or students should be educated by holding seminars, workshops and continuing educational programs. The curriculum for students needs to be more detailed concerning research ethics. Thus, such initiative would further reduce the gaps of knowledge regarding informed consent and that may help in building constructive attitude towards necessity of consent process. Conflicts of interest The authors declare that there is no conflict of interests regarding the publication of this article.   Acknowledgments The authors are grateful to the study participants for their participation and kind cooperation throughout the study.   References 2.     Zimmerman C, Watts C. WHO ethical and safety recommendations for interviewing trafficked women. Geneva: World Health Organization; 2003. 4.     Khare A, Saxena V, Jain M, Sharva V, Singh P, Dayma A. Knowledge and attitude toward informed consent in medical and dental practitioners, of Bhopal city, India. J Dent Res Rev. 2017; 4(1): 17. 6.     Irving DN. What is bioethics? In: Koterski JW. Life and learning X: proceedings of the tenth university faculty for life conference. Washington, DC: University Faculty for Life; 2002. p. 1-84. 8.     Extended Project Dissertation; Can the lack of medical consent ever be justified? Available from: www.edexcel.com/.Medical20Consent-Feb. 2026 Ibrahim Medical College. All rights reserved.