Informed consent in Sri Lanka: A survey among ethics committee members
نویسندگان
چکیده
BACKGROUND Approval of the research proposal by an ethical review committee from both sponsoring and host countries is a generally agreed requirement in externally sponsored research.However, capacity for ethics review is not universal. Aim of this study was to identify opinions and views of the members serving in ethical review and ethics committees in Sri Lanka on informed consent, essential components in the information leaflet and the consent form. METHODS We obtained ethical approval from UK and Sri Lanka. A series of consensus generation meetings on the protocol were conducted. A task oriented interview guide was developed. The interview was based on open-ended questionnaire. Then the participants were given a WHO checklist on informed consent and requested to rate the items on a three point scale ranging from extremely important to not important. RESULTS Twenty-nine members from ethics committees participated. Majority of participants (23), believed a copy of the information leaflet and consent form, should accompany research proposal. Opinions about the items that should be included in the information leaflets varied. Participants identified 18 criteria as requirements in the information leaflet and 19 for the consent form. The majority, 20 (69%), believed that all research need ethical approval but identified limited human resource, time and inadequate capacity as constraints. Fifteen (52%) believed that written consent is not required for all research. Verbal consent emerged as an alternative to written consent. The majority of participants rated all components of the WHO checklist as important. CONCLUSION The number of themes generated for the consent form (N = 18) is as many as for the information leaflet (N = 19) and had several overlaps. This suggests that the consent form should be itemized to reflect the contents covered in the information leaflet. The participants' opinion on components of the information leaflets and consent forms proved to be similar with WHO checklist on informed consent.
منابع مشابه
Ethics Review Committee approval and informed consent: an analysis of biomedical publications originating from Sri Lanka
BACKGROUND International guidelines on research have focused on protecting research participants. Ethical Research Committee (ERC) approval and informed consent are the cornerstones. Externally sponsored research requires approval through ethical review in both the host and the sponsoring country. This study aimed to determine to what extent ERC approval and informed consent procedures are docu...
متن کاملEthical regulation and the new reproductive technologies in Sri Lanka: perspectives of ethics committee members.
OBJECTIVE To report on part of a pilot study done to explore ethical responses to the new reproductive technologies in Sri Lanka. DESIGN Semi-structured interviews carried out with the members of three committees responsible for ethical review of medical research. Members were asked for their views on the ethical, social and legal implications of the new reproductive and genetic technologies....
متن کاملA Survey on the Observance rate of Research Ethics Principles in Approved Proposals at Ilam University of Medical Sciences, Ilam, Iran
Introduction: Considering the ever-increasing developments in medical research, especially the use of human subjects in research projects, the implementation of such research according to the ethical principles and criteria of creditable national and international declarations is of great significance. The present study aimed to investigate the rate of observance of research ethics in proposals...
متن کاملEffectiveness of Tobacco Control Measures in Reducing Tobacco Use among Adolescents and Young Adults in Anuradhapura, Sri Lanka
Background: Sri Lanka became a signatory to the WHO Framework Convention on Tobacco Control in September 2003 and ratified in November 2003. Aiming to reduce tobacco burden in Sri Lanka, National Authority on Tobacco and Alcohol Act [NATA] No. 27 was authorized in 2006. The objective of this study was to assess the behavioral changes related to tobacco use among adolescents and young adults fol...
متن کاملE-survey with researchers, members of ethics committees and sponsors of clinical research in Brazil: an emerging methodology for scientific research.
INTRODUCTION The growth of Internet users enables epidemiological studies to be conducted electronically, representing a promising methodology for data collection. METHODS Members of Ethics Committees, Clinical Researchers and Sponsors were interviewed using questionnaires sent over the Internet. Along with the questionnaire, participants received a message explaining the survey and also the ...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید
ثبت ناماگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید
ورودعنوان ژورنال:
- BMC Medical Ethics
دوره 9 شماره
صفحات -
تاریخ انتشار 2008