ethical issues in clinical trials in developing countries

The key to scientific success resides in human resources. Unable to load your collection due to an error, Unable to load your delegates due to an error. More than 80% of clinical trials listed on clinicaltrials.gov [18] are conducted in the developed world. Earlier this year, the National Bioethics Advisory Commission (NBAC) issued a report on ethical and policy issues in international research, and the AMA passed a new recommendation on ethical considerations in international research at its 2001 Annual Meeting in June. 2020 Jul 30;15(7):e0236563. Thematic and sub thematic presentation of barriers for conducting clinical trials. Although many ethical issues that arise in clinical trials also arise in other types of research, the . PMID: 30267519 DOI: 10.24869/psyd.2018.285 Abstract Practice-based clinical research and ethical decision making--Part II: deciding whether to host a particular research study in your practice. Julka P. Clinical trials in India: dilemmas for developing countries. Understanding the investigators: a qualitative study investigating the barriers and enablers to the implementation of local investigator-initiated clinical trials in Ethiopia. Careers. Geneva: World Health Organization; 2011. Diseases of relevance to high-income countries are investigated in clinical trials seven to eight times more often than diseases whose burden lies mainly in low-income and middle-income countries [17]. Guise J-M, OHaire C, McPheeters M, et al. ISSN 2376-6980, Consent Needed to Perform Procedures on the Newly Deceased for Training Purposes, Through the Patient's Eyes: Once and Again, Global health/Global health system development. JN and GM contributed to the design and assisted with editing the manuscript. 4. Available at. JAMA 284: 29832985, PubMed One reason for outsourcing is that international clinical trials often cost less than they do in the US. We assessed the quality of all included studies and incorporated studies in the review. We believed that, given the paucity of literature on the topic, an inclusive approach would increase the collection of the diverse perspectives and experiences in a largely unexplored area. 2021 Oct 22;21(1):1135. doi: 10.1186/s12913-021-07111-x. Absence of suitable research infrastructure was stated by many articles [45, 4750]. This site needs JavaScript to work properly. 1Faculty of Medicine University of Queensland, Brisbane, Australia, 2The University of Queensland Centre for Clinical Reseaerch (UQCCR), Brisbane, Australia. Barriers for conducting clinical trials in developing countries- a sharing sensitive information, make sure youre on a federal An official website of the United States government. Geneva: WHO Technical Report Series; 1995. Zegers-Hochschild F. Barriers to conducting clinical research in reproductive medicine: Latin America. Ethical issues in clinical trials in developing countries - Brody Relation between the global burden of disease and randomized clinical trials conducted in Latin America published in the five leading medical journals. Research experience, interest and perceived barriers of clinical staff working at the intensive care department of a tertiary care academic hospital in Saudi Arabia. This site needs JavaScript to work properly. The site is secure. New Delhi, Weijer C (1999) Protecting communities in research: philosophical and pragmatic challenges. Many times physicians/clinical researchers from developing countries are faced with the criticisms that they are not of the same quality as physicians from developed countries and that they can be easily bribed by sponsors, which are based on the prejudice that any clinical trial can be executed in developing countries, no matter of quality or risks for patients. Chirac P, Torreele E. Global framework on essential health R&D. Ethical and Policy Issues in International Research: Clinical Trials in government site. Complex regulatory process, low budgets, high costs, poor financial management, and time constraint. Ethical issues in clinical trials in developing countries. (eds) Clinical Trials for the Treatment of Sepsis. This review will enable entities contemplating clinical research in these countries to prepare and plan ahead, to minimize the impact of barriers, and thus contribute to a greater proportion of the worlds trials being conducted where the majority of people reside. In Focus: 26 March 2004. As this process was dependent on the judgement of the reviewers, we repeated the process as a group. This chapter discusses measures to enhance the ethical soundness of collaborative international research by focusing on the following issues: 1) clarification of the substantive and procedural requirements for ensuring the protection of those who participate in research and 2) assistance in building host country capacity to conduct clinical tria. All Rights Reserved. Other studies also reported numbers of qualified researchers not reaching critical mass, inadequate research infrastructure, and inconsistent and limited funding opportunities [64, 65] as factors that hampered the conduct of research in these countries. Ethical Perspectives: Clinical Drug Trials In Developing Countries They are more demand-led and responsive to a countrys needs because they are driven by a local or national agenda [77]. According to the World Bank, most developing countries have a Gross National Income per capita of under US$4036 [5]. 2011 Jul;4(2):160-184. doi: 10.1093/phe/phr013. Geneva, Strauss RP, Sengupta, S, Quinn SC, Goepingger J, Spaulding C, Kegeles SM, Millett G (2001) The role of community advisory boards: involving communities in the informed consent process. Literature indexed in PubMed, Embase, CINAHL and Web of Science, WHO Global Health Library were searched. Katrin Weigmann Author Information EMBO Reports (2015) 16: 566-570 https://doi.org/10.15252/embr.201540398 References PDF Other studies also reported lengthy or ill-defined approval processes, significant bureaucracy, and lack of regulatory staff with expertise in reviewing [66, 67]. Barriers for conducting clinical trials included lack of financial and human capacity, ethical and regulatory system obstacles, lack of research environment, operational barriers and competing demands. Singh H, Rao SV, Kakkar AK, Singh J, Manohar HD. Barry M (1988) Ethical considerations of human investigation in developing countries. Methods for the thematic synthesis of qualitative research in systematic reviews. Bethesda, MD 20894, Web Policies Learning from and adapting best practices at all levels (system, organizational and individual) could be beneficial. . This is reflective of the 10/90 gap, in which less than 10% of health research funds in the world are directed toward problems that affect 90% of the worlds population, and an even smaller percentage go to fund researchers and health problems indigenous to developing countries [6, 7, 61]. Volmink J, Siegfried N, Van der Merwe L, Brocklehurst P. Antiretrovirals for reducing the risk of mother-to-child transmission of HIV infection (review). It also concludes that concerns about exploitation are better addressed by assurances about the future care of the subjects in the trial than by assurances of availability of the drugs in the country in general. Quality assessment for the systematic review of qualitative evidence. Devasenapathy N, Singh K, Prabhakaran D. Conduct of clinical trials in developing countries: a perspective. Geneva: Global Forum for Health Research c/o World Health Organization; 2000. 8600 Rockville Pike Clinical trial research, particularly systematic studies in human subjects (including patients and other volunteers) are required in order to discover or verify the effects of and/or identify any adverse reaction to investigational products in diverse populations [11]. Faith Lagay, PhD is managing editor of VIrtual Mentor. SACHA PFEIFFER, HOST: Now . Barriers and challenges to global clinical cancer research. Ethical and scientific implications of the globalization of clinical research. Ethical Issues in Outsourcing: The Case of Contract Medical Research Christine Grady, RN, MS, CS: Research Associate, Collaborative Intramural Program, National Center for Nursing Research. N Engl J Med 348: 721726, CrossRef Limited capacity in terms of funding were reported in all except two [52, 53] studies conducted in Saudi Arabia [52, 53]. Harris E. Building scientific capacity in developing countries. This potential includes reduced cost and time to recruit patients [9, 22] and increased incidence of diseases (eg cardiovascular diseases, diabetes, cancer) [23] of interest to the developed world. Lang TA, White NJ, Hien TT, et al. Edinburg, Vastag B (2000) Helsinki discord? HHS Vulnerability Disclosure, Help Background Research ethics provides the ethical standards for conducting sound and safe research. Inclusion in an NLM database does not imply endorsement of, or agreement with, Provided by the Springer Nature SharedIt content-sharing initiative, Birkhuser Advances in Infectious Diseases BAID. 1 Citations Part of the Birkhuser Advances in Infectious Diseases BAID book series (BAID) Keywords Ethical Issue Ethical Review Information Sheet Research Proposal Vaccine Trial These keywords were added by machine and not by the authors. Reich MS, Shaw J, Barrett I, Goldberg VM, Schnaser E. Public Health Ethics. Ethical issues in clinical trial collaborations with developing countries - with special reference to preventive HIV vaccine trials with secondary endpoints Reidar K. Lie, M.D., Ph.D. Department of Philosophy University of Bergen Sydnesplassen 7 N-5007 Bergen, Norway Fax. The https:// ensures that you are connecting to the Most of the included studies were qualitative studies with small sample size and narrow diversity of participants. Google Scholar, Preziozi MP, Yam A, Ndiaye M, Simaga A, Simondon F, Wassilak SGF (1997) Practical experiences in obtaining informed consent for a vaccine trial in rural Africa. Geneva, National Health and Medical Research Council (1991) Guidelines on ethical matters in aboriginal and Torres Strait islander health research. Moreover, mobility of highly skilled human resources due to the growing internationalization of the labour market is creating a permanent brain drain [62]. The greatest challenge that faced researchers in developing countries was lack of financial and human capacity. Similarly, concerns may be different for foreign led versus local investigator initiated trials. Two of the studies included in this review [40, 41] were global studies. Lack of research materials for conducting clinical trials [40, 46, 47] and lack of conducive scientific atmosphere (including policy) [43, 45, 50] were also reported. Eligible papers were assessed by two independent reviewers (CMA, JN) for methodological validity prior to inclusion in the review. However, access . Cambridge Quart Healthcare Ethics 8: 501513, CAS Clin. There are several inter-country differences in culture, socioeconomic and political contexts, therefore our findings may not reflect the situation in any specific country. In 2015, a review findings regarding the distribution of global clinical trials was released [33]. However, in China, little empirical research has been conducted on the knowledge and attitudes of medical postgraduates toward research ethics and RECs. Appl Clin Trials 12: Jan 1 www.actmagazine.com/appliedclinicaltrials/article/articleDetail.jsp?id=80369, Coreil J, Losikoff P, Pincu R, Mayard G, Ruff AJ, Hausler HP, Desormeau J, Davis H, Boulos R, Halsey NA (1998) Cultural feasibility studies in preparation for clinical trials to reduce maternal-infant HIV transmission in Haiti. Bull WHO 80: 114120, PubMed Before Participant perception, still a major challenge to clinical research in developing countries-A mixed methods study. Appl Clin Trials 12: Nov 2. www.actmagazine.com/appliedclinicaltrials/article/articleDetail.jsp?id=77704, Brady JS (2003) Multimedia delivery can enhance the consent process. Evidence-based global health. Ethical Issues in Clinical Trials. Regulatory and ethical issues in clinical research in women in ((((Barriers [Title/Abstract]) OR Challenges [Title/Abstract])) AND ((clinical trials [MeSH Terms]) OR clinical trials [Title/Abstract])) AND ((((developing countries [Title/Abstract]) OR Third world countries [Title/Abstract]) OR Low income countries [Title/Abstract]) OR Middle income countries [Title/Abstract]). HHS Vulnerability Disclosure, Help MeSH Accessed on October 15, 2004, Emmanuel EJ, Wendler D, Grady C (2000) What makes clinical research ethical. Financial and human capital barriers were reported across all articles. A controversial declaration. After removing duplicates, the topic and abstracts of 1915 published articles were screened to check if they were eligible for this review. To realize this, instituting a system for wider implementation of local investigator-initiated trials is warranted. Jane Nikles, Phone: 073346 5025, Email: ua.ude.qu@elkinjqu.
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