ethical issues in clinical trials in developing countries

For example, one systematic review regarding barriers for participation of doctors in clinical trials in developed countries identified lack of time as a major barrier [24]. This paper examines. Clinical Trials in Developing Countries | Journal of Ethics | American When designing clinical trial or considering decision to take part in particular clinical trial as investigators, even before submission to responsible Central Ethic Committee, we always make certain private assessment about ethical justification of this clinical trial. N Engl J Med 348: 721726, CrossRef The field of medical research in China is rapidly growing and facing various ethical challenges. How does one avoid ethical imperialism in this case. Ethical Issues in Clinical Trials Background - ResearchGate Abstract Several ethicists have raised criticisms of various placebo-controlled clinical trials conducted in developing countries between 1995 and 1998. Physicians coming from developing countries must ensure that patient population of developing countries is not misused in any ethically questionable clinical trial. To avoid potential restrictions (from using predetermined themes) and to allow the possibility of including emergent key concepts, we used the study findings themselves to conduct a thematic analysis. Ethical issues in the design and conduct of clinical trials in developing countries. National Library of Medicine Medical treatments need to reflect biological and non-biological variations that exist across the world. There must be careful assessment of clinical protocols by various independent local advisory committees (e.g. Glickman SW, McHutchison JG, Peterson ED, et al. An official website of the United States government. Ethical and regulatory issues, administrative issues, lack of finance, lack of infrastructure, poor data quality, and lack of training curricula focusing on clinical research were the major bottlenecks [58, 59]. This research is funded by The University of Queensland. Even within the paucity of literature on conducting clinical trials in low resource countries, the literature mostly relates to ethical issues [19, 2628]. Reich MS, Shaw J, Barrett I, Goldberg VM, Schnaser E. Public Health Ethics. However, in China, little empirical research has been conducted on the knowledge and attitudes of medical postgraduates toward research ethics and RECs. Building scientific capacity is much more than simple science and technology transfer from the developed world to the developing world. One study [41] included seven countries (four from low and middle income countries (LMIC) and three from high income countries (HIC)), with a separate publication of the responses from each of the representatives of included countries. Similarly, concerns may be different for foreign led versus local investigator initiated trials. Bull WHO 80: 114120, PubMed Submit a manuscript for peer review consideration. N Engl J Med 336: 370373, Stapleton H, Kirkham M, Thomas G (2002) Qualitative study of evidence based leaflets in maternity care. Volmink J, Siegfried N, Van der Merwe L, Brocklehurst P. Antiretrovirals for reducing the risk of mother-to-child transmission of HIV infection (review). Update in Intensive Care and Emergency Medicine . These countries host nearly 90% of the worldwide burden of disease, most of which comprises preventable infectious diseases [2]. The authors declare that they have no competing interests. There are wide variations within developing countries with respect to barriers in clinical trial initiation and implementation in these regions. Rodriguez JJRB, Cuales JMD, Herrera MJB, Zubiri LAM, Muallil RN, Ishmael AI, Jimenez EB, Stoneking M, De Ungria MCA. Eligible papers were assessed by two independent reviewers (CMA, JN) for methodological validity prior to inclusion in the review. A recent review indicated that about one-third of 509 clinical trials sponsored by US-based companies from 1995 to 2005 were conducted outside the USA, many in poor and low-income countries [19], without targeting diseases prevalent in these countries. This paper examines each of these issues separately. Absence of suitable research infrastructure was stated by many articles [45, 4750]. Although many of the issues confronting clinical trialists working in resource-limited settings are the similar, the human and other resource capacity of developing countries lags far behind that available in wealthier nations [57]. J Am Med Ass 283: 27012711, World Medical Association (2000) Declaration of Helsinki. The World Medical Association revised its Declaration of Helsinki, a statement of principles for the ethical conduct of medical research, in October 2000. CAS The PRISMA checklist can be found in Additional file 1. Kuper A, Lingard L, Levinson W. Critically appraising qualitative research. If enhancing clinical trials in developing settings is being considered, then identifying barriers and designing context-appropriate strategies are essential. Koski and Nightengale agree with the spirit of the requirement but believe that it will be difficult to implement for many reasons, not least of which is that "a single trial can rarely determine how best to treat or prevent a disease in all settings, or even in the setting in which it was conducted.". In the other study, sample size was not justified and there is no description of the sampling strategy [52]. WHO Expert Committee. In India for example, though there are half a million physicians with 5060 physicians per 100,000 people, fewer than 200 have been trained in Good Clinical Practice (GCP) [55]. Vol 1. Federal government websites often end in .gov or .mil. Ross S, Grant A, Counsell C, Gillespie W, Russell I, Prescott R. Barriers to participation in randomised controlled trials: a systematic review. Bethesda, MD 20894, Web Policies 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. Bethesda, MD 20894, Web Policies Findings: People who participate in clinical trials in poor countries often do so because that may be the only way to gain access to health care. Organizing construct: Principles of ethics and ethical analysis in clinical research. Appl Clin Trials 12 Sept 1. www.actmagazine.com/appliedclinicaltrials/article/articleDetail.jsp?id=79882, Fitzgerald DW, Marotte C, Verdier RI, Johnson WD, Pape JW (2002) Comprehension during informed consent in a less developed country. A recent review indicated that about one-third of 509 clinical trials sponsored by US-based companies from 1995 to 2005 were conducted outside the USA, many in poor and low-income countries [19]. These countries health care systems need evidence to guide decisions about the most efficient and cost-effective interventions for them. The shortage of resources in developing countries paradoxically increases the need for reliable healthcare evidence to prioritize the use of their scarce resources [4]. The https:// ensures that you are connecting to the Ndebele P, Blanchard-Horan C, Shahkolahi A, Sanne I. government site. The Helsinki Declaration requires this, and, to the NBAC authors, it is "an especially important ethical obligation." Three crucial issues are the injustice of the use of placebo control groups, the coerciveness of the offer to participate, and the exploitation of Third World countries. Ethical Complexities of Conducting Research in Developing Countries Challenges related to patient recruitment were also reported. Assessment of study quality for quantitative studies. PDF Ethical issues in clinical trial collaborations with developing This site needs JavaScript to work properly. In recent years, there has been substantial debate about the ethics of research in developing countries [].In general, the controversies have centered on 3 issues: first, the standard of care that should be used in research in developing countries[]; second, the "reasonable availability" of interventions that are proven to be useful during the course of research trials []; and third, the . Clinicaltrials.gov. HHS Vulnerability Disclosure, Help Levels/sustainability of funding, policymakers understanding of the importance of research, infrastructure in research institutions and Human resources available. Ethical Issues in Clinical Trials. 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]. However, access . CrossRef PubMed CAS . Schlaff WD. Perel P, Miranda JJ, Ortiz Z, Casas JP. One reason for outsourcing is that international clinical trials often cost less than they do in the US. and transmitted securely. This is a preview of subscription content, access via your institution. Ethical Issues in Clinical Trials in Developing Countries Three crucial issues are the injustice of the use of placebo control groups, the coerciveness of the offer to participate, and the exploitation of Third World countries. In this essay the ethical issues related to the 'standard of care' are discussed together with the implications for the treatment of the control group in trans-national clinical trials. Financial and human capital barriers were reported across all articles. Regarding health conditions, six (60%) of included studies assessed barriers of conducting clinical trials on non-specific health conditions. Barriers and challenges to global clinical cancer research. Bethesda, MD 20894, Web Policies Reasonable requests for original data will be granted. PubMed The remaining four studies assessed barriers to conducting clinical trials in cancer [40, 51], reproductive disease [41] and acute coronary syndrome [47]. Shared barriers: System and organisational barriers like low resources, weak regulatory and administrative systems, few learning opportunities, little human and material capacity, and few incentives for doing research. Christine Grady, RN, MS, CS: Research Associate, Collaborative Intramural Program, National Center for Nursing Research. 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. Because of the limited number of articles in the review, our analysis did not examine the similarities and differences between barriers among the different developing countries. Whitworth JA, Kokwaro G, Kinyanjui S, et al. Wellington, Health Research Council of New Zealand (1998) Guidelines for researchers on health research involving Maori. Combining single patient (N-of-1) trials to estimate population treatment effects and to evaluate individual patient responses to treatment. The National Bioethics Advisory Commission (NBAC) was established by Executive Order 12975, For studies that involved health professionals, competing demands (particularly lack of time) appeared to be the second predominant theme. All Rights Reserved. Some articles reported difficulty in patient recruitment [40, 44, 47] as a barrier for conducting clinical trials. Li R, Barnes M, Aldinger C, Bierer B. Ethics and regulatory review procedures are critical for protection of the safety and interests of the participants. However, complex and overly strict ethical and regulatory systems could worsen the negative feedback loop between limited research capacity and small numbers of trials conducted. Pediatric clinical drug trials in low-income countries: key ethical issues Available at. However, we believe the rigorous compilation of stakeholder view and experiences lays the foundation to guide future studies. Zegers-Hochschild F. Barriers to conducting clinical research in reproductive medicine: Latin America. Pediatr Infect Dis J. 2022 Oct 13;13:901515. doi: 10.3389/fgene.2022.901515. The process of finding key concepts in each study was not always straightforward in the qualitative studies. 1. Ahmad N, Boutron I, Dechartres A, Durieux P, Ravaud P. Geographical representativeness of published and ongoing randomized controlled trials. Levine R: Referral of patients with cancer for participation in randomized clinical trials: Ethical considerations. Moon S, Bermudez J, Hoen E. Innovation and access to medicines for neglected populations: could a treaty address a broken pharmaceutical R&D system? Research capacity strengthening in Africa: trends, gaps and opportunities. There is much agreement among NBAC, Helsinki, and AMA guidelines on many aspects of clinical research ethics. Gaillard J. Assessment of study quality for qualitative studies. Hearn J, Sullivan R. The impact of the clinical trials directive on the cost and conduct of non-commercial cancer trials in the UK. Preventing mother-to-child transmission of human immunodeficiency virus type 1 in resource-poor countries. eCollection 2022. Therefore, further studies need be conducted and should include diverse views from the different developing countries and various stakeholders. Oncol. Pharma Technol. Finally, as the key findings were similar across studies, we chose to present and discuss the unifying themes and include both for the quantitative and qualitative studies in each theme. The Council for International Organizations of Medical Sciences is currently revising its 1993 guidelines for the ethical conduct of research involving human subjects. Edinburg, Vastag B (2000) Helsinki discord? The site is secure. The .gov means its official. Int J Appl Basic Med Res. Quality of each selected quantitative study was assessed using criteria adapted from the Newcastle-Ottawa scale for cross-sectional studies [34]. Posttrial Access to Medical Interventions: Intricacies, Challenges, and Solutions. 2010;2(1):3044. While outsourcing and globalization of clinical trials is good for LMIC, funding should also extend to promoting investigator driven research by the local researchers. For the majority of questions, all except one study [41] scored good for most criteria. 20092023 Bioethics Research Library Box 571212 Washington DC 20057-1212 202.687.3885 Clinical trials in neonates: ethical issues. Provided by the Springer Nature SharedIt content-sharing initiative, Birkhuser Advances in Infectious Diseases BAID. + 47 55 58 96 51 Tel. doi: 10.1371/journal.pone.0236563. Global comparative assessments in the health sector: disease burden, expenditures and intervention packages. Google Scholar, World Health Organization (2000) Operational guidelines for ethics committees that review biomedical research. Bookshelf Grey literature was also searched. Soc Sci Med 48: 139148, Kuczewski MG, Marshall P (2002) The decision dynamics of clinical research: the context and process of informed consent. Additional applicable papers were included using the reference lists of these publications. Quality assessment for the systematic review of qualitative evidence. Google Scholar, Hochhauser M (2004) Informed consent: reading and understanding are not the same. We would like to express our thanks and appreciation to Marcos Riba for his technical support in conducting the review. the contents by NLM or the National Institutes of Health. Ethical Issues in Clinical Research Studies - QPS Missouri Bhowmik D, Biswajit C, Jaiswal J, Tripathi K. Recent emerging hub for global clinical research in India. Oral Presentation at the 3rd African Conference on Ethical Aspects of Clinical Research in Developing Countries. 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. https://doi.org/10.1007/3-7643-7381-4_9, DOI: https://doi.org/10.1007/3-7643-7381-4_9. J Clin Oncol. Clinical trials in developing countries An analysis of the Indian Clinical Trial Registry showed that in 2015, of the 1124 trials registered, 48 involved only men, 128 only women, and 948 men and women in the inclusion criteria. The online version of this article (10.1186/s12939-018-0748-6) contains supplementary material, which is available to authorized users. The 'Standard of Care' Debate and Global Justice in Research In most low-income countries, research is a luxury because of economic constraints [63]. Clipboard, Search History, and several other advanced features are temporarily unavailable. Med Health Care Philos. Ethical and Policy Issues in International Research: Clinical Trials in Front Genet. 1900 articles were excluded as they were out of the scope of this review (see Fig. 2021 Oct 22;21(1):1135. doi: 10.1186/s12913-021-07111-x. After removing duplicates, the topic and abstracts of 1915 published articles were screened to check if they were eligible for this review. Clinical trials in developing countries: ethical issues. Geneva: World Health Organization; 2011. Although many ethical issues that arise in clinical trials also arise in other types of research, the . Barriers to conducting clinical trials in developing countries were: lack of financial and human capacity, ethical and regulatory system obstacles, lack of research environment, operational barriers and competing demands (see Table2). Chalmers T: The clinical trial. Another study also found that only 10 of 1556 new drugs produced between 1975 and 2004 were targeting diseases specifically prevalent in poor and low-income countries [20]. Of the medium quality studies, one had a low response rate (92 out of 40423%) [51]. The criteria contains six major questions that address different key areas (design, sample, data collection, analysis, reporting), each of which are answered as good, fair and poor. sharing sensitive information, make sure youre on a federal Microbicide research in developing countries: have we given the ethical concerns due consideration? Ethical issues in clinical trials in developing countries. Guise J-M, OHaire C, McPheeters M, et al. Lorenc T, Petticrew M, Whitehead M, et al. International collaboration both from the developed world as well as within the developing world is crucial to foster research development in less developed countries. The transition imposes a double burden [3] on the already pressured resources in developing countries. Who should develop and enforce ethics standards in foreign countries? System barriers to the evidence-based Care of Acute Coronary Syndrome (ACS) patients in China: a qualitative analysis. Ethical Perspectives: Clinical Drug Trials In Developing Countries International Journal for Equity in Health, http://creativecommons.org/licenses/by/4.0/, http://creativecommons.org/publicdomain/zero/1.0/, http://harvardpublichealthreview.org/global-clinical-trials-ethics-harmonization-and-commitments-to-transparency/, https://clinicaltrials.gov/ct2/search/map, Seruga, Africa: 4 countries, Asia: 5 countries, Central/ South America: six countries and 8 developed countries [, Oncologists with clinical trial experience (39 from LMICs and 41 from HICs), Lack of funding, lack of competent authorities and ethical procedures, lack of research materials, lack of time or competing priorities, concerns about insurance/indemnification coverage, lack of trained personnel, lack of patients/patient accrual, Schlaff, Latin America (Chile), the Middle East (Egypt), Europe (Greece), China, India, Australia, and the, United States [, Senior and accomplished investigators (7 participants, one from each country), India: Funding is limited, regulation impediments, misinformation about research, Investigators and other clinical stakeholders (19), Barriers and need for additional training, Impediments in ethics processes, high cost of trials, the potential burden of trial conduct on clinical care, insufficient skilled researchers, Lack of leadership support for implementing quality improvement, lack of resources, fears of patient disputes and litigation, healthcare funding constraints, high out-of-pocket expenses, and patients refusal to participate, Health researchers and stakeholders with research interest (20), Barriers: Human and material capacity, regulatory and other administrative bottlenecks, operational hurdles, awareness, confidence and motivation, Local health-researchers, senior stakeholders and regulators (72). The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Am J Publ Health 91: 19381943, CrossRef Unable to load your collection due to an error, Unable to load your delegates due to an error. The viewpoints expressed in this article are those of the author(s) and do not necessarily reflect the views and policies of the AMA. Although clinical trials are important to address sustained inequity that results from high burden of disease in developing countries, these countries are grossly under-represented in global clinical trial platforms. Clin. Ethical Issues in the Design and Conduct of Clinical Trials in We reviewed the literature on barriers facing clinical researchers in resource-poor settings, and found only a small number. sharing sensitive information, make sure youre on a federal We excluded papers which were not written in English. 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. Careers. Long approval process, shortage of human resource and lack of the institutional support, lack of encouragement, lack of awareness among the research professionals and the general public, lack of time, financial compensation and encouragement and lack of training of research, Complex and strict ethical and regulatory system, European Developing Countries Clinical Partnership, Preferred Reporting Items for Systematic Reviews and Meta-Analyses. Sixth report of the WHO expert committee. 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. Eidelman, L.A., Nyman, D.J. Three crucial issues are the injustice of the use of placebo control groups, the coerciveness of the offer to participate, and the exploitation of Third World countries. In the early 1990s, the commission stated that the rapid expansion of country-specific health research to meet health needs of these countries was a necessity to encourage better health status for more people in settings with sometimes severely limited resources [32]. Grey literature was identified by searching through the Network Digital Library of Theses and Dissertations, ProQuest Dissertations and Theses, and Google Scholar. Shaffer DN, Yebei VN, Ballidawa JB, Sidle JE, Greene JY, Meslin EM, Kimaiyo SJ, Tierney WM. Measuring Research and Development in developing countries main characteristics and implications for the Frascati manual. Shapiro HT, Meslin EM. Oncol. Disclaimer. According to the World Bank, most developing countries have a Gross National Income per capita of under US$4036 [5]. Leadership commitment to practicing clinicians can also improve the degree of clinical-trial participation through supportive managerial functions, including time and space allocations and individual recognition [72, 73]. The main sticking point among various groups is over the study designparticularly the design of the trial's control arm. Jain R, Stern D. Effective utilisation of India for global clinical trials. Clinical trials in developing countries: a review of the moral issues. (1995). Ethical responsibilities toward indirect and collateral participants in pragmatic clinical trials. Mass Medical Soc. Lack of time was a less important barrier for clinical researchers. Anyone you share the following link with will be able to read this content: Sorry, a shareable link is not currently available for this article. Most of the included studies [41, 4650] relied on qualitative methods. Two of the studies included in this review [40, 41] were global studies. We selected this as a logical starting point for assessing clinical trials from the modern era. Disclaimer. Ethical Issues in Clinical Trials | SpringerLink The past year has seen much discussion on participation by physicians from developed countries in research conducted in less-developed countries. Ethical issues in the design and conduct of clinical trials in developing countries. When making assessment if any clinical trial is ethically justifiable, there should make no difference in which country this clinical trial will be executed. The PRISMA checklist has been completed and made available. Clinical trials in developing countries - ethical considerations The benchmarks of ethical research. The Grand Challenge for the Future pp 189208Cite as, Part of the Birkhuser Advances in Infectious Diseases BAID book series (BAID). Delays in regulatory and ethical review were mentioned in most articles [40, 42, 45, 46, 48, 49, 52]. ICH Secretariat/CPMP/World Medical Association, Hochhauser M (2000) The informed consent form: document development and evaluation. Besides, they are more likely to influence policy and sustainably link research to action [78]. 1Faculty of Medicine University of Queensland, Brisbane, Australia, 2The University of Queensland Centre for Clinical Reseaerch (UQCCR), Brisbane, Australia. official website and that any information you provide is encrypted 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. FOIA Before 2007 Sep 19;8:10. doi: 10.1186/1472-6939-8-10. Please enable it to take advantage of the complete set of features! Most senior staff for conducting clinical trials were clinicians or academic staff whose primary jobs still had to be prioritised. As a potential trial participant, if . Clinical trials of medications and procedures for neuropsychiatric conditions raise particular ethical concerns, especially protecting vulnerable subjects in developing countries during the consent process. Lancet 359: 14071407. N Engl J Med 319: 1083-1086.

Cheap Second Hand Container Homes For Sale South Africa, Ojai Valley Athletic Club Waiver, Convert Numpy Int64 To Int, Causes Of Low-performing Schools, Articles E

ethical issues in clinical trials in developing countries

ethical issues in clinical trials in developing countries

rosary blessed by priest