Ethical Challenges in Study Design and Informed Consent for Health Research in Resource-poor SettingsThis review considers ethical challenges to research design and informed consent in biomedical and behavioral studies conducted in resource-poor settings. A review of the literature explores relevant social, cultural, and ethical issues in the conduct of biomedical and social health research in developing countries. Ten case vignettes illustrate ethical challenges that arise in international research with culturally diverse populations. Recommendations for researchers and policy-makers concerned about ethical practices in multinational studies conducted in resource-poor settings are also listed. |
From inside the book
Results 1-5 of 58
Page iii
... RESEARCH DESIGN 3 . 2.1 Cultural context 2.2 Health disparities 2.3 2.3.1 Collaborative partnership in research Strengthening the commitment to ethical conduct in research design 2.3 ... participants in studies of 19024_TDR_Interieur.p3.pdf.
... RESEARCH DESIGN 3 . 2.1 Cultural context 2.2 Health disparities 2.3 2.3.1 Collaborative partnership in research Strengthening the commitment to ethical conduct in research design 2.3 ... participants in studies of 19024_TDR_Interieur.p3.pdf.
Page iv
... studies in Pakistan : responsibilities of researchers for medical care of participants ( Asad J. Raja ) .54 .57 Case 10 : Research and employment opportunities in resource - poor settings ( Jeannine Coreil and Gladys Mayard ) ..60 5 ...
... studies in Pakistan : responsibilities of researchers for medical care of participants ( Asad J. Raja ) .54 .57 Case 10 : Research and employment opportunities in resource - poor settings ( Jeannine Coreil and Gladys Mayard ) ..60 5 ...
Page 1
... studies conducted in resource-poor settings are listed below. • Respect the cultural traditions of study populations and communities Respect for cultural traditions builds a foundation of trust between researchers, study participants ...
... studies conducted in resource-poor settings are listed below. • Respect the cultural traditions of study populations and communities Respect for cultural traditions builds a foundation of trust between researchers, study participants ...
Page 2
... Researchers also may need to consult with local community leaders before implementing a study. In every situation, researchers should pay attention to ethical issues arising from the imbal- ance of power between researchers and participants ...
... Researchers also may need to consult with local community leaders before implementing a study. In every situation, researchers should pay attention to ethical issues arising from the imbal- ance of power between researchers and participants ...
Page 5
... research initiatives. Ethically sound research design and voluntary informed consent are universally accepted preconditions for scien- tific investigations involving human participants. National and international guidelines for ethical ...
... research initiatives. Ethically sound research design and voluntary informed consent are universally accepted preconditions for scien- tific investigations involving human participants. National and international guidelines for ethical ...
Common terms and phrases
Additionally associated behavioural research beliefs benefits Bioethics Advisory Commission biomedical and behavioural biomedical research capacity building CIOMS clinical trials collaborative partnerships community consultation concerns consent forms Council on Bioethics cultural context Declaration of Helsinki design and informed developing countries epidemiological ethical conduct ethical guidelines ethical issues ethical review ethics committees genetic global guidelines for ethical health research health-care individuals informed consent institutional review boards institutions international guidelines international research interventions investigators involving human subjects IRBs and ERCs Journal Levine Macklin Malawi Marshall Medical Research Council Medicine National Bioethics Advisory Nuffield Council Papua New Guinea patients pharmaceutical potential practice programme public health recommendations require research design research ethics research in developing research involving human research participants research protocols resource-poor settings risks social staff standards strategies study participants study population therapy tions traditional birth attendants treatment Uganda University vaccine women Woodsong World Medical Association
Popular passages
Page 19 - The benefits, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic, and therapeutic methods. This does not exclude the use of placebo, or no treatment, in studies where no proven prophylactic, diagnostic or therapeutic method exists.
Page 19 - However, a placebocontrolled trial may be ethically acceptable, even if proven therapy is available, under the following circumstances: Where for compelling and scientifically sound methodological reasons its use is necessary to determine the efficacy or safety of a prophylactic, diagnostic or therapeutic method; or Where a prophylactic, diagnostic or therapeutic method is being investigated for a minor condition and the patients who receive placebo will not be subject to any additional risk of serious...
Page 8 - On December 10, 1948 the General Assembly of the United Nations adopted the Universal Declaration of Human Rights as a standard for all people and all nations.
Page 20 - ... available and unlikely in the foreseeable future to become available, usually for economic or logistic reasons. The purpose of such a study is to make available to the population of the country or community an effective alternative to an established effective intervention that is locally unavailable. Accordingly, the proposed investigational intervention must be responsive to the health needs of the population from which the research subjects are recruited and there must be assurance that, if...
Page 21 - Note of clarification on paragraph 30 of the WMA Declaration of Helsinki The WMA hereby reaffirms its position that it is necessary during the study planning process to identify post-trial access by study participants to prophylactic, diagnostic and therapeutic procedures identified as beneficial in the study or access to other appropriate care. Post-trial access arrangements or other care must be described in the study protocol so the ethical review committee may consider such arrangements during...
Page 20 - An exception to the general rule is applicable in some studies designed to develop a therapeutic, preventive or diagnostic intervention for use in a country or community in which an established effective intervention is not available and unlikely in the foreseeable future to become available, usually for economic or logistic reasons. The purpose of such a study is to make available to the population of the country or community an effective alternative to an established effective intervention that...
Page 72 - Responsible Research: A Systems Approach to Protecting Research Participants. Washington, DC: National Academy Press, 2003, 193^; and IOM, Ethical Conduct, 227.
Page 8 - In 1966, the General Assembly adopted the International Covenant on Civil and Political Rights...
Page 20 - ... population from which the research subjects are recruited and there must be assurance that, if it proves to be safe and effective, it will be made reasonably available to that population. Also, the scientific and ethical review committees must be satisfied that the established effective intervention cannot be used as comparator because its use would not yield scientifically reliable results that would be relevant to the health needs of the study population.
Page 71 - Code of Federal Regulations, Title 45, Part 46, "Protection of Human Subjects.