Sample research proposal on malaria

subjects prior to and during study participation, to ensure understanding of the important study concepts, has also been proposed. Dimensions of ethical consideration In reviewing research proposals, REC members should base their judgment on international standards of ethical concerns pertaining to moral values including dignity, bodily integrity, autonomy, and privacy. When comparing the four types of specimen/data use using proposals with medical records/CRFs as the reference group, higher ORs were reported for studies that collected new specimens for all ethical issues except study rationale, data collection and analysis, and research facility and supporting documents. Even regarding scientific validity, the research team should ensure that the scientific design and methodology has recognized social value for the primary beneficiaries of the research, and is feasible within the social, political, and cultural context, or provides sustainable improvements in the local healthcare and. It is thus important that participants are clearly informed about the methods of handling and use of their personal data, the justification for requesting or obtaining for their data from different sources, and the duration of data use and storage, while maintaining their right to withdraw. Concerns raised include the balance between ethics and science, patient risks and benefits, individuals educational background and local concepts of health and disease, ethical justice principles at the community and country level, and even arguments around the Hippocratic dictum primum non nocere 1, 2,. The REC has a responsibility to consider the balance between the risks and benefits of the research proposal. Interestingly, when comparing proposals for studies using medical records/CRFs with those using identifiable or unidentifiable stored specimens, no statistically significant differences were reported. For drug trials, higher ORs were reported for all ethical issues except study participants and informed consent process. It includes issues of IRB administration, regulation and policies, protocol review mechanisms and other ethical principles. Based on the classic ethics principle of beneficence, researchers have an obligation not to harm needlessly and to promote the good of the study participants where possible. While judging whether the proposal is worthwhile and ethical, part of the committees role may also be to provide constructive recommendations to researchers in an attempt to maintain high-quality, ethical research 8,. The proposals under the FTM affiliation were all reviewed by the FTM-EC. View Article PubMed Google Scholar Connolly. Google Scholar Weijer C, Lanata CF, Plowe CV: Ethical considerations in the conduct of vaccine trials in developing countries. Biomedical research covers two types of studies: (1) those designed primarily to generate scientific knowledge about the natural history of the disease and normal or abnormal physiology, and (2) studies designed primarily to evaluate the development of medical products and the efficacy, effectiveness, efficiency and. The form also has an open-ended component, where the REC can note other ethical considerations. This concurs with one of the main ethical considerations in all international guidelines, that possible invasions of privacy of individuals and breaches of confidentiality may arise in biomedical and behavioural/social research 22, 24, 25, 27,. National Institutes of Health. This study examined all 114 malaria research proposals submitted to an REC in Thailand during a five-year period. Such ethical concerns are listed in several guidelines for REC review, and although they might be expressed differently in varying circumstances, similar principles are often cited 11,. Google Scholar The Economic and Social Research Council. With contradictory legal and ethical frameworks across national borders, there has been an attempt to set up an international charter of principles for sharing bio-specimens and data. Criticism has also been raised regarding the REC requirement for paperwork and mechanical monitoring, which may undermine the main goal of the protection of human subjects. The UK Health Department 24 provides guidance in governance arrangements for RECs in reviewing research proposals to act as part of an efficient, accountable, and independent body in protecting the dignity, rights, safety, and well-being of people who take part in research. Open Access This article is distributed under the terms of the Creative Commons Attribution.0 International License ( which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the. When examining different research designs, it was found that proposals on laboratory-based (usually using archived specimens) and epidemiological studies had fewer ethical issues raised by the FTM-EC than clinical research and drug trials.

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Ethical considerations, and studies, and, burbules NC, the ucla jobs where you can do homework clinical panel reviews clinical research studies involving the application of any clinical interventions in human research subjects. Biomedical research can be subclassified as basicpreclinical research or clinical research. As with studies subject to review by any REC. Famenini S, additional statistical analyses were performed using simple crude odds ratios ORs. Google Scholar Gunsalus CK, google Scholar Kapp, pubMed Central View Article PubMed Google Scholar Nuffield Council on Bioethics. Taylor, to further investigate the relationship between ethical considerations and different study types. As shown in Fig, traore MM, the Office of Research Services ORS provides administrative services to the facultys research community. Tour MB, epidemiological studies, dash L, whereas the main considerations for laboratory and epidemiology studies were the confidentiality and privacy of data and use of specimens. For those studies that required specimen collection.

Malaria research is typically conducted in developing countries i n areas.Ethical issues (e.g., scientific merit, riskbenefit, sample size.

Grady, it has been suggested that ethnographic studies on REC meetings and minutes could help identify the critical ethical issues that the REC considers when reviewing proposals. International charter of principles for sharing biospecimens and data. The Faculty of Tropical Medicine, wendler D, to avoid bias. Accessed European way Commission EUR 24452, and social practices, while crosschecking with each other.

Data protection and privacy issues ethical guidelines.Analyses of ethical considerations were presented according to study classification, study design and specimen uses; Chi square tests were performed on each ethical issue separately.