Malaria control and research studies have many ethical issues that must be adhered to make the process meet the IRB standards. One of these ethical issues is informed consent (Adams et al., 2017; Joly & Knoppers, 2014). For research studies to be ethical, there is a need for participants to be supplied with relevant information regarding the research study and must agree to take part in the study without being forced or coerced. However, Nuffield Council on Bioethics (2018) noted that the existing socio-economic and cultural differences in developing countries mean that some of the ethical procedures may not be adequately or appropriately conducted. More specifically, in developing countries, researchers encounter difficulties when considering who should provide informed consent about taking part in a study. For instance, in some communities, approval is granted by husbands who make decisions on behalf of their partners and children.
Another ethical issue in research is cultural sensitivity (Durham, 2014; Louw, 2016; shirmohammadi, Kohan, Shamsi-Gooshki, & Shahriari, 2018). Since malaria is highly prevalent in less developed countries across the world, there is a concern regarding the best way of carrying out the research on the disease while at the same time ensuring that the researcher remains sensitive to specific cultural dynamics found in those geographical regions. An example of a cultural sensitivity issue concerns the process of getting consent from tribal communities, which is a complicated process. In such instances, the researcher is required to seek approval from the community leaders first with the aim of negotiating a research protocol. Overall, even though informed consent should only be given directly by the potential research participant, the notion of individuality is not entirely applicable in communal societies. Therefore, in such communities, enforcing ethics which are considered by the members as different from their own is insensitive those cultural differences.
Another ethical issue in malaria research is a failure by researchers to fully inform prospective participants of the cost and benefits that are associated with malaria intervention programs. For instance, even though the insecticide DDT has been reported to be highly effective in reducing the prevalence of malaria infection in most of the countries where the disease was previously highly prevalent, such as in India and Sri Lanka where incidences of the disease have dropped by 99%, there is growing concern that DDT negatively affects hormone function (Strong et al., 2015). Therefore, the most critical question that should be addressed by the researchers before administering any intervention is whether the health effects of the treatment outweighs the need to wipe malaria-causing mosquitoes.
Another ethical issue which crops up so much in most research studies is confidentiality and anonymity of participants' data. According to Adams et al. (2017), the issue of confidentiality is common in epidemiological studies or survey work if the participants' data need to be obtained from hospitals' medical records without the person being informed or giving consent. Also, the use of samples or specimens without the permission of the person raises ethical concerns. Based on the standard guidelines of informed consent, the prospective research subjects should be fully provided with all the information pertaining to the research and the data to be gathered from them. This enables them to make decisions on whether or not to participate in the study. Therefore, in a case where the researcher fails to tell the potential participant that their personal data will be obtained from hospitals for research purposes raises critical ethical concerns.
Explanation of Whether the Issues Are Actual or Potential
Some of the ethical issues raised above are actual, while some are potential. For instance, the issue of informed consent usually arises in malaria studies when the researchers consider the research or the intervention to have minimal or no adverse health impact on the participants. For instance, even though some commentators have argued that informed consent should play the crucial role of protecting the research subjects in studies involving genetically modified mosquitoes, others believe that because no human participants are used in field trials, informed consent is not needed (Kolopack & Lavery, 2017).
Even though there might not be a clear guideline on how to approach the issue of informed consent in studies with minimal risk to the participants, I believe that any research that involves the completion of surveys and questionnaires should have informed consent as an ethical and legal requirement. I also agree with Kolopack and Lavery (2017) that even though malaria research studies may not pose health risks to the participants, informed consent must be sought because such studies require the researchers to access participants' households.
The second issue, confidentiality and anonymity, is potential. This is the case when the researcher fails to disclose to the participants their data collection methods and how the data will be utilized. Also, the issue of cost and benefits that are associated with malaria intervention programs, is a potential issue. This is true when the researchers fail to disclose risks and benefits that the participants are likely to incur as a result of participating in the study.
Privacy Level in Malaria Studies
In the proposed malaria research in Kenya and Tanzania, the level of privacy that would be required according meet IRB standards. The socio-demographic data as well as well as hospital malaria visits data will not be disclosed.
Adams, P., Prakobtham, S., Limpattaracharoen, C., Suebtrakul, S., Vutikes, P., Khusmith, S., ... Kaewkungwal, J. (2017). Ethical issues of informed consent in malaria research proposals submitted to a research ethics committee in Thailand: a retrospective document review. BMC Medical Ethics, 18.
Burnette, C. E., Sanders, S., Butcher, H. K., & Rand, J. T. (2014). A toolkit for ethical and culturally sensitive research: an application with indigenous communities. Ethics and Social Welfare, 8(4), 364-382.
Durham, J. (2014). Ethical challenges in cross-cultural research: a student researcher's perspective. Australian and New Zealand Journal of Public Health, 38(6), 509-512.
Joy, Y., & Knoppers, B. M. (2014). Routledge Handbook of Medical Law and Ethics. Routledge.
Kolopack, P. A., & Lavery, J. V. (2017). Informed consent in field trials of gene-drive mosquitoes. Gates Open Research, 1, 14.
Louw, B. (2016). Cultural competence and ethical decision making for health care professionals. Humanities and Social Sciences, 4(2), 41.
Manti, S., & Licari, A. (2018). How to obtain informed consent for research. Breathe, 14(2), 145-152.
Nuffield Council on Bioethics (2018). Ethical issues of malaria oppurtunities for debate. Retrieved from https://sites.duke.edu/superbugs/module-3/activities/activity-1-ethical-issues-of-malaria-opportunities-for-debate/
Shirmohammadi, M., Kohan, S., Shamsi-Gooshki, E., & Shahriari, M. (2018). Ethical considerations in sexual health research: A narrative review. Iranian Journal of Nursing and Midwifery Research, 23(3), 157.
Strong, A. L., Shi, Z., Strong, M. J., Miller, D. F. B., Rusch, D. B., Buechlein, A. M., ... Bunnell, B. A. (2015). Effects of the endocrine-disrupting chemical DDT on self-renewal and differentiation of human mesenchymal stem cells. Environmental Health Perspectives, 123(1), 42-48.
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