Ethics in Research Essay
Ethical issues surround research studies involving human subjects. Some groups in society are regarded as vulnerable, and their inclusion in research is usually under ethical and legal regulations. Vulnerable groups include pregnant women, children, the terminally ill, the elderly, ethnic minorities, and people with physical disabilities.
The government and other regulatory bodies have developed laws and acts that govern research using human subjects from these vulnerable populations. This paper focuses on Institutional Review Board regulations and pregnant mothers as a vulnerable group.
Many ethical issues surround research using pregnant women. According to Artal and Rubenfeld (2017), their exclusion in research studies is rooted in fear of harming the fetus and the mother. Pregnancy changes the body’s physiology, and thus, drugs and other interventions may have deviations from a non-pregnant human’s reaction.
The Institutional Review Board and government regulations strictly and almost always exclude pregnant women from research even if it involves a critically relevant question or few risks associated with the research (Artal & Rubenfeld, 2017). Research interventions such as drug clinical trials may harm the fetus (congenital anomalies), killing it or affecting it after delivery as a child or an adult.
Pregnant mothers are almost always excluded from research studies. Unless mothers are involved in research on matters affecting pregnant mothers, they should be excluded from research studies. However, there has been a tremendous increase in severe medical conditions in pregnancy that warrant medical treatment (van der Graaf et al., 2018).
These conditions include gestational hypertension, diabetes, deep vein thrombosis, and hyperemesis gravidorum. The incidence rate has been rising, and thus, the ethical principle, justice comes into play. Instead of excluding them, they should be included in research studies to mitigate the incidences of medical conditions during pregnancy (van der Graaf et al., 2018).
In 1975, the National Commission for the Protection of Human Subjects incorporated some guidelines for dealing with vulnerable groups, including pregnant mothers (Artal & Rubenfeld, 2017). These guidelines address mother and fetal subjects in therapeutic and nontherapeutic research studies (Saez et al., 2017).
The IRB monitors biomedical research that uses human subjects. The IRB must give specific regulations regarding the vulnerable populations (Saez et al., 2017). Thus, pregnant mothers are not exclusively excluded from research studies.
Research studies geared towards the health welfare of the baby or the mother are done, but they are highly regulated by the modifications of ethical research guidelines (Artal & Rubenfeld, 2017). IRB protects against coercion, physical control, undue influence, and manipulation of subjects. It does so through the development of regulations.
For example, IRB institutes that research using fetal or mother as the subject can be done when the relay cannot be realized using other means (Artal & Rubenfeld, 2017). This regulation minimizes the risk to the fetus and the mother that is conveyed by nontherapeutic procedures. The IRB also protects against coercion, for example, when children are involved in research by threatening them or without seeking their consent.
The IRB instructs that research can be carried out on vulnerable groups only in the research specifically regarding that group, thus protecting the vulnerable group from manipulation (van der Graaf et al., 2018). IRD enforces ethical requirements such as informed consent as stipulated in the Belmont report to prevent subjects from manipulation.
Having a diversified sample during a research study is very important. A diversified group provides a good representation of the society’s culture and conditions. The sample represents all ages and ethnicities, and hence findings can be easily generalized on populations.
Interventions can be personalized to reach all persons and be effective to all people to whom it was intended. Research involves testing interventions, and when a sample is not representative, conclusions may be made, yet interventions impinge on ethical issues in some groups.
Research involving human subjects requires apt regulations. Specifically, concise regulations are essenatial when using vulnerable groups of human subjects, as seen above. The government and legislative bodies’ regulations inform research activities involving these vulnerable groups. Ethical considerations are a must in these research studies. In addition, when carrying out research studies, it is good to diversify the sample to include all groups in the society.
References
Artal, R., & Rubenfeld, S. (2017). Ethical issues in research. Best Practice & Research Clinical Obstetrics & Gynaecology, 43, 107-114. https://doi.org/10.1016/j.bpobgyn.2016.12.006
Saenz, C., Cheah, P. Y., van der Graaf, R., Henry, L. M., & Mastroianni, A. C. (2017). Ethics, regulation, and beyond: the landscape of research with pregnant women. Reproductive Health, 14(3), 9-14. https://doi.org/10.1186/s12978-017-0421-3
van der Graaf, R., van der Zande, I. S., den Ruijter, H. M., Oudijk, M. A., van Delden, J. J., Rengerink, K. O., & Groenwold, R. H. (2018). Fair inclusion of pregnant women in clinical trials: an integrated scientific and ethical approach. Trials, 19(1), 1-9. https://doi.org/10.1186/s13063-017-2402-9