Ethical dilemma and special issues revolve around clinical trials especially when the subject involve vulnerable human participants such as children or pregnant women or ethnicity or socioeconomic. One of the major reasons why a clinical trial involving children is very challenging and complex is the idea surrounding the ability to understand the inform assent clause, and what is expected of them during clinical trials (National Cancer Institute. 2011). Ethically, for anyone to participate in any clinical trial, the international regulatory or regional agencies and the institutional review board (IRB) require informed consent from the participating subjects unless if it is a special situation where the individuals’ mental state is diminished, challenged or under legally authorized treatment to improve their health (Lemaire, 2005). Thus, if any of the aforementioned health status is the case for a given individual, although subjects are protected under the law against medical malpractice, a subject may lose their autonomy rights to inform consent; hence the issue of informed assent comes into place, a proxy consent most opponents deem an unethical practice (Beecher, 1966). Vulnerable populations effected in clinical trials are not limited to children, pregnant women, minorities, low socioeconomic status, prisoners and mentally challenged subjects (Wendler, & Grady, n.d.).

In approximation, 20-30 % approved drugs are labeled for pediatrics (FDA, 2011). However, the safety and efficacy of the medicinal products were not established in children (FDA, 2011). Most medical products are not tested in children before its approval and administration in children (FDA, 2011). Although the institute of medicine (IOM) is still working on the pediatric research ethics and guides, most of the pediatric drugs dosage are extrapolation of the adult’s dosage and weight.

Dr William G. Bartholomew (1995), a pediatrician emphasized that children are becoming “Intelligent, observant, capable, and responsible persons (Kohrman, Clayton, et al. 1995)”. His assessment on children’s mental ability is now a critical aspect of ethical qualms surrounding children participation in a clinical trial.  Thus, revisiting and questioning the idea of “doctors knows best”, or “proxy consent”, a subjective idea that parents always represents the best interest of a child.

The relevance of the use of informed consent in any clinical trial may not be properly applied if the meaning of the word “consent” or “assent” is not understood rationally and literally. The word consent is derived from a Latin word “consentio” or “sentire”, meaning to feel together, to perceive or feel the force of a thing (University of Notre Dame, 2011. The implication therein is to what level does the subject perceive or feel the force in an agreement when a proxy consent or assent is implied. For instance, when a child has a different feeling than the parent/guardian or pediatrician, there is no measurement scale that measures the accuracy, motives and validity of their feeling over what other people feels about the situation in question. Hence, when pregnant women are being considered in clinical trials, conditions that may raise concerns are the health status of the pregnant woman and the well-being of the unborn.

The well-being of the unborn is surrounded by ethical dilemma because when pregnant women gives an inform consent, she basically assents for the unborn participation as well, even though, in some cases, the unborn may not directly benefit from the study. On the other hand, if the unborn will benefit from the trial, it may be ethically justifiable for pregnant women to participate in a clinical trial, but if the unborn is not the target of the research, it creates bigger ethical qualms. Another factor that may affect pregnant women participation in a clinical trial is the potential adverse event or teratogenic effect an investigational medicinal product may have on the unborn. One reminder of this possible grave health impact was the teratogenic effect of thalidomide in mid 1900s.

Under an emergency clinical trial settings, researcher may encounter problems that may require deviation from a set study protocol. Depending on the severity of the emergency, there may not be enough time for informed consent approval from the subjects or the IRB approval of change in protocol. In such emergency situation, the most appropriate fix is ensuring the safety of the subjects at all cost (Iserson, 2007). Perhaps, emergency situation in a clinical trial may create an unrealistic clinical trial setting, even though it reflects the reality of possible clinical situation.

Integrating cultural and ethnic diversity in a clinical study is an integral part in advancing medical innovation (Murthy, Krumholz, & Gross, 2004). Polymorphism effects play an essential role in a medicinal product’s safety and efficacy. The role of cultural and behavioral pattern in medicine is a critical psychosocial and biological characteristic that defines the integrity of the study profile. Thus, in advancing this part of medical aspect in clinical trials, cultural competence ability and awareness is an essential skill to have as a researcher (O’Brien et.al., 2006). Medical community must reassure the participatory community or asset of their invaluable and altruistic values in medical innovation by encouraging transparency and conducting clinical trials with the utmost respect for human subjects.

References

Beecher, H. (1966). Ethics and Clinical Research. The New England Journal of Medicine, 274(1354-60). Retrieve from http://www.nejm.org/doi/full/10.1056/NEJM19660 6162742405.

Food and Drug Administration (FDA). (2011). Drug research in children. Retrieved from http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143565.htm

Iserson, K. (2007). Has emergency medicine research benefited patients? An ethical question. Science & Engineering Ethics, 13(3), 289–295. Retrieved from http://ezp.waldenulibrary .org /login?url=http://search.ebscohost.com/login.aspx?direct=true&db=a9h&AN=3198 9453&site=ehost-live&scope=site

Kohrman, A., Clayton, E., et al. (1995). Informed consent, parental permission, and assent in Pediatric Practice, AAP Pediatrics, 95(2). Retrieved from http://aappolicy.aappublic ations. org/cgi /content/ abstract/pediatrics;95/2/314?fulltext=informed+consent&searc hid=QID _NO _SET.

Lemaire, F. (2005). Waiving consent for emergency research. European Journal of Clinical Investigation, 35(5), 287–289. Retrieved from http://ezp.waldenulibrary.org/login?url =http: //search.ebscohost.com/login.aspx?direct=true&db=a9h&AN=16868490&site =ehost-live&scope=site.

Murthy, V. H., Krumholz, H. M., & Gross, C. P. (2004). Participation in cancer clinical trials: Race-, sex-, and age-based disparities. JAMA, 291, 2720–2726. Retrieved from http://ja ma.ama-assn.org.ezp.waldenulibrary.org/cgi/reprint/291/22/2720?maxtoshow=&HITS= 10&hits=10&RE SULTFORMAT=&fulltext=Participation+in+cancer+clinical+trials& searchid=1&FIRSTINDEX=0&resourcetype=H.

National Cancer Institute. (2011). Children’s assent to clinical trial participation. NCI. Retrieved from http://www.cancer.gov/clinicaltrials/patientsafety/childrensassent0101/page1.

O’Brien, L., Kosoko, L., et.al. (2006). Self-assessment of cultural attitudes and competence of clinical investigators to enhance recruitment and participation of minority in research. Journal of National Medical Association, 98(5), 674-682. Retrieved from http://www .mfdp.med.harvard .edu/catalyst/publications.

University of Notre Dame (2011).  Latin dictionary and grammar Aid. Retrieved from http://archives.nd.edu/latgramm.htm

Wendler, D., & Grady, C. (n.d.). Ethical issues in research with vulnerable populations. Retrieved from the NIH Clinical Center at http://www.bioethics.nih.gov/research/ vulnpop.shtml