Ethical Issues in Randomized Control Trials

Ethical Issues in randomized Control Trials chore 1A enquiry team is conducting a Randomized Control Trial of a new drug to continue the common symptom of the Ebola virus (fever) everywhere the past six (6) months. The observational group consisted of female Ebola patients aged betwixt 30 and 50 historic period to whom the new drug was administered. The give group consisted of male Ebola patients aged between 70 and 80 years. To this control group placebo, a substance that resembles music superficiall(a)y and is believed by the patient to be medicine that that has no medicinal value was administered.Discuss ethical issues associated with this look into founding?Ebola virus disease alike as (EVD) is a highly infectious and degrading disease which has recently killed thousands especially in West Afri locoweed. This disease is a severe and most often portentous illness in humans. The research design employ Randomized Control Trial, however it does non estate how it wa s adequate calculate the RCT sample size. The years in age of wo custody and men be listed but we do not know how m whatever participants the taste had. This research conducted random sampling, was the randomization truly random, or are on that point trustworthyly are two populations being studied here. It is very uncorrectable to come up with two randomized age groups of men and women. As stated above Ebola is a very dangerous disease and champion of the ethical issues in research is that assailable groups should not be intentiond unless benefits outweigh the damages, the age group of men between 70-80yrs fall in that category as elderly. This research design would have been giving this vulnerable group a placebo medicines (dumpy) to this group over a period of 6 months. How many individuals would have been lost to this fatal killer disease? The declaration of Helsinki states that in any medical mull over, every patient including those of a control group, if any should b e assured of the best proven diagnostic and therapeutic method. The controlled group where not assumed of this, placebo control trials are justify when it comes to testing a new product like hair removing creams which has no permanent damage, with severe illness this finishnot be acceptable .illness that are fatal and highly contagious when with a placebo control is not excusable with Ebola because without any medical intervention they will die. The study design also shows macroscopic evidence of both allocation and performance bias, in a finger the women that were selection to the intervention group were specifically chosen to be in the intervention group, due to the fact that they will perform better, by facilitating spry and desirable recovery compared to the elderly men whom their bodies ignorenot respond with the same efficiency. in conclusion some of these elderly men are Husbands, Dads, Granddads, brothers of other people un routineed family will suffer endlessly ove r 6 months, whilst their relative is not getting any help at all.What modifications would you suggest on the research design in future?There is never a iodin way to follow when it comes to research, however they are research design which are more suitable and permit the evidence obtained to answer the initial call into question as explicitly as possible. In future I would use I would use prison term series design. This is due to the fact that Time series design allows each participant to receive an intervention over a period of time and results are measured before and subsequently any intervention. Hence reducing the fatality that are associated with Ebola but also making it less contagious if the medication is being effective. Another channel I would introduce is to remove the placebo medication, one cannot be comparing a drug efficiency to a dumpy Placebo, and if it is a new medication then it will have to be compared to other similar drugs to prize its effectiveness instead of nothing, whilst humans are dying and others getting grime within that 6 months. Another change would be for the research not to use vulnerable elderly as the control group, hence employ adolescent and young adult sample population, since they would give a clearer recital to the efficiency of the new drug. Lastly I would calculate a capacious enough sample size to increase the nonplusings internal and external validity. delinquent to Ebola being fatal a sample size would help, by clarifying the total fatalities experience but most important the number of patients cured.PROBLEM 2One of the leading causes of fast spread of HIV and back up in Africa is poverty particularly income poverty that forces unmarried women and girls to indulge in prostitution. In January2005, the IMF/World Bank designed a 10-year micro-finance targeting 1000 prostitutes. The arrive of the protrude was to see a significant drop in the number of women or girls who indulge in this malpractice. To be registered as a beneficiary, interested women and girls were required submitted an application and pay a processing fee of MK500. A total of 2500 applications were received at the close of the deadline. To identify project beneficiaries, it was trenchant that a lottery be conducted and that all applicants be invited to witness the draw. by and by selecting the beneficiaries (i.e., treated group), a random draw was also conducted to select non-beneficiaries (i.e., control group).Discuss ethical issues associated with this research design?Acquired immune deficiency syndrome ( assist). AIDS develops from infection with HIV (human immunodeficiency Virus), which attacks the immune system and disables a persons defenses against other diseases, including infections and certain cancers. This research used Random selection to find the 1000 participants it wanted to induct into the micro-finance program .Firstly the time frame of the project, the project was meant to run for 10 years and c onsidering that this will have been an observation study design a lot of things can happen within the 10 years, which will affect the internal Validity of the findings. Secondly this enquiry design asked participants to pay for the application ,a sum of K500 which would total up to K1,250,000 million for the 2500 applicants. search ethical motive prohibits payments that can potentially cause pressure, bribes and economic social disadvantages. and then many individuals who really need the help would have been excluded, subsequently them having softness to source out the K500.It is also unethical asking money from a poverty group who happens to practice prostitution, they will engage in this malpractice to chide that K500, leading to the project not trying to stop prostitution but encouraging it on the other hand. Research designs have to respect the secrecy and confidentiality of participants at all times. Conducting a Lottery where everyone is invited and dividing the treatment and control groups of prostitutes in front of a congregation hampers privacy and confidentiality ethics, this sort of exposure can result into the applicants looked down upon by community members.What modifications would you suggest on the research design in future?When it comes to payments, Research ethics promotes that participants should be appropriately compensated for any expenses, compensated for effort, time or lost income, and hold for their contribution.in total this research raised K1,250,000 million. The suitability of this money is not justifiable since IMF bank will actually be spending huge amounts periodic to sustain this project. I would remove this application fee so that its unmannerly to every suitable candidate without having financial hinders. The applicants were unmarried women and girls, I deal that the focus should have been different since these are different age groups. The women can be put on the micro-financing plan whist the girls can be given a di fferent option to continue on with procreation and the money directed towards their fees. To expand on that it would be better to tutor the participants to fish rather than give them fish every time for 10 years, since when the project stops they will go back and continue with their malpractices (prostitution) .However if you can teach some of the women income generating activities and education for the girls then they will be able to become dependent and stop the prostitution altogether. This is known as transformative participatory monitoring and evaluation. Another change that I would install is the time drag of the projects 10 years is a lot of time, I would change the Research design to Randomized Control Trial with Crossover design. This would allow all 2500 participants to partake, thus not having any control groups, but time era when they would be receiving the money, hence follow ups can be conducted to what the individuals are heart-to-heart of with and without benefi ts. Futuristic speaking, I would change the design of the selecting process of the 2 groups, a Lottery selection were everyone is invited would be cancelled and conduct an expert add-in to assess economic, social and health status of the applicants. Decisions would be made and beneficiaries awarded to the real needy ones.REFERENCESKazdin, A.E. (2010).Single-Case Research Designs Methods for Clinical and Applied Settings, 2nd edition. New York Oxford University Press.Millum,J Grady C. (2013) The ethics of placebo-controlled trials methodological justifications.. Contemp Clin Trials.36(2)510-4Rothman KJ, Michels KB The continuing unethical use of placebo controls.N Engl J Med331394398,1994