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Ethical Issues in Randomized Control Trials

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PROBLEM 1

A research team is conducting a Randomized Control Trial of a new drug to treat the common symptom of the Ebola virus (fever) over the past six (6) months. The experimental group consisted of female Ebola patients aged between 30 and 50 years to whom the new drug was administered. The control group consisted of male Ebola patients aged between 70 and 80 years. To this control group placebo, a substance that resembles medicine superficially and is believed by the patient to be medicine but that has no medicinal value was administered.

Discuss ethical issues associated with this research design?

Ebola virus disease also as (EVD) is a highly infectious and contaminating disease which has recently killed thousands especially in West African. This disease is a severe and most often fatal illness in humans. The Research design used Randomized Control Trial, however it does not state how it was able calculate the RCT sample size. The years in age of women and men are listed but we do not know how many participants the experiment had. This research conducted random sampling, was the randomization truly “random,” or are there really are two populations being studied here. It is very difficult to come up with two randomized age groups of men and women. As stated above Ebola is a very dangerous disease and one of the ethical issues in research is that vulnerable groups should not be used 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 study, every patient including those of a control group, if any should be assured of the best proven diagnostic and therapeutic method. The controlled group where not assumed of this, placebo control trials are justified when it comes to testing a new product like hair removing creams which has no permanent damage, with severe illness this cannot be acceptable .illness that are fatal and highly contagious when with a placebo control is not justifiable with Ebola because without any medical intervention they will die. The study design also shows large evidence of both allocation and performance bias, in a sense 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 quick and desirable recovery compared to the elderly men whom their bodies cannot respond with the same efficiency. Lastly some of these elderly men are Husbands, Dads, Granddads, brothers of other people countless family will suffer endlessly over 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 single 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 question as explicitly as possible. In future I would use I would use Time 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 after any intervention. Hence reducing the fatality that are associated with Ebola but also making it less contagious if the medication is being effective. Another change 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 assess its effectiveness instead of nothing, whilst humans are dying and others getting contaminated within that 6 months. Another change would be for the research not to use vulnerable elderly as the control group, hence using adolescent and young adult sample population, since they would give a clearer indication to the efficiency of the new drug. Lastly I would calculate a large enough sample size to increase the findings internal and external validity. Due to Ebola being fatal a sample size would help, by clarifying the total fatalities experience but most important the number of patients cured.

PROBLEM 2

One of the leading causes of fast spread of HIV and AIDS 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 aim of the project 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 decided that a lottery be conducted and that all applicants be invited to witness the draw. After 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 (AIDS). AIDS develops from infection with HIV (human immunodeficiency Virus), which attacks the immune system and disables a person’s 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 considering 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 Research 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. Research ethics prohibits payments that can potentially cause pressure, bribes and economic social disadvantages. Therefore many individuals who really need the help would have been excluded, subsequently them having inability 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 raise that K500, leading to the project not trying to stop prostitution but encouraging it on the other hand. Research designs have to respect the privacy 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 suitably compensated for any expenses, compensated for effort, time or lost income, and acknowledged 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 monthly to sustain this project. I would remove this application fee so that its open to every suitable candidate without having financial hinders. The applicants were unmarried women and girls, I think 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 different option to continue on with education and the money directed towards their fees. To expand on that it would be better to teach 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 span 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 sequence when they would be receiving the money, hence follow ups can be conducted to what the individuals are capable of with and without benefits. 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 panel to assess economic, social and health status of the applicants. Decisions would be made and beneficiaries awarded to the real needy ones.

REFERENCES

  1. Kazdin, A.E. (2010).Single-Case Research Designs: Methods for Clinical and Applied Settings, 2nd edition. New York: Oxford University Press.
  1. Millum,J &Grady C. (2013) The ethics of placebo-controlled trials: methodological justifications.. Contemp Clin Trials.36(2):510-4
  1. Rothman KJ, Michels KB: The continuing unethical use of placebo controls.N Engl J Med331:394–398,1994

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