Quantitative Study on the Protection of Human Subjects
Critique a quantitative study focusing on the protection of human subjects, data collection, data management and analysis, problem statement and interpretation of the findings. You may use a previous quantitative study or critique a new peer-reviewed article.
Identify the statistical procedures used.
Judge whether these procedures were appropriate for the hypotheses, questions, or objectives of the study, and for the level of measurement of the variables.
Judge whether the author’s interpretation of the results is appropriate.
Evaluate the clinical significance of the findings.
A quantitative study research carried out on human subjects is an investigation that is scientific in nature which can adopt the stance of an observational research or an interventional research. This research involves the actual use of human beings as test subjects. Research carried out on human beings is often medical research. Based on the description above, this research paper is a review of a quantitative study that is centrally focussed on the protection of human test subjects, collection of data, management of data and data analysis, problem statement and interpretation of the plausible outcomes for tests in the development of the corona virus vaccine.
Conducting research on human beings can be justified ethically as a benefit to the broad society. Experiments performed on humans as test subjects are more likely to produce positive outcomes that benefit the society. While carrying out these experiments, the extent to which risk is to be taken must never go beyond a certain limit established by the humanitarian significance of the problem hoping to be solved by the said experiment. Ethically, the success of using humans as test subjects is justified as they society has a prospect of finding out new methods of contributing in a beneficial manner to people’s health. (Clapp, Gleason and Joffe, 2017)
The potential human test subjects are taken through the process of informed consent. This usually covers what the participation of the human test subjects would involve. Participants in the medical research to be used as test subjects are expected to volunteer and take part willingly after being taken through all the relevant details of the research. There are special considerations involved if it happens that the human test subjects about to participate are children. In this case, the consent of the parent is important in addition to that of the child involved. Where the participants are a section of the vulnerable population, it is required that arrangements are made to ensure there is adequate protection. These groups of the vulnerable include impaired individuals and prisoners. This entire process entails providing a written consent form that clearly stipulates all the relevant information on that particular research project and this information must be availed to the potential human test subjects. This agreement is sealed by obtaining a signed consent form from the potential human test subject before proceeding with any form of testing. The signature form the participant is a clear indication of voluntary participation by the human test subjects.
This whole process is overseen by the institutional review board from its early stages. The institutional review board comes on board to protect the volunteers and ensure that their consents are upheld. Thus for any medical research experiments, it is mandatory that the approval of the institutional review board is obtained before the whole project to use human test subjects is approved by the same board.
With the human test subjects considered as the independent variable, the medical practitioners become the dependent variable. The success of an experiment is measured based on consistent results from the independent variables. In a random sample survey conducted around eight local hospitals, all medical procedures that require the use of human test subjects were all regulated by the institutional review board. These volunteer are required by the board to append their signatures to a consent form acknowledging that they have read the terms and conditions of the medical procedures and are fully understanding of the whole process.
For risky medical procedures that required the input of human test subjects, every volunteer interviewee was conscious that they were morally engaging only up to a certain level of risk, beyond which they are allowed to withdraw their consent. A survey conducted in the infectious diseases sector revealed that the human test subjects are subjected to injections of the weaker form of the virus while trying to counter the virus with a recently developed cure or even a vaccine. These weakened forms of these viruses that a human test subject is exposed to be first injected to an animal test subject to test its fatality and effects on an organism before it is approved to be injected into a human test subject.
The survey also established that human test subjects are protected by being put under keen observation after being exposed to the test compounds. They are monitored for side effects, effectiveness of the compound and the general health of the individual.is put under tight scrutiny. In most cases, there is promise of financial reward to every individual that volunteers to be a human test subject. The amount awarded to these individuals is quite a substantial amount that at some point may appreciate the life of the human test subject.
Data Management and Analysis
Out of all the human test subjects who were sampled from the various spread out hospitals, only one experienced an allergic reaction to the medical compound being tested. The biomedical firm testing the test compound handles all the data compiled on the same. With these data obtained from the use of human test subjects, the biomedical firm is able to establish whether there needs to be modifications to improve the compound being tested or they have the mandate of clearing this compound for widespread use on human beings. In this case, human trials of the corona virus vaccine by the biomedical firm Pfizer are conducted on several random human subjects are observations tabled for further analysis. In this phase, only those individuals with no pre-existing conditions subjected to the test for concerns of personal safety of the individuals. (Thomas, 2020)
With this data, the number of test subjects who have successfully recovered are noted against the number of patients who have not recovered. By regulation, those patients used as human test subjects and are yet to undergo a full recovery have set up into appropriate medical care until they are fully recovered. This is enforced according to regulations in the medical field which involves the use of human test subjects in research.
Problem Statement and Interpretation of Findings
With these tests, come challenges in the protection of volunteers used as human test subjects. Some complications as a result of a medical injection may not be immediately visible but manifest themselves later than estimated. These are sources of concern by regulatory bodies charged with the protection of these human test subjects
Based on the procedures stated, they are effective to protect individuals volunteering to act as human test subjects willingly. Individuals with prolonged and delayed recoveries are under the care of the biomedical company testing the compounds. The fact that these individuals are informed of their rights to consent improves the credibility of the whole procedure while also allowing an individual to make an informed choice before volunteering to act as a human test subject for the future prosperity of the society. In relation to the objectives of study, these procedures are well aligned with theoretical research data translating into appropriate results. (White, 2020)
In conclusion, the clinical findings from these human test subjects are the most important in several ways. The results ensure the future prosperity of the society by cutting down on the possible health dangers human beings are susceptible to contracting. These findings also enable researchers to implement modifications to some treatment drug under development so as to improve its efficiency when administered to the actual population.
Clapp, J. T., Gleason, K. A., & Joffe, S. (2017). Justification and authority in institutional review board decision letters. Social Science & Medicine, 194, 25-33.
Thomas, K. (2020). New Pfizer results: Coronavirus vaccine is safe and 95% effective. The New York Times [Internet].
White, M. G. (2020). Why human subjects research protection is important. Ochsner journal, 20(1), 16-3