DISCUSSION ASSIGNMENT INSTRUCTIONS
The student must post 1 reply of at least 200 words each to the below classmates post . Each reply must incorporate at least 2 scholarly citations in AMA format. Any sources cited must have been published within the last five years(except for the Bible and the textbook). Acceptable sources include the textbook, the Bible, or professional publications.
Discussion Thread: Ethics in Biostatistics
Author #1: Elizabeth
Ethics in medical research is a highly important and easily looked over issue. With the increased use of humans and human materials in medical research, there is a fine line that develops between what is acceptable and unacceptable as far as experimentation. With that said, there are many different kinds to study designs that have been created with regards to the ethical process of participants. Clinical trials are one such design that have been created to benefit a new generation of investigators in the fields of human health, epidemiology, and genetics 1. Many in the general population do not realize to what extent systematic testing of a hypothesis, analyzation of the gathered data, and the ultimate effect that new technologies and treatments have on human tissue whether it be live individual volunteers of stored tissue from a deceased individual. As explained in the story of Henrietta Lacks, there is an initially fundamental rule that the proper consents be gained for each step in the research process 2. This is in addition to the initial ethical concern of many individuals about whether live humans are to be utilized as the manipulated variable in a research study.
With increasing and everchanging options for the new ‘gold standard’ for medical research comes the next idea of ethical standards. This is a highly important and closely regulated portion of medical research. The branch of the United States Department of Health and Senior Services known as The Office for Human Research Protections or (OHRP) is the primary regulatory body that governs over human participants in medical research studies 3. Smaller portions of the OHRP include the National Institutes of Health and the Centers for Disease Control and Prevention. There are other regulatory bodies such as the ASPCA, the FDA, and the USDA that focus on the zoonotic portions of clinical testing efforts.
One very common and approved research study design in the various different medical specialties is the random controlled trial. In a study involving the creation of new and further study of cancer medication therapies, there were a total of 33 different trial designs that consisted of 32 multicenter trials with 15 of them blinded, and the rest followed an objective reporting response from the participants. The remaining 18 multicenter trials were still randomized but in an open label fashion where the participants knew the treatments that they were getting 4. Overall, the results of these studies turned into approval for the 45 different medications in approximately 68 indications of rare cancers 4.
The advantage of randomized experiments is that they allow reliable conclusions without the need to worry about uncontrolled variables. However, there have been challenges and opposition to randomization by groups of AIDS patients. They claim that each individual patient should be assigned the very best treatment available, rather than a placebo or a possibly substandard type of treatment 5. The potentially ethical dilemma was the balance and potential harm that a placebo-controlled trial could have on participants that are already facing a disease with a high fatality rate and should be entitled to the best forms of treatment in a moral sense. The benefits to future patients notwithstanding the wishes of the initial participants.
Bioethical issues are complicated and multifaceted as there are often multiple views that are being expressed and tested whereas all perspectives are to be considered before an ultimate decision is made. On the one hand, the randomized control trial study design is one of the most trustworthy ones to date as long as the participants are treated fairly and with respect to the guidelines in place by the appropriate governing body.
There will always be a party that can cry foul with any type of trial, study, or design based on the practices and even the results that are communicated by the investigator as the participants do not know the full detail of the experiment as well as the primary caregivers that are working directly with the participants. Through keeping with the current best practice and design a study that is to the benefit of all participants while keeping to the randomized element of interest will face potential conflicts of interest between the patient, provider, investigator, and the public at large.
- Muthuswamy, V. (2013). Ethical issues in clinical research. Perspectives in Clinical Research, 4(1), 9–13. https://doi.org/10.4103/2229-3485.106369
- Skloot, R. (2021). The Immortal Life of Henrietta Lacks. Langara College.
- Protections (OHRP) O for HR. Who Oversees the Regulations to Protect Research Participants? HHS.gov. Published October 11, 2017. https://www.hhs.gov/ohrp/education-and-outreach/about-research-participation/protecting-research-volunteers/who-oversees/index.html
- Gaddipati H, Liu K, Pariser A, Pazdur R. Rare cancer trial design: Lessons from FDA approvals. Clinical Cancer Research. https://clincancerres.aacrjournals.org/content/18/19/5172#sec-3. Published October 1, 2012. Accessed January 20, 2022.
- Munnangi S, Boktor SW. Epidemiology Of Study Design. PubMed. Published 2020. https://www.ncbi.nlm.nih.gov/books/NBK470342/
Author #2: Rafael
Ethical problems can occur in statistics, especially when experimenting with a new virus the public has not yet encountered. In 1982 unusual infections described the conditions as Acquired Immune Deficiency Syndrome (AIDS). The observation study design evolves individuals who are identified positively with the virus. A Case-Control Study displays exposure and outcome with a retrospective investigation in time. A prominent feature is a study starting after the disease has been diagnosed. The main challenge in this type of study is when cases are incorrectly classified having exposure or risk factors leading to a misclassification bias.2 When selecting the study design, one must find out the handling and components involved with the study. AIDS and the COVID-19 (CO’ for ‘corona,’ ‘VI’ for ‘virus,’ and ‘D’ for disease), we all have witnessed encounters with the scientist, media, patients in a study, and the public at large all recognize this as a global pandemic.
There were approximately 36 million adults and 1.7 million children across the globe with human immunodeficiency virus (HIV)/AIDS; over 50 percent of the world cases are in Africa and 15 percent in Asia. This is still over a 20 percent of the decline in over a decade.1 The issue has become even more complicated with our current situation with COVID-19 and the new variant severe acute respiratory syndrome-related virus (SAR-CoV-2).1
The two research designs recommended to research life threatening diseases are Randomized Control Trial causing an ethical issue and Cross-Sectional Survey, an observational study conducted at one point in time minimizing potential ethical issues. The random allocation of volunteered applicants creates an inclusive comparability environment. Still, it can be opposed in pharmaceutical trials, in which often an experimental drug is given to one group and the other a controlled drug. It is considered ethically inappropriate to use a placebo because participants need medication in a death situation. Recruitment can be challenging in a trial because those may never accept randomly assigned to a group. Randomized studies allow reliable conclusions and are considered the gold standard. The Randomized Controlled Trial (RCT) is a design with a analytical feature indiscriminately selecting groups in a trial to make several comparisons using an experimental drug.2
A Cross-sectional survey is fitting when questions include: How is the extent of the disease in a group or region quantified? How is the rate of development of the new illness estimated? How might risk factors or characteristics relate to the development or progression of a disease identified? When the research question is focused on the prevalence of disease, disorder, or virus, the study is non-randomized, involving identified people at a point in time with data collected but do not generalize to future time points.2
HIV and the COVID-19 Pandemic according to the Joint United Nations on HIV/AIDS (UNAIDS), lockdowns and border closures imposed to stop COVID-19 disrupts HIV treatment could lead to more than 500,000 additional deaths from AIDS-related illnesses from both the production of antiretroviral medicines and their distribution, potentially leading to increases in their cost and to supply issues.1
Complete and accurate records are essential to the Food and Drug Administration (FDA), but a failure to publish trial results is a prevalent ethical breach with a negative impact on patient care. Audit is an essential tool for quality improvement; with ongoing monitoring of trials, transparency will help to drive up standards by clinicians, policymakers, ethics committees, regulators, patients, patient groups, healthcare payers, and research funders to impose negative consequences on those who engage in the unethical practice of withholding trial results from doctors, researchers, and patients.3
People in the medical/public health professionals are automatically trusted. We have seen more now than ever that people don’t treat others as if it was their grandmother dying in a nursing home. The transparency from scientistic, doctors, policymakers are affirming their biased opinion than following the data/science. In the book of Matthews teaches us, so in everything, do to others what you would have them do to you, for this sums up the Law and the Prophets.4
References
1. PEPFAR & Global AIDS: Global HIV/AIDS Overview. Updated November 25, 2020. Accessed January 23, 2022.
https://www.hiv.gov/federal-response/pepfar-global-aids/global-hiv-aids-overview
2. Lisa M. Sullivan, PhD. Study Designs In: Essentials of Biostatistics in Public Health. 3rd ed. Jones & Bartlett Learning; 2018.
3. Powell-Smith A, Goldacre B. The Trials Tracker: Automated ongoing monitoring of failure to share clinical trial results by all major companies and research institutions, Updated December 19, 2016. Accessed January 23, 2022.
http://dx.doi.org.ezproxy.liberty.edu/10.12688/f1000research.10010.1.
4. Matthews 7:12 (NIV)
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