In the best-selling book, The Immortal Life of Henrietta Lacks (Skloot, 2010), the author highlights the true story of an African-American woman who died in 1951 from cervical cancer. What makes her story unique is that prior to her death, cells from her tumor were removed and successfully grown in a petri dish. This was the first time scientists were able to successfully replicate cells outside the body, and it is estimated that billions of Lacks’ cells have been used in medical research. However, Henrietta Lacks was never asked for permission to take a sample and her family was never made aware of the widespread use of her cells. Although the culturing of her cells has been pivotal for advancing research, strong ethical concerns later arose about using these cells without patient or family approval. Ethical Dimensions of Research Studies Essay Paper
This week’s readings describe historical examples of unethical research, such as a study of syphilis among African-American men in which treatment was withheld and a study in which live cancer cells were injected into elderly patients. Today, stricter controls that seek to protect study participants are placed on researchers, but breaches still occur. Careful attention must be given toward preventing unethical behavior. In this Discussion, you explore ethical considerations and issues in research.
Select a current health-related case involving research ethics. (If none come to mind, browse the Internet to familiarize yourself with recent cases.)
As you review the case that you have selected, reflect on the ethical principles discussed in “What Are the Major Ethical Issues in Conducting Research?” article found in this week’s Learning Resources. Which principles were breached in the case you have identified?
Discuss a description of the case that you selected and the ethical issues involved. Analyze the ethical principles that were breached by the researchers or organizations in your selected case as well as the possible cause of the breach(es). Suggest how the research might have been conducted differently to avoid or minimize the ethical problems. Discuss how research can be done on sensitive issues while still protecting the rights of the research subjects. Ethical Dimensions of Research Studies Essay Paper
Instructor (Linda Robinson)
Discussion: Ethical Dimensions of Research Studies
Conducting research studies using human subjects should be conducted ethically and the appropriate set standards followed. All research studies involving human subjects are required by the institutional review board to be safe and ensure the required ethics are not violated. Clinical trials are extremely essential in performing medical research and thus they are required to adhere to the ethical prerequisites and standards of research (Jain et al, 2017). This paper will review a case and reflect on the ethical principles that were involved in performing the research. Ethical Dimensions of Research Studies Essay Paper
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Description of the Case
In New York University medical school, psychiatric studies were shut down after the discovery that the studies violated various ethical principles and even falsified records. The violations consisted of lax oversight of the participants as well as failing to maintain accurate records. The Food and Drug Administration (FDA) representative reported that these violations endangered the safety and welfare of the study subjects and also raised issues regarding the validity and integrity of the data collected during the research (New York Times, 2018). It was also reported that the study did not comply with the required laboratory research standards. The study subjects were people with mental health problems and the research team did not evaluate the study subjects 24 hours after administration of the experimental medication, and hence they failed to follow the study protocol. In this trial, the study subjects reported many adverse effects because researchers failed to perform a follow on the study participants. One of the study participants reported that she ended up stopping taking trial drugs, but she was repeatedly told by the researchers to stop and restart the medications all over again (New York Times, 2018). Violated Ethical Principles
Respect is an important ethical principle when conducting a human trial. Respect is apparent in communicating with people and communities prior, during and after the trial and being aware of the people’s concerns (Jain et al, 2017). In this trial, there was no proper follow-up after the trial and hence this shows that the researchers violated the respect during the research.
Beneficence and Non-maleficence
Beneficence refers to the efficacy of the product in regard to benefiting the trial study subject, and that strengthening of the local health capacities. On the other hand, non-maleficence is inscribed into the protocol’s general outline to detect reactions and any adverse effects (Jain et al, 2017). Additionally, since this was a pharmacological trial of no proven efficacy to mental health patients, the issues of non-maleficence and beneficence were raised (Chiumento et al, 2017). In this study, study participants had adverse events such as the participants who experienced significant post-traumatic symptoms indicating that the research violated principles of non-maleficence and beneficence.
Informed Consent and Autonomy/Involuntary Treatment
The study participants should be informed about all the study aspects including their right to refuse to take part or withdraw consent to take part in the research. There are also principles regarding research protocols and post-trial provisions (Chiumento et al, 2017). In this research, the study participants did not receive adequate informed consent. In addition, participants were forced to restart with the trial medications when they stopped which indicates a violation of autonomy and involuntary treatment. In addition, mental health problems normally compromise an individual’s ability to make decisions, and this includes treatment decisions. Treatment focuses on behavior modification and therefore it is necessary to implement principles of non-maleficence and beneficence during treatment and ensure that the autonomy and patient’s consent are respected (Jain et al, 2017). Ethical Dimensions of Research Studies Essay Paper
The research violated the principle of human dignity. This is because people with mental health problems are considered as vulnerable and they need additional protections to eliminate any exploitation. Therefore, in this research, study participants should have been protected from harm such as the adverse effects they experienced (Chiumento et al, 2017).
Avoiding or Minimizing the Ethical Problems
The researchers should have respected the advance directives as well as consent procedure. Since the study subjects were people with mental illness, advance directives should have been availed by a representative with the patient’s best interests (Chiumento et al, 2017). With this, human dignity, as well as principles of autonomy and decision-making ability, would have not been violated. Additionally, the researchers should have provided an information leaflet laying research terms for all participants and containing all the research aspects. The consent process during the research should have been a continuous process. Finally, adequate follow-up of the study subjects would have also prevented violation of ethical principles such as of non-maleficence and beneficence (Yip et al, 2016).
Conducting Research on Sensitive Issues
Conducting research on sensitive matters involves issuing a comprehensive informed consent and constantly in order to ensure that the research subjects adequately understand what the research entails. Respect for autonomy is also an important aspect so that research subject can choose where to disclose some sensitive information or not. In addition, since sensitive issues may come up with potential harm during research, it is important to respect the principles of non-maleficence and beneficence. Finally, when conducting research on sensitive issues it is important to ensure that the rights and welfare of the study subjects are protected.
Chiumento A, Atif R, Frith L, Snider L & Tol W. (2017). Ethical standards for mental health and psychosocial support research in emergencies: a review of the literature and current debates.Globalization and Health. 13(8).
Jain S, Pooja K, Deep P & Sagar R. (2017). Ethics in Psychiatric Research: Issues and Recommendations. Indian J Psychol Med. 39(5), 558–565.
New York Times. (2018). NYU medical school stops studies after ethical violations. Medical Research.
Yip C, Han N & ban L. (2016). Legal and ethical issues in research. Indian J Anaesth. 60(9), 684–688. Ethical Dimensions of Research Studies Essay Paper