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Ethical Conduct of Research; Infections disease: a global perspective

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Ethical Conduct of Research

power point from this document, 15 slides

Introduction

Depending on the context of the study, researchers often encounter ethical dilemmas that are associated with respect for privacy, establishment of honest and open interactions, and avoidance of misrepresentation. From an ethical standpoint, such challenging circumstances may surface if researchers are grappling with conflicting issues and have to choose between different methodological approaches in complex circumstances. In such circumstances, disagreements among different components including participants, researchers, researchers’ disciplines, the financing organization, and the society might be inevitable. Therefore, there are numerous ethical concerns that should be taken into account when undertaking studies that deal with human subjects. Understanding ethical principles can guide researchers to conduct studies that safeguard the wellbeing of human subjects.

Overview of the Research

In a research work titled Resilience of People Living with HIV/AIDS in Indonesia: a Phenomenological Study, Kumboyono et al. (2018) observe that HIV/ AIDS is among the most prevalent and expanding communicable diseases on the planet. The number of individuals who are diagnosed with HIV/AIDS continues to skyrocket every year in Indonesia and other parts of the world. According to Kumboyono et al. (2018), individuals who suffer from HIV/AIDS often plunge themselves into a series of crises, which indicate the challenges of living with the chronic pathological condition. As such, resilience is one distinct phenomenon that is common among persons living with the diseases Indonesia, a pattern that indicates the results of current health management and expectations of HIV/AIDS patients for better and improved health outcomes. In light of this concern, Kumboyono et al. (2018) undertook a study that sought to examine the mechanism of resilience in Indonesian people living with HIV/AIDS and the factors that influence their specific mechanisms. 

Using qualitative phenomenological design, the researchers sampled a total of 27 people living with HIV/AIDS from a primary health care institution in Malang City, East Java, Indonesia. The participants were selected from different socioeconomic, gender, and sexual orientations. The researchers informed participants about the conduct and processes involved in the study, resulting in their consent to participate in the interview process. The findings of the study indicated that the diagnosis of HIV/AIDS reflects the onset of psychological and social distress. Moreover, Kumbomoyo et al. (2018) found that the spiritual response that follows diagnosis is a state that is characterized by crises. As a consequence, the coping strategies and understanding of life by HIV patients is a definite sign on resilience. Based on these findings, Kumbomoyo et al. (2018) infer that HIV/AIDS is a chronic infection that has the potential to induce the unique mechanism of resilience within the Indonesian social system. Therefore, future health and management of persons living with HIV/ AIDS will be needed to enhance and encourage this strategy to guide persons living with HIV into a more comfortable and healthy way of life. 

Ethical Issues in Research

The relationships and interactions established between the researcher and participants in a study can potentially generate a wide range of varying ethical issues. While ethical codes, policies and principles are highly significant and beneficial, like any set of norms, they do not cater for all situations. Thus, they often have a high potentiality of conflicting. Nonetheless, the vast majority of decisions often entail the straightforward application of ethical codes and practices. Ethics is one of the most important issues that are commonly mentioned by educators in the scientific community. Ethical misconducts most commonly stem from environmental and individual causes. For instance, when people who are morally weak or unaware of the rules participate in research, ethical violations are bound to occur. Thus, many significant forms of the ethical deviations that are observed in many scientific studies are attributed to the fact that some researchers are oblivious of the ethical norms of scientific research. 

Protection of Human Rights

The most important ethical principles in research focus on protecting human rights when dealing with human subjects. Principles of protection of human rights during research emerged out of a dark history that was littered with accounts of abuses undertaken in the name of medical research.  One of the most dreadful of these atrocities were undertaken by the Nazi physicians who utilized convicts for human experimentation (Avasthi et al. 2013). The unearthing of these experiments sent ripples of shock across the world, a situation that resulted in the development of the Nuremberg Code to deter recurrence of similar episodes. The Nuremberg Code was the first international code of ethics in clinical research that laid down the guidelines for research dealing with human subjects. This policy made laid down principles, guidelines and standards to be followed by researchers and make voluntary consent essential, allowed subjects withdraw from the experimentation at any time, banned experiments that could lead to major injuries or fatalities of the subjects, and made it mandatory to have preclinical data prior to the experimentation of humans. However, the Nuremberg Code failed to end unethical practices conducted by certain researchers (Avasthi et al. 2013). As a consequence, a collection of guidelines was developed by the 18th World Medical Association General Assembly, also referred to as the Declaration of Helsinki. 

The Helsinki Declaration had a collection of principles, which emphasize on informed consent, confidentiality of data, vulnerable populations, and requirements of a protocol, including the scientific justifications for the study. All researches had to be reviewed based on these standards by the ethics committee for a research to be declared as ethically fit (Avasthi et al. 2013).  However, it is during the time of the Helsinki Declaration that other major scandals continued such as the Tuskegee Syphilis Experiment in the United States. This malpractice raised concerns in the ethics community, thereby resulting in the establishment of the Belmont Report in 1979. The Belmont Report established the modern regulations and human rights principles associated with research dealing with human subjects in the United States and other parts of the world (Avasthi et al. 2013). Nonetheless, with the growing interest in pharmaceutical, health, and psychological research in the developing and the underdeveloped nations, the Council for International Organization of Medical Sciences, in collaboration with the World Health Organization (WHO) and other health researchers designed the International Ethical Guidelines for Biomedical Research Involving Human Subjects in 1982 (Avasthi et al. 2013).  Thereafter, other professional research organizations such as the American Psychological Organization (APA), have designed similar standards that relate to protection of human rights in studies that deal with human subjects. 

The Five Human Rights that Must Be Protected

There are five cardinal ethical principles that reflect the five human rights that must be protected during research. These principles include: nonmaleficence, beneficence, respect for autonomy, justice, as well as right to self-determination. The principle of nonmaleficence states that the researcher has an obligation to avoid infliction of harm on human subjects in a study. This principle is closely interlinked with the maxim primum non nocere (‘first do no harm’). The principle of nonmaleficence prohibits killing, causing pain or suffering, incapacitating, and causing an offense on the human subject during research. Therefore, this principle encourages researchers to act in ways that do not cause physical or mental harm on the research participants. More precisely, the principle states that researchers should not cause avoidable or intentional harm. This should incorporate avoidance of any possible risks associated with harm (Jahn, 2013). Researchers should avoid intentional and unintentional violations of this ethical principle. For instance, a researcher does not necessarily intend to harm in order to violate this principle. As a matter of fact, knowingly or unknowingly subjecting a research participant to unnecessary risk amounts to violation of the principle of nonmaleficense. 

The principle of nonmaleficense has been applied to this study in many ways. One of the primary focuses of the study was to investigate the coping skills of people living with HIV/AIDS. Thus, when analyzing these coping skills and strategies, the researcher must engage in a one-on-one interview with the participants (Jahn, 2013). In the process, questions that trigger psychological and emotional pain might be asked unknowingly. Such situations are likely to occur in the study, especially when dealing with participants who suffer from HIV/AIDS. In almost all parts of the world, HIV/AIDS patients often witness numerous cases of social stigma. These negative experiences may interfere with the manner in which they respond to interview questions. Therefore, it is the task of the researcher to develop strategies that can help to minimize any possible mental and emotional paint that the persons living with HIV are likely o experience as a result of the data gathering and interview questions. Many studies on nonmaleficense often narrow down to physical harm (Chagani, 2014). However, the concept of harm is broad and dynamic, incorporating all dimensions of human life, including the mental and physical realms. In this particular study, there is no serious physical interaction with the participants that might cause physical pain, harm or death. 

The concept of harm is broad and takes many forms. They range from physical and emotional injuries to deprivation of property or violations of human rights. Within the research context, the primary emphasis of harm is often linked to a narrower definition, such as pain, disability, or death (Chagani, 2014). Within these standards, the research has observed avoidance of harm since all the participants who took part in the study did not die, sustain any physical injury or disability stemming from the research. However, harm can be strongly within the eye of the beholder, and a wider definition of harm is often required during ethical considerations. In light of the above, more than one level of harm may come into play in a situation. For instance, the researchers are more likely to inflict mental pain and suffering in the participants by asking questions related to the way in which they responded to the news that they had been diagnosed with HIV/AIDS. However, in such a situation, the researchers have imposed one harm in order to avoid a greater harm. Nonetheless, in all situations, researchers should be prohibited from acting in ways that are likely to generate undue risks or needless harm to participants. 

The principle of beneficence is a moral obligation to act for the benefit of others. In this respect, any research work that observes this principle should be designed in a way that is meant to promote societal good and wellbeing (Jahn, 2013). There are various ways in which this principle comes into play. For instance, the principle suggests that researchers should act in a manner that provides benefits to the society, and balances benefits with risks or harms. The principle of beneficence is broad and multifaceted. It includes protecting and defending the rights of others, preventing harm from occurring to others, removing conditions that will cause harm, and supporting persons with disabilities. Furthermore, this principle advocates for rescuing persons in danger during and after research. In furtherance of these ethical standards advocated by beneficence, there are various ways in which the study can be assessed. For instance, the outcomes of the study seeks to improve health professionals’ understanding of HIV/AIDS patients’ coping skills and strategies and the psychological pain that they undergo in the process of coping. As a result, it provides health professionals and psychological researchers with insights into ways of developing interventions that are meant to address mental health problems that affect HIV patients. 

The study encourages researchers to design interventions that are meant to enable HIV patients to bounce back to their normal psychological and social norms after receiving adversities as a consequence of HIV/AIDS diagnosis. Indeed, the nature of resilience among individuals who are diagnosed with chronic infections can be grouped into the crisis and survival stages. The former is characterized by the onset of a psychological and physical struggle that follows after diagnosis with several struggles. This study can inform future evidence-based practices that seek to design cognitive and counseling strategies for improving the quality of life of persons living with HIV/ AIDS. As such, the study fulfills the ethical principle of benefiting the participants and the society at large by promoting greater good and wellbeing for persons living with HIV/AIDS. 

The ethical principles of beneficence and nonmaleficense are multidimensional and intertwined. These dimensions include positivity and utility. Positivity can be described as the benefits that are gained after undertaking the research, which outweighs its costs. For instance, timely understanding of the mental and pain that HIV patients undergo after diagnosis can help to reduce major depression and help to cope will with the disease. On the other hand, utility refers to the benefits of undertaking an action that balances its costs. For instance, in a clinical research that explores psychological pain that patients undergo, the patient control group may only receive psychological treatment-as-usual instead of the experimental treatment that could generate extra gains. Beneficence and nonmaleficence are fundamental ethical principles that are essential in guiding the clinical practice and research in both psychology and healthcare. Beneficence encourages the researcher to exercise responsibility of promoting the wellbeing of the patients, especially participants in clinical trials, often by researching and administering therapeutic interventions with the highest possibility of positive patient responsivity. One of the biggest ethical dilemmas that psychologists confront is the need to strike a balance between beneficence and nonmaleficence. This balance may sometimes entail weighing the possible benefits and limitations or net risks associated with a specific research. In all jurisdictions, researchers are required by law to inform their participants or patients of the possible risks and gains of a research, procedure, or testy. This move allows the study participants to make an informed decision, with theirs being the burden to assess the potential costs and benefits of the available alternatives. 

Autonomy and self-determination are other fundamental human right that the participants should be granted during a research. Thus, respect for autonomy is a practice that obligates the researcher to respect the decisions of adults who have the capacity to make their own decisions. There are three conditions that must be existent for an action by the research subject to be regarded as autonomous. They include: intentionality, understanding, as well as complete absence of controlling influences that determine the subject’s decisions. In order to meet the ethical obligation of autonomy, there are several moral standards or guidelines that can be used. They include: telling the truth, respecting the privacy of others, protecting the confidentiality of information, as well s seeking consent from the participant before commencing the data gathering process. Respect for autonomy represents an obligation to the researcher to respect the decision making capabilities of the participants. It also denotes the provision of choices and alternatives to the subject so that they can practice self-determination. In this study, the participants’ rights to autonomy were observed by providing them with all the relevant information about the study and giving them the opportunity to decide whether or not to participate in the research. This process was primarily exercised through issuance of informed consent forms to the subjects. 

Within the context of this study, the subjects’ autonomy were respected by first giving them all sufficient information that are necessary for the research and then giving them the opportunity to consent or reject proposals to participate in it. Based on this practice, it is the responsibility of the researcher to ensure that the subject is sufficiently competent to practice autonomy. By competency, a research subject should be not only conscious, but also possess the sufficient knowledge and understanding to gain and maintain the information offered to take relevant decisions. Along with this view, the principle also requires the researcher to offer complete information to the participant and not hide anything so that the patient may seek to meet an obligation or can desire to spend some valuable time with family members and friends. The subject, after knowing the truth, may desire to do a hobby with which he or she desired to do. The participant may also seek to select other options of the research that may not be available or provided by the researchers. However, it is the right of human beings to be treated in a way that does not cause pain and anguish. Therefore, the researcher should go by the data gathering method in which the participants are comfortable with in order to avoid restraining the subject from exercising autonomy. In addition, in many jurisdictions, going ahead with a research against patients’ rights and decisions even if it is meant for their goodwill, is considered as an illegal decision. Therefore, a comprehensive justification on legal is often needed to undertake a research involving subjects who are patients against their knowledge and will. The principle of beneficence supports the autonomy of the patients as in the case of telling the truth to the research subject and respecting the subject’s autonomy can go a long way in generating the desired benefits to the participants, who will feel more confident in determining their course of life. 

Further, self-determination is a human right that is also relevant and interrelated to the right to autonomy. Self-determination is a right and principle that plays a critical role in the contemporary research ethics associated with human subject. Put simply, this principle suggests that ultimately, it is the participant who should make the final decision as to whether or not to accept a proposed research process (Lindberg, Johansson & Broström, 2019).  While this principle is widely discussed in many academic works, one of its most significant elements has often been overlooked- the fact that real-world decision making is temporarily extended. In this respect, decision-making is a process that broadly takes a significant period of time from the time at which the researcher determines that there is a need for the subject to participate in the clinical research and that there is a decision that should be made. Moreover, the participant should be able to make it to the point at which they are actually asked for their views. The principle of self-determination is broadly viewed as the center of research ethics and trials in the health sector (Lindberg, Johansson & Broström, 2019).   It is a principle that is commonly codified in legal frameworks and standards across different parts of the world, and has had a major effect on researchers’ understanding of ways of dealing with several legal and ethical issues associated with handling human subjects in research. 

There are several accounts of the content and implications of the principle that have been put into use within the context of this study.  For instance, in all stages of the study, the patients were given the liberty to opt out of the research. Through the issuance of informed consent documents and explaining to them the conduct and content of the study, they were sufficiently empowered to determine whether or not they would like to chat their own path by either remaining or opting out of the research. In view of this phenomenon, it would be deduced that it is the research subject who ultimately, following evaluation of all relevant information offered by the researchers, has the authority to decide whether or not to consent to the research. The principle of self-determination raises many fundamental questions. One such question revolves around who should self-determination be applicable to. In this study, the main subjects of self determination are the participants of the research. They are the HIV/AIDS patients who were interviewed on their psychological coping skills. Since a right to self-determination is often traditionally ascribed only to people with sufficient decision-making capabilities, one major issue that confronts many researchers is what it takes for a patient to be above the recommended threshold. Based on this standard, it is not clear in this study whether or not the HIV patient populations that were sampled were above the recommended normal mental threshold that is required of them to make informed decision on whether or not they should take part in the research. However, it can still be implied that they were mentally upright at the time of decision-making based on the nature of the data that have been gathered. 

When it comes to self-determination, real-world decision-making capabilities can be temporarily extended in that it broadly takes some significant period of time from the point at which the researcher determines that there is a consent decision that should be made, and that the patient is mentally fit or able to make it (Lindberg, Johansson & Broström, 2019).   Moreover, such a situation should extent to the point at which the subject is asked about their views. Such a temporal element of decision-making raises normative questions. For instance, it may not be clear under what situations and length of time the researcher should wait in order to get the feedback from the subject on the decisions that they have made regarding participation in the research. 

Finally, the principle of justice in research can also be used to analyze the ethical standards that were used in the study. The right to justice requires the researcher to exercise equity in the distribution of the benefits of the research. These include the benefits, costs, and resources. The key justice principles in a study include: promotion of equal share, giving each person in accordance with heir efforts, rewarding each individual according to their contributions, and issuing gains made out of the research according to merits (Silver, Ventura & Castro, 2016). In almost all forms, clinical trials require the active participation of human subjects and entail clinical interventions that are comprised of various procedures. However, this study only engaged human subjects in the interviewing process alone. Still, the performance of a study involving human subject can be beneficial to the economy and the whole society, especially the participating country, thereby generating employment opportunities and promoting local scientific and technological progress through the scientific data found and studied in collaboration with many research centers (Silver, Ventura & Castro, 2016). The financial and economic gains of this particular study have not yet been determined. However, its insights can be used to develop interventions that help to promote psychological wellbeing of persons living with HIV/AIDS. In so doing, the study can immensely improve their quality of life. 

Ethical Scientific Integrity

The credibility of a researcher or author is very critical in assessing the authenticity and quality of a specific research work. The personal details of the authors who developed this research work have not been provided in the journal article. However, there are other standards that can still be used to determine the credibility and level of suitability of the researchers to undertake the above study. For instance, the authors have revealed at the end of the article that their study was funded by the Directorate General of Higher Education, Ministry of Culture and Education in the Republic of Indonesia. Based on this standard alone, it can be deduced that the authors have the necessary academic credentials and intellectual acumen or capacity to undertake such a study. In addition, the mere fact that the study was approved by these higher educational bodies raises the credibility of the authors. Another factor that raises the credibility of this particular study is that its findings were assessed and later published by the Research HIV Nursing, which is a widely known reputable international journal that publishes studies on HIV research. 

Plagiarism is one of the ethical issues in research that are hardly ever mentioned. However, its violations can have far-reaching consequences on the credibility and authenticity of a specific body of knowledge. Plagiarism can be defined as the unethical practice of stealing and passing off ideas or group of words as one’s own (Ben-Yehuda & Oliver-Lumerman, 2017). Plagiarism is also the act of utilizing someone’s ideas and works and pretending to be one’s own. In light of the above, there are various ways in which plagiarism manifests itself in research. For instance, many researchers often fail to recognize the originators of their collection of words. However, this specific study can be said to have passed plagiarism test. First, the body section of the study has various in-text citations, indicating that the authors acknowledged the sources or originators of the ideas that were sued in the study (Ben-Yehuda & Oliver-Lumerman, 2017).  In addition, all the in-text citations have their corresponding bibliographic citations. As such, the authors do not have a case of plagiarism or copyright violation. 

Fabrication and falsification are some of the cardinal malpractices ion research conduct. They are commonly regarded as the key concerns in averting research misconduct. Any deviation or departure from such standards often undermines the integrity of a specific body of research for an individual or organization as a whole (Ben-Yehuda & Oliver-Lumerman, 2017).  Falsification can be described as the practice of altering or omitting research findings to support certain claims, hypotheses, as well as other data. This can include the act of manipulating study instrumentation, materials, or procedures. Usually, manipulations of images or representations in a way that distorts the figures or data or reads too much between the lines can also be regarded as an act of falsification (Ben-Yehuda & Oliver-Lumerman, 2017). The process of identifying a case of falsification or fabrication is often a complex one. As such, it was not possible for this specific study to detect any case of falsification. This is because the main data that were being explored were primarily qualitative and they were derived from the interview responses. In the same way, it was not easy to detect any case of outright fabrication. Fabrication is the development of or inclusion of data, observations, or characterizations that never took place during the collection of data. Fabrications are likely to take place during the process of filling out the entire of an experiment runs (Ben-Yehuda & Oliver-Lumerman, 2017).  Moreover, the researchers might come up with claims on the basis of incomplete or presumed findings, which are regarded as outright forms of fabrication. 

Institutional Review Board

Details on the Institutional Review Board (IRB) pertaining to this study have not been written in the article. However, the researchers indicate that they passed through the due process of informed consent and other ethical standards before they were approved to participate in the study. In addition, the study was approved by the Ministry of Higher Education, although such a ministry may or may not develop an IRB to assess the ethical suitability of the researchers. Therefore, it is not easy to determine whether or not the above study was approved by IRB. However, the researchers’ use of human subjects was not experimental in nature. Rather, use of human subjects in this study was minimized to data collection process through interviews. 

The absence of details regarding the IRB in this study calls for the need for future researchers to report as to whether or not their studies were approved by an ethics body. All individual organizations or sponsors may demand that all studies, irrespective of their sources of funding, be assessed and approved by an IRB (Whitney, 2015). An IRB has the specific power and authority over the nature of the research within its jurisdiction. For instance, no clinical research may be approved to stat enrolling participants until it has been given the green light by the IRB. The IRB primarily has the authority to approve, dismiss, or halt all research activities that fall within its jurisdictions in accordance with the relevant government regulations and institutional standards and procedures. The IRB also ensures that a given research meets the needed ethical standards by demanding for modifications in processes, protocols as well as previously approved studies (Whitney, 2015). Furthermore, the IRB has the power and authority to demand that participants in a specific research be granted any extra information that will enable them to make informed decisions to participate in the study. 

One of the most important documentations that the IRB may require is the informed consent form. While researchers who indicate that they provided participants with informed consent might have gone through the IRB, it might not be the case in all situations. All institutions that take part in the research process that engage human subjects are often tasked with the responsibility of identifying an IRB to assess and approve such studies (Whitney, 2015). The IRB is charged with the responsibility of adhering to the requirements and standards recommended by the Office for Human Research Protections. Many study sites may be under the jurisdiction of more than one IRB. Then IRB plays a significant role in safeguarding the rights, safety, and wellbeing of all human study participants. The IRB meets this responsibility by assessing the full research plan for a specific research study in order to ensure that it meets the standards that have been recommended by local and international codes of research ethics (Whitney, 2015). Moreover, the IRB undertakes a confirmation and approval that the study plan does not expose human subjects to unreasonable risks. In this particular study, human subjects are not exposed to unreasonable risks because their role in the research is to simply explain how they psychologically cope with the news of their diagnosis with HIV/ AIDS. 

Informed Consent

Informed consent is the main ethical practice that has been extensively observed by the researchers in this study. For instance, after selecting the populations to participate in the study, the participants were informed regarding the conduct of the research. Thereafter, the researchers report that the participants consented to the proposals to participate in the interview. The researchers also indicate that the study participants were given the opportunity to opt out of the research at any stage if they so wished. Therefore, it can be deduced that the study adhered to the recommended informed consent procedures and standards. 

Informed consent can be described as the voluntary acceptance by a study subject to participate in a research (Minor, 2015). Thus, informed consent should not be treated simplistically as a form that is signed but a process. As a process, informed consent is regarded as an essentiality before registering a participa

 
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