Ethics In Health Care Research

Document Type:Thesis

Subject Area:Nursing

Document 1

When humans are used in a study, it follows that researchers are bound to uphold high ethical standards to maintain the integrity and dignity of the human participants. This not only helps to protect the participants in the study from harm, but also to ensure that their privacy is protected and confidentiality assured. Ethics is an important subject in the field of medicine. It goes back to the time of Hippocrates. This paper is a review of the ethical aspect of an article, “Individual-level needle and syringe coverage in Melbourne, Australia: a longitudinal, descriptive analysis”, by Daniel, O’keefe, Nick Scott, Campbell Aitken, and Paul Dietze. Literature Review Belmont’s Report The principles contained in the Belmont Report seek to ensure the well-being of research subjects.

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However, most times investigators who are community-engaged prefer the role of a participant to that of a subject. A study conducted by Bromley et al identified four areas of concern to interviewees. These include “embodying ethical action, respecting participants, generalizing beneficence, and negotiating justice”. These were identified in a bid to establish significant ethical concerns. Community engaged studies recruit participants who have particular health problem or people who have a responsibility for such populations to help with “planning, designing, conducting, interpreting, or disseminating research” (Bromley et al. Engagement of a community can take various forms ranging from simple advisory roles to important leadership roles in various stages. For instance, community-based participatory research (Shore e al. Important aspects of community engagement include “consensus-building activities, shared control of data, and long-term partnerships”.

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These types of studies underscore the increasing significance of patient advocacy groups as well as the aspect of participatory science (Harding, 1991). Finally, abstract attribute could be dependably measured in an artificial experiment setting The description and definition of a subject also affected the way research ethics as codified in the “Belmont Report”. The difference between an investigator and a study subject paved the way for trust-based obligations, which formed the foundation of what is now known as research ethics (Miller, 2006). One of the major ethical goals was the protection of human subjects (Bromley et al. Moreover, a research situation that is experimental in nature ought to increase beneficence and lessen threats to subjects as much as possible. An individual also ought to participate in research voluntarily.

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Implication of investigator-participant relationship Many investigators understand the significance of this new relationship between the researcher and study participants. Theoretical aspect of research that seeks to integrate the community is quite nascent and undeveloped (Bromley et al. Community engaged investigators continue to encounter new ethical challenges as they articulate novel research priorities despite their acceptance of the relevance of the three Belmont’s principles. Though ethical priorities can vary between investigators, they continue to come up with new methods to uphold ethical values (Kraemer Diaz, 2013). There lacks consistency on the way to conduct ethical research in this area (Brugge, 2003). When the pharmaceutical companies invite general practitioners in a clinical test or observational study, or come up with their questions on the research, they often get themselves lost in the human research subject.

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A living individual from whom a researcher obtains private or individual information (data) through interaction or intervention is the human subject (Bromley et al. There may be a deterring effect on the ethical conducts, due to regulatory and legal complexity, especially when the research is required to give support on evidence-based medicine. In many instances, the unaware practitioners, unfortunately get into low risk activities unknowingly and is entangled in compliance, legal and auditing procedures (Rose, 2017). The researchers are urged to be well conversant with their rules, local laws and customs. Secondary sources of data will be used to help build insight on ethical consideration in research studies in healthcare. Journal articles, reliable websites, and books, and dissertations on the subject will be used to inform the direction of this paper as it seeks to carry out an ethical review of the research under study.

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Several recommendations will be made for future studies on the subject with regard to ethical considerations. Article under study Overview The article under review is a longitudinal and a descriptive analysis that sought to establish the level of “individual-level needle and syringe coverage” in Melbourne, Australia. The article argues that coverage is an important indicator of the “needle and syringe program” (NSP) effectiveness. Researchers employed logistic regression to predict insufficient coverage and inconsistently covered categorization. The study found that there was high prevalence of insufficiently covered participants. This was mainly caused by an overly high number of people who oscillated between states of coverage. This was an indication of existence of temporal factors. Most importantly, the study found a strong correlation between “insufficient coverage” and the incidence of Hepatitis C virus (HCV) infection.

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It states the coverage helps establish the effectiveness of the needle and syringe program (NSP). It also provides the definitions of coverage. Moreover, it recognizes previous studies conducted on the subject and the information gap they are yet to fill. The study also gives a reason why Australia is its most preferred study population. The rationale behind this is that Australia was able to avert the threat of HIV pandemic through the use of the NSP program. There were two recruitment phases: one in which there were 688 participants and the other in which there were 69 participants. This brought the total number of participants from the two recruitment phases to 757 participants. The two recruitment phases sought to recruit regular injectors. The two recruitment phases occurred in 2008 and in 2011.

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By the end of February 2015, there 2862 interviews had been conducted with each participants responding to seven interviews per year. The rate of unemployment stood at 78%. 85% of the participants were living in comfortable accommodations. Their mean age was 30 years. Heroin was the most used injectable drug at 73%, followed by methamphetamine at 11%. The rest 16% was either a form of OST or other pharmaceutical opioid. The study design allows a comparison between groups of people who inject drugs and captures changes occurring in these groups over time. The study sought to know the number of new syringes used by respondents. It also sought to know how many syringes were given away by the respondents. Respondents were considered to be consistently covered if each injecting episode involved a new syringe.

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Respondents were considered consistently uncovered if each injecting episode did not involve a new syringe and needle. Outcome measures The outcome measures were appropriate and optimal when the study objectives are considered. Participant demographics are an important outcome measure as they show the characteristics of the people who inject drugs as well as their drug injection patterns with regards to use of new needles and syringes. Coverage characteristics are also an important outcome measure. This showed how well the study participants were covered by the NSP program. The time given to collect data about the outcomes was quite appropriate. This is a good indication that a good rapport did exist between the study participants and the investigators. In light of whether the individuals who participated in this research can be considered to be subjects or participants it appears as though they are treated as participants.

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This is because they are not only involved in the study, the findings and recommendations are made to them to help them to increase syringe coverage. Moreover, being a longitudinal study the participants are likely to be contracted for future studies. On a positive note, the confidentiality and privacy of study participants was ensured. The others that followed were OST and other opioid substitution therapies. In this way, justice in the research is ensured since it is determined as a fair balance between risks and benefits. Discussion Ethical consideration is an important aspect of research in the present day. A new generation of researchers has emerged that seeks to ensure high ethical standards are upheld. To be able to do this, they have focused on the integration of participants within studies.

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Clinical trials have to comply with the two laws (Rose, 2017). The two laws are founded on the principles of IRB for research oversight. The federal government registers the IRBs. This is an indication that a research on humans is ongoing and that it complies with the existing federal regulation. It also provides an updated roster of members and officials. Informed Consent in Healthcare Research Research on medical practices exposes challenges of the informed consent and protection of human subject. The research is carried out in the context of physicians giving care to the patients. The assessment on informed consent and risk may differ significantly from the research conducted on testing the new interventions from one researcher to the other, due to failure on providing the patients participants with care.

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Institutional Review Boards (IRBs) is instructed by the current regulations to only consider benefits and risks obtained from the research results. Risk categorization is used by the current regulatory to drive on specific informed consent (Cho et al. It will unethical to do a research randomly by assigning the patients with interventions without a prospective informed consent from them. In a health care learning system, oversight practices and policies in the research may need to be justified by a streamlined consent process and patient consent may not be required. Some research may have minimal risks, while the effects on patients’ welfare in answering some research questions are immense (Faden, Beauchamp, & Kass, 2014, p. An ethical justification on transition to a learning healthcare system has been presented for streamlining of oversight practices and consent requirements within the system.

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In the current consent and the oversight practices, they are justified to overprotect the patient from effects of research on what matters to them, whereas oversight practices in some cases it under protects patients from inappropriate medical errors and management. For appropriate specifications on the implications of framework, extensive consultations between the stakeholders and the patients are necessary. All must approve that they receive care to the continuous learning mission that feeds into improving patient care. An ethical health care learning system must have main commitments of involving transparency, engagement and accountability in manners that is sensitive and keen to the interests and rights of patients (Faden, Beauchamp, & Kass, 2014, p. The patients are engaged in serving on ethics-oversight panels and helping to set research priorities, which will help on the review of the proposed research studies in line with the obligation of a common purpose, ethical requirements and determination of appropriate forms of authorization and consent.

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