Asa qualitative study, the article documents on outcomes following anexecution of various instructive exercises, one-on-one consultations,as well as a decision support procedure to expand groundwork for theInstitutional review board. The focus of is in situations wherehumans are the participants in a research. Therefore, it offersexperience as a methodology for training students on how to safeguardthe human subjects involved in quality enhancement activities(Goldman etal.,2010). The article, “RationalProtection of Subjects in Research and Quality ImprovementActivities,”is authored by Dixon LB and others and it was published byPsychiatric Services in the year 2010. Reconsideration of theshortcomings resulting from oversights in health related studiesleads to quality improvement in clinical settings.
Theauthors of the study in question understood the challenges brought bythe fact that in the initial phases of applying protocols, only asmall percentage of all projects were considered as human subjectresearch. At this point in time, such studies never received any IRBreviews. On the other hand, a bigger portion of projects was judgedas quality improvement projects but received much IRB review. As aresult, the researchers of this particular study saw it wise to causean understanding that whenever human subjects are used as thesubjects of a study, there is the need to conduct procedures in amore ethical way to avoid further health linked risks (Goldman etal.,2010).
Theauthors were determined to collect facts that could assist increating a new foundation of knowledge as a way of counteracting thecumbersome but avoidable obstacles in research. This could help inincreasing safety and functionality of patients through theestablishment of well-informed decisions by the health providers andorganizations that attend to them. In other words, it is evident thatquality improvement researchers based on risks require a degree of anorganizational unit to make decisions regarding the possible risklevels. An example of such an entity is an integrated researchquality progress team. Even though the existing policies may besatisfactory in the determination of risk levels attainable byquality improvement projects, the authors consider that they cannotautomatically moderate the challenges contained in the development ofmodern approaches to health care improvement. As a result, theauthors purport to report an advanced process intended to protectparticipants in research related activities and to ensure thepromptness and ethics in projects that are planned to reach the IRB(Goldman etal.,2010).
Thisis a case of Grounded Theory because of its qualitative nature. Itattempts to develop a notion about the phenomena of concern which isthe dangers in not acknowledging the possible dangers entailed inhuman subjects during studies. In this view, it is an iterativepractice due to its scientific pattern. It starts with questionswhich assist to direct the entire research. As the scholars commencethe data gathering process, they identify various theoreticalconcepts and develop linkages between data and hypothetical concepts.The procedure of transforming suggestions into practice necessitatescare to evade risks to providers, patients, and hospitals. Failure toincorporate care can lead to referrals to institutions that areofficially not certified to deal with human as subjects. Thelikelihood of such oversights is what makes the researchers to beengaged in substantiation and decision (Goldman etal.,2010).
Thestudy uses observational research as a way of initiating acorrelational between health risks and research. They have witnessedthe prevalent challenges caused by innovations and growing complexityof health-related research. Similarly, they recognize that there hasnot been a successful application of IRB in advancing quality studiesdue to possible faults in ongoing practices. Moreover, it includes ahighly critiqued Johns Hopkins study that aimed at evaluating theutilization of checklists to ease central line contaminations in theinstitution’s intensive care units. The investigator who took partin this study recommended that there are actions that should beroutine in any event of catheter insertion as a way of curbingadditional risks to patients. However, the OHRP believed that it wasinappropriate for the scholars to use information from subjects evenafter legally informing them. These are some of the ongoing eventsthat the researchers saw the need to carry out deep scrutiny on andto come up with a strong basis of argument (Goldman etal.,2010).
Theauthors conclude with the recommendation that there need to besufficient protections for participants in every aspect of research. The safety levels must be intensified regardless of the fact thatrisks or challenges involved are psychological, social, vocational,physiological, financial or informational. In addition, theyacknowledge that cumbersome but avoidable obstacles can be reducedfor the collection of vital guiding data aimed at bettering thefunctionality and comfort of patients within health institutions. Inessence, the authors agree that a policy practice of oversightmotivated by risk instead of an uninformed description of researchcan enhance the efficacy and relevance of the dynamism dedicated tosafety (Goldman etal.,2010).
Goldman,Beth, et al. "Rational protection of subjects in research andquality improvement activities." PsychiatricServices (2010).