Journal of clinical research & bioethics最新文献

{"title":"Measuring Workload of Clinical Trials: Transcultural Adaptation and Validation to Portuguese Language of Ontario Protocol Assessment Level (OPAL)","authors":"Roberta B. Sarmento, Zenith Rosa Silvino","doi":"10.4172/2155-9627.1000308","DOIUrl":"https://doi.org/10.4172/2155-9627.1000308","url":null,"abstract":"Introduction: The increase number of clinical protocols with different requirements and specificities, the demand for the quality of the data according to the good clinical practices evidence the need of an instrument capable of measuring the workload of clinical protocols, and to assist the management of research centers. The object of study is the instrument entitled the Ontario Protocol Assessment Level, created for measuring the workload of the research coordinator, focusing on the complexity of clinical protocols in oncology. \u0000Aim: To perform a transcultural adaptation and validation of the instrument in terms of the Portuguese language. \u0000Method: This is a methodological research, whose chosen scenario was the clinical research center of the Brazilian National Cancer Institute, located in Rio de Janeiro. The subjects were the clinical research coordinators. The research was approved by the ethics committee, under protocol 070066-12.50000.5274. \u0000Results: A significantly high degree of agreement between intra- and inter-observers was established; the agreement of the committee of specialists (the golden standard) was considered to be excellent (ICC>0.949) in both research periods (1 and 2); this score demonstrates a high level of validation. The analytical process confirmed that the tool score did not overestimate nor underestimate the evaluation of the committee of specialists. \u0000Conclusion: The instrument was considered valid and reliable based on the statistical tests performed. It provides the support required to calculate the workload generated by clinical protocols.","PeriodicalId":89408,"journal":{"name":"Journal of clinical research & bioethics","volume":" ","pages":"1-6"},"PeriodicalIF":0.0,"publicationDate":"2017-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.4172/2155-9627.1000308","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47278275","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Regulations of Informed Consent: University Supported Research Processesand Pitfalls in Implementation","authors":"N. Almasoud, Badaruddin Abbasi","doi":"10.4172/2155-9627.1000307","DOIUrl":"https://doi.org/10.4172/2155-9627.1000307","url":null,"abstract":"Background: The main responsibility of the Deanship of Scientific Research (DSR) is not only to fund the research \u0000 but more importantly to protect and promote the rights and benefits of research participants and to monitor and review \u0000 research projects for compliance. To this date, the Deanship of Scientific Research has designed a qualitative research \u0000 study to find out the level of adherence to the National/International Regulations while administrating informed consent to determine its process and pitfalls. \u0000 Methodology: The qualitative research study was undertaken in which 40 Principal Investigators administrated \u0000 a questionnaire through Qualtrics online survey software to find the satisfaction level on the grant process in The \u0000 University of Dammam and evaluate the informed consent process of The University of Dammam Standing Committee \u0000 for Research Ethics on Living Creatures (SCRELC) approved research projects. \u0000 Results: The results were presented as simple proportions, means, frequencies, bar charts, and odds ratios with \u0000 95 % confidence intervals. The level of statistical significance was set is at P ≤ 0.05. Results showed that 80% of \u0000 the participants were satisfied with the support being offered through DSR by the University of Dammam. Whereas, \u0000 responding to questions on informed consent process, it was noted that there is a significant gap between knowledge \u0000 and practice of obtaining informed consent from the research participants. \u0000 Conclusion: The findings warrant a strong need to disseminate national and international codes and conduct and \u0000 national law and build a capacity of researchers in Research Integrity and informed consent process in Saudi Arabia","PeriodicalId":89408,"journal":{"name":"Journal of clinical research & bioethics","volume":"8 1","pages":"1-10"},"PeriodicalIF":0.0,"publicationDate":"2017-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44618985","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Knowledge and Perception of Students towards Publication Ethics: A Comparative Study in Two Academic Settings","authors":"S. Jahanfar, Mitra Molainejad, Dzalila Izzat","doi":"10.4172/2155-9627.1000306","DOIUrl":"https://doi.org/10.4172/2155-9627.1000306","url":null,"abstract":"Introduction: Publication ethics is a constant concern for academic and students alike as being an author has important academic, social, and financial implications. However, the perception of academics towards matters related to publication ethics is unclear and often a source of conflict. Objective: The aim of this study was to investigate and compare students’ perceptions regarding publication ethics in two medical universities. Method: The target population was selected from two academic settings (Isfahan University, n=279, University of Kuala Lumpur, n=216). Subjects were asked to fill in a standard questionnaire in a cross sectional study design, testing their perceptions towards publication ethics. Simple random sampling was employed. A p value of 0.05 was considered significant. Result: The result suggests that students from Isfahan had a higher level of knowledge in three areas: publication ethics (P=0.001), funding (P=0.001) and authorship (P=0.005) compared to students from the University of Kuala Lumpur. No significant difference was found between the two groups in terms of reporting the result (P=0.438). Conclusion: Student training on publication ethics is necessary to prevent academic disappointment and conflict. It is recommended that formal training be added to medical curricula and that publication ethics be practiced in university settings.","PeriodicalId":89408,"journal":{"name":"Journal of clinical research & bioethics","volume":" ","pages":"1-5"},"PeriodicalIF":0.0,"publicationDate":"2017-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45797142","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Amnestic MCI Patients’ Perspectives on Volunteer Participation in a Research Context","authors":"G. Vanderschaeghe, J. Schaeverbeke, R. Vandenberghe, K. Dierickx","doi":"10.4172/2155-9627.1000305","DOIUrl":"https://doi.org/10.4172/2155-9627.1000305","url":null,"abstract":"Background: Inclusion of patients in research studies is immensely important when evaluating new biomarkers for Alzheimer’s disease (AD) and when the efficacy of possible treatment options is under trial investigation. If medical treatment is to advance in slowing the progression of AD, or even preventing it, voluntary participation of patients is not only important but also their reliable participation is key. To get closer in achieving this goal, researchers need to understand better what motivates research participants to enroll in a clinical trial and get insight into participants’ expectations about their participation. Furthermore, what researchers perceive as benefits and risks of a study can differ from participants’ view. This difference could lead to a situation in which researchers recruit fewer subjects than they expected or result in unreliable research subject participation.Method: We conducted semi-structured in-depth interviews in 38 patients with amnestic mild cognitive impairment (aMCI) as part of a clinical trial (EUDRACT no. 2013-004671-12) on the predictive value of biomarkers for AD. Patients had the option of receiving their Individual Research Results (IRR; visual binary read amyloid PET results). In this study, the motivations and perceived advantages and disadvantages of trial participation were investigated from the patients’ perspective. Before deciding to participate, patients received an information brochure describing the possible benefits and risks of participation.Results: The two most frequently mentioned reasons for volunteering for the trial were to contribute to scientific progress and to receive their IRRs. Participating to ameliorate scientific progress was not solely motivated by altruistic reasons; it was mostly mentioned along with the possibility of receiving a valuable result about their health condition, suggesting that self-interest also motivated patients to participate. The two most frequently mentioned disadvantages were the possible risks related to being subjected to invasive medical procedures and that volunteering was considered to be time consuming. Most patients felt that their partner and children supported their decision to enroll in the biomarker study.Conclusion: aMCI patients have several reasons for wanting to volunteer in a clinical trial, with the option of IRR disclosure being the primary motivation for enrolling. Most of our patients felt that family members supported their decision to volunteer. However, researchers need to be cautious when recruiting subjects for clinical trials by ensuring that they truly desire to participate in the study and those family members are not coercing them into doing so. In addition, what the information brochure mentions as possible benefits and risks of trial participation was not always perceived similarly by patients.","PeriodicalId":89408,"journal":{"name":"Journal of clinical research & bioethics","volume":"8 1","pages":"1-8"},"PeriodicalIF":0.0,"publicationDate":"2017-05-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.4172/2155-9627.1000305","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42635392","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessment of Cognition and Quality of Life in Non-Hodgkin’s Lymphoma Patients One Year Post-Treatment","authors":"Pooja Gupta, Sakshi Mittal, N. Agarwal, R. Parveen","doi":"10.4172/2155-9627.1000302","DOIUrl":"https://doi.org/10.4172/2155-9627.1000302","url":null,"abstract":"Objectives: An increasing number of patients with cancer are offered chemotherapy given either alone or in combination with radiotherapy, surgery, or both as neo-adjuvant, concomitant, or adjuvant treatment. Cognitive dysfunction is a prevalent side effect of cancer treatments that may persist for years following treatment and has negative impact on quality of life. Thus, the present study was planned to investigate the prevalence of cognitive impairment, assess the quality of life (QOL) and determine the socioeconomic status in NHL patients one year post chemotherapy treatment. Methods: This was an observational study. All the prospective participants were screened on the basis of inclusion and exclusion criteria and the participants who met all the study inclusion criteria and had none of the exclusion criteria were enrolled in the study. Cognitive function was evaluated using Mini Mental State Examination (MMSE) or Hindi Mental State Examination (HMSE), socioeconomic status was determined by Kuppuswamy scale and quality of life (QoL) was assessed by EORTC QLQ. Results: A total of 90 subjects (45 cases and 45 controls) were enrolled in the study. The control group scored more on MMSE/HMSE scale than the Non-Hodgkin’s Lymphoma (NHL) patient group, suggesting difference in cognitive functioning between the groups (26.6 ± 2.4 vs. 27.8 ± 2.1, p=0.019), respectively. Socio-economic status did not have any impact on the prevalence of cognitive impairment in NHL patients; however, NHL was found to be more prevalent in upper-middle class. No significant difference was found between case and control for QoL. Conclusion: Cognitive dysfunction is a prevalent side effect of cancer treatment that may persist for a year following treatment. Further studies are needed to clarify the effect on quality of life.","PeriodicalId":89408,"journal":{"name":"Journal of clinical research & bioethics","volume":" ","pages":"1-7"},"PeriodicalIF":0.0,"publicationDate":"2017-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47847741","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Misconduct in Clinical Research in India: Perception of Clinical Research Professional in India","authors":"M. Patel","doi":"10.4172/2155-9627.1000303","DOIUrl":"https://doi.org/10.4172/2155-9627.1000303","url":null,"abstract":"Misconduct in clinical research is an unfortunate reality and widespread. Researchers are expected to conduct research and report results honestly. However, that is not how clinical trials always get done. Good Clinical Practice (GCP) guideline is adopted internationally as a standard operating process for purpose of conducting, recording or reporting clinical trials. However, unavailability of international harmonized framework for misconduct management makes clinical research industry vulnerable to commit misconduct. Most of the cases of misconduct are probably not published. They are not recognized or covered up altogether. Misconduct and fraud can be due to any reasons and of various types. In all circumstances, any misconduct should be handled strictly and related regulations should be at place to prevent occurrences. Very few cases of scientific misconducts have been identified or reported in India. However, there is no evidence that all clinical trials conducted in India meet ethical standards and misconduct does not exist. Rather it is more likely that the scientific misconduct amongst researcher have not been systematically investigated. This article discusses the possible reasons for the occurrence of scientific misconduct and explores options, which can possibly help prevent such instances.","PeriodicalId":89408,"journal":{"name":"Journal of clinical research & bioethics","volume":"8 1","pages":"1-9"},"PeriodicalIF":0.0,"publicationDate":"2017-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.4172/2155-9627.1000303","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46809971","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Bioethics and Psoriasis","authors":"H. Allen, R. Allawh, L. Ogrich, N. Jariwala, Erum N Ilyas","doi":"10.4172/2155-9627.1000304","DOIUrl":"https://doi.org/10.4172/2155-9627.1000304","url":null,"abstract":"We have presented the clinical, epidemiological, microbiological, pathological, immunopathological, serological, and therapeutic studies showing how the streptococcus may be strongly linked to psoriasis. With this as background, we have presented three ethical arguments that are cogent for psoriasis. First, this microbial “pathogen” theory is both ignored and overlooked even with the abundance of evidence supporting it. That being the case, current treatments, consequently, are aimed not at the onset of the disease, but much later in the pathogenic cascade. Last, the continued use of “biologics” or costly immunosuppressives, which are not curative, presents bioethical challenges. We consider psoriasis a sequela of streptococcal infection similar to rheumatic fever, where treatment, at the earliest stages of the disease, has resulted in its disappearance.","PeriodicalId":89408,"journal":{"name":"Journal of clinical research & bioethics","volume":"8 1","pages":"1-3"},"PeriodicalIF":0.0,"publicationDate":"2017-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46191780","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Palliative care: An alien concept in Pakistan","authors":"Nadia Pyarali Mulji, Sumaira Sachwani","doi":"10.4172/2155-9627.1000301","DOIUrl":"https://doi.org/10.4172/2155-9627.1000301","url":null,"abstract":"Every living being has to die. Respecting a dying individual’s personal values and preferences is a challenge. We live in a culture where family decisions are given priority over individual’s wish. To address this challenge, a concept of palliative or comfort care is newly introduced in Pakistan. Palliative care is a multidisciplinary specialty that emphases on prevention and relieving suffering as well as supporting the optimal quality of life of patients and their families (Bailey, Harman, Bruera, Arnold, & Savarese,2014). In Pakistan, the concept of palliative care is like a newborn baby who needs a lot of ethical attention in terms of patient’s autonomous decision, family members’ care for the patient and the medical team’s professional obligations. So, in a tug of war between the medical team and the family, the patient should not suffer. I, as a nurse, would like to create a universal familiarity and awareness about palliative care and its associated ethical concerns and suggest nurse’s responsibilities to promote comfort care at home. “There is an appointed time for everything. A time to give birth and a time to die”. Ecclesiastes 3:2","PeriodicalId":89408,"journal":{"name":"Journal of clinical research & bioethics","volume":"8 1","pages":"1-2"},"PeriodicalIF":0.0,"publicationDate":"2017-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47606273","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Ethical Issues in Genome Editing for Non-Human Organisms Using CRISPR/Cas9 System","authors":"E. Rodríguez","doi":"10.4172/2155-9627.1000300","DOIUrl":"https://doi.org/10.4172/2155-9627.1000300","url":null,"abstract":"Ethical issues in relation with genome editing for non-human organisms using CRISPR/Cas9 were reviewed. CRISPR/Cas9 system gives rise to significant ethical questions due to its accessibility; ability to make small, precise and specific edits of DNA in living cells; the ability of not leaving trace so that it is not possible to know whether the change has been introduced intentionally or through natural mutation; low cost; speed of use to produce results; and potential to achieve multiple simultaneous edits. The following issues were identified: risks of inducing mutations, the possibility of ecological disequilibrium for edited organisms release in the environment particularly in relation to gene drives, gaps in regulation, animal welfare, military or terrorist applications and the possibility of xenotransplantation between animals and humans. Bioethical issues are also discussed according to principles and about the relation with Nature. The following is recommended: public engagement and ethical reflection are needed to inform decision making; safety issues and environmental risk assessment must be enhanced to ensure efficacious regulation and preventions must be taken to oversee laboratories that use CRISPR technology.","PeriodicalId":89408,"journal":{"name":"Journal of clinical research & bioethics","volume":" ","pages":"1-5"},"PeriodicalIF":0.0,"publicationDate":"2017-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.4172/2155-9627.1000300","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43741655","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"What is Vulnerability?” A Qualitative Study about the Perception of Vulnerability in Adults and Older Adults","authors":"Alethéia Peters Bajotto, L. F. Garcia, José Roberto Goldim","doi":"10.4172/2155-9627.1000299","DOIUrl":"https://doi.org/10.4172/2155-9627.1000299","url":null,"abstract":"Aligned with a global trend, Brazil has been changing demographic profile in recent decades, making this \u0000 structural phenomenon one of the most important achievements of contemporary society. This social process is not \u0000 limited to the combined effects of strictly demographic variables and can both create demographic possibilities that \u0000 enhance the growth of the economy, increasing social welfare, as stressing the economic and social hardships, \u0000 expanding the serious social inequalities of Brazilian society. In this sense, it is important to read vulnerability from \u0000 the perspective of research participants, in order to seek the categorization, bringing support for understanding the \u0000 components of vulnerability allowing the search for strategies to cope with social vulnerability. This paper aims to \u0000 assess qualitatively, through semi-structured interview, the individual perception about the vulnerability, categorizing \u0000 the speech of participants and proposing reflections that may enhance the field of social vulnerability. The study is \u0000 characterized as qualitative content analysis according to Bardin. Nine categories emerged from the speech. The \u0000 more inference was on account of the category \"Health and Disease\", with 25%; then with 20% \"Behaviour\"; 17% \u0000 represented the total of inferences about the \"Autonomy\"; 15% related vulnerability to \"Fragility\"; 9% on \"Family \u0000 relationships, loneliness\"; 4% related to \"Violence\"; 3% to the category \"Hunger\" and two categories represented 2% \u0000 each - \"Financial\" and \"Physical, Age\". The personal conception of vulnerability is directly related to disease or illhealth \u0000 process. The age range, a factor admittedly predisposed to vulnerable, did not have a significant expression \u0000 in the speech of participants.","PeriodicalId":89408,"journal":{"name":"Journal of clinical research & bioethics","volume":"8 1","pages":"1-5"},"PeriodicalIF":0.0,"publicationDate":"2017-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.4172/2155-9627.1000299","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42571009","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}