Introduction:
Circassia is committed to following high ethical standards and transparency when publishing Circassia-sponsored research and supports various industry standards, including but not limited to; Good Publication Practice guideline (GPP3)1, International Committee of Medical Journal Editors’ (ICMJE) Recommendations2, Consolidated Standards of Reporting Trials (CONSORT statement)3 and the “Joint Position on the Publication of Clinical Trial Results in the Scientific Literature” developed by IFPMA, EFPIA, JPMA, and PhRMA4. The scope of this policy covers practices and policies for publications and data access from Circassia-sponsored research from all divisions. For this policy, Publications are defined as abstracts, posters or
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Publication Principles:
Circassia is committed to developing publications that report the results, regardless of the outcome, of Circassia-sponsored clinical studies in a timely, transparent, accurate, fair, and balanced manner. At a minimum, Circassia will submit for publication the results of all Phase III clinical studies and the results of any other clinical studies of significant medical importance, primarily in peer-reviewed journals or as abstracts, posters, or other presentations at scientific congresses.
Authorship Requirements
Circassia, from time to time, may collaborate and work with external Health Care Professionals (HCPs) to assist in publishing or presenting the results of Circassia-sponsored trial in accordance with the requirements below. Circassia’s requirements for authorship aligns with the ICMJE authorship criteria. As such, an author (internal employee or external HCP) must make substantial contributions to the publication as defined by the following ICMJE authorship criteria:
1. Substantial contributions to conception or design of the work; or the acquisition, analysis, or
A review of the proposed participants of the study will ensure high-risk groups (if any) will be considered as per the National Statement on Ethical Conduct in Human Research (‘National Statement’; NHMRC, 2007). While some of these high-risk
The current review was managed according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines (Moher et al., 2009) and established guidelines for narrative synthesis by Popay et al. (2006).
The author considers the simplest way of finding out best practice is by using guidelines. According to Field & Lohr (1992) guidelines are “systematic developed statements to assist practitioners and patients decisions for specific clinical circumstances.” Evidence is always current and a generous collection of many different systematic research reviews with multiple random control trials are available (AGREE, 2000). These types of trials are graded at the top level of hierarchy (Guyatt et al 2002).Nevertheless in contrast Devereaux and Yusuf (2005) argue that top level hierarchy is not a guaranteed deviation from the truth in randomized trials. The clinical guidance used is the National Institute of Clinical Guidance (NICE 2009) is based in the author’s homeland and is an independent organisation responsible for providing guidelines. The ethos behind NICE (2009) is to promote and prevent poor health nationally involving the public, health professionals and patients in the process (NICE 2009).
Respect for human dignity includes two rights; the right to self-determination and the right to full disclosure. When conducting a research study these two rights must be maintained to ensure that the participants are not coerced into participation and that they are making the choice of their own free will. Patients must be provided with all the information necessary to make an informed decision and voluntarily participate. No deception or concealed data collection can be done because it will violate the patients’ rights.
The AGREE II instrument which stands for the "Appraisal of Guidelines for Research & Evaluation” was developed to analyse the variability, methodology and quality of guidelines, as well as what information and how information is reported within the guidelines. (Brouwers et al., 2010).
After the initial search, about 35 journal readings had to be read thoroughly and closely analyzed. From which, 10 of these journal articles were deemed pertinent to this manuscript. These publications were then saved, printed, and re-analyzed for key information. All publications were chosen from reputable sources via online and only pertinent information relating to this manuscript will be discussed.
1.It's so difficult for people to do the right thing because doing the wrong thing because doing the wrong thing is easier than doing the right thing.Some people also derive pleasure from doing the wrong thing
According to the article the information involved it is accurately citied on the reference page. The article had a total of 18 references, with most of them being current. There was a total of five dated back to the last five year, a total of eight dated back to the last ten years, and the last five date back to as far as twenty-two years. For the most part, the references were current with dates in between the five to ten year bench mark, with the exception of the five the exceeded the date criteria. Also, the study was cited twenty-two times in the literature, showing that it has been reviewed and critiqued by other authors.
The topic in this systematic review is clearly defined, initially in the abstract, and being repeated in the introduction. Yes, the search for studies and other evidence was comprehensive and unbiased as it was able to be. Strict criteria were followed as described in Figure 1. Yes, the screening of citations for inclusion in this review was based on explicit criteria, as they wanted to promote confidence in the outcomes appropriate guidelines were followed carefully. Yes, the included studies were evaluated for
Publication bias is defined by Dickersin as “the tendency on the parts of investigator, reviewers, and editors to submit or accept manuscripts for publication based on the strength of the study findings” (Dickersin,1990). Clinical trial registration has been proposed to help resolve these concerns (Dickersin & Min, 1993) and also help improve both the transparency and credibility of clinical research. This can be accomplished by using registries to learn not only about studies that are published but also about studies that have been conducted but not published. Additionally by maintaining a public record of the intended apriori primary outcomes, registration of trials can help to combat the problem of authors changing the primary outcome post hoc to report an outcome that has a statistically significant difference. (Dickersin & Rennie,2003, Jones CW & Platts-Mills, 2012, Chan et al, 2004, Dwan et al,
Similar to the Nuremberg Code, the Belmont Report summarizes ethical principles for human clinical research. The Belmont Report consists of three main principles including respect for persons, beneficence, and justice (US Department of Health & Human Services, 2013). There are also three main areas of application including informed consent, assessment of risks and benefits, and selection of subjects. The first principle is respect for persons which includes treating individuals as autonomous agents and those with decreased autonomy are entitled to protection. This is applied through informed consent. As mentioned earlier informed consent is informing participants what to expect and contains three elements: information, comprehension, and
The Belmont Report was put in place to protect individuals who are involved in biomedical and behavioral research. The Belmont Report assist individuals to understand ethical codes and strategies essential for conducting research where human are involved. Three main ethical principles for research according to The Belmont Report include respect for persons, benificence, and justice. The Belmont Report keeps individuals in line when an issue arises. Sometimes people are faced with adversity and need to come to a decision that would not hurt or harm all parties involved. The individuals conducting the research are welcome to use these ethical codes and strategies to develop a conclusion that best suit all parties involve. In this paper
The initial step in this review was to search CINHAL (Cumulative Index to Nursing and Allied Health Literature) and PubMed, because they are considered two of the best health-related databases, making them the standard and preferred source of information for nurses. Then, a Cochrane Library search was conducted, because it has a high-quality and trusted evidence (i.e. is the largest sources of controlled trials and includes summaries of the best available evidence). Then, Trip database was
For example, Vedula (2012) notes that FDA guidelines state pharmaceutical companies can use peer-reviewed articles to publicize evidence of a drug’s effectiveness for off-label uses, as long as a number of conditions are met—perhaps the most essential of which is that “the information disseminated must not be false or misleading.” However, Vedula continues, there is no unyielding regulation that all research findings have to be published. Therefore, a company can still choose to selectively disseminate favorable findings. His article concludes that there is now a copious amount of evidence that suggests selective reporting of study results, based on the strength and direction of findings, is performed extensively by the pharmaceutical industry.
Helsinki Declaration is a set of guidelines on clinical research for physician as their responsibility toward protection of their research subjects (Williams, 2008). World Medical Association (WMA) also encourage it is used as reference by other parties in conduction of clinical research (Bădărău, 2013). Compared with the Nuremberg Code, which mainly focuses on safeguard of the subjects, its