The updated Good Publication Practice (GPP) guideline, known as GPP3, builds on earlier versions and provides recommendations for individuals and organizations that contribute to the publication of research results sponsored or supported by pharmaceutical, medical device, diagnostics, and biotechnology companies. The recommendations are designed to help individuals and organizations maintain ethical and transparent publication practices and comply with legal and regulatory requirements. These recommendations cover publications in peer-reviewed journals and presentations (oral or poster) at scientific congresses. The International Society for Medical Publication Professionals invited more than 3000 professionals worldwide to apply for a position …show more content…
Although this Act doesn’t directly mention publications, public posting of information about payments to doctors (and about “transfers of value” which might include editing and writing assistance) may affect public perceptions of investigators’ and physicians’ attitudes towards publications developed with companies. Other differences between GPP2 and GPP3 are: new sections on plagiarism and data sharing, more detail about which studies should be published, and a new table on …show more content…
However, GPP3 goes further by providing more decisive guidance, relating specifically to medical publication. GPP3 provides 10 guiding principles that cover reporting results, defining roles and responsibilities of authors and sponsors, and emphasizing the importance of publication planning: 1. The design and results of all clinical trials should be reported in a complete, accurate, balanced, transparent and timely manner 2. Reporting and publication processes should follow applicable laws (for example, Food and Drug Administration Amendments Act of 2007) and guidelines (for example, ICMJE recommendations and reporting guidelines found on Enhancing the Quality and Transparency Of health Research [EQUATOR] Network) 3. Journal and congress requirements should be followed, especially ethical guidelines on originality and avoiding redundancy (that is, duplicate
IRBs review all aspects of the researchers' project: the study design, the recruitment process, the participant population, the informed consent document and process, the risk/benefit ratio, privacy and confidentiality, data storage and protection, and safeguards for vulnerable participants (University of St. Francis, n.d.). In this way, participants' rights are protected because the effort is made even before the research begins. The review process ensures that participants are chosen fairly and adequately and the information collected during research is safeguarded through collection, use, and storage. Research using human participants is such an important part of medicine that it is imperative it is performed in a way that its intrigue is not compromised. The Institutional Review Board Process Applying for exempt research study approval from the IRB at the University of St. Francis involves submitting a copy of the work, an application, and a statement explaining why the researcher believes the study would be exempt from expedited or full-level IRB review approval.
Researchers who conduct interventional clinical research have put into question the Privacy Rule and how it will affect their research activities. The Department of Health and Human Services, Food and Drug Administration and Protection of Human Subjects Regulations are advised to take measures to protect the
The New England Journal of Medicine. Ethical Physician Incentives-From Carrots and sticks to shared purpose. 14 Mar 2013. 20 Mar 2014. Web. {http://www.nejm.org/doi/full/10.1056/NEJMp1300373}
Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule, NIH Publication Number 03-5388. Retrieved November 12, 2011 from http://privacyruleandresearch.nih.gov/pr_02.asp
Sidebotham, P. (2012). What do serious case reviews achieve?. British Medical Journal . 97 (3), 189-192.
Step 3 is defining the evaluation objective, which is “a general statement that conveys the purpose of the planned study in precise terms” (DiClemente et al., 2013, pp. 300). Goals are more manageable when evaluation objectives are precise and contain applicable information. This ensures that the e...
...explains and clarifies key provisions of the medical privacy regulation, this is a reliable source of information which was published last December (HIPAA, 1996). Guaranteeing the accuracy, security and protecting the privacy of all medical information is crucial and an ongoing challenge for many organizations.
Alexander, E. (1997). Gags rules and trade secrets in managed care contracts. Archives of Internal Medicine, 157, 2037-2043.
The next stage is for the team to jointly develop an evidence-based practice standard based on the information compiled during the research process (Doody & Doody, 2011). An important concept of evidence-based practice as pointed out by Doody & Doody (2011) is the involvement of the patient in the development of new standards. The developed standard should apply to the research topic that is being addressed, however; it should also be modified from person to person based on morals and values for the standard to truly be evidence-based (Doody & Doody,
Janssen, Cecile. How FDA and 23andMe Dance Around Evidence That Is Not There. The Huffington Post. TheHuffingtonPost.com, 27 Jan. 2014.
When caring for patients it is fundamentally important to have a good selection of up to date evidence Based Practice clinical articles to support research strategies, this allows professionals to assemble the most resent and accurate information known which enables them to make decisions tailored to the individual’s plan of care. It is essential to have clinical expertise and have the involvement from the individual patient, they must have full engagement and incorporation in order to have the accurate evaluation.
Turner, B. J., Newschaffer, C. J., Zhang, D., Fanning, T., & Hauck, W. W. (1999). Translating clinical trial results into practice. Annals of Internal Medicine, 130(12), 979-986.
Thompson, R, 2005 “Is Pay for Performance Ethical?” The Physician Executive, Nov-Dec 2005, pp 60-63
I hope to develop the career of an academic oncologist and the aspect that has captivated me the most is that of drug development. Any major change in oncology, at least for medical oncologists involves the invention and discoveries of new drugs and every single one of these has to be tested in the setting of a phase I trial. In order to develop a successful career as an academic oncologist, one needs to be able to conduct well-designed clinical trials and to be able to publish reproducible respected genuine papers. I also strongly feel that quality is more important than quantity in terms of final outcome of all the efforts and work. I hope to be working in this field in the future and be able to carry out my ideas and implement the same and in the process make some contribution in the care of the cancer patient.
Paul J., Seib R., Prescott T. The internet and clinical trials: background, online resources, examples and issues. J Med Internet Res. 2005; 7(1):e5