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Ethical principles in medical research
Ethical principles in medical research
Ethical principles in medical research
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This paper explores outsourcing of clinical trials to developing countries focusing on current trend and providing brief overview of the clinical trials. The paper covers major reasons for outsourcing of trials to developing countries especially focusing on India with ethical and scientific concerns raised in conduct of clinical trials at foreign sites, throwing a light on growing career opportunities in developing countries and steps for ethical conduct.
Introduction:
Clinical Trial Outsourcing:
Global Drug and Medical Device makers based in developed countries are now focusing on developing countries to carry out their clinical trials. These players (pharmaceutical and device makers) have embraced outsourcing as a core component of their business models especially in realm of clinical trials. “Outsourcing may be defined as shifting or delegating a company’s day to day operations or business process to an external service provider.”
For instance, 20 largest United States (“U.S.”) based companies are now conducting one third of their clinical trials outside the U.S. According to a report from the inspector general of Department of Health and Human Services (“DHHS”) the number of clinical trials conducted at foreign sites has increased to 6,485 in 2008 from 271 trials in 1990. This trend suggests that the outsourcing of clinical trials has become one of important aspects of business fostering development of safe and effective drugs and devices that are interest of through out the world but at same time raising many ethical and scientific concerns.
According to U.S. government publications, clinical trials that are registered with U.S health authorities are being conducted in middle and low income co...
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...s must be taken into consideration for ethical and scientific integrity of research. Increased harmonization among developed and developing countries is needed to address these concerns. There should be strict compliance with rules and regulations. Further to minimize concerns independent ethical review of all the protocols is necessary. Clinical trials in developing countries must meet all ethical and scientific standards of research trials conducted in developed countries.
Works Cited
http://www.nejm.org/doi/full/10.1056/NEJMsb0803929#t=article
http://www.offshoringtimes.com/Pages/2006/BPO_news926.html
http://www.medicalprogresstoday.com/spotlight/spotlight_indarchive.php?id=1269
http://globalbioethics.blogspot.com/2009/03/ethics-of-outsourcing-clinical-trials.html
http://www.lewistonvetclinic.com/ethics-concern-over-outsourcing-clinical-trial.html
Varmus , Harold, and David Satcher. "Ethical Complexities of Conducting Research in Developing Countries." New England Journal of Medicine. 337.14 1003-1005. Web. 9 Feb. 2014.
When doing any studies with human subjects, “the safest and most reasonable position is that people everywhere are likely to respond similarly to the same treatment” (300). With third world countries, Angell states there are dissimilarities between population, but that cannot be anticipated. The local of standard care should not be different, the best treatment and care should always be given regardless of where the study takes place and who the subjects are. As clinical trial studies are becoming more popular, researchers need to understand the same protection goes to the people rather they are aboard or at home. Studies done in third world countries are unethical because they cannot afford the same effective treatment.
Outsourcing simply means acquiring services from an external organization instead of using internal resources (Butler, 2000). By using outsourced resources, organizations can gain a competitive advantage by utilizing contingent staff to accomplish strategic goals without incurring the fixed overhead. By focusing on the leading edge and highly specialized skill sets, outsourcing providers can often offer higher quality services, or at a lower price than the client organization. Typical reasons for outsourcing go beyond simple contingent staffing. Outsourcing providers are able to maintain economies of scale with regard to specialization (...
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.
Article two entitled “Clinical trials: are they ethical?” is written by Eugene Passamani discusses the importance of randomized clinical trials. Passamani rejects the argument that the physician-patient relationship demands that physicians recommend ...
Outsourcing is a technique for companies to reassign specific responsibilities to external entities. There are several motivations for outsourcing including organizational, improvement, cost, and revenue advantages (Ghodeswar & Vaidyanathan, 2008).
Glassman, A., & Temin, . (2016). Millions Saved New Cases of Proven Success in Global Health. Ctr for Global Development.
In the United States, the basis for ethical protection for human research subjects in clinical research trials are outlined by the Belmont Report developed in the late 1970’s. This document, published by the Nation Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, highlights three important basic principles that are to be considered when any clinical trial will involve human research subjects. They are; respect for persons, beneficence, and justice. (Chadwick & Gunn, 2004)
...obert J.. Ethics and regulation of clinical research. 2nd ed. Baltimore: Urban & Schwarzenberg, 1986. Print.
O'Brien, D. (2009). Randomized controlled trials (RCTs). In R. Mullner (Ed.), Encyclopedia of health services research. (pp. 1017-1021). Thousand Oaks, CA: SAGE Publications, Inc. doi: http://dx.doi.org.proxy1.ncu.edu/10.4135/9781412971942
Freedman B. Equipoise and the ethics of clinical research. N Engl J Med. 1987; 317(3): 141-145
Therefore, publishing standards, regulations and guideliness are needed in order to ensure that everyone knows there responsibilities, liabilities, accountabilities that are linked to the intellectual credibility of their publications. The results of studies that have been funded need to be published accurately, thereby maintaining the transparency and timeliness. The sponsors also need to keep ethical considerations in mind while publishing these results. For the purpose of guaranteeing scientific communications with a high quality, one needs to stay updated about all changes pertinent to industry guidelines and government regulations. These are also needed for ensuring the integrity, completeness and transparency of reports.
manpower and a large base of FDA approved plants, positions India high on the outsourcing
The article titled “Contemporary Ethical Analyses: A Shortfall in Scientific Knowledge” describes the ethics through the public’s eye. One of the major ethical issues brought up is informed consent.
As FDA is stressing the co-development of drug and diagnostics will initiate the pharmaceuticals and diagnostics companies to partner. This would help in the future provision of genetic testing at low costs. CROs, CDOs, Supply Chain Vendors, Biobanks –Pharma companies will contact contract research organizations (CROs) and contract diagnostics organizations (CDOs) to outsource their clinical trials. The CDOs and CROs rely on high-quality samples from biobanks for biomarker discovery and validation studies. This requires the biobanks to provide samples with the highest quality to the research community, which means supply chain partners will play a key role in sample transport and