Introduction
Transparency is critical in conducting clinical research. Transparency is a fundamental value regardless of the department or organization. The issue concerns the need to ensure transparency is maintained when conducting clinical research. The policy that was recently initiated calls for the restoration of transparency that will benefit health care providers, parents and health systems. The lack of transparency in clinical findings puts the patients’ lives at risk (Health Affairs 21). This will mean that inventories will not be accredited better standards due to lack of accountability. It is paramount that such a policy in health care be implemented to ensure that correct results and findings are published. The legislation issue is paramount in enhancing research in clinical care. The health care policy aids in the removal of biases in publishing research content concerning health care. Further, it is significant since it provides critical information that is useful in sustaining health care and providing quality services. The policy ensures that the codes of ethics are observed and maintained. There is a substantial reduction of risks and health care systems are enhanced. The repository bodies have established better ways of ensuring that the trial findings are published. It is deemed significant that researched information requires recognition, and it should be evaluated to find its credibility. The policy is paramount in the program pursue since it ensures the research conducted receives airplay, publication, and recognition. It applies to all health care sectors including all the professionals, for example, nurses, doctors, counselors, surgeons among other health professionals.
Development of legislation
The legislation was developed based on the need to find a lasting solution to the continued lack of transparency in clinical research. The campaigns done by AllTrials showed its support in advocating for transparency. AllTrials conducted a campaign that saw the WHO enacted the policy of transparency by updating the legislation of the policy. It concerned ethics and publication of all medical trials. EMA (European Medical Agency) showed support by enacting newer standards on the policy. There was 2010 and 2014 policy on access to information or documents and publication of the researched clinical data (National Research Council (U.S), 2011). The details of the legislation focused on providing crucial information to be used by clinicians. The medical journals, advocacy institutions, research institutions and pharmaceutical organizations provided the information to help implement the policy. Further, the indulgence by the World Health Organization (WHO) ensured that an updated policy disclosure was provided. The essence of imposing a strict timeline to table its proposals is to instill professionalism. The statutory elements show support by the ECTR (European Clinical Trial Regulation). The guidelines provided stipulate the authentication of the research results, authorization, and the evaluation of the research trials conducted (Süreci 12). The intervention by the EME suggests the need to promote the reanalysis concept concerning the collected results. This will further aid in the research of the medical data and expand knowledge concerning the research, for example, FDAAA of 2007 (Food and Drug Administration Amendments), ClinicalTrials.gov, National Institution of Health (NIH) participant in the enactment of the policy. NIH policy is mandated to push for the implementation of the proposed policy that aids in the authentication of the clinical trials that should be subjected to the FDAA board liable to the public.
The scope of the NPRM indicates the need for the use of "relevant clinical trials" that the parties can apply. Ideally, the sponsor of the varied proposals should ensure that it complies with the jurisdiction set in engaging medical resources and making them available to the public. The access, however, requires a written permission that is approved by the board and a reactive procedure should be abided by in accessing the documents of the clinical trials. The government as an oversight authority oversees the functionality of the policy in sustaining transparency and a giving room for further research. The complete publication is then developed, and the public input is coordinated to ensure the protection of both the research personnel and the patient. Information that is deemed confidential is encrypted to avoid the wrong usage. The policy governs the conduct of the researchers. They are expected to do the research with diligence. This occurs by ensuring that they keep the patients' and the interviewees information confidential. The involvement of the commercialized companies is convoluted in the research to ensure transparency. The companies that produce the medical drugs have a significant role in ensuring that the public develops confidence in the kind of medications they access at the health centers.
Role of stakeholders
The intervention of the stakeholders is significant. They ensure that the health policy is relevant and beneficial. Stakeholders mandate is to see that the legislative processes are strictly followed. They air their views before a policy is regarded as a law.
The stakeholders included patients who saw the policy beneficial, insurance companies, government and companies that manufacture medicine. “Food and Drug Administration Amendments Act of 2007 (FDAAA)” and NPRM (Notice of Proposed Rulemaking), National Institute of Health (NIH) counterchecks the validity of the research done. Crucial elements are explained in the policy to receive stakeholders' approval. IOM (Institute of Medicine) and HHS (Department of Health and Human Services) worked on providing a clear procedure that the stakeholders showed interest since it designed strategies that will ensure responsible and safe sharing of data. Guidelines are provided concerning the legislation of the policy. They need to involve the public since they are the consumers of the health care services is emphasized. They ensure that the statutory regulations are integrated into the enactment of the policy. Additionally, they participant in the formulation of the policy and are engaged enactment process. They are consulted concerning any arising matter on health. Upon the publication of any useful information that regards clinical research, the stakeholders set up a meeting to discuss the credibility and usefulness of the data provided (Health Affairs 32). Disclosure forms are filled, and each member is given a chance to make suggestions before a joint decision is made. EME involvements create the connection between the patients and the stakeholders. Further, data that is received and evaluated are given absolute freedom and made available for use by various other researchers. The stakeholders emphasize the essence of sharing since it minimizes risks and maximizes benefits that accrue the health care. The stakeholders also ensure that the information is shared widely by making links that will guarantee the availability of medical data and analysis. Procedures set by the stakeholders help to implement the policy in the provision of transparent and adequate sharing policies.
Similarly, the stakeholders can help in editing and updating information that concerns healthcare. According to (Health and Human Services) HHS proposal made require approval by the board of directors before any further research is performed. To increase transparency, the stakeholders register the proposals, and the respondents are advised to provide their results at the ClinicalTrials.gov. The information gathered will help the FDAAA personnel identify the proposals that qualify for reporting and those that need improvement are resubmitted upon fulfilling FDAAA requirements (Healthcare policies and institutions 95). This way, transparency is practiced since the rejected proposals are recommended for revisions and improvement. The stakeholder’s sole purpose is to implement the board’s objective in the provision of quality information that is relevant. Diversity in the provision of the clinical work is appreciated. This is seen when the stakeholders adopt technological methods of coding data that is certified. The stakeholders invest in the improvement of the healthcare infrastructure to ensure sustainability, collaboration, and effort to overcome challenges.
The effect of the developed legislation and the stakeholders are involved assists in the improvement of the health services. The consumers are at ease in utilizing the services provided. The level of confidence is developed based on the assurance and clarity of information that reaches the consumers. In most cases, quality assurance policy is displayed at every health care facility (Healthcare policies and institutions 122). The health professionals, on the other hand, benefit from the policy because their research and findings receive credit and support from the stakeholders. Essentially, their work is published, and recommendations are made, highlighted which help in initiating change. Professional’s ideal course is to have their clinical research published with no bias. They are subjected to scrutiny just to ensure that their work is up to standard and contain no malice. The literature published is protected by the policy and are acquitted of any malpractices that may arise. The effect is felt further on the direction of future research. The requirement by the stakeholders to have the entire proposals vetted make the health professionals spend more time in ensuring that their research meets the stakeholder’s expectations.
The recommendations for the reform
The objectives of the reforms are clearly defined. However, it requires various improvements. This will ensure that it achieves its targets. The various bodies need to structure the management process. The upgraded structure will help sustain the projection of the health reform. Further, patent rights need to be involved in the publication of original data. The information, evaluations, and the analyzed data need to be registered. The policy should be amended to provide guidelines on how to identify legit and fake information. The public may be misguided by the publication of inconsistent information. This should be made available on the accredited websites, journals and data books (Süreci 14). Further, diversity on the topics to be researched should be adopted to ensure that all fields in health care services are highlighted. NIH should develop repertory that will ascertain all the data that is sponsored for clinical trials.
The status of the policy has shown compliance by various companies. The proactive commitment of Roche and GSK took the bold step by sharing data has set the pace for other organizations. Others have collaborated in sharing pool data on various platforms. Qualified researchers in Europe and the USA share the following, study level, clinical trials, protocols and patient progressive report. The guideline is provided by (Pharmaceutical Research and Manufacturers of America and European Federation of Pharmaceutical Industries and Associations) PRMAEFPIA. Further, it was recommended to include behavioral interventions and psychosocial behaviors (Turner & Nguyen, 2010). Further, it is recommended that the various bodies develop and network that will create a sharing program; this will ensure that trust and exchange of information are facilitated.
Work Cited
"Health care policies and institutions." Health Care Systems (2010): 95-126. Print.
Health Affairs. Transparency in Clinical Research. Health Policy Briefs (2016): Print. Retrieved from https://www.healthaffairs.org/healthpolicybriefs/brief.php?brief_id=150
National Research Council (U.S.). (2011). Improving health in the United States: The role of health impact assessment. Washington, DC: National Academies Press.
Süreci, Yazar. TRANSPARENCY AND ACCOUNTABILITY IN HEALTCA- RE SERVICES FROM NURSE MANAGERS' PERSPECTIVE: A QUALITATIVE STUDY. The Journal of Academic Social Science Studies (2015): Print. Retrieved from http://dx.doi.org/10.9761/JASSS3048
Turner, S. C., & Nguyen, E. S. (2010). Improving the value of health care. New York: Nova Science Publishers.
