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Impacts of Research Protocol on the Medical Providers' Practice

Buy custom Impacts of Research Protocol on the Medical Providers' Practice essay

Buy custom Impacts of Research Protocol on the Medical Providers' Practice essay

Research protocol is a directive and official document that gives a definite, systematically presented description of the detailed procedures of a research study. It mainly focuses on elements such as the study objective, protocol summary, research question, research design, research methodology and the project management of the study to be carried out. It is designed in a way that the research ethic committee can evaluate the study to ensure that it has complied with ethic’s code and regulatory requirements. The medical providers’ practice and the research protocol have a connection; the connection revolves around the research study of the patients’ privacy protection and safety consideration. In a typical scenario patients enter the research study and there is a high chance the medical provider may misuse the patient’s data for personal gains. Hence, the research protocol ensures provision of health care. The research protocol saves health providers’ practice from being sued and facing other ethical issues, this is so as it acts as a guideline for the study with adherences to HIPAA rules and guidelines and other ethical issues.

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 It helps the medical provider to follow the federal rules and other applicable rules and standards on the confidentiality of the patients’ data; this saves medical providers and their service from various penalties, legal problems and imprisonment. Phases of clinical trials allow the researchers to ask and answer questions that lead to reliable information about drugs and protect patients. Phase I studies how the new drug should be given, either orally or as an injection, how often the drug should be given. Phase II tests safety and the working conditions of the drug. It usually focuses on a particular disease. In Phase III a new combination of drugs is tested in comparison to the existing standard. Phase IV comes into being after a drug has been approved and marketed; it is used to evaluate the side effects, risks and benefits of the drug over a log period of time. HIPAA rules and regulations seek to protect patient’s information that is created by any covered entity and any identifiable information regarding to the patient. These guidelines can be followed by ensuring that information in sheets of patients contains only the name and time to ensure privacy and if the patient insists on not to disclose that he was admitted in the hospital, the medical practitioners are supposed to comply. Informed consent; this is a process in which a patient has adequate knowledge about her/his health care.

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The informed consents originate from rights that the individual has over what happens to her/his body pertaining to ethics and law as well as from the ethical duty that a medical practitioner should involve the patient in the provision of health care. A complete informed consent involves the nature of the decision the patient is to take, the reasonable available alternatives, the relevant risks, benefits and acceptance of the intervention by the patient. For the patient’s consent to be considered valid, he/she must be considered to be very competent to make the decision and do it voluntary. Ethics in clinical trials does not only include formulation of the study design, it also involves necessary monitoring to ensure safety of patient’s data. It also ensures that the informed consent is in order and signed. Monitoring entails activities such as adherence to a given protocol, proper collection of adverse events and ensuring that the collected research is of integrity. The clinical trial should be based on respect for patients, benefits and justice. The bio ethics committee familiarizes the hospital staff and the community at large the ethical issues that are faced by families and health care providers of patients undergoing clinical trials. The committee as well provides guidance on ethical concerns. The clinical trial team has a large database of pharmaceutical companies and their upcoming studies as well as information from www.clinicaltrials.gov where they obtain thousands of research studies to be used by the team.

Questions

  1. What are clinical protocols?
  2. How are patients selected for trials?
  3. What role do ethics play in the clinical trial process?
  4. How are HIPAA guidelines followed for patients on clinical trials?
  5. What are the elements of an informed consent?
  6. Who is eligible to make a valid informed consent?
  7. What are impacts of clinical trials on a health provider’s practice?
  8. What different types of clinical trials do we have?

Cover letter

I am a health informatics professional in the clinic and clinical research department is my favorite area; it has five clinical associates and is involved in working with Phase III and IV clinical trials with its oncologists for cancer research studies and endocrinologist group for patients with diabetes. The cancer research is not heavily funded but we have taken it upon ourselves for ethical reasons to continue with cancer research. The diabetes research, on the other hand, is well financed. Initiative to make clinical trials more popular was initiated by making sure all the medical staff got education regarding clinical trials in the clinic and at large. The survey to be conducted is to test on how much medical practitioners know about clinical trials. There are many trials available in cardiology, internal medicine and pediatrics; these trials in addition to giving a hope to patients, who are dying, bring a lot of revenue to the clinic.

The statistical analysis that I will use is a random sampling; this will help me to pull out some of the survey results, narrow down the data and give me a small number of physicians that I will be able to interview. Interview is the most appropriate to this process as it will help in getting the information from first hands as it is a face to face interaction and refusal by physicians will be minimized as opposed to other methods.

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