Indemnity
Indemnity in the legal sense means immunity from responsibilities for damages. This immunity is attained by a contractual agreement between two parties on a particular issue. In the agreement, one party decides to pay for any future damages or losses caused by the second party on agreed issues. In other words, the second party will not be held responsible for any damages or losses. Indemnity will be paid in terms of monetary benefits or by repairs/replacements. The indemnity payments will be made in accordance with the contractual agreement. A characteristic example is an insurance contract between the insurer and the insured. In this contract, the insurer agrees to compensate the insured for any damages or losses on agreed issues. The insured in turn pays premiums to the insurer. Indemnity in clinical research is a contractual agreement between the Sponsor and the investigation site to protect the site from claims of non-negligent harm because of participation in clinical research. The indemnity will also provide coverage to patients against any untoward events.
Compensation
Compensation is an organised practice which involves providing monetary and non-monetary benefits to affected person. In compensation, the affected person is directly compensated for damages or loss incurred. There is generally no insurance policy or insurer involved in compensation. Monetary compensation in clinical research is a well-known practice. Monetary compensation is provided to the study participants for number of reasons such as gratitude payment for their involvement in the development of pharmaceutical product and also for achievement of required patient recruitment number within specified time period. Study participants are compensated...
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...licy is required to cover the risks associated with the mismanagement of service provider such as CRO. It is particularly important in cases of complete trial undertaking by the CRO. This policy will cover the claim for patient injury directed at the Sponsor. However, as directed by the circumstances, there should be provisions of counter claiming by the Sponsor against the service provider.
Conclusions
Considering the nature of clinical trials, indemnity and compensation are very important elements for protection of the rights and welfare of the study participants. It is a common practice to provide monetary compensation to the study participants for their time and also for discomfort associated with trial related procedures. It is very important to include detailed indemnity and compensation policies in all the contracts related to the conduct of a clinical trial.
Damages are a fundamental principle in the American legal system. However, a number of recent cases in the United States have sparked a debate on the issue, the most famous one being the “hot coffee lawsuit”1. In 1994, Stella Liebeck bought coffee at a McDonald’s restaurant, spilt it, and was severely burnt. She sued the McDonald’s company, received $160,000 in compensatory damages, and $2.9 million in punitive damages. A judge then reduced the punitive damages to $480,000. The final out-of-court settlement was of approximately $500,000. For many, this case is frivolous (meaning that the plaintiff’s prospects of being successful were low or inexistent), but it really highlights the question of excessive punitive damages compared to the damage suffered and its causes.
“One of those obligations is that it must exercise a proper degree of care for its patients, and, to the extent that it fails in that care, it should be liable in damages as any other commercial firm would be
Existence of legal duty: Whenever a layman approaches a person who possess certain skill, or knowledge, the other party is then under an implied legal duty to act in such a manner so as to protect that person to his greatest effort and extent. The medical profession is one such section of society on which such a duty has been imposed in the strictest sense. Every time a patient visits a doctor for his ailments he does not enter into any written contract for care, but there is an implied contract and any lack of proper care can make the erring doctor liable for breach of professional duty. And if the doctor is incompetent to perform his duty it accounts for
Regulate the clinical data by enforcing stringent data management practices and mitigate the deviation in data collection and recording. The study protocol will define the source of data collection with Case Report Forms (CRFs), method of storage paper/ electronic and information retained for data archiving. Each subject will be identified with unique ID and Subject Identification Log will be maintained separately from trail analysis documents. The DMS prevents unblinding of specific documents, which protect the privacy and confidentiality of the subject, unless required by the study protocol. Identifiable documents and records will be maintained in accordance with the data retention period as specified in the protocol and the requirement of the regulations and IRB. Any update or changes implemented will be recorded in the revision history of the respective documents. The clinical trial team will be trained on clinical documentation and
The IRB is an administrative body which has been established to make sure research participants' rights are protected. 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 informed 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.
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)
There are several basic approaches that can be utilized when conducting economic evaluations for any new health care intervention; which can include medications that are designed for the treatment and prevention of disease and how to relate the effectiveness with the overall monetary value of the new treatment. The economic tools that can be employed to perform such an analysis can be broken down into four basic parts that consist of cost-minimization analysis (CMA), cost-effectiveness analysis (CEA), cost-benefit analysis (CBA) and cost-utility analysis (CUA). These four categories will contain the major financial analytical techniques employed when evaluating medical treatments and interventions along with other types termed cost-consequence
To sum things up, the ethical demeanor of research involves respect for the safety and rights of subjects during the sequence of the trial. This includes protecting privacy and confidentiality, monitoring the condition of research subjects to assure their safety, terminating study participation in the case of hostile events, and notifying enrolled subjects about new risks, benefits, or other information that may bear upon subjects’ decisions to continue enrollment in the research. As new evidence shows itself, trial investigators and data safety monitoring boards (DSMBs) can alter the study plan, initiate notice of enrolled subjects, make changes to the informed consent policies, or stop the trials earlier than intended. Investigators should soon classify a technique for ensuring effective communication between the IRB and DSMB throughout these studies.
2- In fact it is notorious clinical study. The patients should know the purpose, benefits and risks of the study. The patients had been mislead
These patients are desperate and are vulnerable, often consenting to research studies without fully understanding the potential outcome. Therefore, it is imperative to educate the patients, public, and regulatory agencies regarding the pros and cons of these therapies.
This essay focuses on intentional tort, which includes trespass to person consisting of battery, assault and false imprisonment, which is actionable per se. It also examines protection from harassment act. The essay commences with a brief description of assault, battery and false imprisonment. It goes further advising the concerned parties on the right to claim they have in tort law and the development of the law over the years, with the aid of case law, principles and statutes.
Healthcare Reimbursement is the financial payment to the provider for meeting face to face with an patient at his/her facility. In order to determine the financial obligation due to the physician for seeing a patient is determined by a number of factors; all of which, should be documented on the patient's medical record. To achieve the maximum reimbursement it is crucial to chart efficiently, documenting completely, scheduling patients and procedures appropriately, utilization of ICD-10, CPT and E/M codes, claims filing and other important factors in receiving the maximum healthcare reimbursement for services provided.
trials of investigation medical products. The FDA also has to review and approve in a
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 ...
Review the scenario below. Consider the legal principles influencing the likelihood of any successful action against Steve in negligence.