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.
In Billy Wilder’s 1944 blockbuster hit Double Indemnity, a fast-talking insurance salesman named Walter Neff (Fred MacMurray) visits the home of the seductive Phyllis Dietrichson (Barbara Stanwyck) to renew the insurance policy on her husband’s automobiles. A romantic affair shortly ensues, and Walter is soon coerced by Phyllis into plotting a murder. Walter then comes up with an idea to receive double the amount Phyllis had previously intended, and they eventually deceive Mr. Dietrichson (Tom Powers) by making him sign a double indemnity insurance policy which in return states that the widow will receive full compensation on behalf of the bearer’s death. Mr. Dietrichson’s death is then made to look accidental; however, all does not go according to plan when Barton Keyes (Edward G. Robinson), a diligent insurance investigator conducts an examination of the case file. It is a tale of love and betrayal where Walter and Phyllis inevitably face the repercussions of their actions. The story transitions from the present to the past with the use of flashbacks. The voice of Walter Neff is used as a narrative style in the form of an office memorandum which is integrated throughout the film. The movie opens and ends with Walter as he tells the story of killing a man to Keyes through the Dictaphone. Billy Wilder uses money, a woman and the ability to cheat the system to denote Walter Neff’s motives to commit the perfect crime.
2. Bonham, Valerie H. "Legal Issue's in Clinical Research." NIH. 15 Jan. 2008. Web. 12 Feb. 2012.
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
Billy Wilder’s Double Indemnity is one of the best representatives of the film noir era in Hollywood as it contains all the main characteristics of the genre. The general darkness present throughout the movie is embodied in the plot which reveals the moral bankruptcy of the main characters. It is also present in the mise-en-scene choices such as the dark costumes and modest lighting with the great emphasis on shadows. The main character’s voice-over, another important film noir characteristic, brings this darkness to life and communicates it to the audience with brutal honesty. One of the scenes of the film which contains all of these features is the one where the two main characters, Neff and Phyllis, meet for the first time. This scene will be analysed with respect to the main film noir elements and techniques that were used in the making of it – mainly mise en scene, the voice-over and the screenplay.
Considering that the researcher protects himself or herself and the participants, a lot of unwanted circumstances including new infections on both sides are prevented thus limiting the miscellaneous costs in the research budget. It also assures the participants that they are protected and thus will come to no harm during the study. This ensures that they are willing to cooperate and thus help the scientific community and humanity as a whole by providing the relevant data for a given investigation. Safety here also prevents errors by ensuring that the possible errors are caught on time. This then translates into results that are not only very reliable but also largely replicable onto another sample population, making them relevant in drawing a generalized
Insurance is a two-way legal agreement between the insurer and the customer. The customer, which may be an individual, business, or other entity, agrees to pay the premiums as required, in exchange for monetary protection from the insurer for any possible substantial loss. Customers usually obtain insurance, not to cover the trivial incidents of life or business, but to cover the potential significant losses which could be a financial hardship for them. The premiums of all customers of the insurance company are pooled together. The insurance applies statistical analysis to determine the chance that a particular event might occur to one of their customers. From this analysis they can determine the premiums which must be collected and the claims which must be paid to keep the insurance company financially profitable. There are many type of insurance including life, property and casualty, car, health, and disability. Each is very specific for what losses then will cover and reimburse (Pareto, n.d.).
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.
Carlson, J.J., Sullivan S.D., Garrison, L.P., Neumann, P.J., Veenstra, D.L. (2010). Linking payment to health outcomes: A taxonomy and examination of performance-based reimbursement schemes between healthcare payers and manufacturers. Health Policy, 96(3), 179-190. doi: 10.1016/j.healthpol.2010.02.005
A patient has the right have the charges explained and be provided with information of availability of financial assistance.
Review the scenario below. Consider the legal principles influencing the likelihood of any successful action against Steve in negligence.
trials of investigation medical products. The FDA also has to review and approve in a
In conclusion, the professional liability insurance policy is one of the most important policies that every employee taking part in the organization will have to consider and people should try to understand the reason why this particular liability policy is very different from other insurance policies that everyone may have seen in their lifetime. Truly understanding how the professional liability insurance system works may not be as simple as it looks, but in time, we will be able to grasp the actual concept of the insurance policies some day when we become a member of the health care organization.
Clinical trial is a gateway to become proved practical medical treatment, so it requires accuracy and validity of the outcomes. Placebo control trials are therefore employed in clinical trials as nearly half of academic physicians have answered in a questionnaire that they had used a placebo in their clinical trials (Sherman and Hickner, 2007). To have the higher scientific validity of results on the clinical trials require that prospective, carefully selected subjects and endpoints, a control group, randomly allocated subjects into a treatment group and a control group, blinded both subject groups and investigators, sufficient sample size, and an approved independent ethics committee and monitoring by data safety and monitor board to have stronger the scientific validity on the clinical trials (Brody, 1997). The use of placebos will enable to have more scientifically reliable outcome. However, unnecessarily or ineffectiveness of placebo use is also claimed therefore considering appropriate conditions and suitable cases would be needed for placebo use.
Tort is a branch of private law that deals with civil wrong committed against an individual, including legal entities such as companies rather than the state. Tort law can be described as a body of obligations and remedies applied by courts in any civil proceeding to offer relieve to an individual who has just suffered emotional or physical harm as a result of the wrongful acts of others. In this case, the individual who suffers a personal injury is known as the plaintiff, while the person responsible for the infliction of the injury is referred to as tortfeasor or respondent. In essence, this law has many goals, one being that of assisting the injured to recover through either monetary compensation or even mental compensation in order to promote civility, discourage private retaliation and deter future wrongful actions.