Updated: Dec 12, 2018
Compensation is offered to research subjects for participating in the clinical trials. Compensation is paid to the research subjects mainly with two objectives-for participation in the clinical trial and for trial related injuries. The compensation to research subjects can be either monetary compensation or non-monetary compensation. Monetary benefits are given in the favor of time and efforts put by the subjects participating in the clinical trials and reimbursement of money takes place for the incurred expenses borne by the patients like travel, loss of daily wages, etc. In cases where harm/injury is encountered by the subjects during their participation in clinical trials free medical management is provided. Besides, free medical management, financial compensation is also provided in case of serious trial-related injuries. In order to decide the amount of compensation to be paid to the trial participants, several models are used out of which some are more acceptable ethically in comparison to other models. There are four models which are used:
Market model– The market model is based on the principle of supply and demand, which decides when and what is to be paid to the research subjects for a particular study in a particular location. This means that compensation is paid to the subjects for the studies that offer little or no benefits or the studies for which the target population is difficult to reach. Advantages associated with this model are achievement of targeted number of subjects in the set time frame, minimization of financial sacrifice by the subjects and increase of protocol compliance The disadvantages associated with this model are that it results in high payment of compensation to the studies where subjects are difficult to find and therefore results in undue commercialization of the research participation, due to high payment subjects do not pay attention to the risks involved in the study and can hide important data which can have significant impact on the study.
Wage model- According to the wage model, for participation in clinical research, skills are not required, but, there is requirement of consideration of time and efforts put by the participating subjects and the discomfort faced by them. It is based on the principle of equality i.e. subjects undergoing similar studies should be paid in a similar manner. This model is advantageous over the market model as it curbs undue inducement and competition between investigators. Besides, it also has the advantage of decreased financial sacrifice by the subjects and prevents discrimination between high and low income groups as subjects of the same study receive equal compensation. However, it creates difficulty in achieving the targeted number of subject recruitment in the required time frame and it usually attracts the low-income population. It views subject’s research participation as an unskilled job and therefore leads to inappropriate commercialization of the research participation.
Reimbursement model– Like the wage model this model is also based on the principle of equality. According to this model compensation should be paid to the subjects in a way to recover for the costs incurred by the subject for participating in the trial and time spent by them away from work. For time spent away from work they would be reimbursed proportional to the earning capacity. Advantages associated with this model are less chances of hiding information by the subjects and decreased financial sacrifice by the subjects. On the other hand this model has the disadvantage in achieving the targeted number of subject recruitment in required timeframe and either preference of low and high income people due to different earning capacities according to their earning ability.
Appreciation model- According to this model, compensation is paid at the end of study completion as a token of gratitude and has no impact on the subject recruitment. This model has an impact on the subject retention and discontinuation from the study.
COMPENSATION ISSUES IN INDIA: India has a vast pool of patient population for conducting clinical trials. In recent years clinical trials in India have come under scrutiny in various courts on the compensation issue. According to data given by the government, at least 370 deaths have been reported in India during clinical trials since February 2013 and only in 21 cases compensation has been paid. Out of 370 deaths, 222 cases were examined so far by regulatory panel on clinical trials and 21 cases were said eligible for compensation on account of deaths associated with drug. There was no clarity on the norms on which the eligibility for the compensation was decided.
Compensation is a very subjective matter as data come from varied investigators associated with the trials in different parts of India. Under the procedure for deciding compensation in India in clinical trial deaths, it is therefore quite possible for the investigators to influence data given to the regulatory agencies .The investigator who reports adverse impacts of a drug under trial has conflict of interest because of the large amount paid by the pharmaceutical industries.
The issue of compensation is of more concern in case of vulnerable populations. For e.g. in case of children and mentally challenged, compensation is sensitive issue because decisions are taken on their behalf by their parents/legal guardians. Compensation is received by parents/legal guardians although they themselves are not the research participants and do not face any risk.
Poverty and illiteracy are two other important aspects in India. The participants in this group are unable to relate to the research information provided in the informed consent document but clearly understand the importance of the monetary benefit in their lives and therefore participate in trial without knowing the risks involved in the trial. In India this group constitutes a large population and hence cannot be excluded from the trial. However for including into trial a limit can be imposed on the number of subjects from this group as a target population.
Steps taken by DCGI– After so many cases of deaths and compensation not paid accordingly, DCGI (Drug Controller General Of India) formulated guidelines for compensating clinical trials deaths in January 2013 wherein an independent expert committee comprising of clinicians and pharmacologists, examine the reported adverse events and makes recommendations to the licensing authority or DCGI which ultimately takes a call on the quantum of compensation to be paid. The expert committee has set up a range of Rs 4-74 Lakhs as a payout on the basis of a formula that computes the sum after considering the age and health risks of the volunteers at the time of enrollment. A healthy volunteer in the age group of 17-64 years with less chances of dying due to medical complications will be paid highest compensation.
According to the guidelines of January 2013,Clinical trial subjects are entitled to free medical management as long as required, and also are entitled to financial compensation for clinical trial related injury or death. In case of death of the subject, the compensation is payable to the nominee(s) of the subject. With respect to the compensation, theÂ Sponsor, whether a pharmaceutical company or an institution, is also required to give an undertaking to the Drugs Controller General of India (DCGI) stating that it will provide compensation in case of clinical trial related injury or death. The time frame for determination of the cause of serious adverse event and order of financial compensation is 3 months from the date of report of the serious adverse event by the Investigator. The Sponsor or Sponsor Representative has been given a time frame of 30 days from receipt of the order of the DCGI to provide compensation to the Subject. Failure of the Sponsor or Sponsor Representative to provide free medical management and/or financial compensation, as ordered, may lead to suspension or cancellation of the existing and further clinical trials in India.
Although compensation have been formulated only for cases resulting in death from clinical trials, steps need to be taken for considering cases resulting in non fatal injuries from clinical trials.
Mr Vinod Arora, Principal Advisor, IGMPI
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