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Journal of Postgraduate Medicine, Vol. 55, No. 2, April-June, 2009, pp. 87-88 Editorial Compensation for research-related injury Bavdekar SB, Thatte UM Department of Pediatrics, Seth GS Medical College and KEM Hospital, Mumbai Code Number: jp09024 PMID: 19550049 Risk of injury is inherent in any research. The injury could be in the form of direct or indirect physical, psychological, social or economic harm. The issue of providing compensation for research-related injury has been a matter of some debate in the world of clinical research. At one end of the spectrum is the view (predominantly in the USA) [1],[2] that sponsors, investigators or institutions are not obliged to provide compensation for such injuries (or even free treatment for injury, for that matter), since individuals agree to participate only after being made aware of the inherent risks. At the other end of the spectrum is the view (mainly in European countries) that individuals participate in trials with altruistic motives and it is unfair to expect them to bear a disproportionate loss in case of mishap. [3] It is, therefore, natural to assist and compensate them in the event of injury and clinical trial insurance is mandated for in these countries. The Indian Guidelines recommend that individuals be compensated for research-related injury. [4],[5] However, awareness among stakeholders, particularly investigators and Ethics Committees (ECs) members regarding such a mandate is poor. [1] In this context, the guidelines drafted for compensation to participants in the event of research-related injury by the Indian Council of Medical Research (ICMR), Forum for Ethics Review Committees in India (FERCI) and Indian Society for Clinical Research (ISCR) (posted at the ICMR website for public debate) [6] are interesting. These Guidelines apply to all clinical research but exclude post-marketing surveillance and ancillary care from their purview. The Guidelines state that the compensation for research related injury could be in the form of payment of immediate medical or surgical management of research-related injury, compensation for temporary or permanent disabilities or compensation to the legal heir in case of death of an individual. The research participant could lose the right to compensation if the injury arises due to wrongful act or default of a third party, there is contributory negligence by research participant or if the injury arises as a result of concomitant medications allowed as per protocol or standard care. The Guidelines further describe the compensation mechanism and lists responsibilities of the individual stakeholders. [6] Importantly, the guidelines do not make any distinction between studies sponsored by pharmaceutical industry and those initiated by investigators themselves, where, by definition, the investigator also plays the role of a sponsor. Many investigators argue that as a) investigator-initiated trials run on shoe-string budgets, b) participation in such trials often does not entail excessive risks, and c) these trials are generally not guided by commercial interests; it would be unfair to expect the researcher to arrange for compensation and free treatment for the injury. However, the guidelines seem justified in making no distinction between the industry-sponsored and investigator-initiated trials mainly because in investigator-initiated trials, the investigator (or the institution where the patient is undergoing the trial) is expected to fulfill all responsibilities of a sponsor as well. What More Could Have Been Done? The guidelines are silent on the issue of how the quantum of compensation would be decided. It is obvious that compensation should be reasonable and based on various factors like the participant′s age, qualifications, years of productive life remaining, need for medical and other care required as a result of injury, etc. A meager compensation amount would be ineffective and an excessive amount could attract unnecessary claims and act as an undue inducement for future participants. Although the guidelines have made some recommendations about manner of initiating arbitration proceedings and membership of arbitration committee, they could have been more explicit in providing recommendations about the decision-making process, need for taking expert opinion and guidelines for deciding the quantum of compensation. These matters have been left to the wisdom of local EC, who are expected to take appropriate decisions depending upon local conditions. However, training of EC members will be needed to ensure consistency in the process. It would have been better if providing treatment for study-related injury was described separately and not clubbed with compensation for study-related injuries leading to temporary or permanent disabilities. For example, the Guidelines state that immediate medical/surgical management of research-related injuries will be the responsibility of investigator and institution. They also mention that compensation may not be provided if it is determined that the injury has occurred through wrongful act or default of a third party; contributory negligence by the research participant. It is not clear which of the two statements would take precedence. It would perhaps be necessary for ECs to be clear in their Standard Operating Procedures (SOPs) how they would arbitrate in such cases. The ECs should also have specific SOPs to clarify if they would hear the participant and his/her legal representative while deciding on these issues. There is also a need to institute an appellate procedure allowing for requesting a review of the decision reached by investigator/EC regarding contributory negligence, default, etc. Impact Once these guidelines are finalized and accepted, the ECs will have to amend their SOPs to ensure that they follow the Guidelines in letter and spirit. They will need to evolve policies for composition and setting up arbitration committees to settle disputes related to compensation, formulate guidelines for deciding quantum of compensation to be awarded following, up on an adverse event not only to confirm medical outcome, but also whether compensation has been given. They would need to decide if they intend to intervene ′ suo moto ′ and assist an injured participant to claim compensation. On one hand, providing such assistance seems obvious for ECs, which are mandated to safeguard participants′ interests. This is especially relevant in the Indian setting where many research participants may be ignorant about their rights. On the other hand, such actions could be viewed by investigators and sponsors as ′undue interference′! The ECs will have to train their members and investigators regarding these guidelines and ensure that insurance-related documents, informed consent documents, and clinical trial documents are in conformity with various provisions of the Guidelines. The ECs should ask the investigator/sponsor to clarify how treatment of study-related injury will be paid for and/or compensation for injury would be provided in situations where the insurance company refuses to act (say, when the amount due is below or above a particular threshold) or when sponsors refuse to pay compensation if the injury has occurred due to protocol deviation or investigator negligence. Legal experts in the ECs should carefully check the fine print in the insurance document for additional caveats and conditions. More importantly, ECs should ensure that all relevant ethical issues (including how payment of research-related injury and compensation for such injuries) are clearly enunciated in the ′Ethics′ section of the protocol. [7] ECs will have to determine risk-benefit ratio with greater diligence and ensure that commensurate risk cover is available. Considering that many Indian ECs find it difficult to even meet regularly, [8] these could prove to be onerous responsibilities. These Guidelines are likely to have a great impact on the investigator-initiated studies. Institutions will need to have policies and support innovative researchers by establishing a fund to provide insurance cover for investigator-initiated trials or offer free treatment and compensation for injured participants of these trials. Such responses will ensure that the initiative of researchers is not dampened. Considering the various factors, one cannot but laud the efforts made for drafting these guidelines. Although these guidelines will probably undergo some changes in response to comments from the public, they constitute an important step in the right direction. More importantly, they will go a long way in assuring the society that research participants are being cared for. It is also noteworthy that India has taken a lead in drafting such comprehensive guidelines on this vexing issue! References
Copyright 2009 - Journal of Postgraduate Medicine |
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