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Indian Journal of Medical Sciences, Vol. 63, No. 10, October, 2009, pp. 455-460 Original Article Informed consent documents submitted for initial review: What do they state about compensation for injured research participants? S. B. Bavdekar Department of Pediatrics, Seth GS Medical College and KEM Hospital, Mumbai, India Code Number: ms09088 PMID: 19901484 DOI: 10.4103/0019-5359.57646 Abstract Background : Research carries a small but definite risk of injury to participants. However, there is no unanimity amongst the stakeholders regarding the nature and extent of compensation to be provided to an injured participant. Aims : To determine the extent to which issues related to the provision of free treatment and compensation for research-related injury are addressed in the protocols submitted to Ethics Committees (ECs). Setting and Design : Retrospective review of protocols submitted to two ECs in India. Material and Methods : Initial protocols submitted to two ECs during the calendar years 2007 and 2008 were reviewed. Statements related to treatment and compensations for study-related injury were studied for adequacy regarding provisions for free emergency treatment, and free treatment and compensation for research-related injury. Presence of special conditions, exclusions, and caveats, if any, were noted. Statistical Analysis Used : The proportion of protocols providing free treatment and compensation for research-related injury was presented as a percentage. Results : The Informed Consent Documents (ICD) of 138 protocols were accessed. These included 115 (83.33%) industry-sponsored, 20 (14.49%) government-sponsored and three (2.17%) investigator-initiated projects. Forty-six (33.33%) intended to provide free treatment for a trial-related injury. Forty-two (30.43%) projects did not have any policy about providing treatment for a trial-related injury, whereas several others included statements that intended to provide treatment, but with certain restrictions. Thirty-three (23.91%) ICDs had statements indicating that there was no provision for compensation and 65(47.10%) ICDs stated nothing on the issue. Conclusion : ICDs submitted for initial review are not in conformity with the provisions for treatment of and compensation for research-related injuries enunciated in national guidelines and draft guidelines.Keywords: Biomedical research, consent, compensation and redress Introductio Every research study has the potential to cause injury. The Indian Council of Medical Research (ICMR) National Guidelines stipulate that injured participants will receive free treatment for the management of study-related injury and would also be compensated for such injuries. [1] These guidelines state that the sponsor should agree, before research begins, in an a priori agreement, to provide compensation for any physical or psychological injury, and delineates a procedure to decide on the issue of providing compensation on a case-by-case basis. The draft guidelines posted on the ICMR website provide additional details on how this has to be ensured. [2] It has been noted that stake-holders involved in research in India, namely, investigators, sponsors, and Ethics Committee members are not always well-informed regarding these issues. [3] Hence, we decided to conduct a study to determine the extent to which compensation for study-related injury and for the treatment of such an injury are addressed in initial submissions to Ethics Committees so as to identify the points for training of the stake-holders. Material and Method The Informed Consent Documents (ICDs) of research projects submitted in 2007 and 2008 were reviewed. These ICDs had been submitted to the Independent Ethics Committee, Mumbai and the Ethics Committee for Research in Human Subjects (ECRHS), an institutional Ethics Committee of Seth GS Medical College and KEM Hospital, Mumbai for initial review. The research trials were classified as being pharmaceutical industry-sponsored, government-sponsored, and investigator-initiated. The statements related to compensation for treatment of study-related injury and compensation for study-related injury in these documents were scrutinized for the following: [A] Management of study-related injury:
[B] Compensation for study-related injury:
The proportion of protocols providing free treatment and compensation for research-related injury was presented as percentage. The caveats, exclusions, and conditions, if any, for accessing these were also noted, and their implications for the study participants examined. Results The ICDs of 138 protocols were accessed including 115 (83.33%) industry-sponsored, 20 (14.49%) government-sponsored, and three (2.17%) investigator-initiated projects. As stated in [Table - 1], only 46 (33.33%) gave an unequivocal statement that free treatment would be provided in case of a trial-related injury. As many as 42 (30.43%) projects did not state anything about providing treatment for a trial-related injury, whereas several others included statements that indicated certain restrictions. Where compensation for trial-related injury was concerned, 33 (23.91%) had statements clearly indicating that there would be no provision for compensation whereas 65 (47.10%) ICDs stated nothing on the issue. Several ICDs imposed caveats while providing treatment for injury and hence, statements such as, ′costs of injury not covered by personal insurance or government program would be reimbursed′ appeared in the reviewed documents. Ambiguous statements such as, ′treatment will be provided in case of trial-related injury,′ or ′treatment will be provided as per insurance′ also appeared in the documents. The first statement does not state who will bear the cost of treatment and the latter does not provide any details. Restrictions such as providing treatment and/or compensation for trial-related injury only to participants in the active drug arm or only if the study would be done as per protocol were also noted. There were ICDs that averred that free treatment or compensation would be provided only if the study would be properly conducted, conducted as per protocol, if the investigator(s) had not erred, or if there had been no negligence on the part of investigating team. [Table - 2] and [Table - 3] provide salient examples of statements that do not provide complete information or put undue restrictions on participants′ rights related to the treatment of and compensation for trial-related injury. It was also observed that the issues of treatment and compensation were not handled separately. For example, one ICD had a statement that the trial was insured for trial-related injury. It was not clear from the statement whether this would make eligible participants receive free treatment in case of trial-related injury or if they would be compensated for such an injury, or both. Discussio The study shows that a large proportion of ICDs submitted with protocols for initial review to Ethics Committees do not conform to National Guidelines, nor do they adequately protect the interests of the participants. This could partly be due to ignorance about these issues among sponsors and investigators. This, however, puts onerous responsibilities on the shoulders of the members of Ethics Committees. They need to be aware of the implications of the way the twin issues of providing treatment and providing compensation are currently being handled [Table - 2] and [Table - 3]. Several documents had statements that indicated what a sponsor would do. For example, it was stated that no compensation would be provided if injury occurred due to the investigator or his/her team failing to adhere to the protocol. This is unfair to the research participant, especially as the sponsor, and not the participant, selects the investigator. Under such circumstances, surely the sponsor could provide compensation by invoking the principle of vicarious responsibility. If the sponsor were unwilling, the participants cannot be left to fend for themselves and there should be some mechanism for providing compensation and free treatment for injury, either through the investigator or his/her institution. It is noteworthy that of the 129 policies of 102 academic medical centers in the USA, 51% made no provision for providing free care and 8% provided only free emergency or immediate care. As many as 19% of the policies did not provide publicly accessible information in this regard. [5] The data was collected from only two ECs situated in Mumbai. It may be argued that this may not be representative of the situation in the whole country. It may be clarified here that the ECRHS received proposals from several pharmaceutical companies and that the Independent EC received research proposals from several other cities and towns in India. The findings of the study provide an insight into the existing lacunae and have helped identify the training needs. The policy regarding ethical issues is generally enunciated in the Ethics section of the Protocol. However, this protocol is not generally accessible to prospective participants, and in any case, the ICD is expected to reflect and clarify the policy stated in the Protocol. Hence, these documents were studied in preference to the Protocol. The EC members need to be very vigilant and ensure that these statements are: i) in conformity with the letter and spirit of national and international guidelines, ii) are not ambivalent or ambiguous, and iii) fully protect the interests of research participants. In addition, the ECs should take the initiative to inform and educate investigators and stake-holders from industry about current opinions and expectations. Some broad suggestions are provided in [Table - 4] that would help investigators and sponsors submit ICDs that provide adequate protection to participants who may suffer from trial-related injury. Acknowledgment The author also expresses his gratitude to Dr ML Kothari, Chairperson, Ethics Committee for Research on Human Subjects and Dr RD Lele, Chairperson, Independent Ethics Committee, Mumbai for permitting the author to carry out the study and put these results in the public domain. The author is also grateful to the staff of these Ethics Committees for extending cooperation in accessing the documents. References
Copyright 2009 - Indian Journal of Medical Sciences The following images related to this document are available:Photo images[ms09083t3.jpg] [ms09083t4.jpg] [ms09083t2.jpg] [ms09083t1.jpg] |
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