Bavdekar S B
Department of Pediatrics, Seth GS Medical College and KEM Hospital, Mumbai, India.
Indian J Med Sci. 2009 Oct;63(10):455-60.
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.
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).
Retrospective review of protocols submitted to two ECs in India.
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.
The proportion of protocols providing free treatment and compensation for research-related injury was presented as a percentage.
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.
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.
研究对参与者存在虽小但明确的伤害风险。然而，在利益相关者中，对于向受伤害参与者提供补偿的性质和范围并未达成一致意见。
确定提交给伦理委员会（EC）的方案中涉及为与研究相关的伤害提供免费治疗和补偿问题的程度。
对提交给印度两个伦理委员会的方案进行回顾性审查。
审查2007年和2008日历年期间提交给两个伦理委员会的初始方案。研究与研究相关伤害的治疗和补偿相关的声明，以了解免费紧急治疗、与研究相关伤害的免费治疗和补偿的规定是否充分。记录是否存在特殊条件、排除条款和警告（如有）。
将为与研究相关的伤害提供免费治疗和补偿的方案比例以百分比形式呈现。
查阅了138份方案的知情同意书（ICD）。其中包括115份（83.33%）行业资助项目、20份（14.49%）政府资助项目和3份（2.17%）研究者发起项目。46份（33.33%）打算为试验相关伤害提供免费治疗。42份（30.43%）项目没有关于为试验相关伤害提供治疗的任何政策，而其他一些项目包括了打算提供治疗但有某些限制的声明。33份（23.91%）ICD声明没有补偿规定，65份（47.10%）ICD未提及该问题。
提交进行初审的ICD不符合国家指南和指南草案中关于与研究相关伤害的治疗和补偿的规定。
