Informed Consent Documents submitted for initial review: what do they state about compensation for injured research participants? 2009

S B Bavdekar
Department of Pediatrics, Seth GS Medical College and KEM Hospital, Mumbai, India. sandeep.bavdekar@gmail.com

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. OBJECTIVE 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). METHODS Retrospective review of protocols submitted to two ECs in India. 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. METHODS 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. CONCLUSIONS 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.

UI MeSH Term Description Entries
D007194 India A country in southern Asia, bordering the Arabian Sea and the Bay of Bengal, between Burma and Pakistan. The capitol is New Delhi. Republic of India
D007258 Informed Consent Voluntary authorization, by a patient or research subject, with full comprehension of the risks involved, for diagnostic or investigative procedures, and for medical and surgical treatment. Consent, Informed
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D012189 Retrospective Studies Studies used to test etiologic hypotheses in which inferences about an exposure to putative causal factors are derived from data relating to characteristics of persons under study or to events or experiences in their past. The essential feature is that some of the persons under study have the disease or outcome of interest and their characteristics are compared with those of unaffected persons. Retrospective Study,Studies, Retrospective,Study, Retrospective
D012307 Risk Factors An aspect of personal behavior or lifestyle, environmental exposure, inborn or inherited characteristic, which, based on epidemiological evidence, is known to be associated with a health-related condition considered important to prevent. Health Correlates,Risk Factor Scores,Risk Scores,Social Risk Factors,Population at Risk,Populations at Risk,Correlates, Health,Factor, Risk,Factor, Social Risk,Factors, Social Risk,Risk Factor,Risk Factor Score,Risk Factor, Social,Risk Factors, Social,Risk Score,Score, Risk,Score, Risk Factor,Social Risk Factor
D016365 Liability, Legal Accountability and responsibility to another, enforceable by civil or criminal sanctions. Institutional Liability,Personal Liability,Professional Liability,Legal Liability,Medical Liability,Torts,Institutional Liabilities,Legal Liabilities,Liabilities, Institutional,Liabilities, Legal,Liabilities, Medical,Liabilities, Personal,Liabilities, Professional,Liability, Institutional,Liability, Medical,Liability, Personal,Liability, Professional,Medical Liabilities,Personal Liabilities,Professional Liabilities,Tort
D032984 Ethics, Research The moral obligations governing the conduct of research. Used for discussions of research ethics as a general topic. Research Ethics
D035842 Research Subjects Persons who are enrolled in research studies or who are otherwise the subjects of research. Human Subjects,Human Subject,Research Subject,Subject, Human,Subject, Research,Subjects, Human,Subjects, Research
D035881 Compensation and Redress Payment, or other means of making amends, for a wrong or injury. Compensation,Redress and Compensation

Related Publications

S B Bavdekar
September 1979, The New England journal of medicine,
S B Bavdekar
March 2009, Contemporary clinical trials,
S B Bavdekar
May 2016, Farmacia hospitalaria : organo oficial de expresion cientifica de la Sociedad Espanola de Farmacia Hospitalaria,
S B Bavdekar
January 2008, Journal of medical ethics,
Copied contents to your clipboard!