Awareness and Perceptions Among the Medical Fraternity on Broad Informed Consent Involving Storage and Use of Biological Samples For Future Research At A Tertiary Medical College

Abstract

Broad informed consent process in clinical research is an additional consent to the main consent, taken by an Investigator at that point in time, to collect, store and re-use biological samples or data for future scientific research with no specific objectives planned at that given moment. As physicians counsel patients regarding the broad informed consent process, we decided to assess the medical fraternity’s awareness and perceptions about the broad consent process. A questionnaire-based survey was conducted among medical professionals and post graduate and undergraduate students at a teaching hospital to evaluate their awareness & perceptions regarding the broad informed consent process for future clinical research. The study had a response rate of 66.77% with most responders aged between 21- 40 years. 271 participants supported broad informed consent for the storage of biological samples and their use in future research, whereas 163 felt that utilizing stored biological samples in future studies conflicted with research ethics principles. Among those who favoured broad consent, 162 approved the indefinite storage of their samples, while 248 were open to sharing their samples with other researchers, provided the research had Ethics Committee approval. On the other hand, among the 163 participants who opposed broad consent, 43 indicated they would agree if their samples were anonymized, 118 preferred re-consent for specific future studies, and 127 wanted the study findings to be shared with them. Thus, although many participants were in favour of broad consent for future research, they wanted transparency regarding the research for which these samples would be used, storage for a pre-defined period and reconsent when their samples were used. These findings underscore the critical need for evolving consent frameworks that balance scientific progress with individual autonomy, suggesting that future broad consent protocols must incorporate participant-centric safeguards to maintain ethical standards and public trust in medical research.

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