Communication and informed consent in phase 1 trials: a review of the literature

Abstract

Phase 1 (P1) trials are vital to the development of cancer treatments; however, the patients involved in these trials are unlikely to receive any therapeutic benefit, and there are significant possibilities that they will experience serious side effects. Ethical requirements stipulate that patients must be adequately informed before they consent to participate in P1 trials. This review focuses on studies that have measured patient comprehension of information given during the informed consent process of P1 cancer trials. Patients consenting to participate in P1 trials currently have a limited understanding of trial purpose, an unrealistic expectation of the benefits and risks associated with trial participation and a questionable appreciation of their right to abstain or withdraw. Health care professionals recruiting to P1 trials need clear and practical guidelines and training packages designed to ensure that all details of P1 trials are communicated effectively to eligible patients.

Understanding of informed consent by parents of children enrolled in a genetic biobank

“…This supports previous studies of informed consent understanding for adults consenting to participate in research studies. [12][13][14][15][16][17][18][19][20][21][22][23][24][25][26] However, our study is the first to measure actual and perceived understanding of informed consent for parents who gave permission for their children to participate in a biobanking study. More than half of the parents were uncertain or responded incorrectly to the main questions of the study, including those regarding the use and storage of samples and the handling of results from the study.…”

Outcomes of Research Biopsies in Phase I Clinical Trials: The MD Anderson Cancer Center Experience

“…Although it is well established that the risk and purpose of research biopsies must be effectively communicated to the involved patients [18], whether or not trials should be permitted to mandate biopsies is still a matter of debate, although a consensus appears to have emerged that such a requirement is ethical. It remains unclear if a negative impact on protocol accrual might outweigh the advantages of getting biopsy specimens.…”

Purpose, Composition and Function of the Research Ethical Committee in the Sarah Rehabilitation’s Hospital

“…Although the informed consent process is recognized as an essential requirement in research, actually it is still far from fully realizing the principle of autonomy and respect for persons [11] [12]. In this study, there were failures in the consent informed on 50% of the protocols.…”