Box 9: What patients should know before agreeing to participate in clinical trials
All clinical research must be approved by an accredited research ethics committee. The Medical Research Council’s guidelines regarding participants’ consent is set out below.
i. “The precise nature, scope, purpose and duration of the proposed research project. That is, whether it is therapeutic, non-therapeutic, invasive, observational, a pilot study, controlled, randomised, single blind, double blind, triple blind or quadruple blind, and whether or not placebos are involved;
ii. the nature, scope and consequences of the proposed research intervention;
iii. the anticipated benefits and disadvantages compared to those expected from available standard therapy;
iv. the foreseeable prognosis and all foreseeable and additional risks, dangers and complications, as well as the possibility of unforeseen risks, dangers and complications, irrespective of whether the proposed research is therapeutic or nontherapeutic;
v. personal benefits, including financial benefits, that may accrue from the research to participants, investigators and anyone giving proxy consent. Moreover, the research participant, or the articipant's proxy, should be informed that participation is voluntary and that he or she is:
1. under no obligation to consent to the research procedure and that a refusal will not adversely affect future treatment;
2. free to withdraw consent at any time without adverse consequences and without having to state a reason.”
Source: MRC, Guidelines on Ethics for Medical Research: General Principles (2006), para 5.3.2.3