In 2013 TREAD conducted a research study in order to evaluate informed consent comprehension by adult South African clinical trial participants at the time of providing consent for clinical trial participation (Burgess et al, 2013).

The aim was to evaluate the understanding of the following important concepts related to clinical research:

  • RESEARCH

  • VOLUNTARINESS

  • THE RIGHT TO WITHDRAW

  • RISKS ASSOCIATED WITH THE TRIAL

  • BENEFITS ASSOCIATED WITH THE TRIAL

  • RISKS ASSOCIATED WITH THE TRIAL

  • SIDE EFFECTS ASSOCIATED WITH THE TRIAL

  • BLINDING

  • PLACEBO

  • ETHICS COMMITTEE

  • RANDOMIZATION

  • ETHICS COMMITTEE

  • COMPENSATION

The results showed that, with the exception of voluntariness and right to withdraw, trial participants’ understanding of the informed consent document was poor – especially with regards to the following concepts: randomization, risks, placebo and blinding.

Thus, it could be seen that the general participant informed consent comprehension at this site was poor and the process for taking informed consent subsequently needed to be modified so as to improve informed consent comprehension.

As a result of this study, TREAD implemented a number of tools in order to better improve patient comprehension of the informed consent process and clinical trials in general. These implementations can be found under Patient Education.

The results showed that, with the exception of voluntariness and right to withdraw, trial participants’ understanding of the informed consent document was poor – especially with regards to the following concepts: randomization, risks, placebo and blinding.
Thus, it could be seen that the general participant informed consent comprehension at this site was poor and the process for taking informed consent subsequently needed to be modified so as to improve informed consent comprehension.
As a result of this study, TREAD implemented a number of tools in order to better improve patient comprehension of the informed consent process and clinical trials in general. These implementations can be found under Patient Education.

These implementations can be
found under Education of Patients