Informed consent for anaesthesiological and intensive care unit research: a South African perspective

Health research is highly regulated and controlled. The South African legal framework consists of the Bill of Rights, the National Health Act, and two sets of Department of Health guidelines, Medical Research Council Ethical Guidelines Book 1, and South African Health Professions Council General Ethical Guidelines for Health Researchers (Booklet 6) add an ethical overlay to the care and protection of research participants. These acts, regulations and guidelines are based on accepted international ethical guidelines and principles. This article notes the historical background to the development of these guidelines, evaluates the South African Acts/regulations/guidelines as they pertain to anaesthesia and ICU research, and discusses attendant difficulties and pitfalls with reference to informed consent in this context. There are general requirements for participants' consent and health research ethics oversight, but a waiver of individual consent is possible under certain circumstances. The regulations/guidelines restrict ICU research on temporary incompetent patients to minimal risk therapeutic research. Yet, there is increasing need for fundamental clinical ICU research which falls outside this limitation. Health research ethics committees (HRECs) generally apply their minds and may allow surrogate decision making (i.e. consent by a person other that the participant), but this can also be problematic since relatives may not know what the participant may have wanted, may object to the added responsibility of providing consent for research on top of consent for clinical treatment, and other surrogates may be subject to conflicts of interest. The regulatory framework should be brought into line with the requirements of the real world, international trends and practices. Section 71 of the NHA was recently promulgated. If applied, it would mandate informed consent in all health research, disallowing surrogate consent and waivers of consent, and would halt almost all research on children since ministerial approval would be required for all non-therapeutic research. The hope is that ministerial approval might be delegated to health research ethics committees.