To be ethical, all health research on animals and on human participants must be scientifically sound. Ethics are as important as scientific considerations when reviewing a clinical trial. An independent South African based research ethics committee must review the ethical and scientific rigour of all clinical trials to be conducted in South Africa.
The Research Ethics Committee which undertakes the review must be accredited by the National Health Research Ethics Council. In the evaluation of clinical trials protocols or study applications, the Research Ethics Committee must ensure that participants are protected in accordance with international standards and guidelines.
The primary role of a research ethics committee is to safeguard the dignity, rights, safety, and well-being of all trial participants. The primary responsibility of each member is to decide, independently, whether in his or her opinion, the conduct of the proposed trial will so protect participants. Special attention should be paid to trials that include vulnerable participants.
The Research Ethics Committee should consider the following issues when reviewing a proposal for a clinical study:
- The scientific relevance of the clinical study;
- The suitability of the investigator(s) for the proposed study in terms of his/her availability, qualifications, experience, supporting staff, and available facilities;
- The relevance of the study rationale and the appropriateness of the inclusion / exclusion criteria to the South African context;
- The suitability of the study application in relation to the objectives of the study; i.e. the potential for reaching sound conclusions with the smallest possible exposure to risk of participants, and the justification of predictable risks and inconveniences weighed against the anticipated benefits for the participants and/or others;
- The suitability of the study population, whether they constitute a vulnerable group, if so whether justified and whether sufficient measures to protect their interest are in place;
- That the number of participants to be recruited is adequate to demonstrate the predicted effect;
- The risk-benefit analysis takes full cognisance of benefits and harms beyond the life of the study itself, particularly in relation to chronic life-threatening conditions;
- If placebos are to be used, whether their use can be justified;
- That by their participation in a clinical study the participants or other persons in the establishment or clinical centre are not denied timely access to medical personnel, investigations, equipment or procedures;
- The means by which initial recruitment is to be conducted and by which full information is to be given and informed consent is to be obtained. All written information for the participant and/or legal representative must be submitted in its final form;
- The adequacy and completeness of the written information to be given to the participants, their relatives, guardians and, if necessary, legal representatives;
- That the application allows the participants and/or their representatives adequate time to consider the patient information package before informed consent is sought;
- The content of any advertisements or public notices which will be used to recruit participants to a study;
- That the study protects participants’ rights to privacy;
- The provision of compensation/treatment in the case of injury or death of a participant if attributable to a clinical study, and the insurance or indemnity to cover the liability of the investigator and sponsor;
- The extent to which investigator(s) and participants are to be compensated for participation;
- Making specific recommendations regarding the continuation of treatments beyond the life of the study, or mechanisms to ensure that participants are fairly protected;
- The demographic information available to assess whether the patient population is adequate to support the study;
- Whether there is any cost to the participant and no charges to medical aids or insurance for protocol specific procedures;
- Whether the product will be made available to participants after the study ends, and if so whether there is any cost to the participant to continue treatment;
- Whether any restrictions will be placed on the publication of results; (i.e. ensure there is a written commitment from investigators to publish the results of trials and there is no contractual clause which reserves the right of publication to the sponsor only;
- The adequacy of the statistical methods proposed to evaluate the data generated; and
- Whether the study is advancing the body of knowledge on the subject.
You can visit the website of the National Health Research Ethics Council: http://www.doh.gov.za/nhrec