HIV Prevention Research Unit of the MRC response to the announcement of an investigation of the clinical trial
Yesterday the Minister of Health convened a meeting to establish the details with regard to the interim results of the cellulose sulphate microbicide study, as well as to gain further insights into the other microbicide trials currently underway in the country.
It was concluded that an investigation be conducted by the National Health Research Ethics Council in order to establish :
- Whether the study followed all protocols approved by the Medicine Control Council (MCC) and the Ethics Committee of the relevant research institutions
- Whether the participants were given sufficient information to make informed decisions about their participation
- and any other issue that might shed light on the preliminary results and their implications for the participants of this study and other similar clinical trials
This study and indeed all Medical Research Council HIV prevention clinical trials are conducted with prior approval of the local Ethics Committee (Biomedical Research Ethics Committee of the University of KwaZulu-Natal) and the Medicines Control Council (MCC). All events and protocol violations are reported to the Ethics Committee, progress reports detailing any safety concerns are submitted on a regular basis and changes to trial protocol are approved prior to implementation.
We are confident that we have followed all approved protocols during trial implementation, and that all clinical trials are conducted according to the highest ethical standards of Good Clinical Practice and ethics guidelines. In addition to the Ethics Committee and MCC, our trials are monitored by external monitors, and stringent internal quality control systems are in place to ensure the trial is conducted according to protocol.
Participants are only enrolled into trials after receiving detailed information about the purpose of the trial and the possible health benefits and risks, all delivered in their local language. During this process, their understanding of the study is assessed through comprehension testing prior to signing a consent form. In addition, participants are informed of the unknown effect of the product and advised on behavioural change and provided with condoms, regular HIV testing and counselling, and safe-sex counselling is done. This is reiterated and repeated at each of her visits to the clinic (usually once a month).
Community partnerships in HIV prevention clinical trials is vital. Community stakeholders are engaged and involved in the research process from inception and are provided with regular updates on the progress of the trials.
Each trial site is linked to local organizations that provide care for women who become HIV-infected during the trial. As part of the trial preparation, CONRAD set aside funding for women who become HIV-positive during the trial to ensure adequate health care, including HIV antiretroviral treatment when needed. The Medical Research Council has partnered with health service providers and has established care clinics through PEPFAR (President's Emergency Plan for AIDS Relief) funding to provide on-going care for women in our trials.
The Medical Research Council is committed to improving the health and wellbeing of all South Africans, and we welcome the Minister's initiative to ensure that the safety of research participants is not compromised.
For more information contact Professor Anthony MBewu on 082 4403073 or 021 938 0240