Oral Abstract Session 01 - Global HIV Vaccine Enterprise
Oral Abstract Session 01 - Global HIV Vaccine Enterprise
Oral Abstract Session 01 - Global HIV Vaccine Enterprise
You also want an ePaper? Increase the reach of your titles
YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.
POSTERS<br />
Posters<br />
Topic 10: Social/Ethical/Access/Regulatory Issues<br />
P10.<strong>01</strong><br />
Dealing with Research Participants’ Complaints in<br />
<strong>HIV</strong>/ AIDS Prevention Studies: Experiences from<br />
Zimbabwe<br />
R. Gunda 1 , S. Ruzario 1 , R. Chekera 1 , M. Phiri 1 , R. Gutsire 1<br />
1 Medical Research Council of Zimbabwe, Harare, Zimbabwe<br />
Background: The Medical Research Council of Zimbabwe<br />
(MRCZ) houses the National Ethics Committee which safeguards<br />
the rights, safety and well-being of all research participants.<br />
Research participants in AIDS Prevention Trials, including <strong>HIV</strong>/<br />
AIDS vaccine trials, do from time to time have complaints during<br />
research implementation. The National Ethics Committee takes<br />
these complaints seriously and works tirelessly to address all<br />
complaints that research participants report to them in order<br />
to continuously improve the ethical conduct of AIDS research.<br />
The research community as a whole suffers when even a few<br />
investigators ignore the basic principles of ethics.<br />
Methods: We ensured that all research participants in Zimbabwe<br />
are well informed of the National Ethics Committee`s complaint<br />
procedure. Adequate information on how to lodge a complaint<br />
is supplied upon request. Complaints are listed with all relevant<br />
details and are investigated fully by the Council. Depending on<br />
each complaint, urgent meetings with investigators and study staff<br />
are done. Urgent for-cause site inspections, interviews with study<br />
participants, impromptu meetings with Community Advisory<br />
Board members and the communities are also done. Community<br />
Research Ethics Awareness Outreaches are conducted periodically<br />
and annual Research Ethics Forums are held for researchers and<br />
participants to bridge the gap between them<br />
Results: The MRCZ managed to address all participants complaints<br />
reported in 2<strong>01</strong>1. The number of for-cause site inspections for<br />
<strong>HIV</strong>/AIDS Prevention Trials increased from 2 in 2<strong>01</strong>0 to 8 in 2<strong>01</strong>1.<br />
Complaints included participants spending longer times at a<br />
research site than the time written on the informed consent,<br />
insufficient food given at research site, laboratory results not<br />
being issued on time as promised, confidentiality not being<br />
maintained and insufficient bus fare reimbursements being given<br />
Conclusion: A functional system to handle complaints from<br />
research participants helps to improve the ethical conduct of<br />
research. Experiences from the Medical Research Council of<br />
Zimbabwe will be shared.<br />
210<br />
AIDS <strong>Vaccine</strong> 2<strong>01</strong>2<br />
P10.02<br />
Protection of Human Research Participants Through<br />
Routine Inspection of Ongoing <strong>HIV</strong> Prevention and<br />
Treatment Clinical Trials:Experiences from Zimbabwe<br />
R.B. Zinyama-Gutsire 1 , R. Musesengwa 1 , S. Ruzario 1 , R. Gunda 1<br />
1 Medical Research Council of Zimbabwe, Harare, Zimbabwe<br />
Background: The Medical Research Council of Zimbabwe<br />
(MRCZ) is the National Ethics Committee in Zimbabwe. MRCZ<br />
was established in 1974 under the Research Act of 1959 and<br />
Government Notice No. 225 of 1974 to promote and co-ordinate<br />
health research in Zimbabwe. The main mandate of MRCZ is the<br />
scientific review, ethics approval and oversight of all ongoing<br />
medical research studies in Zimbabwe inspection of all on<br />
going research studies involving humans using an established<br />
Human Protection System. Routine inspections and ‘for cause’<br />
inspections are carried out to ensure utmost protection of<br />
research participants and to ensure protocol adherence and ICH-<br />
GCP compliance. <strong>HIV</strong> prevention and <strong>HIV</strong> drug treatment clinical<br />
trials receive more detailed attention during inspections as they<br />
are delicate and complicated.<br />
Methods: During the inspection process the following aspects<br />
are checked on and thoroughly reviewed: initial and continuing<br />
MRCZ approval letters, protocol version at study site, National<br />
Drug Regulatory Body approval in case of drug clinical trials, valid<br />
continuing review approvals, staff qualifications, staff registration<br />
with professional bodies and relevant experience, evidence<br />
of research ethics and GCP training, data storage, signed and<br />
dated participant consent forms, external monitors reports and<br />
recommendations, approved study data collection tools, procedure<br />
rooms and interviews study participants. MRCZ adherence to Local<br />
and International Research Ethics Guidelines and offers research<br />
ethics and GCP training courses to local researchers.<br />
Results: A recent development has been proactive requests from<br />
researchers for research ethics and GCP training, an indication of<br />
the increased awareness amongst researchers in Zimbabwe of<br />
the need for this training.<br />
Conclusion: There has been significant improvement in<br />
protection of research participants, protocol adherence and<br />
ICH-GCP compliance by researchers as a result of the increased<br />
inspection of all ongoing research studies in Zimbabwe. More<br />
and more researchers are now aware of international research
Change language