SRC Frequently Asked Questions
Q: What is SRC?
A: The Setshaba Research Centre (SRC), a South African, non-governmental and not-for-profit organization, is a well-established, community-based research center that aims to conduct public health research that is relevant, ethical and cost benefits for the local community and its partners.
Q: What are SRC’s areas of expertise?
A: The site is well experienced in conducting a broad spectrum of clinical research studies, including COVID-19 Vaccine studies, HIV prevention studies, HIV and TB vaccine studies, TB diagnostic studies, Maternal and Paediatric studies which includes RSV vaccine studies, and other studies related to various infectious and non-infectious diseases. In addition, the site is also experienced in conducting social science, behavioral, and multipurpose technology studies.
Q: How are the studies conducted?
A: The studies are conducted according to a study-specific protocol, which has been reviewed and approved by various committees, including SAPHRA and an independent ethics and safety committee.
Q: Are the studies safe and legal?
A: All studies are subject to ongoing and consistent reviews by independent regulatory bodies and a data and safety monitoring board. If there are any concerns about a study’s safety, the specific study can be immediately stopped by the committee. SRC is committed to full compliance with all protocols, processes, safety reviews, and ethical regulations. SRC only conducts studies that have been approved by appropriate regulatory authorities.
Q: How do I become a participant?
A: Our Community Engagement Team recruits potential participants from relevant areas within the community. Individuals who wish to be considered as potential participants for future studies can contact our center by sending their contact and demographic information (Name, Contact number, Gender, and Age) to the following:
Email address: info@setshaba.org.za OR Cellphone number: 064 626 4897
The COT team will review the eligibility of the individual for current recruiting studies.
Q: How do I know if I have met the requirements of becoming a participant?
A: SRC will contact individuals who meet study requirements.
Q: What is expected of me as a participant?
A: Know and understand the study processes shared with you by SRC.
- Willingly give consent to participate in a study,
- Sign an informed consent document detailing a study participant’s benefits and risks.
- Remain committed to study-visits and procedures,
- Be a participant of integrity
Q: What are visits?
A: Study visits are mandatory research study requirements, where participants are generally called on-site (to SRC premises) for study follow-ups. In some instances, the visit may be conducted through a telephone contact or home visit with the participant.
Q: What happens during these visits?
A: The site staff will conduct procedures according to the study protocol and obtain any relevant information as required from the participant. These may include for example a physical exam, certain blood tests, possible vaccination or administration of other medication, and obtaining of any other relevant information.
Q: How long are the visits?
A: Participants are encouraged not to have any other appointments for the day as some visits’ procedures are longer than others.
Q: What happens to the blood drawn from me as a participant?
A: These blood samples are used to complete lab tests as outlined in the protocol in order to conduct the relevant research. Some protocols do specify that blood may be stored for future research – your consent will be obtained for this purpose.
Q: What happens if I experience side effects from the vaccine?
A: Any side effects or symptoms that arise after the administration of any investigational product must immediately be reported to our site staff.
Q: What happens if I fall ill during the study, do I continue with my visits?
A: Unwell participants are required to inform the site staff of their ill health as soon as possible. The study investigator will determine if the illness is related or unrelated to the study product and follow up visits will be conducted or you will be referred to your nearest healthcare centre.
Q: Can I stop participating in a study, if the answer is yes, how?
A: Yes, you are allowed to stop participation at your own free will at any time.
Q: Do you offer free HIV testing?
A: We do not offer HIV testing to the public. We offer HIV testing when it forms part of the study protocol.
Q: Do you offer family planning?
A: We do not offer family planning for the general public. We offer family planning for certain studies, only if approved and required by the study sponsor.
Q: How is SRC different from a clinic?
A: SRC is a research centre, and not a clinic. SRC is a research organisation which includes conducting of a specific research protocol with the objective of collecting data, documenting of critical information, analysing and interpreting of that data/information, in accordance with suitable methodologies set by study protocols. Clinics are government institutions that are open to the general public and respond to the publics’ health and needs.
Q: Are participants paid to partake in a study?
A: The Setshaba Research Centre does not pay participants for site visits. Participants are, however, reimbursed for their time and transportation. The amount paid will depend on the approved reimbursement for the specific project/study. The reimbursement amounts are set by sponsors and approved by an independent committee, and are not at the discretion of our organisation.
Q: What are the advantages of taking part in a study?
A: The benefits include knowing your health status, receiving medical advice as well as counselling and referrals. In addition, your participation and the information gathered from the study will add great value and benefit to your community’s health system and to future advances in medical science.
Q: How will I know the outcome of the study I participated in?
A: Once a study is complete, study results will be disseminated to participants who have completed their visits schedules.