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Retha Britz Copyright 2013 All rights reserved for this presentation1
Other important considerations for RECs
Retha Britz
Conflict of Interest Vulnerability Re-imbursement of Research Participants Privacy and Confidentiality Monitoring by RECs Multi-National Collaborative Research
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Conflict of Interest (SA GCP section 8.12)
IncludesDirect benefits e.g. Sponsorship of the investigationIndirect benefits e.g. provision of materials or facilities, provision for travel expenses to e.g. attend conferences
RECs to have clearly formulated policies regarding conflict of interest
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Conflict of Interest (continues)
Researcher to disclose actual, apparent or potential conflict of interest to RECs at the time of seeking approval
REC to consider whether the apparent conflict of interest might compromise the scientific integrity of the research
If yes, recommend appropriate remedial action and standards to be met in order for the research to be approved
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Conflict of Interest (continues)
Members of REC to withdraw from the committee when their own projects are discussed and voted for (membership list to reflect this)
Care to be taken to ensure members are financially and administratively independent of ECs in order to adequately fulfill their duties
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Vulnerability
“Individuals whose willingness to volunteer for participation in research may be unduly
influenced”
Researchers to demonstrate how they will redress the vulnerability if research is to be
conducted with such participants
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Vulnerability (continues)
REC to ensure that:Vulnerable pts will not be ordinarily be involved in research that could be carried out in non-vulnerable communitiesResearch is relevant to the [health] needs and priorities of the community in which the research will be carried outResearch pts should know that they are taking part in research and they have to give consent
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Re-imbursement of Research Participants
REC to ensure that:Conditions for participation do not constitute undue influence that could possibly compromise participant’s ability to voluntary make an informed decision whether to participate or notConsider time and inconvenience of study participants as well as travel related expensesRe-imbursement or any other incentive to be disclosed to RECs
(value and brand is important)
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Re-imbursement of Research Participants (continues)
Example wording in the ICF
Payment for Participation
“You will not be paid for your participation in this
study, but you will be reimbursed for reasonable
travelling expenses up to R150 per study visit for
travel and/or parking costs that you incur as a
result of participating in this study”
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Privacy and Confidentiality
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Privacy is concerned with access to personal records. Prevention of disclosure to other than authorised individuals, of a sponsor’s proprietary information or of a participant(s) identity
Confidentiality refers to the use of personal information. Protect personal information from unauthorised access, use, disclosure, modification, loss or theft
Privacy and Confidentiality(continues)
(continues)
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Informed consent form has a clause that third parties such as authorities e.g. the REC may access the study information
Example wording in the ICF
“Your records and any information obtained during the study may be inspected by representatives of the sponsor, the ethics committee and government
health authorities to check the procedures and the data or as required by law.”
Monitoring by RECs
REC responsibility to ensure conduct of research approved by the REC is monitored
Frequency and type of monitoring depends on the degree of risk to pts in the project
Reports to be requested from PIs at least annually for annual re-approval
Adopt any additional appropriate mechanism for monitoring including random inspection (as long as pt has consented to it)
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Monitoring by RECs (continues)
Annual reports from researchers to include:Progress to date, or outcome in the case of completed researchInformation concerning maintenance and security of recordsEvidence of compliance with the approved protocolEvidence of compliance with any conditions of approval
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Multi-National Collaborative Research
Study designs to be appropriate for local setting and modifications may be required for a local study e.g. in-and exclusion criteria
Is the research conducted in the country of origin?
Standards of care across countries should be similar e.g. USA vs rural areas in SA
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Multi-National Collaborative Research (continues)
Pay attention to study design (sampling strategy)
Appropriateness of incentives to pts and remuneration packages to investigators
Not universal guidelines for research
Research cannot be considered in isolation
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Multi-National Collaborative Research (continues)
REC to ensure: Benefits accrue to pts in the host country Potential benefits considerably outweigh potential
risks to vulnerable individuals or communities Research must be non-exploitative and in the best
interest of pts and the community Improved access to research for vulnerable groups Pts are encouraged to participate in the research
planning and conduct of the study
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Multi-National Collaborative Research (continues)
Capacity building in healthcare Economic and educational empowerment to promote
delivery of health care and progress Weigh risk to pts vs benefits to sponsor Efforts to translate research findings into component of
accessible care in the community Modify research protocols to suit the situation in local
communities Publications inclusive of investigators from host and
sponsoring countries
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References
SOUTH AFRICA. Department of Health. Directorate: Health Systems, Research, Research
Coordination and Epidemiology. 2004. Ethics in health research: principles, structures and
processes. Research ethics guidelines. Pretoria: Government Printer. 67 p.
SOUTH AFRICA. Department of Health. Directorate: Health Systems, Research, Research
Coordination and Epidemiology. 2006. South African good clinical practice guidelines. 2nd ed.
Pretoria: Government Printer. 96 p.