1. Retha Britz Copyright 2013 All rights reserved for this presentation 1 Other important considerations for RECs Retha Britz

2.  Conflict of Interest  Vulnerability  Re-imbursement of Research Participants  Privacy and Confidentiality  Monitoring by RECs  Multi-National Collaborative Research 2

3. Conflict of Interest (SA GCP section 8.12) Includes  Direct benefits e.g. Sponsorship of the investigation  Indirect 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 3

4. 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 4

5. 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 5

6. 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 6

7. Vulnerability (continues) REC to ensure that:  Vulnerable pts will not be ordinarily be involved in research that could be carried out in non-vulnerable communities  Research is relevant to the [health] needs and priorities of the community in which the research will be carried out  Research pts should know that they are taking part in research and they have to give consent 7

8. 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 not  Consider time and inconvenience of study participants as well as travel related expenses  Re-imbursement or any other incentive to be disclosed to RECs (value and brand is important) 8

9. 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” 9

10. Privacy and Confidentiality 10  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

11. Privacy and Confidentiality (continues) (continues) 11  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.”

12. 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) 12

13. Monitoring by RECs (continues) Annual reports from researchers to include:  Progress to date, or outcome in the case of completed research  Information concerning maintenance and security of records  Evidence of compliance with the approved protocol  Evidence of compliance with any conditions of approval 13

14. 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 14

15. 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 15

16. 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 16

17. 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 17

18. 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. 2 nd ed. Pretoria: Government Printer. 96 p.