1. Improving Process and Outcomes of Ethics Review at Faculty of Nursing, Chiang Mai University Anusra Thaprom, MBA Chawapornpan Chanprasit, PhD Suthisa Lamchang, MNS Pratum Soivong, PhD

2. Faculty of Nursing, Chiang Mai University Overview Introduction Introduction Objectives Objectives Conceptual Framework Conceptual Framework Methodology Methodology Findings Findings Conclusion Conclusion

3. Faculty of Nursing, Chiang Mai University Introduction (1)  Studies with research participants contribute to Advances in human health and welfare Develop knowledge of both medical and social sciences  Unfortunately, not all studies have been justifiable or useful and have caused harm to research participants.  In Thailand, there is no concrete legal provision on research involving participants.

4. Faculty of Nursing, Chiang Mai University Introduction (2)  Ethical review is guided by international standards to protect human rights.  The Research Ethics Committee (REC), Faculty of Nursing at Chiang Mai University, was established in 2003.  REC was accredited by SIDCER in 2013 recognizing that it complied with international ethical guidelines.

5. Faculty of Nursing, Chiang Mai University Objectives To investigate the structure, process, and outcomes of conducting ethical review by the Research Ethics Committee (REC), Faculty of Nursing, Chiang Mai University

6. Faculty of Nursing, Chiang Mai University Conceptual Framework Structure Policy Action plan Standard Operating Procedure (SOPs) Process Activities for ethical review Problem issues when conducting ethical review Outcome Satisfaction with service Donabedian Model (2003) : Evaluating Quality

7. Faculty of Nursing, Chiang Mai University Methodology (1) Design – Descriptive research Research Participants : stakeholders including – 10 REC members and a research administrator – 83 researchers who submitted research protocols for ethical review during Sep 2014 to Feb 2015

8. Faculty of Nursing, Chiang Mai University Methodology (2) Research Instrument Open-ended in-depth interview guide Satisfaction questionnaire Data analysis Descriptive statistics Conceptualized summary

9. Faculty of Nursing, Chiang Mai University Methodology (3) Data Collection Structure Process Outcome In-depth interview Questionnaire (REC members and research administrator) Satisfaction with service (researchers)

10. Faculty of Nursing, Chiang Mai University Findings (1) STRUCTURE & PROCESS The Faculty of Nursing Dean established the REC and provided for protection and support for the operation of the REC so that it could fulfill its functions fairly and independently. Upon the establishment of the REC, its scope of responsibilities, relationships with the investigators both inside and outside institution was determined.

11. Faculty of Nursing, Chiang Mai University Findings (2) STRUCTURE & PROCESS The REC is comprised of both scientific and non- scientific members. The main responsibilities of the REC, like the other ECs, is to protect the rights and well-being of the research participants. The key role of each committee member is to decide independently whether the protocol provides adequate protection. The term for committee members is 2 years

12. Faculty of Nursing, Chiang Mai University Findings (3) STRUCTURE & PROCESS The research findings indicated that the standard operating procedures (SOPs) were followed with the recognition of the rights and welfare of research participants. It is suggested that such SOPs should be regularly modified every 1-2 years. The creation of a document filing system as well as training in research ethics were also carried out.

13. Faculty of Nursing, Chiang Mai University Findings (4) PROBLEM ISSUES consist of 2 main parts Re-Methodology Ethic: – Unclear participant information sheet – Inappropriate language – Technical term – Not indicate essential information

14. Faculty of Nursing, Chiang Mai University Findings (5) OUTCOMES 53(63.9%) Expedited review 30(36.1)% Full-board review Researchers (n=83) Protocol review (n=83) 52(62.6%) 17(20.4%) 9(10.8%) 3(3.6%) 2(2.4%)

15. Faculty of Nursing, Chiang Mai University Findings (6) 40(48.2%) Revised Issues 29(34.9%) 17(20.5%)

16. Faculty of Nursing, Chiang Mai University Findings (7) Satisfaction of researchers (n=83) 26(31.3%) 49(59.1%) 8(9.6%)

17. Faculty of Nursing, Chiang Mai University Conclusion The study results indicated researcher training in ethics is essential. This helps to facilitate the advance of scientific knowledge for the societal benefits, and allows for the effective implementation of REC. Training should include how to properly file applications and amendments for ethical review.

18. Faculty of Nursing, Chiang Mai University