SELIBE PHIKWE & MAHALAPYE IRB TRAINING

The Ministry of Health, Health Research and Development Division (HRDD), University of Botswana, Office of Research and Development (ORD) with the support of BoCTRe project undertook a trip to Selibe Phikwe and Mahalapye to capacitate  the Institutional Review Boards (IRBs). 

The workshops were conducted in Selibe Phikwe and Mahalapye for a week each group. Selibe Phikwe team was facilitated on the 24th – 28th July 2023 and Mahalapye on the 31st July – 4th August 2023. The first group which was at Cresta Bosele Hotel, Selibe Phikwe had 10 participants from Selibe Phikwe DHMT which include Selibe Phikwe, Mmadinare and Bobonong, and 4 facilitators. The second workshop which was held in Cresta Mahalapye, had 11 participants from Mahalapye and also 4 facilitators.

Objectives
Broad Objective
To build capacity of NEC, IRBs, NRA  and investigators.

Specific Objectives

• To build capacity amongst participants on review and appraisal of research protocols
• Decentralization of health research protocols review
• Brainstorm on how the review process will be implemented and monitored

Facilitators

1. Kgomotso Motlhanka
2. Dr. Lesego Gabaitiri (Mahalapye only)
3. Dr. Dimpho Ralefala
4. Ms. Julia Goarekwe (Selibe Phikwe only)
5. Oduetse Moaletsane

Lessons Learned/Shared to IRB members

1.      History of Research Ethics

2.      Regulation of research ethics

• International Guidelines
• National Guidelines
• Case study

3.      Good clinical practice

4.      Fundamental Ethical Principles

5.      Informed consent &Assent

6.      Research Requiring vulnerable populations

7.      Research Proposal Format

8.      Assessing Risk benefit Analysis

9.      Research Requiring special considerations

10.   Community Engagement

11.   Audits & Inspections

12.   Fundamentals and Elements of the review process

13.   Special considerations during the review process

14.   Health Research & Development Division (HRDD) forms:

15.   Composition and management of IRBs

16.   The role and responsibilities of reviewers and IRB members in the review process

17.   IRB communicating with investigator, regulatory body

Recommendations/Action to be taken
 

1.     There is need for clear Terms of Reference for IRBs as they often find themselves clashing with Investigators, especially those in Multi-centered studies, and Monitoring and auditing is needed

2.     Create a WhatsApp group, where discussions and clarifications can be sought and open discussions to all IRBs

3.     Training need to be allocated more time

4.     More feedback needed on studies done in our facilities

5.     Consider having officers of Research in Districts

6.     Committee members should do free online ethics courses, HRDD will share online course/conferences and invitation to join in training other IRBs

Conclusion

The training sessions went distinctively. Trainees actively participated in lengthy discussions and asked questions. Participants wish for continued interaction and good communication with both NRA and NEC. The trainings ended with module assessment and overall training evaluation. Pre and Post Assessments revealed a significant improvement in understanding of the modules.