Q. What is the difference between IRB and REC?IRB-Institutional Review Board and REC-research ethics committee are ethics committees charged with the mandate of reviewing and monitoring of research proposal that involve human participants. In function, they are virtually the same.
Q. I am a foreign student; I have obtained IRB approval from my Institute, do I need another ethical approval when I’m collecting my samples from Ghana?
Yes, because the research would be conducted in Ghana and participant’s rights must be in consonance of the country’s law that is stipulated in the constitution of Ghana and University of Ghana research policies.
Q. Do I need a local supervisor for my proposal to be accepted?Yes, so to help monitor the research by the IRB and to help you understand the local terrain of which the research would be conducted.
Q. How long does it take to obtain ethical approval?It depends as and when the proposal is submitted for the next immediate meeting and when and how the PI responds to the IRB comments.
Q. How many hard copies do I have to submit?14 hard copies are submitted for review.
6. Can the CO-PI sign the submission letter in the absence of the PI?
7. Can two investigators be PI?
Yes, but it is advisable to have a Principal Investigator to streamline communication between the IRB and the research team.
8. How do I apply for the ethical clearance?
All application requirements can be found on NMIMR-IRB website. You could also call the office line on +233 302916438 for any further clarification.
9. How much fee is charged for ethics review?
No fee is currently charged for a review. However the issue is under discussion and the outcome will be posted in due course.
10. When do you require assent and parental consent forms?
They are required when minors (12-17 years) are being recruited for the study.
11. Do you have to be present during the IRB meeting?
No. However, there could be instances that the PI may be invited to the meeting for particular clarification concerning submitted protocol.
12. Why is it that the collaborators or supervisor should have to be
affiliated with University of Ghana and not any other Institution?
This is required because such supervisors are much abreast with research policies of the University and can give credible guidelines to researchers to work within the framework of the university’s research policies.
13. Why do I have to submit hard copies instead of E-copy which is much
convenient compared to the hard copies and also cheaper?
This is to allow for easy review of protocols and archival documentation.
14. Why must I submit my protocol to other IRBs within the University and not NMIMR-IRB?
Because of the collegiate system, the University of Ghana has set up various ethics committee for the colleges mandated to review specific studies. The PI must consider the protocol and choose the appropriate IRB specific for the particular research of interest.
15. How is the secretariat able to cater for the expenses of the office and the board members of NMIMR-IRB?
The secretariat is funded by NMIMR.
16. If am conducting a study at a different Region in the country, can I submit to NMIMR-IRB?
Yes, provided the PI is collaborating with a researcher within the University of Ghana.
17. Does the IRB print copies hard copies of proposals for PIs who are outside Ghana?
No. This is due to administrative challenges and logistic constraints.
18. Why does the IRB take 14 hard copies of protocols for review?
The board is a fourteen-member committee and is expected that each has a look at the protocol.
19. Can I start my study while awaiting approval from the IRB?
No, the board must approve and issue a certificate of approval before the study can be started.
20. At what point in time does the board conduct expedited reviews?
When the magnitude of the risks for which research participants would be exposed to is minimal.
21. What study or protocol qualifies for expedited review?
When the proposal does not include vulnerable participants, sensitive issues and does not abuse the welfare of participants.
22. Does the IRB really vote on protocols as its stated when you check the
membership on the website?
By regulation IRBs vote but practically decision is taken by general consensus by NMIMR-IRB.
23. In cases where there is conflict of interest on a particular protocol, how does the board deal with it since it can lead to a bad decision at the end of the meeting?
Members that have conflict of interest first of all declare it during the meeting and exempt themselves during the review of the protocol to allow the rest to review and take decision.
24. How does the IRB select or appoint its members to the board?
Members are appointed to the board based on their qualification and experience to review and evaluate scientific and medical ethics of research protocol. The administrator in consultation with the Director of NMIMR scouts for members and make the decision by formal invitation to the prospective member.