This blog is closed to new posts due to inactivity. The post remains here as part of the network’s archive of useful research information. We hope you'll join the conversation by posting to an open topic or starting a new one.
In our setting, our protocols take an average of a yearto be approved by three different IRBs/ IECs not to mention the regulatory body. this involves alot of back and forth through the the different IRBs/IECs sometimes leading to the site staff getting mixed up with the whole process! does any one out there go through a better process and if so kindly share how your IRBs/ IECs operate? does this have to take that long? kindly share
-
achapal
24 Aug 2010
Yes in India it is also the case. However it would be good to look at this properly and come up with some suggestions to help our overloaded committees. Does anyone have any suggestions?
-
cdiaz
21 Jul 2010
Yes this is true also in Latin America. I think ethics and institutional review boards are overloaded and also often do not have good training. Review times vary so much and it is difficult to know how long it will take to get a trial approved.
-
Raffaella Ravinetto
14 Jul 2010
We have also been witnessing sometimes very long approval timelines, especially in North-South collaborative studies and in multicentre studies, where the same protocol must be submitted to several bodies. I am absolutely not against the multiple submission (I think it is important that the protocol is checked in all the study countries, and also in the country of the sponsor/funding agency), but ways should be found to make the overall timelines...reasonable.
One of the major problem is, in my experience, the "unpredictability" of the timelines of some bodies. Unfortunately, some ECs or IRBs do not have clear public policies giving timelines for the submission process. This is something that should be improved, to allow researchers to be able to make a reliable plan of activities. -
Moses
6 Jul 2010
Yes I agree. This is an area where capacity development really needs to focus and give these committees more experience and training. They are often under pressure of increasing workloads and need increased knowledge in order to know what is important and where is is acceptable to be practical and flexible.
-
Moses
6 Jul 2010
Yes I agree. This is an area where capacity development really needs to focus and give these committees more experience and training. They are often under pressure of increasing workloads and need increased knowledge in order to know what is important and where is is acceptable to be practical and flexible.
-
Steve Wandiga
6 Jul 2010
One of the things happening to IRBs within East Africa from an initiative through Bill & Melinda Gates Foundation (BMGF) is the harmonization of systems and processes, so I do anticipate a change as globally research in disease areas cannot be localized to a country and so researchers would like to target regions. Change definitely is inevitable.