groups » Research Ethics » IMPROVED RESEARCH ETHICS REVIEW PROCESS FOR STUDIES DONE ACROSS THE NATIONS
Often times, we receive proposals from researchers from the Western World requesting for ethical approval of a studies that have either a component in Western World as well as Uganda or Researcher in Western World wanting to do research in Uganda. Research protocols falling in either setting need clearance from both the researcher's institution in the Western Country and Uganda. In the process the researcher goes through ethical review process in the home institution, then starts the process all over again in Uganda. Whereas, we all need certainty of safety and autonomy of the research participants and to be sure that the investigator is qualified and has presented a scientifically sound protocol, the process of research ethics review in two countries is a very demanding process, often involving a lot of time (delay in execution of the study), tiring for the researcher and often duplicates the process.One way we are starting to view the way forward is to have Dual application and review process. This means, the researcher presents the request for review to both our IRB as well as the home institution IRB at the same time. However, the researcher links the two IRBs so that they sort out ethical issues together. By the time the IRBs come to the researcher, the latter has a final position from both IRBs. This in addition would promote networking, capacity building, sharing of resources, bridges the gap that may exist between the IRBs in the two settings and promotes research.
However, we anticipate some problems due to electronic/technological development differences, confidentiality issues and archival of research information.
We hope to pilot this idea, we welcome ideas, comments and contributions to shape this project.
MRHIRC, Mbale, Uganda.
In our opinion, summarized in the paper "R Ravinetto et al. Double ethical review of North-South collaborative clinical research: hidden paternalism or real partnership? TMIH 2011; 16 (4): 527-530", the double ethical review may strengthen the protection of the study participants and their communities, because it builds on complementarity of views. Unfortunately, ethics committees usually do not proactively seek communication with the other ethics committees that evaluate the same research protocol, e.g. asking information about binding and non-binding comments they raised.
This is a missed opportunity for a mutual learning process among ethics committees from different contexts. Such a communication could provide a space where agreement is reached on common ethical practices and standards, e.g., on informed consent, on indemnity and on harmonization of administrative requirements, where more efficient models and schedules for international ethical reviews are built and where cases of conflicting opinions in
different countries are resolved.
Therefore, I would really welcome your ideal of piloting a system where the ethical review would be carried out based on communication between the ECs in the North and the South, and hope you will keep us updated with this experience,
I will be very interested to hear how you get on with this and if there's any way I can help please let me know.
A number of researchers and empirical studies have suggested that direct IRB to IRB communication would be valuable to stop researchers being placed in the middle of conflicting responses from ethical review but I'm not aware of many examples where this has happened.
I am not sure this is the correct option. Accepting decisions from the IRBs in the developed world in the developing world has indirect implications on the capacity building in ethics in the developing world. However joint decision making if practical is good. However cultural sensitivities and differences needs to be kept in mind
Thanks for sharing. Multiple IRB reviews are very common epecially in international collaborative research and as you stated, this poses a lot of challenges to researchers. Most western IRBs often require proof of local ethics approval as well. Therefore, the local IRB is expected to make the final decision.
I think your proposed plan to streamline the review process by linking the two IRBs is laudable but will require someone (a coordinator) to actively engage the two IRBs in the process.
There are some examples of joint IRB reviews where a selection of members from both IRBs meet to discuss the protocol and make a joint decision. You could explore this approach as well, although this also presents some logistical challenges and might not be feasible for every research protocol.
I suggest that you begin by initiating some discussions with the western IRB first and agree on an approach that works for both of you bearing in mind the challenges you have highlighted.
I agree with you that we need to be promoting more communication and networking between IRBs, afterall we have the same goals.
This is indeed a good idea. We hope that the IRBs consider that. We often have to get multiple IRB approvals - home institution IRB (or sponsor IRB), local IRB, and funder IRB (eg WHO). I also think that there should be some way of defining a 'primary' IRB when multiple IRBs are concnerned. The primary IRB should be the local IRB and makes the final decision.