Defining stakeholders for the review of an international study protocol

Hi this is a challenging situation to our site, we also receive most of the protocols in final stage, although ocassionally we have an optoni of having a site specific addendum if there some areas, where the site can not comply or study on that particular area (for example, recruiting transgenders as is a rare or even unknown to our societies). At least the site is able to modify few areas, otherwise the CAB are most of the time engaged in review of the Informed consent and other recruitment materials.

Hi Heidi,

The example from Thailand may give you an idea about reviewers for international study. For HIV vaccine research, every study has to get approval from the national sub-committee for HIV vaccine research. The sub-committee have regular reviewers to review all the protocol – most of them are MD/researchers, and only one is representative of NGOs. It isn’t an ideal approach but at least there is one non-scientist reviewer who provide community perspectives. So far, the comments and suggestions by the NGO representative were responded to accordingly in writing and in revision of the original protocol. I think that IRB that includes community member can do the same.

This still doesn’t answer your question about how to select the reviewers. Based on my experience, reviewing protocol and related document is time-consuming and very challenging for non-scientist. I also feel that even the researchers themselves find it is time-consuming and they often read only the parts that interested them. Therefore finding the reviewers have to based on the person’s experience (and knowledge) and willingness.

For Jessica’s question on how to overcome the top to bottom approach, I think capacity building for CAB is very important specifically about GPP. Another one is to provide protocol document or detailed summary of the study to CAB in advance before the meeting so that they can study or discuss with other people before the meeting. Another example from one CAB in Thailand is  to allocate tine for a closed CAB session in each meeting. This will be the opportunity for CAB members to discuss candidly without the presence of researchers and the team. The decision or discussion can then be presented to the researchers anonymously.

Udom

I  believe there are reviewers of community protocols social scientists  who have capacity and can be able to do a good job.

Hi all, Charles has summarized on what happens in our local setting. In addition, a mechanism should be put in place to ensure CAB members of participating site get an opportunity during protocol development to give their input so that they do not appear to be rubber stamping what scientist have already deliberated on.

Clever- I think  your point is an interesting one! I took your statement to mean that researchers approach community with the specific points they want feedback on and don’t leave community with the enough room to comment. The researchers are dictating to the community what types of feedback they are looking for.

Do you have any solutions that could over come this top to bottom approach to engagement?

The biggest problem that I see is that in most cases the engagement is top bottom. The researchers tend to dominate the whole process thereby giving little attention to the inputs from the CAB members. The CAB members are in most cases at the receiving end.

Hi everyone, I find this a bit challenging because we usually receive the protocol when it has been approve and then we review it with the CAB. So, even if the CAB has got some ideas nothing can be done about it.

So based on our experience any CAB member can have their capacity build to review any protocol in the HIV field.

In our site  our CAB vice Chair sits on the ACTG Global CAB (GCAB). Every time a protocol is being developed he receives a draft which he shares with other members during their monthly meetings. A questionnaire accompanies the draft which tries to establish;

i)  whether members understand the protocol

ii) whether it addresses or tries to answer a problem that is relevant the site

iii) whether members would participate  in the study if they qualified.

To assist CAB members review the protocol we get one of our scientists to take members through the protocol, demystify the medical jargon thus helping them review the protocol. In our case therefore we do not expert CAB members but get experts to help members understand the protocol  so as to have the capacity to review.