Micky Hingorani
Forum Replies Created
-
Hilda , interesting example. very informative. social cultural issues and community beliefs are relatively important at different sites.
-
1) Give an example of successful stakeholder engagement in protocol and/or IC development. What changes were made as a result of the input gathered?
A Draft Protocol is developed. Community and CABS engage to modifying a trial protocol. This Document will outline the trial details and is developed before trial initiation. A range of stakeholders can provide meaningful input into many aspects of trial protocol development
Changes can be the trial protocol changing. specific changes can result in :
population changes and site selection changes
Site selection -Example Community stakeholders, funders and networks engage to evaluate the site to conduct research.
2) If a protocol gets sent to your trial site in final form, how would you address the GPP recommendation for stakeholder involvement in protocol development?
i would first have to see if the engagement plan is linked to the research program. Engage with CABS for input. look at the partnership for stake holder engagement.
-
Hi prudence .. is it because social media was not informed? or informed ?and made aware
-
HI Jess. very informative.its a way to challenge to also educate.i think it will work regarding responsibility and tasking the cabs.
-
Alicia-i agree the past engagement was just for information but future it is at every step of the way engaging.
-
Ross, great example.with education continuous awareness is explained.
-
Jontraye, i have worked with FHI 360, i agree they do support CABS and work closely with them during trials.
-
A draft protocol that was to be implemented in the site was send to the CAB as is common they were expected to fill a questionnaire that asks whether the protocol answers a scientific that is relevant to the site, and whether if they qualified they would participate in the study. the CAB noted that Phase I IND protocol planned to enroll 18 subjects. They disliked the use of world subject because it make people like object that can not exercise any right. They insisted this be substituted with either volunteers or participants. This was changed to participants,
When a protocol is send to the site in the final form, to comply with the stakeholder engagement guidelines the protocol will be presented to the CAB to review informed Consent document this has been our practice. We have now learned that other stakeholders targeted likely to be affected by research ought to be reached, and their research literacy build so that they can be able to make informed opinion about planned research. It will be easy to have their buy in and help in addressing misconceptions.
-
Social media has not had any negative impact on the study. This is because we have not use it. But we still monitor it to be on top of any issue that might raise.
But it has helped in a way because during the stakeholders meeting when we give updates on progress made in the study, some of the participants comment that they read on the internet of watch the news that the vaccine has shown potential for a 100% protection. This gives our study credibility.
-
At our site, the stakeholders are not involved in the IC development, it is done by the funders. The only thing that the site does is the language translations of the community. But the study information is given to the CAB to review and make comments especially with social cultural issues and community beliefs. CAB are given the chance to review the protocol before it is finalized for use
-
1) During a meeting with the CAB to review the initial draft of the study ICF, the CAB read through the IC and documented the things they were not happy and the suggestions that they had. These were all noted and sent to a regulatory representative. Some of the changes were implemented, but not all and these were discussed at a follow up meeting with the CAB members explaining why some things could not be changed in the ICF.
2) The site will still review the protocol with the CAB members and answer and explain any questions and comments they may have. I think having a representative from the sponsor will also be helpful and if there is anything the site cannot answer, it will be escalated to the IRB.
-
At our site, we have never had media reports about the trials we are doing. We have a communication channel to the media with people who are trained to answer any questions about the trials and site. We have had in the past some community rumours of selling blood, infecting participants with HIV. But this was at the beginning, now we are known especially that CAB and participants are our advocate. Although some community members still know our organisation as working with HIV positive people on ARVs because it started on such programmes and still continues with prevention and care of HIV/TB.
-
I do not consider recruitment as a key engagement outcome,
I understand and completely agree that engagement is beyond participant recruitment, however when it comes to Monitoring and Evaluation issues at least recruitment is something that can give us numbers, or can be used as an indicator.
At times we organize engagement activities like a community meeting or event to raise awareness on a trial, we speak, provide leaflets etc, but at the end of the day is not easy to measure and we are even not sure how many people read and understand the leaflets unless we use other ways of evaluation may be administering a short questionnaire before and after. Additionally just like Charles mentioned in most projects serious community engagement is done around recruitment and that is when the money for outreach activities is released to ensure that we get the desired numbers.
I guess is possible to change this perception but it needs more effort to get the PIs and other scientists understand that community engagement is an ongoing process with or with out recruitment.
-
During the IC review for HVTN study the CAB members noticed that there were some pictures which looked scaring. There was a picture of somebody being given the vaccine with a very big needle on each arm. To the CAB members this was scaring and they thought it may put off some people who want to participate. They asked for it to be removed from the IC and it was removed.
Even if the protocol is sent in the final form,the stakeholders meet and review the protocol and make sure that the protocol meets the requirement of the stakeholders. If there are issues that need to be addressed a report should be sent to the protocol team and relevant bodies so that amendments should be made.
-
1- The CAB at our site has a Review committee which is involved in the review of both informed consents and protocols, in one of the recent ICF reviews the committee made recommendations on the wording for the amount of blood to be drawn they recommended that after mentioning the amount of blood to be drawn we should put in brackets the equivalent in table spoons , they advised would help the participants to have a picture of the quantity of blood that will be drawn.
2- Even when a protocol has been sent in its final form the CAB still sits down and reviews the protocol , if and when there are concerns that they feel need to be addressed they are documented and filled at the sites IRB, the site then has a meeting with the review committee to pave a way forward and where need be amendments sent for the review.