Lesson 1: discussion question (post here for course credit)

Based on my optimum understanding and what I have learnt so far GPP Awareness has been entrenched into any clinical research policy in Nigeria. And most research implementers in our site do have little understanding of GPP Concepts not really entrenched in their understanding. I believe this On-line will go  long way in making sure we all can make a Change and build our capacity as GPP Advocates and also push for it to be entrenched at the national research regulatory board in our various countries.

Knowledge of GPP varies significantly among members of my team.  Most people are aware that it exists and I had encouraged people to participate in the last training.  We plan for an abbreviated training/presentation to an extended team within the next two months.

People are quite interested.  Even at the highest levels of the corporation, we are evaluating how we can incorporate the principles as  much aas possible.

GPP i very important in research and when you work in the cimmunity.
it gives you a good understanding about participation.
it must be implemented in the research world
GPP is not GCP

There is not much experience within the sponsor team with the GPP principles. Only 1 colleague really received training (and has recommended it to complete team). Although we have tried to reach out to the stakeholders it most often has caused some “side effects” as the communication was started too late whereby you always end up in a stressful situation. and stress if of course not contributing to open communication, and good site relationship.
If I look objectively to the current trial, one major item is popping up. The set up should have used a more proactive approach, taking into account the different aspects , partners and stakeholder groups together with all their (linked) processes. I think that our current trial really encounters every possible hurdle but we made it so far. although working with a lot of different parties in a relatively new research field, caused a lot of unforeseen delays, I also think that the potential learning curve is big and exciting. and I really appreciate the patience of all our stakeholders because although there were high stress periods, they stuck by our side and we are moving ahead. I really do hope that for future trials, time is taken to really implement the lessons learned and to engage with all parties in a pro-active way.

In our company, the principles and the importance of GPP is known but not widespread throughout the organization. The intention is that several people follow this course, act as ambassador for GPP within the organization and implement (some of) these principles within our processes and workflows. As such, I am very excited to learn more about GPP. 🙂

The  knowledge About GPP varies among team members but the practices tied to the principles are evident if you observe how members carry out their tasks and duties.The community team is well versed with the concepts ,the flow of procedures for example how to go about with recruitment for a new study,who to talk to first,who to bring on board,how to create rapport in order to strengthen ties but this may change in other departments.Perhaps it should be a requirement for all individuals involved in research activities.

I totally agree with Mahesh view that sponsors should adopt GPP.The way GCP is mandatory in research GPP should equally be mandatory.

To a great  extent my entire research team have a good understanding of the value of GPP and stakeholder engagement. They are aware of the fact that each and every member has an important role to play for the success of any trial.

The ATMI (access to medicine index) is also focusing on GPP.

Until very recently I have never heard of GPP before, GCP and GMP yes, but not GPP. Maybe that is why I was asked to join a working group that is reviewing how to implement GPP first in the vaccine HIV clinical research department and later maybe cross company. However I have a lot of colleagues who do know (a lot) of GPP, some in my team. I work for a sponsor and we want to accomplish to implement GPP by providing sponsor specific guidelines to first raise awareness and facilitate the implementation of GPP in our (sponsor) organization, as we have a slightly different view on GPP as other stakeholder may have, from a financial point of view but also from ethical and pragmatic point of views.

I would say that everyone on our research team has at least basic knowledge of GPP; however, I think that some members of the team are mistaking GCP and GPP for one another and focusing more on GCP. Even in doing so, the importance of stakeholder involvement and engagement should be recognized and taken into consideration, but I do not think this is always the case with every member of our research team.

As a program coordinator for recruitment and community education, I can say that, although the depth of our understanding may vary, both our other recruiter and I are more aware of the intrinsic value of GPP than our PIs, Nurse Coordinators, and administrative staff. This is because we sometimes find it difficult to convey changes that may be necessary in order to better facilitate those who are potential trial volunteers, current trial volunteers, or even those who just drop in to find out what it is that we do. Often times, the feedback revolves around some staff members feeling like our suggestions will take too much time or resources, or that we’re just plain trying to do too much to make participants feel comfortable, but not around the importance of why we are making the suggestion and how it relates to the principles of GPP. This also leads me to believe that the majority of our team thinks that GPP is only up to recruitment/community education. I believe that our administrative staff probably have the least amount of understanding of the value of GPP because they do not work with participants or community members directly.

I’m hoping that, by the end of this course, I will have learned more about how to implement a strong stakeholder plan that will convey the importance of GPP to both my team members and our community.

I have not taken part in Lesson 1. Due to technical problems, I just now succeedded in accessing the Course platform. As a program advisor for my organisation, I deal with community empowerment so as to enable them to own their issues of health, education, environment and broader development. As such My tasks consist of educating and guiding community so as their interests are served at best. I am used to using the term  of Community engagement. Which involves taking into account the principles of Autonomy, added value, non malevolence and justice. I am currently unaware of GPP.

In my group, we are very conversant with GCP than GPP. Although the understanding varies among members.We are involved in organizing meetings, identifying potential risks,and other logistics. But now i have a better understanding of GPP which will be beneficial to entire members.

The research team understands community engagement to a reasonable extent, other than the community programme team that has a better understanding of community engagement. Clinical and pharmacy teams, specifically understand the role of the community programme team, but they do not have an understanding of GPP. CAB members have been involved in GPP activities, for example, they all were issued a GPP book, discussed the content in bits during monthly meetings and an AVAC fellow-2011 visited my site to engage CAB members about GPP.

Sad i have missed alot, had challenges with my internet.

Through my observation i would not say that my entire research team have an understanding of the value of GPP.

personally, the first time i came across the GPP guideliness was when i participated in Engagement Forum 2015 facilitated by Jessica, Stacy and their friends in South Africa.
The first time i got that small powerful book/bible, i understood why sometimes we have challenges in getting the intended results, surport, colaborations or involvent in our trials.

GPP guideliness are a poweful tool or a road map that would help to make any trials even in a difficult enviroment to yield the needed result. GPP guidelines are like a balanced diet, it covers the requirements/needs for all stakeholders.

Personally am so excited to have this opportunity to learn these powerful principles in the GPP guidelines.

I feel my research site team has some knowledge on on the stakeholder engagement but not the full knowledge on GPP. On the other hand i feel somehow we partily practice GPP guideline without knowing.

I feel the GPP team still has a long way to take these GPP guidelines around the world for the good all.

I also feel the GPP team shoul consider introducing a degree on this GPP online course

Thank you

Sad i have missed alot, had challenges with my internet.

Through my observation i would not say that my entire research team have an understanding of the value of GPP.

personally, the first time i came across the GPP guideliness was when i participated in Engagement Forum 2015 facilitated by Jessica, Stacy and their friends in South Africa.
The first time i got that small powerful book/bible, i understood why sometimes we have challenges in getting the intended results, surport, colaborations or involvent in our trials.

GPP guideliness are a poweful tool or a road map that would help to make any trials even in a difficult enviroment to yield the needed result. GPP guidelines are like a balanced diet, it covers the requirements/needs for all stakeholders.

Personally am so excited to have this opportunity to learn these powerful principles in the GPP guidelines.

I feel my research site team has some knowledge on on the stakeholder engagement but not the full knowledge on GPP. On the other hand i feel somehow we partily practice GPP guideline without knowing.

I feel the GPP team still has a long way to take these GPP guidelines around the world for the good all.

I also feel the GPP team shoul consider introducing a degree on this GPP online course

Thank you

The understanding of the GPP among the team is quite good, they understand the importance of implementing GPP when doing community engagement and the fact that at our site we have a GPP team that is responsible for making sure the the principles of GPP are implemented and followed helps a lot.

At my site, the PI and the study cordinator are aware of GPP but they have left it to be a community educator’s baby. I think the course should be made compusory like the GCP and HSP ones so that all people involved in research have the knowledge of GPP and that way the implementation of the guidelines and principles will be enhanced.

I came to this course thinking that I have a strong understanding of the underlying principles of community engagement, but desiring to bolster my understanding of the structured ways these principles are codified in the GPP document. I think that’s true of the research staff at my site. We are long established and primarily working on NIH network trials in the US; these networks have long since been deeply invested in community engagement here and have very much internalized these values. I’ll be making some queries to see if there are gaps that I can help fill both in terms of staff knowledge and educating the CAB about GPP.

To what level is the line drawn when it comes to community involvement in recruitment and avoid it becoming ‘conflict of interest’ ?

At my organization there is limited knowledge about GPP principles and guidelines. I am more than convinced that this forum will help us get equipped with knowledge  and skills that we shall use  to further our work. This  course is so timely for us.

I must say that  for me GPP is a bit alien to my study team .I have seen instances where GPP has been misconstrued to mean results dissemination.It only recently that I saw a sponsor indicating the need for GPP  as a standard operating procedures.I have also seen situations where GPP is confused with community involvement. GPP in my research team is also taken to mean recruitment of study participants .However GPP is yet to take root in my study community from the study conception phase to study completion phase.

Regards

Peter

Also, i frankly agree with Mr Bamidele on the Great benefit being part of capacity building on GPP. Its just the right time in the right direction during an era where research is gradually becoming a priority to improve health for all.

Dear convener
The team is aware on the concept GPP however they have not had a chance to see it in practices. we must remember the community engagement is not normally taken seriously in some cases in the past however as the demand to give the COMMUNITTY ENGAGMENT serious recognition and as compulsory activity from sponsors is now it is take n serious. the team at my side would be open to have an insight from GPP because gradually they see the fruits it bore when it comes to successful recruitment and retention targets as suggested by CAG. The site leadership has taken important decision to even include everyone in the training of GPP including general staff ( cleaners etc.).

Thanks
Lucky

Hope you having a lovely day dear colleagues, and sorry for joining a bit late, was a bit ill.

In my research  team, GPP is moderately practiced the elements have been well embedded yet in process. Currently, am orientating members of my research team on GPP for now and i gladly believe they start accepting the tenets of GPP as sustained practice that enhances research

Anthonia, you actually spoke my mind on GCP versus GPP. Most proposals in my country are currently being reviewed on the basis of GCP and GLP as far as ethics is concerned. This GPP course is very timely for me.

I agree with all your comments. I admit here in my institutions we all having limited knowledge about GPP.  After hearing and understanding the guidelines of GPP, I got that we were  following GCP. GPP and GCP both are different things.  From lesson 1  I got idea that sponsors should be encourage for the adoptions of GPP guideline. Personally I believes the GPP guideline is very important, and assure that after completions of this course, lots of things change we will engage the stakeholder Not recruit.

Mahesh

I totally agree with all your comments that GPP plans and stakeholder engagement should be something that is actively understood and practiced by all members of the team. In reality, however, this is a different story. People in my organisation definitely see me as the GPP person and that that is my role (which is it to coordinate GPP strategy and plans) but the idea that one person  can be responsible for the engagement, communication and education of all stakeholders is not a realistic or practical. It would be great to indicate to our teams that GPP plans should underlie everything that the project is doing and I agree with Kathrine, that having the sponsor on board for this would go a long way.

The trial in which I am involved is still in its very early stages of planning and will take place in a country and at sites that have not previously had any multinational HIV prevention trials.  From my perspective there is extremely limited knowledge about GPP across the whole research team, including the sponsor, the protocol development team, sites investigators being vetted for participation, regulatory bodies, not to speak of community stakeholders.   One very concrete learning from Lesson 1 is the idea that the sponsor should adopt the GPP guidelines as a requirement — this will be a goal which should be achievable with sufficient explanation about GPP and the ways in which they function to strengthen the overall trial design and implementation.  It is very encouraging to read that in other sites the whole research team is knowledgeable about and invested in GPP and gives me hope that we will get there as well.

I am glad that this question has been raised, because some of our CAB members confuse GCP and GPP to be one and the same thing there is a distinction between the two that needs to be clarified among the stakeholders and this course will provide that platform as far as I am concerned. GPP gives a more clear outline of stakeholder involvement whereas GCP is somewhat restricted to site staff only in most cases.

There is a good understanding among the Ndlovu Research Centre team members on the value of GPP and stakeholder engagement. Although not everybody links the principles to GPP, they follow the guidelines indirectly. The entire team is involved in organizing continuous events, meetings and information sessions for participants and the community and explaining the trial to community stakeholders, under guidance of the Community Team.

Based on lesson 1 that I received this morning, I am of the opinion that my research team as a whole has an average understanding of GPP. But at individual level, this understanding varies. This is because we take so much cognizance of good clinical practice (GCP) rather than GPP when engaging the stakeholders at trial participant and community level. We provide information about why the trial, how it will be conducted, logisitics, risks, confidentiality, compensation/reimbursement, autonomy etc. We allay their fears regarding the potential risks (e.g stigmatisation, discrimination, marginalisation where possible). Although individual opinion varies, as a whole,I think we don’t give much time for understanding the perception and expectations of the community, which is very important as I know GPP now. We are too conscious of the budget and are somehow resistant to unplanned request of the community.

I think our entire research team is familiar with the ideas of GPP.  As the community educator, I get to see first hand how our entire team works to include the community in our research.  The main way our site engages the community is through our Community Advisory Board.  Every month numerous staff participate in this meeting.  Our clinicians attend to give reports on ongoing studies.  Investigators participate in each meeting by either reviewing a protocol with the board or discussing results of a recent study.

Our site is federally funded and I know that there are community engagement activities we need to complete in order to obtain our funding, but in the 3 years that I’ve worked at this site, I have never heard our community engagement activities be referred to as anything but essential to good research.  This has never been a time that I felt that our team “was going through the motions”, rather there is a strong desire to get community input so our research will do well.

From my point of view, the GPP should be taken into account for all inquiries. At work, my colleagues  know about it but unfortunately, the group formed for this purpose still does not have sufficient capacity to ensure the application thereof as a whole is a weakness that we must improve and we are in the process of doing so.

GPP is very important between my colleagues , but obviously, some of them (projects managers, researchers) are not  familiar with this and they think that is important but does not have the tools to make it possible for the implementation of the research. My institution improves a CAB, but sometimes I perceive that CAB members need more training or maybe more encourage to be involved in research. I would like to believe that after this training I could help a little bit more with this work.

I would say that understanding of GPP among members of the research team varies quite a bit. some have rather good understanding and are committed to follow its principles. Others acknowledge the importance of GPP and community engagement, but they tend to have a position were community engagement is more of researchers “educating” the community and getting the community groups to “fall in line”.  This type of attitude doesn’t necessarily translate into outright disrespectful behavior, in fact mostly they are still very nice in engagement. Nevertheless, researchers with this attitude tend want to design engagement so that they can better control the implementation of the research, rather than let different voices blossom and be discussed.

GPP is at the heart of all stakeholder engagement and the research team is committed to embracing the GPP guiding principles throughout the implementation of the study. All members of the research team have been trained on the GPP Guidelines in order to facilitate effective implementation of the GPP Guidelines. Additionally, there is a sub-committee which includes a small group of CORE members with experience and expertise in communications and GPP activities.

Hi Santorra,

I’m not sure of the reason behind our PI’s rationale for her desire to improve in community engagement among certain community stakeholders including Black, Latino, and trans*people whether or not they are straight or gay identified.  I think it’s because she feels that these stakeholders are the most affected by HIV/AIDS and she feels we owe it to them to include them in trials for which they will have the most benefit if successful.  Data for vaccine studies in the U.S. demonstrate that white people are most likely to join a trial, although we all know that Blacks and Latinos bear the highest burden of the infection.  We understand that more resources are needed to engage these communities and the community education and recruitment funding we get for studies is never enough to invest adequate resources among Black and Latino (again, including cis-gender and trans*people) stakeholders.  Hence, our PI looks for other resources.

I think it also has to do with thinking long-term.  If we effectively enroll stakeholders into studies that are most likely to benefit from an effective product, then the people that most benefit from the product may be more likely to use the product if the product is found to be effective.

~Jorge

I’m surpised that some sites have not had any GPP training and, considering its importance, I agree that GPP should be a requirement.

Jorge, I think it’s pretty awesome that, even though you guys haven’t been trained on GPP, that your PI still takes the time to try and secure funding for your team’s assessments. Was that something that you had to convince your PI to do, or did he already understand the importance due to his experience and GCP?

I think I agree with Jorge: it would be great if GPP was a requirement. It has been shown that training in GPP increases support for GPP guidelines across all 16 areas and its relevance in research (see Ngongo et al., 2012). I’m currently look at ways to monitor and evaluate GPP awareness, acceptance and implementation (when engaging MSM communities). Any information would be appreciated…

To what extent does your entire research team have an understanding of the value of GPP and stakeholder engagement? For example, how does understanding vary among team members? Explain your answer.

I feel that my co-workers at Columbia Research Unit (and I) have not been trained on GPP, therefore we do not have the capacity to value GPP, however my co-workers and I do understand the importance of engaging with community stakeholders from experience and other training modalities like GCP courses before, during and after the implementation of trials.

We have undertaken projects that include creating spaces for people of different racial, ethnic and cultural backgrounds to have a voice about the trials we conduct and how specific trial results would affect them.  For  example, we share a diverse community advisory board of 19 people whose makeup includes heterosexual, gay and trans*women of from different age groups and racial/ethnic backgrounds.  We are working on the inclusion of at least one trans*man.   We have conducted assessments of knowledge, attitudes, barriers and motivators towards HIV vaccine research among different communities that included Latinos, health providers, men that have sex with men, women that have sex with women, black women, hetero-men, hetero-women, trans-women, and trans*men. We have also hosted a forum along with another CRS in NYC to allow people from the LGBT community to ask questions about PrEP when it was first licensed and to voice their opinions as to how the implementation of PrEP would affect how sexual practices may be affected.

Our principal investigator is often on the lookout for funding to allow these assessments and events to happen and the rest of the staff all chip in to allow these activities to come to fruition.

It would be great if GPP was a requirement and if there would be funds allocated solely to carry out GPP, in addition to operational and community education and recruitment expenses!

• This reply was modified 8 years, 8 months ago by Jorge.

The value of GPP and stakeholder engagement is highly regarded among the members of the research team that I am part of. I think GPP’s guiding principles and the practices are perceived as valuable when the goal is to successfully identify and develop mutually beneficial relationships with community stakeholders. Although there is an understanding and appreciation for GPP, most of the awareness revolves around the principles (respect, mutual understanding, etc.) which are related to research ethics (and overlaps with other disciplines e.g. values of community psychology, such as empowerment and self-determination; collaboration and democratic participation; health, wellness and the prevention of psychosocial stress; and social justice). Awareness and understanding of the 16 GPP topics (stakeholder engagement activities), I think, are general and some of the topics are perceived to be more important than others (formative research, advisory mechanisms & informed consent vs. communication and transparency & policies and documentation). As a research topic, I do not think the entire team is interested in GPP and/ or regard community/stakeholder engagement as an important activity in scientific research (which probably relates to an entirely different forum question).

• This reply was modified 8 years, 8 months ago by Neil Ryan.