1. Participation of Patient Advocates in Community Advisory Boards How to organise a Community Advisory Board?

2. Organising a CAB
Community Advisory Boards can be established in different settings and follow different procedures:
CABs which are specific to a research institution or a single trial are usually organised by the researchers;
Industry initiated CABs are often set up by the company itself, who can select members and organise the meetings; in this case ensuring CAB members independence is crucial;
CABs working on a specific therapeutic area are usually set up by the organisation/s representing people living with that particular disease to discuss specific issues with pharmaceutical companies or researchers working on medicines R&D for that disease.
In this presentation, we will focus on CABs in a specific therapeutic area.

3. Organising a CAB meeting
Three phases can be identified in the process of organising a CAB meeting:
Before the meeting
Clarifying purpose, functions, and rules
Funding
Defining the agenda
Selecting participants
Taking care of the logistics
During the meeting
Chairing the session
After the meeting
Follow up

4. Organising a CAB meeting – Before the meeting
1.1 Clarifying purpose, functions, and rules
Plan efficiently: meetings should have a clear objective and result in measurable outcomes whenever possible.
Establish rules: who is going to ask the questions? Who will moderate the discussion? Is there any specific rule (for example, HIV European CAB meetings participants are advised to limit the use of their laptops during the meeting)?
Allow flexibility: rules observance should not prevent an open discussion on whatever topic may appear as relevant during the meeting.
Confidentiality issues: in many cases, topics which are not in the public domain can be discussed at CAB meetings (e.g. draft trial design before approval, investigational medicines mode of action, etc.). To allow discussion of such topics, participants shall sign a confidentiality agreement.

5. Organising a CAB meeting – Before the meeting
1.2 Funding
Cover costs: It is important that meeting organisers can cover costs incurred by participants, for example travel and accommodation expenses, to reduce barriers to participation.
Find funding sources: these meetings are usually supported by pharmaceutical companies participating in the meeting, who pay a fee to get advice from community representatives.
Optimise resources: every effort should be made to efficiently use funding; for example, meeting with different pharmaceutical companies in separate sessions at one occasion.
Manage correctly: fair and transparent funding management is crucial; this will limit criticism and risk of legal prosecution.

6. Organising a CAB meeting – Before the meeting
1.3. Defining the agenda
Set the topics: the range of topics and questions that will be addressed during the meeting should be identified as precisely as possible: is the meeting just about medicines development? Will access issues be addressed? Are participants asked to provide advice on specific issues (i.e. trial design or information campaigns)?
Know who you are meeting: it is important to be informed about R&D activities of the pharmaceutical company related to the topics proposed (for example, performing a search on clinicaltrials.gov or a literature search).
Plan questions in advance: a list of questions should be prepared in advance with inputs from the participants (and also other community members if possible); the list can be sent to the company ahead of the meeting, to ensure that all the questions are answered and that CAB participants can provide the requested advice.
Allocate time: having enough time to discuss all the topics of interest is crucial.

7. Organising a CAB meeting – Before the meeting
1.4. Selecting participants
Act according to the agenda: the selection process should be guided by the agenda and participants should represent subgroups affected by or interested in the topics to be discussed.
Promote representativeness: participation of people who are able to bring input from their groups into the meeting and to communicate outcomes back to them should be encouraged.
Ensure good contribution: participants should have the knowledge to contribute to the discussion in a meaningful way.
Allow training: less experienced people should be included if possible and they should be adequately mentored in an effort to give them opportunities to improve their knowledge and skills.
Be aware of conflicts of interest: potential individual conflicts of interest should also be taken into account.

8. Organising a CAB meeting – Before the meeting
1.5.Taking care of the logistics
Choose the right place: meeting rooms should be accessible, silent, big enough to accommodate all participants, and allow for privacy.
Ensure availability of technical tools: for example, check need for a microphone, WIFI, a computer, a projector, etc..
Help with travel arrangements: though it is not always the case, some organisations provide support to participants to organise their travel if needed; participants coming from certain countries may need a letter to apply for a visa.

9. Organising a CAB meeting – During the meeting
2.1. Chairing the session
Respect the agenda: timekeeping is crucial to allow all agenda topics to be discussed as planned.
Moderating the discussion: conflicts or difficult discussions may occur and the meeting chairperson should be prepared to deal with that; sometimes challenging discussions may be good for the meeting while others may not be productive and should be stopped as soon as they start.
Keeping the discussion with presenters: CAB participants should avoid debating amongst themselves when the pharmaceutical company is in the room; any internal differences of opinion should be settled within the group privately.
Creating a welcoming environment: participants should feel they can speak out and contribute to the discussion easily.
Focus on objectives: each discussion should be followed by a brief summary of outcomes and next steps.

10. Organising a CAB meeting – After the meeting
3.1. Follow up
Keep the conversation going: a single meeting cannot solve all problems or address all issues; a constant flow of communication between communities and researchers can ensure everything will be addressed properly.
Minutes with assigned action points: sending an to all meeting participants outlining all points of interest and next steps recorded during the meeting for review and agreement.
Track progress: follow up against agreed action points.
Evaluate your meeting: participants should be asked to provide their feedback to the meeting, about both logistics and content.

11. References
EATG ECAB, “The impatient Patient - From Anger to Activism” A systematic review of the history, working models, relevance and perspectives of the European Community Advisory Board
EUPATI, Guidance for patient involvement in industry-led medicines R&D, in-industry-led-medicines-rd/
EUPATI, Guidance for patient involvement in ethical review of clinical trials, involvement-in-ethical-review-of-clinical-trials/
EUPATI, Examples of Patients Involvement,

12. References
Kennedy C, Vogel A, Goldberg-Freeman C, Kass N, Farfel M. Faculty perspectives on community-based research: “I see this still as a journey.” Journal of Empirical Research on Human Research Ethics. 2009;4(2):3–
MacQueen M. et al, What Is Community? An Evidence-Based Definition for Participatory Public Health,  Am J Public Health. 2001;91:1929–
Newman SD, Andrews JO, Magwood GS, Jenkins C, Cox MJ, Williamson DC. Community advisory boards in community-based participatory research: a synthesis of best processes. Prev Chronic Dis 2011;8(3):A
Quinn SC. Ethics in public health research: protecting human subjects: the role of community advisory boards. Am J Public Health. 2004;94:918–

13. References
Silvestre AJ, Quinn SJ, Rinaldo CR. A Twenty-Two-Year-Old Community Advisory Board: Health Research as an Opportunity for Social Change. J Community Pract. 2010;18:58–
South African National Health Research Ethics Council (2012). Guidelines for Community Advisory Groups. NHREC – delines%20for%20Community%20Advisory%20Groups%20for%20Researc h%20(2012).pdf
Strauss R, Sengupta S, Quinn S, Goeppinger J, Spaulding C, Kegeles SM, et al. The role of community advisory boards: involving communities in the informed consent process. American Journal of Public Health ;91(12):1938–