Engagement

UCIMI –COMMUNITY ENGAGEMENT PLAN

(Fact sheet and scope of work)

The mission of the University of California, Irvine, Malaria Initiative (UCIMI) is to promote the discovery and development of novel science for the goal of malaria eradication. This mission is accomplished by providing the necessary intellectual, resource and infrastructure support to test novel genetics-based, sustainable technologies to prevent malaria transmission. The featured activities are to develop and field-test genetically-engineered strains of malaria vector mosquitoes for population modification in collaboration with scientists and public health personnel from disease-endemic countries.

Who and what comprise the community?

Lavery et al. (2010) recognized that ‘what constitutes a community for the purposes of a research project, or how to identify its members’ is not precise. Therefore, we have adopted the defintion proposed in that publication that was based on two principles proposed by Brunger and Weijer (2006). ‘First, the community comprises at least those individuals who share identified risks associated with the proposed research project. Second, that the community is not pre-existing and established, but rather takes form progressively in response to specific aspects of the research and to CE activities associated with the project. Characterizing the community identifies the individuals, groups, organizations, and agencies that have legitimate interests in the research so that they can be engaged effectively and in a timely manner.’

Consistent with the above, community engagement (CE) is specific to the region in which the work is being done. As such, a full CE plan can only be developed when the project knows where it is going to work. However, it is imperative to plan and carry out some activities prior to this decision making. The adoption of a CE plan is part of this process. For example, CE activities overlap those of defining the regulatory domains that must be addressed. It is important to develop a full understanding of the regulatory structures during the site-selection process.

What are our guiding principles?

Ethics, Relationships, Education, Transparency, Support

The UCIMI is dedicated to following the highest Ethics standards for introduction of new technologies. As part of this commitment, this program for community engagement provides complete transparency of information and creates pathways for dialogue and communication with all relevant community members and stakeholder groups. We will provide education and information about the science and technology as it relates to them and will address concerns as they are identified. We will build trusting relationships with people, and as a direct result, will build widespread support and understanding for our work, and allow community members and stakeholders to participate in the process.

What are first steps?

Work with sites selection team to get full list of prospective sites.
Develop a draft description and diagram of the regulatory structures at the prospective field sites. An example of such a description and diagram is found in Ramsey et al. (2014). This one is divided into two components, the first of which addresses the institutional requirements of the in-country collaborating entity. The second component addresses the international, national, state, municipal and community requirements and normative procedures. A complete description may not be possible a priori, but the known entities and gaps define where further work needs to be done.
Have full knowledge of what languages are official and what dialects are spoken locally.

II. Who do we need to talk to?

Determine who the internal and external stakeholders are for the project. This starts with a knowledge of the regulatory systems and the country-specific individuals that the site selection team has contacted.
External Stakeholders: Identify individual stakeholders at potential field sites.
Internal Stakeholders: Funders (who are they?), UC collaborators, contracted entities (social scientists, translators, etc.), other partners.

National Level	Collaborator level	Community level
Public health administrators (Ministry of Public Health, Malaria Control Program)	In-country University scientists	Leadership structures
Environmental protection	Public health sector practitioners	Decision-making norms at local levels
Agricultural protection	Risk Assessment team	Educators
Biotechnology regulatory		Existing community groups
Policy influencers		Local Health Clinic Personnel
Opinion makers		On-site NGOs
Media

III. What are we telling them?

Conduct formative social research in host communities prior to conducting any research or community engagement activities (this could be done by public health/community health professional in partnership with the people doing the science).
1. To identify and understand stakeholders’ perspectives towards the proposed technology, and on the history of malaria control in the region (and the current sociopolitical context).
2. To gain an understanding of stakeholders’ knowledge of malaria transmission and what these stakeholders want to learn more about (and what others would want to learn more about), and how they want to be engaged.
3. This would likely include partnership with local social scientists
4. This would help identify local level assumptions, and concerns.
5. This would help identify other external stakeholder groups that have political interests in the work.
6. Determine core commitments for project approach to community engagement.
  1. What do stakeholder groups what to know (this comes from work outlined in point A above) – what will be meaningful to each of them. Each group is very different.
  2. Establish goals of the community engagement process (open communication pathway, and provides avenue for community education and buy-in).
7. Develop educational tools and resources to socialize the technology and research process.
  1. Understanding of stakeholder scientific and other literacy levels.
  2. Understanding of what types of educational tools have been most successful.
  3. Use the understanding from formative research to help inform what people want to know and how they want to learn more.

IV. How are we going to collect feedback and information from the community/stakeholders?

A. Develop a community engagement strategy and timeline.

B. Identify local community members/leaders who can be regularly engaging with the community and local groups, and who will be trained to provide basic education and information.

C. Integrate community engagement activities and insights into the internal program management.

The community engagement staff should attend any regular meetings, conferences, etc. with the rest of the project team to help keep everyone informed of the community perspectives and challenges.

D. Establish and maintain a presence in the host communities.

Community engagement team members should be regularly available to answer questions, provide information, update existing information and engage new stakeholders.

E. Provide ongoing evaluation and assessment of community engagement strategies.

Conduct regular surveys within the community and with stakeholder groups to ensure that concerns are being addressed in real time.

References

Brunger, F. and Weijer, C. (2006) Politics, risk, and community in the ICBG-Chiapas case. In Ethical Issues in International Biomedical Research: A Casebook (Lavery, J.V. et al., eds), pp. 35–42, Oxford University Press.

Lavery, J.V., Tinadana, P.O, Scott, T.W., Harrington, L.C., Ramsey, J. M., Ytuarte-Nuñez, C. and James, A.A. (2010) Towards a framework for community engagement in global health research. Trends in Parasitology 26, 279-283. PMID: 20299285.

Ramsey, J.M., Bond, J.G., Macotela, M.E., Facchinelli, L., Valerio, L. Brown, D.M., Scott, T.W. and James, A.A. (2014) A regulatory structure for working with genetically-modified mosquitoes: Lessons from Mexico. PLoS Negl Trop Dis 8 (3): e2623. doi:10.1371/journal.pntd.0002623 PMID: 24626164.

Scope of work and timelines

What needs to be done

Determine who the internal and external stakeholders are for the prospective project sites.

1. Comoros

2. Madagascar

3. Sao Tome Principe

Identify individual stakeholders at potential field sites (External and Internal)
Internal Stakeholders: UC collaborators, contracted entities (social scientists, translators, etc.), other partners.

National Level	Collaborator level	Community level
Public health administrators (Ministry of Public Health, Malaria Control Program)	In-country University scientists	Leadership structures
Environmental protection	Public health sector practitioners	Decision-making norms at local levels
Agricultural protection	Risk Assessment team	Educators
Biotechnology regulatory	IRB	Existing community groups
Policy influencers	IACUC	Local Health Clinic Personnel
Opinion makers	FDA/EPA	On-site NGOs
Media

Purpose

To provide the UCIMI teams with contacts, regulatory pathways and knowledge base for filing requirements to ethically conduct malaria prevention project(s) utilizing transgenic mosquitoes who are resistant to P. falciparum and provide a roadmap for initial relationship building between project teams, project stakeholders and community members.

To provide prospective project sites with accurate and transparent information regarding the project goals and activities in line with the UCIMI mission and ethical standards.

Definitions

Anopheles gambiae – The African malaria mosquito.

Communities - Groups of people who live near enough to a potential site where research is taking place or where field releases may take place that they have tangible and immediate interests in the research project. (based on definition found in “National Academies of Sciences, Engineering, and Medicine. (2016)”)

Mutual Respect - Engagement activities will only be successful if they are perceived by all parties as worthwhile exercises undertaken in good faith. The tone of these activities will therefore be a key determinant of positive outcomes.

P. falciparum – the single cell parasite that causes malaria in humans.

Site(s) – locations chosen to carry out project based upon geographic isolation, populations of Anopheles gambiae and project team accessibility

Stakeholder - Organizations, groups, or persons with professional or personal interests sufficient to justify engagement, but who may not have geographic proximity to potential intervention sites for the research project. (based on definition found in “National Academies of Sciences, Engineering, and Medicine. (2016)”)

Transgenic – an organism having genetic material from an unrelated organism inserted into it creating a desired change in the organism. (resistance to P. falciparum)

UCIMI – University of California, Irvine Malaria Initiative (the Project)

Scope of work Community Engagement

1.1 Work with site selection team to get full list of prospective sites.

1.2 Develop a draft description and diagram of the regulatory structures at the prospective field sites. An example of such a description and diagram is found in Ramsey et al. (2014). This one is divided into two components, the first of which addresses the institutional requirements of the in-country collaborating entity. The second component addresses the international, national, state, municipal and community requirements and normative procedures. A complete description may not be possible a priori, but the known entities and gaps define where further work needs to be done.

1.3 Determine who the internal and external stakeholders are for the project. (This starts with a knowledge of the regulatory systems and the country-specific individuals that the site selection team has contacted.) External Stakeholders: Identify individual stakeholders at potential field sites. Internal Stakeholders: Funders (who are they?), UC collaborators, contracted entities (social scientists, translators, etc.), other partners.

1.4 Identify local community members/leaders who can be regularly engaging with the community and local groups, and who will be trained to provide basic education and information.

Have full knowledge of what languages are official and what dialects spoken locally at prospective sites.
Determine the level and type of engagement desired by the prospective sites. To be culturally sensitive to the norms and needs of the prospective sites and communicate these needs to the project team.
To promote mutual respect for project stakeholders
To travel as needed to prospective international sites as well as project team locations.
Develop a community engagement strategy and timeline.
Describe and implement communication plan.
Integrate community engagement activities and insights into the internal program management.
The community engagement staff should attend any regular meetings, conferences, etc. with the rest of the project team to help keep everyone informed of the community perspectives and challenges.
Establish and maintain a presence in the host communities.
Community engagement team members should be regularly available to answer questions, provide information, update existing information, and engage new stakeholders.
Provide ongoing evaluation and assessment of community engagement strategies.
Conduct regular surveys within the community and with stakeholder groups to ensure that concerns are being addressed in real time.
Provide project information in non-academic language that is readily understood by communities and stakeholders.
Identify limitations and restrictions, which may limit engagement.
To manage project expectations with transparency, honesty, compromise and understand that flexibility including cessation of some or all or the project activities may be required.
Develop a grievance process to quickly respond to any real or perceived adverse events.
To provide quarterly reporting to the lead investigator and site selection team.

Communications

For conference calls use:

https://zoom.us/

Or Skype in your Outlook calendar

Data Safety Management

Internal and External Web Portal

Internal team website – secure UC, Irvine location and servers (https://uci.atlassian.net/wiki/display/UMI)
External – secure UC, Irvine location and servers (Link)
http://malaria.bio.uci.edu
http://sites.uci.edu/ucimi
https://webfiles.uci.edu/xythoswfs/webview/fileManager.action?x=y&stk=577A1A0E0C271C1

Google for shared documents, linked to website

https://webfiles.uci.edu/xythoswfs/webview/xythoslogin.action (secure)
Load study shared documents to google drive for group input (Google Documents) Not recommended
Publicity

Public announcements about the UCIMI must be cleared by UC Irvine communications personnel (see communications plan)

Materials will be reviewed and approved by Tom Vasich, (949) 824-6455, tmvasich@uci.edu.
Correspondence or publicity efforts must indicate that they are being funded by the grantee institution (UC Irvine). Suggested language to describe affiliation with the project may include: “… supported by the University of California Irvine Malaria Initiative” or “…the University of California Irvine Malaria Initiative.”
Additional conditions apply to UCIMI work funded by the Bill and Melinda Gates Foundation

PUBLICITY BY UCIMI: The (BMGF) Bill and Melinda Gates Foundation prior written approval must be obtained before: (a) issuing a press release or other public announcement regarding the grant; and (b) any other public use of the Foundation’s name or logo. Requests for permission may be emailed to:

grantee.comms@gatesfoundation.org two weeks in advance to provide the BMGF an opportunity to review and comment.

Detailed guidelines are available at:

www.gatesfoundation.org/grantseeker/documents/guidelines_communications_for_grantees.doc.

PUBLICITY BY OTHERS: The UCIMI, its subgrantees, subcontractors, contingent workers, agents, or affiliates may not state or otherwise imply to third parties that the BMGF directly funds or otherwise endorses their activities.

Mitigation Via

SOP’s (Link)

https://sites.uci.edu/jameslab

https://sites.uci.edu/jameslab/laboratory-standard-operating-procedures/

https://sites.uci.edu/jameslab/basic-laboratory-sop/

https://sites.uci.edu/jameslab/insectary-standard-operating-procedures/

https://sites.uci.edu/jameslab/standard-operating-procedures-and-best-practices-for-the-james-lab-live-insect-management/

https://sites.uci.edu/jameslab/blood-feeding-protocols/

https://sites.uci.edu/jameslab/entry-and-exit-to-facilities/

Communications
Documentation
Regulatory
Transparency

Unanticipated Events

Browser not supported