<H4text="Power-Interest Matrix according to Mendelow"/>
<H4text="Power-Interest Matrix according to Mendelow"id="mendelowH"/>
<p>Using the Mendelow Power-Interest Matrix, we classified the potential stakeholders associated with our project in terms of their power (the ability to provide important feedback on our project design and influence our project development) and interest in our project. The matrix consists of four quadrants arranged in descending order according to their priority level in the project:
</p>
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<p>A <b>SWOT</b> analysis is a strategic tool used to evaluate the <b>S</b>trengths, <b>W</b>eaknesses, <b>O</b>pportunities, and <b>T</b>hreats of an
organization. In the context of our Human Practice approach, this analysis helps us identify internal strengths and weaknesses of our project, such as
technical capabilities and resource limitations, while also examining external opportunities, like potential collaborations, and threats, such as regulatory
<p>To drive stakeholder interactions for the <PreCyse/> project, our team implemented the “Third-Party Feedback Template”. This template helps us introduce individuals to our stakeholders and demonstrate their significance to our project. There are three main sections in this template. First, we address the important question of who our stakeholders are, introducing their backgrounds and explaining why we reached out to them. Next, we summarize the conversations and knowledge exchanged during our interactions. Finally, we share our reflections from these stakeholder conversations and how these interactions have guided the next steps of our project. </p>
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<HPUnderstanding/>
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<p>The AREA Framework Analysis is a model that helps structure and optimize decision-making in complex projects, especially when multiple stakeholders are involved.
</p>
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<HP3new/>
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<H5text="Agenda"/>
<p>
The central goal of the PreCyse project is to develop an innovative gene therapy solution for cystic fibrosis (CF) that is not only technically effective but also socially acceptable and ethically justifiable. The primary questions include:
</p>
<ul>
<li>How can the project improve the lives of CF patients?</li>
<li>How can the project ensure that the proposed therapy meets ethical and regulatory standards?</li>
<li>How can the solution be integrated into current healthcare initiatives?</li>
<li>How does the project influence, and how is it influenced by, the perceptions of stakeholders, particularly patients, regulatory authorities, and the scientific community?</li>
</ul>
<p>
Here, the need is defined to develop a holistic understanding of the project’s impacts, considering both technological aspects and human perspectives.
</p>
<H5text="Research"/>
<p>
To gain a comprehensive understanding of the needs and expectations, the PreCyse team employed various methods to collect data from relevant stakeholders, including:
</p>
<p>
<b>Surveys of CF patients and their families:</b> These provided insights into the specific challenges and needs that CF patients face in daily life. Critical questions regarding safety, accessibility, and the long-term application of gene technology were addressed.
</p>
<p>
<b>Expert consultations with researchers and physicians:</b> Scientists and doctors working in gene therapy provided essential technical feedback and helped assess the feasibility and effectiveness of the proposed therapy.
</p>
<p>
<b>Regulatory authorities:</b> Feedback from agencies like the FDA and EMA played a central role in assessing safety requirements and regulatory challenges that need to be addressed before clinical application. This research phase was critical to ensuring that the technical solution aligned with patient needs and regulatory standards.
</p>
<H5text="Evaluation"/>
<p>Based on the research phase results, a detailed assessment of the strengths, weaknesses, opportunities, and threats (SWOT analysis) was conducted (see above). The evaluation helped the team reflect on the gathered insights and focus on key challenges to ensure long-term feasibility and acceptance.
</p>
<H5text="Agenda"/>
<p>
Based on the analysis, several measures were taken to ensure that the PreCyse project is not only scientifically advanced but also socially and regulatorily acceptable:
</p>
<p>
<b>Integrated feedback loops:</b> Stakeholders were continuously involved, and their feedback was directly incorporated into the adaptation and improvement of the project design. An example of this is the application of Gibbs' Reflection Cycle to ensure that all feedback is thoroughly analyzed and incorporated into future decisions.
</p>
<p>
<b>Regulatory and ethical adjustments:</b> By working closely with regulatory authorities and ethics committees, measures were taken to ensure that the project complies with regulatory requirements and remains ethically justifiable.
</p>
<p>
<b>Safety considerations:</b> The safety of the therapy was a key concern in stakeholder interactions. Specific safety protocols were developed to minimize risks for patients.
</p>
<p>
<b>Public awareness:</b> To increase public awareness of the potential and safety of gene technologies, targeted communication measures were taken to address misunderstandings and improve acceptance of the technology.
<H4text="The Feedback Cycle of our IHP Approach"id="feedH"/>
<p>To foster productive conversations and ensure our team maximizes each stakeholder interaction for the PreCyse project, we developed a feedback cycle that outlines a structured approach for our meetings. The first step in our cycle involves listening to each stakeholder's experiences, personal stories, or insights. Our team then follows up by asking relevant questions to dive deeper into the shared information or to introduce new topics or directions in the conversation. Towards the end of the meeting, we ask clarifying questions and reiterate key points to ensure our understanding is accurate and that the stakeholder has no additional input. Finally, we explore new directions and ideas inspired by the stakeholder interaction, encouraging our team to pursue innovative and novel concepts.
<H4text="Cycle of Reflections according to Gibbs"id="gibsonH"/>
<p>For the <PreCyse/> project to impact the world, it needs to work with all types of stakeholders. Therefore, we are optimizing Gibb's Reflection Cycle to demonstrate our inclusive response to the challenges we encountered during our iGEM journey. The cycle includes the impetus for our engagement, the unbiased two-way communication with stakeholders, our thorough analysis of the feedback and our actions to implement the stakeholder inputs into our project.
<b>Impetus:</b> When developing a systematic approach to a recurring problem, it's easy to get distracted by multiple points of view. We need to prioritize quality over quantity. This section presents the successive impetus that drives the continuous implementation of Human Practices activities.
</p>
<p>
<b>Two-way communication:</b> For our solution to be human-centered, the two-way communication method is to communicate to stakeholders the values we are incorporating into our project design. We make sure they understand the project clearly so that they can articulate their concerns and suggestions precisely.
</p>
<p>
<b>Analysis:</b> The two-way communication with our stakeholders is carefully analyzed. In this section, stakeholder feedback is processed and turned into constructive guidance for project implementation, allowing us to consider what work should be prioritized to best address stakeholder concerns.
</p>
<p>
<b>Implementation:</b> Implementation shows our measures for evaluating and refining the project. These actions are fully integrated into the project designs and other parts of our project to ensure that our project and activities are good, responsible and engaging for the world.
</p>
<p>
In the areas of <b>Communication & Implementation</b>, <b>Necessity & Relevance</b>, <b>Science & Technology</b>, <b>Ethics & Regulation</b>, our Human Practice activities are conducted with X groups of stakeholders throughout our iGEM journey. In doing so, we explore the contexts that define projects, idealize solutions and evaluate outcomes for our human practice approach.
