Difference between revisions of "Team:IISER-Tirupati India/Human Practices"

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                             <h3><strong>Kill switch</strong></h3>
 
                             <h3><strong>Kill switch</strong></h3>
 
                             <p><strong>Feedback</strong>: She raised <strong>the concern of leaky expression</strong> in the proposed model of the kill switch. Also, she asked us to check whether the introduction of Xylose could cause any adverse effects in the fallopian tube.</p>
 
                             <p><strong>Feedback</strong>: She raised <strong>the concern of leaky expression</strong> in the proposed model of the kill switch. Also, she asked us to check whether the introduction of Xylose could cause any adverse effects in the fallopian tube.</p>
                             <p><strong>Integration:</strong> We decided to use the toxin-antitoxin system for the kill switch as it seems to control leaky expression[3]. No literature showed the presence of Xylose in the Human fallopian Tube.</p></div>
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                             <p><strong>Integration:</strong> We decided to use the toxin-antitoxin system for the kill switch as it seems to control leaky expression. No literature showed the presence of Xylose in the Human fallopian Tube.</p></div>
 
                     </div>
 
                     </div>
 
                 </div>
 
                 </div>
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                             <h3><strong>Inclusivity</strong></h3>
 
                             <h3><strong>Inclusivity</strong></h3>
 
                             <p><strong>Feedback:</strong> We asked whether OviCloak can cater to the contraceptive needs of uterus owners with conditions like <strong>PCOS</strong> etc. She said even though they have irregular ovulation, the progesterone raises more than normal during ovulation. Thus eventually, OviCloak should work.</p>
 
                             <p><strong>Feedback:</strong> We asked whether OviCloak can cater to the contraceptive needs of uterus owners with conditions like <strong>PCOS</strong> etc. She said even though they have irregular ovulation, the progesterone raises more than normal during ovulation. Thus eventually, OviCloak should work.</p>
                             <p><strong>Integration </strong>But, the literature studies showed the rise in ovastacin, is lower in PCOS conditions,for this progesterone needs to be sensitive. We set out looking for alternatives ( See<a href="https://2021.igem.org/Team:IISER-Tirupati_India/Inclusivity"> Inclusivity</a>)</p>                            </div>
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                             <p><strong>Integration </strong>But, the literature studies showed the rise in ovastacin, is lower in PCOS conditions,for this progesterone needs to be sensitive. We set out looking for alternatives. Read more in<a href="https://2021.igem.org/Team:IISER-Tirupati_India/Inclusivity"> Inclusivity</a></p>                            </div>
 
                     </div>
 
                     </div>
 
                 </div>
 
                 </div>
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                             <h3><strong>Communication</strong></h3>
 
                             <h3><strong>Communication</strong></h3>
 
                             <p><strong>Feedback</strong>: Initially, we used content focused more on the scientific details for communicating our project. Ms Kathy suggested using simple but impactful communication methods for our project. She pointed at the significance of bringing awareness of reproductive health along through the communication of our project.</p>
 
                             <p><strong>Feedback</strong>: Initially, we used content focused more on the scientific details for communicating our project. Ms Kathy suggested using simple but impactful communication methods for our project. She pointed at the significance of bringing awareness of reproductive health along through the communication of our project.</p>
                             <p><strong>Integration: </strong>According to her suggestions, we thought of<strong> simple strategies for communicating our project to the public</strong>. Besides our goal of educating people about synthetic biology, we decided to disseminate knowledge about sexual and reproductive health through webinars, Instagram lives sessions and many more creative methods (See <a href="https://2021.igem.org/Team:IISER-Tirupati_India/Education">Education and Engagement</a>)</p>
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                             <p><strong>Integration: </strong>According to her suggestions, we thought of<strong> simple strategies for communicating our project to the public</strong>. Besides our goal of educating people about synthetic biology, we decided to disseminate knowledge about sexual and reproductive health through webinars, Instagram lives sessions and many more creative methods.Read more in <a href="https://2021.igem.org/Team:IISER-Tirupati_India/Education">Education</a>.</p>
 
                             <h3><strong>Human Practices</strong></h3>
 
                             <h3><strong>Human Practices</strong></h3>
 
                             <p><strong>Feedback</strong>: Since we are working around a disparaging topic and people are not aware of the importance of eco-friendly contraceptives, she urged us to go thorough social science research to come up with impactful data that would help us make the change. She encouraged us to conduct 'In-Depth Interviews' (IDI) with sexually active women to find out how to bridge the gap between the consumer and a novel green product. She suggested <strong>including more men in the awareness programs</strong>, as they play a crucial role in the choice of women's contraception.&nbsp;</p>
 
                             <p><strong>Feedback</strong>: Since we are working around a disparaging topic and people are not aware of the importance of eco-friendly contraceptives, she urged us to go thorough social science research to come up with impactful data that would help us make the change. She encouraged us to conduct 'In-Depth Interviews' (IDI) with sexually active women to find out how to bridge the gap between the consumer and a novel green product. She suggested <strong>including more men in the awareness programs</strong>, as they play a crucial role in the choice of women's contraception.&nbsp;</p>
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                         </div>
 
                         </div>
 
                         <div class="col-12 pt-5" style="text-align: justify;">
 
                         <div class="col-12 pt-5" style="text-align: justify;">
 +
<h3><strong>Communication&nbsp;</strong>
 
                             <p><strong>Feedback</strong>: She started with an important note on using proper terms, from our project title to our content in comics. We received an invaluable suggestion from her of communicating through <strong>interactive zines</strong>, which resonated with our thoughts about science communication. We discussed languages, drawing tools like 'wink', publishing platforms, and licenses. An important lesson: 'you needn't be a trained artist; anybody can draw and share their knowledge!"&nbsp;</p>
 
                             <p><strong>Feedback</strong>: She started with an important note on using proper terms, from our project title to our content in comics. We received an invaluable suggestion from her of communicating through <strong>interactive zines</strong>, which resonated with our thoughts about science communication. We discussed languages, drawing tools like 'wink', publishing platforms, and licenses. An important lesson: 'you needn't be a trained artist; anybody can draw and share their knowledge!"&nbsp;</p>
                             <p><br /><strong>Integration: </strong>Thus, we decided to make an interactive zine, and for inclusivity, we decided to translate it to a regional language. (see <a href="https://2021.igem.org/Team:IISER-Tirupati_India/Communication">communication</a>)</p>
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                             <p><br /><strong>Integration: </strong>Thus, we decided to make an interactive zine, and for inclusivity, we decided to translate it to a regional language.Read more in <a href="https://2021.igem.org/Team:IISER-Tirupati_India/Communication">communication</a></p>
 
                         </div>
 
                         </div>
 
                     </div>
 
                     </div>
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                         <div class="col-12 pt-5" style="text-align: justify;">
 
                         <div class="col-12 pt-5" style="text-align: justify;">
 
                             <p>Dr Khot is an IVF Specialist at Kalyan Hospital, Thane, Mumbai. We met her to learn about techniques like hysterosalpingogram, Hysteroscopy and catheter for our delivery mechanism.</p>
 
                             <p>Dr Khot is an IVF Specialist at Kalyan Hospital, Thane, Mumbai. We met her to learn about techniques like hysterosalpingogram, Hysteroscopy and catheter for our delivery mechanism.</p>
 
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<h3><strong>Implementation&nbsp;</strong>
 
                             <p><strong>Feedback</strong>: She introduced each technique. One of our primary concerns was <strong>t</strong>he leaking of genetically engineered bacteria into the ovary, which is unwanted. We were assured that injecting a non-motile bacteria directly into the Ampulla would not cause leakage into the ovary.&nbsp;</p>
 
                             <p><strong>Feedback</strong>: She introduced each technique. One of our primary concerns was <strong>t</strong>he leaking of genetically engineered bacteria into the ovary, which is unwanted. We were assured that injecting a non-motile bacteria directly into the Ampulla would not cause leakage into the ovary.&nbsp;</p>
 
                             <p><strong>Integration: </strong>We read more about each technique and <strong>decide to improvise Hysteroscopy</strong>. We chose Hysteroscopy over cath lab because it necessitates the training of gynaecologists.</p>
 
                             <p><strong>Integration: </strong>We read more about each technique and <strong>decide to improvise Hysteroscopy</strong>. We chose Hysteroscopy over cath lab because it necessitates the training of gynaecologists.</p>
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                         <p>We made a pamphlet on green contraceptives upon her suggestion. We also addressed the positive effects of hormonal contraceptives along with their side effects.</p>
 
                         <p>We made a pamphlet on green contraceptives upon her suggestion. We also addressed the positive effects of hormonal contraceptives along with their side effects.</p>
  
                         <p><strong>Implementation</strong></p>
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                         <h3><strong>Implementation</strong></h3>
 
                         <p><strong>Feedback</strong>: She also encouraged us to emancipate the awareness of the significance of green contraceptives. We had less to no idea of the procedures of bringing a contraceptive &ldquo;<strong>from bench to bedside.</strong>&rdquo;</p>
 
                         <p><strong>Feedback</strong>: She also encouraged us to emancipate the awareness of the significance of green contraceptives. We had less to no idea of the procedures of bringing a contraceptive &ldquo;<strong>from bench to bedside.</strong>&rdquo;</p>
 
                         <p>Dr Blithe helped us understand them and also the pipelines currently existing in contraceptive development. She gave us a broader picture of the availability of funding in this field. She was kind enough to provide us with contacts of potential stakeholders who would like to fund our Project. She also put forth the potential of using spermicidal bacteria along with our genetically modified bacteria to increase the efficacy of contraception.</p>
 
                         <p>Dr Blithe helped us understand them and also the pipelines currently existing in contraceptive development. She gave us a broader picture of the availability of funding in this field. She was kind enough to provide us with contacts of potential stakeholders who would like to fund our Project. She also put forth the potential of using spermicidal bacteria along with our genetically modified bacteria to increase the efficacy of contraception.</p>
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                         <div class="col-12 pt-5" style="text-align: justify;">
 
                         <div class="col-12 pt-5" style="text-align: justify;">
 
                             <p>Dr Vemula is a leading scientist in the field of translational research in India. In a vision to build the bridge between discovery and delivery, his lab is solving the challenges in the medical field through an interactive and collaborative mode of research. The meetings were n enlightenment regarding the foundational steps of implementing OviCloak.</p>
 
                             <p>Dr Vemula is a leading scientist in the field of translational research in India. In a vision to build the bridge between discovery and delivery, his lab is solving the challenges in the medical field through an interactive and collaborative mode of research. The meetings were n enlightenment regarding the foundational steps of implementing OviCloak.</p>
                             <p><strong>Feedback</strong>: He highlighted that building a <strong>solid &lsquo;Proof Of Concept (POC)&rsquo; </strong>is the prime step of implementation of a project as it is very crucial in acquiring funding for a project and attracting investors.SinceOviCloak is a multifarious project, he advised us to find the essential elements of the concept and plan the PoC addressing the core functionalities.&nbsp;</p>
+
 
 +
<h3>Implementation</h3>
 +
                             <p><strong>Feedback</strong>: He highlighted that building a <strong>solid &lsquo;Proof Of Concept (POC)&rsquo; </strong>is the prime step of implementation of a project as it is very crucial in acquiring funding for a project and attracting investors.Since OviCloak is a multifarious project, he advised us to find the essential elements of the concept and plan the PoC addressing the core functionalities.&nbsp;</p>
 
                             <p>The involvement of stakeholders plays a pivotal role in translational research which aids the product to meet the clinical benchmark&nbsp;</p>
 
                             <p>The involvement of stakeholders plays a pivotal role in translational research which aids the product to meet the clinical benchmark&nbsp;</p>
 
                             <p>He advised us to procure Intellectual Property Protection (IP) before involving any companies.</p>
 
                             <p>He advised us to procure Intellectual Property Protection (IP) before involving any companies.</p>
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                             <p><strong>Feedback</strong>: She explained how being a <strong>non-hormonal contraceptive</strong> helps people undergoing hormone replacement therapy and people with conditions like CAH and Turner syndrome. She also pointed out a condition called <strong>Cloacal Exstrophy</strong>, which can be considered.</p>
 
                             <p><strong>Feedback</strong>: She explained how being a <strong>non-hormonal contraceptive</strong> helps people undergoing hormone replacement therapy and people with conditions like CAH and Turner syndrome. She also pointed out a condition called <strong>Cloacal Exstrophy</strong>, which can be considered.</p>
                             <p><strong>Integration: </strong>Hence, we read more about the condition and included them among our users. (See <a href="https://2021.igem.org/Team:IISER-Tirupati_India/Inclusivity">inclusivity</a>)</p>
+
                             <p><strong>Integration: </strong>Hence, we read more about the condition and included them among our users. Read more in<a href="https://2021.igem.org/Team:IISER-Tirupati_India/Inclusivity">inclusivity</a>.</p>
                             <h3><p><strong>Implementation&nbsp;</strong></p></h3>
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                             <h3><strong>Implementation&nbsp;</strong></h3>
 
                             <p><strong>Feedback</strong>: She asked us to ponder some other delivery mechanisms as the proposed delivery mechanism may instil gender dysphoria in some patients and also for some it might not suit their anatomy.</p>
 
                             <p><strong>Feedback</strong>: She asked us to ponder some other delivery mechanisms as the proposed delivery mechanism may instil gender dysphoria in some patients and also for some it might not suit their anatomy.</p>
 
                             <p><strong>Integration: </strong>We learned the anatomical differences in them and set on to finding an inclusive alternative.&nbsp;</p>                            </div>
 
                             <p><strong>Integration: </strong>We learned the anatomical differences in them and set on to finding an inclusive alternative.&nbsp;</p>                            </div>
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                         <div class="col-12 pt-5" style="text-align: justify;">
 
                         <div class="col-12 pt-5" style="text-align: justify;">
                             <h2>Dr K B Harikumar is Scientist E-I at Rajiv Gandhi Centre for Biotechnology and Member Secretary of Institutional Biosafety Committee (IBSC). We approached him to get genuine feedback on the biosafety of our project.</h2>
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                             <p>Dr K B Harikumar is Scientist E-I at Rajiv Gandhi Centre for Biotechnology and Member Secretary of Institutional Biosafety Committee (IBSC). We approached him to get genuine feedback on the biosafety of our project.</p>
                             <h3>Biosafety</h3>
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                             <h3>Safety</h3>
 
                              
 
                              
 
                             <p><strong>Feedback</strong>: Dr Harikumar appreciated the novelty of the project. He asked us to make sure that the genetically engineered bacteria will be present in the fallopian tube throughout the menstrual cycle irrespective of hormonal changes.</p>
 
                             <p><strong>Feedback</strong>: Dr Harikumar appreciated the novelty of the project. He asked us to make sure that the genetically engineered bacteria will be present in the fallopian tube throughout the menstrual cycle irrespective of hormonal changes.</p>
 
                              
 
                              
                             <p><strong>Integration: </strong>We sought literature since this is a nuanced topic we couldn&rsquo;t find relevant studies.,</p>                            </div>
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                             <p><strong>Integration: </strong>We sought literature since this is a nuanced topic we couldn&rsquo;t find relevant studies.</p>                            </div>
 
                     </div>
 
                     </div>
 
                 </div>
 
                 </div>
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                         <div class="col-12 pt-5" style="text-align: justify;">
 
                         <div class="col-12 pt-5" style="text-align: justify;">
 
                             <p>Dr Deepika is an associate professor at the Department of Management Studies at Maharshi Dayanand Saraswati University. We met her to get insights on building a business plan.&nbsp;</p>
 
                             <p>Dr Deepika is an associate professor at the Department of Management Studies at Maharshi Dayanand Saraswati University. We met her to get insights on building a business plan.&nbsp;</p>
                            <p><strong>Feedback</strong>: She asked us to reflect on the targeted users of our product. She encouraged us to figure out all the nitty-gritty details of OviCloak including raw materials, production, packaging, transportation, and distribution.</p>
+
                        <h3><strong>Implementation&nbsp;</strong></h3> 
 +
<p><strong>Feedback</strong>: She asked us to reflect on the targeted users of our product. She encouraged us to figure out all the nitty-gritty details of OviCloak including raw materials, production, packaging, transportation, and distribution.</p>
 
                             <p><strong>Integration: </strong>This helped us understand how far we have to proceed to come up with a business plan and how important it is to reflect on the basics of the product, which helped arrive at the conclusion our product could be better <strong>marketed to an urban/suburban population</strong> and could be <strong>subsidised</strong> to cater for the needs of<strong> rural populations</strong>.</p>
 
                             <p><strong>Integration: </strong>This helped us understand how far we have to proceed to come up with a business plan and how important it is to reflect on the basics of the product, which helped arrive at the conclusion our product could be better <strong>marketed to an urban/suburban population</strong> and could be <strong>subsidised</strong> to cater for the needs of<strong> rural populations</strong>.</p>
 
                             <p>Meeting with her encouraged us to find out more about the efficient ways of packaging and post-production strategies of our product leading to a meeting with CTI EXCHANGE.</p>                            </div>
 
                             <p>Meeting with her encouraged us to find out more about the efficient ways of packaging and post-production strategies of our product leading to a meeting with CTI EXCHANGE.</p>                            </div>
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                             <p>CTI Exchange is a global platform for sharing resources on contraceptive developments, registration, and developments powered by FHI360. This meeting involved a panel of six experts:</p>
 
                             <p>CTI Exchange is a global platform for sharing resources on contraceptive developments, registration, and developments powered by FHI360. This meeting involved a panel of six experts:</p>
 
<ul>
 
<ul>
<li>&nbsp;Emily Hoppes, <em>MA, MPH, FHI 360</em></li>
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<li>&nbsp;Emily Hoppes, MA, MPH, FHI 360</li>
<li>Gregory Kopf, Director, Research and Development, Contraceptive Technology Innovation, <em>FHI 360</em></li>
+
<li>Gregory Kopf, Director, Research and Development, Contraceptive Technology Innovation, FHI 360</li>
 
<li>Jennifer Ayres, Scientist, FHI 360</li>
 
<li>Jennifer Ayres, Scientist, FHI 360</li>
 
<li>&nbsp;Ashini Fernando, Scientist, FHI 360</li>
 
<li>&nbsp;Ashini Fernando, Scientist, FHI 360</li>

Revision as of 08:19, 19 October 2021


Ovi-Cloak

SCROLL

OviCloak, throughout its journey, endeavoured to be a people’s project. From brainstorming to implementation, we involved our stakeholders. Our vision was to make our stakeholders understand the design of the project, know their desire and close the loop between both.

OviCloak being a proposed synthetic biology alternative for existing contraceptives, demands thoughtfulness about whether it is responsible and good for the world. Through our human practices, we tried to achieve this via :

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Fig 1. Strategies adopted for planning our Human Practices : Reflection - Thinking about the needs and values of the project, Responsibility - Knowing the responsibilities of the project, Responsiveness - Closing the loop between desired and designer

Our team initiated thoughtfulness from the brainstorming sessions in which we came up with synthetic biology solutions for the problems spanning from poverty to plastic pollution. However, we verified if our proposed synthetic biology solutions are better than the existing solutions ones. The impact of our proposed solutions was understood through extensive social science research.

Our team initiated thoughtfulness from the brainstorming sessions in which the problems we wished to address spanned from poverty to plastic pollution. We came up with solutions using synthetic biology to tackle these problems. However, we also verified if our proposed synthetic biology methods are better than the existing solutions/proposed solutions to these problems. 

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Fig 2. A snap from our brainstorming session with PIs

“About 22.2 million unintended pregnancies in 43 developing countries are due to contraceptive failure.”

“Between 2000 and 2009, the use of modern contraceptives is seen to increase by only 2.1%. WHO points out that limited access to services, fear or experience of side-effects; poor quality of available services are the major reasons for this slower increase. “

“In India, an irreversible procedure like female sterilization is preferable for more than 75% of cases that take away the individual’s right to plan families.”

This caught our attention! We recognised that being an integral part of society, the lack of a sustainable & empowering contraceptive affects the safety of individuals globally & thus this issue demands the centre stage. We wished to bestow an effective and safe alternative to the 933 million contraceptive users through synthetic biology. 

Thus, our journey towards OviCloak started. 

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Fig 3. Tasks taken up for Reflection

  • Stakeholder analysis

The analysis section of The iGEMers Guide to the Future helped us contemplate the values that we want to embed for the potential users of OviCloak through the stakeholder/value matrix. Health (Safety), Environmental Safety, Autonomy/individual choice are values we wish to embed and as well as fulfilled by OviCloak.

  • Market Survey

Further, to understand what needs and values are our stakeholders looking forth in our project and to evaluate whether the values fulfilled OviCloak meet their preferences, we decided to conduct a market survey. We found that a significant fraction of the contraceptive users were seen to experience side effects, hence our vision of prioritising health safety will be endorsed by our stakeholders. Least to no side effects, environmental safety, reversibility and long-term action of the contraceptive were some of the attributes respondents felt were important for their contraceptive, which OviCloak wishes to fulfil.

Thus, we felt that OviCloak would benefit the contraceptive users. 

Market Survey PDF

  • Meeting with stakeholders

Through meetings with Stakeholders, We could understand the importance of some values which were left unaddressed.

  • SWOT Analysis

We performed a SWOT analysis to reflect the strength, weaknesses, opportunities and threats of our project.

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Fig 4. Tasks took up for Responsibility
  • Stakeholder identification

  • Trulli
    Fig 5. The stakeholders we identified for OviCloak

    Identifying the stakeholders was the first step in comprehending the importance of the team and project being safe and responsible.We identified following stakeholders :

  • SWOT Analysis

  • From SWOT analysis, we understood the threats posed by our projects such as lack of awareness about contraception in civilians, horizontal gene transfer or biosafety and lack of funding.

  • The values and risks workshop

  • We attended the values and risks workshop conducted by iGEM Ambassadors.

  • Responsible Research

  •  Our team strived to be responsible and safe throughout the project inside and outside labs by adhering to lab rules and COVID-19 protocols. Read more in Safety.

We understood that our project has a great potential to impact the world outside the lab. For this, we strived to set up a two-way dialogue between us and the world.

Our aim was to :

  • Learn about the world outside the lab
  • Integrate the learning into our project.

This was achieved by a strategic move by our team as the following : 

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Stakeholder Identification

Stakeholder identification which was done as a part of our reflection was the cornerstone for responsiveness.

Reaching out

Finding out the identified stakeholders and experts were challenging. The ongoing pandemic necessitated doing our human practices responsibly with limited personal contact.

With constant online search, we could find contacts (Mail Id, contact number) of experts. Social Platforms such as LinkedIn and Instagram helped us a lot in this step. Some experts were kind enough to introduce us to some other experts and stakeholders. 

Engaging with stakeholders was still a challenge due to COVID restrictions, so we thought why not start from our home. We conducted in-depth interviews with our family members of 18+ age, thereby initiating the conversation around sexual and reproductive health from our homes.

Engaging with stakeholders and Experts.

We opted for in-depth interviews for one-on-one engagement with our stakeholders and experts. While surveys came to the rescue to engage with a large population of stakeholders.

We strived to adhere to all COVID regulations as well as ethics while doing human research. Read more in Safety.

Closing the loop

Analysis

We analysed the IDIs and Surveys following Analysis. IDI recordings were replayed and the answers for each question were recorded separately. Surveys were analysed and infographics were made for better representation.

Integrating 

Closing the loop between what is designed and desired is at the heart of our human practices. We strived to do that through :

  • Discussing the feedback and selecting the relevant ones on the basis of values chosen.
  • Conducting literature surveys or testing through mathematical modelling.
  • Engaging with the stakeholder to get feedback on integration.

This is iterated throughout our project. This feedback and integration helped us build a people’s project. Read how we integrated the feedbacks in Integrated Human Practices

Integrated Human Practices

How iHP moulded OviCloak

Our stakeholders played an unequivocal role in the informing and shaping of OviCloak. Here, we highlight how our Human Practices informed our ethical, technical, safety and communication decisions and closed the loop between what is desired and designed.

Feasibility and Desirability

In our Initial social science research, we understood the need for a novel contraceptive. 

  • In addition to this, we conducted in-depth interviews to learn about the general opinion of people on existing contraceptives and their perspective on the need for new contraceptives. We also wanted to know about people’s views on Ovicloak and the usage of a GMO for contraception. Keeping in view the COVID-19 restrictions, we conducted in-depth interviews with our family members and friends of 18+ age. Since our team members are from different parts of India, we could ensure the diversity of the respondents by conducting this with people at various locations in India.

IDI PDF

  • Through reflection, we wished to embed safety and autonomy into our project. Interaction with stakeholders helped us understand the other values we left out and prioritise the values.

Read more in Reflection to know the needs or values we prioritized in our project’s design and compromises made by us.

Broadening the spectrum of End-users

Iterative feedback from our stakeholders and their integration helped us make the project good for the world, especially for the communities left uncared for.

Dr Madhulika Pathak helped us realize that our approach to contraception has been limited to the ideal reproductive tract anatomy and hormonal levels of "women". We were asked whether our contraceptive caters to the needs of individuals with PolyCystic Ovarian Syndrome. We set out to improve upon this fact by connecting with another expert, Dr Prameela Menon. She gave us direction in the improvement needed in the design.

Frequent discussions with our Institute's LGBTQIA+ awareness club, "Rainbows of IISER Tirupati", helped us understand the importance of individuals belonging to the transmasculine and intersex individuals as our stakeholders. This inspired us to call Ovicloak a "novel female contraceptive" instead of a "novel contraceptive for women as "woman" only refers to a particular gender of the gender binary. 

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Fig 7. How integration of our human practices broadened our end-users spectrum

How integration of our human practices broadened our stakeholder spectrum

In the meeting with the NGO "Sex Education for India", we understood the need for a more inclusive term as the term "female" is not inclusive of individuals belonging to the "transmasculine" and "intersex" communities who don't identify with the words "male" and "female". After brainstorming, we came up with a more inclusive title, 'A novel contraceptive for Uterus owners'

In our initial quest to broaden our end-user spectrum, we came across conditions like Congenital adrenal hyperplasia (CAH), Turner Syndrome, and people from a transmasculine spectrum who could be our potential stakeholders. In the meeting with Dr Frances Grimstad, she pointed out a condition called Cloacal Exstrophy, which can be considered.

Thus, Ovicloak became a contraceptive for all uterus owners. 

Design of Genetic Circuit

Initially, we had a progesterone-induced approach for regulating Ovastacin production. In the meeting with an Emeritus Scientist at the National Institute of Immunology,Dr Satish Gupta pointed out the importance of sensitivity of the transcription factor, SRTF1, for efficient regulation during minimal Progesterone production. Hence, we set out to look for alternative sensing molecules as we found SRTF1 has less sensitivity to sense the minimal concentration of Progesterone during the onset of ovulation.[2]

Meanwhile, we met with Dr Prameela Menon, a gynaecologist. She raised the concern regarding the late expression of Ovastacin, as the fertilisation window is very short. So, we set out to look into an alternative design for the regulation of Ovastacin.

Eventually, we came up with Progesterone repressed regulatory systems for Ovastacin production, which overcame the previous concerns.

Safety 

The prime value we wished to embed in OviCloak was Safety. Safety is not complete without Biosafety, and hence, we gave importance to the kill switch module of our project and most importantly, we made a constant effort to get feedback and integrate them into our kill switches.

Initially, our project was designed to have a kill switch for reversibility which was thought to prevent the unintentional release of genetically modified commensal. But, Dr Gupta raised the concern of dissemination of genetically modified commensal into the environment. So, we reflected on the scenarios where engineered bacteria can escape the fallopian tube. This led to thorough literature surveys [3][4] and designing a kill switch for biosafety.

In the meeting with Dr Madhulika Pathak, who is a doctoral fellow at the Indian Institute of Science working on mammalian embryo development, she raised the concern of leaky expression in the proposed model of the kill switches. We set out to look for a better design with non-leaky expressions. Eventually, we decided to use the toxin-antitoxin system for the kill switch as it seems to control leaky expression [5]. 

Once the genetic circuit design for both the kill switches was ready, we met with Dr Brenda Wilson, a microbiologist from the University of Illinois. Dr Wilson pointed out the possibility of a toxic shock from the endotoxins released on the activation of the kill switch. She suggested alternatives to the kill switch, such as using antibiotics and a replication inhibitor called Psoralen, which can prevent the growth of bacteria instead of killing them. This was indeed a matter of thought which we wish to incorporate into our kill switch in future.

Implementation 

Our meetings with experts helped us understand the challenges and scope of improvement to bring OviCloak to the real world. 

Delivery System

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Fig 8. Delivery System was chosen on integrating stakeholders feedback

In the initial months of our project, we thought of improvising an IUD to deliver the genetically engineered bacteria into the fallopian tube. On reflection, we didn’t want to develop a device that would stay inside the uterus of the user.

We continued our quest for an alternative, and it was meeting with Dr Debjani Paul, an Associate professor in the Department of Biosciences and Bioengineering at IIT Bombay. We realised the challenges of considered alternatives like direct delivery, two fluid delivery and injecting into the Ostia. Dr Prameela and Dr Paul suggested that using an existing method with minimum changes is the best solution

In the meeting with Dr Sidra Khot, an IVF expert we, learned about hysterosalpingogram, Hysteroscopy and Catheter techniques. We knock out hysterosalpingogram as it is only familiar to infertility experts leading to reduced accessibility. Similarly, Catheter needs a well-trained gynaecologist for its operation.

Thus, by integrating the feedback from the stakeholders mentioned above, we decided to deliver the genetically modified bacteria with a technique called Hysteroscopy, as it is more accessible.

Dr Brenda and Ms Nalini raised concerns regarding the user-friendliness of our delivery system. Finding a delivery system, which can deliver the genetically engineered bacteria in a more user-friendly way is our future prospective.

Implementation

Dr Praveen Vemula, a translational researcher, made us understand the importance of proof of concept for each aspect of our project. We were advised to go through safety regulatory guidelines and plan the proof of concept accordingly for biosafety.

Dr Diana Blithe, The Chief of Contraceptive Development Program at the National Institutes of Health, U.S. Department of Health and Human Services and the Co-director of the Contraceptive Clinical Trials Network helped us understand the steps in pre-clinical and clinical trials which Ovicloak have to undergo before potential approval by Regulatory boards. 

To figure out the possibilities of a business model, we met Dr Deepika Upadhyay, an associate professor at the Department of Management Studies at Maharshi Dayanand Saraswati University and brainstormed the end-users. This led us to conclude that our product could be better marketed to an urban/suburban population and subsequently cost subsidised to cater to rural populations’ needs.

We met with Six experts from FHI 360, a nonprofit human development organization with a history in family planning and reproductive health projects. They gave us invaluable insights into the manufacturing and post-production processes, including packaging and delivery. We got to know about the procedures OviCloak, undergoes before it gets subsidised by the Governmental Organisation or marketed. They raised concern regarding maintaining cold-chain during delivery, as it is a crucial factor during procurement by agencies

Read more on our vision about bringing OviCloak into the real world in Implementation.

Communication

The stakeholder engagement was the inspiration behind our educational activities related to sexual and reproductive well-being. 

Meeting Ms Kathy Walkiling was eye-opening as her experience of launching Ecofemme, a menstrual hygiene start-up, made us understand that the stigma surrounding the use of sexual and reproductive health products can be a challenge to implement OviCloak. Thus, we realized the importance of spreading awareness about sexual and reproductive health along with developing a novel contraceptive. This led us to collect data regarding the status of awareness on Reproductive Health and Rights as well as Conducting Sexual and Reproductive Health awareness sessions such as webinars, social media posts and virtual art exhibitions.

We met with Mr Kaustubh Jogelkhar, who is the senior counsellor at an NGO called Pankh that educates young minds about sexual and Reproductive health. The most important takeaway message from him was to deliver the content that fits the short attention span of the current generation. Hence, we explored the possibility of reaching the audience through social media platforms like Instagram reels and Instagram Live sessions.

 Ms Sophie Wang, a communicator from the online magazine ‘Biorad’ made us understand the impact of Interactive Zines through her work..This Idea amazed us all, as this perfectly fits into the iGEM’s human practices strategy, setting a two-way dialogue. 

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References

  1. Lund University. (2016, March 4). Estrogen in birth control pills has a negative impact on fish. ScienceDaily
  2. Grazon, C., Baer, R. C., Kuzmanović, U., Nguyen, T., Chen, M., Zamani, M., ... & Galagan, J. E. (2020). A progesterone biosensor derived from microbial screening. Nature communications, 11(1), 1-10
  3. Patiño, R., Bolamba, D., Thomas, P., & Kumakura, N. (2005). Effects of external pH on hormonally regulated ovarian follicle maturation and ovulation in Atlantic croaker.General and comparative endocrinology, 141(2), 126–134. https://doi.org/10.1016/j.ygcen.2004.12.006
  4. Shi, D., Komatsu, K., Hirao, M., Toyooka, Y., Koyama, H., Tissir, F., ... & Fujimori, T. (2014). Celsr1 is required for the generation of polarity at multiple levels of the mouse oviduct. Development, 141(23), 4558-4568.
  5. Brantl, S., & Müller, P. (2019). Toxin Antitoxin Systems in Bacillus subtilis. Toxins, 11(5), 262. https://doi.org/10.3390/toxins11050262 
  6. https://live.flatland.agency/12290417/rathenau-igem/  
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