Conner Calzone, Roy Ndebvudzemene, Tiffany Pang                                                    

2/28/20

 

• Does your work require IRB approvals?

• If Yes, articulate your detailed IRB strategy.

• If No, explain why you don’t need IRB approval and identify situations when you might need IRB approval

 

The Institutional Review Board (IRB) plays a significant role in research if it involves working with human subjects. They are responsible for approving, reviewing and protecting the rights and welfare of human subjects through informed consent procedures. A student or faculty research advisor determines if a project is research when it meets the three following criteria: the research contributes to an identifiable knowledge, the research is designed in advance, and the research encompasses a systematic approach. These projects indicate a need for an IRB approval when the research involves collecting private data from interacting with one or more persons. Our research involves a medically invasive method of drawing blood or requesting blood, but it is of minimal risk so we hope to go through an expedited review process rather than a full board review. In this case, the level of review will be determined by the degree of potential risk or vulnerability of the human subjects.

Therefore, our work requires an IRB approval. Our IRB strategy must overall encompass the human subject’s consent, clear objective, possible risks and entire research process. The IRB written protocol must include a Table of Contents, in the beginning, to categorize the information efficiently for the IRB reviewers. After the Table of Contents, the objective of the project and the background will be discussed in detail. The objective will briefly state the purpose of this study (comparing our lateral flow diagnostic device for the Sickle Cell Disease (SCD) to current clinical diagnosis), state specifically what we need to conduct this study (blood samples from human subjects) and state why we are seeking the IRB’s confirmation. The background can be an overview of past/current experiences that have contributed to this project, such as fieldwork, partnerships with hospital leaders, physicians, and sickle cell advocates in Sierra Leone. The background must also include how our team plans to address the SCD problem by mentioning current clinical practices versus our team’s clinical tests, quantitative data of how SCD has affected populations of LMICs, and the costs of diagnoses. Ultimately, these two portions of the IRB protocol will explain to the reviewers our scope of the research project. The next steps will involve more in-depth evaluation of the many processes that make up the entire project, which will prove the team’s level of knowledge on the research. Therefore, the remaining protocol must include:

• Inclusion/exclusion of “who” fits the criteria to participate 
  • If certain populations are unable to provide consent, they will be excluded
•  The study of a broad range of subjects (sample size of who will be admitted and screened)
• Recruitment methods (current patients from our partnerships)
• Timelines and Deadlines
• End Goal
• Procedure of the Diagnostic Device
• Confidentiality and How Private Information will be Handled
• Professional Supervision of the Research Team
• Withdrawal of Subjects
• Potential Benefits/Risks (Informed Consent)
• Resources Available
• Compensation if a Research-Related Injury Occurs
• Funding/Financial Burden to Subjects
• References

 

1. Develop an outline for your mid-semester presentations. 

• What supporting evidence will you provide for each point? 
• How will you boost your credibility every step of the way?

 

 

• The first bullet point is the evidence for the outlined point. It is what the speaker will talk about and the pictures on the slide will support what the speaker is saying.

• The second bullet point talks about how we will establish our credibility throughout the presentation.

 

 

• Slide 1: Problem/Opportunity from a Macro Perspective

• We will very briefly talk about the background of Sickle Cell Disease
• We will start the presentation by introducing the team and the problem.

• Slide 2: Problem/Opportunity from a Micro Perspective.

• Keep talking about the disease, but now explaining the devastation it causes, using statistical figures as evidence for why this is a problem/opportunity for development. Show that there are not any good options for this currently on the market.
• The statistical figures show credibility if they are from credible sources. We could also use first hand accounts from Sierra Leone if the travel group has any.

• Slide 3: Our approach/solution on a micro-scale

• Introduce the possibility of having a diagnostic device that can tell who has sickle cell, who doesn’t and who is a carrier.
• The presentation is meant to sell the product’s benefits, not the product itself; personalize the situation. Talk about the product’s benefits/researchers we have worked with.

• Slide 4: Device design 

• We’ll go into detail about the dream device and explain how the lateral flow of the device would work and explain how it would distinguish Sickle Cell Disease, Sickle Cell Carriers and Healthy patients. (Using 6th grade language)
• Mention the tests we have done with antibodies on this design and show a picture of the product with the active test lines

• Slide 5: Our Approach/solution on a macro scale

• Talk about how this device will be a game-changer for the people of Sierra Leone and how it would help the people with a low cost, point of care diagnostic device.
• Having a passionate clear vision on a macro and micro scale will show the potential benefits of our project

• Slide 6: Past work/Work done before we joined the team

• Talk about the past progress on the project and how this is a whole team effort. 
• To establish our credibility, we can have pictures of all the people who were on this project before we were.

• Slide 7: Work we have done thus far this semester

• Talk about our findings on the placement of the test lines and our optimization of resources to have the strongest and most accurate test lines. Also, talk about the printing machine which is a model for the scaling of the manufacturing process.
• Showing prototypes and explaining the benefits and the research we have done, we can show how we are continuing to evolve and develop our product and our goals.

• Slide 8: Work for the rest of the semester and summer

• Show our goals for the semester and summer during Mountaintop for making the project better and advancing it further. These goals are found in one of the spreadsheets in our team drive.
• Having an outlined plan that is reasonable, yet challenging to accomplish shows our determination and how we are set towards our vision

• Slide 9: Research/Design challenge and our solutions around them

• Talk about some of the challenges that we know we are going to face and strategize how we will tackle them. Talk about the design flaws.
• The referees understand we are not asking for funding. These projects are prototypes and there are flaws, problems we do not know how to solve and problems we do not even know exist. Being conscientious of our flaws, they could help us brainstorm solutions. Knowing everything is not the only way to establish credibility.

• Slide 10: End with a big happy overall impact/outcome with a happy slide

• Put a picture of our brand name and logo to burn that image into the minds of the referees. This will help them put an image to our team and the work we have done. 
• This picture, as well as the presentation as a whole, will show we are knowledgeable, passionate, and organized; showing credibility to the referees.

1. List ten things that make you feel human.

• Spending quality time with friends and family
• Eating good food
• Listening to music
• Mindfulness exercises
• Having an ultimate vision that I want to see come to fruition
• Working towards that vision
• Laughter
• Having the capacity to feel for myself and others – being emotional
• Playing music
• Having limitations

 

2. Articulate your philosophy of engagement as it pertains to your work with the GSIF / LVSIF. Specifically discuss 

 

1. Why should I engage?

There used to be a time when knowledge was power and ignorance was bliss: we are way past that time. Ignorance is a plague that kills and knowledge comes with a great responsibility for sustaining humanity at large. That is the set of lenses I view this world with. The work that GSIF does is that of impact and that can be used to help civilizations that are lagging behind; to give them a hand up instead of a handout. I engage with this work because I believe in the physically visible results that it produces. This belief stems from personal experiences growing up in Zimbabwe, my own morals and personal core values, my identity as a person and the knowledge that I have acquired in different spheres. It is all these that have driven me to develop a passion for the work that I do and make a well-informed decision to make decisions that I deem to be in support of better livelihood for people.

2. How must I engage? 

How I engage can validate the reason I am engaging. As such, gathering enough information about Sierra Leone enables me as part of a team to strategize and come up with the perfect angle into which the project system is co-created between us and the people of Sierra Leone. This can only and only if I am able to blend myself into the country and see things in the same way they do. This idea of co-creation gives the people of Sierra Leone a sense of drive to participate in for various personal/social reasons but it also gives us the opportunity to get the support we will need in order to make the launch of this a success. 

3. With whom must I engage? 

As mentioned above, the people of Sierra Leone are the primary target for this development agenda and hence it is important to start building trust and security with them. This, we can do through the field trips by immersing ourselves into their culture and treat them with such respect and hospitality they will show us. Secondly, we must engage with current existing NGOs working in the country. They will be very insightful about certain things or policies that we need to be aware of while proceeding with our project. At some point, it might prove to be useful to have such connections as we might need letters of recommendations from such at some point. The third party to engage with that will also validate the reasoning for engagement will be the potential sponsors for the projects. This will provide the funds to actually start the project and start planning accordingly. The fourth party would be team members on the project as this is where everything will be emerging. Effective communication and duty allocation can prove useful. The last group to engage with will be the government in Sierra Leone but this comes at a very later life of a project when we are ready to start implementing a system that we would have developed.

4. What kinds of challenges, opportunities, and approaches should I care about? 

Opportunities that will make this project move forward not only include lab work but funding as well. If there is any funding source that the project is eligible for, it is important to apply for it and get more resources to push the project forward. The challenge that is of essence is that of having to get paperwork approvals from Sierra Leone. Not all paperwork happens within the timed deadline in our plans and we have to factor that into our planning for the project. For example, for the field trip that we are going to do this summer, we need certain approvals in time for us to do tests that will change the pace and course of this research itself. 

5. What might my epitaph read?

“He lived, He loved and most of all, he will live on in his legacy he left behind”

1. *Based on your life experience, skills and interests, what would a design process that is both uniquely yours and effective look like? (Roy)

The design process that I have used in the past involved working backward from the idea itself. That way, it has always been easy to lay up a plan and develop a step by step execution. A measurable and implementable idea is the first step. From then on, the question is always, who will likely participate in this idea given that it is implemented? This question looks at consumers or customers to the end product of the idea. After answering this question, I would then move a step back into question just how exactly I can deliver the product to the same customers/consumers or how I can get the prospect participants to gain awareness of this product. This requires figuring out the marketing strategies such as advertisement and possible distribution points of the product. After reaching a certain number of possible outlets, the next question would be to look at potential, influential people to buy into this idea and then later up develop a team with certain traits and share the same vision for the possibility of this idea. The last step would be then the actual development of the product and part of it entails analyzing the costs of production and potential mark up price for the product. At that point, at least a strategy is laid out with certain contingencies and flexibility for dynamics that might alter the original strategy.

 

2. *Identify your three most important stakeholders and list five UNIQUE attributes for each one of them. (Conner)

 

1. Possible Sickle Cell Patients in Sierra Leone

• They are the direct recipients of the work we are doing
• However, some of them are unreceptive to the device and Western medicine
• They have the greatest need for our product
• Possible Sickle Cell patients and their families do not have the resources to pay for alternative solutions
• Their feedback will be crucial towards the project’s success

1. World Hope 

• Our creation of the Sickle Cell Test Strips also aligns with their main mission of providing and protecting those who are under-served.
• We are not the only group who is working through the World Hope Organization or in Sierra Leone
• Working through World Hope allows us to give hope to others
• World Hope can give us connections in Sierra Leone 
• Their connections can help to improve the design, implementation, and efficacy of our product

1. Lehigh University

• As Lehigh students, we have a unique opportunity to display the Lehigh brand
• Also, as students, we have to handle ourselves professionally domestically, in conferences, and in-field at Sierra Leone
• Lehigh is one of our funding sources and one organization we have to answer to
• They will receive part of the research’s prestige
• Lehigh faculty and teammates will supply us with much of the technical knowledge for our product

 

3. *Identify three ways in which you will validate your project concept, technology, usability, and business model. (Tiffany)

In order to ensure that the diagnostic device will be in optimal use for low and middle-income countries (LMICs), the team will build partnerships and connections with World Hope International and Lehigh Valley hospital to receive feedback from medical experts on the operational aspects of the device, and learn how to address implementation challenges. By considering these context-specific frameworks for the diagnostic device, together with integrating the Sierra Leone local’s knowledge to guarantee a functioning device, these factors will indicate an overall validation of our project. This is especially significant when validation is given from the locals of Sierra Leone themselves because they are the ones who will be utilizing the device and will incorporate value in the device. The people’s acceptance is the ultimate goal because the technology can be promoted to be amazing and all, but will have no worth unless the acceptance of the device is established. Therefore, another process of validating our project is educating the public about the device’s concept and usability. To do so, every patient must fill out forms that consist of the process of the diagnosis, background information of Sickle Cell Anemia, explanation of risks, waiver of liability and a signature to signify consent. Patients who are still unsure can under-go a walk-through with the assisting health provider to visualize the process first-hand. The goal is to have patients understand what they are being tested for, why it is important to be diagnosed and where they could receive immediate treatment if tested positive of the Sickle Cell trait.

 

4. Give three examples of something very interesting you learned from a friend that was a completely alien concept to you.

• I once had a conversation with one of my teachers in high school about politics. I had the opinion of how politics is a dirty game and I do not want to get involved at all but he had a different perspective. He told me and illustrated how politics affects everything else despite being in the stem field. He was right.
• One of my colleagues in a place I worked in told me how his friend got rich, his means being somewhat not ordinary. He would go to the dumpsters near a fresh market area and collect avocado seeds from rotten produce. He would then make the avocado seedlings from these and sell them to the German Embassy and ended up growing this project into a big business idea even though it started as a method to live just by the day.
• I had no idea about some very historical moments in America until my friend told me about it. it was just a moment of ‘wow’.

1. List the top 20 questions your team needs to answer to advance the venture forward.

 

1. We are able to diagnose Sickle Cell Anemia, so what?
2. How can we implement our project, so that it stays relevant?
3. Why hasn’t an initiative for this project not yet been started?
4. If our project is successful, where can we go from there?
5. How will the locals react or perceive our device?
6. How do we work with individuals who are unsupportive of our research?
7. What can we learn from the locals that could help us with the device?
8. How will their culture affect our project?
9. How will our project affect their culture?
10. How is our project going to change Sierra Leone?
11. What are other treatment or care options if they decide not to participate?
12. If this project is successful, where can we go from there?
13. How will we establish the operation from one clinic to millions of clinics?
14. Is this a project that we will continue providing assistance to? Or do we pass this responsibility onto the locals?
15. How will the devices be distributed?
16. How will we make this project affordable to the locals?
17. What’s this project’s incentive for Lehigh?
18. How will the locals welcome this project?
19. Is there a way where we can train the locals, in order to sustain the system?
20. Are there problems or aspects of the research we don’t know about?

2. Develop and Visualize the Theory of Change (Logic Model) for your venture:

 

Spring Semester Goals:

• Prove the detection of the HbS and HbA hemoglobin with our test strip (antibodies GS5 and GS4)
• Optimizing the amounts of antibodies, beads and running buffer for the device (cost-effectiveness in consideration)
• Prove the functionality of the Conveyor Belt with attached Syringe Pump
• Finding the optimal dimension for test strips
• Manufacturing/producing large amounts (~100) of test strips efficiently
• Complete IRB/SLA forms for Lehigh Health Valley and Sierra Leone at Lehigh (Discuss with other Sierra Leone groups)
• Receive IRB approval for obtaining HbS blood samples from the Lehigh Valley Health Network

Summer Goals (Mountaintop):

• Prepare 100+ test strips and reagents for clinical trial and demonstration purposes.
• Run shelf life experiments 
• Develop interview and questionnaire questions for Sierra Leone 

Sierra Leone Field Trip:

• Carry out clinical trials with locals who are confirmed as sickle cell patients through one of the programs: SCCAN or Sickle Cell Society
• Carry out interviews with recruited patients about their livelihood after being diagnosed with sickle cell (perception)
• Research for a potential Case Study publication for the Fall 2020 semester

 

 

 

 

 

 

1. Give three compelling examples of how cultural issues affect your project.

 

As much as our drive is ‘Impact’, there social issues that might affect the Sierra Leone Sickle cell disease diagnostic device project if not navigated with much respect and understanding they deserve. 

One of these would be the direct impact our project will have within the medical circles that are currently in existence right now. The economy in the country is mainly informal and there are members in the community that hold traditional medicinal practices with high regard for reasons that vary from religion to socioeconomic status. Taking that into account, if our project gets to be successfully implemented and expanded to areas outside of Makeni, there are people who are likely to lose a lot of customers due to our project. This fact taken into account, there is bound to be some resistance from the elders within various tribes as they will envision this come to play.

Secondly, the project might face one of its big hurdles when it comes to getting people in the country educated about the nature and motive behind the initiative. Looking back at the history of Sierra Leone, the country has had bad experiences with outside countries trying to influence their politics and economy only for their gain. That fact gives room for suspicion and questioning of our true objective which might not seem convincing to the majority. Human resistance will be a hurdle as we try to make a positive impact. Hence, the spreading of the word of the device and people accepting it might be a tard situation that needs careful handling.

Last, but not least, Sierra Leone’s economy is informal as mentioned before and this informal sector is mostly filled with women. One challenge that this poses for our initiative is that these people will think they don’t have the time to visit the medical institute where sickle cell diagnostics will be administered. Besides the time factor, about 40% of the population lives in urban areas and the rest in rural areas. This presents a barrier of distance and accessibility to the remote that are far away from medical institutes.

These are some of the many social hindrances to the Sickle Cell disease initiative. For some insight about Sierra Leone at a glance, this a good piece to look at, https://www.everyculture.com/Sa-Th/Sierra-Leone.html.

 

2. Have you experienced or observed any of these social situations at home?

 

For me, home is back home in Zimbabwe. I personally experienced and observed some of these happen. One that stands out the most began around 2014 when China and Zimbabwe had an alliance that resulted in Chinese people coming in to build roads and certain infrastructure within the country. Although their actions would benefit the citizens as well, people got about their intentions. With such a history of being a colony and being controlled from outside, it’s a norm for the nation to be not accepting of help that comes in ways that are not clearly stated and proved.

Another social situation that is blurry but exists is very much involved in politics. In Zimbabwe, there are two main big tribes, namely the Shona and the Ndebele. Although ideas and projects are good, there are always those in politics that will always have something to say for their own politicals reasons. For example, when a road development project was initiated, it began in the main capital, which is mostly Shona populated and the Ndebele people felt neglected by that initiative and as a result of a few protests and some other factors, the program stopped after the completion of the road to the former president’s hometown. Although the idea was good, the choice of the starting point was politically influenced and resulted in somewhat resistance between the tribes. The social scene being the coexistence of more than one tribe in one country.

 

3. Give two examples of cultural practices that can be leveraged to addressed community/market problems.

 

One way to leverage cultural practices is to form alliances with people of Sierra Leone. Due to unfortunate complications of the white savior complexes, making connections with preexisting local communities dedicated to deal with sickle cell is one way to get accepted into the community. It’s easier to have the people who have grown up together in the same struggles to come together and be able to share the relevance of this project than to have foreigners come in and take the complete lead without the host country’s assistance. We can educate a select few talented members of the community and have them understand the idea behind this education. They will then go into various districts and educate the community on some of the real issues their community is facing and that way, they would be advertising and spreading the word of our product.

Another one that might be a bit tricky to navigate will be one that actually incorporates the traditional healers that I have mention earlier on as a way into marketing and also giving people the correct help they need. In this strategy, it would involve teaching the traditional healers about the diseases and make their workplaces points of sickle cell diagnosis. This is even more effective because 1) they don’t lose a lot of customers but instead, they get more 2) they are usually found in all places including remote places and having them as primary medical care providers for sickle cell would decrease the distances that people (who live in rural areas) have to walk to get help 3) Because they are already highly regarded in the community, they will be more effective in spreading and teaching people o better ways to live with sickle cell disease or traits.