Conner Calzone, Roy Ndebvudzemene, Tiffany Pang

 

• 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

 

• Failing an exam you studied many hours for
• Sadness, grief and loss
• Forgetting to do something you set out to do
• Not understanding a concept even after it has been explained several times
• Being confident in the wrong answer
• The Writers’ Block I have thinking of things for this blog post
• The lack of motivation I sometimes have to overcome to complete something important
• Happiness
• Helping those less fortunate
• Overcoming adversity

 

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

Specifically discuss

1. Why should I engage?
2. How must I engage?
3. With whom must I engage?
4. What kinds of challenges, opportunities, and approaches should I care about?
5. What might my epitaph read

 

1. I chose to engage to help those less fortunate. I am blessed to be in a position to help others, and it is the morally righteous and just thing to do. Engaging has many benefits for the people we engage with, but also for ourselves. It is obvious that providing altruistic aid while working to create self-sustaining solutions in other countries is impactful. However, it also will help us students apply concepts from our classes into real-world solutions, work together as a team, improve our interpersonal communication skills and gives us the experience of undergraduate research.  Above all, I think the project I am on, the Sickle Cell Anemia Diagnostic Device team, is an important and impactful project in Sierra Leone.
2. GSIF has given me an unique opportunity to serve others. For this opportunity, I have to be willing to put my time and utmost effort to working on the project. It is a commitment that I made, and must stick to, for the success of the project. I also have to be a “team player” when it comes to working on the project. Everyone in the group has to be motivated, properly splitting up duties and working efficiently and intelligently unless we will not get work done on time.
3. The question of whom I must engage with is a difficult question for me to answer entirely. I have yet to be abroad and I have not met the people, researchers and clinics we will work with. At Lehigh, we have many helpful connections including Professor Cheng, Khanjan, Professor Ersoy, and all of our fellow team members. Our group still has to figure out our exact itinerary in Sierra Leone and exactly who we will be partnering with, but all our Lehigh faculty, team members and other connections will help us through every step of this process.
4. Engaging successfully is a very difficult task. It is an arduous, yet fulfilling thing to do. That being said, there are many challenges to engaging successfully. We have to make sure we use our time efficiently while in Sierra Leone. We have a lot to do there in a limited time. Also, we have to be mindful and respectful of their culture and beliefs. We cannot act like Western medicine is the correct answer to everything as that will violate the beliefs of many. We have to convince them of the benefits of our project while respecting their culture. The most amazing part of this program is the opportunity we get. As undergraduates still in school, we have the opportunity to make an impact and improve people’s lives. We have to be careful in our approach, but if we are personable, listening to community feedback and eventually create a working device, the marketing process should be straight-forward and we will be able to make a difference in Sierra Leone.

5. I don’t really know how long an epitaph should be, but I know I want it to show me for who I was a person. My goal in life is to continue to serve in any way I can while being a great son, father, grandfather and more. I also want my epitaph to be personable, so I am truly remembered for who I am as a person. I want it to read, “Conner Calzone, a loving man, husband and father who was dedicated to helping others”. I also want one of my favorite quotes beneath it: “Tomorrow is the most important thing in life. Comes into us at midnight very clean. It’s perfect when it arrives and it puts itself in our hands. It hopes we’ve learned something from yesterday”.

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, who will 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 to 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 like 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 our work
• However, some may be 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

2. World Hope 

• Our creation of the 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

3. 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 and in Sierra Leone
• Lehigh is one of our funding sources and an organization we have to answer to
• They will receive part of the research’s prestige
• Lehigh faculty and teammates will supply us with 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.

In college, I met my girlfriend, who was born in the United States, but the rest of her family was born in Brazil. I took 10 years before college, so I thought the language and culture would be similar to the Spanish equivalents. However, I soon learned it was completely disparate. Her grandmother only speaks Portuguese, so she has tutored me in conversational Portuguese so I can interact with her. Through her and her family, I have also learned about common characteristics of Brazilians, like being late to gatherings and Braizilian food, like pão de queijo and Churrascos. Secondly, in high school, I joined a robotics team sophomore year. I was more interested in design and construction, but the team needed a second coder. I have always been receptive to trying new things, so I obliged in helping. The main coder, Alex, taught me Java, my computer language. Since then, I have enjoyed coding as a hobby. I am now a Teacher’s Assistant for ENGR 010 and can code in C++, Java and MATLab. Finally, I worked on a research project in high school. I was working on a project involving generating energy through the kinetic energy generated by a Hippo Roller and was not good at circuitry. My mentor, Rudy, an electrical engineer by trade, taught me a lot about basic circuitry, soldering and more for my project.

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

 

• We are able to diagnose Sickle Cell Anemia, so what? 
• • What makes our research so important?
• How can we implement our project, so that it stays relevant?
• • Is there a way where we can train the locals, in order to sustain the system?
• Why hasn’t an initiative for this project not yet been started?
• • Are there problems or aspects of the research we don’t know about?

• What does impact mean?
• How will our project affect the local’s lives?

1. • Will our project have an effect on people’s lives? (Closed-ended)

• If our project is successful, where can we go from there?
• How will the locals react or perceive our device?
• How do we work with individuals who are unsupportive of our research?
• What can we learn from the locals that could help us with the device?
• How will their culture affect our project?
• How will our project affect their culture?
• How is our project going to change Sierra Leone?
• What are other treatment or care options if they decide not to participate?
• If this project is successful, where can we go from there?
• How will we establish the operation from one clinic to millions of clinics?
• Is this a project that we will continue providing assistance to? Or do we pass this responsibility onto the locals?
• How will the devices be distributed?
• How will we make this project affordable to the locals?
• What’s this project’s incentive for Lehigh?
• How will the locals welcome this project?

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

Stakeholders	Inputs	Outputs	Outcomes
-World Hope -St. Luke’s Hospital -Lehigh Valley Health Network -Lehigh University -Sickle Cell Patients in Sierra Leone	-Sickle Cell diagnostic device and its components -Education about Sickle Cell Anemia -Financial Resources -Time and Research	-The number of people who use this device -The number of devices distributed -The number of children under five who received a diagnosis -The results of the diagnosis	Short Term: -Prove the functionality and usefulness of our device in Sierra Leone. Long Term: -Lower the child mortality rate -Have accessible/affordable sickle cell diagnoses -Spread awareness of the effects of sickle cell anemia -Improve the life quality for sickle cell patients