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.