- Does your work require IRB approvals…right now? At a later stage? 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.
- Yes, we do require IRB approvals both now and in the later stages of our project. Currently, we have an IRB that is pending review at St. Luke’s University Health Network (Bethlehem, PA), in order to receive permission to use blood samples from their patients. Because of COVID-19, however, we have experienced delays in receiving IRB approval from St. Luke’s. Such testing is essential for our device advancement and is considered human subject research, as we must know information about the blood donors regarding their sickle cell diagnosis among other private details. In terms of our current IRB approval in Sierra Leone, as of now, our team works under the granted IRB approval of Dr. Cheedy Jaja. We have worked with him in the past, but need to do the paperwork to continue the partnership. However, in the future, we will need to receive our own IRB approval to work in Sierra Leone, because as of now, we are only permitted to run clinical trials if Dr. Cheedy Jaja is present.
- 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?
- Who are you?
- Describe our team
- We are the Sickle Cell Diagnostics Team with 9 GSIF members. We are motivated students who want to create a low-cost screening device for sickle cell anemia.
- What are you doing?
- We are developing an affordable point-of-care screening device to be implemented in Sierra Leone. Sickle cell anemia is a major contributor to the high infant mortality rate in Sierra Leone. With this test strip, we hope to diagnose sickle cell anemia early on and offer treatment.
- Our product will eliminate the need for advanced training by medical professionals and minimize required reagents to allow widespread distribution within the country.
- Where will you be doing it?
- We have been conducting experiments and testing in Iacocca C162 on the Mountaintop campus. However, we would like to do fieldwork in Sierra Leone this summer with the test strips we produce.
- Why are you doing it? (what problem are you solving/addressing?)
- Globally, there are 300,000 babies born every year with SCD. In sub-Saharan Africa, 50-90% of individuals with sickle cell die before the age of 5. The ultimate goal of our project is to lower the death rate.
- Show statistics about the death rate in SL vs. the US.
- How are you doing it?
- We plan to conduct numerous trials in the laboratory in order to create the most accurate and effective test strip. Afterward, we plan to take them over to Sierra Leone to conduct fieldwork. If the test strip functions properly, we will work towards incorporating our test strip into the health network.
- Credibility/validity – partners? funders?
- Partnership w/ Dr. Cheedy Jaja – IRB approval to run clinical trials in Sierra Leone
- Working with Sierra Leone’s Free Healthcare Initiative (FHCI), which is a program that makes healthcare free for mothers and children
- Venturewell – Through their DEBUT challenge and partnership with the NIH, Venturewell is an organization that strives to provide funding for innovative projects/research
- Davis Peace Prize – $10,000
- Published 2 papers; currently in the process of working on more
- Who are you?