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, our team does require IRB approvals right now, seeing as the last approval we received was in 2021. IRB’s need to be updated yearly, so we will need to go through this process again. In order to go about this process, we will first fill out a research application form, in which we will outline our project and purpose, our protocol, precautions, confidentiality and consent. Something to consider for our project specifically are the elements of informed consent. We will need to ensure that those who potentially participate in the clinical trials in local hospitals and clinics fully understand the research we are conducting, data confidentiality, as well as risks and benefits. We will need to consider the best way that this information can be delivered; the most effective method may not be in an overwhelming document full of fine print. Furthermore, we will be utilizing letters of support from mentors such as Dr. Cheedy Jaja; he has already expressed his approval as our team has gone through the IRB application process previously.
Since we will be working with human subjects, we will also need to fill out a human subjects application, in which we will outline the research design and research procedures, as well as how the data will be used to answer proposed research questions. We will also specify that anyone under the age of 18 will need a parent’s legal verbal consent. Furthermore, we cannot only test adults because newborn blood samples (which the device would be used for) are proven to have high fetal hemoglobin and less normal blood, so our device does not need a dilution step. The elimination of this step is preferable to increase efficiency. So if we were to test on adult blood samples, it would not provide accurate and useful results for the development of our research.
Our team will also need to fill out a Lehigh University Review Board International Research Appendix, since our research will be conducted in Sierra Leone. We will have to specify that while our participants may not be fluent in English, we will have Dr. Jaja and his medical team who are fluent in the official language in Sierra Leone. Because children who are under the age of 5 will not be able to understand what our research entails, we will need to outline the significance of a legal guardian’s consent.
Finally, we will utilize and update the consent forms we have already outlined in previous years to ensure the information is complete and up to date with our current project standing. This will include information on the voluntary nature of the study, how to go about contact and questions, consent, confidentiality, and duration. Willing participants that are adults will sign the form, while minors will need to give verbal consent.
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?
Our presentation will start with an introduction of the problem of sickle cell disease in Sub-Saharan Africa. Then we will introduce our team – who we are and what we will be doing. We will build our credibility in this section by explaining our past accomplishments and really developing the idea of how far along our project has come. We will also build the credibility of our device by being transparent about where we are and explaining the science behind how it works in a way that the audience can understand. Then, we will switch to talking about Sierra Leone, specifically why our device will be important in this country and how we will be solving the diagnostics problem of sickle cell disease. The disease places a heavy burden on the healthcare system but is often overlooked, something we hope to change with newborn diagnosis. If we still have time, we can add a section about the financial plan to display the strategy to get this project off the ground. It is important that we are realistic about our project goals and have financial budget statistics to prove that we are capable of implementing our device in Sierra Leone. Our credibility will be established throughout the presentation through the transparency of what we know and do not and how we can improve in terms of our project goals. We will make sure to also have updated and credible data to support our claims about why this issue is important and why we believe we can make a difference. We will work to make our presentation simplistic and to the point, explaining all of the important details about sickle cell anemia (understanding that not everyone is familiar with the disease) and how we plan to tackle the epidemic in Sierra Leone through our diagnostic device. Aware that our test strip only focuses on diagnosing the disease, our team will be prepared to respond to our treatment and care plans as well to further build our credibility. Additionally, we will state which global partners we are in collaboration with to help facilitate our project and implement our device into Sierra Leone communities.