Our research will require human subjects at a certain point. We will need to test the reliability of the test on actual human subjects who either do or do not have the sickle cell traits. Although we will be asking to use human subjects I believe our work is not harmful at all to the subjects. Their blood would be taken the same way by people who were trained to do it through the same protocol every time. In order to receive IRB approval, we would need to give explicit details about what we would be doing with the subjects and how we will make sure that they are safe at all times. We would create a procedure which makes sure that the human subjects are given the same treatment as every other subject. We would have the blood drawn and the questions asked the same way every time to ensure that the subjects are able to give consistent and safe data. We would be using the blood samples to test our test strips accuracy and reliability, we would not need to collect other data which would be deemed private. The risk any given subject is at is very low due to the fact that only a small amount of blood would be needed. Furthermore, we would need to acquire consent from the subjects in order to use their samples. We would need to establish the language in which we are asking the questions and if we would need a translator. If we decide we would like to administer the questions in a language other than English we would need to ensure that we are able to have a translator and that we would be able to provide the correct documentation to allow us to administer the questions in another language. Due to the fact that we would like to collect blood samples from human subjects we would require IRB approval. We would explain the low risk of our procedure and the fact that each subject would be treated exactly the same as any other subject. We would decide on the necessity of a translator, if needed we would fill out the required documentation to administer the questions and blood draw in another language if we felt there was a large enough need. Once we have acquired all the necessary information we would submit our application using the latest version of the application.
Situation: Sickle cell is a major issue within many countries and it has killed thousands of people each year.
Needs and assets: We need to create a product, therefore we need funding, space, and materials. These are provided by Lehigh University.
Problems: Finding the correct procedure which will allow for the conjugation of a control line and a test line for our product.
Stakeholders: All people who believe they may affected by sickle cell are stake holders. Having a very inexpensive way to test for sickle cell could allow people to manage their symptoms in a much more efficient way, keeping them healthier for a longer time.
Priorities: Creating a product which is reliable and will have as little error as possible while also creating the most impact as possible throughout the areas it is implemented and then other areas as we spread our product.
What we Invest: We invest time, money, resources, along with the time of those who helped give their opinion on the project. Anyone who contributes to the project is investing their time, even if it is a small amount. Furthermore, many people have been spoken to about the project and their expertise and knowledge base is also invested into the project.
Who we Reach: We will be reaching all the people who have not had a way to get tested for sickle cell in the past. With our product everyone who in unsure if they have sickle cell can get tested as well as any children who may need an inexpensive way to be tested.
What we do: We are creating a product which will identify if sickle cell is being expressed within that person. Our product will be a small test strip which can be administered by health workers who have received the correct training for the test strips.
Results in terms of Learning: Many people will be bale to gain a sense of medical clarity as they will be able to know if they have a disease which could have drastically changed their lives. This will also hopefully raise awareness for sickle cell anemia as they will have a way to more easily test for the disease.
Results in terms of Changing action: We are filling the void between those who are able to pay for testing and those who are not.
Results in terms of change to the conditions: People will be able to reach out for specific help due to their increased knowledge about their own health, allowing people to live overall healthier lives.