African American/Black males have a higher rate of heart disease yet the medications and medical devices that are used to treat heart disease are designed for White American males. Hispanic/Latino community has a higher rate of diabetes, yet the medication and medical devices used to treat this disease are designed for White American males. The Asian community has a higher rate of kidney disease yet the medications and medical devices that are used to treat this disease are designed for White American males. This is not an inclusive list, there are many illnesses that vastly affect minorities. Yet, Bio Tech/Pharmaceutical companies are developing medications and medical devices based on White American males, because they are the demographic that overwhelmingly participate in clinical/pharmaceutical research.
This is an issue because the differences that people have are not just visible, as we all have different enzymes and metabolizers that afford our bodies to breakdown medication and react to treatment and medical devices differently. To effectively create change in healthcare, minorities must be willing to participate in clinical research. Select the links below to learn more about research
Informed consent is a process, not just a form. When you are reviewing and ICF the information must be presented in way that supports your decision to voluntarily participate or to not participate as a research participant/subject.
The procedures used in obtaining informed consent should be designed to educate about the research study in terms that you can understand. If you need additional clarification on any part of the ICF, ask the Study Team Member.
For additional information on informed consent please click the links below:
https://www.hhs.gov/ohrp/regulations-and-policy/guidance/checklists/index.html
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guide-informed-consent
For additional information on research regulations click the links below:
https://www.hhs.gov/ohrp/regulations-and-policy/guidance/vulnerable-populations/index.html
https://www.hhs.gov/ohrp/regulations-and-policy
https://www.hhs.gov/ohrp/regulations-and-policy/regulations/index.html
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