What Is a Research Study?

Choosing to participate in a research study is an important personal decision. The information on this site is designed to answer questions potential islet transplant patients may have. If you are interested in islet transplantation, we hope this information will help you make an informed decision about whether islet transplantation is the right choice for you.

The study is conducted under the oversight of the Federal Food and Drug Administration (FDA) whose purpose, in part, is to "protect public health by assuring the safety of human drugs and biological products." An investigational new drug application was submitted to and approved by the FDA. This approval allows us to conduct this study.

The study of islet transplantation as a type 1 diabetes treatment is also overseen by Emory's "Institutional Review Board" (IRB). The IRB is a research oversight committee charged with assuring that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in approved research studies. The IRB approves an application for research programs as well as an "informed consent." The informed consent is signed by the patient before any research is conducted. It explains the study purpose, duration, procedures, risks, benefits, alternatives, contact names, confidentiality, compensation/costs, voluntary participation/withdrawal, new findings, and entitlement of consent forms.

Please visit the following websites for more information on islet transplant research and islet transplantation:

  • Juvenile Diabetes Research Foundation
  • The Islet Foundation
  • National Diabetes Information Clearinghouse
  • Clinical Islet Transplant Consortium
  • Collaborative Islet Transplant Registry
  • LifeLink of Georgia
  • Donate Life America
  • Transplant Recipient International Organization
  • Georgia Transplant Foundation
  • United Network for Organ Sharing
  • Clinicaltrials.gov