<< Previous Section | < Previous Page | Next Page > | Next Section >> Case: Tissue Samples Aortic tissue samples from patients undergoing cardiac transplantation have been collected and stored for many years. Permission for the sampling was granted under the blanket research approval in the surgical consent form. Previously, investigations were permitted under waiver of IRB review because the samples were used completely without identifiers. The samples (n=2000) were dated and stored untouched in liquid nitrogen. The medical team gave permission to Dr. Gomez, a geneticist, to sample all 2000 specimens to study the prevalence of a number of gene polymorphisms proposed to relate to development of dilational cardiomyopathy. The genetic findings were to be related to a specific patient by identifying the tissue donor by correlating the sample date to the operative schedule. Dr. Gomez claims that no IRB approval or new consent forms were required for this study because the study did not utilize individuals, only stored tissue. Questons: Are there any limitations on Dr. Gomez' access to the tissues? To perform a complete genetic search, Dr. Gomez would like to provide some of the material to other labs including some commercial labs. Are there any limitations to that? There may be several forms of dilational cardiomyopathy. Dr. Gomez plans to arrange for a cardiology fellow to collaborate and to review all the charts to distinguish between the clinical forms of the condition to further define the genetics. Is there a problem with this? If there are problems how should they be handled? << Previous Section | < Previous Page | Next Page > | Next Section >> Chapter 2 Quick Links Research in Humans History of Rules About Research in Humans Definitions Federal Mandate Respect for Persons Beneficence Justice Common Rule IRB Mission Cases Bibliography Chapter 2 Download (PDF)