IRB-HSR Home Institutional Review Board for Health Sciences Research
Researchers IRB Members Research Subjects IRB STaff







+ Calendars & Deadlines
+ Office Information
+ Directions & Hours
+ Staff Directory
+ Frequently Asked Questions
+ IRB-HSR Membership Lists
+ FWA Information
+ Organizational Charts
+ Research Concerns
+ Standard Operating Procedures
+ Getting Started
+ Protocol Review Process
+ Managing Protocol After Initial Approval
+ Special Issues
+ Protocol Builder and IRB On-Line: On Grounds or UVa VPN access only
+ Forms
+ CITI Training
+ Education
+ Regulations/Guidelines
+ Ethical Principles
+ Search IRB-HSR Protocols
+ Glossary/Acronyms
+ Useful Websites
+ Go to full list >>


IRB-HSR > Special Issues > Genetic Research > FAQs







Genetic Research FAQs

What is genetic research? Specific scenarios explained...

  • Immunology research
    • I'm just looking at immune response, not looking at DNA, is this genetic?
      • Looking at differences in immune response between different individuals could be considered a genetic test. Identifying the cellular and ultimately the genetic cause of the different immune response could indicate who is susceptible to a disease, or who may progress to a more severe disease state.
  • Gene expression
    • I'm comparing different expression patterns from those with or without disease, or between a tumor sample and regular tissue, that's not genetic is it?
      • Looking at differences in gene expression could be considered a genetic test. A certain profile of altered expression could indicate disease susceptibility or prognosis.
      • With regard to testing of tumor samples, the IRB considers somatic alterations to meet the definition of genetic research.
      • As noted by the American Society of Clinical Oncology, "Although ASCO supports a more stringent review process for research involving germline DNA (ie, inherited alterations), it is important to recognize that the distinction between studies assessing somatic alterations in abnormal tissue and those evaluating germline genetic variations is somewhat artifactual. The examination of certain somatic changes by either direct DNA analysis or other techniques may indicate the presence of a germline predisposition (e.g., microsatellite instability, mis-match repair protein expression, gene expression profiles)." (J. Clinical Oncology, Vol 21, No 12 (June 15), 2003).
  • Other questions
    • I am doing a genetic test only to find out if a subject qualifies for my study, does this mean the research is genetic research?
      • Yes, you are conducting a genetic test for research purposes