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OHR-15A 7/2006 Thomas Jefferson University IRB Prospective Collection of Human Biological Specimens Specimens do not exist on the shelf when IRB request is made Biological specimens obtained prospectively and procedures performed specifically for research (i.e., additional blood at the time of clinical venipuncture, additional biopsy, normal control blood drawing) Genetic1 Form Non-Genetic Consent IRB review Form Consent IRB Review Anonymous Protocol2 Yes Full or Exped. Protocol Yes Full or Exped. Identified Protocol Yes Full Protocol Yes Full or Exped. Biological specimens obtained prospectively from future discarded clinical samples (i.e., tumor tissue for all newly diagnosed patients, left over urine/blood after clinical test performed for next 6 months.) Genetic1 Form Non-Genetic Consent IRB review Form Anonymous Specimen form3 No4 Exped. Specimen form Identified Protocol2 Yes Full Specimen form Consent IRB Review No Exped. Waiver can requested5 be Full or Exped. OHR-15A 7/2006 Thomas Jefferson University IRB Retrospective Collection of Human Biological Specimens Specimens already exist, have been collected and are “on the shelf”, stored or frozen at the time the request is made to the IRB. Genetic1 Form Non-Genetic Consent IRB review Form Anonymous Specimen form3 No4 Exped. Specimen form Identified Protocol2 Yes Fullor Exped. Specimen form Consent IRB Review No Exped. Waiver can be requested5 Full or Exped. 1. Genetic-Research (not diagnostic testing) which involves either; 1) the analysis of human chromosomes or DNA from an individual and/or family members for the purpose of deriving information concerning the individual or family about the presence, absence or mutation of genes, DNA markers, gene products or inherited characteristics; or 2) biochemical measurements of proteins or metabolites with the intent of collecting and evaluating information about heritable diseases and/or characteristics within a family. 2. Protocol- Full application 3. Specimen form-one page form to be signed by the IRB and person providing the specimen. 4. No- The hospital’s general informed consent for surgery/procedures will specify that the removed tissue may be collected anonymously and used for research 5. To request a waiver of informed consent the following conditions must be met. The research is: 1.No more than minimal risk; 2. It is not practical to conduct the research without the waiver; 3. Waiving consent will not adversely affect the subject’s rights or welfare; 4. Pertinent information will be provided to subjects later, if appropriate. Full-Full IRB review Exped. Expedited review.
