Tissue Donation Program
For more information, contact Laura Isaacs, at - firstname.lastname@example.org
Clinical research often involves de-identified data or leftover patient specimens, such as tissue and blood samples. This research process is overseen through the regulated supervision of the Institutional Review Board.
What is a Leftover Specimen?
Blood or tissue which may have been removed during surgery or other procedures is sent to the Pathologist for medical analysis. A Pathologist is a doctor trained to examine a specimen under a microscope. After the analysis is completed and the specimen is no longer needed to make patient care decisions, the remaining sample is left over and is available for donation to scientists and clinicians to use for research purposes.
Since your request involves the use of Cottage patient data and/or biospecimens, your project is required to be reviewed by the DUC. Complete the Specimen IRB Cover Page and Specimen Collection Worksheet and follow DUC application procedures, “How and When to Complete a Data Request Form”.
The information presented in these application materials will be reviewed and evaluated by the DUC to ensure that all HIPAA Privacy and Security regulations are in place prior any collection of data and/or biospecimens. While Informed Consent and HIPAA authorization from the patients may not always be required, there may be instances in which individual authorization from the patient may be needed to use their health information and/or biospecimens. Dependent upon the identifiability of the data and/or biospecimens being requested, IRB review may or may not be required. The DUC will assist you in making these determinations and provide you with next steps to move forward with your project. Cottage Health Research Institute will also provide assistance in developing and executing a Material Transfer Agreement to allow the specimens to leave Cottage and be transferred to the researcher after all other approvals are in place.