To establish guidelines for specimen collection and/or tissue banking procedures in research participants.
POLICY: The Cottage Health System IRB has established and shall follow written guidelines for collecting specimens and / or donating tissue to repositories for individuals enrolled in research studies.
The IRB has developed a consent form template for investigators enrolling research participants in studies designed to collect physiological specimens. These specimens may be donated to third party investigators for research purposes or are donated to repositories where they are used for additional research. Individuals participating in specimen collection/tissue donation research must be protected by law and must be fully informed of the procedures and of their rights as research participants. In order to promote optimum oversight of these individuals, investigators are asked to use the consent form template. All language in the template that must be included is indicated.
Certain research studies may use patients' DNA and conduct genetic testing on specimens. Additional safeguards are required in these situations, in order to make certain that patients are aware of the ramifications of genetic research. It is the goal of the IRB to ensure that patients enrolling in genetic studies are fully informed.
Procedures for Coordinating the Collection of Specimens for Research with the Pathology Dept:
- The Research Specimen Collection form is required whenever specimens are to be collected for research purposes. The form will originate in the CHS Office of Research, where the Research Staff will fill in the study number and the type of tissue collected. The CHS Research Staff will provide the pathologist with the partially completed form and a copy of the study protocol.
- The pathologist will check the appropriate boxes, sign the top half of the form, and return the form to CHS Office of Research.
- The CHS Office of Research Staff will make several sets of triplicate copies of the form and provide them to researcher.
- The researcher will check the box instructing how the specimen should be prepared for delivery. (If this is known in advance by CHS Office of Research staff, the box will be checked prior to copying).
- The researcher will bring in a separate form for each specimen pick-up along with a copy of the patient's signed and dated consent form or Authorization to Use or Disclose Protected Health Information form.
- Each time the researcher wishes to pick up a specimen s/he shall bring a copy of the IRB approval letter, so that the individual releasing the specimen can verify IRB approval and note it in the appropriate location on the specimen collection form.
- If the specimen is to be collected during surgery, the surgery staff will have received a copy of the Research Specimen Collection form, as well as a copy of the patient's signed and dated consent form or Authorization form. A member of the surgical staff will fill out the bottom portion of the specimen collection form regarding disposition of the specimen to the researcher. Arrangements may be made for the specimen to be picked up directly from the Surgical Services Department (surgery) by the researcher or it may accompany the Research Specimen Collection form to Pathology.
- If the specimen goes to Pathology prior to pick-up, the canary copy of the form and the consent form or Authorization form will accompany the specimen. Pathology will call the researcher when the specimen is ready for pick-up.
Existing specimens to be picked up from a CHS facility require documentation to verify that the CHS IRB has approved the release of specimens. This documentation must include:
- A copy of the approval letter from CHS IRB. Approval letters from outside IRBs may not be substituted as documentation, as it could mean that the CHS IRB has not reviewed or approved access to the specimens.
- A copy of the signed patient Consent form or Authorization form. This documentation is needed to ensure that specimens are being released for the appropriately consented patient. NOTE: If the IRB waives patient authorization and/or consent, it will be noted in the CHS IRB approval letter. If this is the case, neither a consent form, nor Authorization form, need to be presented for specimen collection.
The IRB application, as well as references and guidelines for specimen collection and tissue donation are available from the IRB Department in the Office of Research.