QUESTIONNAIRE FOR USE OF HUMAN BIOLOGICAL SAMPLES IN RESEARCH

Please send form via e-mail to the attention of Maritza Polania E-mail:

INSTRUCTIONS: Complete this form if the research consists of using, collecting or storing human biological samples for other than routine testing. This form must be typed and completed in its entirety. Incomplete forms will delay the approval process. Please submit a copy of the protocol.

Submission Date: ______

Protocol Title: ______

Principal Investigator: Department/Division

E-mail: Phone: Fax:

Contact Person: ______E-mail: ______Phone: ______Fax: ______Sponsor:______

1. Will you need laboratory services at:

·  UMHC _____ Yes (Continue the rest of the form) _____ No (Skip the rest of this form)

·  UMH _____ Yes (Continue the rest of the form) _____ No (Skip the rest of this form)

·  Deerfield Beach _____ Yes (Continue the rest of the form) _____ No (Skip the rest of this form)

·  Kendall _____ Yes (Continue the rest of the form) _____ No (Skip the rest of this form)

2. Does this study involve only standard laboratory testing (no laboratory testing outside standard of care)?

_____ Yes (Skip the rest of this form) ______No (Complete the rest of the form)

3.  Indicate performance sites where laboratory services are needed, please mark with an X.

_____UMHC-SCCC _____UM Hospital

_____Deerfield Beach _____Kendall

4. Specify needs (Mark all that apply):

Biopsy or solid tissue use: ____tissue processing ____ cut unstained slides

____ cut stained slides (___H&E, ___Immunohistochemistry, ___other)

Body fluid or liquid specimens: ___ blood, ___ urine, ___CSF, ___other (please specify type of fluid)______

Bone marrow biopsy/aspirate ______

FNA _____ Phlebotomy services ____ Others______

5. Will you need a pathologist?

_____ Yes _____ No (If yes, study PI is responsible for contacting pathologist).

If “Yes,” has one been contacted?

_____ Yes ______No

If “Yes,” name of pathologist ______

Purpose: _____ retrieval of tissue (___ fresh, ___ frozen, ___ archived blocks/slides)

_____review of slides ____ consultation

6. Do the samples already exist (collected prior to the development of this research protocol)?

_____ Yes _____ No

If “Yes,” when were the samples collected (E.G., from 1/1/2000-6/30/2002)?

7. Does this research involve human cell lines and/or products that are made from human biological samples?

____Yes _____ No

If “Yes” please explain:

8 Will the samples be linked to their subject source via any identifiers?

____ Yes ____ No

If “Yes”, please describe the linkage:

9. Will the samples be destroyed after the study purpose is served?

_____ Yes _____ No

If “Yes”, please explain when will the samples be destroyed?

If “No”, for what future research purposes will these samples be stored?

Any other information, comments or special conditions that you believe would assist in expediting the review and approval of your protocol should be added below:

NOTE: Any subsequent use of the human biological samples for future research purposes requires HUMAN RESEARCH SUBJECTS OFFICE approval.

NOTE: Release of tissue for research purposes is subject to availability.

For use by the Pathology Protocol and Review Committee only:

Protocol Approved by Pathology Protocol and Review Committee: Yes ____ No ____

Dr. Merce Jorda or Dr. Carmen Gomez (Please circle) Signature______Date ______

Comments:______

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Revised 5/2010