REQUEST FOR AHCBR DE-IDENTIFIED SAMPLES FORM

Date (mm/dd/yyyy): ______

INVESTIGATOR INFORMATION

Principal Investigator (PI): ______

First Last

PI Title: ______

Institution: ______

Department: ______

Phone: ______Fax: ______

E-Mail: ______

Contact Person (if different from PI): ______

Location (Building/Room #): ______

Phone: ______

PROJECT INFORMATION

Title of Research Project: ______

______

Is this Research Project funded? ___ Yes ___ No

If so:

Grant No. / Funding Source / Period of Support

Please attach your Research Project (not to exceed 5 pages) and it must contain the following:

Abstract

Background and Significance

Specific Aims

Methods

Power Calculations

HUMAN BIOLOGICAL SPECIMEN (HBS) PROCUREMENT INFORMATION

List all HBS types (solid tissue, blood, urine, etc.) requested: ______

______

Would you like a copy of the de-identified pathology report for each sample? (If applicable)

___Yes ___ No

If solid tissue is requested, complete the following section:

Total number of specimens requested per body site (example: lung – 5, colon – 4):

______

______

Minimum weight of tissue requested per specimen (example: 0.25 g of x tissue):

______

______

Types of tissue requested:

___ Tumor

___ Tumor and matched normal (if available)

___ Normal non-matched (if available)

Preparation and preservation requirements (examples: frozen (OCT), fixed, fresh) (indicate media):

______

______

If blood is requested, complete the following section:

Type requested:

Serum Plasma Buffy Coat

Amount needed:______

______

Disease category:

Cancer _ Normal control

Matched tissue: ______

Additional comments: ______

______

AHCBR TERMS OF AGREEMENT AND USE

I acknowledge that the conditions for use of this research material are governed by ProMedica’s Institutional Review Board (IRB) in accordance with the Department of Health and Human Services (DHHS) regulations at 45 CFR 46 and Food Drug Administration (FDA) regulations at 21 CFR 50. I agree to comply fully with all such conditions and to report promptly to the Academic Health Center BioRepository (AHCBR) and IRB any proposed changes in the research project and any unanticipated problems involving risks to subjects or others. I remain subject to applicable State or local laws or regulations and institutional policies, which provide additional protections for human subjects.

This HBS may only be utilized in accordance with the conditions stipulated by the AHCBR and the IRB. Any additional use of this HBS requires Scientific Advisory Committee (SAC) review.

I agree to provide the AHCBR with a summary of results obtained from any study I conduct using the HBS from the AHCBR. I acknowledge that the purpose of this disclosure is to provide the AHCBR with information regarding the quality of the HBS to improve quality assurance. I will also provide the AHCBR with any results obtained from the use of the HBS to ensure that the distribution of HBS for future research is done in the most scientifically appropriate manner and to avoid replication of existing studies. I understand that the AHCBR will not release any results provided without permission from the investigator whose name appears on this form. In addition, I agree that the AHCBR will be acknowledged as the source of HBS in all publications submitted or presentations given as a result of the use of HBS or associated information obtained from the AHCBR.

I understand that all HBS are to be handled as potentially infectious. I agree to inform and train all lab personnel on the proper handling procedures for HBS. I acknowledge that I am aware of OSHA regulations for the handling of HBS in my laboratory.

To the extent allowed by law, I agree to hold the AHCBR harmless for any claims, costs, damages, expenses due to illness or death, or other damages or loss that may arise from the use of the HBS provided by the AHCBR.

I agree to allow the use of HBS and associated information only by the research team, for research purposes under my direct supervision, and only after the research team has been informed of and agreed to the restrictions contained in the Agreement. HBS will not be sold or distributed to third parties. I acknowledge that the AHCBR provides HBS as a service to the research community without warranty or merchantability for a particular purpose.

By my signature, I agree to the terms set forth above:

Signature: ______Date: ______

To be completed upon IRB approval

IRB approval #: ______Date of IRB approval: ______Date IRB expires: ______

AHCBR 03.05.12 Page 1 of 4