Type of SRC Review Requested

Office of Research

Scientific Review Committee

Type of SRC Review Requested:

New SRC study.

Amendment to Approved SRC Study.

Prior approved protocol with amendments highlighted attached.

PRMC Approved Study.

PRMC approval letter attached.

Pathology Department confirmation of tissue availability and adequacy attached.

Human subjects’ protection is in place.

Pilot study. Involves non-rare specimens of small quantity (typically less than 10 samples

and small number of sections/or size) to test an assay.

Full SRC application attached.

Banking satellite for specific study. Study protocol is included in this application.

Full SRC application attached.

Approved HTOC ‘HUMAN BIOSPECIMEN REPOSITORY APPLICATION’ attached.

Note: Additional SRC approval is required for use and distribution of satellitesamples.

Banking for satellite collections for future undetermined studies.

Approved HTOC ‘HUMAN BIOSPECIMEN REPOSITORY APPLICATION’ attached.

Note: Additional SRC approval is required for use and distribution of satellite samples.

Office of Research

Scientific Review Committee

Request for Scientific Review

All proposals must be reviewed by the Scientific Review Committee (SRC) before they are submitted to the UNM Human Research Protections Office (HRPO).

Application Date: / SRC#:
Proposal Title:
Principal Investigator:
Title: / UNM Faculty: Yes No
Department or Affiliation:
Telephone: / Email:
Contact Person (if different than above):
Telephone: / Email:

Designated faculty pathologist for this proposal (required if requesting diagnostic materials):

Other investigators and/or collaborators for this project:

Required Signaturesfor Specimens from UNM Surgical Pathology:

Certification by signature of the Medical Director of the HTR that the tissue is available

____ is not rare
____ is rare. The HTR staff will ensure that no blocks are exhausted.

______Date: ______
Signature of HTR Medical Director or Designee

If you are requesting materials from UNM Surgical Pathology, please obtain the approval/signature of the Division Chief of Surgical Pathology or Designee. A signature is also required for the HRPO’s “Biological Specimens Attachment.”

______Date: ______
Signature of Division Chief of Surgical Pathology or Designee

Specimen Details:

Source / Number of Cases / Specimen Description / Sample Type / Paired Normal? / Number of Samples per Donor / Quantity per Sample / Assay to be Performed
EXAMPLE:
Surgical Pathology Archives / 100 / Breast
(ductal tumor) / FFPE / Yes / 2 block per case / 5 sections per block, 5µm thick sections / IHC

Additional comments:

Scientific Merit of Proposed Study:

1. Background of Proposed Investigation:

1. Rationale and Significance:

1. Research Objectives with Specific Aims:

1. Specific Methods [please include assays to be performed]:

1. Relevant Patient Characteristics (inclusion/exclusion criteria):

Expertise of the Investigator/Research Team:

1. List Record of Relevant Publications by Investigator/Research Team:

1. List Record of Relevant Funding by Investigator/Research Team:

Feasibility of Proposed Study:

1. Power Calculation or Justification/Rationale for Number of Subjects Selected:

1. Current Funding Sources (check all that currently apply):

Federal SecuredPendingAgency Name(s):

Industry SecuredPendingAgency Name(s):

UNM/Institutional SecuredPendingAgency Name(s):

Division/DepartmentSecuredPendingAgency Name(s):

Grant title(s):

Potential Risks and Benefits to Study Subjects:

1. Please address all of the potential risks and benefits to study subjects:

Plans to Return Remaining Tissue to the HTR or Satellite Repository:

1. Please discuss your plans on returning any remaining Tissue to the HTR or a Satellite Repository, if applicable (Note: this does not include archival diagnostic paraffin blocks from Surgical Pathology):

1. Comments or Other Relevant Information, if necessary:

1. Relevant Literature References:

For SRC use only
Date Application Received:
Repository Director or Designee:
HRPO#:

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