OFFICE OF RESEARCH Scientific Review Committee Please contact Karen Capobianco (505-272-1127 or src@salud.unm.edu) before attempting to complete this form 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: Proposal Title: Principal Investigator: Title: Department or Affiliation: Telephone: SRC#: UNM Faculty: Yes No 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: 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 Scientific Review Committee: Application (Version09June2015) Page 1 of 5 Please note: Proposals to utilize archived and prospectively-collected specimens, including those from the Human Tissue Repository (HTR), HTR satellite repositories, Surgical Pathology, and Hematopathology must be submitted to the SRC. Any changes to an SRC-approved protocol will require additional review. If this is an amendment to an SRC-approved protocol, please track changes. Questions? Please contact Karen Capobianco (505-272-1127 or src@salud.unm.edu) or visit hsc.unm.edu/research/compliance_and_support/scientific_review_committee.html. The HTR serves as the University of New Mexico’s honest broker. Therefore, HTR staff will exclusively handle all identifiable materials for SRC proposals. Please limit to five pages. 1. Background: 2. Rationale and Significance: 3. Research Objectives with Specific Aims: 4. Specific Methods [please include assays to be performed]: 5. Relevant Patient Characteristics (inclusion/exclusion criteria): Scientific Review Committee: Application (Version09June2015) Page 2 of 5 6. Specimen Details: Source Number of Donors EXAMPLE: 100 Surgical Pathology Archives Specimen Description Breast (ductal tumor) Sample Type Paired Normal? FFPE Yes Number of Samples per Donor 2 block per case Quantity per Sample 5 sections per block, 5µm thick sections Additional comments: Scientific Review Committee: Application (Version09June2015) Page 3 of 5 Assay to be Performed IHC 7. Power Calculation or Justification/Rationale for Number of Subjects Selected While we respect the fact that most studies are of a pilot nature, investigators should show evidence that consultation with a biostatistician has occurred and outline a data analysis plan in the proposal, including assumptions of power calculation. We believe that consulting with a biostatistician early in the exploratory phases of research will help avoid pursuing spurious signals and ultimately increase research reproducibility and productivity. For more information on these issues, please see the recent report from the NIH on reproducibility in exploratory studies: www.nature.com/news/policy-nih-plans-to-enhance-reproducibility-1.14586 8. Brief Description of Funding Source: 9. Plans to Return Remaining Tissue to the HTR or a Satellite Repository, if applicable (Note: this does not include archival diagnostic paraffin blocks from Surgical Pathology): 10. Comments or Other Relevant Information, if necessary: 11. Relevant Literature References: For SRC use only Date Application Received: Repository Director or Designee: HRPO#: Scientific Review Committee: Application (Version09June2015) Page 4 of 5