Rigor and Reproducibility

A. Eight steps to Rigorous and Reproducible Experiments in Biomolecular Research at UNC:

1. If using a core facility, consult with the core staff in the planning stage. Consult with a statistician if you need help developing a Power Analysis to assure that your results will be adequately powered.
2. Design your experiment with sufficient controls (rigor) and replicates (reproducibility).
3. Assure that ALL of your reagents (antibodies, cell lines, mice) are fully validated (see below).
4. Have a clear and detailed protocol (SOP) and data analysis plan. Assure that the protocol is strictly followed or that any deviation is well documented.
5. Assure that the staff or students performing the experiment are well trained and understand each step and the importance of performing them precisely.
6. Use only well-maintained instrumentation, preferably maintained and operated in a core facility with expert staff (see #1 above).
7. Document all steps, reagents, equipment and data analysis methods used in the experiment. Assure that the both the documentation and the data itself are properly stored in a safe data management repository.
8. Acknowledge the Cancer Center Support Grant (P30 CA016086) (if applicable), other grants that support the core, the core (by name), and core staff in publications.

B. Guide to Rigor and Reproducibility for the Animal Studies Core

1. Consult with the core staff in the planning stage by emailing pruadmin@office@unc.edu 
2. Design your experiment with sufficient controls (rigor) and replicates (reproducibility).
3. Any study that makes use of cells lines should verify the identity and purity of the lines through tools such as short tandem repeat (STR) profiling and mycoplasma testing. Genetically modified mice and/or cells should confirm the genome modification using tools such as PCR amplification or Southern blot. Any chemicals that are important to the research study should be validated using tools such as liquid or gas chromatography, or mass spectrometry.
4. Links for Reagent and other material Validation:
   • Antibody Registry
   • Assay Guide to Authenticate Human and Mouse Cell Lines by STR Genotype Analysis
   • BioSample Database
   • Register of Mis-Identified Cell Lines
   • The Single Nucleotide Polymorphism Database
5. Sample Preparation Protocols:
   • Cell Preparation and Instructions for In Vivo Injection of Bioware Brite Tumor Cells (Distributed by Perkin Elmer)
   • Subcutaneous Injection of Tumor Cells
6. All employees within the Preclinical Research Unit are American Association for Laboratory Animal Science certified. They have completed all required IACUC trainings for all techniques we offer and are provided continuing training and education on animal modeling.
7. Our IVIS Lumina Imager is inspected and sent through a preventative maintenance check on an annual basis.
   Documentation of Imager collaboration is available upon request.
8. Please acknowledge the Preclinical Research Unit which is supported by the Cancer Center Support Grant (P30 CA0160086) when using the Preclinical Research Unit. Staff should be acknowledged on a case by case basis; names to be provided as requested.

Reference Resources and Links

Learn about the NIH Initiative to Enhance Reproducibility through Rigor and Transparency.

Resource Authentication Plan

What are ‘Key Biological and/or Chemical Resources’ that should be addressed your application’s authentication plan? Key biological and/or chemical resources include, but are not limited to, cell lines, specialty chemicals, antibodies and other biologics. More on NIH website

FASEB report on enhancing research reproducibility identifies three main gaps to research reproducibility:

• Lack of uniform definitions to describe the problem
• Insufficient reporting of key experimental details
• Gaps in scientific training