Rigor

RIGOR AND REPRODUCIBILITY FOR CFAR HIV/STD LABORATORY CORE

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.

Guide to Rigor and Reproducibility for the CFAR HIV/STD Laboratory Core

1. Consult with the core staff in the planning stage. – Contact Kristina De Paris, Core Director, abelk@med.unc.edu, 919 843-9560 or Robert Krysiak, Associate Director, Robert_krysiak@med.unc.edu, 919-966-3727.
2. Depending on the type of testing needed, appropriate controls and standards will be included. Replicates are important and can vary depending on the type of testing and power calculations. Flow cytometry, soluble marker quantitation, HIV quantitation, PSA detection, and HIV inhibition assays all have different controls and standards. Talk to us about the appropriate controls, standards, and replicates for your project.
3. Validation of methods must be done when using a kit for a different sample type than the kit was designed for (soluble markers, etc.). The Core has validated methods for HIV quantitation from dried blood spots and PSA detection from vaginal swabs, for instance.
4. The HIV/STD Laboratory Core provides training to ensure that all investigators are properly training in our technology unless we are contracted to do the work within the core. Training is provided includes BSL2+ work with HIV or human blood, MagPix and ELISA quantitation, ELISPOT reader use, flow on HIV-infected cells, and in vitro work with HIV. Contact us for more information.
5. The CFAR HIV/STD Laboratory Core participates in external quality assurance for PBMC processing through the IQA and is CAP/CLIA accredited. The Core is also GCLP compliant in accordance with NIH DAIDS Network oversight.
6. All equipment in the HIV/STD Laboratory Core is maintained per GCLP, CAP, or manufacturer’s instructions. In addition, QC measures are in place per GCLP and CAP.
7. Detailed descriptions of experimental procedures and validations, including sample storage and processing, are documented electronically and in notebooks within the Core.
8. Please acknowledge the UNC Center for AIDS Research HIV/STD Laboratory Core in your publications. Instructions for acknowledgment can be found here: http://unccfar.org/acknowledge-the-cfar/