Superstorm Sandy devastated large swathes of the North East in late October. Bringing with it heavy rains and wind, it overwhelmed the region and caused significant damage to infrastructure. Laboratories such as the New York University’s Smillow Research Center were ill equipped to deal with the flooding and power loss Sandy brought. Thousands of genetically engineered lab mice, specialized reagents, tissue samples, and other items stored in laboratory refrigerators and freezers were lost due to loss of power and the absence of proper procedures to deal with natural disasters. Being more prepared for natural disasters could have limited these losses, as they did at the Cold Spring Harbor Laboratory (CSHL) on the North Shore of Long Island. Although the area was hard hit by the hurricane, CSHL’s foresight in preparing their facility to withstand sustained power losses and flooding ensured that almost nothing was lost. These are excellent examples of why emergency preparedness is so important. Additional resources for emergency preparedness include ISBER Best Practices For Repositories (section B9.000) and Genetic Alliance Weekly Biobank Tip #96.
Biorepositories are vital components of effective biomedical research studies. As demand increases, and funding becomes more difficult to secure, fee-for-service business models are becoming more common in the biobanking industry. Sandra McDonald and colleagues at the Tissue Procurement Core at Washington University School of Medicine published their experiences with a fee-for service model at an academic biobank in the October issue of Biopreservation and Biobanking. In this model, customers are charged for laboratory services instead of the biospecimens themselves. The authors discuss the importance of including four value added categories: accessioning and disbursal, laboratory services, pathology review, and storage. The fee-for-service schedule allows biobanks to itemize costs, ensuring that biospecimen users pay a competitive fee for comprehensive services. Once a fee-for-service structure is established, the authors offer additional recommendations for implementation, including outreach and application of quality and accreditation standards.
Using the Internet to recruit patients for clinical trials is becoming more common, but many have concerns about the accuracy of patient-reported data. A new study from Quintiles’ digital patient unit suggests that online recruitment programs can be reliable. Using data from the drug monitoring website MediGuard.org, investigators recruited potential participants with gout, and a chart review confirmed 37 of 38 patients correctly reported their diagnosis. Moving towards an online recruitment system can speed the process and reduce costs associated with recruitment. Using current methods, it costs ~ $1,300 per participant, and delays in recruitment account for 45% of study delays. Companies such as Pfizer, Janssen, and others are using hybrid recruitment approaches that include both in-person and remote strategies.
Budget cuts due to the stipulations of the Budget Control Act of 2011 have the potential to deeply affect medical innovation and scientific research. FasterCures has developed a sequestration resource that aggregates information about pending cuts due to sequestration. This resource provides a cumulative view on the impact that sequestration could have on the NIH, FDA, and other areas of medical research, and includes ways to make your voice heard about the importance of biomedical research.
Registration for the ISBER (International Society for Biological and Environmental Repositories) 2013 Annual Meeting, Turning the World Upside Down: Emerging Perspectives on Biorepositories, May 5-9, in Sydney, Australia is now available. The advanced registration deadline is March 5, 2013.
The Office for Human Research Protections (OHRP) and Orlando Health are co-sponsoring a Research Community Forum, Partners in Research: How Institutions, IRBs, and Researchers Can Collaborate More Effectively, on March 15, 2013, in Orlando, FL. Jerry A. Menikoff, MD, JD, will be the keynote speaker, and registration is now available.