The U.S. Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking (NPRM) issued on September 2, 2015 as a draft of the final rule intended to modernize, strengthen, and make more effective the current Federal regulations on protections of human subjects (the Common Rule).  The NPRM was published in the Federal Register on September 8, 2015 for public comment; comments must be received by 5:00 pm on December 7, 2015. 

There are plans to release several webinars that will explain the changes proposed in the NPRM, and a town hall meeting planned to be held in Washington, D.C. in October.  The ORPC will inform the campus community of the dates of these information sessions and will distribute comments and guidance from the IRB as it becomes available.

Check back regularly on the ORPC events page for more information.

The September 2, 2015 "Important" notice about the use of cloud services such as Box or Google may have led some to conclude both services are inherently and/or equally insecure under the University's data security classification below:

To clarify, Google is not approved for confidential data (levels 2 & 3 above). Since Google stores its data around the world and employs people around the world, ORPC and DoIT do not recommend that Google be used with export controlled data. By contrast, Box.com is approved for level 0, 1, and 2 data. This means that information such as SSNs and passport numbers can be stored in Box. While all Box.com data is currently stored in the USA, there is no guarantee that Box.com will always keep our data in the USA. There are also no guarantees that a foreign person will not be employed by Box.com and have an ability to access our data. Accordingly, Box.com is okay to use with data classified as level 0, 1, and 2, but we would would not recommend it for export controlled data. 

 

For more information, please consult UMBC’s policy for the protection of sensitive information as well as DoIT’s data use guidance for more information. You may also wish to consult with Mark Cather, UMBC's Chief Information Security Officer (CISO), who can be reached at 410.455.3783 or mark.cather@umbc.edu.

Professor Chris D. Geddes, Ph.D., FRSC, has been named a Daily Record  Innovator of the Year 2015.

Dr. Geddes, Director of UMBC's Institute of Fluorescence and a faculty member from the Department of Chemistry and Biochemistry has just received the honor for his lab's recent work developing the Lyse-it™ technology, a technology that enables the rapid lysing of cells to collect their genetic material. This is the 4^th time Professor Geddes has been honored by the Daily Record in the last 8 years for his lab's pioneering innovations.

Sample preparation (lysis) is key to the development of many clinical Point-of-Care (POC) and laboratory tests involving cellular genetic analysis. For example, sample preparation is a significant bottleneck in PCR (Polymerase Chain Reaction)-based approaches, the gold standard in both pathogen and clinical (hospital setting) detection today, with available technologies taking many cumbersome, lengthy and costly steps. In addition, commercially available lysis kits today require different kits and protocols for different media (e.g. broth, urine, blood).

To address this bottleneck of speed, cost and complexity, and to address the fact that many laboratories employ multiple kits for routine testing, Dr. Geddes’ lab has developed Lyse-it™, a means to lyse virtually any cell, spore or virus rapidly (typically <20 seconds) in a single-step on a single platform, thereby enabling the genetic material (e.g. DNA) to be collected for downstream analysis on any platform.

Focused microwaves in small disposable sample chambers readily allow the Lyse-it™ user to lyse cellular samples with near-100% efficiency, within 20 seconds on a single platform at a cost less than other technologies available today. Importantly, this lysing approach is generic to a whole range of cells and viruses. This is because it is a single platform (one size fits all), unlike traditional lysing buffer approaches that all use multiple kits for different media.

Key members of Dr Geddes’ lab that participated in this innovation include: Johan Melendez (graduate student), Tonya Santaus (graduate student); Greg Brinsley (undergraduate); Jacob Roberts (undergraduate); Maraki Negesse (undergraduate) and Daniel Kiang (undergraduate).

The Lyse-it™ technology invented by Dr. Geddes is the technology behind his new company of the same name. Lyse-it™ is Dr. Geddes’ third company to date. Dr. Geddes currently has one patent issued and two patents pending on the Lyse-it™ technology.

Dr Geddes has recently received $100,000 from Maryland’s TEDCO and $20,000 from UMBC’s catalyst fund to push the technology forward towards commercialization. 

Figure – Lyse-it™ disposable slides, a rapid and low cost technology for the efficient lysing of cells.