International Trial of Mystery

Is your department conducting (or planning to conduct) international, patient-oriented research?  NIAID (National Institute of Allergy and Infectious Diseases) has a database of country-specific clinical research regulatory information called ClinRegs, and it is now live (beta)!

 

ClinRegs is a public resource designed to assist in the planning and implementation of international clinical research.   The database is a tool that can be used to examine regulations within a country, and compare requirements across nations.  Search countries currently include Brazil, China, India, Kenya, Malawi, Peru, United Kingdom, Tanzania, South Africa, Thailand, Uganda, and the United States; there are plans in place to incorporate regulations from Mali, Mexico, Vietnam, and Haiti in 2014.  ClinRegs allows you to explore topic areas such as:  clinical trial lifecycle, competent authority oversight, ethical review, informed consent, investigational products, specimens, and sponsorship.

 

ClinRegs is soliciting feedback through a survey (linked in the upper-right corner of their home page) or using their “Contact Us” feedback email address.  Take it for a spin and let them – and us! – know what you think!

 

No Agreement, No Rate, No Problem

When utilizing subcontracts on a proposal, occasionally we run into domestic institutions who have no negotiated federal rate agreement.  This means (among other things) that there is no F&A rate.  If the subcontracting institution doesn’t require administrative overhead in their role on the project, it’s not necessary to grant them these costs.  But what if they do require administrative costs?  Scientists gotta science, administrators gotta administer!

 

For cases like these, there is a minimal threshold set by the federal government for institutions with no negotiated rate: it has been 8%, but has been increased by the OMB Uniform Guidance to 10% for domestic institutions, effective December 26, 2014 (as stated in Section 200.110).  We have been successful here at using the 10% rate on proposals as of late.  To view the full text of the Final OMB Uniform Guidance regarding the increase of the de minimis threshold, take a look at Subpart E, 200.414 on the Federal Register site.  For a breakdown interpretation of the language (for this and other changes), check out the table produced by The Huron Consulting Group, or our post entitled “Super Circular, Super Fun“!

 

RAS is here to help if you have any questions on how to budget your subcontracts with no negotiated rate.  Feel free to reach out if you need us!

Back to the Future

September has officially settled in, which means resuming our monthly Tips & Tools meeting! We hope everyone had a wonderful summer and are gearing up for a very productive fall.

 

For those of you who may be unaware, our School of Medicine Research Administrative Services (RAS) team hosts a regular meeting (Tips & Tools) on the third Wednesday of each month. At these meetings, we highlight changes and information coming down both internally at Wayne, and from external agencies.  Additionally – and perhaps most importantly – these meetings serve as a forum for research administrators to ask and answer each other’s questions, trouble-shoot, and give/request input on processes. These meetings began for the administrators of the departments at the School of Medicine, but we have many administrators attending from outside the SOM as well! If you are interested in attending, please send us a quick note expressing your interest (RAS@med.wayne.edu) and we’ll give you the details of time and place.

 

This month’s meeting will take place in one week (September 17, 2014) and will feature special guests Dr. Stephen Lanier (our new Vice President for Research at Wayne State; check out his Crain’s Q&A!) and Ms. Gail Ryan (Wayne’s Assistant Vice President for Sponsored Program Administration).  Come with your questions; they’ll both have answers!  We look forward to seeing you there.

Farewell to Terri Larrew

Terri Larrew, long-time friend and administrator for Anatomy and Cell Biology, passed away this past Labor Day weekend. Terri was known not only for her keen ability to perform her job with competence and grace, but for her sense of humor and infectious laughter as well. Please keep Anatomy in your thoughts during this difficult time, and take a moment to remember Terri.