Notice Number: NOT-AI-16-033

Key Dates
Release Date: February 19, 2016

Issued by
National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

This Notice from the National Institute of Allergy and Infectious Diseases (NIAID) is to update the research community of the availability of clinical specimens for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) research from Dr. W. Ian Lipkin, Columbia University.  In 2012, Dr. Lipkin and colleagues completed a NIH-supported clinical study titled “XMRV and MLV in Chronic Fatigue Syndrome” to determine the strength of association between ME/CFS and xenotropic murine leukemia virus-related virus (XMRV), MLV (murine leukemia viruses) and/or related retroviruses.  The study enrolled 138 cases and 139 matched controls who each had a single blood draw and consented to future use of leftover clinical specimens. As of February 1, 2016, the following samples are available for each study participant for research purposes:

• 10 x 3 M/1 mL PBMC, never thawed
• 10 x 1.0 mL plasma samples, never thawed
• 6 x 0.5 mL plasma samples, thawed once

The samples are de-identified and therefore do not meet the definition of human subjects research.  Enrollees consented to future use and the samples are accompanied with a code so that many characteristics can be matched with each. For more detail on the original study see: http://mbio.asm.org/content/3/5/e00266-12.

Alter HJ, et al. 2012. A multicenter blinded analysis indicates no association between chronic fatigue syndrome/myalgic encephalomyelitis and either xenotropic murine leukemia virus-related virus or polytropic murine leukemia virus. mBio 3(5):e00266-12. doi:10.1128/mBio.00266-12.

Dr. Lipkin and the NIAID consider these samples from validated cases and well-matched controls to be an extremely valuable resource that may lead to significant advances in the understanding of the etiology and/or pathogenesis of ME/CFS.  Accordingly, our intent is to continue to make these specimens available to the ME/CFS research community. We believe that the NIH peer review process offers the fairest means to decide who should have access to these samples.  To this end, we encourage the submission of new grant applications to the NIH that involve the use of some of these specimens as part/all of a research plan on some aspect of ME/CFS. However, please note there are no set-aside funds associated with these samples.

Prior to the submission of a NIH grant application utilizing these samples, interested investigators are encouraged to contact Dr. Lipkin to ensure that the proposed experimental plan meets the terms specified in obtaining informed consent from study subjects and/or other regulations. Upon submission to the NIH, applications will undergo normal referral and review processes. Samples will be provided to investigators who receive a funding commitment from any NIH Institute or Center for a new ME/CFS research project utilizing some of these samples.   Specimens will be shipped to the Program Director(s)/Principal Investigator(s) following the establishment of an MTA with Columbia University.  Please note that these samples will be provided to funded investigators on a first come, first served basis, based on the outcome of the NIH peer review process, as noted above. This plan will be in effect until the samples have all been assigned; notifications as to changes in availability will be made via updates to this Notice. 

Possible funding opportunities that can be used to pursue these samples include, but are not limited to:

• PA-13-304, Small Research Grant (Parent R03)
• PA-13-303, Exploratory/Developmental Research Grant (Parent R21)
• PA-13-302, Research Project Grant (Parent R01)
• PA-15-269, PHS 2015-02 Omnibus Solicitation of the NIH, CDC, FDA, and ACF for Small Business Innovation Research Grant Applications (Parent SBIR)

The usual grant application submission dates apply; refer to the announcements for guidance.

This Notice is a continuation of the previous Notice: NOT-AI-13-005.

Inquiries

Please direct all inquiries to:

Eun-Chung Park, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3338
Email: epark@niaid.nih.gov