News and Publications

Below you will find related news and articles to biorepositories and the use of biospecimens.

Betsou, F., Gunter, E., Clements, J., DeSouza, Y., Goddard, K.A.B., Guadagni, F., Yan, W., Skubitz, A., Somiari, S., Yeadon, T., and Chuaqui, R. Identification of Evidence-Based Biospecimen Quality-Control Tools: A Report of the International Society for Biological and Environmental Repositories (ISBER) Biospecimen Science Working Group. The Journal of Molecular Diagnostics, Volume 15, Issue 1 (January–February 2013), pp. 3–16. Available at: http://dx.doi.org/10.1016/j.jmoldx.2012.06.008 (last accessed January 17, 2013).

2013 Edition of the International Compilation of Human Research Standards is available at: http://www.hhs.gov/ohrp/international/index.html

Truog RD, Kesselheim AS, Joffe S. Paying Patients for Their Tissue: The Legacy of Henrietta Lacks. Science 6 July 2012: Vol. 337, no. 6090 pp .37-38.

Tolles et al.Optimal tumor sampling for immunostaining of biomarkers in breast carcinoma. Breast Cancer Research 2011 13:R51.

Genetic Heterogeneity in HER2 Testing in Breast Cancer: Panel Summary and Guidelines are available at: http://www.archivesofpathology.org/doi/full/10.1043/1543-2165-133.4.611

Simon CM, L’Heureux J, Murray JC, Winokur P, Weiner G, Newbury E, et al. Active choice but not too active: Public Perspectives on biobank consent models. Genet Med. 2011 May 6. [Epub ahead of print]

Orphanet the pan-European rare disease and orphan drug information portal, has created a comprehensive, and freely-accessible dataset related to rare diseases and orphan drugs called Orphadata. The dataset is a partial extraction of the data stored in Orphanet and will be updated monthly. For user convenience, the date of the last data release will be provided. The Orphadata dataset is available in six languages (English, French, German, Italian, Portuguese and Spanish). To learn more, visit the link below.
http://www.orpha.net/actor/EuropaNews/2011/110601.html#21727

OHRP has updated its Guidance on Written IRB Procedures. The July 1, 2011 guidance document replaces OHRP’s January 15, 2007 guidance on this topic. Specifically, the updated document has been changed as follows; updated sections are identified in the parenthetical following each description of the changes:

1. Guidance related to continuing review has been replaced with content from OHRP’s November 10, 2010 document, “Guidance on Continuing Review of Research,” and a cross-reference to the continuing review guidance document has been added (see Section A.(2)(b) and Section B.(2)(b)).

2. A cross-reference to OHRP’s January 15, 2007 document, “Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events,” has been added (see Section A.(3)).

3. Guidance related to the approval of research with conditions has been replaced with content from OHRP’s November 10, 2010 document, “Guidance on IRB Approval of Research with Conditions,” and a cross-reference to the guidance document on approval of research with conditions has been added (see Section A.(5)).

4. All URLs referenced in the document have been updated to link to OHRP’s new website.

5. A closing paragraph was added to the end of the document to provide OHRP’s contact information.