Trial mobile version Guidances- combined files 6_27_14 - page 3

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B IOBANKS/REPOSITORIES OF HUMAN SUBJECT SPECIMEN
 International Society for Biological and Environmental Repositories (ISBER): 2012 Best
Practices for Repositories: Collection, Storage and Retrieval of Human Biological Materials
for Research
This web resource hosts the most recent edition of this document, published in the
Biopreservation and Biobanking (BIO), April 2012 issue. It provides standards for the collection,
long-term storage, retrieval, and distribution of specimens by specimen repositories. On the page
is also a link to a self- assessment tool for repositories.
 National Cancer Institute: Best Practices for Biospecimen Resources
This 2011 revision of this document created by the National Cancer Institute, is intended to
identify and outline best technical, operational, ethical, and legal practices for not only biobanks
and repositories, but all collections of human specimens and associated data for research
purposes. This resource includes guidelines on:
 Informed Consent
 Privacy and Confidentiality Protection
 Access to Biospecimen Data
 Biospecimen Resource Data Management
 Intellectual Property and Resource Sharing
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CODED PRIVATE INFORMATION OR B IOLOGICAL S PECIMENS
 OHRP – Guidance on Research Involving Coded Private Information or Biological Specimens
This guidance, a 2008 revision provided by the U.S. Department of Health and Human Services
Office for Human Research Protections (OHRP), applicable to any research supported by the U.S.
Department of Health and Human Services. It includes:
 When is Research with Coded Information or Biological Specimens, Human Subjects Research?
When is it not?
 How is the HIPAA Privacy Rule applicable to coded private information or specimens?