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Clinical Research Support

Office for Human Research Studies (OHRS)

Resources for Biospecimen and Biobanking Research

Resources for Biospecimen and Biobanking Research

  Policies

  • Instructions on the Collection and Sharing of Data and Tissue Specimens  [PDF]
  • Guidelines for Writing a Specimen/Data Collection and Banking Research Protocol  [PDF]
  • Linked and Anonymous Specimens  [PDF]
  • Coded Specimen Research Guidance  [LINK]
  • DFCI IRB Requirements Regarding Honest Broker  [PDF]

   Forms

  • Medical Record Review  [Form] | [Guidelines]
  • Research Use of Human Material/Tissue  [Form]  
  • Request for Exemption or Determination that Activity is Not Human Subject Research  [Form] | [Guidance]

  DFCI Cancer Research Study

  • DFCI IRB Approved Cancer Research Study Consent  [PDF]
  • DFCI IRB Cancer Research Study Information Sheet  [PDF]

   Resources Relating to CLIA Requirements

  • CLIA and Clinical Trials  [PPT]

   Publicly Available Information from Other Institutions

  • "Front Door" Consent for Biospecimens (MD Anderson)  [PDF]
  • Partners HRC Policy and Guidance: Section 15: Tissue Banks and Repositories  [LINK]

   Government Resources

  • NCI Best Practices for Biospecimen Resources  [LINK]
  • BioLINCC - a clinical specimen database to search for open specimen collections, request processes, and study datasets and biospecimens  [LINK]

   Articles

  • Developing a Simplified Consent Form for Biobanking  [PDF]
  • National and International Biobanking Programs and Networks  [PDF]
  • Research Participants Perspectives  [PDF]
  • Whitehead Institute: Scientists Expose New Vulnerabilities in the Security of Personal Genetic Information  [LINK]