Research with Biological Materials & Data

Studies that involve the establishment of databases and/or biorepositories are subject to IRB review. Likewise, studies that plan to use data or samples previously collected for research or clinical purposes may also be subject to IRB review. The information on this page will assist investigators in determining whether their project requires IRB review, identify issues to consider during protocol development and clarify IRB review requirements specific to research proposing to use, store and/or maintain data or biological materials for research purposes.



Submission Process for Secondary Use - Human Subjects

1.  Review the New Protocol Application: Secondary Use and the checklist at
     the end of the form.
    Note: this is a compilation of the prior Retrospective, Prospective,
    and Exempt forms.

2.  Create the protocol

     a. Use the Data/Specimen Collection and Use template:
          i.  Research is limited to the use of previously collected data and/or
              specimens.
         ii.  Research establishing a bank or repository using previously
              collected data and/or specimens.

     -OR-

     b. Submit a PDF of an OncDRS request as your protocol.

3.  Complete all supplemental forms identified in the New Protocol Application checklist. 

4.  Submit all materials via OHRS Submit.


Submission Process for Secondary Use - Not Human Subject Research

1.  Review the New Project Application: Not Human Subjects Research (NHSR) Determination 
     and the checklist at the end of the form.

2.  Supplemental Documents - If you do not have a research proposal (e.g. grant) or other
     supporting documents (e.g. OncDRS submission), you may create a brief protocol
     describing the research activity using the Data/Specimen Collection and Use
     protocol template.

3.  Complete all supplemental forms identified in the New Protocol Application checklist. 

4.  Submit all materials via OHRS Submit.


Additional Resources

The resources below provide additional guidance on research with biological materials and data.

1.  The NIH FAQ page answers a variety of common questions.

2.  OHRP Guidance on Biological Materials and Data

3.  NCCN Points to Consider on the Best Practices for Biorepositories, Registries and Databases.

4.  OHRP Issues to Consider in the Research Use of Stored Data or Tissues

5. NIH Best Practices for Biospecimen Resources


Biospecimen Research Contact Information

For Questions Regarding: Please Contact: Contact Information:


IRB and Regulatory Requirements
(including the Privacy Board)

  • Emily Eldh, Director, DF/HCC OHRS
  • Elizabeth Bowie, Associate Director, DF/HCC OHRS, or
  • The Human Research Coordinator (HRC) for the trial


Emily_Eldh@dfci.harvard.edu

Elizbeth_Bowie@dfci.harvard.edu

http://www.dfhcc.harvard.edu/research/clinical-research-support/office-for-human-research-studies/ohrs-contact-list/


Clinical Trials Agreements for Clinical Trials

(e.g., Materials Transfer Agreements, Lab Services Agreements, Data Transfer Agreements, Collaboration Agreements)
  • Mary Melloni, Clinical Trials Agreements Office, or
  • The Clinical Trial Agreement Associate for the trial


Mary_Melloni@dfci.harvard.edu


Transfer and Usage Agreements Non-Clinical Trials

(e.g., Materials Transfer Agreements, Lab Services Agreements, Data Transfer Agreements, Collaboration Agreements, Sponsored Research)

  • Anita Ballesteros, Belfer Office of Dana-Farber Innovation (BODFI), or
  • Your BODFI Case Manager


AnitaL_Ballesteros@dfci.harvard.edu


Grants and Contracts
  • Tina DaSilva, Director, DFCI Grants and Contracts


Tina_DaSilva@dfci.harvard.edu