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 previously-collected data or banked 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 and how to submit the correct application for approval.



Submission Process for Secondary Use - Human Subjects

1.  Create a New Study in iRIS.

2.  Select the Secondary Use / Medical Record Review option.

          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.

3.  Complete all subsequent questions as prompted within the iRIS system. A separate protocol document is not required.


Submission Process for Secondary Use - Not Human Subject Research

1.  Create a New Study in iRIS.

2. Select the Non-Human Subject Research (NHSR) option.

3. Complete all subsequent questions as prompted within the iRIS system. A separate protocol document is not required.

 


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

6. OncDRS requests



Biospecimen Research Contact Information

For Questions Regarding:Please Contact:Contact Information:


IRB and Regulatory Requirements
(including the Privacy Board)

  • OHRS

OHRS@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)
  • BCH: Fernando Valles, Director Boston Children's Hospital Clinical Trials Office
  • BIDMC: Technology Ventures Office
  • DFCI: Mary Melloni, Clinical Trials Agreements Office, or the Clinical Trial Agreement Associate for the trial
  • Partners (MGH and BWH): Maureen Lawton, Director of Partners Clinical Trial Office

 

 

 Fernando.valles@childrens.harvard.edu

 

 tvo@bidmc.harvard.edu

 

Mary_Melloni@dfci.harvard.edu

 

mlawton@partners.org

 


Transfer and Usage Agreements Non-Clinical Trials

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

  • BCH: Boston Children's Hospital Technology and Innovation Development Department
  • BIDMC:  Technology Ventures Office
  • DFCI: Nicole Kousmanidis, Belfer Office for Dana-Farber Innovations (BODFI), or a member of your Cluster in BODFI
  • Partners (MGH and BWH): Partners Innovation

 

http://tido.childrenshospital.org/

 

http://tvo.bidmc.org/

 

https://www.dana-farber.org/research/innovations_

https://innovation.partners.org/


Grants and Contracts
  • BCH: Boston Childen's Clinical Trials Business Office
  • BIDMC: Jennifer Sabbagh, Grants Contracts Office
  • DFCI: Tina DaSilva, Director, DFCI Grants and Contracts
  • Partners (MGH and BWH):  Partners Innovations

 

CTBO@Childrens.harvard.edu 

jsabbagh@bidmc.harvard.edu

 

Tina_DaSilva@dfci.harvard.edu

 https://innovation.partners.org/