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: |
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Fernando.valles@childrens.harvard.edu
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Transfer and Usage Agreements Non-Clinical Trials (e.g., Materials Transfer Agreements, Lab Services Agreements, Data Transfer Agreements, Collaboration Agreements, Sponsored Research) |
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http://tido.childrenshospital.org/
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Grants and Contracts |
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https://innovation.partners.org/
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