Human Data GDS Proposal Development: Regulatory User Scenarios

Investigators with questions about whether the NIH GDS Policy applies to their current or proposed research should consult the relevant NIH Program Official or Project Officer or the IC’s Genomic Program Administrator.

GDS Human Data Study Development: Scenarios by Data Type

Case 1 Identifiable: Prospective Study

A Fred Hutch investigator is starting a new study prospectively banking human specimens from which they intend to generate genomic data sets subject to the GDS policy. Research staff will have access to patient identifiers. This is a single site study.

Case 2 Identifiable and FH Sourced: Retrospective Study

A Fred Hutch investigator is starting a new study prospectively banking human specimens from which they intend to generate genomic data sets subject to the GDS policy. Research staff will have access to patient identifiers. This is a single site study.

Case 3 De-Identified and FH Sourced: Retrospective Study

A Fred Hutch investigator is starting a new study using human specimens already banked and collected at FH and from which they intend to generate de-identified genomic data sets subject to the GDS policy. This is a single site study.

Case 4 De-Identified and Sourced Outside Fred Hutch: Retrospective Study

A Fred Hutch investigator is starting a new study using human de-identified genomic datasets that were generated by someone else outside of Fred Hutch. This is a single site study.

Case 5 De-Identified and Sourced from dbGaP: Restrospective Study

A Fred Hutch investigator is starting a new study using human de-identified genomic datasets from dbGAP. This is a single site study.

Process Overview for Each Case Scenarios

This table specifies the steps involved in performing these types of studies from a regulatory perspective (and that occur alongside the scientific process involved).

Steps in the Process	Case 1	Case 2	Case 3	Case 4	Case 5
Data Sharing Plan(DSP) Needed? Submit to FH IRO and NIH	Y	Y	Y	Y	Y
Need to Select with which NIH Trusted Repository to Share - Aggregate or Individual level?	Y	Y	Y	Y	Y
Need to complete both FH GDS Institutional Certificate and Certificate Information Sheet?	Y	Y	Y	Y	Y
Need GDS appropriate consent (with broad sharing language) for specimen or cell information collected after January 25, 2015?	Y	Y	Y	Y	Not Likely* - Confirm IRO Pre-Approved
Is proposal under Human Subjects? Complete the FH IRO Determination Form	Very Likely	Very Likely	Not Likely	Not Likely	Not Likely* - Confirm IRO Pre-Approved
Does the proposal require a DUA or other sharing agreement**?	N	N	N	Y	N

* dbGaP is part of the Fred Hutch IRO pre-approved list of data sources; such sources are presumptively considered to be research not involving human subjects.

** DUA: What are the security requirements if any of the DUA? Are there data use limitations on the data?

What should be included within the GDS proposal package to the IRO/IRB?

Proposal, completed FH GDS Institutional Certificate Information Sheet (OSR), a signed Intuitional Certificate, if needed a A GDS compliant consent (see chart above and note below), FH IRO Genomic Data Supplement form, Data Sharing Plan.

Note: For samples generated after January 25, 2015, inquire as to their foundational (collection) consent. This consent should be included in the documents submitted to the IRO/IRB. No consent may be needed for speciments/data collected without consent before January 25, 2015. An NIH Institutional Certificate is required regardless the date the of specimen/data collection.

Using dbGaP-sourced data in a proposal (Secondary Research Source):

1. FH IRO pre-approves data in dbGap as non-Human Subjects. This may not apply to ALL NIH trusted repositories.
2. Address plans for requesting access to the data, state intention to abide by the NIH Genomic Data User Code of Conduct in the Research Plan of the NIH application.
3. Researchers may wish to secure access to dbGaP controlled-access data prior to submitting their application for NIH support.

For Identified Data after NIH Approval: Notes on Submitting to NIH for Data Sharing

1. Any unique random ID per person and all other coding keys to remain at Fred Hutch when data is submitted to data share.
2. Data remaining at Fred Hutch stored according to Fred Hutch Information Classification Handling Standard and other Fred Hutch Information Security standards.