APPENDIX E – NIH GENOMIC DATA SHARING (GDS)
PLANS FOR DATA SUBMISSION TO ANNIH REPOSITORY (PART A)
CERTIFICATION BY THE IRB AND INSTITUTIONAL OFFICIAL (PART B)
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Per the NIH Genomic Data Sharing Policy issued on 8/27/2014 and effective 1/25/2015, “Investigators should submit large-scale human genomic data as well as relevant associated data (e.g. phenotype and exposure data) to an NIH designated data repository in a timely manner. Investigators should also submitany information necessary to interpret the submitted genomic data, such as study protocols, data instruments, and survey tools.”
Investigators are encouraged to maintain documentation of shipment of materials, and to request and maintain confirmation of receipt of samples by the NIH. Such records should be accessible for audit.
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PART A - PLANS FOR DATA SUBMISSION TO AN NIH REPOSITORY
PI NAME:STUDY TITLE:
1.Select the applicable status:
A Certificate of Confidentiality regarding submission to an NIH repository
has been applied for and data will not be shared with the NIH repository until the Certificate is in place
will be applied for and data will not be shared with the NIH repository until the Certificate is in place
has been obtained and is in place
2. Identify the research uses that are allowed per the informed consent form.
Response:
3.Identify the research uses, if any, that are specifically excluded by the informed consent form.
Response:
4. Describe plans for de-identification of data prior to submission to the NIH repository. Include in the description the party(ies) who will be responsible for the de-identification, and how data submitted to the repository will be coded such that participant identities will not be known to the repository. Codes cannot be derived from any individually identifiable information (e.g. it is not acceptable to use initials, parts of social security numbers, phone numbers, drivers license numbers etc.)
Response:
5. Describe the potential risks to participants, to the families of participants, and when relevant to groups or populations that are associated with the submission of data to the NIH repository. Also describethe measures that have been taken to minimize those risks (e.g. risk of breach of confidentiality, could lead to harms in employment, insurability, etc., protections are use of coded data and intent to obtain Certificate of Confidentiality)
Response:
6.Consistent with disclosures made in the consent form, distribution of data to be submitted should occur through:
Controlled access repositories (Controlled access data in NIH-designated data repositories are made available for secondary research only after the investigators have obtained approval form NIH to use the requested data for a particular project.
Unrestricted access repositories (Data in unrestricted-access repositories are publicly available to anyone.)
7. Optional additional comments from PI:
Response:
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PART B - CERTIFICATION BY THE IRB AND INSTITUTIONAL OFFICIAL
(Sign-off by IRB and Institutional Official)
Section I - IRB Review:
The IRB has reviewed the investigator’s proposal for data submission and assure that:
a)The protocol for the collection of genomic and phenotypic data is consistent with 45 CFR part 46
b)Data submission and subsequent data sharing for research purposes are consistent with the informed consent of studyparticipants from whom the data were obtained (Note: For studies using data or specimens collected before 1/25/2015, the IRB has reviewed the informed consent materials to ensure that the data submission is not inconsistent with the informed consent provided by the participants.);
c)Consideration was given to the risks to individual participants and their families associated with data submitted to NIH-designated data repositories and subsequent sharing.
d)To the extent relevant and possible, consideration was given to risks to groups or populations associated with submitting data to NIH-designated data repositories and subsequent sharing.
e)The investigator’s plan for de-identifying data sets is consistent with the standards outlined in the NIH Genomic Data Sharing Policy (i.e. with the Common Rule and HIPAA Privacy Rule);
Signature of IRB Chair or designee:Date:
Section ii - Certification of Institutional Official:
- The data submission is consistent, as appropriate, with applicable national, tribal, and state laws and regulations as well as relevant institutional policies (Note: For submission of data derived from cell lines or clinical specimens lacking research consent that were created or collected before 1/25/2015, only this item is applicable to the Certification.)
- The duties of the IRB have been fulfilled as noted above;
- The identities of participants will not be disclosed to NIH-designated data repositories
- The level of access noted by the investigator in Section A, Item 6 is appropriate
- Permitted and excluded uses of the data for research purpose, as delineated in the consent form,are as described in Part A, item 2 (uses) and item 3 (exclusions):
Printed Name of Institutional Official:
Title:
Institution:
Signature Institutional OfficialDate
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NIH Genomic Data Sharing Policy
6/29/2016, 11/7/2014, 3/12/2009