Fillable NHGRI Extramural Genomic Data Sharing Plan and dbGaP (National Institutes of Health)

Fill Online, Printable, Fillable, Blank NHGRI Extramural Genomic Data Sharing Plan and dbGaP (National Institutes of Health) Form

Use Fill to complete blank online NATIONAL INSTITUTES OF HEALTH (MD) pdf forms for free. Once completed you can sign your fillable form or send for signing. All forms are printable and downloadable.

NHGRI Extramural Genomic Data Sharing Plan and dbGaP (National Institutes of Health)

On average this form takes 24 minutes to complete

The NHGRI Extramural Genomic Data Sharing Plan and dbGaP (National Institutes of Health) form is 4 pages long and contains:

  • 5 signatures
  • 77 check-boxes
  • 41 other fields

Country of origin: US
File type: PDF

U.S.A. forms for National Institutes of Health

BROWSE NATIONAL INSTITUTES OF HEALTH (MD) FORMS

Related forms
Fill has a huge library of thousands of forms all set up to be filled in easily and signed.
Fill in your chosen form
Sign the form using our drawing tool
Send to someone else to fill in and sign.
find another form
 
NHGRI Extramural Genomic Data Sharing Plan
and dbGaP Submission Information
Version 2021-01-21
In order for the NIH National Human Genome Research Institute (NHGRI) to register your data into the dbGaP
Submission System, please provide the information listed below and return to your NHGRI Program Officer (PO) or
Genomic Program Administrator (GPA).
You may use the sample document or any other format.
PART II – Study Registration Information
Study name:
Is this a multi-center study?
☐ Yes ☐ No
If YES, list participating sites:
Data will be submitted (choose one):
☐Within 3 months of last data generated or last clinical visit
☐Data will be submitted by batches over Study Timeline (e.g.
based on clinical trial enrollment benchmarks). Specify:
Data to be released will meet the timeframes specified in
the NHGRI Guidance for Data Submission and Data
No
Release
If NO, describe the data release timeline:
Target data delivery date (YYYY-MM-DD): Target public release date (YYYY-MM-DD):
Estimated # of bytes of data to be deposited: Estimated # of study participants:
The individual-level data are to be made available through:
☐ Controlled Access
If UNRESTRICTED ACCESS, Part VII does not need to be completed.
☐ AnVIL dbGaP
☐ GEO
☐ dbVar
dbSNP
Sequence Read Archive (SRA)
1
☐ GenBank
☐ ClinVar
☐ Model Organism
Database (specify):
☐ Other (list all):
☐ Yes ☐ No
Are you requesting an Alternative Data Sharing Plan for samples that cannot be shared through a
public database or repository? If YES, complete the Request for an Alternative Data Sharing Plan in
its entirety and attach it to this document.
If NO, list all submission locations:
The individual-level data are to be made available through:
☐ Unrestricted Access
PART I – Principal Investigator (PI) and Funding Information
PI name: PI email:
PI institution:
PI assistant/submitter name: PI assistant/submitter email:
☐ Yes ☐ NoDo you have an eRA Commons account?
If YES, go to the next field.
If NO, register at https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp.
NIH Grant or Contract Number: NIH Program Officer:
NIH Institutes/Centers supporting the study:
Yes
Samples genotyped/sequenced (check all data types expected for this study).
Note that sufficient phenotypic information
should be submitted to replicate the aims of the study.
General
☐Individual Phenotype
☐Individual Genotype
☐Individual Sequencing
☐Supporting Documents
☐Metagenomic
☐Proteomic/Metabolomic
☐Images
☐Other (specify):
Sample Types
☐Germline
☐Tumor/Normal
☐DNA
☐RNA
☐Mitochondria
☐Microbiome
☐From Repository
☐Other (specify):
Array Data
☐SNP Array
☐Expression Array
☐Methylation Array
☐Other (specify):
Species
☐Human Data
☐Non-Human Data
Phenotype
☐Individual-level Data
☐Aggregate Data
☐N/A- no human data
Genotypes
☐Array derived Genotypes
☐CNV calls from microarray
☐CNV calls derived from
Sequencing
☐Genotype calls derived
from Sequencing
☐Somatic SNV (.MAF)
☐Array CGH CNVs
☐Other (specify):
Sequencing
☐Whole Genome
☐Whole Exome
☐Targeted Genome
☐Targeted Exome
☐Whole Transcriptome
☐Targeted Transcriptome
☐Epigenomic Marks
☐Sanger
☐16S rRNA
☐Other (specify):
Analyses
☐Association/Linkage Results
☐Array derived Expression
☐RNA Seq derived
Expression
☐Array derived Methylation
☐Other (specify):
Sample Collection
☐Prospective Sample
☐Existing (Legacy)
Describe other data that is
anticipated to be shared:
PART IV – Policy
Do you have an Institutional Certification(s) (IC) to submit these data? ☐ Yes ☐ No
The IC will include the Data Use Limitations (DUL), which are based on the informed consent given by each research
subject. For every research subject, his/her corresponding data will be tagged with the appropriate DUL. Each study may
have multiple DULs, based on the informed consent of all the participants in the study.
If Yes, send the IC(s) to your NIH Program Officer along with this document.
If NO, obtain the IC from your Institutional Signing Official. dbGaP requires that the sponsoring NIH Institute/Center
verifies that this certification has been met. A description of the requirements for the IC and an example may be found in the
Points to Consider for Institutions and Institutional Review Boards in Submission and Secondary Use of Human
Genomic Data under the National Institutes of Health Genomic Data Sharing Policy guide.
PART IV – Study Description
Study type(s) (e.g. collection, longitudinal, case-control, case set, control set, parent-offspring trios, cohort):
PART III – Study Description
Study type(s) (e.g. collection, longitudinal, case-control, case set, control set, parent-offspring trios, cohort):
Note: If you are not submitting human data, proceed to Part VII - Extramural Routing Sheet
PART V –
Acknowledgment Statement(s)
The submitting PI should provide specific points that should be included in the Acknowledgment, such as sources of
support or collaborators who provided subjects or samples. NIH support must be specifically acknowledged by including
the grant number. Consider citing a publication that comprehensively describes the origin of the dataset.
The suggested Acknowledgment Statement to accompany the dataset is (if needed, attached additional documentation):
3
PART VI – Original Summary of Study
PART VI - Request for an Exception for Samples Lacking Explicit Consent for Future Research Use and Broad Sharing
1. Name and Description of human specimen(s) or cell lines(s):
2. Rationale for the proposed use (choose one or more options below).
☐ Specimens are from study populations that restrict or limit broad data sharing and future research use (e.g.,
participants from recognized tribal nations) - request an Alternative Data Sharing Plan.
☐ Specimens or cell lines are highly studied, and this research will replace or augment existing data.
☐ The research requires benchmarking of significantly improved, modified protocols generated using existing,
standardized cell lines or specimens.
☐ Other - you must provide a strong justification for the exception.
3. Justification for the reason selected above (limit to 1-2 paragraphs. If needed, attach additional documentation).
Must include:
NHGRI expects all human data generated by NHGRI-supported research will be derived from specimens or cell lines for
which explicit consent for future research use and broad sharing can be documented. NHGRI recognizes that not all
studies are able to meet this expectation. For these studies an exception may be requested with strong justification.
If NO, proceed to Part VII.
If
YES, complete the rest of this section. You must include a written justification for the request in part 3 below.
i. An explanation as to why other existing resources or new biosamples with appropriate
consent cannot be obtained or used.
ii. An explanation as to why this biosample uniquely addresses the needs of the field.
Are you requesting an Exception for samples that lack explicit consent for future research use
and broad sharing?
Yes No
PART VII – Extramural Routing Sheet
If filled out electronically, the “Fill and Sign” tool can be used to electronically sign this document.
______________________
Principal Investigator (Print Name)
______________________
Principal Investigator (Signature)
______________________
Institutional Signing Official (Print Name)
______________________
Institutional Signing Official (Signature)
______________________
Program Officer (Print Name)
______________________
Program Officer (Signature)
______________________
Genomic Data Sharing Program Administrator (GPA)
(Print Name)
______________________
Genomic Data Sharing Program Administrator (GPA)
(Concurrence/Signature)
______________________
Date
______________________
Date
______________________
Date
______________________
Date
Director approval only if an Alternative Data Sharing Plan is requested
Eric D. Green, M.D., Ph.D.___
NHGRI Director (Print Name)
________________________
NHGRI Director (Signature)
________________________
Date
5
Date registered in dbGaP:
(completed by GPA)
click to sign
signature
click to edit
click to sign
signature
click to edit
click to sign
signature
click to edit
click to sign
signature
click to edit
click to sign
signature
click to edit
Download
Save PDF to desktop
Email
Email completed PDF
Send for Signing
Email for others to sign
Print
Print document
Choose a Field
Click on a field and
select the person that should complete it
Want to add a signature?
You can add a signature field
and assign it to someone else
to sign
Choose a Field
Click on a field and
select the person that should complete it

NHGRI Extramural Genomic Data Sharing Plan and dbGaP (National Institutes of Health)

This document is locked as it has been sent for signing.

You have successfully completed this document.

Other parties need to complete fields in the document. You will recieve an email notification when the document has been completed by all parties.

This document has been signed by all parties.

Completed 19 August 2021

Message

View Audit Log
Print With Audit Log
Duplicate Document