The following steps are necessary in order for investigators and NIAGADS to be in compliance with the NIH Genome Data Sharing Policy issued January 25, 2015

Consent Levels:For each individual dataset, investigators should request that their IRB review consent forms and check the consents against the six consent levels listed below to see which subjects fall into respective consent levels. For studies providing data to NIAGADS, the database uses the same six levels of consent as does the Alzheimer’s Disease Sequencing Project (ADSP). NIAGADS will check every application against the consent categories. The consent levels are:

Consent Group Title Options
(select one of the four categories below) / Data Use Limitations
General Research Use
(select any that apply)
IRB approval required / Use of the data is limited only by the terms of the Data Use Certification.
Requestor must provide documentation of local IRB approval.
Publication required / Requestor agrees to make results of studies using the data available to the larger scientific community.
Collaboration required / Requestor must provide a letter of collaboration with the primary study investigator(s).
Not-for-profit use only / Use of the data is limited to not-for-profit organizations.
Methods / Use of the data includes methods development research (e.g., development of software or algorithms)
Genetic studies only / Use of the data is limited to genetic studies only.
Health/Medical/Biomedical (select any that apply)
IRB approval required / Use of the data is limited to health/medical/biomedical purposes, does not include the study of population origins or ancestry.
Requestor must provide documentation of local IRB approval.
Publication required / Requestor agrees to make results of studies using the data available to the larger scientific community.
Collaboration required / Requestor must provide a letter of collaboration with the primary study investigator(s).
Not-for-profit use only / Use of the data is limited to not-for-profit organizations.
Methods / Use of the data includes methods development research (e.g., development of software or algorithms)
Genetic studies only / Use of the data is limited to genetic studies only.
Disease-specific [list disease] (select any that apply)
IRB approval required / Use of the data must be related to the specified disease.
Requestor must provide documentation of local IRB approval.
Publication required / Requestor agrees to make results of studies using the data available to the larger scientific community.
Collaboration required / Requestor must provide a letter of collaboration with the primary study investigator(s).
Not-for-profit use only / Use of the data is limited to not-for-profit organizations.
Methods / Use of the data includes methods development research (e.g., development of software or algorithms)
Related disorders / Use of the data is limited to genetic studies of the specified disease and related conditions, such as ______.
Genetic studies only / Use of the data is limited to genetic studies only.
Other / Enter customized text, if applicable

Institutional Certification: A signingofficial from theinvestigator’s institution must provide anInstitutional Certification that states the following:

  • Thedatabeingsubmitted are consistent, asappropriate, with applicablenational, tribal, and statelaws andregulations as well as relevant institutional policies;
  • Anylimitations on the research useofthedata, asexpressed in theinformed consent documents, aredelineated;
  • Theidentities of researchparticipants will not bedisclosed to NIH-designated data repositories; and
  • AnIRB, privacyboard, and/or equivalent body, asapplicable, hasreviewedthe investigator’s proposal fordatasubmission and assures that:
  • Theprotocol forthe collection ofgenomic and phenotypicdatais consistent with 45

CFR Part 46.

InformedConsentForm: All studyinformedconsent forms used bysubjects must beprovided electronically.

NIH provides additional guidance here:

  • NIH Points to Consider for IRBs and Institutions
  • Standard Data Use Limitations
  • NIH Genomic Data Sharing Policy for Human and Non-Human Data: Guidance for Institutions Submitting Grant Applications and Contract Proposals

NIAGADS Data Request GuidelinesPage 1 of 2

Last Update: 10/29/2018