Consent Definitions

Overview

For each project submitting biospecimens and data to NRGR, subjects are required to provide informed consent to allow for later sharing of their biospecimens and data. Based on this consent, the submitting project must (1) identify an appropriate "consent" and "consent_modifier" category per subject and (2) submit the consent and modifier for each subject to NRGR. The consents and consent modifiers reflect language in the informed consent forms and any additional considerations deemed necessary by an IRB or equivalent review body.

As a user of NRGR biospecimens and data, you are required to review the consent and consent modifier values and ensure that you use the data and/or biospecimens appropriately.

Consent Definitions

Code	Longform	Definition
GRU	General Research Use	Use of the biospecimens and related data is limited only by the terms of the NRGR Institutional Certification. For example: The submission of biospecimens and related data from the study meets the expectations defined in the NIH Genomic Data Sharing Policy. The biospecimens and related data are to be made available through controlled access.
HMB	Health/Medical/Biomedical	Use of the biospecimens and related data can only be used for studying health, medical or biomedical conditions, and does not include the study of population origins or ancestry. Use for methods development is permitted provided there is sufficient evidence that the methodology will further health/medical/biomedical research.
REL	Disorder and Related Disorder	Use of the data must be related to mental health research only. Use for methods development is permitted provided there is sufficient evidence that the methodology will further mental health research.
DIS	Specific Disorder Only	The biospecimens and related data can be used only for research on a specific disease or related condition.

Consent Modifiers

Each subject in a research project has one consent value (i.e., GRU, HMB, REL, or DIS). Use of biospecimens and related data may be further defined by one or more consent modifiers per subject. Almost all the below modifiers limit the use of the data and biospecimens beyond what is defined by the consent value. The exception is Methods Development (MDS), which broadens the allowed use of biospecimens and data; biospecimens and related data from subjects with Specific Disorder Only (DIS) consent can only be used for methods development if they also have the MDS consent modifier.

Code	Longform	Definition
IRB	IRB Approval required	The requesting institution's IRB or equivalent body must approve the requested use.
PUB	Publication Required	The requestor must share their results with the larger scientific community.
COL	Collaboration required	The requestor must provide a letter of collaboration with the primary study investigator(s).
NPU	Non-profit use only	The dataset can only by used by not-for-profit organizations. State specifically if the data should not be made available to commercial organizations.
RPU	Restrictions on for-profit use of samples	If the requestor is a for-profit entity, the requestor must secure permission to use samples directly from the primary study investigator(s).
MDS	Methods	The dataset can be used for methods research and development (e.g., development of statistical software or algorithms).
GSO	Genetic Studies Only	The dataset can only be used only for genetic studies.
NAE	No Animal Engraftment	Biospecimens cannot be engrafted onto animals or humans.
NTC	No Therapeutic Cloning	Biospecimens cannot be used for therapeutic cloning or engrafted onto animals or humans.