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 |
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GRU | General Research Use | Use of the biospecimens and related data is limited only by the terms of the NRGR Institutional Certification. For example:
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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 |
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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. |