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The Databrary Access Agreement is different from a traditional Data Use Agreement because there is no obligation for authorized investigators to use or to contribute data. Once our researchers are planning to share data from lab or repurpose shared data in a systematic way, they would seek proper IRB approval for those activities.
Here are our guidelines regarding ethics board involvement:
Ethics board oversight is required to join Databrary. In other words, your institution must have an IRB or human subjects research ethics board (REB).
Ethics board approval is NOT required:
for access to Databrary. In other words, just to browse.
to contribute data to Databrary that does not contain personally identifying information (PII). In other words, procedural videos, stims, coding files, analysis, computer codes, etc.
Ethics board approval IS required:
to re-use data from Databrary. In other words, to conduct secondary data analyses.
to contribute data to Databrary that contains personally identifying information (PII). In other words, videos containing participant faces, names, dates of birth, etc.
Some researchers view IRB concerns as an impediment to data sharing, even those researchers who understand the many benefits of sharing. Given the checkered history of psychological science with regard to respecting the rights of human participants, it is not surprising that not sharing data has been a generally acceptable practice. However, IRB concerns and recommendations around data sharing vary depending on the specific type of data being shared. Moreover, best practices for seeking informed consent are widely available, thereby properly protecting participants.
Different types and levels of data sharing are associated with different ethical concerns. It is useful to distinguish among different use cases, and the types of concerns raised around data sharing in developmental science.
Using data shared by others (“secondary use”) usually involves low risk to participants because the new study does not involve contact with the participants. However, the level of risk depends on the nature of the data, whether the data are identifiable or otherwise sensitive, and the sort of permission that participants initially granted for sharing. Reuse of existing shared data is common practice, so most IRBs have established procedures for determining the level of risk posed by a particular project involving secondary use. For example, many IRBs deem exempt from review projects that involve the secondary use of non-sensitive, de-identified data.
What’s new, less common, and a potential source of concern to IRBs is the push by investigators under their supervision for more widespread sharing of certain types of data. This push means that PIs and their IRBs must evaluate the risks of sharing data within each particular study. Doing so requires determining what data can be shared, with whom and how, and with what level of risk. The risk of identification raises special concern. Fortunately, practices about what personal identifiers should be eliminated from data files are well established (even in brain imaging), so in many cases, de-identifying data files is uncomplicated. In cases where researchers seek to share sensitive or identifiable data (such as unaltered video or audio recordings that might contain participants’ faces, voices, or audible names), establishing guidelines on restriction of access is essential. Sharing these sorts of data increases risks to participants, and therefore explicit permission to share must be sought, with participants being fully informed of the meaning of “shared data” and who will have access.
Choices about how PIs should share data and who should have access are complicated. PIs or IRBs may be under the mistaken impression that shared data should (or must) be publicly available to meet open science standards, or journal or funder mandates. In fact, some of the most successful examples of data sharing in developmental research involve restricted access, where data are stored in recognized data repositories that limit access to approved researchers. Public access may be appropriate for some datasets, but it should not be the standard to which all studies must be held.
It is critical to seek explicit permission from participants to share data and to be transparent about the uses of those data. This honors participants’ autonomy by ensuring they (and/or their caregivers) fully understand the risks of sharing the data they contribute – as well as the potential benefits to science and the community at large that they are granting by sharing.
Developmental science has a long history of data sharing, and researchers can learn best practices from existing resources. In developing institution- or project-specific language for consents and data sharing permissions, PIs and IRBs can draw on the collective experience of experts and data repositories that have experience sharing data from vulnerable populations, such as children. Sources that provide valuable guidance about how to seek informed consent and data sharing permission, including template language, include:
Several of these organizations are collaborating on developing template language and data sharing procedures that will make these provisions even more consistent in the future.
Be ready with answers to IRB questions about data reuse. The IRB review plays a vital role in ensuring that standard consent, data management, and data sharing practices used for primary data collection enable future secondary uses while minimizing the risks to the original participants. Anticipating the questions that will be raised by IRBs and knowing how best to respond will enhance the likelihood of your IRB granting permission for data sharing. For example, in reviewing data sharing plans, IRBs may raise several practical questions that require an explicit response. For example:
Q. Must minors be re-consented when they reach the age of majority?
A. Federal officials say not if re-consenting is impractical or otherwise increases risks to participants (e.g., by requiring researchers to maintain links between identifiable information and collected data for extended time periods).
Q. Must data be destroyed after a particular time period?
A. Not if they are stored indefinitely in a recognized repository (as should become standard practice); data destruction is not mandated under federal regulations.
Request participant consent for sharing after their participation is complete. Because IRBs are concerned with participants being fully aware of what they are sharing, it is best practice to request participants’ consent to share after they have participated in a study, and therefore know exactly what data were gathered. Most developmental research is innocuous, and most parents are willing to share their children’s data – including video recordings – after they see that the project was fun and their children enjoyed participating. Most parents of children with disabilities are willing to share their children’s data because they hope to speed progress in research.
We have drafted [template language to assist you in completing your IRB applications here].
A Supervised Users is a person who conducts research under an Authorized Investigators sponsorship and supervision and who has been granted access to Databrary by the Authorized Investigator. In most cases, Supervised Users are students or research staff and are not eligible for Authorized Investigator status. (in the proposed Annex III)
The access privileges of Supervised Users are under the control of one or more Authorized Investigators.
Add Step by Step Instructions
You must be sponsored by an Authorized Invstigator and they need to grant you access to ALL Shared Databrary Data.
As a Supervised User, you must abide by the same rights and responsibilities as Authorized Investigators.
Supervised Users are not able to share their own data.
Supervised Users may not authorize other Supervised Users on their own behalf to access Databrary.
Researchers should not worry that participants will decide not to enter a study because they are being asked to share their information. Consenting to participate in a study is an entirely separate decision for participants from giving permission to share their data. They can agree to participate in the study and choose to not release their data for sharing.
Because of this, we recommend that researchers introduce the Databrary Release after the recording–such as at the end of a session, visit, or longitudinal study. By asking participants about sharing with Databrary after the recording is finished, participants will know what was done during the session and have a clearer understanding of what they would be agreeing to share. Even this is entirely adaptable, as there may be other reasons that asking at the end is undesirable or infeasible.
The following considerations may apply when deciding when to introduce the Release:
Databrary does not require contributors to have used the Databrary Release, or that researchers ask about sharing at the end.
The template is designed to help researchers standardize the language used and know exactly which release level to tag each session with based on their participants’ decisions.
No matter what form or language is used to obtain releases for Databrary sharing, contributors must determine which release level each participant agreed to and tag each session (or portion of a session) with the correct level of sharing.
Sample participant release script (upload) Example videos of the release process (upload)
All glossary items from New Glossary and Current Glossary have been merged in this document
Questions:
A person who conducts research under an Authorized Investigators sponsorship and supervision and who has been granted access to Databrary by the Authorized Investigator. In most cases, Supervised Users are students or research staff and are not eligible for Authorized Investigator status. (in the proposed Annex III)
The access privileges of Supervised Users are under the control of one or more Authorized Investigators.
An individual or institution that allows access to some Databrary resource to another individual or institution. For example, Rick Gilmore is sponsored by Penn State, and is also sponsored by Karen Adolph and Stacey Dusing. In turn, Rick sponsors Andrea Seisler, his undergrad RAs, a grad student, and some other collaborators.
In a Volume, people who have read/write/share privileges. Investigators need not be Authorized Investigators; they can be Affiliates.
On DB1.0 a volume lists users who are not the volume’s owners under a Collaborators section. Functionally, Collaborators are granted access to a volume by a Volume Owner.
The Databrary Access Agreement between an Authorized Investigator and his or her Institution and New York University (NYU) on behalf of Databrary.
The documentation of functionality instructions of Databrary.
Collections of information from which all identifiers have been removed or altered in such a way as to prevent the identification of individual persons.
A still frame or a selection from a larger recording that illustrates a particular point or demonstrates a finding. Typically no more than a few seconds or minutes in length, substantially less than the full length of a recording.
Investigators or affiliates may select segments of a recording as an excerpt for informational or educational purposes if the depicted individuals have granted appropriate release level for using selected excerpts.
Collections of information that might be used singly or in combination to determine the identity of research participants or other individuals depicted in recordings or data.
Collections of information that do not contain identifiable data.
Assets or parts of an asset (video clip) highlighted by the investigator to feature on the volume page.
Video or audio recordings or still (photographic) images.
Files related to the volume such as stimuli.
A collection of related data and materials.
A session is a unit within a volume which consists of a set of videos and records. A session most often represents a single visit by a participant or set of particapants interacting together in a study.
A collection of sessions and materials folders that contain data files like videos, coding spreadsheets, and documents.
Collections of one or more files (assets) are organized into slots, and the slots have system-wide unique integer IDs.
In addition, the spreadsheet can contain information about the participants, the tasks, the settings, or other user-defined information about data collected. Information about the participants, tasks, settings are organized into arrays called measures.
The UI represents session and materials information as a spreadsheet, and enables the user to download the participant-, task-, and setting data in a tidy, rectangular CSV that can be easily imported into a spreadsheet application.
A file (image, audio or video recording, or document) that is associated with a session or materials folder (in a slot). Assets have system-wide unique integer IDs.
A sample of time that marks a portion of an audio or video recording. The entire recording may be selected or a portion defined by separate start and end times (in milliseconds) measured from the start of the session.
Investigator contributed terms or keywords that can be attached to a volume, a session, or a record or video within a session. Only owners of a volume can add Keywords to that volume. For example, these might be the keywords that were also used for a published article related to the volume.
Consent missing or not obtained. This content is not shared and is restricted to collaborators.
This content is not shared and is restricted to collaborators.
This content is restricted to authorized Databrary users, who may use clips or images from it in presentations for informational or educational purposes. Such presentations may be videotaped or recorded and those videos or recordings may then be made available to the public via the internet (e.g., YouTube).
This content is available openly to anyone.
Entire Volume Shared
Volume Overview Shared
Private Volume
These terms describe how DB1.0 describes the granting of access to i) Databrary and ii) the sponsor’s own data.
Cannot access my data (except as granted through Databrary authorization)
Full view access to all my group data
Can access and edit (including delete privileges) all my group data
Can create volumes and change volume access on all my group data
Databrary requires all Databrary Authorized Investigators and Supervised Users to embrace best practices for data security.
Databrary contains identifying information, thus special care must be taken.
Our Physical Address
Databrary
4 Washington Place, Room 409
New York, NY 10003
212.998.5800
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