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| Appendix 2. ABC-DS Data Use
Agreement |
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| I have read the ABC-DS Policies for Publications document
located at https://www.nia.nih.gov/research/abc-ds#data.
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| I request access to data collected by the ABC-DS study for
the purpose of scientific investigation, teaching or the planning of clinical research
studies. Upon review and approval of access to data and/or biospecimen, I acknowledge
and agree to the following terms. |
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- I will receive access to de-identified data and will not attempt to establish
the identity of or attempt to contact any of the ABC-DS participants.
- I will not attempt to make direct contact with ABC-DS investigators or staff
at sites concerning the specific results of individual participants.
- I will not further disclose these data beyond the uses outlined in this
agreement and my data use application and understand that redistribution of data in
any manner is prohibited.
- I will require anyone on my team who utilizes these data, or anyone with whom
I share these data to comply with this data use agreement.
- I will accurately provide the requested information for persons who will use
these data and the analyses that are planned using these data.
- I will respond promptly and accurately to annual requests to update this
information.
- I will comply with any rules and regulations imposed by my institution and
its institutional review board in requesting these data.
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| If I publish abstracts using data from the
ABC-DS study, I agree to the following: |
- I will cite ABC-DS as the source of data and the ABC-DS funding sources
(including grant numbers) in the abstract as space allows.
- Acknowledgement of ABC-DS will not be cited in the authorship line of the
abstract.
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| If I publish manuscripts using data from
the ABC-DS study, I agree to the following: |
- On the by-line of the manuscript, after the named authors, I will include
the phrase "for the Alzheimer's Biomarker Consortium on Down Syndrome
study*" with the asterisk referring to the following statement and list of
names:
*Data used in preparation of this article were obtained from the Neurodegeneration
in Aging Down syndrome (NiAD) database (niad.loni.usc.edu) and Alzheimer's
Disease in Down Syndrome (ADDS) database. As such, the investigators within the
ABC-DS study contributed to the design and implementation of ABC-DS and/or provided
data but did not participate in analysis or writing of this report. A complete
listing of ABC-DS investigators can be found at: https://www.nia.nih.gov/research/abc-ds#data.
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- I will include language similar to the following in the methods section
of my manuscripts in order to accurately acknowledge data gathering by the ABC-DS
personnel. Depending upon the length and focus of the article, it may be appropriate
to include more or less than the example below, however inclusion of some variation
of the language shown below is mandatory.
The preparation of this manuscript was made possible from data obtained by
the Alzheimer's Biomarkers Consortium –Down Syndrome (ABC-DS), a
longitudinal study of Alzheimer Disease biomarkers in adults with Down syndrome
supported by grants from the National Institute on Aging (NIA) and the Eunice
Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
The primary goal of ABC-DS is to understand the factors that moderate the
relationship between Aβ, neurodegeneration and dementia in DS and biomarkers
for those factors that could be critically important in the design of effective
therapeutic trials for AD, not only in DS, but in the general population as well.
The Principal Investigators of the ABC-DS study are Benjamin Handen, PhD
and William Klunk, MD, PhD, (University of Pittsburgh), Bradley Christian, PhD
(University of Wisconsin-Madison), Nicole Schupf, PhD, Dr PH (Columbia University),
and Ira Lott, MD and Wayne Silverman, PhD (UC Irvine). The ABC-DS study is a
collaboration of field sites at Pittsburgh, Madison, Phoenix (Banner
Alzheimer's Institute; Marwan Sabbagh, MD), the University of Cambridge
(Shahid Zaman, MD), Washington University (Beau Ances, MD, PhD and John
Constantino, MD), Columbia University, Harvard University (Florence Lai, MD and H
Diana Rosas, MD) and UC Irvine. ABC-DS was established to collect longitudinal
clinical, neuroimaging, genetic and biofluid markers in approximately 400
participants with DS who were primarily non-demented.
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- I will acknowledge the ABC-DS study in the support acknowledgement section of
the manuscript using language similar to the following:
"Data collection and sharing for this project was supported by The
Alzheimer's Disease Biomarker Consortium on Down Syndrome (ABC-DS) funded by
the National Institute on Aging (NIA) and the Eunice Kennedy Shriver National
Institute of Child Health and Human Development (UO1 AG051406 and UO1 AG051412).
The authors thank the adults with Down syndrome volunteering as participates in
this study for their invaluable contributions to this work, along with their
service providers and families. Finally, the authors thank the staff contributing
their many hours of support to this work, including (with names of specific
individuals provided, as determined by the lead author(s)."
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- I will submit all manuscripts to the ABC-DS Steering Committee prior to
submitting to a journal. This review will not be a scientific review, but is intended
to ensure that sections 7-12 above are correctly implemented. The ABC-DS Steering
Committee will maintain confidentiality of the manuscript and will complete its
review within 2 weeks.
- I will ensure that Investigators who utilize ABC-DS data use appropriate
administrative, physical and technical safeguards to prevent use or disclosure of the
data other than as provided for by this Agreement.
- I will report any use or disclosure of the data not provided for by this
Agreement of which I become aware within 15 days of becoming aware of such use or
disclosure.
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| IMPORTANT NOTE: It is the policy of the ABC-DS to make analyzed data
available to investigators as quickly as possible. However, data analysis for this
project is expected to take years as methods for analysis of these datasets evolve.
Therefore, I understand that any processed data that I download might be preliminary
and that results may change as new methods of analysis are implemented. I will
familiarize myself with the analysis methods so that I am aware of the limitations of
these data prior to using them for scientific purposes. |
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| Finally, because "preliminary data" will be posted on the
database, in the event that I download data from the ABC-DS databases for the purposes
of analysis and future publication in the form of abstracts and/or publications, I
will note the version of the data I download, and I will check the databases to
determine if updated data has been provided prior to submission of any material for
publication. |
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| I understand that failure to abide by these guidelines will result in
termination of my privileges to access data from the ABC-DS study. |
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