Data Use Agreement for READISCA Data

Terms and Conditions for Access to READISCA Data and Materials

These Terms and Conditions (“Terms”) govern the access to and use of data or other research materials (“READISCA Data”) originating from the Clinical Trial Readiness for SCA1 and SCA3 (READISCA) Study and jointly controlled by the following institutions (“Joint Controllers”): Houston Methodist Research Institute, Institut du Cerveau et de la Moelle Épinière, German Center for Neurodegenerative Diseases, University of Minnesota, University of Michigan Health System, University of California Los Angeles, University of Utah, and University of Florida.

By accessing or using READISCA Data, you (“Third Party User”) agree to comply fully with the following Terms.

1. Use of Data
   1. READISCA Data may be used solely for scientific or statistical research related to neurodegenerative diseases.
   2. All use must align with the purposes approved by the Joint Controllers and described in participant consent materials, namely for research related to understanding the progression and identifying biomarkers in neurodegenerative diseases.
   3. Data may not be used for any commercial, administrative, or clinical decision-making purpose unless being used for clinical research or expressly authorized in writing.
   4. No attempt may be made to identify, contact, or re-identify any study participant.
   5. Data may not be sold, sublicensed, or shared with any other party without prior written approval from the Joint Controllers.
   6. Data may not be used for purposes that conflict with GDPR, applicable U.S. laws, or participant consent forms.
2. Data Security Requirements
   1. Implement appropriate technical and organizational measures to protect the confidentiality, integrity, and availability of READISCA Data.
   2. Restrict data access only to personnel with a legitimate research need.
   3. Maintain secure storage (encrypted devices, controlled servers, or equivalent protections).
   4. Prevent unauthorized access, disclosure, or modification.
3. Data Breach Obligations
   1. You must notify the designated READISCA Single Point of Contact without undue delay after becoming aware of any actual or suspected data breach.
   2. You must fully cooperate with investigations, notifications, and mitigation efforts required by applicable law or Joint Controllers.
4. Data Retention and Destruction
   1. Data may only be retained for the duration of the research purpose.
   2. You agree to delete specific READISCA datasets if requested to do so by READISCA Principal Investigators, e.g., if certain released datasets are found to have identifying information inadvertently included.
   3. Retention beyond this period requires explicit written authorization.
5. Compliance With Law
   1. You agree to process READISCA Data in accordance with:
      1. The EU General Data Protection Regulation (GDPR);
      2. Applicable national privacy laws;
      3. U.S. federal and state data protection laws where relevant; and
      4. Local institutional review board/ethics committee requirements.
6. Participant Rights
   1. You must support the Joint Controllers in honoring any participant rights requests, including access, correction, erasure, or restriction of processing. You may not correspond directly with participants for these purposes.
7. Data Transfers
   1. READISCA Data may not be transferred outside the jurisdiction where it was received unless you have obtained prior written approval and appropriate safeguards (e.g., standard contractual clauses) are in place.
8. Publications
   1. Any publication using READISCA Data must:
      1. Acknowledge the READISCA Study and the Joint Controllers;
      2. Acknowledge the funding sources, the National Institute of Neurological Disorders and Stroke (NINDS) grant U01 NS104326 and Biogen, Inc.;
      3. Comply with the Authorship guidelines detailed in Appendix below;
      4. Be shared with the Joint Controllers prior to submission, if requested;
      5. Not include identifiable or potentially identifiable participant information.
9. Liability
   1. You are fully responsible for compliance with these Terms.
   2. You will indemnify and hold harmless the Joint Controllers for damages arising from your unlawful, negligent, or unauthorized use of READISCA Data.
10. Audit Rights
    1. The Joint Controllers may request documentation or conduct audits to confirm compliance with these Terms. You must cooperate fully and provide required information within a reasonable time.
11. Termination
    1. Access may be suspended or terminated immediately if you violate these Terms or applicable law.
    2. Upon termination, all data must be securely destroyed, and certification of destruction must be provided.
12. Contact
    1. All inquiries, data rights requests, and breach notifications must be directed to the READISCA Single Point of Contact:

Dr. Gulin Oz

Email: gulin@cmrr.umn.edu

APPENDIX: Authorship Guidelines for READISCA Publications

Authorship for any READISCA publications will be based on the following framework:

Lead authors:

First Author and Last Author will be provided by the READISCA team which has had the lead for a particular publication. In cases where two or more READISCA teams have conceptualized and generated a publication in equal shares, there will be joint first authorship and joint last authorship between these teams.

Any persons from the lead team(s) who have had major contributions to the publication besides the first and last author will be listed right after the first author(s).

Default co-authors:

For any publications including READISCA data and/or materials and that are prepared by members of the READISCA team, the multiple principal investigators (MPIs) of READISCA, i.e., Tetsuo Ashizawa, Gulin Oz, Henry L. Paulson, Thomas Klockgether, and Alexandra Durr, should always be acknowledged by a co-authorship in the main author list.

For manuscripts that use READISCA data downloaded from the NIMH Data Archive (https://nda.nih.gov/) or other databases, only those READISCA team members who contribute to the preparation of the manuscript should be listed as primary authors and the MPIs listed as Collaborating Authors to acknowledge their project leadership in PubMed.

Further co-authors:

In terms of further authors, the READISCA MPIs will decide the number of authors for each READISCA site based on the contribution to the particular publication. For manuscripts including follow-up data, not the number of enrolled study participants but the number of study visits from which data was contributed will determine the number of author slots for that site. Each READISCA team can then appoint the respective number of contributors for the authors list (to be placed before the last author), with the order sorted based on the resources the respective team contributed for the publication (e.g. number of datasets).

If any READISCA member(s) submit a pre-submission review that significantly changes the manuscript content, the READISCA team may change the authorship order or category of the READISCA member(s) in the particular publication.

READISCA investigators:

In case that either (a) the number of authors for a publication in a certain journal is limited by the journal or (b) the contribution of some investigators is below the level that would justify a full co-authorship, those who made contributions but are not listed as authors with their full name will appear as “READISCA investigators” (if permitted by the respective journal). This typically applies for clinical investigators who performed only a small number of assessments and ensures that all READISCA contributors will be findable in PubMed also when they do not have an individual author slot in a certain publication (https://www.nlm.nih.gov/pubs/techbull/ma08/ma08_collaborators.html).

Whether or not it is indicated to use the “READISCA investigators” for a particular manuscript will be decided by the READISCA MPIs on a case-by-case basis.

For the “READISCA investigators” the MPIs trust all sites to appoint the people who contributed significantly to the collection of data and material, therefore the full list of names submitted by the sites will be used for the study group. The list of “READISCA investigators” can be found on the READISCA website (www.readisca.org). Each site is responsible for informing the lead authors and MPIs of any necessary adjustments. The website also lists clinical research coordinators and key personnel of the Consortium. The READISCA team is welcome to use the information on this website to make the list of “READISCA investigators” and, if needed, the acknowledgment for the particular publication.