Conditions for Publishing
The data in the Collection is doubly firewalled on protected servers. This is to protect the identities of vulnerable persons and their guardians who have agreed to share their voices with you. You will need to sign the form below as part of your access to the Collection.
RESTRICTED DATA USE AGREEMENT Restricted Data Use Agreement between the Medical University of South Carolina Library Carolinas Conversations Collection Charleston, South Carolina and
(Restricted Data Investigator’s Name- Please print or type)
_________________________________________________________ (Receiving Organization/Current Department)
This agreement is entered into by the Medical University of South Carolina Library and the Carolinas Conversations Collection archive and ____________________________, the Restricted Data Investigator, patterned after and consistent with the requirements of Section 28 of the Federal Regulations (CFR) Part 22 (http://www.ojjdp.gov/funding/confidentiality.pdf) as applied to the Protection of Human Subjects by the National Human Research Protections Advisory Committee Recommendations on Confidentiality and Research Data Protections (http://www.hhs.gov/ohrp/nhrpac/documents/nhrpac14.pdf),
IRB Study Number ____________
for the research proposed in the Restricted Data Investigator’s proposal submitted with this agreement and no other purposes.
The research proposal should address the topics and methods of the proposed research, why the restricted data are required instead of publicly available data, and the procedures to be used to protect the confidentiality of research subjects and the security of the transferred data.
The Restricted Data Investigator and the Receiving Organization/Department understand that the data to be transferred are not to be used to identify persons or organizations and/or the cases of persons or organizations within the meaning of Section 28 of the Federal Regulations (CFR) Part 22 and the National Human Research Protections Advisory Committee Recommendations on Confidentiality and Research Data Protections.
The Restricted Data Investigator and the Receiving Organization agree to the following terms and conditions:
Definition of Terms:
1. “Restricted Data” refers to the original restricted data in all its forms (audio, video and transcription) provided by the Carolinas Conversations Collection archive and any fields or variables derived from these data, on whatever media they shall exist. (Aggregated statistical summaries of dat and analyses, such as tables, factor analyses and regression statisticsa are not considered “derived” for the purposes of this agreement.
2. "Restricted Data Investigator" refers to the investigator who serves as the primary point of contact for all communications involving this Agreement. The Restricted Data Investigator assumes all responsibility for compliance with all terms of this Agreement by employees of the Receiving Organization. 3. "Principal Investigator(s)" refers to the Restricted Data Investigator and any Co-Principal Investigators. 4. "Receiving Organization" refers to the organization employing the Restricted Data Investigator. 5. "Research Staff" refers to any individuals other than the "Restricted Data Investigator(s)" with access to the restricted data. 6. The "Representative of the Receiving Organization" refers to an individual who has the authority to represent your organization in agreements of this sort, such as a Vice President, Dean, Provost, Center Director, or similar official. (Note that a Department Chair is not acceptable unless specific written delegation of authority exists.) 7. "CCC" refers to the Carolinas Conversations Collection, a data repository wholly owned by the Medical University of South Carolina Library. Ownership of Data 8. Ownership of restricted data will be retained by CCC. Permission to use restricted data by the Restricted Data Investigator(s) and Receiving Organization may be revoked by CCC at any time, at their discretion. The Restricted Data Investigator(s) and Receiving Organization must return or destroy all originals and copies of the restricted data, on whatever media it may exist, within 5 days of a written request to do so. Failure to do so will result a formal complaint to both involved Institutional Review Boards (IRBs) and sanctions. Access to the Restricted Data 9. Access to the restricted data will be limited solely to the individuals signing this agreement and the Restricted Data Investigator’s research staff on a “need to know” only basis. The data may not be "loaned" or otherwise conveyed to anyone other than the signatories to this agreement. The data cannot be posted on any public venue or shared in any social media. 10. Copies of the restricted data or any subsequent variables or data files derived from the restricted data will not be provided to any other individual or organization without the prior written consent of the CCC. Uses of the Restricted Data 11. The restricted data will be used solely for the purpose of scientific and public policy research, and not for any administrative, proprietary, or law enforcement purposes or in any forum that allows public access out of the listed research team (i.e. social media). 12. The restricted data will be used to generate only statistical summary information or qualitative description that does not allow any individual, family, household, business, or organization to be identified. 13. The restricted data will be used solely for the research project described in the research proposal attached to this Agreement. 14. No attempt will be made to identify any individual person, family, household, business, or organization. If an individual person, family, household, business, or organization is inadvertently identified, or if a technique for doing so is discovered, the identification or discovery will be immediately reported to CCC, and the identification or discovery will not be revealed to any other person who is not a signatory to this agreement. 15. No attempt will be made to link this restricted data with any other dataset, including other datasets provided by CCC, unless specifically identified in the approved research proposal attached to this Agreement.
16. Use of the restricted data will be consistent with the receiving organization's policies regarding scientific integrity and human subjects research. Data Confidentiality Procedures 17. If the Receiving Organization requires a review of research proposed in this Agreement by an Institutional Review Board/Human Subjects Review Committee or equivalent body, the Research Data Investigator certifies that the review has taken place and all approvals have been granted prior to this application for use of the restricted data. 18. The Receiving Organization will treat allegations, by CCC or other parties, of violations of this agreement as allegations of violations of its policies and procedures on scientific integrity and misconduct. If the allegations are confirmed, the Receiving Organization will treat the violations as it would violations of the explicit terms of its policies on scientific integrity and misconduct. 19. The Restricted Data Investigator certifies that all aspects of the plan for protecting the confidentiality of the data provided under this Agreement, as detailed in the attached research proposal, will be followed until which time all copies of the restricted data are destroyed.
Destruction of Data Upon Completion of Research Project 20. The Restricted Data Investigator will certify to CCC that all originals and copies of the restricted data, on whatever media, will be destroyed at the completion of the research project described in the research proposal attached to this Agreement, or within 5 days of written request from the CCC. The IRB protocol must stipulate in what time period the original data will be destroyed. Duration of This Agreement 21. This Agreement will go into effect upon approval of the Agreement by CCC, and will remain in effect until the completion of the research project, or 24 months from the date this Agreement is accepted by CCC, whichever comes first. If, at the end of 24 months, access to the restricted data is still desired, the Restricted Data Investigator must contact CCC in writing requesting such continued access. If continued access is denied by CCC, or if the Restricted Data Investigator neglects to contact the CCC prior to the end of the 24-month period, all originals and copies of the restricted data, on whatever media they exist, must be destroyed by the Restricted Data Investigator. Post-Approval Modifications to Submitted Materials 22. If changes in research plans or computer environment will alter the information originally submitted as part of this Agreement, the Restricted Data Investigator shall provide the CCC with a copy of the revised materials and a memorandum describing the changes in advance of the revisions. These revisions will be considered amendments to this Agreement and may not be implemented until written approval is received from CCC. 23. A change in the employer of the Restricted Data Investigator requires the execution of a new Restricted Data Use Agreement, including an updated research proposal that details the plans for the protection of the confidentiality and security of the data. These materials must be approved by CCC before restricted data may be accessed at the new place of employment.
24. When research staff join the project (either at its beginning or while in progress), they shall be informed of the necessary procedures to protect the confidentiality and security of the restricted data and shall agree in writing to abide by those procedures. A form for these staff agreements is provided at the end of this agreement and was derived from: http://www.icpsr.umich.edu/icpsrweb/ICPSR/access/restricted/supplemental.jsp The Restricted Data Investigator shall maintain these signed agreements until the restricted data have been destroyed pursuant to the terms of this Agreement. Violation of This Agreement 25. If CCC determines that the Agreement may have been violated, CCC will inform the Restricted Data Investigator(s) of the allegations in writing and will provide them with an opportunity to respond in writing within 10 days. CCC may also, at that time, require immediate return or destruction of all copies of the restricted data in possession of the investigators. Failure to do so will be determined to be a material breach of this Agreement and, among other legal remedies, may be subject to injunctive relief by a court of competent jurisdiction. If CCC deems the allegations unfounded or incorrect, the data may be returned to the Restricted Data Investigator under the terms of the original agreement. If CCC deems the allegations in any part to be correct, CCC will determine and apply the appropriate sanction(s). 26. If CCC determines that any aspect of this agreement has been violated, CCC may invoke these sanctions as it deems appropriate: 1. Denial of all future access to restricted data files.
2. Report of the violation to the Receiving Organization’s office responsible for scientific integrity and misconduct, with a request that the institution's sanctions for misconduct be imposed. 3. Report of the violation to appropriate Federal and private agencies or foundations that fund scientific and public policy research, with a recommendation that all current research funds be terminated, that future funding be denied to the investigator(s) and to all other persons involved in the violation, and that access to ther restricted data be denied in the future. 4. Such other remedies that may be available to CCC under law or equity, including injunctive relief. Restricted Data Investigator _________________________________________________ Date___________ (Signature)
Name _________________________________________ (Please print or type name and information below)
Address _________________________________________
_________________________________________
City/ST/Zip _________________________________________
Telephone _________________________________________
E-mail address _________________________________________ ***************************************************************************** Receiving Organization By _________________________________________ Date___________ (Signature)
Name _________________________________________ (Please print or type name and information below)
Title/Position _________________________________________
Address _________________________________________
_________________________________________
City/State/Zip _________________________________________
Telephone _________________________________________
E-mail address _________________________________________ *****************************************************************************
For the Archive _______________________________________ (Signature) Date___________
__________________________________________(Name) Director: Charlene Pope, PhD Approved [ ] Modifications required [ ] Declined [ ]
Restricted Data Use Agreement: Supplemental Agreement With Research Staff INSTRUCTIONS: Please submit an original-signature copy of this agreement. (It will be countersigned and a copy returned to you.) Use additional copies of this page if necessary.
The undersigned staff, in consideration of their use of this restricted data certify the following:
1. That they have read the associated Policy and Data Transfer Agreement, and the Data Protection Plan incorporated by reference into this Agreement.
2. That they are "Research Staff" within the meaning of the Agreement (any research staff other than the Restricted Data Investigator).
3. That they will fully comply with the terms of the Agreement, including the Data Protection Plan incorporated by reference into it.
4. That they will not attempt to access this restricted data until approved to do so by CCC. 5. They will be subject to all penalties as the Restricted Data Use Investigator.
Study Title ___________________________________________________________
1) Signature:____________________________________________________________ Date:_____________________
Typed Name:___________________________________________________________
Title/Formal Affiliation with Research Project:________________________________
2) Signature:____________________________________________________________ Date:_______________________
Typed Name:____________________________________________________________
Title/Formal Affiliation with Research Project:_________________________________
The above Research Staff are hereby granted approval to access this restricted data:
____________________________________________________________ Carolinas Conversations Collection of the Medical University of South Carolina
** Adapted from the Restricted Data Use Agreement of the National Archive of Criminal Justice Data http://www.icpsr.umich.edu/icpsrweb/ICPSR/access/restricted/restricted.jsp |
