Data Contract Condition Language for:
Centers for Medicare and Medicaid Service-Health and Retirement Study
sorted by Category and Condition
March 12, 2014, 3:53 pm
Cannot merge new files w/o amendment
FOR HRS: 8. a-c. No attempt will be made to link Restricted Data with anyother dataset, except as specified in the approved Research Plan; specifically, there may be no linkages of:
a. any HRS Restricted Dataset with any other HRS Restricted Datasets; or
b. any HRS Restricted Dataset containing information derived from Social Security Administration records, with any dataset containing geographic information at a level of aggregation more detailed than Census Division, except with explicit written permission from the Social Security Administration.
c. any HRS Restricted Dataset with any other dataset without written approval from HRS.
FOR CMS: 10. The User agrees that, absent express written authorization from the appropriate System Manager or the person designated in section 20 of this Agreement to do so, the User shall not attempt to link records included in the file(s) specified in section 5 to any other individually identifiable source of information. This includes attempts to link the data to other CMS data file(s). A protocol that includes the linkage of specific files that has been approved in accordance with section 4 constitutes express authorization from CMS to link files as described in the protocol.
Data used for statistical purposes
HRS Restricted Data will be used to generate only statistical summary information that does not permit the ident- ification of any individual person, family, household, employer, or benefit provider (except sole source pro-viders of public benefits), either directly or inferentially.
CMS No verbiage in contract
Only minimum necessary data
FOR CMS: 4. The User agrees that, within the User organization and the organizations of its agents, access to the data covered by this Agreement shall be limited to the minimum amount of data and minimum number of individuals necessary to achieve the purpose stated in this section (i.e., individual's access to the data will be on a need-to-know basis).
Stick to original research plan
FOR HRS: 10. Use of Restricted Data provided by HRS to the Investigator will be confined to the research described in the Research Plan submitted to and approved by HRS; the approved Research Plan is incorporated by reference into this Agreement
FOR CMS: 4. The User represents, and in furnishing the data file(s) specified in section 5 CMS relies upon such
representation, that such data file(s) will be used solely for the following purpose(s).
The User represents further that the facts and statements made in any study or research protocol or project plan submitted to CMS for each purpose are complete and accurate.
11. The User understands and agrees that they may not reuse original or derivative data file(s) without prior written approval from the appropriate System Manager or the person designated in section 20 of this Agreement
Inspections & Penalties
FOR HRS : 21. The Receiving Agency represents that it has in place policies and procedures on scientific integrity and misconduct. The Receiving Agency recognizes that certain violations of this agreement might constitute actions covered by such policies and procedures. If the HRS notifies the Receiving Organization's office responsible for scientific misconduct that a violation of this agreement has occurred and alleges that the violation constitutes scientific misconduct, the Receiving Organization will handle the allegation according to its policies and procedures applicable to scientific integrity and misconduct.
24. If HRS determines that this Agreement has been violated, HRS may:
a. prohibit any of the signatories of this Agreement, and of any Supplemental Agreements with Research Staff, from obtaining access to any HRS Restricted Data.
b. report the violation(s) to the Receiving Agency's office responsible for Code of Conduct on the safeguard of confidential information, and request that sanctions be imposed on the person(s) responsible for the violations.
c. report (directly or through the National Institute on Aging) the violation(s) to funding agencies with a recommendation that current funding be terminated, and future funding denied, to the Investigator(s), the Research Staff, and any other person implicated in the violation(s).
d. utilize such other remedies as may be available to it under law
FOR CMS: 14. The User hereby acknowledges that criminal penalties under 1106(a) of the Social Security Act (42 U.S.C. 1306(a)), including a fine not exceeding $10,000 or imprisonment not exceeding 5 years, or both, may apply to disclosures of information that are covered by 1106 and that are not authorized by regulation or by Federal law. The User further acknowledges that criminal penalties under the Privacy Act (5 U.S.C. 552a(i) (3)) may apply if it is determined that the Requestor or Custodian, or any individual employed or affiliated therewith, knowingly and willfully obtained the file(s) under false pretenses. Any person found to have violated sec. (i)(3) of the Privacy Act shall be guilty of a misdemeanor and fined not more than $5,000. Finally, the User acknowledges that criminal penalties may be imposed under 18 U.S.C. § 641 if it is determined that the User, or any individual employed or affiliated therewith, has taken or converted to his own use data file(s), or received the file(s) knowing that they were stolen or converted. Under such circumstances, they shall be fined under Title 18 or imprisoned not more than 10 years, or both; but if the value of such property does not exceed the sum of $1,000, they shall be fined under Title 18 or imprisoned not more than 1 year, or both.
Inspections & Penalties
Site Inspections can/will occur
FOR HRS: 22. The Receiving Agency agrees to allow HRS to conduct unannounced and unscheduled inspections of the restricted data site(s) to assess compliance with the terms of this Agreement.
FOR CMS: 8. The User agrees to grant access to the data to the authorized representatives of CMS or DHHS Office of the Inspector General at the site indicated in section 17 for the purpose of inspecting to confirm compliance with the terms of this agreement.
Amendments require UM signature
FOR CMS: the user is the U of M, and must sign amendments
Removal of Personnel on contract
Signer has authority to bind university
FOR CMS: the user is the U of M, and the custodian is the PI using the data