Guidelines for Grant and Contract Management
404C. Subaward Agreement -- Non-Federal Clinical (Prototype)
The University of Chicago ("Chicago") enters into this subaward with Institution ("Institution") for the performance of the studies described in the protocol entitled "____________________" under the sponsorship of Institution ("_________________") (Exhibit A--Study Protocol). The Principal Investigator at Chicago is __________________, M.D. Principal Investigator at __________________ ("_______________ Investigator") is __________________.
All the terms, conditions, provisions and obligations that exist between Chicago and ______________ are extended to this subaward, unless specifically modified herein, and are made a part of this subaward.
ARTICLE 1.
SCOPE OF WORK: ________________ Investigator shall conduct the work
indicated in Exhibit A, which is incorporated herein and made a part of this
subaward.
ARTICLE 2.
PERIOD OF PERFORMANCE: This subaward shall be in effect from ________,
________, through __________, _________.
ARTICLE 3.
CONSIDERATION: The sum of $_______ is authorized as the maximum compensation
to be paid to __________________ under this subaward. This amount will be
earned by ________________ based on $_______ per completed case report form
delivered to Dr. ________________ for a maximum of __________ (__) qualified
subjects.
ARTICLE 4.
PAYMENTS: Chicago will provide funding in accordance with the following
schedule:
ARTICLE 5.
PATENTS: Pursuant to Public Law 96-517, as amended by Public Law 98-620,
title to any invention or discovery made or conceived under this subaward
shall vest in ________________. ___________________ shall promptly notify
Chicago Principal Investigator in writing of any such inventions or discoveries.
__________________ hereby grants to Chicago a royalty-free, non-exclusive
license for internal research purposes to any ___________________ invention
or discovery under this subaward.
ARTICLE 6.
HUMAN SUBJECTS: As human subjects are involved in this study, the policies
and procedures of ___________________________'s Institutional Review Board
will be observed.
ARTICLE 7.
HIPAA COMPLIANCE: The provisions of this Article 7 apply to the extent
that Institution receives from Chicago, or creates for Chicago, any Protected
Health Information (as defined below) in connection with its work under this
subaward.
7.1 Institution will not, and will ensure that its directors, officers, employees, contractors and other agents do not, and will implement appropriate safeguards to assure that it does not, use or disclose Protected Health Information other than as permitted or required by this subaward or as permitted or required by law, but in no event in any manner that would constitute a violation of the Standard for Privacy of Individually Identifiable Health Information, 45 C.F.R. Parts 160 and 164 (the "Privacy Standards"), if used or disclosed by Chicago. Institution may use PHI to carry out the legal responsibilities of Institution. Without limiting the foregoing, Institution agrees it will (a) secure and protect PHI consistent with applicable laws and standards that apply to the security and protection of patient information, and (b) make all reasonable efforts to only use the minimum amount of PHI necessary to accomplish the intended purpose of the use. To the extent Institution discloses PHI to a third party, Institution must obtain, prior to making any such disclosure, written assurances from such third party that the party will abide by the same restrictions and conditions contained in this subaward, including that (a) the PHI will be held confidential as provided in this subaward and only disclosed as required by law or for the purposes for which it was disclosed to such third party, and (b) the third party will immediately notify Institution of any breaches of the confidentiality of the PHI. Institution will promptly report to Chicago any disclosure of PHI in violation of this subaward.
7.2 As used in this subaward, "Protected Health Information" or "PHI" means Individually Identifiable Health Information received from Chicago or its affiliates (or created using the same) or received or created on behalf of Chicago or its affiliates, except that "Protected Health Information" will not include (i) education records covered by the Family Educational Right and Privacy Act, as amended, 20 U.S.C. §1232g and (ii) records described in 20 U.S.C. §1232g(a)(4)(B)(iv).
7.3 "Individually Identifiable Health Information" means information that is a subset of health information, including demographic information collected from an individual, and (i) is created or received by a health care provider, health plan, employer, or health care clearinghouse; and (ii) relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present or future payment for the provision of health care to an individual; and (x) identifies the individual, or (y) with respect to which there is a reasonable basis to believe the information can be used to identify the individual.
7.4 Upon request, Institution will make available to Chicago or its affiliates any PHI it requests, including for amendment of an individuals PHI. Institution will have no responsibility to respond to requests of individuals who are seeking PHI directly from Institution. If any individual requests access to PHI directly from Institution, Institution will within two (2) business days forward such request to the Chicago. Any denials of access to the PHI requested will be the responsibility of Chicago. Institution will incorporate any such amendments in the PHI as required by 45 C.F.R.§164.526.
7.5 Within ten (10) days of notice by Chicago to Institution that it has received a request for an accounting of disclosures of PHI regarding an individual, which disclosures include the time during the six (6) years prior to the date on which the accounting was requested, Institution will make available to Chicago such information as is in Institution's possession and is required for Chicago to make the accounting required by 45 C.F.R. §164.528. Institution will have no responsibility to respond to requests of individuals who are seeking an accounting of PHI disclosures directly from Institution. If the request for an accounting is delivered directly to Institution, Institution will within two (2) days forward such request to Chicago. It will be Chicago's responsibility to prepare and deliver any such accounting requested. Institution hereby agrees to implement an appropriate record keeping process to enable it to comply with the requirements of this Section.
7.6 Institution hereby agrees to make its internal practices, books and records relating to the use and disclosure of PHI available to the Secretary of the Department of Health and Human Services for purposes of determining Chicago's and/or Institution's compliance with the Privacy Standards.
ARTICLE 8.
AUTHORIZED REPRESENTATIVES:
A) For Technical Matters:
For Chicago:__________________________, M.D.
For ________:__________________________, M.D.
B) For Business Matters:
For Chicago: __________________________
For ________: ____________________________
ARTICLE 9.
TERMINATION: Either party may terminate this subaward upon thirty days
written notice to the other party. In the event this subaward is terminated,
compensation will be made in accordance with Article 3, contingent upon Chicago
receiving said funds from _____________________.
ARTICLE 10.
CONFLICT OF INTEREST: __________________ shall disclose to Chicago
any perceived or apparent conflict of interest related to the scope of work
of this subaward. In signing this subaward, __________________ accepts the
responsibility for disclosure, to the Principal Investigator at Chicago, of
all applicable perceived or apparent conflicts of interest.
ARTICLE 11.
EQUAL OPPORTUNITY: During the performance of the work under this subaward,
__________________ shall not discriminate against any employee or applicant
for employment because of race, color, religion, sex, national origin, handicap,
or special disabled or Vietnam Era veteran status, and all the provisions
of the nondiscrimination clause set forth in Executive Order No. 11246, as
amended, are hereby incorporated by reference in this subaward.
ARTICLE 12.
INDEMNIFICATION: In no event shall the University be liable any loss,
claim, damage or liability, of whatsoever kind or nature, which may arise
from or in connection with this Agreement.
_________________________ |
THE UNIVERSITY OF CHICAGO: |
By: ______________________ |
By: ______________________ |
_________________________ (Typed Name) |
_________________________ (Typed Name) |
_________________________ (Title) |
_________________________ (Title) |
_________________________ (Date) |
__________________________ (Date) |
