Research Agreements

Process

Agreements

A.   Send routing package to Industry Relations which consists of the following:

i)   Completed Route Form with all required signatures

ii)  Completed Research Agreement Questionnaire

iii)  Copy of proposed protocol/project summary

iv) Copy of proposed agreement (electronic if available)

v)  Copy of internal budget for funded projects, if finalized

vi) Copy of external budget for funded projects, if finalized

vii) Copy of draft consent form if human subjects involved

B.  Industry Relations will review all information provided and negotiate the agreement to meet institutional requirements and policies, as well as fiscal and regulatory requirements.  As part of the negotiation process, Industry Relations will copy the PI and the coordinator/administrator on communications to the company.

C.  Industry Relations will review the budget and provide feedback as necessary to the PI and coordinator/administrator based upon their review.  Industry Relations will discuss the payment terms with the PI/coordinator/administrator to make sure they meet the needs of the study and will re-negotiate such terms.

D.  Once the negotiations are completed and the appropriate institutional approvals are in place, Industry Relations will process the signatures of the agreement as follows:

i)   Industry Relations will provide the originals of the agreement to the PI for signature, if required, and for the PI to confirm the budget terms and amount outlined in the contract is what was agreed to by the PI.

ii)  Industry Relations will obtain institutional and company signatures.

iii)  Once fully-executed by all parties, Industry Relations will send a copy of the fully-executed agreement to the Controller’s Office for their reference in account activation, a copy to the PI, a copy to the coordinator/administrator and will retain one original in Industry Relations’ files for management of the obligations.  If the Department receives the original, it must be forwarded to Industry Relations.

Amendments

A.   Send following information to Industry Relations:

i)   Copy of proposed protocol/project summary amendment

iv) Copy of proposed amendment (electronic if available)

v)  Copy of internal budget if finalized for any additional funding

vi) Copy of external budget if finalized for any additional funding

B.  Industry Relations will review all information provided and negotiate the amendment to meet institutional requirements and policies, as well as fiscal and regulatory requirements.  As part of the negotiation process, Industry Relations will copy the PI and the coordinator/administrator on communications to the company.

C.  Industry Relations will review the budget and provide feedback as necessary to the PI and coordinator/administrator based upon their review.  Industry Relations will discuss the payment terms with the PI/coordinator/administrator to make sure they meet the needs of the study and will re-negotiate such terms.

D.  Once the negotiations are completed and the appropriate institutional approvals are in place, Industry Relations will process the signatures of the amendment as follows:

i)   Industry Relations will provide the originals of the amendment to the PI for signature, if required, and for the PI to confirm the budget terms and amount outlined in the contract is what was agreed to by the PI.

ii)  Industry Relations will obtain institutional and company signatures.

iii)  Once fully-executed by all parties, Industry Relations will send a copy of the fully-executed amendment to the Controller’s Office if funding is involved for their reference in account management, a copy to the PI, a copy to the coordinator/administrator and will retain one original in Industry Relations’ files for management of the obligations.

General Information

All research agreements are entered into by the institution and not by any investigator individually.  Research agreements must be consistent with institutional policy and requirements on issues such as data ownership, publication, inventions, indemnification, limitation of damages, governing law, as well as subject injury for clinical trials.  Research agreements must also be consistent with institutional fiscal policies and requirements including but not limited to requiring appropriate F&A rate, IRB fee if applicable and consistency in reimbursement of study related expenses. 

Various factors go into determining the terms and provisions applicable to each research project.  For example, multi-center studies may involve more flexibility in certain provisions than investigator-initiated studies.  Also, registry studies may not require the same provisions as a Phase II clinical trial.  Industry Relations takes into all account each of these factors in their negotiations.