Contract process - checklist

Before the legal review

1. Get confirmation from Head of Department or Head of Administration that:

• the proposed scientific and financial terms of the contract are acceptable
• the contract is appropriate for the activities, guidelines and ethical principles of KI and of the department
• KI is the contractual party and not a researcher through a secondary occupation, see Rules for handling secondary occupations
• the counterparty is suitable. An assessment of the risks associated with the collaborator should be made, for example to assess if KI’s reputation can be damaged by being associated with the collaborator or its operations.  
• a responsible Contract Administrator is appointed (often the PI)

2. The appointed Contract Administrator should:

• Organise internal communication with the legal unit and other support functions
• Negotiate with the counterparty
• Engage in all revisions of the agreement draft

And must know the content of:

• Guidelines for research related contracts
• Guidelines on conflict of interest
• Guidelines on intellectual property and corporate collaborations (IP Policy)

3. Define the type of contract, for example:

• Confidentiality agreement
• Commissioned research agreement
• Research Collaboration Agreement
• Material Transfer Agreement
• Consortium Agreement
• Data transfer agreement
• Purchase of goods or services (contact the Purchase and Procurement Unit)
• Donation/sponsorship, see Rules on donations and sponsorships, contact Development Office do@ki.se
• Grant agreement, contact grantsoffice@ki.se for international grants

Read To collaborate with KI
Contact the Research Data Office rdo@ki.se or the External Engagement Office for support

4. Define the ownership of results and the parties’ right to use the results

• Read To collaborate with KI
• Guidelines on intellectual property and corporate collaborations (IP Policy)
• SUHF Principles for managing intellectual property in research contracts, Recommendation 2016:3

5. Decide how the results will be published

• Individually
• By one of the parties
• Jointly by all parties

6. Decide who at KI will participate in the project

Inform the counterparty of any affiliated participants.

7. Ensure the budget is appropriate for the type of contract

Contact the department’s economy administrator to clarify the following:

• Financial contributor
• Client, full cost coverage is required for commissioned research
• Ensure a suitable payment plan

8. Prepare a detailed research plan

• Describe the responsibilities and tasks of each party (e.g. project plan, milestones)
• List KI background, see  Guide till Vinnovas villkor om nyttjanderätt

9. Verify if ethical or animal permits are required

Verify if KI must be the principal research party.

Contact Compliance Data Office (CDO) for support

10. Ensure that clinical research studies are approved by the clinic

Clinical research studies regarding patients must be approved by the clinic where they are going to be carried out.

Define the respective roles and responsibilities of KI and the clinic. See the Checklist for clinical research projects

11. Find out if prior approval for the transfer of material or data is required

Export control of dual-use items

12. Identify the need for insurance

•  Insurance for research subjects
•  Insurance
•  Insurance for international students

Contact Compliance Data Office (CDO) or HR for support

13. If the project involves processing of personal data:

• Prepare a Data Management Plan
• Carry out a data protection impact assessment when necessary, according to the Instructions
• Determine which role/responsibility KI and each of the other parties has
• Register the personal data processing activities at KI (registeranmälan) with KI’s Data Protection Officer

Contact Research Data Office or KI Data Protection Officer for support

14. If you collect human biological samples:

• Decide where biobank materials are handled (KI Biobank, SMB or other biobank)
• MTA should be established

15. Decide the duration of the contract: start & end dates

After the legal review

16. Make sure that the final version is approved by the official signatories

17. Check who will sign the contract and how

• Read the Delegation rules
• Digital signatures, read the Guidelines for digital signatures
• Date and sign the contract

18. Send the researcher consent form to all KI researchers 

During signature of the contract, send the researcher consent form to all the participating KI researchers for their signature.

19. Register and archive the fully signed contract and researcher consent forms