Research is great…

Except for all the paperwork!

Hel–lo-o, if you will do all of your essential paperwork first, you may certainly have your money much more quickly...

Susan Shands Jones,

Staff Attorney

Legal Documents for Res earchers

Material Transfer Agreements (MTAs)Confidentiality Agreements Confidential Disclosure Agreements (CDAs)Clinical Trial AgreementsAgreements with the Mississippi State Department of Health (MSDH)SubcontractsIndependent Contractor/Consultant Agreements

• Contact Information• Description of Substance• Records• Indemnity/Tort Claims• Language re: Entitlement to Relief • Choice of Law• Signatures – Investigator and Institution

Material Transfer AgreementsMaterial Transfer Agreements

Confidential Confidential Disclosure Disclosure Agreement Agreement

(CDA)(CDA)

• Length of TimeLength of Time• Governing Law and Venue: Governing Law and Venue:

“This Agreement shall be “This Agreement shall be governed by Florida law governed by Florida law without reference to conflicts without reference to conflicts of law principles. Any of law principles. Any conflicts will be resolved in conflicts will be resolved in the courts of Hillsborough the courts of Hillsborough County, Florida”County, Florida”

• Used before Clinical Trial Used before Clinical Trial Agreements orAgreements or

• Intellectual Property – with Intellectual Property – with potential companiespotential companies

Clinical Trial AgreementsClinical Trial Agreements

With Pam Tazik, Office of Research

• • TransmittalTransmittal

• • Publication Publication

• • Remedies Remedies

• • ConfidentialityConfidentiality

• • Indemnity/Insurance/Tort ClaimsIndemnity/Insurance/Tort Claims

• • Change in Principal InvestigatorChange in Principal Investigator

• • Ownership of DataOwnership of Data

• • Intellectual PropertyIntellectual Property

• • HIPAA LanguageHIPAA Language

• • Choice of LawChoice of Law

HIPAA

Personal Health Information (PHI)Clinical Trial Agreement Standard LanguageBusiness Associate Agreement

Health Insurance Portability and Accountability Act

Clinical Trial AgreementsClinical Trial Agreements

PRIVACY LAWS: The parties agree that all use and disclosure of patient/participant health and medical information is subject to compliance with applicable state and federal privacy laws. The parties, therefore, agree to take all necessary steps to protect the confidentiality of any patient/participant health and medical information that it has access to and comply with applicable state and federal privacy laws. The obligations set forth in this Section shall survive the termination or expiration of this Agreement.

Tort Claims LanguageTort Claims Language

As the University of Mississippi Medical Center is a state-supported educational entity, any liability claims will be handled under the Mississippi Tort Claims Act, M.C.A. Sections 11-46-1 et seq., subject to the Act’s limitations.

• • TransmittalTransmittal

• • Form ContractForm Contract

• • Conflicts FormConflicts Form

• • IHL Board MembersIHL Board Members

• • Employee ConflictsEmployee Conflicts

• • Previous ContractsPrevious Contracts

• • UMMC AddendumUMMC Addendum

• • Contract Employee/Independent Contractor Contract Employee/Independent Contractor Determination WorksheetDetermination Worksheet

Miss. State Department of Health Miss. State Department of Health (MSDH)(MSDH)

•Go to the Intranet home page

•Mouse over Academic Programs

•Then select Office of Research

• Next choose Forms & then• UMC Forms

•Choose Conflict of Interest form

• Click Open

• The Conflict of Interest form should open in the window

SubcontractsSubcontracts Contact Information Budget Figures (Direct/Indirect Costs) Time Period Attachments

Notice of AwardBudgetsSpecific Scope of Work

Issues with Multiple Sites

Independent Independent Contractor/Consultant Contractor/Consultant AgreementsAgreements

1. Form Agreement2. Resume3. W-94. Scope of Work5. Defined Basis for Pay

MUST MEET THE IRS TEST

Top 10 Things to Remember Top 10 Things to Remember About Legal Documents About Legal Documents for the Office of Researchfor the Office of Research

1. Complete Contact Information for you:Name, Address, E-mail, Phone, Fax, Helper

3. Complete Contact Information for the Other Party:

- If you are contracting with another institution, the person you’re dealing with may be your scientific contact.

- Usually there is another business or contract or Office of Sponsored Research contact.

3. Time: Review of Agreements takes time. Please allow a minimum of a week for Legal and Compliance Review.

2. Name of Contracting Entity: University of Mississippi Medical Center

4. Keep a copy for your file.5. If you bring or receive two originals of an

Agreement to bring to us for review, make an extra copy for us.

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7. After routing, review and signature of two originals, we will be glad to send the two originals to the other party for review and return if we have the complete address for the other party.

8. Once the signed original comes back to our office, we will send it to you by campus mail or leave it in the pick-up box for pick-up. (Don’t delay in pick-up).

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Multiple Sites: If you know your research is going to take place at 2 or more sites, please start earlier and get a form subcontract or agreement approved. It is up to you to keep a complete contact list for each site.

10. REMEMBER: Don’t wait until the last minute. Sometimes emergencies arise, but proper planning will help avoid them.

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