REQUEST TO TRANSFER DATA OR MATERIALS

Use this form if you want to transfer data and/or materials from Marshfield Clinic to an external organization or scientist. Please complete this form thoroughly and provide detailed responses. ORIP will use the information to review existing agreements, determine if additional human subject or privacy protection measures are necessary, and draft necessary agreements. Do not transfer any data or materials until ORIP notifies you that transfer can occur. If you want to receive data and/or materials from an external organization or scientist, please contact ORIP directly to discuss the proposed transfer.

Date:

MC Principal Investigator Requesting Transfer:

Routing Location:	Phone:

Email:

Title of Related Study:

Recipient Organization:

Anticipated date of transfer:

SP Code:

Fiscal No: (If applicable)

To whom is data and/or materials being transferred?

Public academic or research institution

Private academic or research institution

Government agency

Non-profit organization

Other ( Contact ORIP- Ext: 7-5858 to discuss)

For what purpose?

Research or Education

Other ( Contact ORIP- ext: 7-5858 to discuss)

Is the Recipient planning to Transfer the Data and/or Materials to any third party?

No

Yes ( Contact ORIP- ext: 7-5858 to discuss)

What is being transferred? (Check ALL that apply):

DATA – Check the type, and complete the sections referenced.

Aggregate – No individual subject level data; no direct or indirect identifiers (see chart below). ( No agreement or review by ORIP necessary if 2.a. above is checked. If 2.b. is checked, contact ORIP – ext. 7-5858 to discuss)

Coded Data with no Direct or Indirect Identifiers – See chart below. Complete this section and Section A.

Data with Indirect Identifiers, but no Direct Identifiers – See chart below. Complete this section and Section B.

Data with Direct Identifiers – See chart below. Complete this section and Section C.

MATERIAL - Complete this section and Section D.

** If Material will be labeled with, or accompanied by a direct or indirect identifier (see chart below), complete the appropriate data section above in addition to the Material Section.

Direct Identifiers	Indirect Identifiers
Name

Postal address

Phone number

Fax number

Email

Social security number

Health plan numbers

Account numbers

Certificate/license number/vehicle identifiers & serial numbers, including license plate numbers

Device identifiers and serial number

A unique identifying number, characteristic or code (Note: a code is not considered an identifier if it is not derived from or related to information about the individual and is not otherwise capable of being translated so as to identify the individual)

URL

IP address numbers

Biometric identifiers, including finger and voice prints

Full face photographic images and any comparable images	Town or city

State

County

Precinct

Zip code

All elements of dates (except year) directly related to the individual; and all ages over 89 and all elements of dates (including year) indicative of such age; may aggregate over 90 into single category

Submit completed paperwork to Office of Research Integrity & Protections - 1R4.

SECTION A

Transfer of Coded Data – No Direct or Indirect Identifiers

A Letter of Agreement1 will typically be initiated by ORIP with the proposed recipient after the following issues are addressed:

Need for IRB approval of data transfer (check one section):

The research study involving the data proposed to be transferred has been approved by the IRB and (check only one box):

The proposed transfer was disclosed in the documentation submitted to, and approved by,	the IRB. Attached is the documentation reviewed by the IRB discussing the transfer (which

can include the relevant sections of the IRB application and/or protocol), along with the IRB

approval letter. OR

The proposed transfer was not disclosed or discussed in the documentation submitted to, and approved by, the IRB ( Submit an amendment for IRB review).

The research study involving the data proposed to be transferred is pending IRB approval and:

No approval letter has been received ( Wait until you receive IRB approval before submitting this form with the documentation required in 1.a.i. above).

IRB review and approval of the proposed transfer is not required (all must be checked):

Marshfield Clinic staff will not be involved in the research study involving the data proposed to be shared AND

The data was not collected specifically for the currently proposed research project (ex. data collected for clinical purposes, or for another research project) AND

Marshfield Clinic staff will not provide identifiable data to the proposed recipient, nor a key to coded data.

Transfer Information

Recipient Organization (Legal name as it will appear on the Agreement):

Recipient Organization Address:

Recipient Scientist Name (First and Last, Degree(s)) and Title:

Recipient Scientist Email:

Recipient Scientist Address (if different):

Recipient Organization contact, if different than Recipient Scientist:

Name: (First and Last, Degree(s))

Email, Phone, and Address (if different than above):

MCRF staff member to contact with questions about this request:

SP Code(s) of study(ies) under which the data was collected (Please review consent form to ensure any restrictions/commitments are honored):

Detail below or attach a list of all data elements to be transferred. Contact BIRC for assistance if necessary.

Do you have knowledge that any person or entity receiving or viewing the data identified could use the data alone, or in combination with other information, to identify an individual who is the subject of the information?

No Yes.

Is the transfer of sharing to any non-U.S. individual (not a U.S. Citizen or National, Lawful Permanent Resident, Person Granted Asylum or Refugee Status, or Legal Temporary Resident)?

No Yes. Explain:

Indicate the legally binding written agreement(s) that authorize or define the research activity related to this proposed transfer 2:
Government grant/contract/cooperative agreement. Name of the granting entity:

Foundation or Association award. Name of the granting entity:

Industry Cooperative Research and Development Agreement (CRADA).Name of sponsor:

Other. Identify:

None.

** If you believe this agreement covers the transfer of the data, attach a copy of the relevant sections.

List other agreements between MCRF and the proposed recipient that are related to this proposed transfer (e.g. sub agreement, purchased service agreement, etc.) 2:

** If you believe this agreement covers the transfer of the data, attach a copy of the relevant sections.

Did the research study from which the data was generated or collected involve any of the following:
Licensing Agreement

Data or Material Transfer Agreement(s) with Third Parties

Collaborative Research and Development Agreement (CRADA)

N/A

Approximate number of subjects whose data is included in the data set being transferred:

What is the primary intended use of the data by the Recipient Organization and/or Recipient Scientist?

Was the data collected as part of the Marshfield Clinic Personalized Medicine Research Project (“PMRP”) or during a research study that utilized PMRP data or materials?
No Yes

Assistance to prepare and transfer the data, and related costs:

Do you need assistance to prepare and transfer the data?

No Yes. Specify which group’s assistance is needed:

BIRC (Biostatistics, Research Data & Analytics, ICR, PMRP Data)

Other – Note the Office or Center and contact the Office/Center Manager

b.	Describe the assistance needed. (Send a copy of this form to the contact listed above for a cost estimate. Investigator is responsible for this step.)

How will data be provided to recipient?

Via collaboration server. List the names and email addresses of all individuals accessing the collaboration server to receive data:

Via encrypted email. List the email addresses of all individuals to receive data:

Other (explain):

Approval Signature of Party Providing Assistance

Approval email is attached in lieu of signature.

Who will pay for the preparation and transfer costs?
Bill to transferee. (Send a copy of this completed form to Sponsored Programs, 1R3 for budget)

Scientist transferring data:

Fiscal account number:

Descriptive Title:

No cost (Please explain):

Center Administrator or Office Director Approval of Transfer

Center Administrator / Office Director Signature

Approval email is attached in lieu of signature.

Certification by Responsible Marshfield Clinic Investigator/Staff Member

I, ______________________________ (print name) as the individual responsible for the security of the data

(usually the principal investigator), approve of the proposed transfer. I do not believe the data could be used alone or in combination with other publicly available information to identify individuals who are subjects of this information.

____________________________________	_____________________

Signature	Date

1A MTA will be initiated in addition to a Letter of Agreement if both data and material are being shared.

2Existing agreements or grant/contract awards may include provisions eliminating the need for a separate agreement. If you feel this may be relevant to your situation, attach the relevant portions of the agreement for ORIP evaluation. In addition, HIPAA Privacy Rule’s provision allowing disclosure of data to public health authorities for specific purposes (see 45 CFR 164.512(b)(i)) may eliminate the need for an agreement.

Submit completed paperwork to Office of Research Integrity & Protections - 1R4.

SECTION B

Transfer of Data with Indirect but no Direct Identifiers

A Data Use Agreement1 with the proposed recipient will typically be initiated by ORIP after the following is addressed:

Need for IRB approval of data transfer (Check only one box)

a.	The research study involving the data proposed to be transferred has been approved by the IRB and (check only one box):

i.	The proposed transfer was disclosed in the documentation submitted to, and approved by,	the	IRB. Attached is the documentation reviewed by the IRB discussing the transfer (which can

include the relevant sections of the IRB application and/or protocol), along with the IRB approval letter. OR

The proposed transfer was not disclosed or discussed in the documentation submitted to, and

approved by, the IRB ( Submit an amendment for IRB review).

b.	The research study involving the data proposed to be transferred is pending IRB approval and:

No approval letter has been received ( Wait until you receive IRB approval before	submitting this form with the documentation required in 1.a. above).

HIPAA Privacy Rule Requirements Satisfied (Check only one box):

HIPAA authorization under which data was collected allows for disclosure of identifiers to the proposed recipient (Attach the authorization and highlight relevant areas); or

The IRB has approved a waiver of the requirement to obtain authorization for this transfer; OR

The use or disclosure of PHI is for a review preparatory to research or for research on decedents, and the form “HIPAA Researcher Representation – Use of PHI in Reviews Preparatory to Research or for Research on Decedents” is completed and attached (Attach the completed form).

Transfer Information

Recipient Organization (Legal name as it will appear on the Agreement):

Recipient Organization Address:

Recipient Scientist Name (First and Last, Degree(s)) and Title:

Recipient Scientist Email:

Recipient Scientist Address (if different):

Recipient Organization contact, if different than Recipient Scientist:

Name: (First and Last, Degree(s))

Email, Phone, Address (if different from above):

MCRF staff member to contact with questions about this request:

SP Code(s) of study(ies) from which the data was collected (Please review consent form to ensure any restrictions/commitments are honored):

Detail below or attach a list of all data elements to be transferred. Contact BIRC for assistance if necessary.

Approximate number of subjects whose Protected Health Information is included in the data set being transferred:

What is the primary intended use of the data by the Recipient Organization and/or Recipient Scientist?

List the individuals or class of individuals at the Recipient Organization, other than the Recipient Scientist, who need access to the data in performance of the Research Activities. (If choosing to list specific individuals, include full name and relevant degrees):

Is the transfer of sharing to any non-U.S. individual (not a U.S. Citizen or National, Lawful Permanent Resident, Person Granted Asylum or Refugee Status, or Legal Temporary Resident)?

No Yes. Explain:

Indicate the legally binding written agreement(s) that authorize or define the research activity related to this proposed transfer 2:
Government grant/contract/cooperative agreement. Name of the granting entity:
Foundation or Association award. Name of the granting entity:

Industry Cooperative Research and Development Agreement (CRADA).Name of sponsor:

Other. Identify:

None.

* * If you believe this agreement covers the transfer of the data, attach a copy of the relevant sections.

List other agreements between MCRF and the proposed recipient that are related to this proposed transfer (e.g. sub agreement, purchased service agreement, etc.) 2:

* * If you believe this agreement covers the transfer of the data, attach a copy of the relevant sections.

Did the research study from which the data was generated or collected involve any of the following:

Licensing Agreement

Data or Material Transfer Agreement(s) with Third Parties

Collaborative Research and Development Agreement (CRADA)

N/A

Was the data collected as part of the Marshfield Clinic Personalized Medicine Research Project (“PMRP”) or during a research study that utilized PMRP data or materials?

No Yes

Assistance to prepare and transfer the data, and related costs:

Do you need assistance to prepare and transfer the data?

No Yes. Specify which group’s assistance is needed:

BIRC (Biostatistics, Research Data & Analytics, ICR, PMRP Data)

Other – Note the Office or Center and contact the Office/Center Manager

Describe the assistance needed. (Send a copy of this form to the contact listed above for a cost estimate. Investigator is responsible for this step.)

How will data be provided to recipient?

Via collaboration server. List the names and email addresses of all individuals accessing the collaboration server to receive data:

Via encrypted email. List the email addresses of all individuals to receive data:

Other (explain):

Approval Signature of Party Providing Assistance

Approval email is attached in lieu of signature.

d.	Who will pay for the preparation and transfer costs?
Bill to transferee. (Send a copy of this completed form to Sponsored Programs, 1R3 for

budget)

Scientist transferring data:

Fiscal account number:

Descriptive Title:

No cost (Please explain):

4.	Center Administrator or Office Director Approval of Transfer

Center Administrator / Office Director Signature

Approval email is attached in lieu of signature.

Certification by Responsible Marshfield Clinic Investigator/Staff Member

I, ____________________________ (print name) as the individual responsible for the security of the data (usually the principal investigator), approve of the proposed transfer and certify that only the minimum necessary protected health information is being proposed for transfer.

___________________________________________	_____________________

Signature	Date

1A Material Transfer Agreement and a Data Use Agreement may be needed if both data and material are being shared.

2 Existing agreements or grant/contract awards may include provisions that would eliminate the need for a separate agreement. If you feel this may be relevant to your situation, attach the portion of existing agreement for ORIP evaluation. In addition, the Privacy Rule’s provision allowing disclosure of data to public health authorities for specific purposes (see 45 CFR 164.512(b)(i)) may eliminate the need for an agreement.

Submit completed paperwork to Office of Research Integrity & Protections, 1R4.

SECTION C

Transfer of Data with Direct Identifiers

If the requirements for transferring data with direct identifiers are met, ORIP will coordinate the development of a custom agreement in coordination with Legal Services.

Need for IRB approval of data transfer (Check only one box)

The research study involving the data proposed to be transferred has been approved by the IRB and (check only one box):

The proposed transfer was disclosed in the documentation submitted to, and approved by,	the IRB. Attached is that section of that documentation reviewed by the IRB (which can

include the relevant sections of the IRB application and/or protocol), along with the IRB

approval letter. OR

The proposed transfer was not disclosed in the documentation submitted to, and approved by, the IRB ( Submit an amendment for IRB review)

The research study involving the data proposed to be transferred is pending IRB approval and:

No approval letter has been received from the IRB ( Do not submit this form until IRB

approval is issued. Submit it with the documentation required in 1.a. above)

HIPAA Privacy Rule Requirements Satisfied (Check only one box):

HIPAA authorization under which data was collected allows for disclosure of specific direct identifiers

to the proposed recipient (Attach the authorization and highlight relevant areas); or

The IRB has approved a waiver of the requirement to obtain authorization for this transfer; OR

The use or disclosure of PHI is for a review preparatory to research or for research on decedents,

and the form “HIPAA Researcher Representation – Use of PHI in Reviews Preparatory to Research

or for Research on Decedents” is completed and attached (Attach the completed form).

Transfer Information

Recipient Organization (Legal name as it will appear on the Agreement):

Recipient Organization Address:

Recipient Scientist Name (First and Last, Degree(s)) and Title:

Recipient Scientist Email:

Recipient Scientist Address (if different):

Recipient Organization contact, if different than Recipient Scientist:

Name: (First and Last, Degree(s))

Email, Phone, Address (if different from above):

MCRF staff member to contact with questions about this request:

SP Code(s) of study(ies) under which the data was collected (Please review consent form to ensure any restrictions/commitments are honored):

Detail below or provide a detailed list of all data elements to be transferred. Contact BIRC for assistance if necessary.

Is the transfer of sharing to any non-U.S. individual (not a U.S. Citizen or National, Lawful Permanent Resident, Person Granted Asylum or Refugee Status, or Legal Temporary Resident)?

No Yes. Explain:

Indicate the legally binding written agreement(s) that authorize or define the research activity related to this proposed transfer 2:
Government grant/contract/cooperative agreement. Name of the granting entity:

Foundation or Association award. Name of the granting entity:

Industry Cooperative Research and Development Agreement (CRADA).Name of sponsor:

Other. Identify:

None.

* * If you believe this agreement covers the transfer of the data, attach a copy of the relevant sections.

List other agreements between MCRF and the proposed recipient that are related to this proposed transfer (e.g. sub agreement, purchased service agreement, etc.) 2:

* * If you believe this agreement covers the transfer of the data, attach a copy of the relevant sections.

Indicate the legally binding written agreement(s) that authorize or define the research activity related to this proposed transfer:
Government grant/contract/cooperative agreement. Name of the granting entity:

Foundation or Association award. Name of the granting entity:

Industry Cooperative Research and Development Agreement (CRADA). Name of sponsor:

Other. Identify:

None.

List other agreements between MCRF and the proposed recipient that are related to this proposed transfer (e.g., sub agreement, purchased service agreement, etc.):

Did the research study from which the data was generated or collected involve any of the following:
Licensing Agreement

Data or Material Transfer Agreement(s) with Third Parties

Collaborative Research and Development Agreement (CRADA)

N/A

Approximate number of subjects whose information is included in the data set being transferred:

What is the primary intended use of the data by the Recipient Organization and/or Recipient Scientist?

List the individuals or class of individuals at the Recipient Organization, other than the Recipient Scientist, who need access to the data in performance of the Research Activities. If choosing to list specific individuals, include full name and relevant degrees:

Was the data collected as part of the Marshfield Clinic Personalized Medicine Research Project (“PMRP”) or during a research study that utilized PMRP data or materials?
No Yes

Does the Recipient Organization plan to use the data in the future for purposes other than the currently proposed research?

No Yes. (If “Yes,” explain planned future use):

Assistance to prepare and transfer the data, and related costs:

Do you need assistance to prepare and transfer the data?

No

Yes. Specify which group’s assistance is needed:

BIRC (Biostatistics, Research Data & Analytics, ICR, PMRP Data)

Other – Note the Office or Center and contact the Office/Center Manager

Describe the assistance needed. (Send a copy of this form to the contact listed above for a cost estimate. Investigator is responsible for this step.)

How will data be provided to recipient?

Via collaboration server. List the names and email addresses of all individuals accessing the collaboration server to receive data:

Via encrypted email. List the email addresses of all individuals to receive data:

Other (explain):

Approval Signature of Party Providing Assistance

Approval email is attached in lieu of signature.

Who will pay for the preparation and transfer costs?
Bill to transferee. (Send copy of this form to Sponsored Programs, 1R3 for a budget) Scientist transferring data:

Fiscal account number:

Descriptive Title:

No cost (Please explain):

Center Administrator or Office Director Approval of Transfer

Center Administrator / Office Director Signature

Approval email is attached in lieu of signature.

Required Attachment:

Recipient Organization IRB Approval Letter for the Recipient Scientist’s research activity or study for which the transferred data will be used.

Certification by Responsible Marshfield Clinic Investigator/Staff Member

I, ____________________________(print name) as the individual responsible for the security of the data (usually the principal investigator), approve of the proposed transfer of direct identifiers and certify that only the minimum necessary protected health information is being proposed for transfer.

___________________________________________	_____________________

Signature	Date

Submit completed paperwork to Office of Research Integrity & Protections - 1R4.

SECTION D

Transfer of Biological Material

A Material Transfer Agreement with the proposed recipient will be initiated by ORIP1 after the following issues are addressed:

Need for IRB approval of material transfer (Check only one box).

The research study involving the material proposed to be transferred has been approved by the IRB and (check only one box):

The proposed transfer was disclosed in the documentation submitted to, and approved by,

the IRB. Attached is the documentation reviewed by the IRB discussing the transfer (which

can include the relevant sections of the IRB application and/or protocol), along with the IRB approval letter. OR

The proposed transfer was not disclosed or discussed in the documentation submitted to

and approved by, the IRB ( Submit an amendment for IRB review).

The research study involving the material proposed to be transferred is pending IRB approval and:

No approval letter has been received ( Wait until you receive IRB approval before	submitting this form with the documentation required in 1.a. above).

Activity does not require IRB review:

Marshfield Clinic staff will not be involved in the research study involving the material

proposed to be shared AND

The material to be transferred is not labeled with information that could enable the

identification of a living individual, and does not include a code that could be linked to data that could enable the identification of a living individual.

Transfer Information

Recipient Organization (Legal name as it will appear on the Agreement):

Recipient Organization Address:

Recipient Scientist Name (First and Last, Degree(s)) and Title:

Recipient Scientist Email:

Recipient Scientist Address (if different):

Recipient Organization contact, if different than Recipient Scientist:

Name: (First and Last, Degree(s))

Email:

Phone:

Address (if different than above):

MCRF staff member to contact with questions about this request:

SP Code(s) of Study(ies) from which the Material was collected, or if not collected under a study, an explanation of how the material was obtained:

Describe the Material to be transferred. If assistance by others is needed to prepare and ship the material, be very specific about the material, including the amount of each sample:

Approximate number of subjects whose material samples are being transferred:

Will you be charging the recipient a fee for preparing and shipping the material?
No Yes. Specify amount to be included in agreement:

Is the transfer of sharing to any non-U.S. individual (not a U.S. Citizen or National, Lawful Permanent Resident, Person Granted Asylum or Refugee Status, or Legal Temporary Resident)?

No Yes. Explain:

Was the Material collected as part of the Marshfield Clinic Personalized Medicine Research Project, or collected during a research study that utilized PMRP data or materials?
No
Yes.

If Yes, has the PMRP Oversight Committee approved the transfer and use of the material?

No Yes. If yes, attach documentation of approval.

What is the primary intended use of the material by the Recipient Organization and/or Recipient Scientist?

List the individuals or class of individuals at the Recipient Organization who need to access the material in performance of the Research Activities. If choosing to list specific individuals, include full name and relevant degrees.

Was the Material generated using, or from being combined with another material?

No Yes – If Yes, the other material (Check all that apply):

Was obtained from another organization. Identify organization:

Was received under a Material Transfer Agreement. Identify source:

Was obtained from a Marshfield Clinic colleague/lab. Identify source:

Was purchased from a commercial entity

Was brought from a previous institution. Identify source:

Indicate the legally binding written agreement(s) that authorize or define the research activity related to this proposed transfer:

Government grant/contract/collaborative agreement. Name of the granting entity:
Foundation or Association award. Name of the granting entity:

Industry Cooperative Research and Development Agreement (CRADA).

Name of sponsor:

Other. Identify:

None

* * If you believe this agreement covers the transfer of the data, attach a copy of the relevant sections.

If the Material was generated or collected as part of a research study, did that study involve any of the following?

Licensing Agreement. Identify parties to agreement:

Data or Material Transfer Agreement(s) with Third Parties

Collaborative Research and Development Agreement (CRADA)

* * If you believe this agreement covers the transfer of the data, attach a copy of the relevant sections.

Does the Recipient Organization or Scientist plan to use the Material in the future for purposes other than the currently proposed research?

No Yes (If Yes, explain future use):

Is the Recipient Organization or Scientist requesting to share the Material with others not under its/his/her direct supervision, either now or in the future?

No	Yes (If “Yes,” provide the name, title, email and address of these individuals, who will be added to the agreement as recipient scientists.)

CRADA

To determine whether a Collaborative Research and Development Agreement (CRADA) is necessary, information is needed regarding the involvement of Marshfield Clinic investigators in the research related to the material transfer. Indicate the nature of the providing investigator’s relationship with the recipient:

Non-collaborative (Serving only as a source of material)

Non-collaborative (Other). Explain:

Submission to a central repository:

Is the submission required by grant/contract terms or funding agency policy?

No

Yes (attach agreement or policy and highlight relevant sections)

Collaborative

i.	Describe the role of MC/MCRF researcher(s):

Is the Material being disclosed of a proprietary nature (i.e., potentially patentable or already patented)?

Discuss the likelihood of a novel discovery resulting form the collaboration:

Assistance needed to prepare and transfer the Material, and related costs:

Do you need assistance to prepare and transfer the material, and related costs?

No Yes. Specify which group’s assistance is needed:

PMRP Specimens – Contact Dr. Murray Brilliant
Integrated Research and Development Lab (IRDL) – Contact Dr. Jennifer Meece

Other – Note the Office or Center and contact the Office/Center Manager

Describe the assistance needed. (Send a copy of this form to the contact listed above for a cost estimate. Investigator is responsible.)

Approval Signature of Party Providing Assistance

c.	Who will pay for the preparation and transfer costs?

Bill to transferee (Send a copy of this completed form to Sponsored Programs, 1R3 for

budget development.)

Scientist transferring data:

Fiscal account number:

Descriptive Title:

No cost (please explain):

Center Administrator or Office Director approval of transfer

Center Administrator / Office Director Signature

Certification by Responsible Marshfield Clinic Investigator/Staff Member

I, ____________________________ (print name), as the individual responsible for the security of the material (usually the principal investigator), approve of the proposed transfer.

___________________________________________	_____________________

Signature	Date

1Existing agreements or grant/contract awards may include provisions that would eliminate the need for a separate agreement. If you feel this may be relevant to your situation, attach the existing agreement for ORIP evaluation.

Submit completed paperwork to Office of Research Integrity & Protections - 1R4.

Version – December 16, 2015

Request to Transfer Data or Materials	Page 6 of 6

Request to Transfer Data or Materials	Page 15 of 15

Baer, Patricia E

2016-07-13

Knecht, Justin E

Marshfield Clinic