Datasharing

ATTACHMENT 6
Data Sharing Agreement Form

Appendix 2. IRB Protocol 1976

Revised 3/21/2012

National Breast and Cervical Cancer Early Detection Program (NBCCEDP)
Minimum Data Elements (MDEs)
Data Sharing for Special Use Agreement
Background
The National Breast and Cervical Cancer Early Detection Program (NBCCEDP) is a
program of the Division of Cancer Prevention and Control (DCPC), NCCDPHP
established by the Breast and Cervical Cancer Mortality Prevention Act of 1990 (Public
Law 101-354). The purpose of the NBCCEDP is to reduce breast and cervical cancer
morbidity and mortality among low income, medically under-served women by providing
community based screening and diagnostic services. For women diagnosed with
cancer or pre-cancer, the NBCCEDP assures access to treatment services. The
NBCCEDP currently funds 68 cooperative agreement grantees in all 50 states, the
District of Columbia, 12 tribal organizations and 5 U.S. territories.
The NBCCEDP grantees collect surveillance data on women served through the
program. These data are submitted twice a year by all NBCCEDP grantees to CDC and
represent a minimum set of data collected by grantees on all women served through the
NBCCEDP. Called the Minimum Data Elements (MDEs), these are surveillance data
primarily used for program monitoring, quality assurance, and evaluation. Secondary
research analysis of data is conducted by scientists in DCPC and sometimes scientists
outside of CDC.
Policy Statement
This agreement is authorized through CDC IRB Protocol 1976, Collection and Analysis
of Minimum Data Elements Data Set from the National Breast and Cervical Cancer
Early Detection Program.
Results from the program are shared with the public through reports available on the
CDC website. The National Report is a comprehensive report on the first 12 years of
the program and reports incremental screening results and outcomes by age and race
at the national aggregate level. Also available through the public website is a limited
set of grantee-specific data, reported as a five-year aggregate, and includes volume and
demographic profiles of women screened through the program, screening results and
diagnostic outcomes.
Proposed research activities involving the use of MDE data through a Data Sharing for
Special Use Agreement are reviewed and approved through a DCPC interdisciplinary
team called the MDE Committee.
CDC does not release grantee-specific data to other grantees or in response to external
inquiries without the grantee’s permission, through either communication with
NBCCEDP Program Directors or through their Council.

NBCCEDP MDE Data Sharing for Special Use Agreement

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Appendix 2. IRB Protocol 1976

Revised 3/21/2012

The special use dataset will be generated from a subset of the NBCCEDP analysis
dataset used at CDC and will be provided in a format determined for each request.
Data may be restricted based on completeness, quality and applicability to requested
use, reasons of invading the privacy of the subject, or sensitivity of release. Data will
be stripped of all program, provider, patient and geographic indicators and may be
provided in aggregate form rather than service-level records.
Data Sharing for Special Use Agreement
There are specific laws that insure the confidentiality of individuals diagnosed with
cancer when information about their cancer is entered into a database for the purpose
of establishing a research resource. In utilizing data on such individuals for research
purposes, it is absolutely necessary to insure, to the extent possible, that uses of such
data will be limited to research. Uses for any other reason, particularly those resulting
in personal disclosure, will be prosecuted to the full extent of the law.
In order for the Division of Cancer Prevention and Control to provide a dataset to you for
secondary analysis, it is necessary that you agree to the following provisions.

I, ______________________________________, as principal investigator on this
proposed analysis of the NBCCEDP MDEs, agree to the following requirements for the
use of the data and assure compliance with the requirements.
1.

I will not use nor permit others to use the data in any way other than for statistical
reporting and analysis. I will not use nor permit others to use these data to
conduct analyses other than those described in the proposal which accompanies
this statement. I will not conduct analyses other than those specifically approved
by CDC.

2.

I will not present nor publish analyses that include any restricted uses of the data,
without written approval of CDC, including the following:
• Cell of less than five individuals/records
• Identification of a specific grantee or provider
• Aggregation of data at the grantee or provider level, or any geographic unit of
data.

3.

I will not release nor permit others to release the data in full or in part to any
person other than those listed as collaborators in the attached proposal, except
within the written approval of CDC.

4.

I will provide information on how the data will be stored and safeguarded from
unauthorized access.

5.

I will involve a DCPC collaborator in the project. If a DCPC collaborator is a coauthor on a publication, CDC publication clearance is required.

NBCCEDP MDE Data Sharing for Special Use Agreement

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Appendix 2. IRB Protocol 1976

Revised 3/21/2012

6.

I will not attempt nor permit others with access to the data to attempt to learn the
identity of any person or provider whose data are contained in the supplied
file(s). If the identity of a subject should be discovered inadvertently, then I will
make no use of this knowledge. I will inform the Division of Cancer Prevention
and Control of discovery so they can prevent future discoveries. I pledge that
neither I nor other members of my team will inform anyone else of the discovered
identity.

7.

When the proposed analyses are completed, I will assure that all copies of these
data are destroyed or returned to CDC and provide written confirmation that this
was completed.

8.

All written or oral presentations of the results of the analyses will include an
acknowledgement of the CDC as the original source of the data.

9.

As a courtesy, I agree to submit an abstract, expected date of publication, and
journal name for articles resulting from analysis of the data at least four weeks
prior to publication, and a copy of the article after publication.

10.

Other conditions or special circumstances, as specified:

Signed:_________________________________

Date:_____________________

My signature indicates my agreement to comply with these requirements and above
stated provisions. Deliberately making a false statement regarding any matter within
the jurisdiction of any department or agency of the Federal Government violates 18
USC 1001 and is punishable by fine or prison.
Please return this signed form, list of investigators and project summary to:
Janet Royalty, MS
Division of Cancer Prevention and Control
NCCDPHP, Centers for Disease Control and Prevention
4770 Buford Hwy, N.E., Mailstop K-57
Atlanta, GA 30341-3724
Phone: (770) 488-3085 Fax: (770) 488-3230

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Appendix 2. IRB Protocol 1976

Revised 3/21/2012

Project Investigators
* Investigators outside of CDC’s Division of Cancer Prevention and Control
(DCPC) are required to include a DCPC collaborator.

Primary Investigator

DCPC Collaborator*

Co-Investigator

Co-Investigator

Co-Investigator

Co-Investigator

Co-Investigator

Co-Investigator

Name
Email
Phone
Institution
Address
Name
Email
Phone
Institution
Address
Name
Email
Phone
Institution
Address
Name
Email
Phone
Institution
Address

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Appendix 2. IRB Protocol 1976

Revised 3/21/2012

Project Summary

1. Project Title:

2. Abstract:

3. Brief description of the project (Background, Study Questions, Methods):

4. Data Requested (Specify data elements and years of data. A listing of MDE data
elements available upon request). Years of data requested: ______________
Data Element Name

Proposed Use

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Appendix 2. IRB Protocol 1976

Revised 3/21/2012

5. Proposed Draft Table Shells (a generic example is provided)
Year of Pap
Age Group
18-44
45-64
65 and older

2000

2003

2005

2008

6. Intended/Potential Use of Study Findings:

7. Procedures/Methods for Dissemination, Notification and Reporting of Results

8. Procedures/Methods to Safeguard Data and Assure Confidentiality:

9. Procedures/Methods for Handling of Unexpected or Adverse Events:

10. Procedures for Destruction of Dataset at Study Completion:

11. Project start and end dates: Start ___________

End _____________

INVESTIGATORS SHOULD CONSULT WITH THEIR INSTITUTION ABOUT LOCAL
HUMAN SUBJECTS/IRB REQUIREMENTS. CDC RECOMMENDS THAT YOU
SUBMIT YOUR STUDY PROTOCOL FOR LOCAL IRB REVIEW.

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