MDEs_STAR Draft_Attachment 08

ATTACHMENT 8

Data Sharing Agreement Form

Appendix 2, IRB Protocol 1976

Revised 6/6/2005

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 involves 68 cooperative agreement grantees including all
50 state health departments and 13 tribal organizations and 4 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.
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.

Appendix 2, IRB Protocol 1976

Revised 6/6/2005

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 co-author
on a publication, CDC publication clearance is required.

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.

Appendix 2, IRB Protocol 1976

Revised 6/6/2005

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 a fine up to $10,000 or up to five years in prison.
Please return this signed form and the 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

Appendix 2, IRB Protocol 1976

Revised 6/6/2005

PROJECT SUMMARY
NBCCEDP MDE SECONDARY ANALYSIS
External Investigator (or Investigator in CDC funded agreement)
(Please limit summary to 2-3 pages)
1. Project Title:
2. Protocol Summary:

3. Principal Investigator Information: (Name, Institution, Address, Telephone/Fax Number,
E-mail Address)

4. Other Investigators Involved: (Name, Institution, Address, Telephone/Fax Number, E-mail

Address)

5. DCPC Collaborator: (Name and Telephone Number)

6. Data Requested: (Please specify the time period for data requested, and data variables. A

listing of data variables potentially available to external investigators is attached.)

7. Purpose of Study: (Proposed Objective, Research Questions)

8. Intended/Potential Use of Study Findings:

9. Study Design:

10. Procedures and Methods to Safeguard Data and Assure Confidentiality:

11. Procedures and Methods for Handling of Unexpected or Adverse Events:
12. Procedures for Destruction of Dataset at Study Completion:

Appendix 2, IRB Protocol 1976

Revised 6/6/2005

13. Procedures and Methods for the Dissemination, Notification and Reporting of Results

14. Anticipated Date for Project Initiation:
15. Projected Date for Completion of Data Analysis:

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

Appendix 2, IRB Protocol 1976

Revised 6/6/2005

PROJECT SUMMARY
NBCCEDP MDE SECONDARY ANALYSIS
Internal CDC Investigator
(Please limit summary to 2-3 pages)
1. Project Title:
2. Protocol Summary:

3. DCPC Principal Investigator:
4. Other Investigators/Collaborators:
5. Purpose of Study: (Proposed Objective, Research Questions)

6. Intended/Potential Use of Study Findings:

7. Study Design:

8. Procedures and Methods for the Dissemination, Notification and Reporting of Results

9. Anticipated Date for Project Initiation:
10. Projected Date for Completion of Data Analysis: