AGREEMENT BETWEEN
applicant
AND
CANCER DATA REGISTRY OF IDAHO
applicant
AND
CANCER DATA REGISTRY OF IDAHO
PURPOSE OF AGREEMENT
The Cancer Data Registry of Idaho (CDRI) is a population-based cancer registry that collects
incidence and survival data on all cancer patients who reside in the state of Idaho or who are
diagnosed and/or treated for cancer in the state of Idaho.
This document serves as an agreement between CDRI and applicant. The purpose of this
agreement is to secure the confidential exchange of data from CDRI to applicant to be used in a
composite database for research, statistical or public health purposes as permitted by Idaho
Department of Health and Welfare Rules and Regulations, Title 5, Chapter 1, "Rules Governing the
Protection and Disclosure of Department Records," and §57-1706 of Idaho Code.
In the event that information which may identify patients or report sources is needed for research,
statistical or public health purposes, the following policies will be practiced.
POLICIES ON DATA DISCLOSURE
REQUEST FOR CONFIDENTIAL DATA
Investigators seeking approval to access confidential data from CDRI must submit their proposal in
writing using the form contained herein. Comprehensive research protocols should be attached.
Applications will be reviewed and evaluated by the Cancer Analysis Work Group (CAWG), which
consists of individuals from the Division of Health, Idaho Department of Health and Welfare, and
the Cancer Data Registry of Idaho, Idaho Hospital Association.
REQUEST FOR HOSPITAL SPECIFIC INFORMATION
Researchers requesting data containing hospital identifiers must contact CDRI directly for the
information. The data will be released only upon written approval by the source hospital(s) stating
that the facility agrees to participate in the study. All research protocols and a copy of the proposal
will be sent to the facility's administrator and/or institutional review board for approval.
PATIENT CONTACT
Researchers proposing to make contact with patients or family members of patients must contact
CDRI directly, not the patients or family members. CDRI will contact physicians to identify patients
who should not be contacted. CDRI will assume passive approval by physicians who do not
respond by a specific date. In some cases, CDRI may contact the patient directly for his/her
permission to participate in a proposed project.
CONDITIONS OF AGREEMENT
This agreement prohibits the following:
1.
The use of data for other than the stated purposes.
2.
Disclosure by applicant to any party or organization other than those listed within this
agreement unless otherwise authorized.
3.
The release of death certificate information without prior approval from the Idaho Bureau of
Vital Records and Health Statistics.
4.
The transfer of confidential data via the Internet, unless there is a plan for data encryption.
This agreement requires the following:
1.
Destruction of data (and copies) after the stated purposes have been fulfilled.
2.
Recipients of CDRI data accept all liability and legal expenses which may accrue to CDRI
resulting from an unauthorized re-disclosure of confidential data by the investigator or
associated staff.
3.
A violation of the signed confidentiality pledge will result in a material breach of contract and
can result in appropriate disciplinary actions, civil damages, and criminal prosecution under
Idaho laws.
4.
Any changes in proposed methodology as described in this agreement require a written
request for amendment and CDRI authorization.
5.
All manuscripts for publication that make reference to CDRI, or use CDRI data, will be
subject to review by CDRI and the Cancer Analysis Work Group. CDRI shall be provided
courtesy copies of all final publications.
6.
Signed confidentiality pledges from persons having access to CDRI data as specified within
this contract, and other approved projects, will be sent to CDRI prior to release of data by
CDRI.
7.
Requests for data linkage projects are usually carried out by CDRI staff. However, if a
researcher obtains permission from CDRI to conduct a linkage project, records from CDRI
that do not link with the secondary database will be discarded immediately and will not be
available for use. Special permission can be obtained from CDRI to retain unlinked data
that has been de-identified. Researchers are required to report the number and percentage
of cases that were linked, and return to CDRI a signed statement verifying that unlinked
cases were discarded and/or de-identified, using the form contained herein. Case data are
considered de-identified when the following variables have been stripped from the case: full
name, zip code, county code, Social security number, birth day, birth month.
8.
Compliance with applicant's internal policies as specified in item F of this application.
9.
CDRI’s checklist of requirements shall be attached to all proposals submitted to CDRI.
PROVISION FOR TERMINATION OF AGREEMENT
If at any time CDRI wishes to discontinue participation as a data contributor, this agreement can be
terminated without liability.
CANCER DATA REGISTRY OF IDAHO
CHECKLIST
This form must be completed and submitted with each proposal to use data from the Cancer Data
Registry of Idaho (CDRI). This is to assure that pertinent information has been addressed and
included with the proposal.
Type of proposal submitted:
1) New
2) Amended
3) Annual review
YES
1.
Has the project received IRB approval?
If so, please attach to proposal.
2.
Has a copy of CDRI’s policies regarding
patient contact been given to the principal
investigator?
3.
If invasive testing is planned, a
sample patient consent form should be attached.
4.
Attached are signed confidentiality pledges, as
required on page 4 of the agreement between
CDRI and applicant.
5.
If data linkage with a secondary database is
proposed, a plan for data security is
attached.
6.
If patient-identifying data are transmitted via
Internet, a plan for data encryption is
attached.
NO
NOT
Applicable
APPLICATION TO ACCESS CONFIDENTIAL DATA
A.
Name of researcher responsible for conducting the study:
B.
Affiliation:
C.
Specific data items requested and desired format:
D.
Purpose and intent of requested data. List all uses of the CDRI data:
E.
List all persons who will have access to the data and their positions. Principal investigator is
required to sign CDRI's confidentiality pledge and is responsible for assuring that all
persons listed below are aware of the conditions of agreement. Persons not listed below
will not be authorized to access confidential data.
F.
Describe policies and procedures that will be used to protect confidentiality of data once
released to your possession.
G.
Describe the methodology of the research including plans to conduct follow-backs and
direct contact with patients and/or family members, physicians, and hospitals. Attach
research protocols, if any.
CANCER DATA REGISTRY OF IDAHO
CONFIDENTIALITY PLEDGE
The contract signatory for applicant and all persons having access to the CDRI data must agree
with and affix their signature to the following:
As a condition for my access to confidential CDRI data, I agree to uphold the confidentiality of the
data in accordance with the following requirements:
1.
I will avoid any action that will provide confidential information to unauthorized individuals or
agencies.
2.
I will not make copies of or view any CDRI records or files to which I do not have specific
authorization.
3.
All confidential data to which I have access will be maintained in a safe manner which
restricts unauthorized individuals from access.
4.
I will not discuss information that might lead to identification of individuals described in
CDRI’s files with any unauthorized person.
5.
I will limit my use of confidential CDRI data to the purposes for which I have been
specifically authorized.
6.
I will not give my password(s) or file access codes to any unauthorized person, and upon
termination of the project will arrange for appropriate disposition of all confidential data in
my possession.
7.
If I become aware of unauthorized access to, or divulgence of confidential CDRI data by
someone else, I will report it immediately to the Cancer Data Registry of Idaho Vice
President, Operations and Registry Services. I understand that failure to report violations of
confidentiality by others is just as serious as my own violation and may subject me to legal
prosecution.
I understand that if I fail to keep my pledge of confidentiality I will be denied access to the CDRI
data and I may be subject to legal penalties.
I hereby swear or affirm to comply with CDRI policies for data disclosure, the delineated conditions
of this agreement, the provision for termination of this agreement, and the assertions within the
application completed by applicant. I will effectively communicate all provisions of the agreement
between CDRI and applicant to all persons who have access to CDRI data. I will assure that all
persons at applicant having access to CDRI data, as well as researchers using the database, will
sign confidentiality pledges.
Signature
Date
FOR OFFICE USE:
Response to requesting party:
Application for requested data was:
accepted
denied
Reason for denial:
Comments:
Vice President, Operations and Registry Services
Date