- APPLICATION INFORMATION
- Access to RGE-controlled
data:
- All access to RGE-controlled data is project specific.
- Access to data may be requested for any and/or all
of the following purposes:
- statistical analysis, no individual identifiers
- data linkage, individual identifiers needed, no
contact planned
- subject identification and contact
- Continued access to RGE data requires annual review
and approval. Major changes in access require amendment
and re-review.
- Use of RGE data requires that any manuscript resulting
from a project using the data be reviewed by RGE prior
to publication.
- Levels of access within
the Utah Population Database (UPDB):
Within UPDB, three different levels of access are available:
- General Project Information. These
data include the individual's UPDB identification number,
demographic information and relationship information.
Not all information is available on all individuals.
All RGE-approved projects have access to all of General
Project Information for the duration of the project.
- Dataset-Specific Information. These
data are contributed to RGE by different data contributors
and include information specific to each file (e.g.,
cause of death, cancer status, birth complications,
etc.). Access to each must be justified through your
proposal. (Please note that each file contains many
variables. Your proposal should note which of those
variables are necessary for your project.) In addition,
the length of time the project needs access to the data
must be specified. Access will be terminated at that
time unless other arrangements have been made.
- Individually-Identifying Information. This
the most restricted level of access within UPDB. These
data include name, Social Security Number and address.
Not all information is available on all individuals.
Access to individually identifying information must
be specifically justified in your proposal.
Identifying information for any individual approved
will be provided either in writing or on disk. As with
dataset specific information, the length of time the
project needs access to the data must be specified.
Data must be returned at that time unless other arrangements
have been made. {NOTE: If you are providing
individually identified records to RGE for linkage to
UPDB, those links are considered part of this category.}
- Access Procedures:
- The form, Request for Approval of a NEW Project,
must be submitted to the RGE office (1C133 SOM, University
of Utah), along with a description of the study.
- Your access request should include a general description
of the study, with the balance describing your proposed
use of UPDB. Access to either Dataset Specific Information
or Individually Identifying Information must be specifically
requested and justified. The request for access to either/both
of these sets of information must include the time period
for which access is requested. Very strong justification
must be made for access to individual identifiers, such
as names, SSNs, etc. Please indicate why your project
could not reasonably be conducted without such access.
The period of time for access must be tied to your project
methodology. Keep it as short as is reasonably possible.
- Your description should answer the following questions:
- What are your procedures for data security? How
do you ensure that UPDB data are not accessible
by unauthorized users? If you plan to store any
UPDB data on any computer other than that maintained
by PPR, please list those computers and their operating
systems (e.g. Windows 95, NT, UNIX etc. Please identify
all individuals who have access to the computer(s)
where UPDB data are stored.
- What are your procedures for contacting individuals
(if applicable)?
- What data will you return to RGE (if applicable)?
- What is your plan for disposition of data at the
end of the project? (RGE requires that all UPDB
data be destroyed or reposited with RGE at the end
of the project.)
- Does this project have commercial funding? If
so, please describe the nature of the funding, what
data you will be providing to the funder and how
the confidentiality of UPDB data will be protected.
- The description should be five pages or less.
- Where applicable, a copy of the grant or contract
application should be attached also.
- PROCEDURES WHICH MEET
RGE REQUIREMENTS FOR USE AND PROTECTION OF DATA IN ITS OVERSIGHT
(These are examples of the kind of information about your
project that is required in your project description.)
- Procedures for database
access
- Studies where some subjects are already known to the
researcher and he/she wishes to know more about individuals
or the family.
- UPDB is searched for names of subjects already in
investigators research program. Searches (or linking)
are done by PPR staff.
- PPR staff will provide the investigator with UPDB
ID numbers for the subjects who linked to UPDB, and,
where relevant to the project, pedigree (relationship)
information for all identified relatives of those
subjects. {NOTE: This information is considered
level III information.}
- If the researcher has approval for access to names
other than those already known to the researcher,
PPR staff will use the UPDB ID numbers ascertained
above to provide names for those individuals who link
to the subjects provided by the researcher.
- Studies where investigators wish to identify people,
or groups of people, who meet certain research criteria.
- PPR staff will identify potential subjects (by ID
number) according to research criteria and provide
a file to the investigator.
- ID numbers may be used to analyze level II data,
without names.
- The investigator may determine that s/he wishes
to contact certain individuals identified through
the search. If so, names may be provided directly
to the investigator, if approved. Or, a third
party may contact potential subjects, determine those
who wish to know more about the project, and release
those names to the investigator. (In either case,
the protocol must be described in the study description
provided to RGE. See Section II. C.
below.)
- Procedures for assurance
of database security:
- All printouts of names are kept in locked filing cabinets
when not in use. Access to those filing cabinets is
limited to those individuals who are using them for
research.
- Disks with names are also kept in locked filing cabinets
when not in use. Alternately, disks of names from UPDB
may be returned to RGE/PPR after the information has
been analyzed and/or downloaded.
- Computer files should be accessible only by members
of the research group involved with each specific project.
(This can usually be done by your system administrator
if you are working on a departmental server.) All such
files should be password protected both at the system
and the file level. Identifying information will be
provided in writing, on disk, or by direct file transfer;
please do not email identifying information.
- Procedures for contacting
individuals:
- Studies where individuals to be contacted meet some
research criteria but are not previously known to the
investigator:
- Individuals identified through Utah Cancer Registry
or the Central Data Registry of Idaho must
be contacted through those agencies. Contact them
directly for their contact protocols.
- Unless a specific research request to do otherwise
is approved, all other individuals identified will
be contacted by RGE. A letter will be sent explaining
the reason for contact, identifying the study, and
inviting the potential subject to return a form indicating
her/his interest in knowing more about the study.
Only names of individuals who return the form indicating
an interest will be provided to the researcher.
- Studies where some members of the family are already
participating in the research:
- Names of family members identified solely through
family history records provided by the LDS Church
may not be provided to the researcher by RGE. The
relationship of those individuals to persons already
participating may be provided. Contact may only be
made through family members already consented into
the research.
- Permission to contact family members must be obtained
from subjects already participating in the research.
- Studies where patients meeting some research
criteria are to be recruited into a study based on results
of UPDB searches:
- Contact must be made by the potential subject's
physician or by the medical institution where the
potential subject was a patient.
- Data to be returned
to RGE (if applicable)
- When incorrect (or missing) information is identified
regarding an individual or family relationships, or
demographic information such as birth or death date,
and verifiable correct information is available to the
researcher, it will be provided to PPR staff.
- Projects may make arrangements to provide individual
datasets to RGE. These data may be maintained separately,
or incorporated into existing datasets if subjects
have given permission to do so.
- Disposition of data
at the end of the project.
- All disks/printouts containing individually identifying
information will be returned to RGE on an on-going basis
throughout the project (for archive or destruction);
or
- All disks/printouts containing individually identifying
information will be maintained by the research project
until the end of the project, at which time they will
all be returned to RGE for archive. If archiving is
not required, the data may be destroyed, either on site
or by RGE.
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