| The
OHSU Oregon Alzheimer’s Disease
Center (OADC) is one of 30
Alzheimer’s Disease Research
Centers (ADCs), funded by the
National Institutes of Health,
National Institute on Aging.
ADCs were established to translate
research advances into improved
diagnosis and care for Alzheimer’s
disease patients while, at
the same time, focusing on
the program’s long-term
goal—finding a way to
cure and possibly prevent AD.
ADCs provide several important
services: |
· Diagnosis
and medical management,
· Information about the disease, services, and
resources
· Opportunities to participate in drug trials
and clinical research projects,
· An accessible source of data for collaborative
research. |
|
| In
order to enact the last aspect
of our mission, we collaborate
extensively with OHSU investigators
and researchers at other institutions
to analyze and publish findings
of professional interest in
aging and dementia research.
Such collaboration facilitates
efficient and productive use
of the data, as well as rapid
development and dissemination
of knowledge. |
| This
protocol addendum formally
establishes the practice of
sharing data from the OADC
Database with other investigators
(within OHSU and from collaborating
institutions). |
| |
| 1)
OADC Database |
| a)
Includes data collected in
the course of OADC affiliated
activities, including (but
not limited to) the following: |
| |
i)
Clinical care of OADC patients |
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ii)
Alzheimer Disease Center Clinical
Core (Clinical Core, IRB project
2217-C) – subjects are
recruited from OADC clinic |
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iii)
The Oregon Brain Aging Study
(OBAS IRB#2560) |
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iv)
Community Brain Donor Program
(CBDP, IRB#4455) |
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v)
Preventing Cognitive Decline
with Alternative Therapies
(informally called the Dementia
Prevention Study or DPS, IRB#5356) |
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vi)
Klamath Exceptional Aging Project
(KEAP, IRB#5473) |
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vii)
African American Dementia and
Aging Project (AADAPt, IRB#5907) |
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viii)
Aging and Health in Native
Americans of the Confederated
Tribes of the Warm Springs
Reservation (IRB#4675) |
| b)
Includes the following types
of data: |
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i)
physical and neurological exam
findings |
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ii)
neurocognitive test scores |
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iii)
personal and family history |
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iv)
positive/negative family history
of dementia |
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v)
personal demographics |
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vi)
genotypes |
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vii)
age at service evaluations |
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viii)
age at onset, age at death |
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ix)
clinical diagnosis |
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x)
neuropathology diagnosis and
inventory information (when
available) |
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xi)
health status |
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xii)
medications |
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xiii)
laboratory tests |
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xiv)
MRI volumetrics |
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xv)
contact information required
to manage ongoing clinical
care and study operations |
| 2)
Principles of Data Use and
Disclosure |
| |
a)
The OADC is committed to protecting
patient and subject confidentiality
in compliance with OHSU and
HIPAA guidelines. Shared research
records will be identified
by a randomly assigned ID number
having no relationship to any
direct identifiers. Only the
OADC will maintain a code-breaking
list, which will be held in
confidence. Data will be shared
according to the minimum necessary
principle, where disclosures
will include only the data
necessary to accomplish the
aims of the project. |
| |
b)
One mission of the OADC is
to make its database available
to collaborative investigators
for the most effective use
of the data in an open but
secure environment. Limited
data sets will be shared within
the OHSU community, with researchers
outside of OHSU, and with the
National Alzheimer’s
Coordinating Center (NACC)
NIH/NIA U01 AG016976. The only
HIPAA defined identifier that
will be shared is date of birth/age.
[Note: limited data sets will
include date of birth or age
over 89.] |
| |
c)
The OADC will protect the integrity
of original work contributed
to the database. Specifically,
investigators will be given
first opportunity to analyze
and publish with OADC data
from projects that they either
have played a major role in
designing and conducting or
in cases where their specialized
interpretation of the data
was required. |
| 3)
Center Approved Investigators |
| Center
approved investigators fall
into one of three categories: |
| |
a)
Investigators named in the
OADC grant (NIA P30 AG08017),
or |
| |
b)
Principal investigators or
co-investigators of OADC affiliated
studies, or |
| |
c)
Investigators designated by
review of the OADC Director
and/or the OADC Executive Committee. |
| 4)
Data and Recruitment Requests |
| |
a)
Data Requests |
| |
|
i)
The OADC is authorized to disclose
research data to investigators
because: |
| |
|
|
(1)
subjects have either been consented
with the understanding that
results of their participation
will be shared, or
(2) the OADC has obtained a Waiver of Authorization
from the OHSU IRB. |
| |
|
ii)
A Data Use Agreement will be
completed for data shared with
OADC approved investigators
outside of OHSU (see http://www.ohsu.edu/cc/hipaa/forms.shtml). |
| |
|
iii)
Investigators initiate requests
for data or subject recruitment
by the submitting an OADC Request
Form to the Data Manager. OADC
Request Forms are obtained
from the Data Manager or through
the Layton Center's request
page. |
| |
|
iv)
With the OADC Request form,
investigators will also provide
the following supporting documentation: |
| |
|
|
(1)
A clear statement of the hypothesis
or objectives for each project,
(2) Current CV (if not already on file
with the OADC),
(3) Protocol or description of the proposed
analysis project,
(4) Data requirements (data fields: i.e.
age, height, weight, etc.),
(5) A signed statement (on the request
form) agreeing to comply with the OADC
Data Use and Disclosure Practices and the
Authorship Policy, (These policies will
be provided to the applying investigator
with the request form.) |
| |
|
v)
The Data Manager reviews the
request and presents it to
the OADC Director and/or the
OADC Executive Committee for
approval. |
| |
|
vi)
If approval is granted, the
Data Manager notifies a designated
OADC faculty member with related
expertise to serve as the contact
to the approved investigator.
The OADC contact may decide
to meet with the investigator
to discuss the project in more
detail before the data is released. |
| |
|
vii)
Once the Data Manager receives
written or verbal agreement
from the designated OADC contact,
the requested data is provided. |
| |
|
viii)
All requests are logged by
the Data Manager to track the
number and nature of OADC database
requests. |
| |
|
ix)
Limited data sets may be provided
to OADC approved investigators
to explore the feasibility
of or to complete minimal risk
projects such as: |
| |
|
|
(1)
Abstracts, manuscripts or book
chapters submitted for publication,
(2) Posters, lectures or other presentations
for educational, professional or research
conferences,
(3) Grant applications (i.e. pilot data
to justify funding) or Grant progress reports,
(4) Theses, dissertations or other student
projects, or
(5) Other OADC operations. |
| |
|
x)
Requests for updates on previously
approved requests can be handled
in person, via e-mail or by
phone. |
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b)
Recruitment Request |
| |
|
i)
The OHSU Terms and Conditions
of Service/ Consent for Treatment
and Notice of Privacy Practices
state that patients may be
contacted regarding voluntary
participation in clinical research.
New OADC Clinic Patients/ caregivers
are also mailed a survey prior
to their first evaluation that
requests permission to be contacted
by OADC staff (or designate)
to discuss available research
projects. If permission is
not refused, names and contact
information may be provided
to an OADC approved study investigator. |
| |
|
ii)
In addition to the supporting
materials listed above, the
investigator must submit a
protocol, consent form, and
IRB approval. |
| |
|
iii)
The Data Manager reviews the
request and presents it to
the OADC Director and/or the
OADC Executive Committee for
approval. If approval is granted,
the Data Manager notifies a
designated OADC faculty member
with related expertise to serve
as the contact to the approved
investigator. The OADC contact
may decide to meet with the
investigator to discuss the
project in more detail before
the data is released. |
| |
|
iv)
Once the Data Manager receives
written or verbal agreement
from the OADC Director or Executive
Committee and the OADC designated
contact, subjects who meet
study eligibility requirements
will be identified. |
| |
|
v)
The OADC Clinical Director
sends a letter to the identified
potential subjects or their
caregivers explaining the study,
alerting them that an approved
investigator will soon contact
them and offering reassurance
that participation is entirely
voluntary and refusal will
in no way impact the care provided
through the Oregon Alzheimer’s
Disease Center. Alternatively,
OADC staff or designate may
telephone participants or their
authorized representative to
discuss the research opportunity
and obtain permission for the
approved investigator to contact
them. If patients or participants
decline to be contacted regarding
the research opportunity, their
wishes will be respected. |
| |
|
vi)
If permission is not refused,
the Data Manager will give
names and contact information
of potential subjects to the
approved investigator. Only
the minimum necessary contact
information will be provided. |
| |
|
vii)
The investigator will be provided
with a Subject Enrollment Status
log form which must be completed,
updated at least every 6 months
for ongoing studies and submitted
to the Data Manager for tracking
purposes. |
| 5)
Access to OADC Database for
Center Staff and Approved
Investigators |
| |
a)
Full access to the data and
structure of the database is
restricted to the data manager
and the database consultant.
Access to all information in
the database is controlled
through individual passwords
assigned by the data manager
after project approval by the
OADC Director &/ or the
OADC Executive Committee. Write
privileges are restricted to
those persons authorized by
the data manager for the purpose
of data entry. Specialized
access can be provided by individual
passwords that allow only a
portion of the data to be viewed
and/or retrieved. |
| |
b)
Approved investigators are
authorized to have limited
read-only browsing and print/export
access to data in the OADC
database. As noted above, research
records will be identified
by a numeric ID number having
no relationship to any direct
identifiers (as defined by
HIPAA). The only HIPAA defined
identifier that will be accessible
is date of birth/age. Confidential
contact information may only
be shared in special limited
circumstances – see Recruitment
Requests above. |
| |
c)
To prevent duplication of research
efforts and to assure accurate
interpretation of the data,
approved investigators must
discuss any plans to use data
retrieved from the 4D database
(for papers, presentations,
or grants) with the designated
OADC contact before proceeding. |
| 6)
Authorship Credit |
| |
a)
It is the responsibility of
the OADC contact for each data/subject
request to ensure that the
OADC is acknowledged (“This
research was supported in part
by the Alzheimer’s Disease
Center NIA Grant P30 AG 08017”)
and that appropriate authorship
credit is given in professional
papers and presentations by
investigators. |
| |
b)
It is the responsibility of
the OADC Director and Executive
Committee to determine whether
any additional data generated
(for each data/subject request)
should be returned to the OADC. |
| |
c)
Investigators must comply with
the OADC Authorship Policy
(available from the Data Manager
or online at http://www.ohsu.edu/research/alzheimers/data/datarequest.htm). |
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d)
For all publications, investigators
must provide a copy of the
final data used in published
analyses saved in Excel or
tab delimited format on a labeled
zip disk, CD, or other suitable
media to the OADC Data Manager. |
| 7)
Oversight and Review |
| The
OADC will maintain a log of
all disclosures, to be reported
to IRB at each continuing review.
The log will include date of
disclosure, name of investigator,
description of the data disclosed,
and description of the project.
At the time of continuing review,
the OADC will report any breaches
of confidentiality or state
that no instances have been
brought to our attention. |
| |
a)
The following types of data
will be allowed for disclosure
exempt from IRB review because
of the minimal risk involved
for data and recruitment requests
that are carefully reviewed
and approved by the OADC Director
or Executive Committee. |
| |
|
i)
Limited data sets with age
over 89, but otherwise unidentified.
The nature of OADC research
requires that ages be disclosed
to collaborators in order to
accomplish research goals. |
| ii)
ApoE and other genotypes. All
OADC genetic samples and information
were collected under protocol
7022 that specifically obtains
consent for genotype and data
disclosure to other investigators. |
| |
b)
If any identifying data other
than age is requested, the
OADC will not disclose that
data without authorized IRB
review and approval, as outlined
below. Collaborating investigators
must provide assurances for
the confidentiality and privacy
of disclosed data. |
| |
|
i)
Investigators with an IRB approved
project must present the OADC
Executive Committee with a
protocol, consent form and
IRB approval letter from either
the OHSU IRB or the IRB of
another Federal Wide Assurance
(FWA) institution. |
| ii)
Projects not yet approved will
be submitted to the OHSU IRB
for expedited review. |
Data Use and Disclosure Policy
