Repository
Application Guidelines
Applications that involve
establishing repositories
are reviewed in light of
the following guidelines,
which follow the format
of the Human Subjects Application
form. These issues should
be fully addressed in a
Human Subjects application
for a repository; they
should also be clearly
covered in the consent
form. Because of the wide
variation in projects,
however, these points should
not be taken as exhaustive:
other issues may also need
to be addressed.
It is often useful to
layer the consent form
so that potential subjects
can specify their level
of involvement. For example,
would it be possible for
subjects to choose to donate
tissue, but not be in the
database? Or to choose
to have tissue stored anonymously?
Or to have medical information
recorded, but to choose
whether or not their disease
or disorder can be followed
for outcome? Can subjects
choose whether or not to
participate in genetics
studies? Could subjects
choose whether or not to
be contacted in the future
about other studies.
If repositories will include
protected health information,
the obtaining and maintaining
of the information must
comply with relevant HIPAA
provisions. Relevant issues
should be addressed in
the application. NIH has
produced a helpful
guide: Research
Repositories, Databases,
and the HIPAA Privacy Rule to
the impact of the HIPAA
Privacy rule on research
repositories.
If you have any questions,
please contact Geri
Faris,
Administrator for minimal
risk research.
A. Background and Purpose
of Research.
The final paragraph of this
section should state the
scientific purpose or hypothesis
of your research. Please
be somewhat specific about
the diseases and disorders
you will study. For example,
you may be studying cancers
of the gastrointestinal tract.
B.1. Research Procedures
Involved. Explain all procedures
involved.
Tissue Repository
- Describe subjects
from whom who you will
obtain tissue samples.
Include information about
both normals and controls.
- If it is your intent
to keep the tissue samples
linked to the subjects'
identity, explain why.
Repeat this information
the consent form.
- If it is your intent
to follow the progress
of diseases or disorders,
explain why and for how
long. Repeat that information
in the consent form.
- Explain what information
will be obtained from
the subjects' medical
records. Clarify whether
or not you will continue
to obtain information
from medical records,
and if so, your purpose
in doing so. Repeat that
information in the consent
form.
- State whether or not
your lab is clinically
certified, either under
CLIA (Clinical Laboratory
Improvement Act) or under Washington
State Medical Test Site
Licensure
- If
it is your intent to
use the registry as a
possible subject pool
for other specific studies,
please explain. Obtain
explicit consent to re-contact
subjects in the consent
form.
- When explaining the
genetics component of
your research, please
address the following
concerns:
- The ability
to detect markers
of disease susceptibility
that both subjects
and other persons
may wish to know.
Is it possible
that your research
over a period of
time will provide
evidence of previously
undiagnosed or
unrecognized illnesses,
or susceptibility
to illness, over
time? Would the
results have clinical
value for the subjects?
Please explain
in the consent
form how you will
inform subjects
that they have
a right to be informed
(or not) about
the results.
- Attempts by
employers and insurers
to gain access
to research data,
specifically for
the purpose of
denying employment,
denying insurance,
or rating insurance
higher.
- Commercial developments
involving stored
samples, in which
there might be
ownership issues
- Use of stored
samples for research.
It is important
to understand that
a separate Human
Subjects application
will be necessary
for investigators
using coded data
or specimens for
a research study.
Also, tissue or
information in
the database can
only be used within
the parameters
of the research
defined by the
initial application
for the tissue
repository and
database. At that
time, Human Subjects
will help determine
if the investigator
needs to contact
subjects and ask
for additional
consent to do the
research. If data
are stripped of
any link to the
subjects' identities
(anonymous), it
may be possible
for research to
be exempt from
institutional review.
In that case the
PI would submit
a Certification
of Exemption to
their department
for review, and
a copy of the Certification
to the Human Subjects Division for administrative
review.
The concerns numbered
#1 - #4 above must
also be addressed
in the consent form,
as indicated in the
following points:
- State whether
or not you will
be attempting to
find markers of
disease susceptibility
and if that information
will be available
to the subjects
or their health
care providers.
Consider using
checkboxes where
subjects may indicate
that they would
like to know the
results of tests
that have clinical
value, or to not
be advised. In
addition, state
whether or not
genetic counseling
is available.
- Explain how
you will keep study
data confidential.
For example, you
could say, "Information
about a subjects
is confidential,
and a copy of the
consent form will
not be placed in
the subjects' medical
records."
- Explain whether
or not subjects
can benefit from
future commercial
products. For example
you could say, "Future
research using
your specimen may
lead to the development
of commercial products.
You will not share
in any profits
that this work
my produce."
- Delineate, in
a general way,
how the tissue
will be used. For
example, you could
say, "Tissue
samples will only
be to study gastrointestinal
cancer." In
addition, define
and delimit the
subjects' consent
for research activities
in the future.
For example, you
could say, "We
will store your
specimen to use
in future research.
If we want to use
your specimen for
a research purpose
not described in
this consent form,
we will send our
request to an Institutional
Review Board. This
Board protects
the rights and
welfare of research
subjects like you.
The Board will
determine if we
need to contact
you and ask your
consent to do the
research."
Database
- Explain what information
about subjects will be
in the database and whether
or not any information
can directly identify
the subjects. Repeat
this information in the
consent form.
- Attach copies of the
screen print out of the
database, listing all
variables.
- Explain how subject
information will be coded.
- Explain how long data
will be linked to the
subjects' identity. Repeat
this information in the
consent form.
- Explain who will have
access to the database,
and how the database
will be used. Repeat
this information in the
consent form.
- State who will have
access to the link between
the subjects' identities
and the study codes.
Repeat this information
in the consent form.
- Explain how information
in the database will
be kept confidential.
For example, what process
will be in place for
investigators to use
banked tissue or have
access to database information?
What information will
they obtain from the
tissue repository or
database in order to
access other information
from the subjects' medical
records?
D.3. Explain what surgical
procedures for both cases
and controls would qualify
subjects to be in this
study.
D.4. Explain what subset
of both cases and controls
described above would not
qualify to be in this study.
D.5. and D.6. Describe
how subjects will be recruited.
Be sure to consider the
following issues:
- The confidentiality of
patient information cannot
be breached. For example,
potential subjects should
hear about the study
from their health care
provider.
- Investigators should
not recruit their own
patients in order to
avoid even the appearance
of coercion, and
to avoid a potential conflict
of interest.
D. 6. Explain how coercion
will be avoided.
If investigators will not
recruit their own subjects,
coercion is often avoided.
It is also important to use
language that consistently
emphasizes the voluntary
nature of the study.
D.10.
Where will subjects be recruited?
Where will the database be
located? Where will the tissue
bank be located? Will tissue
be transferred to another
institution? If so, please
obtain a Materials
Transfer Agreement with
the Office of Technology
Transfer. All of this
information needs to be repeated
in the consent form.
E.1. Please consider the risks to the
subject's privacy and confidentiality if
data are linked to the subjects' identity
over a period of time, or if the progress
or a subjects' disease or disorder are
followed.
E.2. Explain how you will assure the
confidentiality of the subjects.
For example, will the investigators and staff
who have access to coded information sign
a Confidentiality Agreement? Will the primary
responsibility of the tissue bank and database
rest with one designated person?
E.3.
Please consider the possibility that research
can begin with a general hypothesis that
may become more specific over a period of
time so that eventually results may have
clinical significance for the subjects or
their families. In addition, consider the
possibility of discovering genetic markers
for some diseases. Is it your intention to
keep tissue or data linked to the subjects'
identity for longer than the time necessary
to conduct clinical tests? If that is a possibility,
how will you communicate information to the
subject, the subject's families, or the subject's
health care provider, and provide genetic
counseling?
G.3. Clearly state whether data and
tissue are anonymous or confidential.
The terms "anonymous" and "confidential" are
mutually exclusive. Data that are stripped
of all identifiers are anonymous; they are
not linked in any way to the subjects' identity.
Confidential data are assigned a unique study
code, and the codes are linked to the subjects'
identities.
H.2. State what information you will
obtain from the subjects' medical records
at the time the subjects' tissue is placed
in the tissue repository.
If it is your intention to follow the progress
of disease or disorders, state what information
you will obtain in the future. Attach copies
of the data collection to the application
that you will use to obtain this information.
It is important that the form does not list
information that will directly identify the
subject, such as name, address, phone number,
Social Security number, or birth date (use
age or year of birth). Instead, provide a
space to assign a unique study code.
I. Attach to the application copies
of the consent form that you will use to
document the consent of subjects. |
