Consent Elements
Vanderbilt
Northwestern
Project Name
Consent for
Treatment and
Agreement to Pay
(Adult)
NUgene: GeneDisease Association
and Treatment
Outcomes
Mayo Clinic
Biobank
Research Tissue
Bank with Certificate
of Confidentiality
Duke Biobank
Principal Investigator
Vanderbilt
University Medical
Center (VUMC)
Rex L. Chisholm
J.R. Cerhan &
Colleagues
General template for
use by PIs for
studies involving
collection and
storage of tissue
samples to be used
by multiple
researchers over
time. May be
modified for specific
studies.
Partners HealthCare
System
Laura M. Beskow &
Colleagues
(Beskow LM, Friedman JY,
Sponsor
VUMC
NU Center for
Genetic Medicine
Mayo
Mayo Clinic
(Rochester MN)
Partners
Duke
Hardy NC, Lin L, Weinfurt KP
(2010) Developing a
Simplified Consent Form for
Biobanking. PLoS ONE
5(10): e13302)
Duke University
Outside sponsors
per individual project
Scope
Purpose
BioVU Project.
NUgene Project.
General consent
to treatment,
payment, and
“use, retention
and disposal of
tissue and blood”
Genetic bank with
‘blood-based
samples and health
information’
Unrestricted.
Retention and use
of otherwise
Unrestricted.
Samples and
information to be
General biobank
“Library for
researchers” to use
samples and
General ‘research
tissue bank’
General Template:
‘collect, process,
store samples until
Kaiser
Research
Program on
Genes,
Environment, and
Health (RPGEH)
Catherine
Schaefer
Kaiser
Permanente
Division of
Research (No
Cal)
Kaiser
Foundation
Hospitals
General biobank
The Permanente
Group, Inc
RPGEH Program
Studies of health
problems to find
new ways to
detect, treat,
prevent, cure,
including studies
of genes.
‘Long-term
research
program’ to
understand how
genes, behaviors,
and environment
affect health
Unrestricted.
‘“Collect and store
blood and health
May help
scientists
discover new
ways to diagnose,
treat, or prevent
common health
conditions
Unrestricted
‘Long-term
research
Eligible Individuals
disposable
specimens or
tissues for
education or
research,
including genetic
studies
Adult in- or outpatients at VUMC
‘shared with
researchers for
future research
about the role of
genes play in human
disease’
information already
collected instead of
looking for
volunteers for each
new project
researchers need
them to do research’
Patients at
Northwestern
Memorial Hospital or
its affiliates
All Mayo Clinic
patients at least 18
years old
Adults at least 18
years old in Partners
HealthCare System
Specific Studies:
Determined by each
PI for each study
information so
researchers can
use them in future
studies’
program’ to
understand how
genes, behaviors,
and environment
affect health
Patients of Duke
University Health
System
Adult members of
Kaiser
Permanente in
Northern
California
Unspecified
Blood donation
500,000
Saliva or Blood
Donation
Minors (less than 14
years old)
Number of Subjects
Procedures
Unspecified
None
Unspecified
Blood donation
20,000
Blood donation
Brief questionnaire
Health
questionnaire
(background,
environment, family
history)
Allow ongoing
access to EMR from
any visit at any
facility
Allow access to
medical records
now and in future
Unlimited
General Template:
None if leftover
samples and
medical record data
are used
Specific Studies:
Determined by
each PI for each
study
Questionnaire
(demographics
and family health
history)
Allow continued
access to medical
records
Collate research
data from any
studies done using
subject’s sample
and information
Health survey
(family history,
personal health
and health related
behaviors)
Current and
continued access
to medical record
Use of DNA for
future unspecified
tests of genes
Retention of
samples and
information even
if leave KP
Sharing of
genetic and
health data with
NIH database
Materials and Data
Collected
Discard
specimens and
Blood
Blood/DNA/genetic
information
General Template:
Blood
Saliva or blood
tissue, including
leftover blood
Questionnaire data
Tissue specimens
Information from all
current and previous
health care from all
NU affiliates
Leftover samples
(e.g., tumor, blood,
urine)
Medical record data
“Some of your
health info’ to be
stored
Questionnaire
data (family
demographic and
health history)
Medical record
data
Continued review of
medical record to
update health
information
Blood studied for
environmental
exposures and
contaminants
Health survey
(family history,
personal health
and health related
behaviors)
Medical record
data
Specific studies:
Tissues/specimens
collected de novo
for research (e.g.,
blood; skin biopsy)
Questionnaire data
Other data (e.g.,
radiology findings)
Linkages to Other
Samples or Data
Access to
Materials/Data
No specific
mention of linkage
to medical records
or other diagnostic
(e.g., MRI) or
treatment data but
BioVU does link to
the de-identified
‘synthetic
derivative EMR’
VUMC
researchers but
not specific
EMR linkage,
including HIV and
mental health data
Medical record
now and in future
General Template:
Medical record
Questionnaire data
Specific Studies:
Determined by each
PI for each study
Tissues obtained
during surgery or
procedures.
NU Administrative
staff (e.g., IRB,
Office of Research)
Other NU research
Access determined
by Biospecimen
Trust Oversight
Group (BTOG)
comprised of Mayo
General Template:
Researchers at
MGH, BWH, and
other Partner
Institutions, as well
Current medical
record (including
images as X-rays,
medicines, test
results). If
permission given,
periodically
updated medical
record
No mention of
linkage to discard
tissue, leftover
samples
Access
determined by a
science committee
at the Biobank
plus ethics review.
Medical record
now and with
updates
KP Division of
Research and
‘outside
researchers’
centers and NU
contractors
Study monitors and
auditors
Clinic employees.
Local residents on
Biobank’s
Community
Advisory Board
(CAB).
as non-Partners
academic
institutions or forprofit companies.
Samples will not be
sold for profit.
Access may include
non-Mayo
researchers with
Mayo collaborator.
Researchers at
Partner Institutions
may review medical
record to collect
more information
after approval by
Ethics Board
Other researchers
Commercial
research and drug
companies
Government
agencies (e.g., FDA,
NIH, DHHS)
Other academic
research centers
Uses for Materials
Education or
research,
including genetic
studies
Research about the
role of genes play in
human disease
Data (‘disguised’)
may be entered into
databases shared
with other
researchers.
Unspecified genetic
research
De-identified
materials may be
used by
researchers from
Duke, other
universities,
government, and
drug-or healthrelated
companies.
Specific Studies:
Determined by each
PI for each study
General template:
Research related to
condition
(understanding,
prevention,
diagnosis,
treatment) including
new research
questions that arise
over the next years.
Also may be used
for research on
other conditions,
including mental
illness, HIV/AIDS,
cancer
If genetic research,
include brief
explanation of
genes
If cell lines to be
created, include
Studies of health
problems to find
new ways to
detect, treat,
prevent, cure,
including studies
of genes
Unspecified
research to learn
‘how people’s
health is affected
by their genes,
health-related
behaviors, and
the environment’
brief explanation
If iPS cells to be
created, included
brief explanation
If GWAS or large
scale gene
sequencing, include
brief explanation
If tissue/data to be
sent to NIH or other
repository, include
brief explanation
and state that
‘samples and whole
genome information
is important for the
study of virtually all
diseases and
conditions....the
samples/data banks
will provide study
data for researchers
working on any
disease”
Retention Period
Unspecified
Indefinite; consent
does not expire
unless specifically
revoked
Indefinite, including
after death
Specific Studies:
PIs may restrict
sample/data use to
the condition under
study, to a specific
group of
investigators, to the
sample collected
(e.g., no cell lines)
General Template:
Indefinite
May include
establishment of
permanent cell lines
Indefinite
Indefinite
Return of Results to
Individual, Physician,
or Medical Record
Not included
Not included. Opt in
or opt out for
NUgene Newsletter
Not informed if
researchers access
records
Results may be
returned based on
decision of
researchers,
doctors, and
Community
Advisory Board
Code linking
samples to medical
record may be
retained indefinitely
for future research
General Template:
No specific results
returned to
participant or doctor
No information from
the research will be
placed in medical
records
May receive
newsletter with
general findings
Generally, no
individual results
from research, but
offer to disclose if
‘discover… info…
about a disease
that is likely to
cause early death
if not treated”
May get general
news through the
Biobank website
No information
entered into
medical record
Specific Studies:
Future Contact
Not included
Opt in or out
May be mailed
additional
questionnaires for
voluntary
completion. Not
more than two
contacts per year.
Certain information
from the research
that relates to your
general medical
care may be
included in your
regular medical
record (description
of information to be
included). This
information may not
be protected by the
Certificate of
Confidentiality
General Template:
Future contact by
tissue bank staff at
medical visit or by
phone to update
information on
Generally, not
receive personal
health or medical
results, but if
information of
substantial
medical
importance
learned, will be
re-contacted and
asked if would
like results
Opt in or out for:
Annual contact to
update personal
information
Access to medical
May be contacted
‘at some time in
the future’ and
invited to
participate in
other studies
May be asked for
additional voluntary
blood donation.
medical condition or
health status
record from ‘time
to time to get
updated
information’
Up to two contacts
per year to invite
participation in
specific other
studies (new
consents)
Confidentiality and
Privacy
Not explicit. Only
states that
specimens and
tissues are deidentified
De-identified
samples and health
information stored in
one or more
scientific databases
with restricted
access
Results may be
used for teaching,
research,
publications,
meeting
presentations
Unique code
assigned to
samples and
personal medical
information
General Template:
Identifiable
information to be
collected, stored
and updated.
Genetic information
is unique ‘like your
fingerprint so it is
impossible…to fully
hide your identity”
Info may be shared
with sponsor of
research; data use
and safety group;
Partners’ data
storage companies,
insurers, and
lawyers; federal and
state agencies;
public health and
safety authorities
Contagious
diseases must be
reported under MN
law
Opt In or Opt Out
Mandatory except
for DNA databank
No option for
specimens and
tissues. Opt-out
for use of leftover
blood for DNA
research (i.e.,
exclusion from
Only release
information as
required by law
Opt in or out for:
Voluntary
Voluntary
Voluntary
Opt in/out for future
contact
Opt out for use of
“extra tissue” from
surgeries or
procedures
No options
Opt in or out for:
Opt in/out for receipt
of newsletter
Opt out of allowing
family access to
De-identified
samples and
information
Researchers using
samples and data
sign agreement
not to try to find
identities
Release of deidentified genetic
and health
information into
scientific
databases
Voluntary
No data placed in
medical record
Voluntary
De-identified
samples and
information
Annual contact to
update personal
information
Access to medical
Voluntary
No options
‘DNA Databank’)
but presumably
would allow use of
plasma/serum
record from ‘time
to time to get
updated
information’
samples after
participant’s death
Up to two contacts
per year to invite
participation in
specific other
studies (new
consents)
Release of deidentified genetic
and health
information into
scientific
databases
Risks and Discomforts
Not included
Blood draw
Psychological
discomfort
(questionnaire)
Genetic research
results may possibly
lead to health or life
insurance
discrimination as
well as job or social
discrimination
General risk in
allowing access to
hospital medical
records
Emotional
(questionnaire)
Physical (blood
draw)
Future risks:
a. Loss of privacy.
Small chance of
accidental release.
Federal Genetic
Information
Nondiscrimination
Act (GINA) prohibits
employers and
insurers from
discrimination
b. Risks related to
test results. If
valuable
information, BTOG
and CAB will decide
whether to release
General Template:
Blood draw
Blood draw
Potential loss of
privacy
Risk of access to
stored data that
might make it
harder to get or
keep a job or
insurance
Risk of loss of
privacy or
confidentiality
Risk that information
about taking part in
a genetic study may
influence insurance
companies and/or
employers
Risk that
participation may
have a negative
impact on family
members
Specific Studies:
Risks if additional
blood draws,
biopsies, or other
procedures
Risk of tracing deidentified
information in
scientific database
back to individual
since ‘genetic
information is
unique to you’ and
that this risk may
grow as new ways
of tracing
information are
developed
Protections
De-identified
samples and data
De-identified
samples and data
to participants and
how to best
release. Learning
results may lead to
emotional upset,
changes in family
relationships,
insurance or job
discrimination. May
need to meet with
Mayo health care
professional to
learn test results.
Coded samples and
data
Coded samples and
data
Certificate of
Confidentiality from
Fed’l Govt
Certificate of
Confidentiality from
Fed’l Govt
Certificate of
Confidentiality from
Fed’l Govt
No data placed in
medical record
(unless as specified
in individual study)
Benefits
Rights
Not included
Not included
No direct benefits
No direct benefits
Discouraged from
sharing information
about participation
with family members
No direct benefits
General societal
benefits
Right to respectful
treatment,
withdrawal at any
time without
untoward
consequences,
speak with someone
not directly involved
in project (OPRS
phone number)
General societal
benefits
Right to leave the
project at any time
Options for
withdrawal:
1. no longer wish to
be contacted, but
allow continued use
of samples and
personal medical
information;
Coded sample and De-identified
data
samples and
information
May opt out of
contributing
genetic and health
data to scientific
databases
Only release
information as
required by law
Certificate of
Confidentiality
from Fed’l Govt
No information
placed in medical
record or shared
with Kaiser
Foundation
Health Plan
No direct benefits
No direct benefits
General societal
benefits
Right to withdraw at
any time
General societal
benefits
Right to withdraw
at any time
General societal
benefits
Right to withdraw
at any time
Participation or
withdrawal not affect
continued care with
Partners
If withdraw, right to
tell what should be
done ‘with any
blood not already
given out for a
study”
Right to withdraw
authorization to
use protected
health information
(will end study
participation)
2. destroy
remaining sample,
but allow use of
previously provided
information and
samples;
3. destroy
remaining samples
and stop using
personal medical
information
No option for
withdrawal of
samples and
information:
1. studies alreadyd
begun;
2. samples or
information shared
with other research
institutions;
3.cannot remove
medical information
in database, but
biobank staff will
stop using this info
Costs/Remuneration
Not included.
Inventions/Commercial No compensation
Value
No cost
No remuneration
No compensation
No cost
Remuneration by
choice of items
worth up to $20.
No compensation
No cost. No
payment for
samples
No cost
No remuneration
No cost
No remuneration
No payment from
future products or
technologies No
compensation
No share in future
profits
No personal
financial benefit
from any
commercialization
effort
Any benefits to
KP will be used
for research and
non-profit public
benefit purposes
Withdrawal
Contact Information
Signatures
Not included
General phone
number
Yes, subject or
legal
representative
Revoke at any time.
Separate revocation
needed for blood/
tissue and for health
information. Health
information obtained
before revocation
still may be used
and/or shared
OPRS phone
number
PI address and
phone number
Yes, subject or
subject’s authorized
representative
within KP
Withdrawal at any
time.
Withdrawal at any
time during life.
Upon death,
samples considered
‘gift’ to Mayo Clinic
regardless of family
wishes. Family
may wish access to
sample after death
since it may contain
valuable genetic
information. May
deny family access.
General Template:
Multiple contact
phone numbers
depending on type
of question (e.g.,
PI, IRB, Research
Subject Advocate)
Phone numbers for
tissue bank staff and
Partners Human
Research
Committee
Phone numbers
for Biobank
director and Duke
IRB
Yes, adult subject
Yes, subject or
subject advocate,
guardian, health
Yes, adult subject
Withdrawal at any
time. Samples and
information will be
destroyed, but not
possible to destroy
samples/info already
given to
researchers.
Samples and
unpublished data
from samples will
be destroyed
If samples stripped
of all identifiers and
codes that link to
identifiers, the
samples and data
cannot be withdrawn
If withdraw
authorization to
use protected
health
information,
participation in
study will end. KP
researchers and
approved
research
colleagues may
continue to use
your health
information
obtained before
authorization
withdrawn,
including
‘recording and
reporting anything
that relates to
your safety and
the safety of
others’
Phone numbers
for RPGEH and
IRB
Name and
address of PI
Yes, adult subject
Two part consent:
Consistency with
Proposed Common
Rule
Version Date
No. Does not
state that
biological
materials are
inherently
identifiable
1/07; rev 6/09
No change in
VUgene language
(parent, spouse,
legal guardian, or
other authorized
agent)
care proxy, durable
power of attorney, or
family member/nextof-kin.
No. Does not state
that biological
materials are
inherently
identifiable
Yes. States that
genetic data are
inherently and
uniquely identifiable
If minor subject,
parental/guardian
signatures plus
assent for children
14-17 or assent for
children ages 7-13
No. Does not state
that biological
materials are
inherently
identifiable
Yes. States that
genetic
information is
unique to
individual
11/04/09
9/15/10
4/10
Publ 10/10
Participation in
Medical Research
Program
Authorization to
Use and Disclose
Protected Health
Information
No. Does not
state that
biological
materials are
inherently
identifiable
7/29/10