Supplementary Materials
List of biobanks included in the analysis and their website URLa
Name of Biobank by Type
NIH Biobanks
AIDS and Cancer Specimen
Resource
Alopecia Areata Registry (AAR)
Ancillary Pharmacogenetic Studies
in Heart, Lung, Blood, and Sleep
Disorders (APS)
Blood Repository for the Validation
of Lung Cancer Biomarkers
Breast and Colon Cancer Family
Registries
Cancer Genetics Network DNA
Bank (CGN)
Cancer Human Biobank
Candidate Gene Association
Resource
Cohort Consortium
Cooperative Breast Cancer Tissue
Resource (CBCTR)
Cooperative Human Tissue Network
(CHTN)
Environmental Polymorphism
Registry (EPR)
eyeGENE (National Ophthalmic
Disease Genotyping and
Phenotyping) Network
FBPP: Family Blood Pressure
Website URL
http://acsr.ucsf.edu/dotnetnuke/
http://www.mdanderson.org/education-and-research/departments-programs-andlabs/programs-centers-institutes/alopecia-areata-registry/index.html
http://public.nhlbi.nih.gov/GeneticsGenomics/home/app.aspx
http://edrn.nci.nih.gov/resources/sample-referencesets/LCBG%20protocol%20July%209%202009.pdf
http://epi.grants.cancer.gov/CFR/
http://hedwig.mgh.harvard.edu/cgn/public/studies/biorepository
http://www.cancer.gov/recoveryfunding/page10
http://public.nhlbi.nih.gov/GeneticsGenomics/home/care.aspx
http://epi.grants.cancer.gov/Consortia/cohort.html
http://cbctr.nci.nih.gov/
http://www.chtn.nci.nih.gov/
http://www.niehs.nih.gov/research/resources/databases/epr/index.cfm
http://www.nei.nih.gov/resources/eyegene.asp
http://public.nhlbi.nih.gov/GeneticsGenomics/home/fbpp.aspx
Name of Biobank by Type
Program (FBPP)
Framingham Heart Study
Genetic Association Information
Network
Geneva (Gene Environment
Association Studies)
Liver (Hepatocellular Carcinoma)
Reference Set
Lupus Family Registry and
Repository (LFRR)
National Cell Repository for
Alzheimer's Disease (NCRAD)
National Database for Autism
Research
NHGRI Sample Repository for
Human Genetic Research
(NHGRI SRHGR)
NIA Aging Cell Repository (NIA
ACR)
NIA Genetics of Alzheimer's Disease
Data Storage Site
NIDA Center for Genetic Studies
(NIDA CGS)
NIDCR Salivary Gland Tumor
Biorepository
NIDDK Central Repository
NIGMS Human Genetic Cell
Repository (NIGMS HGCR)
NIMH Genetics Repository
NINDS Human Genetics Repository
PLCO Screening Trial
Prostate Cancer Reference Set
Website URL
http://www.framinghamheartstudy.org/
http://www.genome.gov/19518664
http://www.genevastudy.org/
http://edrn.nci.nih.gov/resources/sample-reference-sets/edrn-hcc-reference-set.pdf
lupus.omrf.org/
http://ncrad.iu.edu/
http://ndar.nih.gov/ndarpublicweb/
http://ccr.coriell.org/Sections/Collections/NHGRI/?SsId=11
http://ccr.coriell.org/Sections/Collections/NIA/?SsId=9
http://www.niageneticsdata.org/
http://zork.wustl.edu/nida/
https://www.fbo.gov/index?s=opportunity&mode=form&id=12767d6dfc166473ded6f15a
e6d2d8eb&tab=core&_cview=1
https://www.niddkrepository.org/niddk/home.do
http://www.nigms.nih.gov/Initiatives/HGCR/
http://www.nimhgenetics.org/
http://ccr.coriell.org/Sections/Collections/NINDS/?SsId=10
http://prevention.cancer.gov/programs-resources/groups/ed/programs/plco
http://edrn.nci.nih.gov/resources/sample-reference-sets/Prostate%20Ref%20SOP.pdf
Name of Biobank by Type
Website URL
Prostate SPORE National
Biospecimen Network (NBN)
Pilot
Repository of Molecular Brain
Neoplasia Data (REMBRANDT)
Scleroderma Family Registry (SFR)
SEER Residual Tissue Repository
(RTR)
The Breast Cancer Intergroup of
North America
The Database of Genotypes and
Phenotypes (dbGaP)
The Cancer Genome Atlas
The eMERGE Network
The Large-Scale Genome
Sequencing Program
The National Children's Study
Women’s Health Initiative (WHI)
SNP Health Association Resource
Other U.S. Biobanks
23andMe
Alpha-1 DNA and Tissue Bank
Asterand
http://prostatenbnpilot.nci.nih.gov/
http://caintegrator-info.nci.nih.gov/rembrandt
http://www.uth.tmc.edu/scleroderma_reg/
http://seer.cancer.gov/biospecimen/
http://ctep.cancer.gov/investigatorResources/tbci/correlative_studies.htm
http://www.ncbi.nlm.nih.gov/sites/entrez?db=gap
http://cancergenome.nih.gov/
https://www.mc.vanderbilt.edu/victr/dcc/projects/acc/index.php/About
http://www.genome.gov/10001691
http://www.nationalchildrensstudy.gov/Pages/default.aspx
http://www.nhlbi.nih.gov/whi/
https://www.23andme.com/
http://www.alphaone.ufl.edu/dna_tissue_bank.php
http://www.asterand.com/Asterand/human_tissues/frozenfixed.htm?gclid=CPem6cbbiJ4C
FQjyDAodZQj6rA
Autism Genetics Resource Exchange http://www.agre.org/
(AGRE)
Bioserve Global Respository Human http://www.bioserve.com/globalRepository/globalRepositoryOverview.cfm
Tissue Bank (and Serum Sample
Bank)
CCTS Virtual Biobank
http://ccts.uth.tmc.edu/ccts-services/biobank
CDC National Health and Nutrition
http://www.cdc.gov/nchs/nhanes/genetics/genetic.htm
Name of Biobank by Type
Examination Survey
Crohn's and Colitis Foundation DNA
Data Bank
Duke IGSP Biospecimen Repository
El Camino Hospital MT Group
Biobank
HIHG Biorepository
Hollings Cancer Center Tissue
Biorepository
Kaiser Permanente Research
Program on Genes, Environment,
and Health
Mayo Clinic Biobank
Medical College of Georgia
Alzheimer's Disease DNA Bank
Medical College of Wisconsin
Pancreatic Cancer Tissue Bank
Michigan Neonatal Biobank
Mount Sinai Biobank
National Psoriasis Victor Henschel
BioBank
Nephrology Research Biobank
NUGene
Origene
Personalized Medicine Research
Project
PrecisionMed, Inc.
SFARI Base
South Carolina Cancer Center Tissue
Bank
The Accelerated Cure Project MS
Website URL
http://www.ccfadatabank.org/
http://www.genome.duke.edu/cores/biorepository/
http://www.elcaminohospital.org/Cancer_Center/Clinical_Trials/MT_Group_Biobank_Tis
sue_Study/
http://www.mihg.org/weblog/core_resources/2007/11/mihg-biorepository.html
http://hcc.musc.edu/research/sharedresources/biorepository/index.htm
http://www.dor.kaiser.org/external/rpgeh/index.html
http://mayoresearch.mayo.edu/mayo/research/biobank/
http://www.mcg.edu/alzres/questions.htm
http://www.mcw.edu/AnnualReport2009/DiscoveryTissuebanktoadvanceclinicalcare.htm
http://www.mnbb.org/
http://www.mountsinai.org/Research/Centers%20Laboratories%20and%20Programs/IPM/
IPM%20Research/Biobank
http://www.psoriasis.org/NetCommunity/Page.aspx?pid=672
http://clinicaltrials.gov/ct2/show/NCT00381121
https://www.nugene.org/
http://www.origene.com/tissue/?gclid=CMSLjZrY5Z4CFQ_yDAodfG_oMw
http://www.marshfieldclinic.org/chg/pages/default.aspx?page=chg_pers_med_res_prj
http://www.precisionmed.com/about.html
https://sfari.org/sfari-base
http://www.palmettohealth.org/body.cfm?id=1010
http://www.acceleratedcure.org/repository/
Name of Biobank by Type
Repository
The Biorepository at The Feinstein
Institute for Medical Research
UC Davis Cancer Center
Biorepository
UConn Behavioral Gene Bank
Non-U.S. Biobanks
Biobank Japan
CARTaGENE
Chernobyl Tissue Bank
Estonian Genome Project
Genome Austria Tissue Bank
Icelandic Biobank
King's College London (KCL)
Infectious Diseases BioBank
Latvian Genome Project
Medical Biobank
Singapore Tissue Network
UK Biobank
Western Australian DNA Bank
Website URL
http://www.biorep.org/
http://ccresources.ucdmc.ucdavis.edu/csr/publicaccess.csr?pg=specimenhome
http://gcrc.uchc.edu/Documents/RecruitmentAds/GCRC646%20Gene%20Bankbrochure.
pdf
http://www.src.riken.go.jp/english/index.html
http://www.cartagene.qc.ca/index.php?lang=english
http://www.chernobyltissuebank.com/
http://www.genomics.ee/index.php?lang=eng&PHPSESSID=ff45af7e1d8c3e94dd1be102
0517923b
http://www.univie.ac.at/LSG/gatib/about.htm
http://www.decode.com/
http://www.kcl.ac.uk/schools/medicine/research/diiid/centres/pii/biobank.html
http://bmc.biomed.lu.lv/site/main/cgi/YaBB.cgi?action=lo
http://www.biobanks.se/medicalbiobank.htmhttp://www.biobanks.se
http://www.stn.org.sg/
http://www.ukbiobank.ac.uk/
http://www.wadb.org.au/
a
The listed websites and links were active at the time of data collection; however, that may no longer be the case given the nature of online
material.
List of 65 Coding Questions
Key Document
Areas
Coding Category
Circle Response
Y = Yes, specifically mentioned/allowed
N = No, specifically not allowed
NA = not addressed (If there is no
definitive statement Y or N, but only
discussion of the idea, then its NA)
Q1. Document Type
Select A or B and further define if B:
A. Webpage
A
B. Document:
B
i. Actual consent form for research project
i
ii. Actual consent form for biobank specimen collection
ii
iii. Consent form template
iii
iv. Model consent form
iv
v. Guidebook/Manual
v
vi. Guidelines
vi
vii. Assent form template
vii
viii. Model assent form
viii
ix. Adverse Event document
ix
x. Script for Oral Consent
x
Q2. Study Population
Guidelines
xi. Policy document
xi
xii. Other
xii; describe:
May the following be included as participants? (A-F):
A. Children/Adolescents (< 18)
B. Adults (18+) (If document specifically states only those 18+
included, then A is “N”.)
C. People whose competence is in question
D. People with a prior medical condition
E. People who are pregnant
F. Controls
G. In the signatures on the consent form is there a place for a parent,
guardian, or some other type of witness to sign?
Q3.Qualifications of the
Biobank Researchers
A. Does the document have instructions on clarifying the
qualifications of the biobank researchers (i.e. listing credentials)?
A. Y N NA
B. Y N NA
C. Y N NA
D. Y N NA
E. Y N NA
F. Y N NA
G. Y N NA
A. Y N
Q4. Clarification Statement
B. Is medical attention available if necessary:
B:
1. as part of the collection procedure?
1. Y N NA
2. due to an individual research result?
2. Y N NA
3. due to an incidental finding?
3. Y N NA
A. Is there a clarification statement explicit on this document that
clarifies the study is research?
A. Y N
B. Is the data from the project of clinical quality (e.g. – clinical data,
data gathered in a clinic or by clinic staff)?
B. Y N NA
Q5. Research Results:
A. Will screening individual research results be offered?
A. Y N NA
Specifies if disclosure of
research results is addressed
and if so, how and to whom
B. Will study individual research results be offered?
B. Y N NA;
C. Definition/terms used to describe individual research results:
C. list terms:
D. Is there a time limit for return of IRRs?
D. Y N NA
E. Will aggregate research results be shared with participants?
E. Y N NA
F. May participants elect to know their IRRs?
F. Y N NA
G. May participants elect to NOT know their IRRs?
G. Y N NA
H. Will some IRRs be returned even if the participant refuses consent
to receive or opts not to receive results?
I. With whom will individual results be shared?
1. Individual Participants
2. Participant’s parent, guardian, or legal representative
3. Other family members
4. Primary Care Provider
5. Specialist Physician
H. Y N NA
I:
1. Y N NA
2. Y N NA
3. Y N NA
4. Y N NA
5. Y N NA;
List specialist type:
6. Counselor/Psychologist/Mental health professional
7. Genetic Counselor
8. Other researchers
Q6. Incidental Findings: Broad
Statement (Specific to genetic
research)
A. Is there a broad statement about risks that may apply to incidental
findings?
B. Does anything about risks suggest that an incidental finding would
receive further attention or would be disclosed?
6. Y N NA
7. Y N NA
8. Y N NA
A. Y N
B. Y N NA
Q7. Incidental Findings:
specifies if incidental findings
are addressed and if so, how
and to whom
A. Is there a specific statement about identification of incidental
findings?
B. Definition/terms used to describe incidental findings
C. Types of specific incidental findings addressed:
A. Y N
B: List definition/terms:
C: List specifics:
D. May participants elect to know if incidental findings were
discovered?
D. Y N NA
E. May participants elect NOT to know if incidental findings were
discovered?
E. Y N NA
F. Will some IFs be returned even if the participant refuses consent to
receive or opts not to receive results?
G. Is there a time limit for return of IFs?
F. Y N NA
H. Will the investigators consult with a specialist if an IF is found?
If yes, specify:_____
I. Will IFs be disclosed to any of the following individuals?
G. Y N NA
H. Y N NA
1. Participant
2. Participant’s guardian
3. Primary care provider
Specify:
I:
1. Y N NA
4. Specialist physician
2. Y N NA
3. Y N NA
4. Y N NA
5. A counselor/ psychologist/mental health professional
List type of specialist:
6. A genetic counselor
7. Other researchers
5. Y N NA
6. Y N NA
7. Y N NA
Q8. Future Studies: specify if
the document deals with future
studies and if so how
Researchers at the biobank:
A1: Is participation in future biobank studies mentioned?
A(1) Y N
A2: Is the participant specifically asked if s/he elects to participate in
future biobank studies?
A(2) Y N NA
Researchers outside the biobank:
B1: Is participation in future studies by researchers at non-profit
organizations outside the biobank mentioned?
B(1) Y N
B2: Is the participant specifically asked if s/he allows her/his
data/samples to be used in future studies by non-profit researchers
B(2) Y N NA
outside the biobank?
For-profit companies outside the biobank:
C1: Is participation in future studies by researchers at for-profit
organizations outside the biobank mentioned?
C2: Is the participant specifically asked if s/he allows her/his
data/samples to be used in future studies by for-profit researchers
outside the biobank?
C(1) Y N
C(2) Y N NA
D. Does the information explain the application and decision making
process for future studies?
E. Is the method of how the data/samples from the biobank will be
shared with other researchers explained (e.g. – completely or partially
de-identified)?
D. Y N
F. Is there a statement telling researchers how to cite the biobank in
their research?
E. Y N
G. Future contact:
1) Is there an option for participants to choose to be contacted for
future studies?
2) Is there a statement that the biobank may contact participants in
the future (e.g. – to obtain updated medical info, a blood sample, or
samples for additional studies?)
F. Y N
H1 Does the participant and/or his/her heirs receive compensation for
discoveries made with his/her samples?
H2 Does the researcher with whom the biobank shares the
data/samples exercise intellectual property rights?
G(1) Y N NA
G(2) Y N
H3 If yes, is there a time limit to the intellectual property rights?
H4 May the researcher use the data/samples to develop commercial
products?
H1. Y N NA
I. If the data or samples are shared with a researcher outside the
biobank, can that researcher share them with a third party?
J. Do participants have to contact the researcher to have their
data/samples withdrawn from future research?
K. Is it the case that samples/data already used cannot be withdrawn
from the research?
H2. Y N NA
H3. Y N NA
H4. Y N NA
L. Does the biobank address what to do with an IRR discovered in a
future study?
M. Does the biobank address what to do with an IF discovered in a
future study?
N. Are researchers using biobank samples/data NOT allowed to
attempt to identify the participant?
O. Are researchers using biobank samples/data NOT allowed to test for
certain IFs (e.g. non-paternity)?
I. Y N NA
J. Y N NA
K. Y N NA
L. Y N NA
Describe:
M. Y N NA
Describe:
N. Y N NA
O. Y N NA;
List:
List:
Q. 9 Other Interesting
statements in the biobank
documents related to IRR and
IF (not covered in Q2-8)