genomic medicine program ronald m. przygodzki, md associate director, genomic medicine ord march...
TRANSCRIPT
![Page 1: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/1.jpg)
Genomic Medicine Program
Ronald M. Przygodzki, MDAssociate Director, Genomic Medicine
ORD
March 2008
![Page 2: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/2.jpg)
2
What is Genomic Medicine?
Genomic Medicine (personalized medicine) is healthcare tailored to an individual based on their genetic makeup (genes).
Genes are the basis for all our characteristics. There are about 25,000 genes in a human cell. In 2003, the entire human genome was
sequenced. This has resulted in an explosion in new and
advanced technologies.
![Page 3: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/3.jpg)
3
VA Genomic Medicine Program
VA launched the Genomic Medicine Program in 2006 to– Optimize medical care for veterans (for
example, avoid adverse drug reactions)– Enhance development of tests and treatments
for relevant diseases– Examine the potential of emerging genomic
technologies
![Page 4: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/4.jpg)
4
VA Genomic Medicine Program (cont’d)
VA is uniquely positioned to implement the genomics medicine program– Largest healthcare system in the US,
providing care for >5.3 million veterans– Equipped with an unrivaled electronic medical
record system– Stable and diverse patient population
![Page 5: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/5.jpg)
5
VA Genomic Medicine Program (cont’d)
Veterans may volunteer to participate– Provide blood sample for genetic analysis – Genetic information linked to their electronic
health records
![Page 6: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/6.jpg)
6
Implementation
VA Secretary established Genomic Medicine Program Advisory Committee (GMPAC)
GMPAC felt earning trust of and partnering with veterans was paramount
Recommended VA assess veterans’ knowledge, attitudes, and beliefs about genomic medicine and research participation
![Page 7: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/7.jpg)
7
Veteran Consultation Project
VA moved to assess veterans’ knowledge and attitudes in 2007.
VA established inter-agency agreement (IAA) with National Human Genome Research Institute (NHGRI) to add veteran-specific component to their ongoing project to assess public attitudes toward genomic medicine.
![Page 8: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/8.jpg)
8
Veteran Consultation Project (cont’d)
NHGRI project conducted by Genetics and Public Policy Center (GPPC) at Johns Hopkins University (PI: Kathy Hudson)
GPPC will conduct veteran focus groups and surveys over a 1-year period
![Page 9: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/9.jpg)
9
Focus Groups
Knowledge and attitudes about genomic medicine
General acceptability of proposed goals and methods of VA genomic studies
Areas of concern Methods of recruitment and consent issues Role of Veteran Service Organizations (VSOs) Expectations of potential participants with regard
to confidentiality, privacy, and security Use of research findings Return of results, ongoing communication, etc.
![Page 10: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/10.jpg)
10
Focus Groups (cont’d)
Nine focus groups were conducted (10-12 participants in each group).
Focus group guides and questions were developed in consultation with VACO.
![Page 11: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/11.jpg)
11
Focus Groups (cont’d)
Veterans were recruited from:– Local chapters of VSOs that reflect the
diversity of veterans using VA healthcare system
– VAMCs, VA Community-Based Outpatient Clinics, and VET Centers (Readjustment Counseling Centers) from various geographic regions and demographic groups
![Page 12: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/12.jpg)
12
Focus Groups (cont’d)
Pilot Southeast Northeast Midwest West
DC
Sept 19
Atlanta
Sept 26-27
Bronx
Oct 4
Denver
Oct 17-18
San Antonio
Nov 5
1. Mixed group
2. Women 5. African
American
7. Hispanic 9. Hispanic
3. Caucasian
>70
6. Caucasian
<$39K/yr
8. <30 yrs
4. African
American
10. >$55K/yr
![Page 13: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/13.jpg)
13
Initial Observations from Focus Groups
Areas of optimism include:– Altruism and a sense of community– No expectations of compensation for
participation– Community leaders to voice their
opinions/concerns– Appreciative of being consulted– Generally knowledgeable about genetics
![Page 14: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/14.jpg)
14
Initial Observations from Focus Groups (cont’d)
Areas of concern include:– Trust issues – Data privacy, security, and access– Data sharing (trusted VA and academic
researchers but not the commercial sector)– Loss of benefits
![Page 15: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/15.jpg)
15
Survey
Based on issues raised in focus groups, GPPC will develop internet-based survey
Plan to survey 850 veterans, including those receiving their healthcare through VA
![Page 16: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/16.jpg)
16
Fears about Genetic Research
Genetic information could be used against people by employers or insurers– To counteract concern, House passed the
Genetic Information Nondiscrimination Act (2007), which is expected to be passed in Senate and signed into law soon.
![Page 17: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/17.jpg)
17
Fears about Genetic Research (cont’d)
Veteran’s benefits would be affected if shown to have genetic disposition to a disease– Having dealt with genetically based diseases,
consistent position of VA that genetic disease that first appears during a period of active service constitutes a service-connected condition
– Genomic medicine program aims only to improve effectiveness of VA’s health care system
![Page 18: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/18.jpg)
18
Data and Sample Sharing Policy
Samples and data will only be available to VA researchers.
Policy may change to reflect veterans’ attitudes revealed in Veteran Consultation Project focus groups and survey.
![Page 19: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/19.jpg)
19
GMPAC Working Groups
Ethics Advisory - ethical considerations, esp. informed consent of special populations
Hereditary Non-Polyposis Colon Cancer (HNPCC) - research on routine genetic/genomic analysis for clinical management of HNPCC & sporadic colon cancer
Endocrine Tumors - research on routine genetic/genomic analysis for clinical management of tumors with known genetic abnormalities
![Page 20: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/20.jpg)
20
Infrastructure Development
DNA Bank/Biorepository (Boston VA)– About 30,000 blood samples collected as part of CSP
trials Pharmacogenomics Analysis Laboratory (Little
Rock) Educational tools—collaboration between VA
Employee Education Resource Center and National Coalition ofr Health Professionals Education in Genetics (NCHPEG)
Assessing current capabilities and activities related to genomics at VAMCs
![Page 21: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/21.jpg)
21
Ongoing Genomics/ Genetics-Related Projects
VA funds 142 investigator-initiated Merit Review projects– Cover wide spectrum of conditions prevalent
in veterans: schizophrenia, PTSD, bipolar disorder, substance abuse, Alzheimer’s, cardiovascular disease, diabetes, cancer (prostate, breast, colon, bladder, lung), stroke, chronic viral infections, autoimmune disorders, Gulf War Illness, etc.
– Genetic-association, pharmacogenomics– Candidate gene analysis, SNP analysis,
linkage studies, microarrays, si RNA, gene expression
![Page 22: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/22.jpg)
22
Studies in Planning
Serious Mental Illness Cohort Study – Concept letter approved for
planning/submitting full proposal to CSP – Goal to develop 3 longitudinal cohorts, each
consisting of 5000 veterans suffering from 1) schizophrenia or 2) bipolar disorder or a 3) control group
– Genome-wide association studies• Variants that contribute to functional disability• Responsiveness to therapy• Drug toxicity
![Page 23: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/23.jpg)
23
Studies in Planning (cont’d)
PTSD Genetics Working/Planning Group– Goal to explore/ define basis to conduct
research on PTSD through development of new/ expansion of current cohorts (e.g., ongoing CSP clinical trials).
– Via careful clinical characterization and genetic analyses, cohort should be longitudinally available.
– Use cohort to determine genetic variants contributing to PTSD risk, as well as treatment response and outcomes.
![Page 24: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/24.jpg)
24
Interactions With Other Organizations
VA involved in ongoing discussions and in working groups with: – Pharmacogenetic Research Network, supported by
several NIH Institutes– National Human Genome Research Institute
(NHGRI)– Institute of Medicine Roundtable on Translating
Genomic-Based Research for Health– American Health Information Community (AHIC)
![Page 25: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/25.jpg)
Tissue Banking Policies
January 2008
![Page 26: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/26.jpg)
26
Topics Covered
Definitions of human biological specimens, banked specimens, and de-identified
On-site tissue banks Off-site tissue banks Specimens stored at non-academic, for-
profit institutions Applying for an off-site waiver Elements required in an informed consent
![Page 27: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/27.jpg)
27
Human Biological Specimens
Any material derived from a human subject—such as blood, urine, tissues, organs, hair, nail clippings, or any other cells or fluids
Whether collected for research purposes or as residual specimens from diagnostic, therapeutic, or surgical procedures
![Page 28: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/28.jpg)
28
Banked Specimens
Biological specimens collected and stored for future research purposes that are beyond the scope of work described in the original protocol and informed consent
OR Biological specimens collected under a
protocol designed for banking of specimens
![Page 29: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/29.jpg)
29
Non-Banked Human Biological Specimens
Human biological specimens collected under a VA-approved protocol that are used for only the specific purposes defined in the protocol and are destroyed when the specific testing/use is completed or at the end of the protocol
Important Notes:– If specimens are stored off-site at a non-profit
institution 5 years, then the investigator must obtain a waiver from ORD.
– If specimens are stored off-site at a non-academic, for-profit institution for >3 months, a waiver must be obtained from ORD.
![Page 30: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/30.jpg)
30
Non-Banked Specimens
If the specimens are sent to a non-VA institution for testing as defined in the protocol, once the specific analyses are performed, the remainder of the specimens must be destroyed or returned to the VA for destruction.
If the specimens are destroyed at another institution, that institution must certify the destruction of the specimens in writing.
![Page 31: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/31.jpg)
31
De-identified De-identified data is health or other information
about an individual that:
Does not contain any of the 18 HIPAA identifiersAND
Is de-identified according to the Common Rule
Coded information is not considered de-identified if the tissue bank or data coordinating center has access to the codes.
![Page 32: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/32.jpg)
32
HIPAA Identifiers
1. Names or initials
2. All geographic subdivisions smaller than a state
3. All elements of dates except the year and all ages over 89
4. Telephone numbers
5. Fax numbers
6. E-mail addresses
7. Social Security numbers (or scrambled SSNs)
8. Medical record numbers
9. Health plan beneficiary numbers
![Page 33: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/33.jpg)
33
HIPAA Identifiers (cont’d)
10. Account numbers
11. Certificate or license numbers
12. Vehicle identifiers
13. Device identifiers and serial numbers
14. URLs
15. IP addresses
16. Biometric identifiers, including finger and voice prints
17. Full-face photographs and any comparable images
18. Any other unique identifying number, characteristic, or code
![Page 34: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/34.jpg)
34
On-Site Tissue Banks
A tissue bank established at a VA site by a VA-paid investigator does not require ORD approval.
The ACOS/R or research office should maintain records of all tissue banks within the facility.
![Page 35: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/35.jpg)
35
On-Site Tissue Banks (cont’d)
If a VA site does not have the resources to bank specimens, then they may be banked at any VA site that has an established tissue bank.
Alternatively, specimens may be banked at the Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC) core laboratory at the Boston VA. It serves as the Cooperative Studies Program (CSP) Genetic Tissue Core Laboratory.
Either option is considered on-site banking.
![Page 36: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/36.jpg)
36
Off-Site Tissue Banks
The researcher must obtain a waiver from ORD before banking human biological specimens at an off-site location.
Off-site tissue banks are approved on a per protocol basis.
Exception: National Cancer Institute (NCI)-sponsored cooperative tissue banks listed on the next slide. As a result of a letter of understanding with the NCI, these banks are designated as VA-approved if they are used for one of their protocols (for example, the SWOG-supported tissue bank can be used for SWOG protocols without ORD approval).
![Page 37: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/37.jpg)
37
VA-Approved NCI Tissue Banks
Clinical Trials Cooperative Groups Tissue Resources – American College of Surgeons Oncology Group (ACOSOG) – Cancer and Leukemia Group B (CALGB) – Eastern Cooperative Oncology Group (ECOG) – Gynecologic Oncology Group (GOG) – North Central Cancer Treatment Group (NCCTG) – National Surgical Adjuvant Breast and Bowel Project (NSABP) – Radiation Therapy Oncology Group (RTOG) – Southwest Oncology Group (SWOG)– National Cancer Institute of Canada Clinical Trials Group (NCIC
CTG) Cooperative Breast Cancer Tissue Resource Cooperative Human Tissue Network Gynecologic Oncology Group Tissue Network Cancer Prevention Network
![Page 38: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/38.jpg)
38
Banked Specimens
Specimens may not be banked at a non-academic, for-profit institution
Specimens must be labeled with a code that does not contain any of the 18 HIPAA identifiers.
The key to the code must be maintained at the VA unless there is a compelling reason otherwise.
![Page 39: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/39.jpg)
39
Data Related to Banked Specimens
If data linked to the sample leaves the VA, then it must be de-identified or stored in a database that is encrypted according to FIPS 140-2 standards.
See VA Handbook 6500 “Information Security.”
![Page 40: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/40.jpg)
40
Non-Banked Specimens Stored at Non-Academic
For-Profit Sites If the specimens are held for >3 months, then a
waiver must be obtained from ORD. Only analyses/tests listed in the protocol and
informed consent may be performed. The code must be maintained at the VAMC. All specimens and associated data must be de-
identified. DNA and RNA may not be analyzed. The company must inform the PI in writing when
samples are destroyed.
![Page 41: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/41.jpg)
41
Non-Banked Specimens Stored at Non-Academic For-Profit Sites (cont’d)
HIPAA authorization must expire. Case reports may not contain initials if they
leave VA. Specimens must be destroyed upon request of
the subject. Before company personnel may view files at the
VA, they must complete VA security and privacy training.
Specimens must be destroyed within 1 year of the study completion date.
![Page 42: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/42.jpg)
42
Application Process
The investigator must complete VA form 10-0436. This is a pdf form that can be filled in and saved using Acrobat Reader version 7 or higher (http://www.va.gov/vaforms/medical/pdf/vha-10-0436-fill.pdf).
The information requested on page 5 of the application can be scanned and attached to the pdf or to the e-mail. – Biographical sketch of the PI– Research protocol– Tissue bank manual or SOPs– VA consent form
![Page 43: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/43.jpg)
43
Application Process (cont’d)
The application should be e-mailed to Marilyn Mason ([email protected]). The ACOS/R must be carbon copied.
Alternatively, the form and requested information can be mailed to the address given on the form.
![Page 44: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/44.jpg)
44
Application Process (cont’d)
After the application is reviewed, the PI and ACOS/R will receive a memo listing any issues found with the application. Frequently, the informed consent needs to be modified.
![Page 45: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/45.jpg)
45
Multi-Site Trials
If several VAMCs are planning to participate in the same clinical trial, then only one of the VA sites needs to apply for a waiver.
A list of multi-site clinical trials in which more than one VAMC is participating is posted on the VA R&D web site. (http://www.research.va.gov/programs/tissue_banking)
![Page 46: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/46.jpg)
46
Informed Consent
Several elements must be included in an informed consent when the protocol involves banking–either on-site or off-site– of human biological specimens.
The elements are important for transparency to the subject.
The list of elements is posted on the VA R&D web site, and some are given on the next slide.
![Page 47: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/47.jpg)
47
Informed Consent (cont’d)
Some informed consent elements– Types of samples stored and length of time to
be stored– Name and location of tissue bank– Types of future studies– Subject may withdraw from the study and
request that his/her samples be destroyed– If the specimen will be shared with other
researchers for approved research protocols
![Page 48: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/48.jpg)
48
Informed Consent (cont’d)
The informed consent does not need to narrowly specify the future uses of the banked specimens.
But if it is not specific, in the consent form or during the consent process, the PI should explain what such phrases as “related diseases” or “unspecified research” means for the use of the sample and the impact on the subject.
![Page 49: Genomic Medicine Program Ronald M. Przygodzki, MD Associate Director, Genomic Medicine ORD March 2008](https://reader038.vdocuments.us/reader038/viewer/2022110321/56649cee5503460f949bb210/html5/thumbnails/49.jpg)
49
Contact Information
For additional information and questions, contact Marilyn Mason– E-mail: [email protected]– Phone: 202-254-0496– Fax: 202-254-0521