-
1
-
-
67650391208
-
Disclosure of research results from cancer genomic studies: State of the science
-
Systematic review of common themes, areas of controversy and remaining gaps of recommendations and guidelines from federal agencies (NIH, NCI, DOD, NHGRI and OHRP), advisory groups (National Bioethics Advisory Committee) and advocacy groups (National Action Plan on Breast Cancer) regarding the process and conditions for returning genetic or genomic research results
-
Dressler LG. Disclosure of research results from cancer genomic studies: state of the science. Clin. Cancer Res. 15(13), 4270-4276 (2009). Systematic review of common themes, areas of controversy and remaining gaps of recommendations and guidelines from federal agencies (NIH, NCI, DOD, NHGRI and OHRP), advisory groups (National Bioethics Advisory Committee) and advocacy groups (National Action Plan on Breast Cancer) regarding the process and conditions for returning genetic or genomic research results.
-
(2009)
Clin. Cancer Res.
, vol.15
, Issue.13
, pp. 4270-4276
-
-
Dressler, L.G.1
-
2
-
-
84856722686
-
IRB perspectives on the return of individual results from genomic research
-
Dressler LG, Smolek S, Ponsaran R et al. IRB perspectives on the return of individual results from genomic research. Genet. Med. 14(2), 215-222 (2012).
-
(2012)
Genet. Med.
, vol.14
, Issue.2
, pp. 215-222
-
-
Dressler, L.G.1
Smolek, S.2
Ponsaran, R.3
-
3
-
-
79951863517
-
Ethical and practical guidelines for reporting genetic research results to study participants: Updated guidelines from a National Heart, Lung, and Blood Institute working group
-
A 28-member multidisciplinary working group was assembled by the National Heart, Lung and Blood Institute in early 2009 to update previous recommendations (2004) on the same topic. The working group produced five recommendations, two of which address the criteria necessary to determine when genetic results should and may be returned to study participants. These two criteria are used to guide the assessment in this paper
-
Fabsitz RR, Mcguire A, Sharp RR et al. Ethical and practical guidelines for reporting genetic research results to study participants: updated guidelines from a National Heart, Lung, and Blood Institute working group. Circ. Cardiovasc. Genet. 3(6), 574-580 (2010). A 28-member multidisciplinary working group was assembled by the National Heart, Lung and Blood Institute in early 2009 to update previous recommendations (2004) on the same topic. The working group produced five recommendations, two of which address the criteria necessary to determine when genetic results should and may be returned to study participants. These two criteria are used to guide the assessment in this paper.
-
(2010)
Circ. Cardiovasc. Genet.
, vol.3
, Issue.6
, pp. 574-580
-
-
Fabsitz, R.R.1
Mcguire, A.2
Sharp, R.R.3
-
4
-
-
79959276553
-
Deploying whole genome sequencing in clinical practice and public health: Meeting the challenge one bin at a time
-
Excellent ana lysis of the return of incidental findings from whole-genome sequencing in the context of a clinical environment and clinical care
-
Berg JS, Khoury MJ, Evans JP. Deploying whole genome sequencing in clinical practice and public health: meeting the challenge one bin at a time. Genet. Med. 13(6), 499-504 (2011). Excellent ana lysis of the return of incidental findings from whole-genome sequencing in the context of a clinical environment and clinical care.
-
(2011)
Genet. Med.
, vol.13
, Issue.6
, pp. 499-504
-
-
Berg, J.S.1
Khoury, M.J.2
Evans, J.P.3
-
5
-
-
44949211505
-
Managing incidental findings in human subjects research: Ana lysis and recommendations
-
Seminal article on return of incidental findings from genetic and genomic research. Led by SM Wolf, a national group of experts was assembled to address this issue. Recommendations were proposed based on a net-benefit approach to the research participant
-
Wolf SM, Lawrenz FP, Nelson CA et al. Managing incidental findings in human subjects research: ana lysis and recommendations. J. Law Med. Ethics 36(2), 219-248, 211 (2008). Seminal article on return of incidental findings from genetic and genomic research. Led by SM Wolf, a national group of experts was assembled to address this issue. Recommendations were proposed based on a net-benefit approach to the research participant.
-
(2008)
J. Law Med. Ethics
, vol.36
, Issue.2
-
-
Wolf, S.M.1
Lawrenz, F.P.2
Nelson, C.A.3
-
6
-
-
34248647304
-
Medicine. Reestablishing the researcher-patient compact
-
Kohane IS, Mandl KD, Taylor PL, Holm IA, Nigrin DJ, Kunkel LM. Medicine. Reestablishing the researcher-patient compact. Science 316(5826), 836-837 (2007).
-
(2007)
Science
, vol.316
, Issue.5826
, pp. 836-837
-
-
Kohane, I.S.1
Mandl, K.D.2
Taylor, P.L.3
Holm, I.A.4
Nigrin, D.J.5
Kunkel, L.M.6
-
8
-
-
84872758402
-
Return of individual results from cancer genomic research: ICGC researcher experiences and institutional practices
-
on behalf of the Ethics and Policy Working Group of the International Cancer Genome Consortium (ICGC) Presented at
-
Dressler LG, Markey J, Deal A, Knoppers B; on behalf of the Ethics and Policy Working Group of the International Cancer Genome Consortium (ICGC). Return of individual results from cancer genomic research: ICGC researcher experiences and institutional practices. Presented at: 6th Annual Meeting of the International Cancer Genome Consortium (ICGC). Cannes, France, 21 March 2012.
-
6th Annual Meeting of the International Cancer Genome Consortium (ICGC). Cannes, France, 21 March 2012
-
-
Dressler, L.G.1
Markey, J.2
Deal, A.3
Knoppers, B.4
-
10
-
-
0032576111
-
Professional integrity in clinical research
-
Miller FG, Rosenstein DL, Derenzo EG. Professional integrity in clinical research. JAMA 280(16), 1449-1454 (1998).
-
(1998)
JAMA
, vol.280
, Issue.16
, pp. 1449-1454
-
-
Miller, F.G.1
Rosenstein, D.L.2
Derenzo, E.G.3
-
11
-
-
77956628518
-
Researcher perspectives on disclosure of incidental findings in genetic research
-
Meacham MC, Starks H, Burke W, Edwards K. Researcher perspectives on disclosure of incidental findings in genetic research. J. Empir. Res. Hum. Res. Ethics 5(3), 31-41 (2010).
-
(2010)
J. Empir. Res. Hum. Res. Ethics
, vol.5
, Issue.3
, pp. 31-41
-
-
Meacham, M.C.1
Starks, H.2
Burke, W.3
Edwards, K.4
-
12
-
-
77951102340
-
Genetic research with stored biological materials: Ethics and practice
-
Wolf LE, Bouley TA, Mcculloch CE. Genetic research with stored biological materials: ethics and practice. IRB 32(2), 7-18 (2010).
-
(2010)
IRB
, vol.32
, Issue.2
, pp. 7-18
-
-
Wolf, L.E.1
Bouley, T.A.2
Mcculloch, C.E.3
-
13
-
-
0029834131
-
ASHG report. Statement on informed consent for genetic research
-
The American Society of Human Genetics
-
ASHG report. Statement on informed consent for genetic research. The American Society of Human Genetics. Am. J. Hum. Genet. 59(2), 471-474 (1996).
-
(1996)
Am. J. Hum. Genet.
, vol.59
, Issue.2
, pp. 471-474
-
-
-
14
-
-
33750388916
-
The emergence of an ethical duty to disclose genetic research results: International perspectives
-
Knoppers BM, Joly Y, Simard J, Durocher F. The emergence of an ethical duty to disclose genetic research results: international perspectives. Eur. J. Hum. Genet. 14(11), 1170-1178 (2006).
-
(2006)
Eur. J. Hum. Genet.
, vol.14
, Issue.11
, pp. 1170-1178
-
-
Knoppers, B.M.1
Joly, Y.2
Simard, J.3
Durocher, F.4
-
15
-
-
41149120561
-
A critical appraisal of the scientific basis of commercial genomic profiles used to assess health risks and personalize health interventions
-
Janssens AC, Gwinn M, Bradley LA, Oostra BA, Van Duijn CM, Khoury MJ. A critical appraisal of the scientific basis of commercial genomic profiles used to assess health risks and personalize health interventions. Am. J. Hum. Genet. 82(3), 593-599 (2008).
-
(2008)
Am. J. Hum. Genet.
, vol.82
, Issue.3
, pp. 593-599
-
-
Janssens, A.C.1
Gwinn, M.2
Bradley, L.A.3
Oostra, B.A.4
Van Duijn, C.M.5
Khoury, M.J.6
-
16
-
-
22344451611
-
Comparison of HER2 status by fluorescence in situ hybridization and immunohistochemistry to predict benefit from dose escalation of adjuvant doxorubicin-based therapy in node-positive breast cancer patients
-
Dressler LG, Berry DA, Broadwater G et al. Comparison of HER2 status by fluorescence in situ hybridization and immunohistochemistry to predict benefit from dose escalation of adjuvant doxorubicin-based therapy in node-positive breast cancer patients. J. Clin. Oncol. 23(19), 4287-4297 (2005).
-
(2005)
J. Clin. Oncol.
, vol.23
, Issue.19
, pp. 4287-4297
-
-
Dressler, L.G.1
Berry, D.A.2
Broadwater, G.3
-
17
-
-
0028872836
-
Points to consider: Ethical, legal, and psychosocial implications of genetic testing in children and adolescents
-
American Society of Human Genetics Board of Directors, American College of Medical Genetics Board of Directors
-
American Society of Human Genetics Board of Directors, American College of Medical Genetics Board of Directors. Points to consider: ethical, legal, and psychosocial implications of genetic testing in children and adolescents. Am. J. Hum. Genet. 57(5), 1233-1241 (1995).
-
(1995)
Am. J. Hum. Genet.
, vol.57
, Issue.5
, pp. 1233-1241
-
-
-
18
-
-
0031991614
-
ASHG statement. Professional disclosure of familial genetic information
-
The American Society of Human Genetics Social Issues Subcommittee on Familial Disclosure
-
The American Society of Human Genetics Social Issues Subcommittee on Familial Disclosure. ASHG statement. Professional disclosure of familial genetic information. Am. J. Hum. Genet. 62(2), 474-483 (1998).
-
(1998)
Am. J. Hum. Genet.
, vol.62
, Issue.2
, pp. 474-483
-
-
-
19
-
-
70350241800
-
How will GINA influence participation in pharmacogenomics research and clinical testing?
-
Dressler LG, Terry SF. How will GINA influence participation in pharmacogenomics research and clinical testing? Clin. Pharmacol. Ther. 86(5), 472-475 (2009).
-
(2009)
Clin. Pharmacol. Ther.
, vol.86
, Issue.5
, pp. 472-475
-
-
Dressler, L.G.1
Terry, S.F.2
-
20
-
-
71849090072
-
Public opinion about the importance of privacy in biobank research
-
Seminal qualitative study demonstrating the preference and expectation of the public to receive individual research results when joining research biobanks
-
Kaufman DJ, Murphy-Bollinger J, Scott J, Hudson KL. Public opinion about the importance of privacy in biobank research. Am. J. Hum. Genet. 85(5), 643-654 (2009). Seminal qualitative study demonstrating the preference and expectation of the public to receive individual research results when joining research biobanks.
-
(2009)
Am. J. Hum. Genet.
, vol.85
, Issue.5
, pp. 643-654
-
-
Kaufman, D.J.1
Murphy-Bollinger, J.2
Scott, J.3
Hudson, K.L.4
-
21
-
-
84861462252
-
Survey of US public attitudes toward pharmacogenetic testing
-
doi:10.1038/tpj.2011.1 (Epub ahead of print). An excellent survey study about the public's support of pharmacogenomic testing, including their concerns
-
Haga SB, O'Daniel JM, Tindall GM, Lipkus IR, Agans R. Survey of US public attitudes toward pharmacogenetic testing. Pharmacogenomics J. doi:10.1038/tpj.2011.1 (2011) (Epub ahead of print). An excellent survey study about the public's support of pharmacogenomic testing, including their concerns.
-
(2011)
Pharmacogenomics J.
-
-
Haga, S.B.1
O'Daniel, J.M.2
Tindall, G.M.3
Lipkus, I.R.4
Agans, R.5
-
22
-
-
48849115644
-
Pharmacogenetic testing: Not as simple as it seems
-
Haga SB, Burke W. Pharmacogenetic testing: not as simple as it seems. Genet. Med. 10(6), 391-395 (2008).
-
(2008)
Genet. Med.
, vol.10
, Issue.6
, pp. 391-395
-
-
Haga, S.B.1
Burke, W.2
-
23
-
-
66349085616
-
Apolipoprotein E: Strucutre determines function: from atheroslcerosis to Alzheimer's disease to AIDS
-
Mahley Robert W, Weisgraber Karl H, Yadong H. Apolipoprotein E: strucutre determines function: from atheroslcerosis to Alzheimer's disease to AIDS. J. Lipid Res. 50(Suppl.), S183-S188 (2011).
-
(2011)
J. Lipid Res.
, vol.50
, Issue.SUPPL.
-
-
Mahley, R.W.1
Weisgraber, K.H.2
Yadong, H.3
-
24
-
-
67749114265
-
CYP2D6 and tamoxifen: DNA matters in breast cancer
-
Hoskins JM, Carey LA, Mcleod HL. CYP2D6 and tamoxifen: DNA matters in breast cancer. Nat. Rev. Cancer 9(8), 576-586 (2009).
-
(2009)
Nat. Rev. Cancer
, vol.9
, Issue.8
, pp. 576-586
-
-
Hoskins, J.M.1
Carey, L.A.2
Mcleod, H.L.3
-
25
-
-
77957318902
-
Pharmacogenetics in breast cancer: Steps toward personalized medicine in breast cancer management
-
Rofaiel S, Muo EN, Mousa SA. Pharmacogenetics in breast cancer: steps toward personalized medicine in breast cancer management. Pharmacogenom. Personal. Med. 3, 129-143 (2010).
-
(2010)
Pharmacogenom. Personal. Med.
, vol.3
, pp. 129-143
-
-
Rofaiel, S.1
Muo, E.N.2
Mousa, S.A.3
-
26
-
-
29544447266
-
The AmpliChip CYP450 genotyping test: Integrating a new clinical tool
-
De Leon J, Susce MT, Murray-Carmichael E. The AmpliChip CYP450 genotyping test: integrating a new clinical tool. Mol. Diagn. Ther. 10(3), 135-151 (2006).
-
(2006)
Mol. Diagn. Ther.
, vol.10
, Issue.3
, pp. 135-151
-
-
De Leon, J.1
Susce, M.T.2
Murray-Carmichael, E.3
-
27
-
-
80053950209
-
Association of BRCA1 and BRCA2 mutations with survival, chemotherapy sensitivity, and gene mutator phenotype in patients with ovarian cancer
-
Yang D, Khan S, Sun Y et al. Association of BRCA1 and BRCA2 mutations with survival, chemotherapy sensitivity, and gene mutator phenotype in patients with ovarian cancer. JAMA 306(14), 1557-1565 (2011).
-
(2011)
JAMA
, vol.306
, Issue.14
, pp. 1557-1565
-
-
Yang, D.1
Khan, S.2
Sun, Y.3
-
28
-
-
79955035027
-
Electronic medical records for genetic research: Results of the eMERGE consortium
-
Kho AN, Pacheco JA, Peissig PL et al. Electronic medical records for genetic research: results of the eMERGE consortium. Sci. Trans. Med. 3(79), 79re71 (2011).
-
(2011)
Sci. Trans. Med.
, vol.3
, Issue.79
-
-
Kho, A.N.1
Pacheco, J.A.2
Peissig, P.L.3
-
30
-
-
75749155367
-
-
(Accessed 1 December 2011) NIH points to consider for IRBs and institutions in their review of data submission plans for institutional certifications. Under NIH's policy for sharing of data obtained in NIH supported or conducted genome-wide association studies
-
NIH genome-wide association studies. http://gwas.nih.gov/pdf/PTC-for- IRBs-and-Institutions-revised5-31-11.pdf (Accessed 1 December 2011) NIH points to consider for IRBs and institutions in their review of data submission plans for institutional certifications. Under NIH's policy for sharing of data obtained in NIH supported or conducted genome-wide association studies.
-
NIH Genome-wide Association Studies
-
-
-
31
-
-
84859561576
-
Report and Recommendations of the National Bioethics Advisory Commission
-
Accessed 5 December 2011
-
National Bioethics Advisory Commission (NBAC). 1999. Research involving human biological materials: ethical issues and policy guidance - Volume 1. Report and Recommendations of the National Bioethics Advisory Commission. http://bioethics.georgetown.edu/nbac/hbm.pdf (Accessed 5 December 2011).
-
(1999)
Research Involving Human Biological Materials: Ethical Issues and Policy Guidance
, vol.1
-
-
-
32
-
-
84872749136
-
-
Statute 102, PL100-578 (Accessed 10 May 2012)
-
Clinical Laboratory Improvement Amendment of 1988. Statute 102, PL100-578. www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ IVDRegulatoryAssistance/ucm124105.htm (Accessed 10 May 2012)
-
Clinical Laboratory Improvement Amendment of 1988
-
-
-
33
-
-
84860426408
-
-
Public Health Genomics. Accessed 1 December 2011
-
CDC, Public Health Genomics. ACCE Model Process for Evaluating Genetic Tests. www.cdc.gov/genomics/gtesting/ACCE (Accessed 1 December 2011)
-
ACCE Model Process for Evaluating Genetic Tests
-
-
-
35
-
-
84872750996
-
Evaluation of predictive genetic tests for common diseases: Bridging epidemiological, clinical and public health measures
-
Public Health Genomics. (2nd Edition): building the evidence for using genetic information to improve health and prevent disease. Chapter 22. Accessed 3 January 2012
-
CDC, Public Health Genomics. Human Genome Epidemiology (2nd Edition): building the evidence for using genetic information to improve health and prevent disease. Chapter 22. Evaluation of predictive genetic tests for common diseases: bridging epidemiological, clinical and public health measures. Cecile A, Janssens JW, Gwinn M, Khoury MJ. http://cdc.gov/genomics/resources/books/ 2010-HuGE/chap22.htm (Accessed 3 January 2012)
-
Human Genome Epidemiology
-
-
Cecile, A.1
Janssens, J.W.2
Gwinn, M.3
Khoury, M.J.4
-
36
-
-
12344312699
-
-
US Department of Health and Human Services. NIH. National Cancer Institute. Accessed 5 December 2011
-
US Department of Health and Human Services. NIH. National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE) (2009). http://ctep.cancer.gov/protocolDevelopment/electronic-applications/ctc.htm. (Accessed 5 December 2011)
-
(2009)
Common Terminology Criteria for Adverse Events (CTCAE)
-
-
-
37
-
-
84872748833
-
-
Accessed 10 May 2012
-
WHO Toxicity Scale. www.icssc.org/Documents/Resources/ AEManual2003AppendicesFebruary-06-2003%20final.pdf (Accessed 10 May 2012)
-
WHO Toxicity Scale
-
-
|