OSP Library
OSP Publications
Below, please find a selection of OSP staff publications.
Jorgenson, L. A., Wolinetz, C. D., & Collins, F. S. (2021). Incentivizing a New Culture of Data Stewardship. JAMA, 326(22), 2259. https://doi.org/10.1001/jama.2021.20489
Wolinetz, C. D., & Collins, F. S. (2020). Recognition of Research Participants’ Need for Autonomy: Remembering the Legacy of Henrietta Lacks. JAMA. https://doi.org/10.1001/jama.2020.15936
Ekweani, E., Paine T., Tapley K. (2018) Certificates of Confidentiality Following Enactment of the 21st Century Cures Act, Journal of Health & Life Sciences Law
Jorgenson, L. (Ed.). (2018). Cancer Moonshot [Special issue]. The Cancer Journal: The Journal of Principles & Practice of Oncology, 24(3)
Wolinetz, C. D., & Collins, F. S. (2017). Single-Minded Research Review: The Common Rule and Single IRB Policy. The American Journal of Bioethics, 17(7), 34-36. doi:10.1080/15265161.2017.1328542
Wong, K. M., Langlais, K., Tobias, G. S., Fletcher-Hoppe, C., Krasnewich, D., Leeds, H. S., . . . Sherry, S. T. (2016). The dbGaP data browser: a new tool for browsing dbGaP controlled-access genomic data. Nucleic Acids Research, 45(D1). doi:10.1093/nar/gkw1139
Gordon, V., Culp, M., & Wolinetz, C. (2017). Final NIH Policy on the Use of a Single Institutional Review Board for Multisite Research. Clinical and Translational Science, 10(3), 130-132. doi:10.1111/cts.12447
Zarin, D. A., Tse, T., Williams, R. J., & Carr, S. (2016). Trial Reporting in ClinicalTrials.gov — The Final Rule. New England Journal of Medicine, 375(20), 1998-2004. doi:10.1056/nejmsr1611785
Dyke, S. O., Philippakis, A. A., Argila, J. R., Paltoo, D. N., Luetkemeier, E. S., Knoppers, B. M., . . . Sherry, S. T. (2016). Consent Codes: Upholding Standard Data Use Conditions. PLOS Genetics, 12(1). doi:10.1371/journal.pgen.1005772
Harris, K.L., Bayha, R.T., Corrigan-Curay, J., Wolinetz, C.D., (2016). IBCs – A cornerstone of public trust in research. In C.R. Baskin & A.P. Zelicoff (Eds.), Ensuring National Biosecurity (pp. 201-215). Cambridge, MA: Academic Press.
King, K., Grazette, L. P., Paltoo, D. N., McDevitt, J. T., Sia, S. K., Barrett, P. M., … Libby, P. (2016). Point-of-Care Technologies for Precision Cardiovascular Care and Clinical Research: National Heart, Lung, and Blood Institute Working Group. JACC. Basic to Translational Science, 1(1-2), 73–86. http://doi.org/10.1016/j.jacbts.2016.01.008
Stevens, A.J., Jensen, J.J., Wyller, K., Kilgore, P.C., London, E., Zhang, Q., Chatterjee, S., and Rohrbaugh, M.L, (2016). The commercialization of new drugs and vaccines discovered in public sector research. In University Technology Transfer: The Globalization of Academic Innovation, S.M. Breznitz and H. Etzkowitz, eds., (pp. 102-145) United Kingdom: Routledge.
Bayha, R., Harris, K. L., Shipp, A. C., Corrigan-Curay, J., & Wolinetz, C. D. (2015). The NIH Office of Biotechnology Activities Site Visit Program: Observations about Institutional Oversight of Recombinant and Synthetic Nucleic Acid Molecule Research. Applied Biosafety, 20(2), 75-80. doi:10.1177/153567601502000202
Chen, H.-S., Hutter, C. M., Mechanic, L. E., Amos, C. I., Bafna, V., Hauser, E. R., … Feuer, E. J. (2015). Genetic Simulation Tools for Post-Genome Wide Association Studies of Complex Diseases. Genetic Epidemiology, 39(1), 11–19. http://doi.org/10.1002/gepi.21870
Corrigan-Curay, J., O’Reilly, M., Kohn, D. B., Cannon, P. M., Bao, G., Bushman, F. D., … Porteus, M. H. (2015). Genome Editing Technologies: Defining a Path to Clinic: Genomic Editing: Establishing Preclinical Toxicology Standards, Bethesda, Maryland 10 June 2014. Molecular Therapy, 23(5), 796–806. http://doi.org/10.1038/mt.2015.54
Jorgenson, L. A., Newsome, W. T., Anderson, D. J., Bargmann, C. I., Brown, E. N., Deisseroth, K., . . . Wingfield, J. C. (2015). The BRAIN Initiative: developing technology to catalyse neuroscience discovery. Philosophical Transactions of the Royal Society B: Biological Sciences, 370(1668), 20140164-20140164. doi:10.1098/rstb.2014.0164
O’Reilly, M., et al., (2015). The National Institutes of Health oversight of human gene transfer research: enhancing science and safety. In Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective, M.C. Galli and M. Serabian, eds., (pp 31-47) New York: Springer
Chatterjee, S. K., & Rohrbaugh, M. L. (2014). NIH inventions translate into drugs and biologics with high public health impact. Nature Biotechnology, 32(1), 52-58. doi:10.1038/nbt.2785
Paltoo, D. N., Rodriguez, L. L., Feolo, M., Gillanders, E., Ramos, E. M., Rutter, J. L., . . . Green, E. D. (2014). Data use under the NIH GWAS Data Sharing Policy and future directions. Nature Genetics, 46(9), 934-938. doi:10.1038/ng.3062
Patterson, A., Fennington, K., Bayha, R., Wax, D., Hirschberg, R., Boyd, N., & Kurilla, M. (2014). Biocontainment laboratory risk assessment: perspectives and considerations. Pathogens and Disease, 71(2), 102-108. doi:10.1111/2049-632x.12162
Portilla, L., & Rohrbaugh, M. (2014). Leveraging Public Private Partnerships to Innovate under Challenging Budget Times. Current Topics in Medicinal Chemistry, 14(3), 326-329. doi:10.2174/1568026613666131127155703
O’Reilly, M., Federoff, H. J., Fong, Y., Kohn, D. B., Patterson, A. P., Ahmed, N., … Corrigan-Curay, J. (2014). Gene Therapy: Charting a Future Course—Summary of a National Institutes of Health Workshop, April 12, 2013. Human Gene Therapy, 25(6), 488–497. http://doi.org/10.1089/hum.2014.045
Corrigan-Curay, J., Kiem, H.-P., Baltimore, D., O’Reilly, M., Brentjens, R. J., Cooper, L., … Kohn, D. B. (2014). T-Cell Immunotherapy: Looking Forward: T Cell Immunotherapy: Optimizing Trial Design Bethesda, Maryland 10-11 September 2013. Molecular Therapy, 22(9), 1564–1574. http://doi.org/10.1038/mt.2014.148
O’Reilly, M., Kohn, D. B., Bartlett, J., Benson, J., Brooks, P. J., Byrne, B. J., … Corrigan-Curay, J. (2013). Gene Therapy for Rare Diseases: Summary of a National Institutes of Health Workshop, September 13, 2012. Human Gene Therapy, 24(4), 355–362. http://doi.org/10.1089/hum.2013.064
Deo, R., Nalls, M. A., Avery, C. L., Smith, J. G., Evans, D. S., Keller, M. F., … Whitsel, E. A. (2013). Common genetic variation near the connexin-43 gene is associated with resting heart rate in African Americans: A genome-wide association study of 13,372 participants. Heart Rhythm : The Official Journal of the Heart Rhythm Society, 10(3), 401–408. http://doi.org/10.1016/j.hrthm.2012.11.014
Fox, E. R., Musani, S. K., Barbalic, M., Lin, H., Yu, B., Ogunyankin, K. O., … Vasan, R. S. (2013). Genome-Wide Association Study of Cardiac Structure and Systolic Function in African Americans: The Candidate Gene Association Resource (CARe) Study. Circulation. Cardiovascular Genetics, 6(1), 37–46. http://doi.org/10.1161/CIRCGENETICS.111.962365
Galarneau, G., Coady, S., Garrett, M. E., Jeffries, N., Puggal, M., Paltoo, D., … Papanicolaou, G. J. (2013). Gene-centric association study of acute chest syndrome and painful crisis in sickle cell disease patients. Blood, 122(3), 434–442. http://doi.org/10.1182/blood-2013-01-478776
Wojczynski, M. K., Li, M., Bielak, L. F., Kerr, K. F., Reiner, A. P., Wong, N. D., … Reilly, M. P. (2013). Genetics of coronary artery calcification among African Americans, a meta-analysis. BMC Medical Genetics, 14, 75. http://doi.org/10.1186/1471-2350-14-75
Corrigan-Curay, J., Cohen-Haguenauer, O., O’Reilly, M., Ross, S. R., Fan, H., Rosenberg, N., … Kohn, D. B. (2012). Challenges in Vector and Trial Design Using Retroviral Vectors for Long-Term Gene Correction in Hematopoietic Stem Cell Gene Therapy: Retroviral and Lentiviral Vectors for Long-Term Gene Correction: Clinical Challenges in Vector and Trial Design Bethesda, Maryland, USA 9–10 December 2010. Molecular Therapy, 20(6), 1084–1094. http://doi.org/10.1038/mt.2012.93
Hammersla, A.M. and Rohrbaugh, M.L., (2012). Intellectual Property Claims to Stem Cell Technologies: Research Clinical Testing and Product Sales. In Progenitor and Stem Cell Technologies and Therapies, A. Atala, ed., Cambridge: Woodhead Publishing Ltd.
Masys, D. R., Jarvik, G. P., Abernethy, N. F., Anderson, N. R., Papanicolaou, G. J., Paltoo, D. N., … Levy, H. P. (2012). Technical Desiderata for the Integration of Genomic Data into Electronic Health Records. Journal of Biomedical Informatics, 45(3), 419–422. http://doi.org/10.1016/j.jbi.2011.12.005
Mechanic, L. E., Chen, H.-S., Amos, C. I., Chatterjee, N., Cox, N. J., Divi, R. L., … Gillanders, E. M. (2012). Next Generation Analytic Tools for Large Scale Genetic Epidemiology Studies of Complex Diseases. Genetic Epidemiology, 36(1), 22–35. http://doi.org/10.1002/gepi.20652
Musunuru, K., Roden, D. M., Boineau, R., Bristow, M. R., McCaffrey, T. A., Newton-Cheh, C., … Hasan, A. A. K. (2012). Cardiovascular Pharmacogenomics: Current Status and Future Directions—Report of a National Heart, Lung, and Blood Institute Working Group. Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease, 1(2), e000554. http://doi.org/10.1161/JAHA.111.000554
O’Reilly, M., Shipp, A., Rosenthal, E., Jambou, R., Shih, T., Montgomery, M., . . . Corrigan-Curay, J. (2012). NIH Oversight of Human Gene Transfer Research Involving Retroviral, Lentiviral, and Adeno-associated Virus Vectors and the Role of the NIH Recombinant DNA Advisory Committee. Methods in Enzymology Gene Transfer Vectors for Clinical Application, 313-335. doi:10.1016/b978-0-12-386509-0.00016-8