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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 StewardshipJAMA326(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 LacksJAMAhttps://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 PolicyThe 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 dataNucleic 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 RuleNew 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 ConditionsPLOS 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 Science1(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 ResearchApplied 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 DiseasesGenetic Epidemiology39(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 Therapy23(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 discoveryPhilosophical 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 impactNature 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 directionsNature 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 considerationsPathogens 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, 2013Human Gene Therapy25(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 2013Molecular Therapy22(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, 2012Human Gene Therapy24(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 Society10(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 Genetics6(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. Blood122(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-analysisBMC Medical Genetics14, 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 2010Molecular Therapy20(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 Informatics45(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 DiseasesGenetic Epidemiology36(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 GroupJournal of the American Heart Association: Cardiovascular and Cerebrovascular Disease1(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