Search Results - "OʼRourke, P Pearl"

Recurring and Emerging Ethical Issues in Pragmatic Clinical Trials by Propes, Caleigh, O'Rourke, P Pearl, Morain, Stephanie R

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Central Institutional Review Board Review for an Academic Trial Network by Kaufmann, Petra, O’Rourke, P Pearl

“…PROBLEMTranslating discoveries into therapeutics is often delayed by lengthy start-up periods for multicenter clinical trials. One cause of delay can be…”
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Framework for development of physician competencies in genomic medicine: report of the Competencies Working Group of the Inter-Society Coordinating Committee for Physician Education in Genomics by Korf, Bruce R., Berry, Anna B., Limson, Melvin, Marian, Ali J., Murray, Michael F., O’Rourke, P. Pearl, Passamani, Eugene R., Relling, Mary V., Tooker, John, Tsongalis, Gregory J., Rodriguez, Laura L.

“…Completion of the Human Genome Project, in conjunction with dramatic reductions in the cost of DNA sequencing and advances in translational research, is…”
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Global implementation of genomic medicine: We are not alone by Manolio, Teri A, Abramowicz, Marc, Al-Mulla, Fahd, Anderson, Warwick, Balling, Rudi, Berger, Adam C, Bleyl, Steven, Chakravarti, Aravinda, Chantratita, Wasun, Chisholm, Rex L, Dissanayake, Vajira H W, Dunn, Michael, Dzau, Victor J, Han, Bok-Ghee, Hubbard, Tim, Kolbe, Anne, Korf, Bruce, Kubo, Michiaki, Lasko, Paul, Leego, Erkki, Mahasirimongkol, Surakameth, Majumdar, Partha P, Matthijs, Gert, McLeod, Howard L, Metspalu, Andres, Meulien, Pierre, Miyano, Satoru, Naparstek, Yaakov, O'Rourke, P Pearl, Patrinos, George P, Rehm, Heidi L, Relling, Mary V, Rennert, Gad, Rodriguez, Laura Lyman, Roden, Dan M, Shuldiner, Alan R, Sinha, Sukdeb, Tan, Patrick, Ulfendahl, Mats, Ward, Robyn, Williams, Marc S, Wong, John E L, Green, Eric D, Ginsburg, Geoffrey S

“…Around the world, innovative genomic-medicine programs capitalize on singular capabilities arising from local health care systems, cultural or political…”
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Ethical and Practical Guidelines for Reporting Genetic Research Results to Study Participants: Updated Guidelines From a National Heart, Lung, and Blood Institute Working Group by Fabsitz, Richard R, McGuire, Amy, Sharp, Richard R, Puggal, Mona, Beskow, Laura M, Biesecker, Leslie G, Bookman, Ebony, Burke, Wylie, Burchard, Esteban Gonzalez, Church, George, Clayton, Ellen Wright, Eckfeldt, John H, Fernandez, Conrad V, Fisher, Rebecca, Fullerton, Stephanie M, Gabriel, Stacey, Gachupin, Francine, James, Cynthia, Jarvik, Gail P, Kittles, Rick, Leib, Jennifer R, OʼDonnell, Christopher, OʼRourke, P Pearl, Rodriguez, Laura Lyman, Schully, Sheri D, Shuldiner, Alan R, Sze, Rebecca K.F, Thakuria, Joseph V, Wolf, Susan M, Burke, Gregory L

“…In January 2009, the National Heart, Lung, and Blood Institute convened a 28-member multidisciplinary Working Group to update the recommendations of a 2004…”
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Clarifying the Ethics and Oversight of Chimeric Research by Johnston, Josephine, Hyun, Insoo, Neuhaus, Carolyn P., Maschke, Karen J., Marshall, Patricia, Craig, Kaitlynn P., Matthews, Margaret M., Drolet, Kara, Greely, Henry T., Hill, Lori R., Hinterberger, Amy, Hurley, Elisa A., Kesterson, Robert, Kimmelman, Jonathan, King, Nancy M. P., Lopes, Melissa J., O'Rourke, P. Pearl, Parent, Brendan, Peckman, Steven, Piotrowska, Monika, Schwarz, May, Sebo, Jeff, Stodgell, Chris, Streiffer, Robert, Wilkerson, Amy

“…This article is the lead piece in a special report that presents the results of a bioethical investigation into chimeric research, which involves the insertion…”
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Return of Genetic Research Results to Participants and Families: IRB Perspectives and Roles by Beskow, Laura M., O'Rourke, P. Pearl

“…We surveyed IRB chairs' perspectives on offering individual genetic research results to participants and families, including family members of deceased…”
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Returning Individual Research Results from Digital Phenotyping in Psychiatry by Shen, Francis X., Baum, Matthew L., Martinez-Martin, Nicole, Miner, Adam S., Abraham, Melissa, Brownstein, Catherine A., Cortez, Nathan, Evans, Barbara J., Germine, Laura T., Glahn, David C., Grady, Christine, Holm, Ingrid A., Hurley, Elisa A., Kimble, Sara, Lázaro-Muñoz, Gabriel, Leary, Kimberlyn, Marks, Mason, Monette, Patrick J., Onnela, Jukka-Pekka, O'Rourke, P. Pearl, Rauch, Scott L., Shachar, Carmel, Sen, Srijan, Vahia, Ipsit, Vassy, Jason L., Baker, Justin T., Bierer, Barbara E., Silverman, Benjamin C.

“…Psychiatry is rapidly adopting digital phenotyping and artificial intelligence/machine learning tools to study mental illness based on tracking participants'…”
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Return of research results from genomic biobanks: cost matters by Bledsoe, Marianna J., Clayton, Ellen Wright, McGuire, Amy L., Grizzle, William E., O’Rourke, P. Pearl, Zeps, Nikolajs

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Harmonization and streamlining of research oversight for pragmatic clinical trials by O’Rourke, P Pearl, Carrithers, Judith, Patrick-Lake, Bray, Rice, Todd W, Corsmo, Jeremy, Hart, Raffaella, Drezner, Marc K, Lantos, John D

“…The oversight of research involving human participants is a complex process that requires institutional review board review as well as multiple…”
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Responding to signals of mental and behavioral health risk in pragmatic clinical trials: Ethical obligations in a healthcare ecosystem by Ali, Joseph, Morain, Stephanie R., O'Rourke, P. Pearl, Wilfond, Benjamin, O'Brien, Emily C., Zigler, Christina K., Staman, Karen L., Weinfurt, Kevin P., Sugarman, Jeremy

“…Ethical responsibilities for monitoring and responding to signals of behavioral and mental health risk (such as suicidal ideation, opioid use disorder, or…”
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Expert Perspectives on Oversight for Unregulated mHealth Research: Empirical Data and Commentary by Beskow, Laura M., Hammack-Aviran, Catherine M., Brelsford, Kathleen M., O'Rourke, P. Pearl

“…In qualitative interviews with a diverse group of experts, the vast majority believed unregulated researchers should seek out independent oversight. Reasons…”
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The OHRP and SUPPORT by Wilfond, Benjamin S, Magnus, David, Antommaria, Armand H, Appelbaum, Paul, Aschner, Judy, Barrington, Keith J, Beauchamp, Tom, Boss, Renee D, Burke, Wylie, Caplan, Arthur L, Capron, Alexander M, Cho, Mildred, Clayton, Ellen Wright, Cole, F. Sessions, Darlow, Brian A, Diekema, Douglas, Faden, Ruth R, Feudtner, Chris, Fins, Joseph J, Fost, Norman C, Frader, Joel, Hester, D. Micah, Janvier, Annie, Joffe, Steven, Kahn, Jeffrey, Kass, Nancy E, Kodish, Eric, Lantos, John D, McCullough, Laurence, McKinney, Ross, Meadow, William, O'Rourke, P. Pearl, Powderly, Kathleen E, Pursley, DeWayne M, Ross, Lainie Friedman, Sayeed, Sadath, Sharp, Richard R, Sugarman, Jeremy, Tarnow-Mordi, William O, Taylor, Holly, Tomlinson, Tom, Truog, Robert D, Unguru, Yoram T, Weise, Kathryn L, Woodrum, David, Youngner, Stuart

“…A group of medical ethicists and pediatricians asks for reconsideration of the recent Office for Human Research Protections decision about informed consent in…”
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Implementation of Electronic Consent at a Biobank: An Opportunity for Precision Medicine Research by Boutin, Natalie T, Mathieu, Kathleen, Hoffnagle, Alison G, Allen, Nicole L, Castro, Victor M, Morash, Megan, O'Rourke, P Pearl, Hohmann, Elizabeth L, Herring, Neil, Bry, Lynn, Slaugenhaupt, Susan A, Karlson, Elizabeth W, Weiss, Scott T, Smoller, Jordan W

“…The purpose of this study is to characterize the potential benefits and challenges of electronic informed consent (eIC) as a strategy for rapidly expanding the…”
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Mainstreaming animal-assisted therapy by Palley, Lori S, O'Rourke, P. Pearl, Niemi, Steven M

“…The term animal-assisted therapy (AAT) commonly refers to the presentation of an animal to one or more persons for the purpose of providing a beneficial impact…”
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Return of research results from genomic biobanks: a call for data by Bledsoe, Marianna J., Clayton, Ellen Wright, McGuire, Amy L., Grizzle, William E., O’Rourke, P. Pearl, Zeps, Nikolajs

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Pragmatic Tools for Sharing Genomic Research Results with the Relatives of Living and Deceased Research Participants by Wolf, Susan M., Scholtes, Emily, Koenig, Barbara A., Petersen, Gloria M., Berry, Susan A., Beskow, Laura M., Daly, Mary B., Fernandez, Conrad V., Green, Robert C., LeRoy, Bonnie S., Lindor, Noralane M., O'Rourke, P. Pearl, Breitkopf, Carmen Radecki, Rothstein, Mark A., Van Ness, Brian, Wilfond, Benjamin S.

“…Returning genomic research results to family members raises complex questions. Genomic research on life-limiting conditions such as cancer, and research…”
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Returning incidentally discovered Hepatitis C RNA-seq results to COPDGene study participants by Silverman, Edwin K., Kim, Arthur Y., Make, Barry J., Regan, Elizabeth A., Morrow, Jarrett D., Hersh, Craig P., O’Brien, James, Crapo, James D., Hansel, Nadia N., Criner, Gerard, Flenaugh, Eric L., Conrad, Douglas, Casaburi, Richard, Bowler, Russell P., Hanania, Nicola A., Barr, R. Graham, Bhatt, Surya P., Sciurba, Frank C., Anzueto, Antonio, Han, MeiLan K., McEvoy, Charlene E., Comellas, Alejandro P., DeMeo, Dawn L., Rosiello, Richard, Curtis, Jeffrey L., Uchida, Tricia, Wilson, Carla, O’Rourke, P. Pearl

“…The consequences of returning infectious pathogen test results identified incidentally in research studies have not been well-studied. Concerns include…”
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The Final Rule: When the Rubber Meets the Road by O'Rourke, P. Pearl

“…The Common Rule originally issued in 1991 and last amended in 2005 is scheduled to be replaced on January 19, 2018 by a revised Common Rule (the final rule)…”
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Part-Human Animal Research: The Imperative to Move Beyond a Philosophical Debate by Abelman, Melinda, O'Rourke, P. Pearl, Sonntag, Kai C.

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