Search Results - "O’Rourke, P Pearl"

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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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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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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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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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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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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Returning a Research Participant's Genomic Results to Relatives: Analysis and Recommendations by Wolf, Susan M., Branum, Rebecca, 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.

“…Genomic research results and incidental findings with health implications for a research participant are of potential interest not only to the participant, but…”
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Post‐trial responsibilities in pragmatic clinical trials: Fulfilling the promise of research to drive real‐world change by Morain, Stephanie R., O'Rourke, P. Pearl, Ali, Joseph, Rahimzadeh, Vasiliki, Check, Devon K., Bosworth, Hayden B., Sugarman, Jeremy

“…While considerable scholarship has explored responsibilities owed to research participants at the conclusion of explanatory clinical trials, no guidance exists…”
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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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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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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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Canadian Research Ethics Board Leadership Attitudes to the Return of Genetic Research Results to Individuals and Their Families by Fernandez, Conrad V., O'Rourke, P. Pearl, Beskow, Laura M.

“…Genomic research may uncover results that have direct actionable benefit to the individual. An emerging debate is the degree to which researchers may have…”
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Centralized banks for human embryonic stem cells: a worthwhile challenge by O'Rourke, P Pearl, Abelman, Melinda, Heffernan, Kate Gallin

“…Centralized banking of human embryonic stem (hES) cells is an endeavor that can benefit individual research efforts and enhance international collaboration but…”
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