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https://www.readbyqxmd.com/read/30387976/therapeutic-misperceptions-in-early-phase-cancer-trials-from-categorical-to-continuous
#1
Bryan A Sisk, Eric Kodish
Appropriate enrollment in early-phase clinical trials demands that potential research participants understand and appreciate critical study-related information, because discrepancies in understanding or appreciation can potentially invalidate informed consent to participate in research. Four terms were previously developed to categorize these discrepancies: therapeutic "misconception," "therapeutic misestimation," "therapeutic optimism," and "unrealistic optimism." In this article, we propose a continuous framework of therapeutic misperceptions, rather than discrete categorical concepts...
July 2018: IRB
https://www.readbyqxmd.com/read/30387975/the-need-to-track-payment-incentives-to-participate-in-hiv-research
#2
Brandon Brown, Jerome T Galea, Karine Dubé, Peter Davidson, Kaveh Khoshnood, Lisa Holtzman, Logan Marg, Jeff Taylor
Providing incentives is an accepted and common practice in human subjects research, including clinical HIV research. While we know that financial incentives among similar studies can greatly vary, surprisingly little research exists on how to determine when such incentives are excessive or constitute an "undue inducement." Multiple factors, such as risks and benefits, study procedures, study budget, historical precedent, recommendations from institutional review boards, advice from other investigators, and local regulations may influence decisions about appropriate incentives, but little empirical data exist about what incentives are offered to potential research participants...
July 2018: IRB
https://www.readbyqxmd.com/read/30387974/potential-benefits-to-families-children-and-adolescents-enrolled-in-longitudinal-qualitative-research
#3
Minisha Lohani, Kristopher A Hendershot, Wendy Pelletier, Kristin Stegenga, Margie Dixon, Pamela S Hinds, Melissa A Alderfer, Rebecca D Pentz
Previous research has focused on the risks of research participation but has rarely considered possible benefits. For a study of family decision-making during pediatric bone marrow transplant, we conducted qualitative interviews with 132 family members across 36 families up to three times over the course of a year, before and after transplant. We concluded the study with qualitative interviews of 70 family members from 21 of the original families one year after the transplants, focusing on benefits and concerns regarding their research participation...
July 2018: IRB
https://www.readbyqxmd.com/read/29910527/the-food-and-drug-administration-s-federal-review-of-a-pediatric-muscular-dystrophy-protocol
#4
Donna L Snyder, Robert M Nelson
No abstract text is available yet for this article.
January 2018: IRB
https://www.readbyqxmd.com/read/29881132/reaping-the-bounty-of-publicly-available-clinical-trial-consent-forms
#5
Holly Fernandez Lynch, Emily A Largent, Deborah A Zarin
Public access to clinical trial consent forms, beyond those individuals involved in reviewing, conducting, or participating in a trial, has been notoriously poor, resulting in missed opportunities for empirical analysis and improvement, among other benefits. However, recent changes to the Common Rule and policies governing ClinicalTrials.gov promise to make trial consent forms more accessible to the public, including prospective trial participants, other trialists and IRBs, and those seeking to study research consent...
November 2017: IRB
https://www.readbyqxmd.com/read/30387977/research-on-medical-practices-why-patients-consider-participating-and-the-investigational-misconception
#6
Stephanie A Kraft, Kathryn M Porter, Diane M Korngiebel, Cyan James, Melissa Constantine, Maureen Kelley, Alexander M Capron, Douglas Diekema, Sandra Soo-Jin Lee, Mildred K Cho, David Magnus, Benjamin S Wilfond
Understanding how patients decide whether to enroll in research can help improve educational materials, protocols, and recruitment rates. However, little is known about patients' willingness to participate in research on medical practices (ROMP), or studies comparing interventions within usual care. We assessed willingness to consider participating in ROMP by surveying 1095 adults in the United States, of whom 834 answered at least one open-ended question about their reasons for being willing or unwilling to consider participating in two scenarios involving ROMP...
July 2017: IRB
https://www.readbyqxmd.com/read/29187769/adolescent-sexual-behavior-research-perspectives-of-investigators-irb-members-and-irb-staff-about-risk-categorization-and-irb-approval
#7
Kyle A McGregor, Devon J Hensel, Amy C Waltz, Elizabeth Molnar, Mary A Ott
No abstract text is available yet for this article.
July 2017: IRB
https://www.readbyqxmd.com/read/29038611/paying-research-participants-the-outsized-influence-of-undue-influence
#8
Emily A Largent, Holly Fernandez Lynch
No abstract text is available yet for this article.
July 2017: IRB
https://www.readbyqxmd.com/read/30148334/reducing-consent-form-length-stakeholder-support-evidence-based-strategies-and-regulatory-requirements
#9
Amy Corneli, Jeremy Sugarman
No abstract text is available yet for this article.
March 2017: IRB
https://www.readbyqxmd.com/read/30148333/pregnancy-testing-of-adolescents-during-clinical-research-managing-the-process
#10
Marilyn C Morris, Susan L Rosenthal
No abstract text is available yet for this article.
March 2017: IRB
https://www.readbyqxmd.com/read/30148331/why-research-oversight-bodies-should-interview-research-subjects
#11
Carl Elliott
No abstract text is available yet for this article.
March 2017: IRB
https://www.readbyqxmd.com/read/30148330/the-guinea-phase-iii-ebola-vaccine-trial-lessons-for-research-ethics-review-in-public-health-emergencies
#12
Reidar K Lie, David Wendler
No abstract text is available yet for this article.
March 2017: IRB
https://www.readbyqxmd.com/read/30148327/public-engagement-notice-and-comment-rulemaking-and-the-common-rule
#13
Holly Fernandez Lynch, I Glenn Cohen, Barbara E Bierer
No abstract text is available yet for this article.
January 2017: IRB
https://www.readbyqxmd.com/read/30146866/research-on-medical-practices-romp-attitudes-of-irb-personnel-about-randomization-and-informed-consent
#14
Kathryn M Porter, Mildred K Cho, Stephanie A Kraft, Diane M Korngiebel, Melissa Constantine, Sandra Soo-Jin Lee, Maureen Kelley, Cyan James, Ellen Kuwana, Adrienne Meyer, Douglas Diekema, Alexander M Capron, David Magnus, Benjamin S Wilfond
No abstract text is available yet for this article.
January 2017: IRB
https://www.readbyqxmd.com/read/30146864/identifying-gaps-in-suicide-research-a-scoping-review-of-ethical-challenges-and-proposed-recommendations
#15
REVIEW
Victoria Saigle, Monique Séguin, Eric Racine
No abstract text is available yet for this article.
January 2017: IRB
https://www.readbyqxmd.com/read/30088378/incident-reports-and-corrective-actions-received-by-ohrp
#16
Kemnique Ramnath, Sarita Cheave, Lisa Buchanan, Kristina Borror, Marinna Banks-Shields
No abstract text is available yet for this article.
November 2016: IRB
https://www.readbyqxmd.com/read/30088377/recontacting-pediatric-research-participants-for-consent-when-they-reach-the-age-of-majority
#17
Bartha Maria Knoppers, Karine Sénécal, Joanne Boisjoli, Pascal Borry, Martina C Cornel, Conrad V Fernandez, Jasjote Grewal, Ingrid A Holm, Erin Nelson, Wim Pinxten, Mahsa Shabani, Anne Marie Tassé, Ma’n Zawati, Wright Clayton
Because children are presumed to have insufficient cognitive ability to consent to participate in research, pediatric research raises particular ethical and legal issues. For children who have not reached the age of consent stipulated by law or policy, parents (or legal guardians) must authorize their participation. This paper explores the issue of whether, to satisfy the ethical and legal norms of consent for research, participants in pediatric studies who attain the age of majority after their parents or guardians enrolled them in a study should be “recontacted” to obtain their consent to remain in the study...
November 2016: IRB
https://www.readbyqxmd.com/read/30146860/erratum
#18
(no author information available yet)
No abstract text is available yet for this article.
September 2016: IRB
https://www.readbyqxmd.com/read/30146859/digitizing-consent-the-food-and-drug-administration%C3%A2-s-draft-guidance-on-electronic-informed-consent
#19
Christian M Simon, David W Klein, Helen A Schartz
No abstract text is available yet for this article.
September 2016: IRB
https://www.readbyqxmd.com/read/30146857/the-impact-of-unrealistic-optimism-on-informed-consent-in-early-phase-oncology-trials
#20
Lynn A Jansen, Daruka Mahadevan, Paul S Appelbaum, William M P Klein, Neil D Weinstein, Motomi Mori, Racky Daffé, Daniel P Sulmasy
No abstract text is available yet for this article.
September 2016: IRB
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