Challenging cases in clinical research ethics:
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| Format: | Buch |
| Sprache: | Englisch |
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Boca Raton ; London ; New York
CRC Press
2024
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| Ausgabe: | First edition |
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| Links: | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=034804444&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=034804444&sequence=000003&line_number=0002&func_code=DB_RECORDS&service_type=MEDIA |
| Umfang: | xxv, 318 Seiten Diagramme |
| ISBN: | 9781032370958 9781032370965 |
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Datensatz im Suchindex
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| adam_text | Contents xv Foreword Contributors xvii Acknowledgments xxv 1 Introduction Benjamin S. Wilfond, Liza-Marie Johnson, Devan Μ. Duenas, and Holly A. Taylor A framework for research ethics Principles of research ethics Topics in research ethics Values of research ethics Summary 1 Collaborative partnership Benjamin S. Wilfond Case 1.1: Supporting community-academic research partnerships: reflections from the ground Introduction References Commentary 1.1.1: Community-partnered participatory research in Southeastern Louisiana communities threatened by climate change: the C-LEARN experience Benjamin F. Springgate, Olivia Sugarman, Kenneth B. Wells, Lawrence A. Palinkas, Diana Meyers, Ashley Wennerstrom, Arthur Johnson, Catherine Haywood, Daniel Sarpong, and Richard Culbertson Commentary 1.1.2: Leveraging academic institutional structures to support asian american community organizations engagement in research: the Korean community service center Joon~Ho Yu Commentary 1.1.3: Engaging the sickle cell community in participatory research Yvonne Carroll Commentary 1.1.4: Being in good community: engagement in support of indigenous sovereignty Jessica Blanchard and Vanessa Hiratsuka 2 2 3 4 5 7 14 14 15 15 18 20 23 V
vi Contents Case 1.2: Protecting research subject welfare in preventive trials for autosomal dominant Alzheimer s disease Introduction Case summary Commentary 1.2.1: When there are only two who can tango: ethical concerns at the juncture of highly novel interventions and precisely targeted research populations Mark Yarborough Commentary 1.2.2: Conceptualization and assessment of vulnerability in a complex international Alzheimer s research study Stanley Korenman, Stuart G. Finder, and John Μ. Ringman Commentary 1.2.3: Barriers and facilitators to the consent process in a study of complex genetic factors Anne R. Simpson Case 1.3: Studying the role of financial incentives to promote hepatitis В vaccination in a community clinic Introduction Case summary References Commentary 1.3.1: Treatment incentives and the nature of the doctor-patient relationship Hannah Giunta Commentary 1.3.2: The ethics of studying financial incentives in public health implementation: study design challenges Adelaide Doussau and Christine Grady Commentary 1.3.3: You can lead a horse to water, but can you pay to make him drink? An ethical analysis of research on using incentives to promote patient health Ponni Perumaiswami, Andrea Branch, and Rosamond Rhodes Case 1.4: A cluster randomized trial to screen for abusive head trauma in the pediatric intensive care unit—how to manage site-specific evidence of racial/ethnic disparity Introduction Case summary References 27 27 27 28 30 32 35 35 35 36 36 38 40 43 43 43 44 Commentary 1.4.1: Issues of justice and risk: setting stopping criteria in cluster
randomized trials 45 Emma Tumilty and Jeffrey S. Farroni Commentary 1.4.2: Clinical trials not causing harm with potential for realizing benefit should continue 47 Brian Michael Jackson Commentary 1.4.3: Responding to implicit bias in abusive head trauma evaluations and reporting in the PICU: ethical considerations during a clinical trial 5$ Jennifer B. McCormick and Kent P. Hymel Case 1.5: When a clinical trial is the only option Introduction ~ Case summary Commentary 1.5.1: Respect for persons, not respect for citizens Rachel Fabi ^^ 52
Contents vii Commentary 1.5.2: The potentially high cost of a free clinical trial Elizabeth Heitman Commentary 1.5.3: Contextualizing choice for undocumented immigrants in U.S. clinical trials research Nancy J. Burke Case 1.6: A randomized trial of rapamycin to increase longevity and health span in companion animals: navigating the boundary between protections for animal research andhuman subjects research Introduction Case summary References Commentary 1.6.1: Rapamycin: risking harmfor canine longevity Cheryl Abbate Commentary 1.6.2: Companion animal studies: slipping through a research oversight gap Rebecca L Walker and Jill A. Fisher Commentary 1.6.3: Research to promote longevity and health span in companion dogs: a pediatric perspective Benjamin S. Wilfond, Kathryn Μ. Porter, Kate E. Creevy, Matt Kaeberlein, and Daniel Promislow 2 Respect for participants Holly A. Taylor Case 2.1: Ethical considerations for unblinding a participant s assignment to interpret a resolved adverse event Introduction Case summary Commentary 2.1.1: Considerations for unblinding in biopharmaceutical industry-sponsored trials J. Jina Shah and John Bond Commentary 2.1.2: Blinds and research risks Robert Steel and Marion Danis Commentary 2.1.3: The scientific and social implications of unblinding a study subject Lynne Μ. Quittell Case 2.2: Should research participants be notified about results of currently unknown but potential significance? Introduction Case summary References Commentary 2.2.1: The need for national guidance around informed consent about GBCA safety Stephen D. Brown Commentary
2.2.2: Returning individual research results regarding gadolinium deposition in the brain is the preferable choice Caroline J. Huang, W. Patricia Bandettini, and Marion Danis Commentary 2.2.3: Research participants should have the option to be notified of results of unknown but potential significance Nora Hutchinson, Alexander Capron, and Adélaïde Doussau 55 57 60 60 60 61 61 63 65 68 77 77 77 78 80 82 85 85 85 86 86 88 90
viii Contents Case 2.3: The ethics of contacting family members of a subject in a genetic research study to return results for an autosomal dominant syndrome Introduction Commentary 2.3.1: What does the duty to warn require? Seema K. Shah, Sara Chandros Hull, Michael A. Spinner, Benjamin E. Berkman, Lauren A. Sanchez, Ruquyyah Abdul-Karim, Amy P. Hsu, Reginald Claypool, and Steven Μ. Holland Commentary 2.3.2: Should researchers disclose results to descendants? Mark A. Rothstein Commentary 2.3.3: Relationships matter: ethical considerations for returning results to family members of deceased subjects Lauren C. Milner, Emily Y. Liu, and Nanibaa A. Garrison Case 2.4: Ethics of continuing to provide a drug on an open-label extension study for an unapprovedindication Introduction Case summary Commentary 2.4.1: When shouldopen-label extension studies be stopped? Joshua S. Crites Commentary 2.4.2: The role of clinical equipoise and practical considerations in deciding whether to continue to provide a drug on an open-label extension study for an unapproved indication” Ryan R. Nash Commentary 2.4.3: Open-label extension studies: are they really research? Mildred K. Cho Case 2.5: Supporting investigators in challenging cases: unease in the face of an ethically appropriate action Introduction Case summary Commentary 2.5.1: Researchersexperience moral distress too! Toby Schönfeld and Cynthia Μ. A. Geppert Commentary 2.5.2: Relieving investigator angst after an appropriate but concerning ethics consultation Shannon Blee, Hannah Claire Sibold, Margie Dixon, and Rebecca D. Pentz
Commentary 2.5.3: Acknowledging angst: research ethics consultation in disclosing experimental research results of uncertain benefit Ryan Spellecy and Alan Nyitray Case 2.6: Recontact and recruitment of young adults previously enrolled in neonatal herpessimplex virus research Introduction Case summary References Commentary 2.6.1: Research recruitment of adult survivors of neonatal infections: is there a role for parental consent? Ann J. Melvin, Kathleen Μ. Mohan, Anna Wald, Kathryn Porter, and Benjamin S. Wilfond Commentary 2.6.2: A knotty problem of intertwined rights Ross E. McKinney Commentary 2.6.3: Consent is the cornerstone of ethically valid research: ethical issues in recontacting subjects who enrolled in research as a minor Erin Talati Paquette and Lainie Friedman Ross 93 93 94 96 98 100 100 100 101 103 105 107 107 107 108 110 112 115 115 115 116 116 118 120
Contents ix Case 2.7: Genotype-driven recruitment in population-based biomedical research Introduction Case summary References Commentary 2.7.1: Genotype-driven recruitment without deception Pilar Ossorio and Marsha Mailick Commentary 2.7.2: Harms of deception in FMR1 premutation genotype-driven recruitment Sam Doernberg and Sara Chandros Hull Commentary 2.7.3: Genotype-driven recruitment and the disclosure of individual research results Laura Μ. Beskow 3 Fair participant selection Holly A. Taylor Case 3.1: Is it ethical to enroll cognitively impaired adults in research that is more than minimal risk with no prospect of benefit? Introduction Case summary Commentary 3.1.1: Inconsistent approaches to research involving cognitively impaired adults: why the broad view of substituted judgment is our best guide Mark Yarborough Commentary 3.1.2: Ethical and regulatory considerations regarding enrollment of incompetent adults in more than minimal risk research as compared with children Arthur R. Derse and Ryan Spellecy Commentary 3.1.3: Acceptable approaches to enrolling adults who cannot consent in more than minimal risk research Marion Danis, David Wendler, and Scott Y. H. Kim Case 3.2: Should patients be required to undergo standard chemotherapy before being eligible for novel phase I immunotherapy clinical trials? Introduction Case summary References Commentary 3.2.1: A rationale for relaxing the requirement to undergo a noncurative chemotherapy for advanced cancer in a phase I immunotherapy trial Adélaïde Doussau and Clark B. Hanmer Commentary 3.2.2: Participation of citizen
scientists in clinical research and access to research ethics consultations Elaine Collier and Marion Danis Commentary 3.2.3: Forgoing conventional therapy in phase I oncology research: don t forget about the children Cynthia Wetmore Case 3.3: Involving pregnant women in research: what should we recommend when the regulations seem ethically problematic? Introduction Case background References 123 123 123 124 124 127 129 132 139 139 139 140 142 145 148 148 148 149 149 151 153 156 156 156 157
X Contents Commentary 3.3.1: Conflicts between regulations and ethical principles: resolving ambiguity in favor of the ethically preferable outcome 157 Seema K. Shah and Kathryn Porter Commentary 3.3.2: When to avoid giving advice on the ethical conduct of research 159 Richard R. Sharp and Megan A. Allyse Commentary 3.3.3: When research regulations and ethics conflict 160 Haley K. Sullivan, Derek W. Braverman, and David Wendler Case 3.4: Enrolling adolescents with rare disease for early-phase clinical trials while under the care of child protective services: balancing protection and access 163 Introduction 163 Case summary 163 Reference 164 Commentary 3.4.1: Fuzzy logic: how the practicalities of state involvement shape the most ethically supportable way forward 164 Jessica Μ. Turnbull and Daniel J. Benedetti Commentary 3.4.2: Enrolling foster youth in clinical trials; avoiding the harm of exclusion 166 Mary V Greiner and Armand H. Matheny Antommaria Commentary 3.4.3: No justification to exclude a state ward from pediatric transplant research 168 Kathy J. Forte and Emily E. Anderson Commentary 3.4.4: Lifesaving experimental treatment for a teenage ward of the state 171 Henry Sacks and Rosamond Rhodes Case 3.5: Selecting children for an autism spectrum disorder study: justice and geography 174 Introduction 174 Case summary 174 Commentary 3.5.1 : Fair participant selection: a negative obligation not to exclude 175 Stephanie C. Chen Commentary 3.5.2: Unequal individual risk and potential benefit balanced by benefits to the population at large in autism clinical trials? 177
Mark A. Stein and Bryan H. King Commentary 3.5.3: Justice in selecting participants for a study in PhelanMcDermid syndrome 179 Rosamond Rhodes and Alex Kolevzon 4 Favorable risk-benefit ratio Liza-Marie Johnson Case 4.1: Obligations to act on patient-reported outcomes in electronic health records Introduction Case summary Commentary 4.1.1: Informed consent for pros in ehr research: are additional requirements necessary? Danielle Whicher and Emily Evans Commentary 4.1.2: Patient-reported outcomes at the crossroads of clinical research and informatics Eric S. Swirsky and Andrew D. Boyd 182 188 188 188 188 191
Contents xi Commentary 4.1.3: Pros in the balance: ethical implications of collecting patient-reported outcome measures in the electronic health record Joshua S. Crites, Cynthia Chuang, Anne Dimmock, Wenke Hwang, Bobbie Johannes, Anuradha Paranjape, and Albert W. Wu Case 4.2: A trial to test a novel approach to diabetes prevention Introduction Case summary References Commentary 4.2.1 : Is it ethically acceptable to screen patients for obstructive sleep apnea and not offer them positive airway pressure therapy in a clinical trial? Jennifer B. Mccormick, Joel T. Wu, and Adélaïde Doussau Commentary 4.2.2: Can we breathe easy if pap therapy is withheld? Holly A. Taylor and Naresh Μ. Punjabi Commentary 4.2.3: Risks of clinical research must be reasonable and necessary D. Gibbes Miller and Scott Y. H. Kim Case 4.3: Is it ethically appropriate to refuse to compensate participants who are believed to have intentionally concealed medical conditions? Introduction Case summary Commentary 4.3.1 : Mutual obligations in research and withholding payment from deceptive participants Holly Fernandez Lynch, Luke Gelinas, and Emily A. Largent Relevant principles Commentary 4.3.2: Best to exclude but pay Marion Danis, Sam Doernberg, Matthew Memoli, and Joseph Milium Commentary 4.3.3: To pay or not to pay? Withholding payment from research participants Rosamond Rhodes and Michael Danziger Case 4.4: Ethical drug development for rare childhood diseases: when there are limited but promising data in adults, how to choose between safety or efficacy studies? Introduction Case summary References
Commentary 4.4.1: The use of pediatric extrapolation to avoid unnecessary pediatric clinical trials Robert Μ. Nelson Commentary 4.4.2: Flexibility required: balancing the interests of children and risk in drug development for rare pediatric conditions Kathryn Μ. Porter, Anne Stevens, and Benjamin S. Wilfond Commentary 4.4.3: When higher risk does not equal greater harm: doing the most good in a limited pediatric study population Jeff Matsler and Jamila Μ. Young Case 4.5: Greater than minimal risk, no direct benefit: bridging drug trials and novel therapy in pediatric populations Introduction Case summary Specific questions 193 195 195 195 196 196 198 200 203 203 203 204 205 207 208 211 211 212 212 214 216 218 221 221 221 222
xii Contents Commentary 4.5.1: Balancing risk and reward: greater research oversight is appropriate for novel therapies for children with life-limiting illness Yoram Unguru Commentary 4.5.2: Bringing known drugs to pediatric research: safety, efficacy, and the ambiguous minor increase over minimal risk Akshay Sharma and Liza-Marie Johnson Commentary 4.5.3: Balancing scientific progress with pediatric protections: no direct benefit now, but potential novel therapy in the future Susannah W. Lee and Jessica C. Ginsberg 5 Informed consent Liza-Marie Johnson Case 5.1: The ethics of disclosing to research subjects the availability of off-label marketed drugs Introduction Case summary Commentary 5.1.1: Researchers have an ethical obligation to disclose the availability of off-labelmarketed drugs Tomas J. Silber Commentary 5.1.2: The relevance of the research study phase to disclosure of off-label drug availability Amrutha Baskaran and Robert Μ. Sade Commentary 5.1.3: Which alternatives should investigators disclose to research subjects? John Phillips and David Wendler Case 5.2: A pragmatic trial of suicide risk assessment and ambulance transport decision making among emergency medical services providers: implications for patient consent Introduction Case summary References Commentary 5.2.1: Improving care for suicidal patients while protecting human subjects: addressing ethical challenges in mental health research involving emergency medical services providers Christopher R. DeCou, Seema K. Shah, and Kathryn Μ. Porter Commentary 5.2.2: A stepwise approach to ethically assess
pragmatic cluster randomized trials: implications for informed consent for suicide prevention implementation research Cory E. Goldstein and Charles Weijer Commentary 5.2.3: Informed consent in a pragmatic emergency suicide trial: rejecting the research-practice distinction Kristin Canavera and Kendra Parris Commentary 5.2.4: A pragmatic trial for emergency medical services providers prehospital response to suicidality: consent is not essential, but limited patient engagement may be meaningful Neal И/. Dickert Case 5.3: The obligations to report statutory sexual abuse disclosed in a research study Introduction 222 224 227 230 240 240 240 241 242 243 246 246 246 247 248 250 253 255 25S 258
Contents xiii Case summary Commentary 5.3.1 : The moral and legal need to disclose despite a certificate of confidentiality Erin Talati Paquette and Lainie Friedman Ross Commentary 5.3.2: Informed consent and the implications for statutory rape reporting in research with adolescents Stacy Hodgkinson, Amy Lewin, Bora Chang, Lee Beers, and Tomas J. Silber Commentary 5.3.3: Community, context, and the contrasting roles of clinicians and researchers: challenges raised by statutory rape Stuart G. Finder and Stanley Korenman Case 5.4: Conjoined consent: informed consent when donor and recipient are both research participants Introduction Case summary Commentary 5.4.1 : Moving beyond standard informed consent for interventional organ transplant research Brooklyn Aaron, Jessica C. Ginsberg, and Jason Lesandrini Commentary 5.4.2: Risks to relationships in kidney transplant research with living donors and recipients Philip Ghobrial, Sanjeev Akkina, and Emily E. Anderson Commentary 5.4.3: Respecting donor-recipient relationships in research decision making: when a living donor and kidney transplant recipient are both research subjects Stephanie A. Kraft Case 5.5: Navigating parental permission for neonatal research Introduction Case summary Commentary 5.5.1: Informed consent and parental permission for research: rules, roles, and relationships Robin N. Fiore and Reid Cushman Commentary 5.5.2: Researchinvolving premature infants: timing is everything Leah R. Eisenberg Commentary 5.5.3: Precluding consent by clinicians who are both the attending and the investigator: an outdated
shibboleth? Anita Shah, Kathryn Porter, Sandra Juul, and Benjamin S. Wilfond Case 5.6: Click here to complete this survey: online research, adolescents, and parental consent Introduction Case summary Commentary 5.6.1: Digital negotiations: navigating parental permission and adolescent assent for online survey participation Holly A. Taylor and Douglas B. Mogul Commentary 5.6.2: Constrained adolescent autonomy for healthcare should include participation in survey research Amy E. Caruso Brown Commentary 5.6.3: Respecting parental permission and maintaining flexibility in online research involving adolescent participants Esther Elise Knapp 258 258 261 263 266 266 266 267 269 272 275 275 275 276 278 279 282 282 282 283 284 286
xiv Contents Case 5.7: When professional meets personal: how should research staff advertise on social media forresearch opportunities? Introduction Case summary References Commentary 5.7.1: Sharing research opportunities on personal social media accounts and fair subject selection Emily E. Anderson Commentary 5.7.2: How should investigators advertise on social media for research opportunities? Ryan Spellecy and Lindsay D. Nelson Case 5.8: The limitations of boilerplate language in informed consent: a single-irb review of multisite genetic research in military personnel Introduction Case summary Commentary 5.8.1 : The bane of boilerplate language in research consent forms: ensuring consent forms promote autonomous authorization Jeffrey R. Botkin Commentary 5.8.2: Single IRBs are responsible to ensure consent language effectively conveys the local context Sara Chandros Hull and Adam I. Schiffenbauer Commentary 5.8.3: Solving the single-IRB/boilerplate bind: establishing institutional guidelines Melissa E. Abraham, Elizabeth Hohmann, and Megan Morash 289 289 290 290 290 293 295 295 295 296 298 300 Appendix A: Cases organized by principles 303 Appendix B: Cases organized by topics 307 Appendix C: Cases organized by values 312 Index 315
Clinical research ethics consultation has emerged in the last 15 years as a service to those involved in the conduct of clinical research who face challenging issues for which more than one course of action may be justified. To respond to a growing field and need for opportunities to share knowledge and experience, the Clinical Research Ethics Consultation Collaborative, established in 2014, holds monthly webinars for its 90 members to present their most challenging cases to each other and engage in substantive discussion. Every year, the group selects the four most interesting cases with accompanying commentaries for publication in the American Journal of Bioethics. This timely book brings together these cases and commentaries under a range of common themes for the first time, creating a permanent collection in book format that encourages and supports readers to gain a better understanding of the ethical challenges that they may face, and providing them with a convenient and reflective resource to reference in their own deliberations. Key Features: • Comprehensive collection of cases and commentaries, chosen to reflect the range of issues faced by clinical researchers and oversight committees and illustrate the diversity of analysis that can arise • Supplemented by short introductions to each section • Focus on ethical rather than regulatory issues • Essential reading for graduate students in bioethics and postdoctoral bioethics fellows, and useful for all participants in training grants that are funded by either NIH or NSF Presenting challenging cases to stimulate
reflection, the book provides invaluable guidance to clinicians in training and in practice and to investigators, bioethics consultants, regulators, and oversight bodies.
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| genre | (DE-588)4522595-3 Fallstudiensammlung gnd-content |
| genre_facet | Fallstudiensammlung |
| id | DE-604.BV049458680 |
| illustrated | Not Illustrated |
| indexdate | 2024-12-20T20:12:41Z |
| institution | BVB |
| isbn | 9781032370958 9781032370965 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-034804444 |
| oclc_num | 1418700534 |
| open_access_boolean | |
| owner | DE-384 DE-578 |
| owner_facet | DE-384 DE-578 |
| physical | xxv, 318 Seiten Diagramme |
| publishDate | 2024 |
| publishDateSearch | 2024 |
| publishDateSort | 2024 |
| publisher | CRC Press |
| record_format | marc |
| spellingShingle | Challenging cases in clinical research ethics Medizinische Ethik (DE-588)4074672-0 gnd Klinisches Experiment (DE-588)4164223-5 gnd |
| subject_GND | (DE-588)4074672-0 (DE-588)4164223-5 (DE-588)4522595-3 |
| title | Challenging cases in clinical research ethics |
| title_auth | Challenging cases in clinical research ethics |
| title_exact_search | Challenging cases in clinical research ethics |
| title_full | Challenging cases in clinical research ethics edited by Benjamin S. Wilfond, Devan M. Duenas, Liza-Marie Johnson, and Holly A. Taylor |
| title_fullStr | Challenging cases in clinical research ethics edited by Benjamin S. Wilfond, Devan M. Duenas, Liza-Marie Johnson, and Holly A. Taylor |
| title_full_unstemmed | Challenging cases in clinical research ethics edited by Benjamin S. Wilfond, Devan M. Duenas, Liza-Marie Johnson, and Holly A. Taylor |
| title_short | Challenging cases in clinical research ethics |
| title_sort | challenging cases in clinical research ethics |
| topic | Medizinische Ethik (DE-588)4074672-0 gnd Klinisches Experiment (DE-588)4164223-5 gnd |
| topic_facet | Medizinische Ethik Klinisches Experiment Fallstudiensammlung |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=034804444&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=034804444&sequence=000003&line_number=0002&func_code=DB_RECORDS&service_type=MEDIA |
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