Challenging Cases
Clinical Research Ethics Consultation CollaborativeEstablished a semi-annual series of “Challenging Cases in Clinical Research Ethics” in the American Journal of Bioethics.
All Cases
October 2022
To Disclose or Not to Disclose: Secondary Findings of XXY Chromosomes. Wilfond BS, Duenas DM, Johnson LM. Am J Bioeth. 2022 Oct;22(10):87-88. doi: 10.1080/15265161.2022.2110982. PMID: 36170065.
- Miner SA, Hester DM. Respecting Autonomy and Balancing Benefits by Disclosing the Secondary Finding of Klinefelter’s. Am J Bioeth. 2022 Oct;22(10):89-91. doi: 10.1080/15265161.2022.2110974. PMID: 36170084.
- McGrew S, Berkman BE. When to Disclose a Borderline Incidental Finding. Am J Bioeth. 2022 Oct;22(10):91-93. doi: 10.1080/15265161.2022.2110975. PMID: 36170085.
- Brown J, Howard D. The Importance of Defining Actionability as Related to Disclosure of Secondary Findings Identified in Research. Am J Bioeth. 2022 Oct;22(10):93-95. doi: 10.1080/15265161.2022.2110976. PMID: 36170082.
- Noohi F, Ross LF. Clarifying the Blurry Boundaries between Research and Clinical Care. Am J Bioeth. 2022 Oct;22(10):96-98. doi: 10.1080/15265161.2022.2110977. PMID: 36170083.
April 2022
Enrolling Adolescents with Rare Disease for Early Phase Clinical Trials While Under the Care of Child Protection Services: Balancing Protection and Access. Wilfond BS, Duenas DM, Johnson LM. Am J Bioeth. 2022 Apr;22(4):81-82. doi: 10.1080/15265161.2022.2044552. PMID: 35420512; PMCID: PMC9534357.
- Turnbull JM, Benedetti DJ. Fuzzy Logic: How the Practicalities of State Involvement Shape the Most Ethically Supportable Way Forward. Am J Bioeth. 2022 Apr;22(4):83-84. doi: 10.1080/15265161.2022.2044545. PMID: 35420527.
- Greiner MV, Antommaria AHM. Enrolling Foster Youth in Clinical Trials: Avoiding the Harm of Exclusion. Am J Bioeth. 2022 Apr;22(4):85-86. doi: 10.1080/15265161.2022.2044546. PMID: 35420526.
- Forte KJ, Anderson EE. No Justification to Exclude State Ward from Pediatric Transplant Research. Am J Bioeth. 2022 Apr;22(4):87-89. doi: 10.1080/15265161.2022.2044547. PMID: 35420533.
- Sacks H, Rhodes R. Life-Saving Experimental Treatment for a Teenage Ward of the State. Am J Bioeth. 2022 Apr;22(4):89-91. doi: 10.1080/15265161.2022.2044548. PMID: 35420532.
October 2021
When Professional Meets Personal: How Should Research Staff Advertise on Social Media for Research Opportunities? Johnson LM, Duenas DM, Wilfond BS. Am J Bioeth. 2021 Oct;21(10):38-39. doi: 10.1080/15265161.2021.1965251. PMID: 34554059; PMCID: PMC8591987.
- Anderson EE. Sharing Research Opportunities on Personal Social Media Accounts and Fair Subject Selection. Am J Bioeth. 2021 Oct;21(10):40-42. doi: 10.1080/15265161.2021.1965252. PMID: 34554068.
- Spellecy R, Nelson LD. How Should Investigators Advertise on Social Media for Research Opportunities? Am J Bioeth. 2021 Oct;21(10):42-43. doi: 10.1080/15265161.2021.1965254. PMID: 34554066.
Supporting Community-Academic Research Partnerships: Reflections from the Ground. Wilfond BS, Duenas DM, Johnson LM. Am J Bioeth. 2021 Oct;21(10):44-45. doi: 10.1080/15265161.2021.1965255. PMID: 34554061; PMCID: PMC8591989.
- Springgate BF, Sugarman O, Wells KB, Palinkas LA, Meyers D, Wennerstrom A, Johnson A, Haywood C, Sarpong D, Culbertson R. Community Partnered Participatory Research in Southeast Louisiana Communities Threatened by Climate Change: The C-LEARN EXPERIENCE. Am J Bioeth. 2021 Oct;21(10):46-48. doi: 10.1080/15265161.2021.1965248. PMID: 34554077.
- Yu JH. Leveraging Academic Institutional Structures to Support Asian American Community Organizations’ Engagement in Research: The Korean Community Service Center. Am J Bioeth. 2021 Oct;21(10):49-51. doi: 10.1080/15265161.2021.1965253. PMID: 34554067; PMCID: PMC9904358.
- Carroll Y. Engaging the Sickle Cell Community in Participatory Research. Am J Bioeth. 2021 Oct;21(10):51-53. doi: 10.1080/15265161.2021.1965245. PMID: 34554074.
- Blanchard J, Hiratsuka V. Being in Good Community: Engagement in Support of Indigenous Sovereignty. Am J Bioeth. 2021 Oct;21(10):54-56. doi: 10.1080/15265161.2021.1965243. PMID: 34554065; PMCID: PMC9400818.
April 2021
Supporting Investigators in Challenging Cases: Unease in the Face of an Ethically Appropriate Action. Wilfond BS, Duenas DM, Johnson LM. American Journal of Bioethics. 2021; 21(4):98-99. doi: 10.1080/15265161.2021.1891342
- Schonfeld T, Geppert CMA. Researchers Experience Moral Distress Too! Am J Bioeth. 2021 Apr;21(4):100-101. doi: 10.1080/15265161.2021.1891327. PMID: 33825626.
- Blee S, Sibold HC, Dixon M, Pentz RD. Relieving Investigator Angst After an Appropriate But Concerning Ethics Consultation. Am J Bioeth. 2021 Apr;21(4):102-104. doi: 10.1080/15265161.2021.1891329. PMID: 33825637.
- Spellecy R, Nyitray A. Acknowledging Angst: Research Ethics Consultation in Disclosing Experimental Research Results of Uncertain Benefit. Am J Bioeth. 2021 Apr;21(4):104-105. doi: 10.1080/15265161.2021.1891331. PMID: 33825651.
Conjoined Consent: Informed Consent When Donor and Recipient Are Both Research Participants. Johnson LM, Duenas DM, Wilfond BS. Am J Bioeth. 2021 Apr;21(4):106-107. doi: 10.1080/15265161.2021.1891343. PMID: 33825622; PMCID: PMC8607986.
- Aaron B, Ginsberg J, Lesandrini J. Moving Beyond Standard Informed Consent for Interventional Organ Transplant Research. Am J Bioeth. 2021 Apr;21(4):108-110. doi: 10.1080/15265161.2021.1891328. PMID: 33825627.
- Ghobrial P, Akkina S, Anderson EE. Risks to Relationships in Kidney Transplant Research with Living Donors and Recipients. Am J Bioeth. 2021 Apr;21(4):110-112. doi: 10.1080/15265161.2021.1891330. PMID: 33825649.
- Kraft SA. Respecting Donor-Recipient Relationships in Research Decision-Making Commentary on: When Living Donor and Kidney Transplant Recipient Are Both Research Subjects. Am J Bioeth. 2021 Apr;21(4):112-114. doi: 10.1080/15265161.2021.1891326. PMID: 33825630.
October 2020
Click Here to Complete This Survey: Online Research, Adolescents, and Parental Consent
Johnson LM, Duenas DM, Wilfond BS. American Journal of Bioethics 2020; 20(10): 82-83. DOI: 10.1080/15265161.2020.1806381
- Digital Negotiations: Navigating Parental Permission and Adolescent Assent for On-Line Survey Participation
Taylor HA and Mogul DB. American Journal of Bioethics 2020; 20(10): 84-85. DOI: 10.1080/15265161.2020.1806375 - Constrained Adolescent Autonomy for Healthcare Should Include Participation in Survey Research
Caruso Brown AE. American Journal of Bioethics 2020; 20(10): 85-87. DOI: 10.1080/15265161.2020.1806377 - Respecting Parental Permission and Maintaining Flexibility in Online Research Involving Adolescent Participants
Knapp EE. American Journal of Bioethics 2020; 20(10): 87-89. DOI: 10.1080/15265161.2020.1806390
Conflicts of Interest and Recommendations for Clinical Treatments That Benefit Researchers
Wilfond BS, Duenas DM, Johnson LM. American Journal of Bioethics 2020; 20(10): 90-91. DOI: 10.1080/15265161.2020.1806380
- Not All Conflicts Are Bad: Why Some Conflicts of Interests Advance Patients’ Interests
Benedetti DJ and Langerman A. American Journal of Bioethics 2020; 20(10): 92-94. DOI: 10.1080/15265161.2020.1806626 - Inherent Conflict of Interest in Clinical Research: A Call for Effective Guidance
Nicolini ME and Wendler D. American Journal of Bioethics 2020; 20(10): 94-96. DOI: 10.1080/15265161.2020.1806376 - A Therapeutic Conundrum: Should a Physician Serve Simultaneously as Caregiver and Researcher?
Hutchinson RJ. American Journal of Bioethics 2020; 20(10): 96-98. DOI: 10.1080/15265161.2020.1806378
April 2020
Ethical Drug Development for Rare Childhood Diseases: When There are Limited but Promising Data in Adults, How to Choose Between Safety or Efficacy Studies?
Johnson LM, Duenas DM, Wilfond BS. American Journal of Bioethics 2020; 20(4): 111-113. DOI: 10.1080/15265161.2020.1730490
- The Use of Pediatric Extrapolation to Avoid Unnecessary Pediatric Clinical Trials.
Nelson R. American Journal of Bioethics 2020; 20(4): 114-116. DOI: 10.1080/15265161.2020.1730489 - Flexibility Required: Balancing the Interests of Children and Risk in Drug Development for Rare Pediatric Conditions.
Porter KM, Stevens A, Wilfond BS. American Journal of Bioethics 2020; 20(4): 116-118. DOI: 10.1080/15265161.2020.1730494 - When Higher Risk Does Not Equal Greater Harm: Doing the Most Good in a Limited Pediatric Study Population.
Mastler J and Young J. American Journal of Bioethics 2020; 20(4): 118-120. DOI: 10.1080/15265161.2020.1730491
Greater than Minimal Risk, No Direct Benefit – Bridging Drug Trials and Novel Therapy in Pediatric Populations.
Wilfond BS, Duenas DM, Johnson LM. American Journal of Bioethics 2020; 20(4): 102-103. DOI: 10.1080/15265161.2020.1730488
- Balancing Risk and Reward: Research with Novel Therapies for Children with Life-limiting Illness.
Unguru Y. American Journal of Bioethics 2020; 20(4): 104-105. DOI: 10.1080/15265161.2020.1730484 - Bringing Known Drugs to Pediatric Research – Safety, Efficacy, and the Ambiguous Minor Increase in Minimal Risk.
Sharma A and Johnson LM. American Journal of Bioethics 2020; 20(4): 106-108. DOI: 10.1080/15265161.2020.1730485 - Balancing Scientific Progress with Pediatric Protections: No Direct Benefit Now, but Potential Novel Therapy in the Future.
Lee SW and Ginsberg JC. American Journal of Bioethics 2020; 20(4): 108-110. DOI: 10.1080/15265161.2020.1730486
October 2019
A Pragmatic Trial of Suicide Risk Assessment and Ambulance Transport Decision Making Among Emergency Medical Services Providers: Implications for Patient Consent.
Wilfond BS, Zambrowski J, Johnson LM. American Journal of Bioethics 2019; 19(10): 97-98.
- Improving Care for Suicidal Patients While Protecting Human Subjects: Addressing Ethical Challenges in Mental Health Research Involving Emergency Medical Services Providers.
DeCou CR, Shah SK, Porter KM. American Journal of Bioethics 2019; 19(10): 99-101. - A Stepwise Approach to Ethically Assess Pragmatic Cluster Randomized Trials: Implications for Informed Consent for Suicide Prevention Implementation Research.
Goldstein CE and Weijer C. American Journal of Bioethics 2019; 19(10): 101-103. - Informed Consent in a Pragmatic Emergency Suicide Trial: Rejecting the Research–Practice Distinction.
Canavera K and Parris K. American Journal of Bioethics 2019; 19(10): 103-105. - A Pragmatic Trial for Emergency Medical Service Providers’ Prehospital Response to Suidality: Consent Is Not Essential, but Limited Patient Engagement May Be Meaningful.
Dickert NW. American Journal of Bioethics 2019; 19(10): 105-107.
A Cluster Randomized Trial to Screen for Abusive Head Trauma in the Pediatric Intensive Care Unit—How to Manage Site-Specific Evidence of Racial/Ethic Disparity.
Johnson LM, Zabrowski J, Wilfond BS. American Journal of Bioethics 2019; 19(10): 108-109.
- Issues of Justice and Risk: Setting Stopping Criteria in Cluster-Randomized Trials.
Tumilty E and Farroni JS. American Journal of Bioethics 2019; 19(10): 110-111. - Clinical Trials Not Causing Harm With Potential for Realizing Benefit Should Continue.
Jackson BM. American Journal of Bioethics 2019; 19(10): 112-114. - Responding to Implicit Bias in Abusive Head Trauma Evaluations and Reporting in the PICU: Ethical Consideration During a Clinical Trial.
McCormick JB and Hymel KP. American Journal of Bioethics 2019; 19(10): 114-115.
April 2019
Should Research Participants Be Notified About Results of Currently Unknown by Potential Significance?
Johnson LM, Zabrowski J, Wilfond BS. American Journal of Bioethics 2019; 19(4): 73-74.
- The Need For National Guidance Around Informed Consent About GBCA Safety.
Brown SB. American Journal of Bioethics 2019; 19(4): 75-77. - Returning Individual Research Results Regarding Gadolinium Deposition in the Brain Is the Preferable Choice.
Huang CJ, Bandettini WP, Danis M. American Journal of Bioethics 2019; 19(4): 77-78. - Research Participants Should Have the Option to Be Notified of Results of Unknown but Potential Significance.
Hutchinson N, Capron A, Doussau A. American Journal of Bioethics 2019; 19(4): 78-80.
The Limitation of “Boilerplate” Language in Informed Consent: Single IRB Review of Multisite Genetic Research in Military Personnel.
Wilfond BS, Zambrowski J, Johnson LM. American Journal of Bioethics 2019; 19(4): 81-82.
- The Bane of “Boilerplate” Language in Research Consent Forms: Ensuring Consent Forms Promote Autonomous Authorization.
Botkin JR. American Journal of Bioethics 2019; 19(4): 83-84. - Single IRBs Are Responsible to Ensure Consent Language Effectively Conveys the Local Context.
Hull SC and Schiffenbauer AI. American Journal of Bioethics 2019; 19(4): 85-86. - Solving the Single IRB/Boilerplate Bind: Establishing Institutional Guidelines.
Abraham ME, Hohmann E, Morash M. American Journal of Bioethics 2019; 19(4): 87-88.
October 2018
A Randomized Trial of Rapamycin to Increase Longevity and Healthspan in Companion Animals: Navigating the Boundary Between Protections for Animal Research and Human Subjects Research.
Taylor HA, Morales C, Johnson LM, Wilfond BS. American Journal of Bioethics 2018; 18(10): 58-59.
- Rapamycin: Risking Harm for Canine Longevity.
Abbate C. American Journal of Bioethics 2018; 18(10): 60-61. - Companion Animal Studies: Slipping Through a Research Oversight Gap.
Walker RL and Fisher JA. American Journal of Bioethics 2018; 18(10): 62-63. - Research to Promote Longevity and Health Span in Companion Dogs: A Pediatric Perspective.
Wilfond BS, Porter KM, Creevy KE, Kaerberlein M, Promislow D. American Journal of Bioethics 2018; 18(10): 64-65.
Ethical Considerations for Unblinding a Participant’s Assignment to Interpret a Resolved Adverse Event.
Wilfond BS, Morales C, Johnson LM, Taylor HA. American Journal of Bioethics 2018; 18(10): 66-67.
- Considerations for Unblinding in Biopharmaceutical Industry Sponsored Trials.
Shah JJ and Bond J. American Journal of Bioethics 2018; 18(10): 68-70. - Blinds and Research Risks.
Steel R and Danis M. American Journal of Bioethics 2018; 18(10): 70-71. - The Scientific and Social Implications of Unblinding a Study Subject.
Quittell LM. American Journal of Bioethics 2018; 18(10): 71-73.
April 2018
Is It Ethically Appropriate to Refuse to Compensate Participants Who Are Believed to Have Intentionally Concealed Medical Conditions?
Taylor HA and Morales C. American Journal of Bioethics 2018; 18(4): 83-84.
- Mutual Obligations in Research and Withholding Payment From Deceptive Participants.
Fernandez Lynch H, Gelinas L, Largent EA. American Journal of Bioethics 2018; 18(4): 85-87. - Best to Exclude but Pay.
Danis M, Doernberg S, Memoli M, Millum J. American Journal of Bioethics 2018; 18(4): 87-88. - To Pay or Not to Pay? Withholding Payment From Research Participants.
Rhodes R and Danziger M. American Journal of Bioethics 2018; 18(4): 88-90.
Involving Pregnant Women in Research: What Should We Recommend When the Regulations Seem Ethically Problematic?
Taylor HA and Morales C. American Journal of Bioethics 2018; 18(4): 91-92.
- Conflicts Between Regulations and Ethical Principles: Resolving Ambiguity in Favor of the Ethically Preferable Outcome.
Shah SK and Porter K. American Journal of Bioethics 2018; 18(4): 93-94. - When to Avoid Giving Advice on the Ethical Conduct of Research.
Sharp RR and Allyse MA. American Journal of Bioethics 2018; 18(4): 94-95. - When Research Regulations and Ethics Conflict.
Sullivan HK, Braverman DW, Wendler D. American Journal of Bioethics 2018; 18(4): 96-97.
October 2017
Expanded Access for Nusinersen in Patients With Spinal Muscular Atropy: Negotiating Limited Data, Limited Alternative Treatments, and Limited Hospital Resources.
Wilfond BS, Morales C, Taylor HA. American Journal of Bioethics 2017; 17(10): 66-67.
- Hard Choices for Vulnerable Patients: Some Lessons Learned That May Apply.
Kearns L and Caplan AL. American Journal of Bioethics 2017; 17(10): 68-69. - Is There a ‘Right to Try’ Experimental Therapies? Ethical Criteria for Selecting Patients With Spinal Muscular Atrophy to Receive Nusinersen in an Expanded Access Program.
Jecker NS. American Journal of Bioethics 2017; 17(10): 70-71. - Fairness and Transparency in an Expanded Access Program: Allocation of the Only Treatment for SMA1.
Burgart AM, Collier J, Cho MK. American Journal of Bioethics 2017; 17(10): 71-73.
A Trial to Test a Novel Approach to Diabetes Prevention.
Taylor HA, Morales C, Wilfond BS. American Journal of Bioethics 2017; 17(10): 74-75.
- Is It Ethically Acceptable to Screen Patients for Obstructive Sleep Apnea and Not Offer Them Positive Air Pressure Therapy in a Clinical Trial?
McCormick JB, Wu JT, Doussau A. American Journal of Bioethics 2017; 17(10): 76-77. - Can We Breathe Easy If PAP Therapy Is Withheld?
Taylor HA and Punjabi NM. American Journal of Bioethics 2017; 17(10): 78-79. - Risks of Clinical Research Must Be Reasonable and Necessary.
Gibbes Miller D and Kim SYH. American Journal of Bioethics 2017; 17(10): 79-81.
April 2017
Genotype-Driven Recruitment in Population-Based Biomedical Research.
Taylor HA, Morales C, Wilfond BS. American Journal of Bioethics 2017; 17(4): 58-59.
- Genotype-Driven Recruitment Without Deception.
Ossorio P and Mailick M. American Journal of Bioethics 2017; 17(4): 60-61. - Harms of Deception in FMR1 Premutation Genotype-Driven Recruitment.
Doernberg S and Hull SC. American Journal of Bioethics 2017; 17(4): 62-63. - Genotype-Driven Recruitment and the Disclosure of Individual Research Results.
Beskow LM. American Journal of Bioethics 2017; 17(4): 64-65.
Should Patients Be Required to Undergo Standard Chemotherapy Before Being Eligible for Novel Phase I Immunotherapy Clinical Trials?
Wilfond BS, Morales C, Taylor HA. American Journal of Bioethics 2017; 17(4): 66-67.
- A Rationale for Relaxing the Requirement to Undergo a Noncurative Chemotherapy for Advanced Cancer in a Phase I Immunotherapy Trial.
Doussau A and Hanmer CB. American Journal of Bioethics 2017; 17(4): 68-69. - Participation of Citizen Scientists in Clinical Research and Access to Research Ethics Consultation.
Collier E and Danis M. American Journal of Bioethics 2017; 17(4): 70-72. - Forgoing Conventional Therapy in Phase I Oncology Research: Don’t Forget About the Children.
Wetmore C. American Journal of Bioethics 2017; 17(4): 72-73
Clinical Obligations to Research Participants
A Cluster Randomized Trial to Screen for Abusive Head Trauma in the Pediatric Intensive Care Unit—How to Manage Site-Specific Evidence of Racial/Ethic Disparity.
Johnson LM, Zabrowski J, Wilfond BS. American Journal of Bioethics 2019; 19(10): 108-109.
- Issues of Justice and Risk: Setting Stopping Criteria in Cluster-Randomized Trials.
Tumilty E and Farroni JS. American Journal of Bioethics 2019; 19(10): 110-111. - Clinical Trials Not Causing Harm With Potential for Realizing Benefit Should Continue.
Jackson BM. American Journal of Bioethics 2019; 19(10): 112-114. - Responding to Implicit Bias in Abusive Head Trauma Evaluations and Reporting in the PICU: Ethical Consideration During a Clinical Trial.
McCormick JB and Hymel KP. American Journal of Bioethics 2019; 19(10): 114-115.
Should Research Participants Be Notified About Results of Currently Unknown by Potential Significance?
Johnson LM, Zabrowski J, Wilfond BS. American Journal of Bioethics 2019; 19(4): 73-74.
- The Need For National Guidance Around Informed Consent About GBCA Safety.
Brown SB. American Journal of Bioethics 2019; 19(4): 75-77. - Returning Individual Research Results Regarding Gadolinium Deposition in the Brain Is the Preferable Choice.
Huang CJ, Bandettini WP, Danis M. American Journal of Bioethics 2019; 19(4): 77-78. - Research Participants Should Have the Option to Be Notified of Results of Unknown but Potential Significance.
Hutchinson N, Capron A, Doussau A. American Journal of Bioethics 2019; 19(4): 78-80.
Ethical Considerations for Unblinding a Participant’s Assignment to Interpret a Resolved Adverse Event.
Wilfond BS, Morales C, Johnson LM, Taylor HA. American Journal of Bioethics 2018; 18(10): 66-67.
- Considerations for Unblinding in Biopharmaceutical Industry Sponsored Trials.
Shah JJ and Bond J. American Journal of Bioethics 2018; 18(10): 68-70. - Blinds and Research Risks.
Steel R and Danis M. American Journal of Bioethics 2018; 18(10): 70-71. - The Scientific and Social Implications of Unblinding a Study Subject.
Quittell LM. American Journal of Bioethics 2018; 18(10): 71-73.
Expanded Access for Nusinersen in Patients With Spinal Muscular Atropy: Negotiating Limited Data, Limited Alternative Treatments, and Limited Hospital Resources.
Wilfond BS, Morales C, Taylor HA. American Journal of Bioethics 2017; 17(10): 66-67.
- Hard Choices for Vulnerable Patients: Some Lessons Learned That May Apply.
Kearns L and Caplan AL. American Journal of Bioethics 2017; 17(10): 68-69. - Is There a ‘Right to Try’ Experimental Therapies? Ethical Criteria for Selecting Patients With Spinal Muscular Atrophy to Receive Nusinersen in an Expanded Access Program.
Jecker NS. American Journal of Bioethics 2017; 17(10): 70-71. - Fairness and Transparency in an Expanded Access Program: Allocation of the Only Treatment for SMA1.
Burgart AM, Collier J, Cho MK. American Journal of Bioethics 2017; 17(10): 71-73.
A Trial to Test a Novel Approach to Diabetes Prevention.
Taylor HA, Morales C, Wilfond BS. American Journal of Bioethics 2017; 17(10): 74-75.
- Is It Ethically Acceptable to Screen Patients for Obstructive Sleep Apnea and Not Offer Them Positive Air Pressure Therapy in a Clinical Trial?
McCormick JB, Wu JT, Doussau A. American Journal of Bioethics 2017; 17(10): 76-77. - Can We Breathe Easy If PAP Therapy Is Withheld?
Taylor HA and Punjabi NM. American Journal of Bioethics 2017; 17(10): 78-79. - Risks of Clinical Research Must Be Reasonable and Necessary.
Gibbes Miller D and Kim SYH. American Journal of Bioethics 2017; 17(10): 79-81.
Genotype-Driven Recruitment in Population-Based Biomedical Research.
Taylor HA, Morales C, Wilfond BS. American Journal of Bioethics 2017; 17(4): 58-59.
- Genotype-Driven Recruitment Without Deception.
Ossorio P and Mailick M. American Journal of Bioethics 2017; 17(4): 60-61. - Harms of Deception in FMR1 Premutation Genotype-Driven Recruitment.
Doernberg S and Hull SC. American Journal of Bioethics 2017; 17(4): 62-63. - Genotype-Driven Recruitment and the Disclosure of Individual Research Results.
Beskow LM. American Journal of Bioethics 2017; 17(4): 64-65.
When a Clinical Trial Is the Only Option.
Taylor HA, Morales C, Wilfond BS. American Journal of Bioethics 2016; 16(10): 67-68.
- “Respect for Persons,” Not “Respect for Citizens”.
Fabi R. American Journal of Bioethics 2016; 16(10): 69-70. - The Potentially High Cost of a Free Clinical Trial.
Heitman E. American Journal of Bioethics 2016; 16(10): 70-72. - Contextualizing “Choice” for Undocumented Immigrants in U.S. Clinical Trials Research.
Burke, NJ. American Journal of Bioethics 2016; 16(10): 72-74.
Obligations to Act on Patient Reported Outcomes in Electronic Health Records.
American Journal of Bioethics 2016; 16(4): 62.
- Informed Consent for PROs in EHR Research: Are Additional Requirements Necessary?
Whicher D and Evans E. American Journal of Bioethics 2016; 16(4): 63-65. - Patient Reported Outcomes at the Crossroads of Clinical Research and Informatics.
Swirsky ES and Boyd AD. American Journal of Bioethics 2016; 16(4): 65-66. - PROs in the Balance: Ethical Implications of Collecting Patient Reported Outcome Measures in the Electronic Health Record.
Crites JS, Chuang C, Dimmock A, Hwang W, Johannes B, Paranjape A, Wu AW. American Journal of Bioethics 2016; 16(4): 67-68.
The Obligations to Report Statutory Sexual Abuse Disclosed in a Research Study.
Taylor HA, Kuwana E, Wilfond BS. American Journal of Bioethics 2014; 14(10): 50.
- The Moral and Legal Need to Disclose Despite a Certificate of Confidentiality.
Paquette ET and Ross LF. American Journal of Bioethics 2014; 14(10): 51-53. - Informed Consent and the Implications for Statutory Rape Reporting in Research With Adolescents.
Hodgkinson S, Lewin A, Chang B, Beers L, Silber T. American Journal of Bioethics 2014; 14(10): 54-55. - Community, Context, and the Contrasting Roles of Clinicians and Researchers: Challenges Raised by Statutory Rape.
Finder SG and Korenman S. American Journal of Bioethics 2014; 14(10): 55-57.
The Ethics of Disclosing to Research Subjects the Availability of Off-Label Marketed Drugs.
Taylor HA, Kuwana E, Wilfond BS. American Journal of Bioethics 2014; 14(4): 51.
- Researchers Have an Ethical Obligation to Disclose the Availability of Off-Label Marketed Drugs.
Silber TJ. American Journal of Bioethics 2014; 14(4): 52. - The Relevance of Research Study Phase to Disclosure of Off-Label Drug Availability.
Baskaran A and Sade RM. American Journal of Bioethics 2014; 14(4): 53-54. - Which Alternatives Should Investigators Disclose to Research Subjects?
Phillips J and Wendler D. American Journal of Bioethics 2014; 14(4): 54-55.
Ethics of Continuing to Provide a Drug on an Open-Label Extension Study for an “Unapproved Indication”.
Taylor HA, Kuwana E, Wilfond BS. American Journal of Bioethics 2014; 14(4): 56.
- When Should Open-Label Extension Studies Be Stopped?
Crites JS. American Journal of Bioethics 2014; 14(4): 57-58. - 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”.
Nash RR. American Journal of Bioethics 2014; 14(4): 59-60. - Open-Label Extension Studies: Are They Really Research?
Cho MK. American Journal of Bioethics 2014; 14(4): 60-61.
Community / Cultural Concerns
A Cluster Randomized Trial to Screen for Abusive Head Trauma in the Pediatric Intensive Care Unit—How to Manage Site-Specific Evidence of Racial/Ethic Disparity.
Johnson LM, Zabrowski J, Wilfond BS. American Journal of Bioethics 2019; 19(10): 108-109.
- Issues of Justice and Risk: Setting Stopping Criteria in Cluster-Randomized Trials.
Tumilty E and Farroni JS. American Journal of Bioethics 2019; 19(10): 110-111. - Clinical Trials Not Causing Harm With Potential for Realizing Benefit Should Continue.
Jackson BM. American Journal of Bioethics 2019; 19(10): 112-114. - Responding to Implicit Bias in Abusive Head Trauma Evaluations and Reporting in the PICU: Ethical Consideration During a Clinical Trial.
McCormick JB and Hymel KP. American Journal of Bioethics 2019; 19(10): 114-115.
When a Clinical Trial Is the Only Option.
Taylor HA, Morales C, Wilfond BS. American Journal of Bioethics 2016; 16(10): 67-68.
- “Respect for Persons,” Not “Respect for Citizens”.
Fabi R. American Journal of Bioethics 2016; 16(10): 69-70. - The Potentially High Cost of a Free Clinical Trial.
Heitman E. American Journal of Bioethics 2016; 16(10): 70-72. - Contextualizing “Choice” for Undocumented Immigrants in U.S. Clinical Trials Research.
Burke, NJ. American Journal of Bioethics 2016; 16(10): 72-74.
Studying the Role of Financial Incentives to Promote Hepatitis B Vaccination in a Community Clinic.
Wilfond BS, Morales C, Taylor HA. American Journal of Bioethics 2016; 16(10): 75-76.
- Treatment Incentives and the Nature of the Doctor-Patient Relationship.
Giunta H. American Journal of Bioethics 2016; 16(10): 77-78. - The Ethics of Studying Financial Incentives in Public Health Implementation: Study Design Challenges.
Doussau A and Grady C. American Journal of Bioethics 2016; 16(10): 78-80. - 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.
Perumalswami P, Branch A, Rhodes R. American Journal of Bioethics 2016; 16(10): 80-82.
Selecting Children for an Autism Spectrum Disorder Study: Justice and Geography.
American Journal of Bioethics 2016; 16(4): 69-70.
- Fair Participant Selection: A Negative Obligation Not to Exclude.
Chen SC. American Journal of Bioethics 2016; 16(4): 71-72. - Unequal Individual Risk and Potential Benefit Balanced by Benefits to the Population at Large in Autism Clinical Trials?
Stein MA and King BH. American Journal of Bioethics 2016; 16(4): 72-74. - Justice in Selecting Participants for a Study in Phelan-McDermid Syndrome.
Rhodes R and Kolevzon A. American Journal of Bioethics 2016; 16(4): 74-76.
Protecting Research Subject Welfare in Preventive Trials for Autosomal Dominant Alzheimer’s Disease.
Taylor HA, Kuwana E, Wilfond BS. American Journal of Bioethics 2015; 15(4): 83-84.
- When There Are Only Two Who Can Tango: Ethical Concerns at the Juncture of Highly Novel Interventions and Precisely Targeted Research Populations.
Yarborough M. American Journal of Bioethics 2015; 15(4): 85-86. - Conceptualization and Assessment of Vulnerability in a Complex International Alzheimer’s Research Study.
Korenman S, Finder SG, Ringman JM. American Journal of Bioethics 2015; 15(4): 87-89. - Barriers and Facilitators to the Consent Process in a Study of Complex Genetic Factors.
Simpson AR. American Journal of Bioethics 2015; 15(4): 89-90.
Drugs & Devices
Ethical Drug Development for Rare Childhood Diseases: When There are Limited but Promising Data in Adults, How to Choose Between Safety or Efficacy Studies?
Johnson LM, Duenas DM, Wilfond BS. American Journal of Bioethics 2020; 20(4): XX-XX.
- The Use of Pediatric Extrapolation to Avoid Unnecessary Pediatric Clinical Trials.
Nelson R. American Journal of Bioethics 2020; 20(4): XX-XX. - Flexibility Required: Balancing the Interests of Children and Risk in Drug Development for Rare Pediatric Conditions.
Porter KM, Stevens A, Wilfond BS. American Journal of Bioethics 2020; 20(4): XX-XX. - When Higher Risk Does Not Equal Greater Harm: Doing the Most Good in a Limited Pediatric Study Population.
Mastler J and Young J. American Journal of Bioethics 2020; 20(4): XX-XX.
Greater than Minimal Risk, No Direct Benefit – Bridging Drug Trials and Novel Therapy in Pediatric Populations.
Wilfond BS, Duenas DM, Johnson LM. American Journal of Bioethics 2020; 20(4): XX-XX.
- Balancing Risk and Reward: Research with Novel Therapies for Children with Life-limiting Illness.
Unguru Y. American Journal of Bioethics 2020; 20(4): XX-XX. - Bringing Known Drugs to Pediatric Research – Safety, Efficacy, and the Ambiguous Minor Increase in Minimal Risk.
Sharma A and Johnson LM. American Journal of Bioethics 2020; 20(4): XX-XX. - Balancing Scientific Progress with Pediatric Protections: No Direct Benefit Now, but Potential Novel Therapy in the Future.
Lee SW and Ginsberg JC. American Journal of Bioethics 2020; 20(4): XX-XX.
Expanded Access for Nusinersen in Patients With Spinal Muscular Atropy: Negotiating Limited Data, Limited Alternative Treatments, and Limited Hospital Resources.
Wilfond BS, Morales C, Taylor HA. American Journal of Bioethics 2017; 17(10): 66-67.
- Hard Choices for Vulnerable Patients: Some Lessons Learned That May Apply.
Kearns L and Caplan AL. American Journal of Bioethics 2017; 17(10): 68-69. - Is There a ‘Right to Try’ Experimental Therapies? Ethical Criteria for Selecting Patients With Spinal Muscular Atrophy to Receive Nusinersen in an Expanded Access Program.
Jecker NS. American Journal of Bioethics 2017; 17(10): 70-71. - Fairness and Transparency in an Expanded Access Program: Allocation of the Only Treatment for SMA1.
Burgart AM, Collier J, Cho MK. American Journal of Bioethics 2017; 17(10): 71-73.
Should Patients Be Required to Undergo Standard Chemotherapy Before Being Eligible for Novel Phase I Immunotherapy Clinical Trials?
Wilfond BS, Morales C, Taylor HA. American Journal of Bioethics 2017; 17(4): 66-67.
- A Rationale for Relaxing the Requirement to Undergo a Noncurative Chemotherapy for Advanced Cancer in a Phase I Immunotherapy Trial.
Doussau A and Hanmer CB. American Journal of Bioethics 2017; 17(4): 68-69. - Participation of Citizen Scientists in Clinical Research and Access to Research Ethics Consultation.
Collier E and Danis M. American Journal of Bioethics 2017; 17(4): 70-72. - Forgoing Conventional Therapy in Phase I Oncology Research: Don’t Forget About the Children.
Wetmore C. American Journal of Bioethics 2017; 17(4): 72-73.
Protecting Research Subject Welfare in Preventive Trials for Autosomal Dominant Alzheimer’s Disease.
Taylor HA, Kuwana E, Wilfond BS. American Journal of Bioethics 2015; 15(4): 83-84.
- When There Are Only Two Who Can Tango: Ethical Concerns at the Juncture of Highly Novel Interventions and Precisely Targeted Research Populations.
Yarborough M. American Journal of Bioethics 2015; 15(4): 85-86. - Conceptualization and Assessment of Vulnerability in a Complex International Alzheimer’s Research Study.
Korenman S, Finder SG, Ringman JM. American Journal of Bioethics 2015; 15(4): 87-89. - Barriers and Facilitators to the Consent Process in a Study of Complex Genetic Factors.
Simpson AR. American Journal of Bioethics 2015; 15(4): 89-90.
The Ethics of Disclosing to Research Subjects the Availability of Off-Label Marketed Drugs.
Taylor HA, Kuwana E, Wilfond BS. American Journal of Bioethics 2014; 14(4): 51.
- Researchers Have an Ethical Obligation to Disclose the Availability of Off-Label Marketed Drugs.
Silber TJ. American Journal of Bioethics 2014; 14(4): 52. - The Relevance of Research Study Phase to Disclosure of Off-Label Drug Availability.
Baskaran A and Sade RM. American Journal of Bioethics 2014; 14(4): 53-54. - Which Alternatives Should Investigators Disclose to Research Subjects?
Phillips J and Wendler D. American Journal of Bioethics 2014; 14(4): 54-55.
Ethics of Continuing to Provide a Drug on an Open-Label Extension Study for an “Unapproved Indication”.
Taylor HA, Kuwana E, Wilfond BS. American Journal of Bioethics 2014; 14(4): 56.
- When Should Open-Label Extension Studies Be Stopped?
Crites JS. American Journal of Bioethics 2014; 14(4): 57-58. - 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”.
Nash RR. American Journal of Bioethics 2014; 14(4): 59-60. - Open-Label Extension Studies: Are They Really Research?
Cho MK. American Journal of Bioethics 2014; 14(4): 60-61.
Genetics
The Limitation of “Boilerplate” Language in Informed Consent: Single IRB Review of Multisite Genetic Research in Military Personnel.
Wilfond BS, Zambrowski J, Johnson LM. American Journal of Bioethics 2019; 19(4): 81-82.
- The Bane of “Boilerplate” Language in Research Consent Forms: Ensuring Consent Forms Promote Autonomous Authorization.
Botkin JR. American Journal of Bioethics 2019; 19(4): 83-84. - Single IRBs Are Responsible to Ensure Consent Language Effectively Conveys the Local Context.
Hull SC and Schiffenbauer AI. American Journal of Bioethics 2019; 19(4): 85-86. - Solving the Single IRB/Boilerplate Bind: Establishing Institutional Guidelines.
Abraham ME, Hohmann E, Morash M. American Journal of Bioethics 2019; 19(4): 87-88.
Genotype-Driven Recruitment in Population-Based Biomedical Research.
Taylor HA, Morales C, Wilfond BS. American Journal of Bioethics 2017; 17(4): 58-59.
- Genotype-Driven Recruitment Without Deception.
Ossorio P and Mailick M. American Journal of Bioethics 2017; 17(4): 60-61. - Harms of Deception in FMR1 Premutation Genotype-Driven Recruitment.
Doernberg S and Hull SC. American Journal of Bioethics 2017; 17(4): 62-63. - Genotype-Driven Recruitment and the Disclosure of Individual Research Results.
Beskow LM. American Journal of Bioethics 2017; 17(4): 64-65.
Protecting Research Subject Welfare in Preventive Trials for Autosomal Dominant Alzheimer’s Disease.
Taylor HA, Kuwana E, Wilfond BS. American Journal of Bioethics 2015; 15(4): 83-84.
- When There Are Only Two Who Can Tango: Ethical Concerns at the Juncture of Highly Novel Interventions and Precisely Targeted Research Populations.
Yarborough M. American Journal of Bioethics 2015; 15(4): 85-86. - Conceptualization and Assessment of Vulnerability in a Complex International Alzheimer’s Research Study.
Korenman S, Finder SG, Ringman JM. American Journal of Bioethics 2015; 15(4): 87-89. - Barriers and Facilitators to the Consent Process in a Study of Complex Genetic Factors.
Simpson AR. American Journal of Bioethics 2015; 15(4): 89-90.
The Ethics of Contacting Family Members of a Subject in a Genetic Research Study to Return Results for an Autosomal Dominant Syndrome.
Taylor HA and Wilfond BS. American Journal of Bioethics 2013; 13(10): 61.
- What Does the Duty to Warn Require?
Shah SK, Hull SC, Spinner MA, Berkman BE, Sanchez LA, Abdul-Karim R, Hsu AP, Claypool R, Holland SM. American Journal of Bioethics 2013; 13(10): 62-63. - Should Researchers Disclose Results to Descendants?
Rothstein MA. American Journal of Bioethics 2013; 13(10): 64-65. - Relationships Matter: Ethical Considerations for Returning Results to Family Members of Deceased Subjects.
Milner LC, Liu EY, Garrison NA. American Journal of Bioethics 2013; 13(10): 66-67.
Miscellaneous
Is It Ethically Appropriate to Refuse to Compensate Participants Who Are Believed to Have Intentionally Concealed Medical Conditions?
Taylor HA and Morales C. American Journal of Bioethics 2018; 18(4): 83-84.
- Mutual Obligations in Research and Withholding Payment From Deceptive Participants.
Fernandez Lynch H, Gelinas L, Largent EA. American Journal of Bioethics 2018; 18(4): 85-87. - Best to Exclude but Pay.
Danis M, Doernberg S, Memoli M, Millum J. American Journal of Bioethics 2018; 18(4): 87-88. - To Pay or Not to Pay? Withholding Payment From Research Participants.
Rhodes R and Danziger M. American Journal of Bioethics 2018; 18(4): 88-90.
Ethical Implications of Social Media in Health Care Research.
Taylor HA, Kuwana E, Wilfond BS. American Journal of Bioethics 2014; 14(10): 58-59.
- Using Social Media in Research: New Ethics for a New Meme?
Swirsky ES, Hoop JG, Labott S. American Journal of Bioethics 2014; 14(10): 60-61. - Connectivity and Consent: Does Posting Imply Participation?
Farnan JM. American Journal of Bioethics 2014; 14(10): 62-63. - Conducting Research on Social Media—Is Facebook Like the Public Square?
Parsi K and Elster N. American Journal of Bioethics 2014; 14(10): 63-65.
Managing Disclosure of Research Misconduct by a Graduate Student to a University Mental Health Professional During a Clinical Counseling Session.
Taylor HA and Wilfond BS. American Journal of Bioethics 2013; 13(10): 68.
- A Systems-Level Approach to Resolve Tension between Research Misconduct and Confidentiality.
Limehouse W. American Journal of Bioethics 2013; 13(10): 69-70. - Let Therapists Be Therapists, Not Police.
Appelbaum PS. American Journal of Bioethics 2013; 13(10): 71-72. - Why Misconduct Trumps Patient–Therapist Confidentiality and Ways to Avoid the Disclosure Dilemma.
Steneck NH. American Journal of Bioethics 2013; 13(10): 73-74.
Pediatrics
Ethical Drug Development for Rare Childhood Diseases: When There are Limited but Promising Data in Adults, How to Choose Between Safety or Efficacy Studies?
Johnson LM, Duenas DM, Wilfond BS. American Journal of Bioethics 2020; 20(4): XX-XX.
- The Use of Pediatric Extrapolation to Avoid Unnecessary Pediatric Clinical Trials.
Nelson R. American Journal of Bioethics 2020; 20(4): XX-XX. - Flexibility Required: Balancing the Interests of Children and Risk in Drug Development for Rare Pediatric Conditions.
Porter KM, Stevens A, Wilfond BS. American Journal of Bioethics 2020; 20(4): XX-XX. - When Higher Risk Does Not Equal Greater Harm: Doing the Most Good in a Limited Pediatric Study Population.
Mastler J and Young J. American Journal of Bioethics 2020; 20(4): XX-XX.
Greater than Minimal Risk, No Direct Benefit – Bridging Drug Trials and Novel Therapy in Pediatric Populations.
Wilfond BS, Duenas DM, Johnson LM. American Journal of Bioethics 2020; 20(4): XX-XX.
- Balancing Risk and Reward: Research with Novel Therapies for Children with Life-limiting Illness.
Unguru Y. American Journal of Bioethics 2020; 20(4): XX-XX. - Bringing Known Drugs to Pediatric Research – Safety, Efficacy, and the Ambiguous Minor Increase in Minimal Risk.
Sharma A and Johnson LM. American Journal of Bioethics 2020; 20(4): XX-XX. - Balancing Scientific Progress with Pediatric Protections: No Direct Benefit Now, but Potential Novel Therapy in the Future.
Lee SW and Ginsberg JC. American Journal of Bioethics 2020; 20(4): XX-XX.
A Cluster Randomized Trial to Screen for Abusive Head Trauma in the Pediatric Intensive Care Unit—How to Manage Site-Specific Evidence of Racial/Ethic Disparity.
Johnson LM, Zabrowski J, Wilfond BS. American Journal of Bioethics 2019; 19(10): 108-109.
- Issues of Justice and Risk: Setting Stopping Criteria in Cluster-Randomized Trials.
Tumilty E and Farroni JS. American Journal of Bioethics 2019; 19(10): 110-111. - Clinical Trials Not Causing Harm With Potential for Realizing Benefit Should Continue.
Jackson BM. American Journal of Bioethics 2019; 19(10): 112-114. - Responding to Implicit Bias in Abusive Head Trauma Evaluations and Reporting in the PICU: Ethical Consideration During a Clinical Trial.
McCormick JB and Hymel KP. American Journal of Bioethics 2019; 19(10): 114-115.
Expanded Access for Nusinersen in Patients With Spinal Muscular Atropy: Negotiating Limited Data, Limited Alternative Treatments, and Limited Hospital Resources.
Wilfond BS, Morales C, Taylor HA. American Journal of Bioethics 2017; 17(10): 66-67.
- Hard Choices for Vulnerable Patients: Some Lessons Learned That May Apply.
Kearns L and Caplan AL. American Journal of Bioethics 2017; 17(10): 68-69. - Is There a ‘Right to Try’ Experimental Therapies? Ethical Criteria for Selecting Patients With Spinal Muscular Atrophy to Receive Nusinersen in an Expanded Access Program.
Jecker NS. American Journal of Bioethics 2017; 17(10): 70-71. - Fairness and Transparency in an Expanded Access Program: Allocation of the Only Treatment for SMA1.
Burgart AM, Collier J, Cho MK. American Journal of Bioethics 2017; 17(10): 71-73.
Selecting Children for an Autism Spectrum Disorder Study: Justice and Geography.
American Journal of Bioethics 2016; 16(4): 69-70.
- Fair Participant Selection: A Negative Obligation Not to Exclude.
Chen SC. American Journal of Bioethics 2016; 16(4): 71-72. - Unequal Individual Risk and Potential Benefit Balanced by Benefits to the Population at Large in Autism Clinical Trials?
Stein MA and King BH. American Journal of Bioethics 2016; 16(4): 72-74. - Justice in Selecting Participants for a Study in Phelan-McDermid Syndrome.
Rhodes R and Kolevzon A. American Journal of Bioethics 2016; 16(4): 74-76.
Recontact and Recruitment of Young Adults Previously Enrolled in Neonatal Herpes Simplex Virus Research.
Taylor HA, Kuwana E, Wilfond BS. American Journal of Bioethics 2015; 15(10): 56-57.
- Research Recruitment of Adult Survivors of Neonatal Infections: Is There a Role for Parental Consent?
Melvin AJ, Mohan KM, Wald A, Porter K, Wilfond BS. American Journal of Bioethics 2015; 15(10): 58-59. - A Knotty Problem of Intertwined Rights.
McKinney RE. American Journal of Bioethics 2015; 15(10): 60-61. - Consent Is the Cornerstone of Ethically Valid Research: Ethical Issues in Recontacting Subjects Who Enrolled in Research as a Minor.
Paquette ET and Ross LF. American Journal of Bioethics 2015; 15(10): 61-63.
Navigating Parental Permission for Neonatal Research.
Taylor HA, Kuwana E, Wilfond BS. American Journal of Bioethics 2015; 15(4): 76.
- Informed Consent and Parental Permission for Research: Rules, Roles, and Relationships.
Fiore RN and Cushman R. American Journal of Bioethics 2015; 15(4): 77-78. - Research Involving Premature Infants: Timing Is Everything.
Eisenberg LR. American Journal of Bioethics 2015; 15(4): 79-80. - Precluding Consent by Clinicians Who Are Both the Attending and the Investigator: An Outdated Shibboleth?
Shah A, Porter K, Juul S, Wilfond BS. American Journal of Bioethics 2015; 15(4): 80-82.
The Obligations to Report Statutory Sexual Abuse Disclosed in a Research Study.
Taylor HA, Kuwana E, Wilfond BS. American Journal of Bioethics 2014; 14(10): 50.
- The Moral and Legal Need to Disclose Despite a Certificate of Confidentiality.
Paquette ET and Ross LF. American Journal of Bioethics 2014; 14(10): 51-53. - Informed Consent and the Implications for Statutory Rape Reporting in Research With Adolescents.
Hodgkinson S, Lewin A, Chang B, Beers L, Silber T. American Journal of Bioethics 2014; 14(10): 54-55. - Community, Context, and the Contrasting Roles of Clinicians and Researchers: Challenges Raised by Statutory Rape.
Finder SG and Korenman S. American Journal of Bioethics 2014; 14(10): 55-57.
Recruitment and Consent
A Pragmatic Trial of Suicide Risk Assessment and Ambulance Transport Decision Making Among Emergency Medical Services Providers: Implications for Patient Consent.
Wilfond BS, Zambrowski J, Johnson LM. American Journal of Bioethics 2019; 19(10): 97-98.
- Improving Care for Suicidal Patients While Protecting Human Subjects: Addressing Ethical Challenges in Mental Health Research Involving Emergency Medical Services Providers.
DeCou CR, Shah SK, Porter KM. American Journal of Bioethics 2019; 19(10): 99-101. - A Stepwise Approach to Ethically Assess Pragmatic Cluster Randomized Trials: Implications for Informed Consent for Suicide Prevention Implementation Research.
Goldstein CE and Weijer C. American Journal of Bioethics 2019; 19(10): 101-103. - Informed Consent in a Pragmatic Emergency Suicide Trial: Rejecting the Research–Practice Distinction.
Canavera K and Parris K. American Journal of Bioethics 2019; 19(10): 103-105. - A Pragmatic Trial for Emergency Medical Service Providers’ Prehospital Response to Suidality: Consent Is Not Essential, but Limited Patient Engagement May Be Meaningful.
Dickert NW. American Journal of Bioethics 2019; 19(10): 105-107.
The Limitation of “Boilerplate” Language in Informed Consent: Single IRB Review of Multisite Genetic Research in Military Personnel.
Wilfond BS, Zambrowski J, Johnson LM. American Journal of Bioethics 2019; 19(4): 81-82.
- The Bane of “Boilerplate” Language in Research Consent Forms: Ensuring Consent Forms Promote Autonomous Authorization.
Botkin JR. American Journal of Bioethics 2019; 19(4): 83-84. - Single IRBs Are Responsible to Ensure Consent Language Effectively Conveys the Local Context.
Hull SC and Schiffenbauer AI. American Journal of Bioethics 2019; 19(4): 85-86. - Solving the Single IRB/Boilerplate Bind: Establishing Institutional Guidelines.
Abraham ME, Hohmann E, Morash M. American Journal of Bioethics 2019; 19(4): 87-88.
Genotype-Driven Recruitment in Population-Based Biomedical Research.
Taylor HA, Morales C, Wilfond BS. American Journal of Bioethics 2017; 17(4): 58-59.
- Genotype-Driven Recruitment Without Deception.
Ossorio P and Mailick M. American Journal of Bioethics 2017; 17(4): 60-61. - Harms of Deception in FMR1 Premutation Genotype-Driven Recruitment.
Doernberg S and Hull SC. American Journal of Bioethics 2017; 17(4): 62-63. - Genotype-Driven Recruitment and the Disclosure of Individual Research Results.
Beskow LM. American Journal of Bioethics 2017; 17(4): 64-65.
Should Patients Be Required to Undergo Standard Chemotherapy Before Being Eligible for Novel Phase I Immunotherapy Clinical Trials?
Wilfond BS, Morales C, Taylor HA. American Journal of Bioethics 2017; 17(4): 66-67.
- A Rationale for Relaxing the Requirement to Undergo a Noncurative Chemotherapy for Advanced Cancer in a Phase I Immunotherapy Trial.
Doussau A and Hanmer CB. American Journal of Bioethics 2017; 17(4): 68-69. - Participation of Citizen Scientists in Clinical Research and Access to Research Ethics Consultation.
Collier E and Danis M. American Journal of Bioethics 2017; 17(4): 70-72. - Forgoing Conventional Therapy in Phase I Oncology Research: Don’t Forget About the Children.
Wetmore C. American Journal of Bioethics 2017; 17(4): 72-73.
When a Clinical Trial Is the Only Option.
Taylor HA, Morales C, Wilfond BS. American Journal of Bioethics 2016; 16(10): 67-68.
- “Respect for Persons,” Not “Respect for Citizens”.
Fabi R. American Journal of Bioethics 2016; 16(10): 69-70. - The Potentially High Cost of a Free Clinical Trial.
Heitman E. American Journal of Bioethics 2016; 16(10): 70-72. - Contextualizing “Choice” for Undocumented Immigrants in U.S. Clinical Trials Research.
Burke, NJ. American Journal of Bioethics 2016; 16(10): 72-74.
Studying the Role of Financial Incentives to Promote Hepatitis B Vaccination in a Community Clinic.
Wilfond BS, Morales C, Taylor HA. American Journal of Bioethics 2016; 16(10): 75-76.
- Treatment Incentives and the Nature of the Doctor-Patient Relationship.
Giunta H. American Journal of Bioethics 2016; 16(10): 77-78. - The Ethics of Studying Financial Incentives in Public Health Implementation: Study Design Challenges.
Doussau A and Grady C. American Journal of Bioethics 2016; 16(10): 78-80. - 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.
Perumalswami P, Branch A, Rhodes R. American Journal of Bioethics 2016; 16(10): 80-82.
Selecting Children for an Autism Spectrum Disorder Study: Justice and Geography.
American Journal of Bioethics 2016; 16(4): 69-70.
- Fair Participant Selection: A Negative Obligation Not to Exclude.
Chen SC. American Journal of Bioethics 2016; 16(4): 71-72. - Unequal Individual Risk and Potential Benefit Balanced by Benefits to the Population at Large in Autism Clinical Trials?
Stein MA and King BH. American Journal of Bioethics 2016; 16(4): 72-74. - Justice in Selecting Participants for a Study in Phelan-McDermid Syndrome.
Rhodes R and Kolevzon A. American Journal of Bioethics 2016; 16(4): 74-76.
Recontact and Recruitment of Young Adults Previously Enrolled in Neonatal Herpes Simplex Virus Research.
Taylor HA, Kuwana E, Wilfond BS. American Journal of Bioethics 2015; 15(10): 56-57.
- Research Recruitment of Adult Survivors of Neonatal Infections: Is There a Role for Parental Consent?
Melvin AJ, Mohan KM, Wald A, Porter K, Wilfond BS. American Journal of Bioethics 2015; 15(10): 58-59. - A Knotty Problem of Intertwined Rights.
McKinney RE. American Journal of Bioethics 2015; 15(10): 60-61. - Consent Is the Cornerstone of Ethically Valid Research: Ethical Issues in Recontacting Subjects Who Enrolled in Research as a Minor.
Paquette ET and Ross LF. American Journal of Bioethics 2015; 15(10): 61-63.
Is It Ethical to Enroll Cognitively Impaired Adults in Research That Is More Than Minimal Risk With No Prospect of Benefit?
Taylor HA, Kuwana E, Wilfond BS. American Journal of Bioethics 2015; 15(10): 64-65.
- Inconsistent Approaches to Research Involving Cognitively Impaired Adults: Why the Broad View of Substituted Judgment Is Our Best Guide.
Yarborough M. American Journal of Bioethics 2015; 15(10): 66-67. - Ethical and Regulatory Considerations Regarding Enrollment of Incompetent Adults in More Than Minimal Risk Research as Compared With Children.
Derse AR and Spellecy R. American Journal of Bioethics 2015; 15(10): 68-69. - Acceptable Approaches to Enrolling Adults Who Cannot Consent in More Than Minimal Risk Research.
Danis M, Wendler D, Kim S. American Journal of Bioethics 2015; 15(10): 70-71.
Navigating Parental Permission for Neonatal Research.
Taylor HA, Kuwana E, Wilfond BS. American Journal of Bioethics 2015; 15(4): 76.
- Informed Consent and Parental Permission for Research: Rules, Roles, and Relationships.
Fiore RN and Cushman R. American Journal of Bioethics 2015; 15(4): 77-78. - Research Involving Premature Infants: Timing Is Everything.
Eisenberg LR. American Journal of Bioethics 2015; 15(4): 79-80. - Precluding Consent by Clinicians Who Are Both the Attending and the Investigator: An Outdated Shibboleth?
Shah A, Porter K, Juul S, Wilfond BS. American Journal of Bioethics 2015; 15(4): 80-82.
Protecting Research Subject Welfare in Preventive Trials for Autosomal Dominant Alzheimer’s Disease.
Taylor HA, Kuwana E, Wilfond BS. American Journal of Bioethics 2015; 15(4): 83-84.
- When There Are Only Two Who Can Tango: Ethical Concerns at the Juncture of Highly Novel Interventions and Precisely Targeted Research Populations.
Yarborough M. American Journal of Bioethics 2015; 15(4): 85-86. - Conceptualization and Assessment of Vulnerability in a Complex International Alzheimer’s Research Study.
Korenman S, Finder SG, Ringman JM. American Journal of Bioethics 2015; 15(4): 87-89. - Barriers and Facilitators to the Consent Process in a Study of Complex Genetic Factors.
Simpson AR. American Journal of Bioethics 2015; 15(4): 89-90.
The Ethics of Disclosing to Research Subjects the Availability of Off-Label Marketed Drugs.
Taylor HA, Kuwana E, Wilfond BS. American Journal of Bioethics 2014; 14(4): 51.
- Researchers Have an Ethical Obligation to Disclose the Availability of Off-Label Marketed Drugs.
Silber TJ. American Journal of Bioethics 2014; 14(4): 52. - The Relevance of Research Study Phase to Disclosure of Off-Label Drug Availability.
Baskaran A and Sade RM. American Journal of Bioethics 2014; 14(4): 53-54. - Which Alternatives Should Investigators Disclose to Research Subjects?
Phillips J and Wendler D. American Journal of Bioethics 2014; 14(4): 54-55.
Results Disclosure
A Cluster Randomized Trial to Screen for Abusive Head Trauma in the Pediatric Intensive Care Unit—How to Manage Site-Specific Evidence of Racial/Ethic Disparity.
Johnson LM, Zabrowski J, Wilfond BS. American Journal of Bioethics 2019; 19(10): 108-109.
- Issues of Justice and Risk: Setting Stopping Criteria in Cluster-Randomized Trials.
Tumilty E and Farroni JS. American Journal of Bioethics 2019; 19(10): 110-111. - Clinical Trials Not Causing Harm With Potential for Realizing Benefit Should Continue.
Jackson BM. American Journal of Bioethics 2019; 19(10): 112-114. - Responding to Implicit Bias in Abusive Head Trauma Evaluations and Reporting in the PICU: Ethical Consideration During a Clinical Trial.
McCormick JB and Hymel KP. American Journal of Bioethics 2019; 19(10): 114-115.
Should Research Participants Be Notified About Results of Currently Unknown by Potential Significance?
Johnson LM, Zabrowski J, Wilfond BS. American Journal of Bioethics 2019; 19(4): 73-74.
- The Need For National Guidance Around Informed Consent About GBCA Safety.
Brown SB. American Journal of Bioethics 2019; 19(4): 75-77. - Returning Individual Research Results Regarding Gadolinium Deposition in the Brain Is the Preferable Choice.
Huang CJ, Bandettini WP, Danis M. American Journal of Bioethics 2019; 19(4): 77-78. - Research Participants Should Have the Option to Be Notified of Results of Unknown but Potential Significance.
Hutchinson N, Capron A, Doussau A. American Journal of Bioethics 2019; 19(4): 78-80.
Genotype-Driven Recruitment in Population-Based Biomedical Research.
Taylor HA, Morales C, Wilfond BS. American Journal of Bioethics 2017; 17(4): 58-59.
- Genotype-Driven Recruitment Without Deception.
Ossorio P and Mailick M. American Journal of Bioethics 2017; 17(4): 60-61. - Harms of Deception in FMR1 Premutation Genotype-Driven Recruitment.
Doernberg S and Hull SC. American Journal of Bioethics 2017; 17(4): 62-63. - Genotype-Driven Recruitment and the Disclosure of Individual Research Results.
Beskow LM. American Journal of Bioethics 2017; 17(4): 64-65.
Recontact and Recruitment of Young Adults Previously Enrolled in Neonatal Herpes Simplex Virus Research.
Taylor HA, Kuwana E, Wilfond BS. American Journal of Bioethics 2015; 15(10): 56-57.
- Research Recruitment of Adult Survivors of Neonatal Infections: Is There a Role for Parental Consent?
Melvin AJ, Mohan KM, Wald A, Porter K, Wilfond BS. American Journal of Bioethics 2015; 15(10): 58-59. - A Knotty Problem of Intertwined Rights.
McKinney RE. American Journal of Bioethics 2015; 15(10): 60-61. - Consent Is the Cornerstone of Ethically Valid Research: Ethical Issues in Recontacting Subjects Who Enrolled in Research as a Minor.
Paquette ET and Ross LF. American Journal of Bioethics 2015; 15(10): 61-63.
Protecting Research Subject Welfare in Preventive Trials for Autosomal Dominant Alzheimer’s Disease.
Taylor HA, Kuwana E, Wilfond BS. American Journal of Bioethics 2015; 15(4): 83-84.
- When There Are Only Two Who Can Tango: Ethical Concerns at the Juncture of Highly Novel Interventions and Precisely Targeted Research Populations.
Yarborough M. American Journal of Bioethics 2015; 15(4): 85-86. - Conceptualization and Assessment of Vulnerability in a Complex International Alzheimer’s Research Study.
Korenman S, Finder SG, Ringman JM. American Journal of Bioethics 2015; 15(4): 87-89. - Barriers and Facilitators to the Consent Process in a Study of Complex Genetic Factors.
Simpson AR. American Journal of Bioethics 2015; 15(4): 89-90.
The Ethics of Contacting Family Members of a Subject in a Genetic Research Study to Return Results for an Autosomal Dominant Syndrome.
Taylor HA and Wilfond BS. American Journal of Bioethics 2013; 13(10): 61.
- What Does the Duty to Warn Require?
Shah SK, Hull SC, Spinner MA, Berkman BE, Sanchez LA, Abdul-Karim R, Hsu AP, Claypool R, Holland SM. American Journal of Bioethics 2013; 13(10): 62-63. - Should Researchers Disclose Results to Descendants?
Rothstein MA. American Journal of Bioethics 2013; 13(10): 64-65. - Relationships Matter: Ethical Considerations for Returning Results to Family Members of Deceased Subjects.
Milner LC, Liu EY, Garrison NA. American Journal of Bioethics 2013; 13(10): 66-67.
Risks & Benefits
Ethical Drug Development for Rare Childhood Diseases: When There are Limited but Promising Data in Adults, How to Choose Between Safety or Efficacy Studies?
Johnson LM, Duenas DM, Wilfond BS. American Journal of Bioethics 2020; 20(4): XX-XX.
- The Use of Pediatric Extrapolation to Avoid Unnecessary Pediatric Clinical Trials.
Nelson R. American Journal of Bioethics 2020; 20(4): XX-XX. - Flexibility Required: Balancing the Interests of Children and Risk in Drug Development for Rare Pediatric Conditions.
Porter KM, Stevens A, Wilfond BS. American Journal of Bioethics 2020; 20(4): XX-XX. - When Higher Risk Does Not Equal Greater Harm: Doing the Most Good in a Limited Pediatric Study Population.
Mastler J and Young J. American Journal of Bioethics 2020; 20(4): XX-XX.
Greater than Minimal Risk, No Direct Benefit – Bridging Drug Trials and Novel Therapy in Pediatric Populations.
Wilfond BS, Duenas DM, Johnson LM. American Journal of Bioethics 2020; 20(4): XX-XX.
- Balancing Risk and Reward: Research with Novel Therapies for Children with Life-limiting Illness.
Unguru Y. American Journal of Bioethics 2020; 20(4): XX-XX. - Bringing Known Drugs to Pediatric Research – Safety, Efficacy, and the Ambiguous Minor Increase in Minimal Risk.
Sharma A and Johnson LM. American Journal of Bioethics 2020; 20(4): XX-XX. - Balancing Scientific Progress with Pediatric Protections: No Direct Benefit Now, but Potential Novel Therapy in the Future.
Lee SW and Ginsberg JC. American Journal of Bioethics 2020; 20(4): XX-XX.
Should Research Participants Be Notified About Results of Currently Unknown by Potential Significance?
Johnson LM, Zabrowski J, Wilfond BS. American Journal of Bioethics 2019; 19(4): 73-74.
- The Need For National Guidance Around Informed Consent About GBCA Safety.
Brown SB. American Journal of Bioethics 2019; 19(4): 75-77. - Returning Individual Research Results Regarding Gadolinium Deposition in the Brain Is the Preferable Choice.
Huang CJ, Bandettini WP, Danis M. American Journal of Bioethics 2019; 19(4): 77-78. - Research Participants Should Have the Option to Be Notified of Results of Unknown but Potential Significance.
Hutchinson N, Capron A, Doussau A. American Journal of Bioethics 2019; 19(4): 78-80.
A Randomized Trial of Rapamycin to Increase Longevity and Healthspan in Companion Animals: Navigating the Boundary Between Protections for Animal Research and Human Subjects Research.
Taylor HA, Morales C, Johnson LM, Wilfond BS. American Journal of Bioethics 2018; 18(10): 58-59.
- Rapamycin: Risking Harm for Canine Longevity.
Abbate C. American Journal of Bioethics 2018; 18(10): 60-61. - Companion Animal Studies: Slipping Through a Research Oversight Gap.
Walker RL and Fisher JA. American Journal of Bioethics 2018; 18(10): 62-63. - Research to Promote Longevity and Health Span in Companion Dogs: A Pediatric Perspective.
Wilfond BS, Porter KM, Creevy KE, Kaerberlein M, Promislow D. American Journal of Bioethics 2018; 18(10): 64-65.
Involving Pregnant Women in Research: What Should We Recommend When the Regulations Seem Ethically Problematic?
Taylor HA and Morales C. American Journal of Bioethics 2018; 18(4): 91-92.
- Conflicts Between Regulations and Ethical Principles: Resolving Ambiguity in Favor of the Ethically Preferable Outcome.
Shah SK and Porter K. American Journal of Bioethics 2018; 18(4): 93-94. - When to Avoid Giving Advice on the Ethical Conduct of Research.
Sharp RR and Allyse MA. American Journal of Bioethics 2018; 18(4): 94-95. - When Research Regulations and Ethics Conflict.
Sullivan HK, Braverman DW, Wendler D. American Journal of Bioethics 2018; 18(4): 96-97.
A Trial to Test a Novel Approach to Diabetes Prevention.
Taylor HA, Morales C, Wilfond BS. American Journal of Bioethics 2017; 17(10): 74-75.
- Is It Ethically Acceptable to Screen Patients for Obstructive Sleep Apnea and Not Offer Them Positive Air Pressure Therapy in a Clinical Trial?
McCormick JB, Wu JT, Doussau A. American Journal of Bioethics 2017; 17(10): 76-77. - Can We Breathe Easy If PAP Therapy Is Withheld?
Taylor HA and Punjabi NM. American Journal of Bioethics 2017; 17(10): 78-79. - Risks of Clinical Research Must Be Reasonable and Necessary.
Gibbes Miller D and Kim SYH. American Journal of Bioethics 2017; 17(10): 79-81.
Is It Ethical to Enroll Cognitively Impaired Adults in Research That Is More Than Minimal Risk With No Prospect of Benefit?
Taylor HA, Kuwana E, Wilfond BS. American Journal of Bioethics 2015; 15(10): 64-65.
- Inconsistent Approaches to Research Involving Cognitively Impaired Adults: Why the Broad View of Substituted Judgment Is Our Best Guide.
Yarborough M. American Journal of Bioethics 2015; 15(10): 66-67. - Ethical and Regulatory Considerations Regarding Enrollment of Incompetent Adults in More Than Minimal Risk Research as Compared With Children.
Derse AR and Spellecy R. American Journal of Bioethics 2015; 15(10): 68-69. - Acceptable Approaches to Enrolling Adults Who Cannot Consent in More Than Minimal Risk Research.
Danis M, Wendler D, Kim S. American Journal of Bioethics 2015; 15(10): 70-71.
Protecting Research Subject Welfare in Preventive Trials for Autosomal Dominant Alzheimer’s Disease.
Taylor HA, Kuwana E, Wilfond BS. American Journal of Bioethics 2015; 15(4): 83-84.
- When There Are Only Two Who Can Tango: Ethical Concerns at the Juncture of Highly Novel Interventions and Precisely Targeted Research Populations.
Yarborough M. American Journal of Bioethics 2015; 15(4): 85-86. - Conceptualization and Assessment of Vulnerability in a Complex International Alzheimer’s Research Study.
Korenman S, Finder SG, Ringman JM. American Journal of Bioethics 2015; 15(4): 87-89. - Barriers and Facilitators to the Consent Process in a Study of Complex Genetic Factors.
Simpson AR. American Journal of Bioethics 2015; 15(4): 89-90.
The Obligations to Report Statutory Sexual Abuse Disclosed in a Research Study.
Taylor HA, Kuwana E, Wilfond BS. American Journal of Bioethics 2014; 14(10): 50.
- The Moral and Legal Need to Disclose Despite a Certificate of Confidentiality.
Paquette ET and Ross LF. American Journal of Bioethics 2014; 14(10): 51-53. - Informed Consent and the Implications for Statutory Rape Reporting in Research With Adolescents.
Hodgkinson S, Lewin A, Chang B, Beers L, Silber T. American Journal of Bioethics 2014; 14(10): 54-55. - Community, Context, and the Contrasting Roles of Clinicians and Researchers: Challenges Raised by Statutory Rape.
Finder SG and Korenman S. American Journal of Bioethics 2014; 14(10): 55-57.
Subject Selection
Involving Pregnant Women in Research: What Should We Recommend When the Regulations Seem Ethically Problematic?
Taylor HA and Morales C. American Journal of Bioethics 2018; 18(4): 91-92.
- Conflicts Between Regulations and Ethical Principles: Resolving Ambiguity in Favor of the Ethically Preferable Outcome.
Shah SK and Porter K. American Journal of Bioethics 2018; 18(4): 93-94. - When to Avoid Giving Advice on the Ethical Conduct of Research.
Sharp RR and Allyse MA. American Journal of Bioethics 2018; 18(4): 94-95. - When Research Regulations and Ethics Conflict.
Sullivan HK, Braverman DW, Wendler D. American Journal of Bioethics 2018; 18(4): 96-97.
Should Patients Be Required to Undergo Standard Chemotherapy Before Being Eligible for Novel Phase I Immunotherapy Clinical Trials?
Wilfond BS, Morales C, Taylor HA. American Journal of Bioethics 2017; 17(4): 66-67.
- A Rationale for Relaxing the Requirement to Undergo a Noncurative Chemotherapy for Advanced Cancer in a Phase I Immunotherapy Trial.
Doussau A and Hanmer CB. American Journal of Bioethics 2017; 17(4): 68-69. - Participation of Citizen Scientists in Clinical Research and Access to Research Ethics Consultation.
Collier E and Danis M. American Journal of Bioethics 2017; 17(4): 70-72. - Forgoing Conventional Therapy in Phase I Oncology Research: Don’t Forget About the Children.
Wetmore C. American Journal of Bioethics 2017; 17(4): 72-73.
Selecting Children for an Autism Spectrum Disorder Study: Justice and Geography.
American Journal of Bioethics 2016; 16(4): 69-70.
- Fair Participant Selection: A Negative Obligation Not to Exclude.
Chen SC. American Journal of Bioethics 2016; 16(4): 71-72. - Unequal Individual Risk and Potential Benefit Balanced by Benefits to the Population at Large in Autism Clinical Trials?
Stein MA and King BH. American Journal of Bioethics 2016; 16(4): 72-74. - Justice in Selecting Participants for a Study in Phelan-McDermid Syndrome.
Rhodes R and Kolevzon A. American Journal of Bioethics 2016; 16(4): 74-76.
Is It Ethical to Enroll Cognitively Impaired Adults in Research That Is More Than Minimal Risk With No Prospect of Benefit?
Taylor HA, Kuwana E, Wilfond BS. American Journal of Bioethics 2015; 15(10): 64-65.
- Inconsistent Approaches to Research Involving Cognitively Impaired Adults: Why the Broad View of Substituted Judgment Is Our Best Guide.
Yarborough M. American Journal of Bioethics 2015; 15(10): 66-67. - Ethical and Regulatory Considerations Regarding Enrollment of Incompetent Adults in More Than Minimal Risk Research as Compared With Children.
Derse AR and Spellecy R. American Journal of Bioethics 2015; 15(10): 68-69. - Acceptable Approaches to Enrolling Adults Who Cannot Consent in More Than Minimal Risk Research.
Danis M, Wendler D, Kim S. American Journal of Bioethics 2015; 15(10): 70-71.