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Challenging Cases

Clinical Research Ethics Consultation Collaborative

 Challenging Cases

Established a semi-annual series of “Challenging Cases in Clinical Research Ethics” in the American Journal of Bioethics.

All Cases

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): 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.

 

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.

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.

 

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 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.

 

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.

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.

 

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.

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.

 

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.

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.

 

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.

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.

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.

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.

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.

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.

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.

Genotype-Driven Recruitment in Population-Based Biomedical Research.
Taylor HA, Morales C, Wilfond BS. American Journal of Bioethics 2017; 17(4): 58-59.

When a Clinical Trial Is the Only Option.
Taylor HA, Morales C, Wilfond BS. American Journal of Bioethics 2016; 16(10): 67-68.

Obligations to Act on Patient Reported Outcomes in Electronic Health Records.
American Journal of Bioethics 2016; 16(4): 62.

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 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.

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.

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.

When a Clinical Trial Is the Only Option.
Taylor HA, Morales C, Wilfond BS. American Journal of Bioethics 2016; 16(10): 67-68.

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.

Selecting Children for an Autism Spectrum Disorder Study: Justice and Geography.
American Journal of Bioethics 2016; 16(4): 69-70.

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.

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.

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.

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.

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.

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.

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.

Genotype-Driven Recruitment in Population-Based Biomedical Research.
Taylor HA, Morales C, Wilfond BS. American Journal of Bioethics 2017; 17(4): 58-59.

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.

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.

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.

Ethical Implications of Social Media in Health Care Research.
Taylor HA, Kuwana E, Wilfond BS. American Journal of Bioethics 2014; 14(10): 58-59.

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.

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.

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.

Selecting Children for an Autism Spectrum Disorder Study: Justice and Geography.
American Journal of Bioethics 2016; 16(4): 69-70.

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.

Navigating Parental Permission for Neonatal Research.
Taylor HA, Kuwana E, Wilfond BS. American Journal of Bioethics 2015; 15(4): 76.

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.

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.

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.

Genotype-Driven Recruitment in Population-Based Biomedical Research.
Taylor HA, Morales C, Wilfond BS. American Journal of Bioethics 2017; 17(4): 58-59.

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.

When a Clinical Trial Is the Only Option.
Taylor HA, Morales C, Wilfond BS. American Journal of Bioethics 2016; 16(10): 67-68.

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.

Selecting Children for an Autism Spectrum Disorder Study: Justice and Geography.
American Journal of Bioethics 2016; 16(4): 69-70.

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.

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.

Navigating Parental Permission for Neonatal Research.
Taylor HA, Kuwana E, Wilfond BS. American Journal of Bioethics 2015; 15(4): 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.

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.

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.

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.

Genotype-Driven Recruitment in Population-Based Biomedical Research.
Taylor HA, Morales C, Wilfond BS. American Journal of Bioethics 2017; 17(4): 58-59.

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.

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.

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.

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.

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.

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.

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 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.

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.

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.

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.

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.

Selecting Children for an Autism Spectrum Disorder Study: Justice and Geography.
American Journal of Bioethics 2016; 16(4): 69-70.

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.