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.

Clinical/Research Relationships

Expanded Access for Nusinersen in Patients With Spinal Muscular Atrophy: Negotiating Limited Data, Limited Alternative Treatments, and Limited Hospital Resources. Wilfond BS, Morales C and 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 and 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 and 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 and 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 201616(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 201616(4): 67-68.

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 J. 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

Genotype-Driven Recruitment in Population-Based Biomedical Research. Taylor HA, Morales C and 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, 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.

Participants Withholding Information

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. Lynch HF, 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.

Pediatrics

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.

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 Trial to Test a Novel Approach to Diabetes Prevention. Taylor HA, Morales C and 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 and 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. Miller DG and Kim SYH. American Journal of Bioethics 2017;17(10):79-81.

Studying the Role of Financial Incentives to Promote Hepatitis B Vaccination in a Community Clinic. Wilfond BS, Morales C and 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 and Rhodes R. American Journal of Bioethics 2016;16(10):80-82.

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):64-66.

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 Oct;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 Oct;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 Oct;15(10):70-71.

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;14(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 Oct;15(10):58-59.

A knotty problem of intertwined rights. McKinney RE. American Journal of Bioethics. 2015 Oct;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 Oct;15(10):61-63.

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 alternative should investigators disclose to research subjects? Phillips J and Wendler D. American Journal of Bioethics 2014;14(4):54-55.

Regulations and Ethics

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 ofo 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.

Research Misconduct

Managing Disclosure of Research Misconduct by a Graduate Student to a University Mental Health Professional During A Clinical Counseling Session Taylor HA, 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.

Social Media Research

Ethical Implications of Social Media in Healthcare Research Taylor HA, Kuwana E, Wilfond BS. American Journal of Bioethics 2014;14(10):58-9.

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. 2014. 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.