Ryan Spellecy

Reviving Ulysses Contracts

Ulysses contracts have faced paternalism objections since they first were proposed. Since the contracts are designed to override a present request from a legally competent patient in favor of a past request made by that patient, enforcement of these contracts was argued to be unjustifiable strong paternalism. Recent legal developments and new theories of practical reasoning suggest that the discussion of Ulysses contracts should be revived. This paper argues that with a proper understanding of the future-directed planning embodied in Ulysses contracts, the charge of strong paternalism can be answered, and the enforcement of some Ulysses contracts may be justified under the rubric of weak paternalism.

Easy-to-Read Informed Consent Forms for Hematopoietic Cell Transplantation Clinical Trials

Informed consent is essential to ethical research and is requisite to participation in clinical research. Yet most hematopoietic cell transplantation (HCT) informed consent forms (ICFs) are written at reading levels that are above the ability of the average person in the United States (U.S.). The recent development of ICF templates by the National Cancer Institute, National Institutes of Health, and the National Heart Blood and Lung Institute have not resulted in increased patient comprehension of information. Barriers to creating Easy-to-Read ICFs that meet U.S. federal requirements and pass institutional review board (IRB) review are the result of multiple interconnected factors. The Blood and Marrow Transplant Clinical Trials Network (BMT CTN) formed an ad hoc review team to address concerns regarding the overall readability and length of ICFs used for BMT CTN trials. This paper summarizes recommendations of the review team for the development and formatting of Easy-to-Read ICFs for HCT multicenter clinical trials, the most novel of which is the use of a 2-column format. These recommendations intend to guide the ICF writing process, simplify local IRB review of the ICF, enhance patient comprehension, and improve patient satisfaction. The BMT CTN plans to evaluate the impact of the Easy-to-Read format compared with the traditional format on the informed consent process.

Viewpoint: IRBs, hospital ethics committees, and the need for "translational informed consent".

In this paper, the authors contrast the model of informed consent oversight employed by most IRBs with that most commonly employed by hospital ethics committees at academic medical centers. The challenge of developing adequate consent forms is complicated by competing aims that are difficult to reconcile. “Completeness” in conveying highly technical information is often at odds with comprehensibility for lay audiences. The authors argue that the problems posed by consent are tied to the fact that in clinical research, consent documents are perceived as the primary mechanism for securing informed consent, as opposed to viewing the consent process and conversation as the primary mechanism. Concerns for informed consent should be refocused to the consent process rather than IRB review of documents, using teams of consent monitors, and this new emphasis should be piloted through the National Institute of Health’s recent turn toward clinical and translational science awards.

Is ‘informed consent’ an ‘understood consent’ in hematopoietic cell transplantation?

Hematopoietic cell transplantation (HCT) is a complex and highly specialized medical treatment that is associated with significant risks, including death. Furthermore, transplantation is offered to patients who often have no other curative treatment alternatives. The routine-consent process for HCT typically occurs before HCT and is influenced by many factors related to patients, physicians and the transplant per se. These factors can impede the consent process and subsequently result in a failure of proper engagement in and an understanding of the procedure with resultant adverse consequences influencing patients and even the patient–physician relationship. We contend that informed consent is a dynamic and ongoing process and that better patient education can assist in the decision making, fulfill the ethical principle of respect for autonomy and engage the patient to maximize compliance and adherence to therapy. This manuscript reviews the key literature pertaining to the decision-making and consent process in HCT and proposes guidelines for improving the consent process. Strategies for improving patient comprehension, engagement and enhancing consent forms are discussed.

The Limits of Traditional Approaches to Informed Consent for Genomic Medicine

This paper argues that it will be important for new genomic technologies to recognize the limits of traditional approaches to informed consent, so that other-regarding implications of genomic information can be properly contextualized and individual rights respected. Respect for individual autonomy will increasingly require dynamic consideration of the interrelated dimensions of individual and broader community interests, so that the interests of one do not undermine fundamental interests of the other. In this, protection of individual rights will be a complex interplay between individual and community concerns.

Psychiatric Outpatient Commitment: One Tool Along a Continuum

economic outcome than the alternatives, but that does not make it morally justified from the vantage of protecting individual autonomy. The argument might be made on other ethical grounds, e.g., utilitarianism, but again the moral debate must be pitched against personal freedoms, and the clinical data again fails to alter the ethical argument. Beyond these concerns, the empirical evidence of this study does not necessarily support the clinical conclusions made by Zanni and Stavis (2007). The most significant clinical problems derive from partial and ill-considered use of clinical data: nonequivalent groups and failure to apply multivariate controls. The most interesting findings relate to the reduced use of restraint and seclusion, yet, the strength of these data lie in the observation that while the OPC group experienced a decline in the use of restraint and seclusion, no similar decline was observed in the control group leading the authors to note that “. . . the findings cannot be attributed to decreases in overall utilization of . . . seclusion and restraint” (Zanni and Stavis 2007, 31). This observation is problematic as the new and less seriously ill controls were less likely to have had a previous hospitalization and an opportunity to be secluded or restrained in either period. One might suspect that, in a multivariate analysis controlling for the amount of time patients were at risk of seclusion or restraint (i.e., in hospital), the attribution of the decline in seclusion or restraint to the use of OPC would disappear. While not altering our judgment about differentiating the moral argument from the clinical science, we would be interested as a clinical matter in a better-controlled analysis.

Facilitating Autonomy With Broad Consent

ISSN: 1526-5161 (Print) 1536-0075 (Online) Journal homepage: http://www.tandfonline.com/loi/uajb20 Facilitating Autonomy With Broad Consent Ryan Spellecy To cite this article: Ryan Spellecy (2015) Facilitating Autonomy With Broad Consent, The American Journal of Bioethics, 15:9, 43-44, DOI: 10.1080/15265161.2015.1062185 To link to this article: http://dx.doi.org/10.1080/15265161.2015.1062185 Published online: 25 Aug 2015.

Piloting a Nationally Disseminated, Interactive Human Subjects Protection Program for Community Partners: Unexpected Lessons Learned from the Field

Funders, institutions, and research organizations are increasingly recognizing the need for human subjects protections training programs for those engaged in academic research. Current programs tend to be online and directed toward an audience of academic researchers. Research teams now include many nonacademic members, such as community partners, who are less likely to respond to either the method or the content of current online trainings. A team at the CTSA‐supported Michigan Institute for Clinical and Health Research at the University of Michigan developed a pilot human subjects protection training program for community partners that is both locally implemented and adaptable to local contexts, yet nationally consistent and deliverable from a central administrative source. Here, the developers of the program and the collaborators who participated in the pilot across the United States describe 10 important lessons learned that align with four major themes: The distribution of the program, the implementation of the program, the involvement of community engagement in the program, and finally lessons regarding the content of the program. These lessons are relevant to anyone who anticipates developing or improving a training program that is developed in a central location and intended for local implementation.

Children and Parents as Members of the Research Team: Fair Employment Practices Without a Union Contract

In clinical mental health research with children, both child and parent are essential members of the research team. The 3 Rs of parent/child team membership are respect, rapport, and recognition. Respect and recognition include fair reimbursement for time, expense, and inconvenience, but the most important compensation for many families is the appreciation of the other team members for their sacrifice and cooperation. Reimbursement, although honoring the principles of justice and respect for persons, raises difficult issues about appropriate amount, particularly in research involving children. The 3 Rs are supported by the investigator 5 As: attitude, adaptability, availability, attachment, and appreciation. Although the principles seem clear in the abstract, implementation encounters many practical problems. Perhaps the most difficult of these is determining the appropriate amount of compensation that avoids undue inducement but not at the expense of the 3 Rs and 5 As.

The Real-Time IRB: A Collaborative Innovation to Decrease IRB Review Time

Lengthy review times for institutional review boards (IRBs) are a well-known barrier to research. In response to numerous calls to reduce review times, we devised “Real-Time IRB,” a process that drastically reduces IRB review time. In this, investigators and study staff attend the IRB meeting and make changes to the protocol while the IRB continues its meeting, so that final approval can be issued at the meeting. This achieved an overall reduction in time from submission to the IRB to final approval of 40%. While this process is time and resource intensive, and cannot address all delays in research, it shows great promise for increasing the pace by which research is translated to patient care.