The views and experiences of these respondents do not support the claim that pediatric research without the potential for clinical benefit treats subjects as mere means. Instead, the findings provide proof of principle for the claim that non-beneficial pediatric research involves a type of charitable activity which offers children the opportunity to contribute to a valuable project to help others.

Purpose Adolescents join clinical research after investigators obtain their positive agreement, or ‘assent.’ Although intended to respect adolescents, little is known about the views of adolescents or their parents regarding assent or research enrollment decisions. This study aimed to better understand perspectives of adolescent research participants and their parents about assent and parental permission. Methods Structured interviews were conducted with 13 through 17 year old teens, enrolled in clinical research at NIH or Seattle Children’s Hospital, and separately with one parent. Results 177 adolescent-parent pairs were interviewed. Teens were well distributed by age and gender, represented a wide variety of research and illnesses ranging in severity from mild to life-threatening; 20% were healthy volunteers. Teens and parents were generally satisfied with the assent/permission process. Normally, they made the enrollment decision together and teens wanted parents’ input and support. About 25% of teens reported pressure to enroll, from parents or relatives, but also from doctors/nurses/research teams. Only 2% of teens preferred not to sign a consent form. Conclusions Despite some differing views about how decisions should be made, the current assent/permission process is perceived as satisfactorily respectful by most teens in research. Many teens want to sign consent forms and teens’ signatures should generally be sought. Flexible guidance allows research teams and IRBs to customize the assent process for teens in particular studies in order to facilitate an appropriate balance between giving teens a voice reflective of their emerging independence and enabling supportive collaboration with parents.

Recent guidance from the Food and Drug Administration supports the conduct of a new type of exploratory clinical trial, commonly called phase 0 clinical trials. Proponents argue that phase 0 clinical trials have the potential to expedite the development of new oncology drugs while exposing fewer research subjects to the risks of experimental treatments. At the same time, phase 0 oncology trials raise important ethical concerns that have received little attention. In particular, there is a question of whether it is ethical to enroll individuals in research that offers them no potential for clinical benefit. Further concern focuses on the inclusion of terminally ill and consequently vulnerable cancer patients in these trials. To evaluate these concerns, this article considers relevant empirical data from phase 1 oncology trials and develops several recommendations regarding the conduct of phase 0 clinical trials in oncology.

Purpose Physicians frequently prescribe antimicrobials inappropriately, leading to an increase in the rate of resistance, which in turn, harms patients. To better understand why physicians prescribe specific antimicrobials in particular cases, the authors investigated the decision-making processes underlying physicians’ antimicrobial choice (i.e., their antimicrobial reasoning). Method Applying a clinical reasoning framework, the authors conducted semi-structured, qualitative interviews with a purposive sample of attending physicians in infectious diseases and hospital medicine at 2 hospitals in fall 2018. An interviewer asked participants to describe how they would choose which antimicrobial to prescribe in 3 clinical vignettes, to recall how they chose an antimicrobial in an example from their own practice, and to indicate their steps in antimicrobial selection generally. The authors identified steps and factors in antimicrobial reasoning through thematic analysis of interviews and the note cards that participants used to delineate their general antimicrobial reasoning processes. Results Sixteen participants described 3 steps in the antimicrobial reasoning process: naming the syndrome, delineating pathogens, and selecting the antimicrobial (therapy script). They mentioned 25 different factors in their reasoning processes, which the authors grouped into 4 areas: preexisting patient characteristics, current case features, provider and health care system factors, and treatment principles. Participants used antimicrobial (therapy) scripts that included 14 different drug characteristics. The authors present the steps and factors in a framework for antimicrobial reasoning. Conclusions Through this exploratory study, the authors identified steps and factors involved in physicians’ antimicrobial reasoning process, as well as the content of their antimicrobial (therapy) scripts. They organized all these findings into a framework for antimicrobial decision making. This information may ultimately be adapted into educational tools to improve antimicrobial prescribing across the spectrum of learners and practicing physicians.