This essay is about the timing of research consent, a process that involves participants being given information about, among other things, upcoming research interventions and then being invited to waive their claims against those interventions being undertaken. The standard practice, as regards timing, is as follows: participants are invited to waive all their claims at a single moment in time, and that point in time immediately follows the information-provision. I argue that there we’re not justified in keeping to this practice. (...) What we ought to do is disaggregate the claim-waiving part of the process and move it later, such that the participant is invited to waive her claim against the undertaking of any given intervention only the immediate moment before that intervention is to be undertaken. (shrink)

This study is the first to examine the understandings that participants have of the consent process in a pharmacogenetic trial of anti-depressant medication.

Informed consent is central to modern research ethics. Informed consent procedures have mainly been justified in terms of respect for autonomy, the core idea being that it should be every competent individual’s right to decide for herself whether or not to participate in scientific studies. A number of conditions are normally raised with regard to morally valid informed consent. These include that potential research subjects get adequate information, understand those aspects that are relevant to them, and, based on that information, (...) make a voluntary decision whether or not to participate. These conditions are meant to guarantee that participation is genuinely the individual’s own choice and is coherent with his or her authentic interests. (shrink)

Although international research is increasing in volume and importance, there remains a dearth of knowledge on similarities and differences in “national human research ethics”, that is, national ethical guidelines, Institutional Review Boards, and research stakeholder’ ethical attitudes and behaviors. We begin to address this situation by reporting upon our experiences in conducting a multinational study into the mental health of children who had a parent/carer in prison. The study was conducted in 4 countries: Germany, Great Britain, Romania, and Sweden. Data (...) on NHREs were gathered via a questionnaire survey, two ethics-related seminars, and ongoing contact between members of the research consortium. There was correspondence but even more so divergence between countries in the availability of NEGs and IRBs and in researcher’ EABs. Differences in NHREs have implications particularly in terms of harmonization but also for ethical philosophy and practice and for research integrity. (shrink)

Objective Recent legislation mandating the inclusion of children in clinical trials has resulted in an increase in the number of children participating in research. We reviewed the literature regarding the reasons parents chose to accept or decline an invitation to enrol their children in clinical research. Methods We searched for qualitative studies, written in the English language that considered the experiences of parents who had been invited to enrol their children in research. SCOPUS and Web of Knowledge electronic databases and (...) reference lists of retrieved articles and review papers were searched. Retrieved articles were synthesised using the narrative synthesis method. Results 16 qualitative studies exploring the experiences of parents living in five countries whose children had a range of health conditions of varying severity were included. The health status of the child appeared to influence parents' reasons for participation. Parents whose children had life threatening conditions often considered they had no choice but to participate and many welcomed the innovation offered through research participation. Such parents also viewed the risks of research less negatively than those whose children were healthy or in the stable stage of a chronic condition. This raises questions regarding the voluntariness of informed consent by such parents. Conclusions A tailored approach is needed when discussing research participation with parents of eligible children. While parents of healthy children may be more open to discussions of altruism, those whose children have life threatening illnesses should be given adequate information about the alternatives to, and risks of, research participation. (shrink)

ObjectiveThis study aimed to describe how parents and physicians experienced the informed consent interview and to investigate the aspects of the relationship that influenced parents’ decision during the consent process for a randomised clinical trial in a tertiary neonatal intensive care unit. The secondary objective was to describe the perspectives of parents and physicians in the specific situation of prenatal informed consent.SettingSingle centre study in NICU of the Centre Hospitalier Intercommunal de Créteil, France, using a convenience period from February to (...) May 2016.DesignAncillary study to a randomised clinical trial: Prettineo. Records of interviews for consent. Population: parents and physicians. Mixed study including qualitative and quantitative interview data about participants’ recall and feelings about the consent process. Interviews were reviewed using thematic discourse analysis.ResultsParents’ recall and understanding of the study’s main goal and design was good. Parents and physicians had a positive experience, and trust was one of the main reasons for parents to consent. Misunderstanding was the main reason for refusal.Before birth, three situations can compromise parents’ consent: the mother already consented to participate in other studies, the absence of the father during the interview and the feeling that the baby’s birth is not an imminent possibility.ConclusionsConfronting parents and physicians’ perspectives in research can help us reach answers to sensitive issues such as content and timing of information. Each different types of study raises different ethical dilemmas for consent that might be discussed in a more individual way. (shrink)