The challenge of community engagement and informed consent in rural Zambia: an example from a pilot study.

BACKGROUND: There is a need for empirically based research on social and ethical challenges related to informed consent processes, particularly in studies focusing on adolescent sexual and reproductive health. In a pilot study of a school-based pregnancy prevention intervention in rural Zambia, the majority of the guardians who were asked to consent to their daughters' participation, refused. In this paper we explore the reasons behind the low participation in the pilot with particular attention to challenges related to the community engagement and informed consent process. METHODS: The pilot was implemented in two schools and examined the acceptability of a package of interventions including economic support to families to keep their girls in school, pocket money for girls, youth club meetings on reproductive health, and community meetings to sensitize the community. Focus group discussions (4) were conducted with girls who participated in the pilot, boys in their class and with parents. Individual semi-structured interviews (11) were conducted with teachers, peer educators and community health workers involved in the coordination of the intervention as well as with religious and traditional leaders. Data were analyzed through thematic analysis. RESULTS: The findings indicate that inadequate use of recognized community communication channels during the community engagement process and dissemination of information about the pilot resulted in limited understanding of the pilot concept by the community. This surfaced through uncertainty and fear that the intervention may result in loss of control over daughters, worries about why money was provided unconditionally to girls, and suspicion of links to satanism. The sense of insecurity appeared to be exacerbated by low literacy levels, poverty, fear of loss of bride wealth, perceived disregard for local perceptions of social status, and scanty trust in the actors implementing the pilot. CONCLUSIONS: Inadequate use of locally appropriate channels in the dissemination of information created room for interpretation and facilitated development of mistrust, undermining the conditions for community engagement and actual informed consent. A key lesson learnt is the importance of taking seriously the complexity of local values and structures that may impact people's capability to consent or not consent to a study in an informed manner.

Developing guidance for pregnancy testing of adolescents participating in research: ethical, legal and practical considerations.

Adolescents need safe effective drugs that have undergone ethically approved testing in clinical trials; such studies often require pregnancy testing in 'women of childbearing age' which includes children/adolescents. There is a lack of consistent standard operating procedures for pregnancy testing in these individuals, in either research or clinical (ie, both preprocedure and clinical emergency) settings. Some harmonisation between a selective or universal testing approach based on a risk analysis of the trial drug or procedure would seem sensible. The need for pregnancy testing and the reasons for the method chosen (universal or selective) should be clearly defined in the research protocol. Research ethics committees (RECs) need to satisfy themselves that the selection of subjects to be tested, the procedures for obtaining consent and the respecting of the young person's confidentiality are appropriate and that management of any positive tests are in accord with local safeguarding policies and procedures. Researchers should have core competencies necessary to manage sensitive questioning and child safeguarding training. Clinical trials of medicinal product (CTIMP) pregnancy testing in females 13-15 years of age requires parental consent and the child's active involvement in the decision-making process ('assent') the implications of a positive test should be discussed in advance Children under 13 years should not normally be subject to pregnancy testing in CTIMPs, unless there are exceptional circumstances, for example, a trial of contraceptive agents of a high teratogenicity risk, as reviewed by a specialist paediatric REC. We analyse the ethical, legal and practical aspects of this issues and supply guidance to support those involved.

Pediatric obstetrical ethics: Medical decision-making by, with, and for pregnant early adolescents.

Pregnancy in an early adolescent carries with it specific ethical considerations, in some ways different from pregnancy in an adult and from medical care of a non-pregnant adolescent. Obstetrical ethics emphasizes the right of the patient to autonomy and bodily integrity, including the right to refuse medical intervention. Pediatric ethics recognizes the right of parents, within limits, to make medical decisions for their children, and the right of a child to receive medical or surgical interventions likely to be of benefit to her, sometimes over her own objections. As the child gets older, and particularly during the years of adolescence, there is also a recognition of the right to an increasingly prominent role in decisions about her own healthcare. Pediatric obstetrical ethics, referring to ethical decisions made by, with, and for pregnant early adolescents, represents the intersection of these different cultures. Principles and approaches from both obstetrical and pediatric ethics, as well as a unified understanding of rights, obligations, and practical considerations, will be needed.

Questioning the significance of the non-identity problem in applied ethics: a reply to Tony Hope.

In this paper I reply to Tony Hope's response to my non-identity paper, aiming to clarify the nature of my objections, and also to address, briefly, Hope's suggestion that the implications of my view are that any book written for a lay audience ought to seek to present a 'balanced overview'. Essentially, I suggest that there may be a pro tanto consideration in favour of such an approach, but this would only be one consideration, to be weighed against competing considerations.

Questioning the significance of the non-identity problem in applied ethics.

Authors such as Tony Hope and Julian Savulescu appeal to Derek Parfit's non-identity problem in relation to particular questions in applied ethics, and particularly in reproductive ethics. They argue that the non-identity problem shows that an individual cannot be harmed by being brought into existence, and therefore, we cannot say that the individual is harmed if, for example, we select an embryo in order to have a deaf child. Thus, they argue that an appeal to the non-identity problem blocks (or significantly reduces the force of) objections in a number of cases. I argue that these discussions often give the impression that this is a clear conclusion, shared by most philosophers, and largely beyond dispute. This is particularly significant because these discussions are often in journals or books with an interdisciplinary readership. My concern is that they give the impression of stating: 'philosophers have studied this issue, and this is the conclusion they have reached. Now I will emphasise the implications for medical ethics'. I argue that, far from being the consensus view, the view presented by Hope and Savulescu is rejected by many, including Parfit himself.

El aborto no punible. Algunas consideraciones bioéticas y legales / Nonpunishable abortion. Some bioethical and legal considerations

El aborto no punible (ANP) es aquél permitido por la ley. Pero ciertamente aún hoy en día existen en nuestro país barreras administrativas que enfrentan las mujeres en condiciones de acceder a un ANP. A partir del fallo de la Corte Suprema de Justicia de la Nación, "F.A.,L. s/ medida autosatisfactiva", ha resurgido la necesidad de establecer protocolos intrahospitalarios de atención de los ANP, de modo de garantizar el acceso a una práctica legal y segura, para todas las mujeres que se encuentren dentro de las previsiones de la norma (Art. 86 Código Penal) (AU)

Justifiable abortion is the one that is allowed by law. Even now women who are in condition of gaining access to a justifiable abortion are faced with administrative odds. Our National Supreme Court declaration in re "F.A.,L. s/ medida autosatisfactiva", has set the duty to establish hospital protocols in order to assist women in need of a justifiable abortion, and guarantee the access to a safe and legal practice for all women who are protected by law (art. 86 Criminal Code) (AU)

Physicians' duties and the non-identity problem.

The non-identity problem arises when an intervention or behavior changes the identity of those affected. Delaying pregnancy is an example of such a behavior. The problem is whether and in what ways such changes in identity affect moral considerations. While a great deal has been written about the non-identity problem, relatively little has been written about the implications for physicians and how they should understand their duties. We argue that the non-identity problem can make a crucial moral difference in some circumstances, and that it has some interesting implications for when it is or is not right for a physician to refuse to accede to a patient's request. If a physician is asked to provide an intervention (identity preserving) that makes a person worse off, then such harm provides a good reason for the physician to refuse to provide the intervention. However, in cases where different (identity-altering) interventions result in different people having a better or worse life, physicians should normally respect patient choice.

A model of moral identity: applications for education.

The purpose of this chapter is to build an intellectual bridge between moral psychology and education. Our hope is that the findings from moral psychology will inform and explain best practices in moral education. With that end in mind, we briefly and selectively review the moral education and character education literature highlighting some of the challenges these domains have faced. Next, we review the moral identity literature and offer our own model of moral identity formation emphasizing the "characteristic adaptations" (i.e., moral orientation, moral self, moral emotions, and social relationships and opportunities) of the model. Finally, we illustrate and explain how some of these "characteristic adaptations" have been or could be used in the development of successful moral education programs, and provide specific examples for application of our model in the domain of sex education.

The case of the pregnant adolescent.

In this case an adolescent, minor female presents herself for routine dental care, but is pregnant without parental knowledge. She asks the dentist not to reveal the pregnancy to her parents. Three experts including one attorney, one dental educator with 25 years of private practice experience, and one member of a state psychological association's ethics committee comment on the difficult ethical and legal issues found in this actual case.

Should medicine assist a teenager to achieve a pregnancy?

This article discusses a scenario of a teenager seeking medical assistance for infertility. Despite its apparent simplicity, the case poses a significant challenge to healthcare professionals. It requires consideration of maternal and child welfare and examination of the legitimate limits of doctors' role vis-à-vis the policy objective of reducing teenage pregnancy rate. The negative stereotypic representation of teenage pregnancy is an important confounding factor.