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Friends call him The Hoomanator, a darkly comical conflation of his first name, Hooman, and morcellator, the medical device he has aggressively campaigned against. Enemies—who are great in number—call him much worse. Over a two-year investigation, The Cancer Letter tracked Noorchashm and his wife, Amy Reed, as they challenged FDA, Congress, hospitals, the gynecology profession and manufacturers of medical devices. I have a wife with advanced cancer and six young children. The Root Causes of Harm From Medical Devices The FDA Office of Criminal Investigations is being asked to determine why the agency has failed to detect the upstaging of cancers in women who had been operated on with a power morcellator. These devices, widely used to shred uterine tissue in minimally invasive gynecological surgery, are now known to upstage undetected cancers that, according to FDA, occur in one of about patients undergoing hysterectomies and myomectomies. It took over two decades for the agency to realize that thousands of women may have died from metastatic uterine sarcoma upstaged by power morcellators, Rep. Mike Fitzpatrick R-Pa. There is no need to revamp the k process, Pilot said. The agency should instead enforce existing laws to make device manufacturers and user facilities report adverse outcomes.

Health maximisation Non-maleficence and beneficence can be understood in both deontological and consequentialist terms. Yet as principles they do not seem to go to the core of public health values.

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This is at least partly because of their tendency to be associated with, and used in trying to analyse, individual professional-client encounters. Even when following beneficence and non-maleficence in these individual encounters, it does not necessarily mean that population health is maximised, as the population is not at all within the focus of these micro- encounters.

In the field of public health, the primary end sought is the health of the broader constituency of the public and improvements to this are the key outcome used to measure success [ 10 ].

In fact, the maximisation of population health, on the one hand, and beneficence and non-maleficence, on the other hand, can come into conflict. Here we are thinking of the idea that public health professionals have an obligation to maximise health in the populations for which they are responsible. In fact, our preference is for the ethical principle underscoring this obligation to be referred to as one of health maximisation.

It seems perverse to claim that public health professionals are primarily interested in other kinds of benefit over and above maximising health and opportunities for health; thus a specific principle of health maximisation, we argue, needs to constitute the third of the mid-level principles that form the content grounds of our short course teaching and learning.

Of course, none of this is to deny the disputability of the concept of health, and the possibility of profound disagreement about what exactly it is that we are attempting to maximise [ 20 ].

We will return to this point later in our discussion. Efficiency There will always be more health need than resources to deal with that need. Literally all public health systems and health care systems worldwide lack resources.

These two statements prompt the advocacy of a moral duty to use scarce health resources efficiently. This duty exists at least partly because efficient use will enable public health professionals to produce more health benefit for greater numbers of people.

So a moral principle of efficiency would demand, for example, the use of the evidence base and the performance of cost-benefit analyses to decide what should be done and how to do it. For example, in considering the cost and benefit of undertaking or not undertaking a particular public health intervention, are we limiting our views of these things simply to the health sector or to the effect of the intervention on the wider social fabric and governance of public services?

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Here we need to emphasise that the principle of efficiency has moral applicability, which needs to be disentangled from other considerations of efficiency, such as economics. Respect for autonomy The paternalistic benevolence contained in the principles of non-maleficence and beneficence is strongly tempered by the emphasis on respect for the autonomy of the patient who the health care professional is seeking to serve [ 9 , 21 ].

The principle of respect for autonomy extends, however, beyond the confines of individual health care; it is crucially important within the public health context. The frequent focus of public health on benefit for populations holds the potential for concern with individual welfare to be side- lined. Despite this, however, the tension between individual rights and broader conceptions of public benefit is a profound one for public health as a field of practice.

This tension, and the relative command that such broader conceptions of benefit often seem to possess, leads us to assert that in cases where autonomy restriction for wider public health goals is being contemplated e.

Because as humans we all have or should have autonomy, we all have or should have equal moral worth. Thus, proposals for the unequal treatment of people again require the burden of proof. Justice, to the contrary, demands equal opportunities. In a very prominent conception of justice in the context of health, Daniels [ 13 ] considers health equity thus a matter of fairness and justice. Justice is also the principle that covers normative aspects that are often discussed in the terminology of solidarity and reciprocity.

Justice does so by giving an answer to the question of what we owe to each other [ 13 ]. To have a concise set of principles, we focus only on justice. Proportionality Our seventh and final principle differs somewhat from those preceding it. As a principle, proportionality is certainly normative. It demands that in weighing and balancing individual freedom against wider social goods, considerations will be made in a proportionate way.

According to Childress et al.

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For instance, the policy may breach autonomy or privacy and have undesirable consequences. However, proportionality is also a methodological principle. In a manner different to the principles we have so far discussed, it forms the basis for casuistic reasoning in relation to problems of individual welfare versus collective benefit in public health.

Singer et al. Beyond this, the balancing of private goods and public interests provides a way into debating many of the central problems of ethics in public health policy and practice such as resource allocation, the location of individual responsibility and foundational rights in the sphere of health and health care.

It is this idea of debating the proportionality of interventions, and the help it offers in advancing understanding of situations, that leads us to our conception of the principle as partly methodological. Even though a methodological principle, it is normative nevertheless, and thus we include it in our concise set of principles: as with the other principles so far discussed, it contains essential prima facie moral guidance for public health practitioners.

Process foundations for teaching and learning in public health ethics: case studies and problem based-learning Having outlined and discussed the seven principles that form the content basis of teaching on our short course, we turn now to describing and discussing the processes for teaching and learning related to these content foundations. Our approach can be summarised as the use of case studies to stimulate debate and discussion around the principles that we have identified and discussed.

Why case studies? Case studies in this context are short narratives describing a real-world or at least realistic example of a professional ethical dilemma.

Case studies have a central role in the process of teaching and learning that aims to build the capacity of moral awareness and discrimination.

The use of case studies has been widespread and successful in various areas of medical ethical education generally [ 25 ] and bioethics more particularly [ 26 ]. They also have a history of success in public health, in particular public health ethical-scientific discourse [ 27 ].

The narratives embodied in case studies help to identify and illustrate ethical difficulties. Case studies, with their obvious focus on practice and practical examples, can help to unpack difficulty that is simply impossible through purely abstract ethical reasoning or generalised philosophical examples.

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The requirement for inter- disciplinary dialogue extends, moreover, beyond simply public health practitioners and moral philosophers to a range of others for example, politicians and policy makers simply by virtue of what public health is and what it tries to do.

An important benefit of a case study-type approach centrally embedded in public health ethics teaching and learning is that it allows access to an enormous range of sources and experience. There is perhaps a tendency to think of case studies as artefacts solely designed by those charged with the teaching and learning process. Of course, the development and use of case studies designed by those teaching short courses in ethics is important. But there are simple actions that can open up a research project to wider social and cultural group and improve the quality of the study.

This might include translating research tools and supporting documents into other languages or providing an easy read version. Researchers should also consider how, where and when the research takes place to ensure that specific groups aren't excluded from taking part. It's good practice to have a version of the final report written specifically for the children who participated on the research.

This will help show the outcomes of their participation and create a more positive and inclusive experience.

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Identifying potential risks of harm Managing risks and avoiding harm to participants and researchers 4 key things can influence whether a participant suffers harm during a research project: individuals can find participating in research stressful, especially if they are vulnerable hidden or suppressed feelings or memories may be uncovered additional concerns may come up participants may worry about what they have shared.

Researchers must access whether the research or the inclusion of child participants is justified. Research for the sake of research is not ethically sound especially when it may expose children to harm. Unexpected topics Qualitative research will often go into more depth than a qualitative approach, so there's more opportunity to discuss issues that the researcher or participant wasn't expecting.

The interview schedule should be structured so that difficult topics are given enough time and aren't crammed in at the end. Interviewing friends and family It can become difficult to remain impartial when interviewing different family members Gorin et al, But researchers can't discuss the content from interviews with other family members without ethically compromising the research.

Revealing information given in confidence could not only affect the participation in the research but could also place participants at risk. Past experiences When selecting participants, it's important to take personal histories into account.

Researchers should consider how participants are likely to cope with being asked to talk about their past experiences. Being sensitive to past experiences can help minimise distress for example, avoiding interviewing about past abuse in the house where that abuse occurred. Children who have been abused can be particularly vulnerable and researchers must take extra measures to protect both the children and themselves.

There must be a balance between the needs of the researcher and the need to protect children from any further harm. Having a clear ethics statement at the beginning of a project can help researchers with assessing potential risks to a child or stopping if abuse is disclosed Gorin et al, Non-disclosure of identity and personal information A participant's personal information and their identity should remain confidential unless a child is at risk of harm.

Complaints procedure It's good practice to have a complaints procedure when conducting any research. If children are involved, this should include a way for them to be able to make a complaint and be adequately represented. You should make the complaints procedure available when obtaining consent. What to do if a child discloses abuse It's essential to have clear procedures to follow if a child says anything that indicates they or another child may be at risk of harm.

The researcher must include a confidentiality policy that clearly sets out the circumstances when a researcher can or should break confidentiality.

The procedures should also include places where a researcher or child can access further support. If a researcher suspects that a child might be at risk of harm then the research must be stopped until that child's safety is secured. References Gorin, S et al.

Child Abuse Review, 17 4 : Childhoods Today, 3 1 :

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