Unlike its friendly cousin the placebo effect, the nocebo effect (the effect of expecting a negative outcome) has been almost ignored. Epistemic and ethical confusions related to its existence have gone all but unnoticed. Contrary to what is often asserted, adverse events following from taking placebo interventions are not necessarily nocebo effects; they could have arisen due to natural history. Meanwhile, ethical informed consent (in clinical trials and clinical practice) has centred almost exclusively on the need to inform (...) patients about intervention risks with patients to preserve their autonomy. Researchers have failed to consider the harm caused by the way in which the information is conveyed. In this paper, I argue that the magnitude of nocebo effects must be measured using control groups consisting of untreated patients. And, because the nocebo effect can produce harm, the principle of non-maleficence must be taken into account alongside autonomy when obtaining (ethical) informed consent and communicating intervention risks with patients. (shrink)

The underreporting of suspected adverse drug reactions hinders pharmacovigilance. Solutions to underreporting are oftentimes directed at clinicians and health care professionals. However, given the recent rise of public inclusion in medical science, solutions may soon begin more actively involving patients. I aim to offer an evaluative framework for future possible proposals that would engage patients with the aim of mitigating underreporting. The framework may also have value in evaluating current reporting practices. The offered framework is composed of three criteria that (...) are bioethical, social-epistemic, and pragmatic: (i) patients should not be exposed to undue harms, e.g., nocebo effects; (ii) data should be collected, analyzed, and communicated prioritizing pharmacovigilance’s aims, i.e., free from industry bias; and (iii) proposals should account for existing and foreseeable pragmatic constraints like clinician ‘buy in’ and existing reporting infrastructure. Proposals to engage patients in pharmacovigilance that fulfil or address these criteria are preferable to those that do not. (shrink)

The American Journal of Bioethics, Volume 12, Issue 3, Page 35-36, March 2012.

Once I had explored the research issue of North and South unification with a focus on the legal integration for uniform constitution and various statutes. It pushed me to deal with a big question, and looked like a semi-textbook with an inchoate idea and baby theory upon the completion of research project. The literature review thankfully had allowed the space of creativity and originality of my work product, and can also be a typical way of foreign graduate legal researchers in (...) the process of his dissertation work. They would be beneficial with new statutes and codes, for example, from the Korean Congress, that are enacted recently, which would be their research topic certainly original and contributive. This could be viewed as one of qualitative enclaves enmeshed into a larger scope of qualitative inquiry. This interplay is fairly consequential in excavating a new knowledge and research findings. It could be aboriginal -- one trait word to characterize the qualitative studies-- from the viewpoint of host country, but became original as a crop to expand the horizon of new knowledge. I have once argued that the quantitative studies are on generality of subjects and commonness for involved strands. This profile would vary that the qualitative studies tend to be strong with the story and enclaves. The e-age and rapid compression of space with the development of telecommunication technology also factor to change a paradigm of knowledge and research activities. At least, the contemporary society certainly would be more specific as if we can trace a person with the satellite spotting and the electronic identifier on the leg of sex criminals in Korea guarantees to be safeguarded from his potential danger. That may be favorable concerning the elements and environments of qualitative studies. For example, we may follow up by comparing the research work of Korean statute with the e-government of Korea displaying the statute. We can entertain many on-line sources of information and stories with the dissertations of aboriginal culture. With my time on the qualitative studies, I came across the nocebo effect illustrated with the fear of MERs-CoV in Korea. The effect looks into the negative dimension of human mind and his personality, which could aggravate the current challenge of national crisis, June, 2015. Paradoxically, the nocebo effect can be said to characterize the qualitative context of inquiry. As Freud suggested, the vast of human element is of unexplainable dimension that is less easily quantifiable or generizable over the population (Broome, 2010). This does not say that the continental researchers had been affected with a late nationalization or late development of region leaving them to search for an ego. This is to say that the qualitative studies could explain the part of truths for the universe and human. The researchers interested in deep knowledge could employ their method, but in ethics, who would not vulture the objects of his theme and conduct on due scientific ground. (shrink)