The concept of risk and responsible conduct of research

Assessment of risk is one of the key issues in the field of responsible conduct of research which covers discourses of research ethics and research integrity. The principle of minimizing risks and balancing of risks and benefits is one of the main requirements of research ethics. In addition, the content of informed consent that is another fundamental principle of research ethics derives from the assessment of risks and benefits related to a particular research project. Risk assessment also plays a crucial role in methodological design of the research project. This is an important point where research ethics and research integrity discourses overlap. Firstly, because the choice of a control group (e.g., placebo control) is a key ethical issue related to the protection of the research subjects' interests. Secondly, because the quality of the research data, that is one of the key elements of research integrity, is closely connected to the choice of research methodology as well. The problem of biased interpretation or manipulation of risk related features of biomedical research should also be taken into account. Despite the importance of the concept of risk to the field of biomedical research, its relevance has not yet attracted a sufficient attention in the responsible conduct of research debate.     

The protection of patients’ rights in clinical trials

The Helsinki Declaration is a very important document regarding the protection of patients’ rights in clinical trials and one of the fundamental sources of operational principles for every ethics committee. Although they have been updated, the international guidelines for ethics committees continually fail to address certain issues pertaining to the protection of patients’ rights in clinical trials. These issues include, most significantly, the method of electing ethics committees (a free, secret ballot should be preferred to direct appointment), the avoidance of conflict of interest during the election of ethics committee members, and the necessary insurance coverage for the participants of clinical trials. Polish law should, on the other hand, be developed in such way as to not limit the effectiveness of ethics committees in protecting patients’ rights in clinical trials. The ideal solution would be to draft a uniform law concerning not only clinical trials, but all medical experiments. The opinions of experts who have been reviewing medical research projects for several years may prove to be especially valuable in this setting. This paper was presented at the 6th International Bioethics Conference on the subject of ‘The Responsible Conduct of Basic and Clinical Research’, held in Warsaw, Poland, 3–4 June 2005. The author is Chairman, Bioethics Committee of the Warsaw Regional Chamber of Physicians and Dentists.     

The mentor and the trainee in academic clinical medicine

Medicine is a scientific discipline, but it is sometimes difficult to separate what is scientific and what is a clinical, practical activity. Man is the object, but he is always the subject of medical research and therefore these two elements become closely bound together by a thread of moral interdependencies. Every mentor of a young academic and all institutions dealing with the teaching of and research into medicine must understand multidimensional, multifaceted, and multilevel aspects of their activity and give them due regard in the educational process. The educational mission of an academic institution and of the teacher working there may be summed up in one phrase: Teach thinking! At the same time, the task of a school and the individual mentor is to teach the student to distinguish personal freedom from a lack of the feeling of responsibility. The medieval principle “Universitas magistrorum et scholarium”, and thus the corporation, the community of teachers and students, has not lost any of its relevance and value today. The situation is, in its far-reaching consequences, tragic in which the “insufficiently tutored teach”. Both physician and teacher, and especially physician-teacher, are not only professions, but also callings. This paper was presented at the 6th International Bioethics Conference on the subject of ‘The Responsible Conduct of Basic and Clinical Research’, held in Warsaw, Poland, 3–4 June 2005.     

Transformations of mathematical and stimulus functions

Following a pretest, 8 participants who were unfamiliar with algebraic and trigonometric functions received a brief presentation on the rectangular coordinate system. Next, they participated in a computer-interactive matching-to-sample procedure that trained formula-to-formula and formula-to-graph relations. Then, they were exposed to 40 novel formula-to-graph tests and 10 novel graph-to-formula tests. Seven of the 8 participants showed substantial improvement in identifying formula-to-graph relations; however, in the test of novel graph-to-formula relations, participants tended to select equations in their factored form. Next, we manipulated contextual cues in the form of rules regarding mathematical preferences. First, we informed participants that standard forms of equations were preferred over factored forms. In a subsequent test of 10 additional novel graph-to-formula relations, participants shifted their selections to favor equations in their standard form. This preference reversed during 10 more tests when financial reward was made contingent on correct identification of formulas in factored form. Formula preferences and transformation of novel mathematical and stimulus functions are discussed.     

Scope of attention, control of attention, and intelligence in children and adults

Recent experimentation has shown that cognitive aptitude measures are predicted by tests of the scope of an individual's attention or capacity in simple working memory tasks and also by the ability to control attention. However, these experiments do not indicate how separate or related the scope and control of attention are. An experiment with 52 children (10 to 11 years old) and 52 college students included measures of the scope and control of attention, as well as verbal and nonverbal aptitude measures. The children showed little evidence of using sophisticated attentional control, but the scope of attention predicted intelligence in that group. In adults, both the scope and control of attention varied among individuals and accounted for considerable individual variance in intelligence. About one third that variance was shared between scope an d control, and the rest was unique to one or the other.Scope and control of attention appear to be related but distinct contributors to intelligence.     

Deconstructing therapy outcome measurement with Rasch analysis of a measure of general clinical distress: the Symptom Checklist-90-Revised

Rasch analysis was used to illustrate the usefulness of item-level analyses for evaluating a common therapy outcome measure of general clinical distress, the Symptom Checklist-90-Revised (SCL-90-R; Derogatis, 1994). Using complementary therapy research samples, the instrument's 5-point rating scale was found to exceed clients' ability to make reliable discriminations and could be improved by collapsing it into a 3-point version (combining scale points 1 with 2 and 3 with 4). This revision, in addition to removing 3 misfitting items, increased person separation from 4.90 to 5.07 and item separation from 7.76 to 8.52 (resulting in alphas of .96 and .99, respectively). Some SCL-90-R subscales had low internal consistency reliabilities; SCL-90-R items can be used to define one factor of general clinical distress that is generally stable across both samples, with two small residual factors.     

Psychiatry Residents' Attitudes on Ethics and Professionalism: Multisite Survey Results

Recent studies show that psychiatry residents express a relatively greater need for ethics curricula than their colleagues in other specialties. Such studies have been limited in their generalizability because they were conducted at one site. This study of 151 psychiatry residents at seven U.S. psychiatry programs aims to address that limitation. Residents were surveyed on issues pertaining to ethics and professionalism education. Participants were found to support such curricula during training and to value its relevance to the practice of psychiatry. Gender differences and the influence of the “hidden curriculum” on such results merit further study.