Statistics and ethics in medical research

Ethical conduct is an essential component in research, especially in medical research. Statistical methods for design and analysis are powerful research tools if used properly. Abuse of these principles and methods are just as unethical as other laboratory or clinical misconduct. Inadequate research design can produce worthless results and thus wastes effort and valuable resources. For clinical research, patient resources are wasted. Inappropriate analysis of data can also produce misleading results and conclusions. For clinical research, inferior therapy might be given to patients as a consequence. These ethical concerns can have implications for and affect the individuals responsible for the statistical design and analysis. Examples are provided which illustrate some possible abuses and inappropriate pressures.     

Confronting misconduct in science in the 1980s and 1990s: What has and has not been accomplished?

In 1985, after nearly a decade of inconclusive professional response to public concern about misconduct in research, Congress passed legislation requiring action. Subsequent to this legislation, federal agencies and research universities adopted policies for responding to allegations of misconduct in research. Conferences, sessions at professional meetings, and special publications were organized. New educational initiatives were begun, many in response to a 1989 National Institutes of Health/ Alcohol, Drug Abuse, and Mental Health Administration requirement to include ethics instruction in training grants. Notwithstanding a few key unresolved issues, such as the lack of a uniform federal definition of misconduct in research, the years since 1985 have witnessed a marked change in the professional response to misconduct in research. This paper evaluates the change since 1985 from the perspective of three key goals: 1) confronting misconduct, 2) promoting integrity and 3) ensuring integrity. While significant progress has been made in achieving the first two goals, the third remains largely unaddressed. The latter is due to the fact that researchers have not been interested in studying the integrity of their own profession. It is therefore suggested that studies are needed of routine or normal research practices and their impact on integrity for use in making decisions about research conduct policy. An earlier version of this paper was presented at the symposium entitled “Misconduct in Science: A Decade of Progress or Merely Years of Controversy” held during the Annual Meeting of the American Association for the Advancement of Science, Philadelphia, Pennsylvania, 13 February, 1998.     

Cloning humans from the perspective of the christian churches

The announcement of the birth of Dolly the cloned sheep evoked widespread response from the Christian Churches. These responses are identified, organized thematically, and discussed critically. The churches have viewed reproductive human cloning either with unqualified opposition or with grave suspicion. Some statements have discussed animal cloning, generally granting limited approval, and nonreproductive human cloning, either in opposition or expressing an openness to entertain specific proposals as the technology develops. This paper is based on a presentation at the 164th Annual Meeting of The American Association for the Advancement of Science (1998), Philadelphia, in the session entitled The Rights and Wrongs of Cloning Humans, February 13, 1998.     

“Yet there’s method in his madness …”: Dimensions of deception and dangerousness

Undiagnosed malingering (symptom overreporting or fabrication) can endanger mental health staff. This review paper presents a systematic and empirically based framework to assess symptom overreporting and violence potential. The first half reviews three models of malingering and their implications for violence potential. The first model proposes that people who malinger are attempting to cope with major mental disorders or organic deficits. The violence potential of these often overlooked disorders is explained. The second model describes how some people with character disorders overreport psychological symptoms and use violence to manage interpersonal relationships. The third model proposes that people who malinger are attempting to get their needs met in complex situations. Mishandling these often desperate people can result in a dangerous situation. The second half of this article focuses on conducting evaluations with potential malingerers, including ethical issues, assessment techniques, and treatment recommendations. Public policy implications are also addressed.     

Ethics in Long-Term Care: Are the Principles Different?

It has become common in medical ethics to discuss difficult cases in terms of the principles of respect for autonomy, beneficence, nonmaleficence, and justice. These moral concepts or principles serve as maxims that are suggestive of appropriate clinical behavior. Because this language evolved primarily in the acute care setting, I consider whether it is in need of supplementation in order to be useful in the long-term care setting. Through analysis of two typical cases involving residents of long-term care facilities, I argue for the additional principles of candor and responsibility for narrative integrity.     

Critiques of Casuistry and Why They Are Mistaken

Casuistic methods of reasoning in medical ethics have been criticized by a number of authors. At least five main objections to casuistry have been put forward: (1) it requires a uniformity of views that is not present in contemporary pluralistic society; (2) it cannot achieve consensus on controversial issues; (3) it is unable to examine critically intuitions about cases; (4) it yields different conclusions about cases when alternative paradigms are chosen; and (5) it cannot articulate the grounds of its conclusions. Two main versions of casuistry have been put forward, and the responses to these objections depend in part on which version one is defending. Jonsen has advocated a version modeled on the approach to casuistry used by moral theologians in the 15th and 16th century, involving comparison of the case at hand with a single paradigm and a lineup of cases. The present author has advocated another version, drawn from experience with cases in clinical ethics, which involves comparing the case at hand with two or more paradigms. Four of the five objections are unsuccessful when directed against Jonsen'sapproach, and all of them are unsuccessful when directed against the approach involving comparison with two or more paradigms.     

THE RIGHT TO EFFECTIVE BEHAVIORAL TREATMENT

We propose that individuals who are recipients or potential recipients of treatment designed to change their behavior have the right to a therapeutic environment, services whose overriding goal is personal welfare, treatment by a competent behavior analyst, programs that teach functional skills, behavioral assessment and ongoing evaluation, and the most effective treatment procedures available.     

Medical ethics in Poland

The work related to medical ethics written by Polish authors are reviewed and some topics concerning teaching and various other activities in this field are presented. The attention is centered on the opinions and attitudes concerning the essence of medical profession and the personal model of the physician, doctor-patient relationship (including duties of the doctor), medical research on humans, abortion and other problems. The role of medico-ethical tradition in Poland is described. Main trends in polish ethical thought in relation to medicine are taken into consideration. General aspects of medical ethics in present-day Poland are tentatively characterized.