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P Riis

Publications and source records attributed to P Riis.

At least 19 recordsLinked to original sources

[How detailed information and how long consideration time do the potential trial subjects want?].

Questionnaires were sent to 508 citizens in Copenhagen county and given to 200 patients attending two out-patient clinics. Questions concerned attitudes and preferences towards either a short or a more detailed information form about an invented trial, and preferences regarding required time for reflection before giving informed consent. One sixth of responders were satisfied with the short form, while about three quarters preferred the long form. Three quarters of the non-hospitalized citizens and the patients from one of the out-patient clinics required at least 24 hours before answering about consent. Among responders in the other outpatient clinic half of the patients only required 15 minutes, or stated that they could answer at once. We conclude that written information to trial patients should be detailed, as a majority of potential research participants prefer this. At least 24 hours should be given before an informed consent is obtained.

Adult

Ethical aspects of clinical trials: the attitudes of the public and out-patients.

OBJECTIVES: To investigate attitudes to clinical research amongst potential research participants. DESIGN: Questionnaire-survey. SETTING: Two medical out-patient clinics and the background population. SUBJECTS: A total of 508 randomly selected citizens in Copenhagen County (64% responded) and 200 consecutive patients attending the out-patient clinics (64% responded). OUTCOME MEASURES: Attitudes toward different aspects of clinical research. RESULTS: Positive attitudes toward medical research were disclosed. The majority found scientific testing necessary, although only a minority considered participation a moral obligation. Both personal benefits and altruistic motives for participation were highly rated, whereas former positive experiences from trial participation had only minor impact on decisions. Several respondents stated former trial participation had changed their attitudes negatively. Lack of feedback of results was of major importance for this change. Attitudes are significantly influenced by the presence of independent research ethics committees, whereas trial technicalities such as drawing lots and blinding was found problematic by only a few respondents. Altruistic motives of physicians to conduct trials were highly rated by a majority of respondents, but the motive of promoting doctors' careers was also judged important. Respondents rated nondiscomforting procedures as acceptable or having only a small impact or strain on their lives. CONCLUSION: Attitudes toward medical research are positive amongst out-patients and the general public. Altruistic and nonaltruistic motives both concerning trial participation and concerning the motives of physicians to conduct medical research were rated highly. Lack of feedback concerning results of trials to participants was important for a negative change in attitude toward participation.

Attitude

Misconduct in clinical research--the Scandinavian experience and actions for prevention.

The Nordic countries, Denmark, Norway, Sweden and Finland, started relatively early with the establishment of national committees dealing with scientific misconduct within the health sciences. They originally included slightly different parts of the dishonesty spectrum, when launching their independent control bodies, but have since then converged, with the end result that all four countries now include all aspects of the spectrum. In other words, the ranges now cover alleged fabrication and plagiarism on one side, and quarrels about authorship and terms of procedure within cooperating groups of scientists on the other. The Nordic experiences have made it possible to estimate a prevalence rate of 1-2 presented cases per million inhabitants, of which only approximately 1/5 is serious. The preventive actions have been publications of guidelines for: scientific co-operation; raw data storage; authorship. Further, educational initiatives include postgraduate courses for senior scientists; postgraduate courses for junior scientists; influence via inquiries and investigations. The Nordic experiences point strongly to the necessity of an independent national control body.

Humans

[Basic ethics].

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Denmark

Ethics.

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Bioethical Issues

Simple guidelines for experimental reports, documentation and storage of data. A new initiative to further research integrity.

Since 1992, the Danish Medical Research Council has taken several initiatives to oppose scientific misconduct. One preventive measure has been the development of concise guidelines for the presentation of experimental reports and data documentation. After revisions and accept by the major user institutions, these guidelines have been well-received by a large number of research units and are made available to all Ph.D. students and their supervisors. We here describe the motives for the choice of guidelines and how they are adapted to the requirements of ongoing medical research in Denmark.

Clinical Medicine