PubMed · 489483
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J Grabowski, C P O'Brien, J Mintz. 1979. Increasing the likelihood that consent is informed.. https://pubmed.ncbi.nlm.nih.gov/489483/
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OBJECTIVE: This article proposes ethically justified clinical guidelines for family planning interventions to prevent pregnancy in female patients. STUDY DESIGN: We reviewed literature on family planning and consequences of pregnancy in patients with chronic mental illness and related that literature to ethical principles. RESULTS: Patients with chronic mental illness are ethically unique because they have chronically and variably impaired autonomy. Existing guidelines and proposals for family planning interventions for mentally retarded patients are shown not to apply to such patients. CONCLUSION: Three sets of guidelines for three groups of patients, representing the continuum of chronically and variably impaired autonomy, are proposed: (1) a set of guidelines for patients who can achieve thresholds of autonomy, (2) a set of guidelines for patients irreversibly near thresholds of autonomy, and (3) a set of guidelines for patients irreversibly below thresholds of autonomy. These guidelines should contribute significantly to the quality of obstetric and gynecologic care for female patients with chronic mental illness.
Consent forms in research are a source of current and retrospective information for the subject, a "prompt" for the person who is obtaining consent, and a documentation of the "informed" consent process and its adequacy. Occasionally, these forms may be administered by inexperienced trainees or ancillary personnel, and thus stand virtually alone. Therefore, the forms must be inherently comprehensible to the subjects. To test whether this is the case, 65 new applications were randomly selected from 13 consecutive IRB agendas, and their consent documents were computer-analyzed (Flesch/Fry scoring) after correction for expected confounding features, such as lists, tables, and polysyllabic proper names and jargon. Mean U.S. school grade for 70% comprehension (Fry score) was 15.03 +/- 0.19 (standard error of the mean), implying readability by 37.4 +/- 1% of the U.S. adult population. In contrast, a consecutive sampling of 21 Ann Landers columns yielded a mean Fry score of 7.67 +/- 0.5 (p < 0.01; readable by 75 +/- 3%). Fifteen Reader's Digest articles yielded a mean Fry score of 9.95 +/- 0.65 (p < 0.01; readable by 59.1 +/- 3%), and 15 "Talk of the Town" columns from The New Yorker averaged a grade level of 13.3 +/- 0.83; p < 0.01; readable by 42.7% +/- 4.8%). No document was improved by more than one grade level by the IRB review process, and most were unchanged.(ABSTRACT TRUNCATED AT 250 WORDS)
Changes in the care of handicapped people has resulted in them being more evenly distributed within the community. This increases the likelihood that they, or their carers, will seek treatment from general dental practitioners. It is, therefore, important to be aware of the regulations and forms involved in consent of a handicapped patient.