Consent form can improve the credentials search.
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Hospital Administration↗
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Obtaining informed consent. Form or substance.
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Adolescent↗
A randomized controlled trial comparing quantitative informed consent formats.
Informed consent has been indirectly studied only in settings that do not replicate the actual consent process. We designed a sham study and randomly allocated adult ambulatory patients to receive one of two consent forms: Consent A (n = 52) described a randomized trial of usual treatment vs a new medication that "may work twice as fast as the usual treatment"; or Consent B (n = 48) that described a randomized trial of a new medication that "may work half as fast as the usual treatment". Patients randomized to Consent A were more likely to consent than those randomized to Consent B (consent rate A = 67%, consent rate B = 42%, p less than 0.01). Among patients who cited quantitative information, the difference in consent rate was even more marked (95% vs 36%, p less than 0.001); patients who did not cite quantitative information had equivalent consent rates. Patients who perceived minimal or severe symptoms had lower consent rates than those with mid-range symptom scores (chi 2(2) = 8.35, p = 0.015). Patients who recognize quantitative information will use it to make informed consent decisions.
Behavioral Research↗
Legal aspects of consent 2: the different forms of consent.
Mary, following preoperative medication, was taken to theatre for a biopsy for possible breast cancer. When the theatre staff went through their checklist they could not find a consent form. The consultant surgeon said that he had seen her in the outpatients' department 2 weeks before and she had given a clear consent, not only for the biopsy but also for a radical mastectomy should the results show that to be necessary. He said that he had no problems with continuing the operation. The theatre sister was unsure of the legal position.
Biopsy↗
The specificity of epidemiological correlates of major depression.
Some of the variables associated with major depression in community samples may be nonspecific correlates of mental ill-health. The study objective was to evaluate this hypothesis by comparing two groups of psychiatric patients with the general population. Subjects were recruited from psychiatric inpatients at a general hospital in Calgary, Alberta, Canada, by dissemination of a consent form. Consenting subjects completed the mood disorders section of the Composite International Diagnostic Interview (CIDI). All subjects were interviewed to evaluate a set of variables that may be risk factors for major depression. The measurement instruments were identical to those used in a national survey so that comparisons to population-based data were possible. The psychiatric inpatients differed dramatically from community subjects in terms of stress, traumatic life events, recent life events, and social support. However, differences were not observed between inpatients with major depression (according to the CIDI) and inpatients without major depression. Associations between certain variables and major depressive disorders in community populations may reflect nonspecific associations with mental ill-health. This may occur because of nonspecific impacts of these variables on the etiology or prognosis of mental disorders or some nonspecific impact of mental illness itself.
Adult↗
The body of a trial master file for a pivotal phase I study.
This paper describes in detail the documentation which would form the body of a Trial Master File for Phase I pivotal investigations filed to render easily and totally auditable all the documentation. The body of a Trial Master File is formed by formal documents (study protocol, research report), by documents to be attached to the research report (clinical report, analytical validation report, statistical report, blank case report form, blank consent form, approval from Ethics Committee), by documents to be kept in file (investigator's brochure, clinical source documentation, clinical trial supplies, filled case report forms, monitoring reports, auditing reports, letters, contracts, faxes, phone notes) and by confidential documents that must be filed in the Clinical Unit only (signed consent forms which contain the subjects' identification).
Clinical Trials, Phase I as Topic↗
High rate of consent to bank biologic samples for future research: the Eastern Cooperative Oncology Group experience.
The Eastern Cooperative Oncology Group (ECOG) requires patient consent for the storage and future use of samples left over from its therapeutic cancer clinical trials. The ECOG consent instrument evolved from a simple statement requiring a signature to a more detailed three-question format. Between February 1998 and October 2000, more than 7000 patients were accrued to studies using one of the two consent forms. We analyzed our consent response data by consent type, demographic information, disease site, and institution type to determine the assent rates for future storage and research on biologic samples and to identify possible factors predicting patient refusal. The assent rate for the original banking consent statement was 89.4%, whereas that for the more detailed consent form was 93.7%. Higher assent rates were statistically significant for the detailed consent form versus the original consent form (P=.001), for community-based practices versus academic centers (P<.001), and for patients aged at least 65 years versus those younger (P=.002). The results show that increased patient protection does not result in decreased availability of biologic samples for future research purposes.
Aged↗
A readable form for patient consent.
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Forms and Records Control↗
Informed consent -- why are its goals imperfectly realized?
We explored reasons for the failure of patients to recall major portions of the information on consent forms and in oral explanations about consent. Within one day of signing consent forms for chemotherapy, radiation therapy, or surgery, 200 cancer patients completed a test of their recall of the material in the consent explanation and filled out a questionnaire regarding their opinions of its purpose, content, and implications. Only 60 per cent understood the purpose and nature of the procedure, and only 55 per cent correctly listed even one major risk or complication. We found that three factors were related to inadequate recall: education, medical status, and the care with which patients thought they had read their consent forms before signing. Only 40 per cent of the patients had read the form "carefully." Most believed that consent forms were meant to "protect the physician's rights." Although most thought that consent forms were necessary and comprehensible and that they contained worthwhile information, the legalistic connotations of the forms appeared to lead to cursory reading and inadequate recall.
Adult↗
Physical restraint, informed consent and the child patient.
Parent's expressed, informed consent should be obtained before physical restraining devices are used on the child patient, in the course of dental treatment. Implied consent does not apply to any procedure not normally expected by an average, reasonable person; these procedures include the use of premedicating agents, the use of nitrous oxide sedation, or the use of physical restraint. It is a good, preventive idea to use a well-written general consent form. A specific consent form, clearly labelled, provides a strong defense in court for the dentist.
Child↗
The stipulations of one institutional review board: a five year review.
OBJECTIVES: This study was designed to explore the prevalence and types of stipulations (such as clarifications or changes) required of investigators by the institutional review board (IRB) of one institution over a five year period. DESIGN: Stipulations to research proposals (n = 124) were documented from the minutes of the IRB meetings. SETTING: Community hospital. PARTICIPANTS: IRB submissions. MAIN MEASUREMENTS: Number and type of IRB stipulations. RESULTS: Nineteen research submissions (15.3%) were approved without any stipulations. For the remainder, the majority of stipulations related to consent forms (74.2%). CONCLUSIONS: Consent forms appear to be at highest risk for IRB stipulations. Being aware of high risk areas before submission of research proposals may reduce the frequency of stipulations required of investigators.
Consent Forms↗
A prospective study comparing conventional methods against a structured method of gaining patients' informed consent for tonsillectomy.
OBJECTIVE: By providing junior members of medical staff with appropriate guidelines one can achieve an improved standard of informed consent for tonsillectomy, than is provided at present. DESIGN: A prospective study of 138 consecutive patients. SETTING: District General Hospital. PARTICIPANTS: A total of 138 patients undergoing routine tonsillectomy split into two groups. Group A (n=87), the conventional group, gave consent in our unit's standard manner to various grades of doctors by using a hospital general surgical consent form. Most gave their consent as outpatients, while some consented on admission. Group B (n=51), the structured consent group, gave their consent in pre-admission clinic, to an SHO using a standardized tonsillectomy consent form and a structured interview technique. MAIN OUTCOME MEASURES: A preoperative questionnaire regarding the knowledge of tonsillectomy. RESULTS: Improvement of the awareness of the risks involved with tonsillectomy was achieved by the structured consent Group B; 82% of Group A were aware of postoperative pain compared with 94% of group B (P=0.04); 63% of group A were aware of infection compared with 82% of group B (P=0.02); 100% of group B had read the consent form before signing compared with 80% of group A (P<0.01). There was no statistical difference in the awareness of postoperative haemorrhage (91 versus 98%, P=0.15). CONCLUSION: By providing junior medical staff with guidelines, senior staff retain responsibility for consent while improving the standard of informed consent for tonsillectomy.
Adolescent↗
Informed consent for upper gastrointestinal endoscopy.
Informed consent for upper gastrointestinal endoscopy requires that the patient understands the nature of, and reason for, the proposed procedure, and that he or she is given adequate time to deliberate and ask questions. In a prospective study, 200 outpatients completed questionnaires immediately before, and one day after, endoscopy, which assessed satisfaction with information provided by: (a) the referring doctor, (b) a standard information sheet sent out two to four weeks before endoscopy, and (c) the endoscopist. The first 100 patients were asked to read and sign a standard consent form immediately before the endoscopy. In the second 100 patients, a new endoscopy consent form that was simpler and easier to read than the standard form was sent out with the information sheet. Patients were directed to sign the new consent form before arriving at the unit only if they had no further questions. Overall, the indication for the endoscopy, and how it would be done, were explained clearly by the referring doctor in 79% and 68% of cases, respectively. Of the first 100 patients, only 54% had read the standard consent form in the endoscopy unit before signing it. In contrast, of the second 100 patients, the new form sent with the information sheet was read by 95%, and signed by 88% before coming to the unit. Furthermore, 84% found the new form easier to read and understand than the standard form. In our unit, roughly one quarter of patients referred for endoscopy are not adequately informed about the procedure. In contrast with the standard consent form, a simple endoscopy consent form sent out with the information sheet is preferred by most patients, and safeguards against patients undergoing endoscopy without informed consent.
Adult↗
Patients' perceptions of written consent: questionnaire study.
OBJECTIVE: To examine patients' understanding of the status, function, and remit of written consent to surgery. DESIGN: Prospective questionnaire study. Questionnaires were sent to patients within one month of surgery. Responses were analysed with frequencies and single variable analyses. SETTING: Large teaching hospital. PARTICIPANTS: 732 patients who had undergone surgery in obstetrics and gynaecology over a six month period. MAIN OUTCOME MEASURES: Patients' awareness of the legal implications of written consent and their views on the function and remit of the consent form. RESULTS: Patients had limited understanding of the legal standing of written consent. Nearly half (46%, 95% confidence interval 43% to 50%) of patients believed the primary function of consent forms was to protect hospitals and 68% (65% to 71%) thought consent forms allowed doctors to assume control. Only 41% (37% to 44%) of patients believed consent forms made their wishes known. CONCLUSIONS: Many patients seem to have limited awareness of the legal implications of signing or not signing consent forms, and they do not recognise written consent as primarily serving their interests. Current consent procedures seem inadequate as a means for the expression of autonomous choice, and their ethical standing and credibility can be called into question.
Consent Forms↗
Variability among institutional review boards' decisions within the context of a multicenter trial.
BACKGROUND: Institutional review boards (IRBs) are given discretion to interpret and apply the federal regulations governing the protection of human subjects in research. OBJECTIVE: To determine the extent of the variability among different IRBs on their approved research practices and informed consent forms within the context of a multicenter trial that used a common protocol. DESIGN: Descriptive analysis of survey information and informed consent forms. SETTING AND PARTICIPANTS: Sixteen IRBs from the institutions participating in a multicenter trial comparing lower vs. traditional tidal volume ventilation in patients with acute lung injury. MEASUREMENTS: Analysis of survey information on IRBs' approved research practices. Analysis of informed consent forms for the presence and the adequacy of description of each basic element of informed consent specified in the federal regulations. Reading levels of informed consent forms. MAIN RESULTS: Surveys and IRB-approved consent forms were obtained from all of the contacted IRBs (n = 16). Variability was observed among several of the research practices; one IRB waived the requirement for informed consent, five IRBs permitted telephone consent, and three IRBs allowed prisoners to be enrolled. Three consent forms contained all of the basic elements of informed consent outlined in the federal regulations, and 13 forms had varying numbers of these elements absent (six forms without one element, four without two, one without three, and two without four). Reading levels of the consent forms ranged from grades 8.2 to 13.4 (mean +/- sd was 11.6 +/- 1.2 grade level). CONCLUSIONS: Within a multicenter trial, IRBs reviewing a common protocol varied in several of their approved research practices and in the extent to which the basic elements of informed consent were included in their consent forms.
Clinical Protocols↗
Informed versus uninformed consent for prostate surgery: the value of electronic consents.
PURPOSE: We evaluated the documentation of informed consent for 2 common prostate operations using current, conventional, paper based consent forms. Based on the results of the review the conventional paper based consent system was replaced with a new, standardized electronic consent system. MATERIALS AND METHODS: We retrospectively reviewed the consent forms obtained for transurethral resection of the prostate and radical prostatectomy procedures during the 6-year period 1995 to 2000 at Atlanta Veterans Affairs Medical Center. Analysis focused on the basic elements of informed consent, including a description of the proposed treatment, and the purpose, benefits, risks and alternatives. Based on these findings we standardized the procedure specific information contained in consent forms and stored it electronically in a central network accessible to all urology providers throughout the medical center. RESULTS: Of the 222 total procedures 204 consent forms were available for review. Senior residents, junior residents and physician assistants obtained consent for 42.2%, 30.9% and 25.5% of procedures, respectively. Information on the purpose and benefits of treatment was missing in 4.4% of cases and deficient in 22.6%. General or procedure specific risks were documented inconsistently in 0% to 96% of cases. Alternative treatment options were missing in 49% of the consent forms and they were significantly deficient in the remaining 51%. Prognosis and surgical risks were documented variably for each procedure. For example, in the radical prostatectomy group 79 patients (88.8%) had appropriate documentation regarding the potential for significant blood loss and yet only 23 (25.8%) had documented consent for blood transfusion. Following the implementation of a new standardized electronic consent program 96.1% of the patients surveyed preferred the new system. CONCLUSIONS: Conventional nonstandardized consent forms have significant deficiencies and errors. The new system of electronic informed consent is standardized, legible and understandable, and it assists providers in fully informing patients about the treatment, risks, benefits and alternative therapies, thereby supporting ethical and legal standards, and improving the quality of care. In our opinion standardized electronic informed consent should be the new standard of care.
Humans↗
Quality of informed consent in cancer clinical trials: a cross-sectional survey.
BACKGROUND: Investigators have to obtain informed consent before enrolling participants in clinical trials. We wanted to measure the quality of understanding among participants in clinical trials of cancer therapies, to identify correlates of increased understanding, and to assess providers' beliefs about clinical research. We also sought evidence of therapeutic misconceptions in participants and providers. METHODS: We sent a standard questionnaire to 287 adult patients with cancer who had recently enrolled in a clinical trial at one of three affiliated institutions, and surveyed the provider who obtained each patient's consent. FINDINGS: 207 of 287 (72%) patients responded. 90% (186) of these respondents were satisfied with the informed consent process and most considered themselves to be well informed. Nevertheless, many did not recognise non-standard treatment (74%), the potential for incremental risk from participation (63%), the unproven nature of the treatment (70%), the uncertainty of benefits to self (29%), or that trials are done mainly to benefit future patients (25%). In multivariate analysis, increased knowledge was associated with college education, speaking only English at home, use of the US National Cancer Institute consent form template, not signing the consent form at initial discussion, presence of a nurse, and careful reading of the consent form. Only 28 of 61 providers (46%) recognised that the main reason for clinical trials is benefit to future patients. INTERPRETATION: Misconceptions about cancer clinical trials are frequent among trial participants, and physician/investigators might share some of these misconceptions. Efforts to educate providers and participants about the underlying goals of clinical trials are needed.
Adult↗