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Results for “Consent Forms”

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PubMed2003

Disclosure of the right of research participants to receive research results: an analysis of consent forms in the Children's Oncology Group.

BACKGROUND: The offer of return of research results to study participants has many potential benefits. The current study examined the offer of return of research results by analyzing consent forms from 2 acute lymphoblastic leukemia studies of the 235 institutional members of the Children's Oncology Group. METHODS: Institutional review board (IRB)-approved consent forms from 2 standard-risk acute lymphoblastic leukemia studies (Children's Cancer Group [CCG] 1991 and Pediatric Oncology Group [POG] 9407) were analyzed independently by 2 reviewers. RESULTS: The authors received replies from 202 of the 235 institutions that were contacted (85%). One hundred eighty-one institutions had CCG 1991 (n = 96) or POG 9905 (n = 85) protocols that were approved by an IRB. Most institutions provided contact information for the principal investigator (n = 175; 97%) and a member of the institution's research services office (n = 154; 85%). Only 5 (2.8%) institutions provided an indication of a participant's right to receive a summary of research results; most of these institutions provided details on how (n = 5) or when (n = 5) this was to occur. All of these institutions (n = 162; 89.5%) provided a specific statement offering new information that might affect a participant's decision to continue to participate in a study. Only 2 institutional consent forms offered participants the option to receive research results, and only 10 (5.5%) consent forms contained an unambiguous, specific statement offering to provide new information after the study was closed. CONCLUSIONS: Few institutional review board-approved consent forms explicitly indicate the right of research recipients to receive a summary of the results of the research in which they have participated.

Child↗
PubMed1998

In search of the abominable consent form: the impact of readability and personalization.

This study assessed the impact of readability and personalization of informed consent forms on initial impressions of therapists and on recall of the information provided on the forms. Eighty-five participants received consent forms that varied in terms of readability and personalization, and were asked to rate their impressions of the therapist. More readable forms increased participants' impressions of the therapist's expertness and the form's helpfulness. Personalized forms increased ratings of the attractiveness of the therapist, and of the relevance of-and satisfaction with-the forms. Personalized forms also tended to increase recall. These properties of consent forms may indeed influence how clients initially react to therapists.

Adolescent↗
PubMedDate not supplied

Consent form return rates for third-grade urban elementary students.

OBJECTIVE: To maximize active parent consent form return rates for third-grade minority, urban students enrolled in predominantly low-income elementary schools in Chicago, Ill. METHODS: Research staff used a class incentive and class visits to retrieve consent forms from students. RESULTS: Of the 811 third-grade students, 98% returned a form and 79% (n = 627) of those students' parents provided an affirmative response. Return rates did not vary by students' ethnicity or by the schools' demographic variables. CONCLUSION: Incentives and class visits can yield a high return rate of active parent consent forms for third-grade minority, urban, low-income students.

Adult↗
PubMed2003

Readability standards for informed-consent forms as compared with actual readability.

BACKGROUND: Institutional review boards (IRBs) are charged with safeguarding potential research subjects with limited literacy but may have an inadvertent role in promulgating unreadable consent forms. We hypothesized that text provided by IRBs in informed-consent forms falls short of the IRBs' own readability standards and that readability is influenced by the level of research activity, local literacy rates, and federal oversight. METHODS: To test these hypotheses, we conducted a cross-sectional study linking data from several public-use sources. A total of 114 Web sites of U.S. medical schools were surveyed for IRB readability standards and informed-consent-form templates. Actual readability was measured with the Flesch-Kincaid scale, which assigns a score on the basis of the minimal grade level required to read and understand English text (range, 0 to 12). Data on the level of research activity, local literacy rates, and federal oversight were obtained from organizational Web sites. RESULTS: The average readability score for text provided by IRBs was 10.6 (95 percent confidence interval, 10.3 to 10.8) on the Flesch-Kincaid scale. Specific readability standards, found on 61 Web sites (54 percent), ranged from a 5th-grade reading level to a 10th-grade reading level. The mean Flesch-Kincaid scores for the readability of sample text provided by IRBs exceeded the stated standard by 2.8 grade levels (95 percent confidence interval, 2.4 to 3.2; P<0.001). Readability was not associated with either the level of research funding (P=0.89) or local rates of literacy (P=0.92). However, the 52 schools that had been made subject to oversight by the Office for Human Research Protections (46 percent) had lower Flesch-Kincaid scores than the other schools (10.2 vs. 10.9, P=0.005). CONCLUSIONS: IRBs commonly provide text for informed-consent forms that falls short of their own readability standards. Federal oversight is associated with better readability.

Comprehension↗
PubMed1997

Emergency medicine research consent form readability assessment.

STUDY OBJECTIVE: To determine the level of education necessary to understand informed consent documents used to enroll subjects in emergency medicine research. METHODS: The directors of 96 accredited emergency medicine residency programs were asked to provide copies of research consent forms approved for patient enrollment at their facilities. A computer program was used to evaluate the readability of the documents submitted. The consent forms were stratified by degree of risk to the subject and compared with the use of ANOVA and the Kruskal-Wallis test. RESULTS: Ninety-four informed consent documents were received from 45 program directors. After exclusion of 6 forms, 88 were analyzed using the software program RightWriter 5.0. The mean readability index (years of education needed to understand the content) was 10. The length and complexity of the consent forms increased as risk to the subject increased (P = .03). CONCLUSION: Informed consent documents used in emergency medicine research may be too complex for the average patient to understand. A positive correlation exists between protocol risk and consent from complexity.

Clinical Protocols↗
PubMedDate not supplied

[Informed consent forms in medical practice: the results of a knowledge survey].

"Federico II" University of Naples Hospital Management's Staff considered 47 informed consent forms in order to evaluate quality and quantity of the information transmitted to patients. Every form, distinguished by procedure (surgical, pharmacological, anesthesiologic or related to blood transfusions) was evaluated for the accuracy and validity of information related to: diagnosis, prognosis, diagnostic and therapeutic opportunities, expected benefits, adverse-side effects, iatrogenic risks, privacy policy on personal data. The forms were judged by information completeness criteria "conformed" or "not conformed" with standards. Our analysis demonstrate that physicians often are unaware of legal and ethical topics related to constructing informed consent forms. They usually omit crucial information or would use strict technical language. So far, we conclude Hospital Management's Staff definitively has a role in improving informed consent forms by establishing guidelines and promoting ethical issues. Final result could be to deserve stronger patient confidence in medical institutions.

Adult↗
PubMed1990

Guidelines: egg donation and consent forms.

Egg donation has caused the Interim Licensing Authority concern in the last year. In its latest annual report it has issued additional guidelines on the subject. It has also issued a booklet 'Egg Donation: your questions answered' to be given to all prospective egg donors. The booklet contains a consent form for egg donation. The new guidelines and consent form are reproduced below. Also reproduced is the standard ILA consent form for in vitro fertilisation, which all licensed IVF units must use.

Consent Forms↗
PubMed1997

Effects of consent form information on self-disclosure.

When researchers encounter preexisting psychological distress in participants, ethical codes provide little guidance on how to balance issues of beneficence and autonomy. Although researchers may inform participants what will occur given responses indicating distress, this information may lead to biased self-reports. This important issue was addressed in this study by manipulating consent form information regarding the type of psychopathology to be assessed and various levels of possible follow-up. In comparing responses on self-report measures of anxiety, depression, and general psychological distress, men who believed depression was the focus of the study reported fewer symptoms of depression and less trait anxiety as intrusiveness of experimenter follow-up increased. These results are discussed within the framework of socialization theory. Given that half of the sample did not correctly answer questions regarding information contained in the consent form, guidelines to improve consent form comprehension are offered.

Altruism↗
PubMed2005

Therapeutic optimism in the consent forms of phase 1 gene transfer trials: an empirical analysis.

BACKGROUND: "Therapeutic misconception" arises when human subjects interpret a clinical trial as aimed primarily at therapy rather than producing knowledge. Therapeutic misconceptions may be more prevalent in trials enrolling gravely ill subjects or involving novel and well publicized investigational agents. OBJECTIVE: To examine the extent to which investigators express therapeutic optimism in phase 1 human gene transfer consent documents, whether highly active gene transfer researchers are more prone to expressing therapeutic optimism, and whether consent forms have grown more optimistic in their descriptions of personal benefit over the last decade. DESIGN: Content analysis was performed on 277 consent documents to measure the number of sentences describing possibility of benefit, terminology used for experimental agents, the proportion of statements describing personal versus societal benefits, and whether investigators attempted to thwart therapeutic misconceptions. RESULTS: Consent forms generally used therapeutic terminology to describe study agents, devoted more sentences to describing possible personal benefits than to describing benefits to society, and infrequently explained that a particular benefit was unlikely. Consent documents used by highly active gene transfer researchers tended to portray significantly greater optimism about personal benefit than less active investigators, though they were also significantly more cautious with agent terminology. Finally, therapeutic optimism expressed in consent forms has declined over the past decade. CONCLUSIONS: Consent documents used in phase 1 gene transfer trials, although increasingly attentive to possible therapeutic misconceptions, are inappropriately optimistic about direct benefits of trial participation. Such optimism is expressed more emphatically in trials involving highly active gene transfer researchers as principal investigators.

Clinical Trials, Phase I as Topic↗
PubMed1997

Review by a local medical research ethics committee of the conduct of approved research projects, by examination of patients' case notes, consent forms, and research records and by interview.

OBJECTIVE: To monitor the conduct of medical research projects that have already been approved by the local medical research ethics committee. DESIGN: Follow up study of ethically approved studies (randomly selected from all the studies approved in the previous year) by examination of patients' case notes, consent forms, and research records and by interview of the researchers at their workplace. SETTING: Tayside, Scotland (mixed rural and urban population). SUBJECTS: 30 research projects approved by Tayside local medical research ethics committee. MAIN OUTCOME MEASURES: Adherence to the agreed protocol, particularly for recruitment (obtaining and recording informed consent) and for specific requirements of the ethics committee, including notification of changes to the protocol and of adverse events. RESULTS: In one project only oral consent had been obtained, and in a quarter of the studies one or more consent forms were incorrectly completed. Inadequate filing of case notes in five studies and of consent forms in six made them unavailable for scrutiny. Adverse events were reported, but there was a general failure to report the abandoning or non-starting of projects in two studies the investigators failed to notify a change in the responsible researcher. CONCLUSIONS: Monitoring of medical research by local medical research ethics committees promotes and preserves ethical standards, protects subjects and researchers, discourages fraud, and has the support of investigators. We recommend that 10% of projects should undergo on-site review, with all others monitored by questionnaire. This would require about six person hours of time and a salary bill of 120 pounds per study monitored.

Consent Forms↗
PubMed2004

The personalized consent form: an optional, but useful tool!

Dentistry began to incorporate informed consent and risk management into its practice after 1950. Today, an obligation to ensure that the patient has accepted a given treatment and understands all its implications are part of a dentist"s prime responsibilities. The purpose of this article is to inform dentists who are asking for consent that they can use a tool to make this task easier--the personalized consent form.

Consent Forms↗
PubMed1983

Readability of informed consent forms for research in a Veterans Administration medical center.

This study examined the effects of federal regulations on the readability and length of consent forms used in medical research from 1975 through 1982. Materials evaluated were 49 information sheets from four sample time periods and the 1975 and 1979 revisions of the Veterans Administration consent document. Flesch readability scores were at college level for both the consent documents and information sheets from all sample time periods. Thus, consent forms always may have been too difficult for typical volunteers to comprehend. Changes in length and content of the consent documents suggest that difficulty levels actually may have increased since 1975. Efforts to protect the rights of research subjects through federal regulations have resulted in presentation of appropriate information, but little progress has been made in ensuring that the information is comprehensible, understood, and used.

Behavioral Research↗
PubMed1995

The adequacy of consent forms for informing patients entering oncological clinical trials.

The impact on 100 patients of information and consent forms signed prior to medical oncology clinical trials was evaluated by a survey at a subsequent visit. Only 40 patients believed that the purpose of the form was to explain the treatment. The form was listed as the major source of information by 12 patients while 52 listed a doctor and 26 a nurse. Although 21 patients believed that the form mad them less anxious, 19 patients believed that it made them more anxious. Despite 80 patients reading all of the form, 60 claiming to understand all of it and 68 claiming that in contained adequate information, in tests of recall only 52 patients could name all of their drugs and only 4 all of the side effects. The number of drugs named correlated with how much of the consent form had been read (p = 0.003) and the highest education level achieved by the patient (p = 0.0003). Patients under 55 years had significantly better recall. Patients with a better ECOG performance status were more likely to find the form very helpful. Such forms may not ensure that the requirements for informed consent are satisfied.

Adult↗
PubMed1979

[First experiences with a written consent form for patients prior to cataract surgery (author's transl)].

The first experiences with a written consent form signed by patients prior to cataract surgery are presented. Details of possible surgical complications were discussed with the patient. The average time for this type of discussion was 15,6 min (7--30 min). The positive outcome of this study appeared to be that the confidence of the patient towards the surgeon or the hospital did not suffer nor did any patient change his decision to undergo surgery. This was tasted in a questionnaire showed to the patients after the discussion on possible complications. Some patients stated that they preferred enlightment on the day before surgery, whereas others would have preferred to have the written consent form sent home some days before surgery to have chance to discuss the problems with their relatives.

Cataract Extraction↗
PubMed1992

Evaluating the readability of informed consent forms used in contraceptive clinical trials.

The readability level of informed consent forms used in clinical trials on contraceptives was determined. Three different formulas for measuring readability were used. Some forms received relatively high scores by all three methods. The most common problems associated with high readability scores were the use of 'unfamiliar' words, long words and long sentences. At present all forms used must be readable, using the SMOG formula, at a grade 6 level or less.

Clinical Trials as Topic↗
PubMed1996

Documenting informed consent for treatment with neuroleptics: an alternative to the consent form.

Clinicians can comply with Ohio state regulations for documenting patients' informed consent for treatment with neuroleptic medication by checking a box in the medical record stating that a periodic discussion of informed consent has occurred and writing a note about the discussion in the narrative record. The authors discuss clinicians' experience with this alternative to the conventional consent form in a large community support agency. Although the approach has been largely successful, implementation has been hindered by some clinicians' incomplete understanding of the informed consent process. Continued training is needed to bring the ideal of informed consent into clinical practice.

Antipsychotic Agents↗