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PubMed1991

Are research participants truly informed? Readability of informed consent forms used in research.

Researchers typically attempt to fulfill disclosure and informed consent requirements by having participants read and sign consent forms. The present study evaluated the reading levels of informed consent forms used in psychology research and other fields (medical research; social science and education research; and health, physical education, and recreation research). Two standardized measures of readability were employed to analyze a randomly selected sample (N = 108) of informed consent forms used in Institutional Review Board-approved research projects at a midwestern university during the 1987-1988 academic year. Results indicate that informed consent forms are typically written at a higher reading level than is appropriate for the intended population and that there are no consistently significant differences in readability among areas of research or between college student and noncollege student participants. Due to the unacceptably high reading level of the consent forms, one must question whether participants can comprehend the information contained in the consent form.

Adolescent↗
PubMed2003

[Assessment of the quality and psychological impact of information delivered using official consent forms in digestive endoscopy].

AIM: To test the impact of information brochures and informed consent forms in patients undergoing digestive endoscopy procedures. METHOD: All patients undergoing digestive endoscopy procedures during a two-month period were given information about the procedure to be performed by delivery of an information form produced by the French Endoscopy and Gastroenterology Societies. The patients were then asked to sign an inform consent form. A questionnaire about the informed consent form and the consent experience was given to all patients after the endoscopic procedure. RESULTS: The questionnaire was completed by 108 consecutive patients. The informed consent form was completely read by 96.3% and understood by 95%. Sixteen percent asked for complementary information, all about complications. Twenty percent were distressed by the explanations. Receiving written information was surprising for 22.2% of the patients, and distressing for 18.5% mainly when endoscopy was planned without general anesthesia (P=0.01 versus general anesthesia). Obtaining informed consent was qualified as a normal procedure for 47.2%, but distressing for 19.4%. It was considered by 41.1% as a way for doctors to be discharged from their obligations. CONCLUSION: The informed consent forms written by scientific societies are easy to understand. One third of the patients were distressed or surprised to be given oral or written information. To sign a written consent form before an endoscopy procedure is considered to be a means of discharging practitioners from their responsibilities for 30% of the patients.

Adult↗
PubMed2004

The new consent form: is it any better?

BACKGROUND: The UK Department of Health (DoH) introduced a new consent form into the National Health Service (NHS) in April 2002 following the Bristol Royal Infirmary Inquiry. AIM: To compare the efficacy of the new consent form with the old on the quality of consent. METHODS: A questionnaire consisting of 11 questions was distributed to two groups of 100 patients before and after the introduction of the new consent form in the pre-assessment clinic at Glenfield Hospital, Leicester. RESULTS: Of the 11 questions, there were four significant differences that favoured the new consent form. These were: (i) success and benefits of the operation (old, 81%; new, 97%, P < 0.001; 95% CI, 7.3-24.4%); (ii) information that patients received about the operation from the doctor (old, 34%; new, 93%; P < 0.001; 95% CI, 46.7%-68.9%) and nurse (old, 21%; new, 67%; P < 0.001; 95% CI, 33.3-58.3%) in the pre-assessment clinic; (iii) postoperative recovery (old, 56%; new, 96%; P < 0.001; 95% CI, 30.0%-51.2%); and (iv) ability to list potential complications that could arise from the operation (old, 61%; new, 97%; P < 0.001; 95% CI, 26.4-52.6%). Despite the above differences, an overall assessment involving all questions failed to show a significant improvement with the new consent form (old, 57%; new, 67%; P = 0.264;, 95% CI, -35.6% to 12.6%). DISCUSSION AND CONCLUSIONS: The new consent form resulted in improvement in some, but not all, aspects of consent and no question reached the ideal standard of 100%. We suggest a formatted consent form for procedures in conjunction with additional information.

Consent Forms↗
PubMed1994

The effect of an introduction of a new consent form on settlement of the doctrine "informed consent".

Paternalism has been criticized lately in the japanese medical world, but it remained rather unfamiliar for a majority of the medical doctors to exercise the informed consent in the daily practice. It seemed that a consent form was one of the ways by which the medical and co-medical staffs became aware of importance of the informed consent. As it has been believed in Japan to be too formal to obtain a signature from the patient only for the evidence of the consent, it was worth while directing attentions of both the attending staffs and their patients to a renewed form, making them know that the doctrine of the informed consent had been introduced in the daily practice. Although it was an effective way, it turned out to be rather time-consuming process for a practical understanding of the informed consent.

Forms and Records Control↗
PubMed1978

Consent forms--how, or whether, they should be used.

If written consent forms are to be used--their use normally is not mandatory--care should be taken that their use is proper and, hence, beneficial. To be of benefit to the physician, the consent forms must help him in meeting his duty to inform the patient or in protecting him from a patient's claim that his was not an informed consent (or both). Consent forms are of no benefit to the physician or the patient if they are worded poorly or put to poor use. Suggestions are provided to help the physician in considering his or her use of written consent forms.

Consent Forms↗
PubMed2005

Telephone reminder calls increased response rates to mailed study consent forms.

BACKGROUND: This study assessed the impact of follow-up reminder phone calls on response rates to a mailed consent form packet. METHODS: Patients with rheumatoid arthritis were invited to enroll in a study by signing and returning consent forms by mail. Patients not returning completed study consent forms were called and reminded to return the signed consent forms. RESULTS: Among 724 mailed consent form packets, 376 (52%) were returned without further follow-up. Follow-up reminder calls were made to 220 of the 348 patients who did not return signed consent forms. Among subjects contacted by phone, 67 (31% of those called) returned signed consent forms. CONCLUSION: Follow-up reminder phone calls raised the overall consent rate of 52 to 61%, suggesting that they can be an effective technique in increasing response rates.

Arthritis, Rheumatoid↗
PubMed1994

Are informed consent forms that describe clinical oncology research protocols readable by most patients and their families?

PURPOSE: This study was conducted to assess the readability of informed consent forms that describe clinical oncology protocols. METHODS: One hundred thirty-seven consent forms from 88 protocols that accrued patients at The Johns Hopkins Oncology Center were quantitatively analyzed. These included 58 of 99 (59%) institutional protocols approved by The Johns Hopkins Oncology Center's Clinical Research Committee and the Institutional Review Board (IRB) over a 2-year period, and 30 active Eastern Cooperative Oncology Group (ECOG), Radiation Therapy Oncology Group (RTOG), and Pediatric Oncology Group (POG) trials. The consent forms described phase I (17%), phase I/II (36%), phase III (29%), and nontherapeutic (18%) studies. Each was optically scanned, checked for accuracy, and analyzed using readability software. The following three readability indices were obtained for each consent form: the Flesch Reading Ease Score, and grade level readability as determined by the Flesch-Kincaid Formula and the Gunning Fog Index. RESULTS: The mean +/- SD Flesch Reading Ease Score for the consent forms was 52.6 +/- 8.7 (range, 33 to 78). The mean grade level was 11.1 +/- 1.67 (range, 6 to 14) using the Flesch-Kincaid Formula and 14.1 +/- 1.8 (range, 8 to 17) using the Gunning Fog Index. Readability at or below an eighth-grade level was found in 6% of the consent forms using the Flesch-Kincaid Formula and in 1% using the Gunning Fog Index. Readability was similar for consent forms that described institutional, cooperative group, and phase I, II, and III protocols. CONCLUSION: Consent forms from clinical oncology protocols are written at a level that is difficult for most patients to read, despite national, cooperative group, institutional, and departmental review. The consent process, which is crucial to clinical research, should be strengthened by improving the readability of the consent forms.

Clinical Protocols↗
PubMed1993

An attempt to standardize the radiodiagnostic risk statement in an Institutional Review Board consent form.

RATIONALE AND OBJECTIVES: The communication of a suitable radiation risk consent form statement to a potential research subject has always been difficult to formulate. Concomitant with this is the equally problematic task of ensuring that subjects understand the true risks of the study. In an effort to document how other Institutional Review Boards (IRBs) express radiation risk associated with participating in a research investigation, a questionnaire was developed and was sent to 23 large medical-research institutions. METHODS: Questions pertained to the manner of comparing risk, units for expressing radiation dose, patient population differentiation, and statements for given situations. In addition, each institution was asked to provide examples of radiation-related in-house consent form statements. Thereafter, the examples were forwarded to the responding institutions for grading. RESULTS: Fourteen responses were received and summarized. The majority compared the study test to a similar radioactivity study, Nuclear Regulatory Commission (NRC) occupational limits and/or Radioactive Drug Radiation Committee (RDRC) limits. There was an equal distribution of radiation units used; absorbed dose, dose equivalent, and effective dose equivalent. The majority of respondents did not differentiate between normal individuals and patient volunteers. Included in the 14 responses were 46 in-house generated radiation-related consent form statements. The latter were assembled and forwarded to the 14 responding institutions with instructions to "approve" or "disapprove" each. Nine statements obtained an 80% or greater acceptance rating, with three > 90%. The remaining were overwhelmingly rejected as suitable radiation risk statements. CONCLUSIONS: Based on the submitted material and statement grading results, recommendations were formulated toward producing a standard format for expressing radiation risk in the consent form. Effective dose equivalent in comparison to annual natural environmental radiation or occupational radiation dose limits were recommended based on these data. While an "optimum" radiation risk consent form statement may not be attainable, these results nevertheless provide recommendations based on a consensus of practitioners in the field.

Consent Forms↗
PubMed2004

Do written consent forms provide medicolegal protection from litigation in radiotherapy?

Two methods were used in an attempt to determine whether written consent forms serve a useful medicolegal purpose in Australian radiotherapy departments. First a survey was posted to all practising radiation oncologists to ask about their use of written consent forms and whether they had ever been useful in any claims made against them. Second, the largest medical defence organization in Australia was contacted for de-identified details about every claim ever made against a radiation oncologist. The survey yielded a response rate of 50.3%. Only one respondent indicated that any consent form had ever played a role in any claim and was not prepared to discuss it. Many radiation oncologists did not routinely use a consent form and its use could not be considered standard practice. The submitted consent forms generally did not contain warnings to the patient about specific risks of treatment. The details of the previous claims provided by the medical defence organization indicated that more often claims arose from circumstances in which a written consent form could not provide any useful protection such as radiation dose calculation errors. The medicolegal value of written consent forms in radiotherapy seems low, although further research may be necessary before dispensing with them completely.

Australia↗
PubMed2005

[Readability of informed consent forms for subjects participating in biomedical research: updating is required].

OBJECTIVE: We compared informed consent forms of subjects participating in biomedical research with those of references texts in order to determine the factors that influence readability. METHODS: We assessed the readability of 73 informed consent forms of research protocols conducted in the clinical investigation centres in the Rhone-Alpes area, and then compared them with 33 reference texts corresponding to 5 French school grades (first year infant, primary school, GCS level, high school, and classics aggregation), using the Flesch test and Cordial" analyser. RESULTS: Median Flesch scores were 66 for the first year infant level, 62 for the primary school level, 58 for the GCS level, 42 for the high school level, and 43 for the aggregation level. It was 22 for the informed consent forms. Median Cordial scores were 86 for the first year infant level, 77 for the second, 74 for the third, 49 for the fourth, 43 for the fifth. It was 1 for the informed consent forms. No methodological factor correlated with Flesch and Cordial" results. CONCLUSION: The quantitative readability scores for informed consent forms for subjects participating in biomedical research are low, lower than those proposed to aggregation candidates, whatever the type of protocol. Some thought must be given to the impact of the reduced readability on patients' understanding, and steps should be taken to improve the readability of the forms.

Adolescent↗
PubMed1996

[The legibility of written informed consent forms].

BACKGROUND: The generation of the use of informed consent forms makes necessary to grant their legibility for patients. Up to now, we didn't have in Spain a suitable yardstick for evaluating the reading levels. METHODS: A sample of 10 texts of diverse procedence, 8 journals and 16 informed consent forms were collected. They were analyzed using the Grammatik 6.0 utility of the word processor Word Perfect 6.1, and four parameters were obtained: number of words, number of sentences, Flesch-Kincaid Grade Level and Sentence Complexity. In addition an Integrated Readability Level (LEGIN) was calculated. RESULTS: Flesch Level and Sentence Complexity give a suitable and complementary analysis of readability, which is enhanced by the LEGIN. The acceptably reading level is obtained when the Flesch-Kincaid Level is above 10, the Sentence Complexity is under 40 and, overcoat, the LEGIN is above 70. Just 5 of the 16 consent forms had the adequate LEGIN level. Another 5 had the Flesch correct levels and 7 the adequate Sentence Complexity. CONCLUSIONS: The Grammatik utility of the word processor Word Perfect 6.1 is a suitable yardstick to analyze the readability, but is necessary to complete the analysis with the LEGIN, to render more sensibility and especificity. It's mandatory to enhance the readability of written forms to grant the ethical quality of the informed consent process.

Forms and Records Control↗
PubMed2002

Descriptions of benefits and risks in consent forms for phase 1 oncology trials.

BACKGROUND: Ethicists have suggested that written consent forms encourage participants in phase 1 cancer trials to expect benefit from the experimental agent and to overlook serious risks. METHODS: To evaluate the written description of direct benefit as well as risk, all consent forms for 1999 phase 1 cancer trials were compiled from 80 percent of the National Cancer Institute-designated cancer centers and from six of eight large pharmaceutical developers of anticancer drugs. In each case, we evaluated the characteristics of the trial, the descriptions of the purpose and procedures of the research, the promise of benefit, the description of risks, and the description of alternatives. RESULTS: Of 272 forms, 268 explicitly mentioned that the trial was research, and 249 stated that the purpose of the trial was testing for safety. Nearly all forms (269) mentioned the right to withdraw from the trial. Almost all forms (260) referred to the experimental agent as "treatment" or "therapy." Only one consent form promised direct benefit to subjects. Most forms (181) mentioned death as a risk, and very few (14) mentioned cure as even a possible benefit. Most (229) stated that there was unknown risk involved and indicated that severe or permanent harms were possible (224). CONCLUSIONS: Consent forms for phase 1 oncology studies almost never promise direct benefit to subjects, rarely mention cure, and usually communicate the seriousness and unpredictability of risk. Although there is room for improvement, the substance of these forms is unlikely to be the primary source of misunderstanding by subjects in phase 1 oncology trials.

Biomedical Research↗
PubMed1980

On the readability of surgical consent forms.

A great deal of attention has been paid to ensuring that surgical consent forms have valid content, but little effort has been made to ensure that the average patient can read and understand them. Five representative surgical consent forms were analyzed with two standardized readability tests. The readability of all five was approximately equivalent to that of material intended for upper-division undergraduates or graduate students. Four of the five forms were written at the level of a scientific journal, and the fifth at the level of a specialized academic magazine. I suggest that few consent forms currently in use could pass readability tests. The implication of these findings is that thousands of persons may be undergoing surgery each year on the basis of inadequate consent. The problem has a reasonably simple solution: analysis of all consent forms for readability, and rewriting of those found excessively difficult.

California↗
PubMed2005

Recommendations for informed consent forms for critical care clinical trials.

BACKGROUND: Many subjects enrolled in research studies have a limited understanding of the research to which they consented. OBJECTIVE: To develop recommendations to enhance comprehensiveness and understanding of informed consent forms used in critical care clinical trials. DESIGN: Consensus process. RECOMMENDATIONS: We provide recommendations regarding the U.S. federally required basic and additional elements of informed consent as applied to critical care clinical trials. We also identify issues that investigators need to address, if relevant, in the informed consent forms of critical care clinical trials. These include the description, in understandable language, of complex and detailed experimental protocols that are the focus of the clinical trial, disclosure of death as a risk factor if mortality is an outcome variable, and the identification of who can legally serve as the prospective subject's surrogate. We also offer suggestions to enhance subjects' understanding of informed consent forms. CONCLUSIONS: The literature on informed consent forms suggest that shorter informed consent forms written at a lower reading level, when read carefully, might provide better subject understanding. Prospective evaluation is needed to determine whether our recommendations enhance the informed consent process.

Clinical Trials as Topic↗
PubMedDate not supplied

Consent forms: how to determine and improve their readability.

This study investigated the reading level estimates of cancer clinical trial consent forms from actively accruing studies at the Medicine Branch and the Clinical Pharmacology Branch of the National Cancer Institute. Forty-four consent forms were analyzed using the SMOG formula. Readability levels ranged from grade 12 to grade 17.5 (mean = 14.3). The conclusion was that these consent forms were written above most subjects' reading levels. The usefulness of consent forms could be improved significantly by using readability formulas, applying rewriting techniques, and being aware of subjects' comprehension levels. This paper suggests a number of strategies that nurses can use to enhance comprehension of the information contained in informed consent documents.

Clinical Trials as Topic↗
PubMed2006

Disclosure of HIV status on informed consent forms presents an ethical dilemma for protection of human subjects.

The privacy of copies of consent forms provided to research participants cannot be guaranteed. Therefore, consent forms that disclose a subject's HIV status may result in breach of confidentiality and cause social harms. Under the ethical principle of beneficence defined in the Belmont Report, we recommend that disclosure of HIV status be through voluntary counseling and testing; however, whenever possible, copies of consent form should not specify HIV status.

Consent Forms↗
PubMed1997

The consent form signature: a useful clinical sign?

The quality of a patient's consent form signature was assessed in 42 adult patients undergoing emergency major abdominal surgery. Patients with a poor quality or absent consent form signature had a significantly higher mortality and higher APACHE II scores than those with a satisfactory consent form signature.

APACHE↗