Evaluating the quality of information about alternatives to research participation in oncology consent forms

A careful consideration of the alternatives to research participation is an essential element of making an informed choice to enroll in a biomedical research study. While there is general agreement on the importance of informing prospective subjects about alternatives to research participation, little is known about how investigators communicate this information. The purpose of this study was to attempt to assess the quality of information about alternatives contained in informed consent documents in oncology randomized controlled trials. Our study indicates that there is room for improvement concerning the discussion of alternatives to research participation in informed consent documents in oncology randomized controlled trials. Though most of the documents in our study met the minimal disclosure standard found in the U.S. federal regulations, less than a third met the reasonable person standard, a widely accepted principle endorsed by the common law and various ethics guidelines and documents. There was a statistically significant difference between the alternative discussions in local and model forms (P < 0.0014). The alternatives discussions in local informed consent documents were more likely to receive higher scores than those in model consent documents, with an odds-ratio of 3.5 to 1.     

National efforts to improve the informed consent process

OBJECTIVES: To inform oncology nurses about several national efforts to improve the informed consent document and process. DATA SOURCES: A federally funded grant program to stimulate research of informed consent, an initiative from the National Cancer Institute to improve informed consent documents in cancer clinical trials, and a model consent document developed by the National Action Plan on Breast Cancer. CONCLUSIONS: These initiatives assist investigators and institutional review boards in presenting relevant and understandable information to potential clinical trial participants. IMPLICATIONS FOR NURSING PRACTICE: These national efforts will raise awareness of providing potential research participants with clear information to assist them in making an educated, informed decision.     

The quality of parental consent for research with children: a prospective repeated measure self-report survey

BACKGROUND: Researchers have ethical and legal responsibilities to ensure that individuals give informed consent to participate in research. The few studies of parental consent for paediatric research suggest there may be inadequate competence, information, understanding, or voluntariness for valid consent to occur. OBJECTIVES: To determine parents' level of understanding of the research study requirements and satisfaction with the informed consent process. PARTICIPANTS: English literate parents of children actively involved in research studies. METHODS: A repeated measures self-report survey was conducted to measure parent understanding (actual and perceived) of the study consented for and satisfaction with the informed consent process. Relationships between parents understanding of the research and their satisfaction with the consent process were explored and changes in parent understanding or satisfaction over time were described. RESULTS: Questionnaires from 109 parents were returned, representing 25 different studies. Parents demonstrated a high level of knowledge of information essential for informed consent, such as the purpose, benefits, and participant rights. Nervousness or inability to concentrate, and reading ease of the information sheet were found to relate to parents' knowledge and their perceptions of the adequacy of the consent. Parents overall reported high satisfaction with the consent process. CONCLUSIONS: These findings support and extend previous research on parental consent for research with children. They suggest areas where further research is indicated, including: the value and use of information and consent documents given to parents, the views and concerns of parents for whom English is not their first language, and further exploration of the concerns of the few dissatisfied parents. Current practices of obtaining informed consent for research lack supporting research evidence and may not be ethically justifiable.     

The nurse's role in the informed consent process

OBJECTIVES: To review the informed consent process in relation to oncology nursing roles and responsibilities, patient comprehension, cultural sensitivity, and qualitative methodologies. DATA SOURCES: Scientific and review articles, regulatory documents, and texts relating to informed consent. CONCLUSIONS: Nursing is involved in almost every aspect of the informed consent process. To be effective, nurses must be knowledgeable about fundamental concepts associated with informed consent and corresponding responsibilities and willing to address the complexities of the informed consent process. IMPLICATIONS FOR NURSING PRACTICE: Situations related to informed consent provide challenges and opportunities for professional growth. Keeping abreast of the evolving standards and concepts of informed consent enhances the essential roles that nurses play in clinically based research.     

Readability of Participant Informed Consent Forms and Informational Documents: From Phase 3 COVID-19 Vaccine Clinical Trials in the United States

ObjectiveTo assess the readability of the informed consent forms from the phase 3 COVID-19 vaccine trials conducted in the United States.Patients and MethodsEnglish consent forms were used for patients in phase 3 COVID-19 vaccine clinical trials. Consent forms were obtained in October 2020. Using Microsoft Word tools, we analyzed the readability (ie, the ease of reading) of written consent forms and informational documents from phase 3 COVID-19 vaccine clinical trials in the United States from the following manufacturers: AstraZeneca, Moderna, Pfizer, Johnson & Johnson, and Novavax.ResultsOwing to low readability and several format factors, this study determined that none of the consent forms or informational documents from the recent phase 3 COVID-19 vaccine clinical trials conducted in the United States met readability standards at the recommended 7th grade readability level for the average vaccine research volunteer in any readability category. The average English-speaking vaccine trial volunteer would have great difficulty comprehending the information provided in the consent forms and informational documents. To ensure that study subjects receive and fully comprehend information regarding a clinical study and can provide reliable consent, greater attention should be given to the development and use of simplified consent forms, multimedia formatting, personal discussion, and comprehension assessments.     

Do informed consent documents matter?

This commentary argues that, despite extensive critiques of informed consent documents, there are several ethical and legal reasons for investigators and IRB members to take these documents seriously.     

Informed consent to treatment in clinical trials

Special characteristics of clinical trials place unique demands on the concept and practice of informed consent to treatment. We focus on the practical problem that consent to treatment forms are not typically able to be understood by patients in clinical trials research. Informed consent forms are significantly less comprehensible than popular press written material and may be as difficult to read as medical journals. Several guidelines for improving informed consent to treatment documents such as the use of non-professionals and patients to critique drafts of consent to treatment forms are proposed and discussed. The use of these guidelines can insure that patients have the opportunity to understand more clearly what their treatment will involve within a clinical trial before they give an informed consent.     

Informed consent for blood transfusion: a regional hospital survey

Ninety-two hospitals in a three-state mid-Atlantic region were surveyed to determine their policy toward obtaining written informed consent for transfusion and to examine the content of written consent documents and the process by which consent is obtained. Of 81 hospitals responding, 50 (62%) required written informed consent. Hospitals with fewer than 200 beds were more likely to require written informed consent. The attending physicians had responsibility for obtaining consent in 28 (57%) of 49 institutions, most often on the day or evening before surgery. Twenty-seven of 48 forms mentioned complications: hepatitis in 80 percent, human immunodeficiency virus infection in 46 percent, nonhemolytic reactions in 32 percent, and hemolysis in 25 percent. Alternatives to allogeneic transfusion were mentioned infrequently; eight hospital forms listed autologous transfusion options and only two mentioned designated donation. The reading level required to comprehend 34 consent forms submitted was grade 14.6, which has been attained by only 23 percent of the adult United States population. Although the majority of respondent institutions require written informed consent, those forms, per se, do not document that the fundamental tenets of informed choice have been applied to the decision to transfuse blood.     

Patients' recall and perceptions regarding consent to blood transfusion at Universitas Academic Hospital,Bloemfontein, South Africa

We studied the recall and perceptions of transfused patients at a single centre. Fifty-three patients were included. In 11 (20.8%) cases, no written informed consent document could be traced. Four patients who had informed consent documents in their records had no recollection of the consent process. Approximately 11% of patients stated that the consent process was performed using unfamiliar terms. When compared to Caucasian and mixed race respondents, more African respondents (83%) would have preferred the presence of a family member (p < 0.01). Although not all the patients experienced the informed consent positively, it did not impact on their perception of the blood transfusion itself.     

Paving the way to a more effective informed consent process: Recommendations from the Clinical Trials Transformation Initiative

Ethically sound clinical research requires that prospective study participants provide voluntary informed consent before any study procedures begin. The original intent was to provide the participant with clear, accurate information about study specifics (e.g., risks/benefits) to aid in the decision to participate. Broad consensus among sponsors, research staff, study participants, and advocates indicate that the current process could be improved to enhance participants' understanding of study-related information and meet the needs of individuals.The Clinical Trials Transformation Initiative (CTTI) convened a project to identify problems in the current process and to formulate recommendations for improvement. A literature review, expert interviews, and multi-stakeholder meeting were conducted to identify barriers and develop solutions for a more effective informed consent process.Four key topics were the foundation of the recommendations: 1) defining an effective informed consent process, 2) training research staff, 3) improving the informed consent document, and 4) exploring the use of electronic consent. The ideal informed consent process involves an ongoing, interactive conversation between the participant and knowledgeable, responsive research staff who were trained in best practices. The informed consent process should be supported by a tiered informed consent document that provides critically relevant information to aid in the decision to participate in a study.Adoption of the CTTI informed consent recommendations should lead to a more participant-centric informed consent process. Participant involvement better meets the needs of participants and benefits the clinical trial enterprise by promoting a research culture that encourages informed participation in clinical studies.     

The role of the consent document in informed consent for pediatric leukemia trials

PURPOSE: To examine both the use of the consent document during the informed consent process for pediatric leukemia clinical trials, as well as relationships between the use of the document and parental understanding of essential elements of informed consent. METHODS: Participants included 140 parents of children diagnosed with pediatric leukemia. Informed consent conferences in which randomized clinical trials were discussed were observed, audiotaped, and coded for specific behaviors. Parents were also interviewed within 48 h of their participation in informed consent conferences. RESULTS: Observations revealed that 74% of cases included explanation of consent documents during consent conferences. Parents who reported that they read the consent document were more likely to understand differences between the clinical trial and off study therapy and were more likely to understand the right to withdraw. Reading of the consent document was not associated with understanding of voluntariness. In comparison to racial/ethnic majority parents, racial/ethnic minority parents were less likely to report that they read the consent document, understand voluntariness or the right to withdraw, and were less likely to be able to distinguish between the clinical trial and off study therapy. Low SES was associated with a lower probability of reading the consent document and being able to distinguish between clinical trials and off study therapy. CONCLUSIONS: Attention to the importance of reading the consent document and improving communication during consent conferences is likely to enhance understanding of essential elements of informed consent.     

Using principles of health literacy to enhance the informed consent process

THE LANGUAGE COMMONLY used in procedural/surgical consent forms often exceeds the average reading level of US patients, and many do not read the document before signing it.INCORPORATING READER-FRIENDLY language and formatting makes it more likely that patients will read the document, understand it, and therefore give informed consent. Adding “teach back” into the document provides a means of evaluating patient understanding.USING READER-FRIENDLY procedural/surgical consent documents merges the objectives of both health literacy and informed consent. AORN J 88 (July 2008) 23-29. © AORN, Inc, 2008.     

The requirement for informed consent prior to nursing care procedures

AIM OF THE PAPER: The aim of this paper is to examine the extent to which there is a requirement to obtain informed consent prior to nursing care procedures. RATIONALE: The requirement for nurses to obtain consent prior to nursing care procedures is addressed in various nursing policy documents. It is important that nurses understand the legal and ethical rationale behind the principles of informed consent so that the principles are applied appropriately to the particular context of nursing care. ARGUMENT: The ethical and legal rationale behind the concept of informed consent and its relevance to nursing practice are examined. In this paper, it is argued that the function of informed consent is to protect patient autonomy and to promote meaningful decision-making. Given the potential for nursing care procedures to infringe patient autonomy, consent is clearly a relevant concept in nursing. Furthermore, in law, any touching without consent is a potential battery. Informed consent is often associated as a rigid procedure, only relevant to surgical or research procedures. Consent should be obtained prior to nursing care procedures whenever patient autonomy is at stake. However, information-giving should be determined by the needs of the patient and approached in such a way as to facilitate meaningful decision-making. Given the individual nature of infringements to patient autonomy, it is difficult to predetermine all those care procedures that require consent; any list of procedures would fail to be comprehensive. CONCLUSIONS: The principles of informed consent should underpin our approach to nursing care procedures, which should not be mechanistic but determined by the needs of individual patients.     

Intensive care patients' evaluations of the informed consent process.

This study examines the informed consent process from the perspective of intensive care patients. Using the largest single-method database of patient-derived information in the United States, we systematically outlined and tested several key factors that influence patient evaluations of the intensive care unit (ICU) informed consent process. Measures of information, understanding, and decision-making involvement were found to predict overall patient satisfaction and patient loyalty intentions. Specific actions supportive of ICU informed consent, such as giving patients information on advance directives, patient's rights, and organ donation, resulted in significantly higher patient evaluation scores with large effect sizes. This research suggests that the effectiveness of the informed consent process in the ICU from the patient's perspective can be measured and evaluated and that ICU patients place a high value on the elements of the informed consent process.     

Effectiveness of a writing improvement intervention program on the readability of the research informed consent document.

BACKGROUND: Problems with the comprehensibility of human research informed consent have been documented since the 1970s, and efforts aimed at rewriting consents have not been successful in consistently producing more readable consents. This study employed researched principles of reading comprehension research to create writing intervention program designed to help the research writer produce more comprehensible informed consent documents. The purpose of this study was to determine if this intervention program was effective. METHOD: The key component of the writing improvement intervention packet was a newly formatted consent form that contained annotated instructions for researchers on how to write each section for optimum comprehension. The resulting consent forms were evaluated using a Readability and Processability Form (RPF). The RPF is based on reading research and includes the Fry Scale, which yields an approximate grade reading level. The RPF assigned points to each of the 20 areas of comprehension analysis according to strict scoring criteria, and target scores were established by the authors in consultation with the hospital institutional review board. RESULTS: We evaluated 66 post-intervention informed consents. The mean readability and processability score was 62, resulting in the RPF classification of "good." The established readability and processability target range was good to excellent or 61-100 points; 66% of the forms scored in this range. In our 1995 pre-intervention study, the corresponding score was 12%. The target range for grade reading level was 8th grade: 53% scored in that range as compared with 4% in 1995. A question-by-question analysis of each of the 20 checklist items on the RPF identified important aspects of the consent writing that improved and others that were still weak and needed improvement. CONCLUSIONS: The Hartford Hospital writing improvement intervention program was associated with the production of more comprehensible informed consent documents. Using the intervention materials, investigators from a variety of departments could function independently to produce readable consent forms. This program may help others who wish to assist their research departments in creating consents that are written for optimal reading comprehension.     

Critical evaluation of informed consent forms for adult and minor aged whole blood donation used by United States blood centers

BACKGROUND: Blood donation is a medical procedure with attendant risks, and thus blood donors should undergo acceptable informed consent. There are no guidelines for the informed consent forms (ICFs) for whole blood donors or for parental consent forms (PCFs) for minor age blood donors. The goal of the study was to determine if the majority of the generally accepted elements of informed consent are provided to volunteer allogeneic whole blood donors in the United States.
STUDY DESIGN AND METHODS: ICFs and PCFs along with their accompanying general information forms (GIFs) from nonmilitary blood collection establishments for allogeneic whole blood donation were collected throughout the United States and scored using a system based on the essential elements of informed consent derived from guidelines of consent for research subjects. The overall score for each ICF and PCF was obtained.
RESULTS: Twenty-one ICFs and 37 PCFs from 48 states representing major collection centers within the United States were scored. The mean score for the common essential elements ICFs was 35 percent (range, 10%-80%) and for PCFs was 46 percent (range, 10%-90%).
CONCLUSION: None of the whole blood allogeneic donation informed consents surveyed contained all the common essential or specific blood donation information desired. There is a need for national guidelines for the informed consent process for both the donor and the parent of a minor to ensure adequate information is specified.     

Comprehension of information for informed consent by spouses of surgical patients

The adequacy of comprehension of the information needed for informed consent to participate in research on spouse responses to a husband's or wife's general surgery was assessed. Comprehension of information about the research study by 75 spouses was measured by the Informed Consent Questionnaire containing questions on study purpose, time involvement, nature of participation, risks, benefits, voluntariness, confidentiality, and anonymity. The result showed that 72 of the 75 spouses had adequate comprehension of the information for informed consent. Because adequate comprehension is atypical of most studies, possible reasons for this unexpected result are discussed and then explained within a self-determination theory of informed consent.     

儿童药物临床试验研究知情同意的伦理审查

由于儿童的生理、药理、心理及认知和自主权与成人有较大的差异,且各年龄段儿童又呈现不同的特点,儿童药物临床试验研究的知情同意除需遵循一般临床试验研究知情同意的基本原则外,在知情告知的信息、知情同意过程和同意的决定等各个环节又有其特殊要求。文章对儿童药物临床试验研究知情同意的伦理学和特殊性进行了辨析,以更好地指导开展儿童药物临床试验研究知情同意的伦理审查。     

Informed choice and consent for cervical spine manipulation

Informed consent is essential in ethical health care practice. Information and advice regarding choices is a precondition of informed consent. Autonomy, truthfulness and ethical decision making are all relevant to the informed choice and consent process. The purpose of this paper is firstly to discuss these topics. Following this, a case of informed choice and consent for cervical spine manipulation is examined. This case illustrates ethical problems that can arise in the informed choice and consent process. The moral reasoning in the case is clarified with the assistance of an ethical grid. The conclusion is that autonomy, a patient's right to self determination, is paramount in the informed choice and consent process. Autonomy enhancing informed consent requires more than a mechanical recitation of procedures, hazards and options. In order to uphold a patient's right to self determination, patients need to be included in the decision making process by allowing them to make treatment choices based on accurate information and advice from the physiotherapist.