Informed Consent for Medical Research: Common Discrepancies and Readability

Objective: To identify common discrepancies and average reading grade levels for informed consent forms (ICFs) us submitted to institutional review boards (IRBs) by medical researchers.
Methods: A retrospective evaluation of ICFs as submitted to IRBs of 3 university-affiliated hospitals during a I-year period. ICF content was evaluated using a checklist of 23 requirements specified in the federal regulations governing human research. Documents then were computer-analyzed to determine the readability scores using 2 common indexes of comprehension. A discrepancy was defined as any instance in which an ICF did not address an applicable requirement in the Code of Federal Regulations.
Results: Eighty-two ICFs representing 16 medical specialties were evaluated; 8 (10%) were from emergency medicine. Eighteen ICFs (22%) were conspicuously incomplete, lacking 29 federal requirements. The mean number of discrepancies was 4.7 (95% CI, 3.9–5.5) Common omissions included: a statement about who is doing the research, number of subjects in the study, circumstances when a subject's participation may be terminated, disclosure of alternative procedures, and notice to subjects regarding new findings. The mean Flesch grade level required to read all ICFs was 13.8 (95% CI, 13.5–14.2), implying that the majority of the U.S. adult population would be unable to comprehend these forms.
Conclusion: Designing a consent form to meet all of the federal requirements while maintaining a level of reading comprehension suitable for the general population is a difficult task for investigators.     

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.     

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.     

Readability of Invasive Procedure Consent Forms

Background

Informed consent is a pillar of ethical medicine which requires patients to fully comprehend relevant issues including the risks, benefits, and alternatives of an intervention. Given the average reading skill of US adults is at the 8th grade level, the American Medical Association (AMA) and the National Institutes of Health (NIH) recommend patient information materials should not exceed a 6th grade reading level. We hypothesized that text provided in invasive procedure consent forms would exceed recommended readability guidelines for medical information.

Materials and methods

To test this hypothesis, we gathered procedure consent forms from all surgical inpatient hospitals in the state of Rhode Island. For each consent form, readability analysis was measured with the following measures: Flesch Reading Ease Formula, Flesch–Kincaid Grade Level, Fog Scale, SMOG Index, Coleman–Liau Index, Automated Readability Index, and Linsear Write Formula. These readability scores were used to calculate a composite Text Readability Consensus Grade Level.

Results

Invasive procedure consent forms were found to be written at an average of 15th grade level (i.e., third year of college), which is significantly higher than the average US adult reading level of 8th grade (p < 0.0001) and the AMA/NIH recommended readability guidelines for patient materials of 6th grade (p < 0.0001).

Conclusion

Invasive procedure consent forms have readability levels which makes comprehension difficult or impossible for many patients. Efforts to improve the readability of procedural consent forms should improve patient understanding regarding their healthcare decisions.     

A strategy for learning principles and elements of informed consent

Nurses frequently provide potential study participants with informed consent forms and information regarding involvement in research studies However, there is little information in the nursing literature that emphasizes how to evaluate informed consent documents for appropriateness. The authors present an instructional project for critiquing informed consent documents for content, clarity, readability, and conciseness.     

Barriers to informed consent

OBJECTIVES: To provide oncology nurses with a review of barriers that may limit the ability of adults to provide informed consent. DATA SOURCES: Published articles, research studies, and review articles pertaining to informed consent and clinical research. CONCLUSIONS: Patient-centered barriers to informed consent (such as age, education, and illness) and process-centered barriers (such as content and readability of the consent form, timing of discussion, and amount of time allotted to the process) can affect an individual's ability to provide substantial informed consent. IMPLICATIONS FOR NURSING PRACTICE: Oncology nurses must be aware and knowledgeable of the various barriers to informed consent to minimize these barriers and to improve and facilitate the informed consent process.     

Factors influencing comprehension of information for informed consent: ethical implications for nursing research

Empirical studies on comprehension of information for informed consent show that research subjects often do not understand major portions of that to which they have consented. This raises the ethical question of whether or not the consent process has accomplished its purpose — the protection of the individual's right to self-determination. This article focuses on the following factors derived from the research literature that influence comprehension of information for informed consent: the nature of information, method of presentation of information, demographic factors, and personal factors. From these factors and methodological considerations, ethical implications for nursing research are addressed.     

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.     

Assessing the readability statistics of national consent forms in the UK

Introduction: When obtaining consent for an invasive procedure, the patient needs to understand what is happening to them in broad terms. Best medical practice advocates that written consent is given to acknowledge patient agreement. Across the UK, the Department of Health has provided standard consent forms for obtaining consent in all situations. Potentially these written sources of information may not be comprehended by patients and thus invalidate consent. Method: Consent forms were assessed by the Flesch readability and Flesch‐Kincaid grade formulae and compared with the national reading age, the recommended level for patient medical information, three newspaper articles and a journal article. Results: The consent forms have acceptable statistics [average Flesch readability 61.1 (range 57.2–66.1) and Flesch‐Kincaid grade 7 (range 6.3–8)]. This grade, however, is above the recommended level of patient health information (Flesch‐Kincaid grade 6). When the patient statements are isolated the reading statistics worsen [average Flesch readability 52.6 (range 41–62.6) and Flesch‐Kincaid grade 9.6 (range 7.9–11.1)]. Conclusion: Consent forms should be used as adjuncts to detailed conversations, describing what a procedure involves to ensure that a patient understands, in broad terms, what is happening to them. The patient’s statement section of the form may be being written at a level above patient comprehension currently and thus could invalidate any consent given. We would advocate a documented conversation with patients to ensure they have a broad understanding of the procedure and using the consent form as an adjunct to this discussion. The patient’s statement section should be re‐written to avoid invalidating consent.     

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.     

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.     

Research ethics, informed consent, and participant recruitment

PURPOSE/OBJECTIVES: This analysis explores ethical issues and challenges in participant recruitment. BACKGROUND/RATIONALE: The clinical nurse specialist (CNS) as researcher faces many issues and challenges, including ethical issues of informed consent. Balancing participant expectations of care with the research purpose is often challenging. DESCRIPTION OF THE ANALYSIS: This analysis synthesizes literature in key areas related to participant recruitment. Medline, CINAHL, and hand search techniques were used to collect relevant materials for this analysis. OUTCOMES: Key issues related to ethics and informed consent included readability of consent documents, education level, relationships between participants and health care providers, therapeutic misconception, and illness severity. Related issues include compensation of participants, recruitment of special populations, and the role of clinical research associate. INTERPRETATION/CONCLUSIONS: The CNS faces considerable ethical and logistical challenges in any research study. Strategies to support the CNS as researcher are available. IMPLICATIONS FOR NURSING PRACTICE: Increased awareness of ethical issues and challenges in recruitment is important for the CNS to creatively design strategies to enhance recruitment and retention in research studies.     

Using decision aids may improve informed consent for research

This commentary argues that the existing approach towards obtaining informed consent for clinical research may be improved by using decision aids. Problems with the current approach include i) an emphasis on documentation to the detriment of good quality decision-making; ii) ad hoc rather than theory-based research studying how to improve informed consent; and iii) a lack of clarity around what is meant by ‘comprehension’ and how to measure it. Decision aids, which clearly improve patient treatment decisions but are new to decisions surrounding study participation, have strengths in precisely the areas where the informed consent literature is weak. Decision aids facilitate a process of decision-making, combining clear documentation, exercises to facilitate decision-making, and consultation. They are increasingly informed by theory and clear, empirically-derived standards. Furthermore, decision aid research has clearly defined and operationalized three indicators of good quality decision-making in situations where there is no objectively correct answer: demonstrable knowledge of key aspects of the decision, accurate perceptions of the probabilities of various outcomes, and a match between preferred outcomes and the choice made. We identify outstanding issues and propose a research approach that will determine whether the use of decision aids can improve the informed consent process.     

How informed is informed consent? The BHAT experience

In the Beta-blocker Heart Attack Trial (BHAT) a number of strategies were implemented to increase the probability of informed voluntary consent among survivors of an acute myocardial infarction. To evaluate the subjects' comprehension of the study, a bioethicist conducted in-depth home interviews with a random sample of 64 participants from 11 geographic areas. The great majority of respondents proved to be well informed about the study design, its scientific logic, and possible risks of the experimental drug. However, five subjects (8% of the sample) appeared to believe they were involved in a therapeutic program rather than a research project. The analysis of predictor variables indicates that education, race, and age were associated with the degree of respondent awareness of fundamental aspects of the trial.     

Improvement of the comprehension of written information given to healthy volunteers in biomedical research: a single-blind randomized controlled study

Writing an informed consent form (ICF) for biomedical research is a difficult task. We conducted a multicenter single-blind randomized controlled trial to identify whether a working group or the systematic improvement in lexico-syntactic readability or an association of the two could increase the comprehension of the written information given to healthy volunteers enrolled in biomedical research. Participants were randomized to read one of four versions of the ICF: unchanged ICF (A), ICF with systematic lexico-syntactic readability improvement (B), ICF modified by a working group (C), and ICF modified by the working group followed by systematic lexico-syntactic improvement (D). The primary end-point was the objective comprehension score at day 0 for each study group. The scores of objective comprehension at day 0 were statistically different between the four study groups (anovaP = 0.020). The pairwise analysis showed an improvement in the working group vs. the unchanged group (P = 0.003), and a tendency to improvement in the group who read the ICF modified using lexico-syntactic readability and in the group who read the ICF modified using the two methods (P = 0.020 and 0.027 respectively). We conducted a two-way anova to identify some characteristics of the population which could explain this score. There was a significant interaction between the type of informed consent document (ICD) and the gender. Improving the ICD in phase I biomedical research leads to better comprehension, whether the method used is systematic lexico-syntactic improvement or a review by a working group. The improvement is specifically observed in men compared with women. Conversely, while both methods diverge in their effect on lexico-syntactic readability, their association is not mandatory. We suggest that in all phase I clinical trials, the ICF be improved by either method.     

Lack of standards in informed consent in complementary and alternative medicine

OBJECTIVES: To examine whether U.S.-based professional complementary and alternative medicine (CAM) organizations have explicit informed consent policies. DESIGN AND SETTING: Phone survey conducted in July-August 2003. RESULTS: Data were obtained from 37 out of a total of 39 eligible and accessible organizations representing 19 commonly used provider-administered CAM techniques (95% response rate.) Only 21 organizations (57%) had any informed consent policy and standards, whilst only six (16%) mandate their clinician members to routinely obtain an informed consent. CONCLUSIONS: We found no consistent standards with respect to the practice of informed consent across a broad range of CAM practices. CAM information that is not communicated appropriately or is otherwise unavailable to patients during the decision-making process may increase the potential for healthcare oversights and adversity.     

Evaluation of the ability of clinical research participants to comprehend informed consent form

BackgroundThe comprehension of informed consent is an integral part of clinical trials. Though India is rapidly becoming a hub of clinical trials very few studies have dealt with the issue of comprehension of informed consent by the patients participating in these trials.MethodsPatients who were invited to participate in a phase 3 multicentric trial of a novel lipid lowering agent were evaluated for comprehension score. The participants were explained about the structured consent form which included the question on background details for the study, design of the study, rights of the patients and miscellaneous aspects pertinent to the clinical trial. The questionnaire comprised of 24 items and each correct answer was assigned a score of 1. Total comprehension score (CS) was obtained by summing all the scores.ResultsParticipants were from diverse socio economic and educational backgrounds. The mean ± SD CS achieved by the participants was 13.4 ± 2.9; median 14(6 to 20). The highest correct responses were obtained for questions on background details (38%). For most of the categories the mean CS was more than 50%. Aspects related to design were mostly difficult to comprehend. No significant difference in the CS was noted between participants from different educational and socioeconomic groups. 8 patients refused to give consent, fear of adverse drug reactions (n = 3) and inability to follow up (n = 5) were the reasons cited by the patients.ConclusionIn conclusion, CS of patients in trials conducted in developing countries can be reasonably good if the investigators explain the consent form in simple language to the participants and CS is not related to the educational status of the participants. Moreover, though a larger majority of patients agree to participate after knowing study details, some patients exercise their right to refuse.     

How are we communicating about clinical trials?: An assessment of the content and readability of recruitment resources

Clinical trials (CTs) are important for advancing public health and medical research, however, CT recruitment is challenging. The high reading level of CT information and the technical language of providers or researchers can serve as barriers to recruitment. Prior studies on the informed consent process found that consent documents often contain complicated terms. Limited research has examined resources specifically used to recruit individuals into CTs. The purpose of this study was to examine the content and readability of CT recruitment education resources in one U.S. state. Convenience sampling was employed for the collection of CT recruitment materials. A codebook was developed based on previous content analyses and emergent themes from statewide focus groups about CTs. A total of 127 materials were collected and analyzed (37.8% print; 62.2% Web). Most content was focused on treatment-related CTs (60.6%). Inclusion criteria related to specific disease conditions (88.9%) and age (73.6%) were described most often. Only 30% of resources had an explicit call to action. Overall mean readability level was Grade 11.7. Web-based materials were significantly more likely to be written at a higher grade level than print materials (p ≤ .0001). Readability also differed significantly according to resource distributor/creator, CT type, person quoted, and presence or absence of inclusion criteria and an explicit call to action. Our study provides insight into the content and difficulty level of recruitment materials intended to provide initial information about a CT. Future studies should examine individuals’ comprehension of recruitment materials and how participation intentions are associated with recruitment messages.