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.     

Assessing readability and comprehension of informed consent materials for medical device research: A survey of informed consents from FDA's Center for Devices and Radiological Health

Legally effective informed consent has been a long-standing requirement for FDA-regulated clinical studies. However, informed consent forms (ICFs) are often thought to be too long, too complex, and too difficult for participants to understand. In this article, investigators from the FDAs Center for Devices and Radiological Health (CDRH) surveyed 399 ICFs from approved investigational device exemption (IDE) applications for fiscal years 2015 and 2016 to evaluate the readability of ICFs.The investigators collected data from the ICFs, using variables related to structure, readability, and comprehension.The investigators found that the mean grade-reading levels of the ICFs ranged from 10th grade to college level (Table 2), higher than the recommended 6th to 8th grade level, when measured by major readability evaluation tools (the SMOG readability grade level formula, the Flesch-Kincaid Index Grade Level Readability Formula, the Flesch Reading Ease test, and the Dale-Chall readability formula).Overall, the ICFs and informed consent (IC) processes, as described in the IDE application, lacked components that enhanced participants' comprehension, such as short sentences (e.g., no more than 8 to 10 to words) and the use of pictures, tables, and diagrams.CDRH investigators believe that information about ICFs' readability, comprehension, and structure will help support current and future efforts to improve the IC process. The intent of the article is to demonstrate that improvements are needed in the IC process and to encourage clinical trial stakeholders to consider implementing those approaches that optimize patient comprehension in the development of their IC processes.     

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.     

Structure and Practice of Institutional Review Boards in the United States

Objective: The institutional review board (IRB) is a critical element in the protection of patients' and subjects' rights with regard to their participation in research protocols. The purpose of this study was to describe the structure and current practices of IRBs in the United States.
Methods: A self-administered questionnaire was mailed to the IRB chair of each U.S. hospital with a capacity of at least 400 beds (n = 907). The survey contained 21 questions outlining committee size and structure, review of research proposals, and policies concerning scientific misconduct. Chairs also were asked what advice they would offer a young investigator preparing a proposal for submission.
Results: A total of 488 surveys (54%) were returned; 447 of the responding institutions had an IRB committee. Committees had an average of 14 members, representing 27 medical specialties. Orthopedics had the least IRB representation (10% of committees), followed by emergency medicine (12%) and ophthalmology (15%). The majority of research proposals go through 5 specific steps once submitted for review. Common reasons for proposal rejection were improperly designed consent form (54%), poor study design (44%), unacceptable risk to subjects (34%), ethical or legal reasons (24%). and scientific merit (14%). When a research proposal is rejected, 86% of the responding IRBs assist the investigator in making appropriate revisions. Although a number of IRBs (17%) have dealt with scientific misconduct allegations, only 58% have a written policy regarding research integrity.
Conclusion: Despite variations in committee structure and representation, IRBs have similar procedures for governing research. Investigators should be familiar with these procedures and are encouraged to discuss their proposal with an IRB representative prior to formal review.     

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.     

Parental Consent and Adolescent Risk Behavior Research

Purpose: To identify methodological issues related to the use of active or passive parental consent in school-based research on adolescent risk behavior research and to propose recommendations consistent with current legal and ethical standards in the United States.
Methods: Review and synthesis of the professional literature related to adolescents and parental consent, federal regulations and guidelines in the United States, and the author's experience presenting these arguments and issues to institutional review boards and funding agencies for over 10 years.
Findings: The procedures used for parental consent affect a study's participation rates, costs, and selection bias. When active parental consent is required, parental permission is typically obtained for only 30%–60% of students, compared to 93%–100% when passive consent is used. Extensive follow-up may result in 55%–100% of parents giving permission, but at significant cost (typically $20–$25 per student). Active consent results in the exclusion of minorities, students having problems in school, and students already engaged in or at risk for problem behaviors. Strong methodological reasons were identified for using passive parental consent procedures when possible. Current federal regulations include four areas for possible waiver or alterations in parental consent procedures, including the use of passive parental consent.
Conclusions: Health researchers must understand the methodological, legal, and ethical issues related to parental consent to produce high-quality, valid research about adolescents and to provide evidence for laws, policies, and regulations.     

Variation in Institutional Review Board Responses to a Standard Protocol for a Multicenter Clinical Trial

Multicenter clinical trials require approval by multiple local institutional review boards (IRBs). The Multicenter Airway Research Collaboration mailed a clinical trial protocol to its U.S. investigators and 44 IRBs ultimately reviewed it. OBJECTIVE: To describe IRB responses to one standard protocol and thereby gain insight into the advantages and disadvantages of local IRB review. METHODS: Two surveys were mailed to participants, with telephone follow-up of nonrespondents. Survey 1 was mailed to 82 investigators across North AMERICA: Survey 2 was mailed to investigators from 44 medical centers in 17 U.S. states. Survey 1 asked about each investigator's local IRB (e.g., frequency of meetings, membership), whereas survey 2 asked about IRB queries and concerns related to the submitted clinical trial. RESULTS: Both surveys had 100% response rate. Investigators submitted applications a median of 58 days (interquartile range [IQR], 40--83) after receipt of the protocol, and IRB approval took an additional 38 days (IQR, 26--62). Although eight applications were approved with little or no changes, IRBs requested an average of 3.5 changes per site. Changes involved study logistics and supervision for 45%, the research process for 43%, and the consent form for 91%. Despite these numerous requests, all eventually approved the basic protocol, including inclusion criteria, intervention, and data collection. CONCLUSIONS: The IRBs showed extreme variability in their initial responses to a standard protocol, but ultimately all gave approval. Almost all IRBs changed the consent form. A national, multicenter IRB process might streamline ethical review and warrants further consideration.     

Informed Consent for Research: Current Practices in Academic Emergency Medicine

Background:  The emergency department (ED) environment presents unique barriers to the process of obtaining informed consent for research.
Objectives:  The objective was to identify commonalities and differences in informed consent practices for research employed in academic EDs.
Methods:  Between July 1, 2006, and June 30, 2007, an online survey was sent to the research directors of 142 academic emergency medicine (EM) residency training programs identified through the Accreditation Council for Graduate Medical Education (ACGME).
Results:  Seventy-one (50%) responded. The average number of simultaneous clinical ED-based research projects reported was 7.3 (95% confidence interval [CI] = 5.53 to 9.07). Almost half (49.3%) of respondents reported that EM residents are responsible for obtaining consent. Twenty-nine (41.4%) participating institutions do not require documentation of an individual resident's knowledge of the specific research protocol and consent procedure before he or she is allowed to obtain consent from research subjects.
Conclusions:  It is common practice in academic EDs for clinical investigators to rely on on-duty health care personnel to obtain research informed consent from potential research subjects. This practice raises questions regarding the sufficiency of the information received by research subjects, and further study is needed to determine the compliance of this consent process with federal guidelines.     

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.     

Implementation of community consultation for waiver of informed consent in emergency research: one Institutional Review Board's experience.

BACKGROUND: This article describes how one Institutional Review Board (IRB) chose to implement the issue of waiver of consent for a research study involving brain trauma victims brought to an emergency department. METHODS: Presentations were conducted in the state of Mississippi among cultural and ethnic groups representative of Mississippi's demographic composition. Individuals from the neurotrauma research team, including neurosurgeons and nurse study coordinators, conducted all of the presentations. One IRB member served as an objective "community liaison" and attended all presentations. This individual administered evaluation forms to attendees that measured their levels of comprehension and acceptance for the use of waiver of consent in the brain trauma study. RESULTS: All of the 137 attendees in 7 community consultation meetings gave their approval for the use of "waiver of consent." Continued community consultations are planned for the duration of the brain trauma study. CONCLUSION: Based on our experience, we conclude that in collaborating with local IRBs, research teams can successfully develop strategies for obtaining "acceptable community consultations" as required by regulatory mandates. We suggest that standardized community consultation guidelines be developed for obtaining waivers of informed consent in emergency research. Such criteria should form the basis for local IRBs to obtain their respective community consultations.     

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.     

Literacy in the health care system: a study on open heart surgery patients

PURPOSE: To determine if patients recovering from open heart surgery were able to read and understand written discharge instructions and further to analyze the level of difficulty of standard discharge instructions and consent forms for open heart surgery. DATA SOURCES: After screening for visual acuity and efficiency, literacy was assessed with the Rapid Estimate of Adult Literacy in Medicine test (REALM) and comprehension was tested by a post-test of five questions based on the discharge instructions. Flesch-Kincaid scores were calculated on four sets of standard written discharge instructions and consent forms. CONCLUSIONS: Results from the study indicated that the REALM test was more accurate than the reported grade level and that reading skills are needed to understand and comprehend information needed for post-operative care. The study further substantiated that health care facilities are not providing written instructional material that is within the reading level of the patient. IMPLICATIONS FOR PRACTICE: Illiteracy can have a major impact in the health care system. Low reading skills can disempower and can prove to be costly for patients who are requiring health care services. Further investigation is needed on the impact of patients' reading skills on the health care system.     

The subjective incremental cost of informed consent and documentation in hospital care: a multicentre questionnaire survey in Japan

Objective  To reveal the amount of time and financial cost required to obtain informed consent and to preserve documentation.
Methods  The questionnaire was delivered to all staff in six acute care public hospitals in Japan. We examined health care staff perceptions of the time they spent obtaining informed consent and documenting information. All data were collected in 2006 and estimates in the past week in 2006 were compared to estimates of time spent in a week in 1999. We also calculated the economic costs of incremental amounts of time spent in these procedures.
Results  In 2006, health care staff took about 3.89 hours [95% Confidence Interval (CI) 3.71–4.07] per week to obtain informed consent and 6.64 hours (95% CI 6.40–6.88) per week to write documentation on average. Between 1999 and 2006, the average amount of time for conducting informed consent was increased to 0.67 ( P  < 0.001) hours per person-week, and the average amount of time for documentation was increased to 0.70 ( P  < 0.001) hours per person-week. The annual economic cost of activities for informed consent and documentation in a 100-bed hospital increased from 117 755 to 449 402 US dollars.
Conclusions  We found a considerable increase in time spent on informed consent and documentation, and associated cost over a 7-year time period. Although greater attention to the informed consent process should be paid to ensure the notions of patient autonomy and self-determination, the increased resources devoted to these practices must be considered in light of current cost containment policies.     

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.     

Conducting research using the emergency exception from informed consent: the Public Access Defibrillation (PAD) Trial experience

BACKGROUND: The Public Access Defibrillation (PAD) Trial, a prospective, multicenter, randomized clinical trial comparing two prehospital resuscitation strategies, was conducted under the regulations for exception from informed consent (21CFR50.24) in 24 communities in North America. These regulations place additional requirements for human subject protection on investigators and Institutional Review Boards (IRBs), including conducting community consultation (CC) and public disclosure (PD). OBJECTIVE: To describe the IRB approval process at study sites and the number and types of community consultation and public disclosure activities conducted. METHODS: The 24 study sites in the United States and Canada submitted IRB applications, CC and PD plans, and a structured report on IRB process and investigator perceptions to the Clinical Trial Center at the University of Washington. RESULTS: The primary IRBs for all 24 trial sites and a total of 101 IRBs approved the study. The median interval from submission to approval was 108 days (IQR 43-196), and the mean number of revisions was two (range 0-7). Investigators conducted nearly 12,000 activities to achieve CC and PD; activities varied greatly from site to site in both type and quantity. CONCLUSION: The length of time to obtain IRB approval and the extent of community consultation and public disclosure varied greatly among trial sites in meeting the current regulations for conducting emergency research with exception from informed consent. This suggests that more specific guidance may be useful and that determination of effective strategies for community consultation and public disclosure is needed.     

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.     

A Truncated E-code System for Injury Surveillance in the Emergency Department: Description and Clinometric Testing

Objectives: ED injury surveillance requires accurate information about mechanism. This study explored the clinometric properties of an E-code system specifically designed to track ED injuries.
Methods: All patients assessed in the ED had cause-of-injury information documented using a truncated E-code system. Patient records were hand-searched to determine coding compliance. A selection of 98 charts (50 injury/48 noninjury) were coded by 7 physicians, 2 nurses, and 2 nosologists. Agreements (interrater and intrarater) on the diagnosis of trauma and exact E-codes were determined (using kappa; κ).
Results: E-coding compliance was high (overall 90%: 95% CI: 85–93%), and accuracy of injury classification was 99%. Compared with an expert's coding, agreement on injury classification was excellent for physicians (κ = 0.91; 95% CI: 0.80–1.0), nurses (κ = 0.88; 95% CI: 0.75–1.0), and nosologists (κ = 0.92; 95% CI: 0.81–1.0). Agreement was substantial for the exact E-codes between physicians (κ = 0.77; 95% CI: 0.60- 0.94) and nurses (κ = 0.72; 95% CI: 0.54–0.90). Recode reliability was also excellent for physicians (κ = 0.88; 95% CI: 0.75–1.0) and nurses (κ = 0.96; 95% CI: 0.88–1.0).
Conclusions: Injury coding using a truncated E-code system can provide valid and reliable data from the ED. Differences between nurses, physicians, and nosologists in the ability to accurately code using this system were minimal, thus eliminating the need for additional staff and resources.     

A brief educational intervention may increase public acceptance of emergency research without consent

Objectives: We hypothesized that knowing the regulations regarding emergency research without consent would increase public support for this type of research. Methods: Randomized controlled trial. Consecutive patients presenting during eight 24-h periods received one of two interviews; the intervention interview included an educational paragraph. Results: There were 473 (74% of eligible) patients who participated: 51% (95% confidence interval [CI] 46–55) were willing to be enrolled in a study using exception to informed consent; 84% (95% CI 80–87) believed that current therapy for cardiac arrest offers ≥ 50% chance of full recovery, and these patients were less willing to enroll (odds ratio [OR] 0.5, 95% CI 0.3–0.9). The educational intervention increased willingness to enroll (OR 1.3, 95% CI 1.0–1.6, p = 0.03). Conclusions: A brief educational intervention had only a modest effect on willingness to participate in emergency research without consent. It may be more important to educate patients on the shortcomings of current therapy than on the ethical and regulatory justifications for such research.