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PubMedDate not supplied

Physician-investigator phone elicitation of consent in the field: a novel method to obtain explicit informed consent for prehospital clinical research.

OBJECTIVE: To describe and report the feasibility of a novel field telephonic strategy to elicit explicit informed consent in prehospital trials for conditions in which patients retain decision-making capacity. METHODS: In a pilot prehospital neuroprotective stroke therapy trial, ambulances carried written informed consent forms and dedicated trial cellular phones permitting rapid connection to on call physician-investigators. The physician-investigator discussed the trial with the consent provider [patient if competent, on scene legally authorized representative (LAR) if patient not competent] by phone, while paramedics carried out prehospital care duties unimpeded. RESULTS: 32 patients met consent elicitation criteria. 20 (63%) were enrolled. The most frequent reasons for non-enrollment were: patient not competent and no available on-scene LAR-5; patient/LAR declined participation-4. Among enrollees, 15 (75%) were competent and self-enrolled; 5 (25%) were not competent and were enrolled by LAR family members. Site of consent initiation was: patient home-15 (74 = 5%), work-2(10)%, other-3(15)%. Consent was elicited via cell phone in 11 (55%) and site landline in 9 (45%). Compared with patients enrolled in prior studies employing standard in-hospital consent, prehospital consent procedures reduced time from paramedic arrival on-scene to start of study agent (26 vs 139 mins, p < 0.0001), and did not prolong the on-scene to ED arrival time (37 vs 34 min, p = 0.50). No patient/family withdrew consent during the 3-month follow-up period. CONCLUSION: Physician phone elicitation of prehospital research consent from individuals with retained competency or on-scene legally authorized representatives is feasible, permits rapid patient study entry, and does not delay field transport times.

Biomedical Research↗
PubMed2004

Confronting the ethical challenges to informed consent in emergency medicine research.

The Society for Academic Emergency Medicine believes that protection of human subjects is vital in emergency medicine research and that, whenever feasible, informed consent is at the heart of that protection. At the same time, the emergency setting presents unique barriers to informed consent both because of the time frame in which the research is performed and because patients in the emergency department are a vulnerable population. This report reviews the concept of informed consent, empirical data on patients' cognitive abilities during an emergency, the federal rules allowing exemption from consent under certain circumstances, issues surrounding consent forms, and the new Health Insurance Portability and Accountability Act regulations as they relate to research. The authors conclude that, in many circumstances, informed consent is possible if the researcher is diligent and takes time to adequately explain the study to the potential subject. In cases in which it is possible to obtain consent, precautions must be taken to ensure that subjects have decision-making capacity and are offered time to have their questions answered and their needs met. Sometimes resuscitation and other emergency medicine research must be conducted without the ability to obtain consent. In these cases, special protections of subjects under the exception from consent guidelines must be followed. Protection of research subjects is the responsibility of every researcher in emergency medicine.

Emergency Medicine↗
PubMed2003

[Oral anticoagulation treatment--control, risks, benefits, and informed consent].

The most common indications for warfarin therapy are atrial fibrillation, the presence of a mechanical heart valve and venous thromboembolism. The risks and benefits of treatment for these conditions have been fairly well characterized and recent consensus groups have provided guidelines which are nearly identical. Although we can define the recommended range of the PT in INR units, it is often difficult under the best of circumstances to keep the INR in the desired range. Physicians often dont recognize the limitations of INR testing. Furthermore, the continued risk of thromboembolic and bleeding complications despite state of the art treatment might not be recognized by the patient. This places the physician at risk of a malpractice suit and emphasizes the need for informed consent. The following review will summarize current recommendations for the major conditions requiring long-term management with oral anticoagulants, identify problems with PT-INR testing, consider when the laboratory should contact the physician urgently, define acceptable control of the PT-INR during audits, and finally suggest information for the patient, which might be used in an informed consent form.

Administration, Oral↗
PubMed1999

Medical records and privacy: empirical effects of legislation.

OBJECTIVE: To determine the effects of state legislation requiring patient informed consent prior to medical record abstraction by external researchers for a specific study. DATA SOURCES/STUDY SETTING: Informed consent responses obtained from November 1997 through April 1998 from members of a Minnesota-based IPA model health plan. STUDY DESIGN: Descriptive case study of consent to gain access to medical records for a pharmaco-epidemiologic study of seizures associated with use of a pain medication that was conducted as part of the FDA's post-marketing safety surveillance program to evaluate adverse events associated with approved drugs. DATA COLLECTION: The informed consent process approved by an institutional review board consisted of three phases: (1) a letter from the health plan's medical director requesting participation, (2) a second mailing to nonrespondents, and (3) a follow-up telephone call to nonrespondents. PRINCIPAL FINDINGS: Of 140 Minnesota health plan members asked to participate in the medical records study, 52 percent (73) responded and 19 percent (26) returned a signed consent form authorizing access to their records for the study. For 132 study subjects enrolled in five other health plans in states where study-specific consent was not required, health care providers granted access to patient medical records for 93 percent (123) of the members. CONCLUSION: Legislation requiring patient informed consent to gain access to medical records for a specific research study was associated with low participation and increased time to complete that observational study. Efforts to protect patient privacy may come into conflict with the ability to produce timely and valid research to safeguard and improve public health.

Cohort Studies↗
PubMed1978

New sterilization regs lengthen waiting time to 30 days.

New sterilization regulations lengthen waiting time to 30 days, from the previous 72 hours required by regulations issued in 1974. Department of Health, Education, and Welfare (HEW) Secretary Califano said the regulations "strictly" limit the se of federal funds "to sterilizations for individuals who knowingly and freely consent to them and prohibit HEW funding of coerced and uninformed sterilizations or of sterilizations based on hasty decisions." Califano said th compliance with the regulations will be rigidly monitored and that HEW is instituting a bilingual education program to make certain they are understood. The new regulations include a detailed HEW-approved consent form requiring certification by medical personnel that the patient has received, both in writing and orally, an explanation of the operation, advice about alternate forms of birth control, and assurances that no federal benefits will be lost if sterilization is refused. The 30-day waiting period between the time consent is given and the operation is performed can be waived in cases of premature delivery and emergency abdominal surgery. To reduce chances of the operation being chosen under duress, consent cannot be obtained from anyone in labor, under the influence of alcohol or other drugs, or seeking or obtaining an abortion. Interpreters must be provided where language barriers exist and special arrangements are required for handicapped persons. Funds cannot be provided for hysterectomies performed for sterilization purposes. Patients undergoing hysterectomies for medical reasons must be advised orally and in writing that sterilization will result. The new regulations, to take effect in 90 days, also eliminate the distinction between therapeutic and nontherapeutic sterilization and provide that safeguards be applied uniformly to all federally funded sterilizations. Sterilization funding will not be available for prisoners or those confined to mental hospitals or other rehabilitative facilities. The prohibition against using federal funds for sterilization of mentally incompetent persons and those under 21 years of age continues.

Americas↗
PubMedDate not supplied

Linking survey data with administrative health information: characteristics associated with consent from a neonatal intensive care unit follow-up study.

BACKGROUND: Health services and population health research often depends on the ready availability of administrative health data. However, the linkage of survey-based data to administrative data for health research purposes has raised concerns about privacy. Our aim was to compare consent rates to data linkage in two samples of caregivers and describe characteristics associated with consenters. METHODS: Subjects included caregivers of children admitted at birth to neonatal intensive care units (NICU) in British Columbia and caregivers of a sample of healthy children. Caregivers were asked to sign a consent form enabling researchers to link the survey information with theirs and their child's provincially collected health records. Bivariate analysis identified sample characteristics associated with consent. These were entered into logistic regression models. RESULTS: The sample included 1,140 of 2,221 NICU children and 393 of 718 healthy children. The overall response rate was 55% and the response rate for located families was 67.1%. Consent to data linkage with the child data was given by 71.6% of respondents and with caregiver data by 67% of respondents. Families of healthy children were as likely to provide consent as families of NICU children. Higher rates of consent were associated with being a biological parent, not requiring survey reminders, involvement in a parent support group, not working full-time, having less healthy children, multiple births and higher income. CONCLUSION: The level of consent achieved suggests that when given a choice, most people are willing to permit researcher access to their personal health information for research purposes. There is scope for educating the public about the nature and importance of research that combines survey and administrative data to address important health questions.

British Columbia↗
PubMed2004

Neonatal research and the validity of informed consent obtained in the perinatal period.

BACKGROUND: Consent for participation in clinical research is considered valid if it is informed, understood, and voluntary. In the case of minors, parents give permission for their child to participate in research studies after being presented with all information needed to make an informed decision. Although informed consent is a vital component of clinical research, there is little information evaluating its validity in neonatal intensive-care populations. The objective of this project was to determine the validity of informed consent obtained from parents of infants enrolled in the multicenter randomized research study, neurologic outcomes and pre-emptive analgesia in the neonate (NEOPAIN). DESIGN/METHODS: Parents of infants who survived to discharge and had signed consent for their newborn to participate in the NEOPAIN study at the University of Kentucky were asked 20 open-ended questions to determine their level of understanding about the NEOPAIN study. The NEOPAIN consent form, which had been approved by the University of Kentucky Medical Institutional Review Board (IRB), was used to formulate these questions. Questions addressed the timing of consent, parental understanding of the purpose, benefits, and risks of the study, the voluntary nature of the project, and their willingness to enroll in future studies if the opportunity presented. Answers were scored on a Likert scale, with 1 for no understanding and 5 for complete understanding. RESULTS: Five of 64 parents (7.8%) had no recollection of the NEOPAIN study or of signing consent. Of those who remembered the study, only 67.8% understood the purpose of the study, with a higher proportion of the mothers than fathers knowing the purpose of the study (73.3% vs 57.1%), (p=0.029). Of those who understood the purpose of the study 95% were able to verbalize the benefits, but only 5% understood any potential risks. No parents reported feeling pressured or coerced to sign consent for the project and all parents reported they would enroll their child in additional studies if asked. CONCLUSIONS: Valid consent in the antenatal/perinatal population is difficult, if not impossible, to obtain. To maximize validity of consent in the antenatal/perinatal population every effort should be made to include mothers in the consent process. Additional attention during the consent process should be given to possible risks of the study.

Adult↗
PubMed2005

[The process of consent in clinical trials: from elaboration to accomplishment].

The consent form is a document recommended for international declarations, resolutions and specific laws currently used in research on health. The practice or the accomplishment of the informed consent in the exercise of the medicine and the research in human beings is pertains to the last decades and characterizes the perfectioning of biomedical ethics, constitutes a legal and ethical requirement in clinical research involving human beings. The main challenge of the consent process is to guarantee the adequate understanding of the individual, however the social, cultural and intellectual aspects as well as the relationship between physician and patient, sometimes, can affect this process. The purpose of this paper is to present important criteria in the consent process that need to be highlighted in accordance with specific tenets and resolutions, such as Resolution 196/96 of the National Council of Health.

Biomedical Research↗
PubMed2006

[Effects of video information in patients undergoing coronary angiography].

BACKGROUND: informed consent is a fundamental and legal obligation for each interventional cardiologist. The effect of consent form describing risks of invasive procedure on anxiety is controversial. This trial was aimed to assess the added value of video information to the standard informed consent process. METHODS: 200 consecutive patients undergoing coronary angiography were enrolled. The first one hundred were assigned to conventional education conducted by the physician (no video group) and the second one hundred had consent obtained in the conventional manner assisted by video information (video group). The outcome variables for this comparison consisted of a standard anxiety score (Spielberger Statement Anxiety Inventory questionnary) plus hemodynamics measurements of heart rate, systolic and diastolic blood pressure obtained at baseline and immediately after written informed consent In addition, before discharge, patients graded the tolerability and satisfaction on a 4-point scale. RESULTS: The groups were similar with regard to their baseline characteristics and anxity score (37+23 vs 37+23). Patients who had not had prior experience of catheterization had higher baseline anxiety than those who had prior angiography (45 + 22 vs 31 + 20; p = 0.027). Patients who watched the video were significantly less anxious after informed consent (28 + 21 vs 34 + 22; p = 0.048) and had a significantly lower heart rate (65 + 10 vs 71 + 12; p = 0.03). The benefits of video information were especially prominent in those with higher anxiety scores at baseline (score after 45 + 24 vs 57 + 26; p = 0.046). Tolerability were higher in the video group compared with no video group (98% vs 86%; p = 0.003). Finally, satisfaction of information for informed consent process was higher in video group than in no video group (99% vs 76%; p = 0.001). CONCLUSION: a video information decreased anxiety level after written informed consent and improved tolerability and satisfaction scales in patients undergoing coronary angiography. The most likely to benefit from video information are patients with higher anxiety level at baseline. Beneficial effect on informed refusal should be investigated in larger population.

Adaptation, Psychological↗
PubMed2003

Informed consent for medical procedures: local and national practices.

BACKGROUND: No studies have assessed whether clinicians obtain informed consent for invasive medical procedures, and there are no explicit national standards to guide the process. HYPOTHESIS: Informed consent practices are inconsistent for commonly performed invasive medical procedures. METHODS: A simple questionnaire was electronically mailed and/or faxed to training program directors of critical care medicine and internal medicine departments, and to ICU directors in the state of Connecticut. The questionnaire listed common invasive medical procedures and asked the respondents to check those for which practitioners routinely obtain informed consent in their hospital. RESULTS: The three samples, national intensivists (88 respondents), Connecticut intensivists (29 respondents), and national internists (56 respondents) demonstrated heterogeneity of consenting practices. The rate of obtaining consent for common vascular access procedures ranged from 20 to 90%. The rates of obtaining consent for Foley catheterization and nasogastric intubation were uniformly < 10%, and those for endoscopic procedures were > 90%. Separate consent (beyond the general consent to treat) was not uniformly obtained for the transfusion of blood products (range, 74 to 93%) and common diagnostic medical procedures (eg, thoracentesis, paracentesis, or lumbar puncture; range, 77 to 96%). Surgical intensivists reported that the obtaining of consent for invasive procedures was less routine compared to medical intensivists. Lower rates of consent were noted by those respondents who used a "blanket" consent form, which was signed at the time of hospital admission, to cover subsequent procedures. CONCLUSIONS: In this relatively small sample, there was no uniform practice of informed consent for commonly performed invasive medical procedures. Consent was routinely obtained for GI endoscopy, bronchoscopy, and medical research, and was not obtained for Foley catheterization and nasogastric intubation. The obtaining of consent for vascular cannulation and diagnostic procedures was not routine in the ICUs of a substantial number of respondents. Explicit standards that delineate specifically which procedures require consent may be required to assure more uniform practices.

Connecticut↗
PubMedDate not supplied

[Informed consent in health legislation of Mexico].

This paper deals with informed consent in Mexican Health Legislation in the context of a contract regulated by the Mexican Civil Code, in which a patient capable of making a thoughtful decision agrees to a specific plan of medical management and has received sufficient information, in a clear and explicit manner so that he/she can make a decision and in consequence agrees, or does not agree, to a course of action and to its consequences, under the Nuremberg Code. In Mexico, informed consent has recently been incorporated into health care legislation, and is basically oriented toward the field of medical research, while in other medical procedures, a legal authorization, and not an informed consent form is required, as with surgical procedures such as definitive fertility control (e.g. vasectomy or fallopian tube ligation). We emphasize the necessity of the adding of informed consent to Mexican health legislation in general, substituting it for other terms to legalize medical action, such as authorization, permission, dispositioned compliance, acceptance or approval-all of which have an essentially different and limited connotation, and are not Patient's Rights legal protector mechanisms, from our point of view.

Informed Consent↗
PubMed2005

'Even if they ask you to stand by a tree all day, you will have to do it (laughter)...!': community voices on the notion and practice of informed consent for biomedical research in developing countries.

Ethical dilemmas in biomedical research, especially in vulnerable populations, often spark heated debate. Despite recommendations and guidelines, many issues remain controversial, including the relevance, prioritisation and application of individual voluntary informed consent in non-Western settings. The voices of the people likely to be the subjects of research have been notably absent from the debate. We held discussions with groups of community members living in the rural study area of a large research unit in Kenya. Discussions were facilitated by three research study vignettes outlining one field-based and two hospital-based studies being planned or taking place at the time. In addition to gathering general views about the aims and activities of the research unit, questions focused on whether consent should be sought for studies, and if so from whom (chiefs, elders, men/women, children), and on ascertaining whether there are any special concerns about the physical act of signing consent forms. The findings revealed the community's difficulty in distinguishing research from clinical investigations conducted in clinical settings. There was a spectrum of views regarding perceived appropriateness of consent procedures, in part because of difficulty in disentangling clinical from research aims, and because of other challenges to applying consent in practice. Debates between community members highlight the inadequacy of simplistic assumptions about community members' views on informed consent, and the complexity of incorporating lay opinions into biomedical research. Failure to appreciate these issues risks exaggerating differences between settings, and underestimating the time and resources required to ensure meaningful community involvement in research processes. Ultimately, it risks inadequately responding to the needs and values of those on whom the success of most biomedical research depends. Although compliance with community views does not necessarily make the research more ethical, it is argued that community opinions on local issues and practices should inform ethical decision-making in health research.

Biomedical Research↗
PubMed2005

Information, consent and perceived coercion: patients' perspectives on electroconvulsive therapy.

BACKGROUND: Electroconvulsive therapy (ECT) is a procedure that attracts special safeguards under common law for voluntary patients and under both current and proposed mental health legislation, for those receiving compulsory treatment. AIMS: To review patients' views on issues of information, consent and perceived coercion. METHOD: Seventeen papers and reports were identified that dealt with patients' views on information and consent in relation to ECT; 134 'testimonies' or first-hand accounts were identified. The papers and reports were subjected to a descriptive systematic review. The testimony data were analysed qualitatively. RESULTS: Approximately half the patients reported that they had received sufficient information about ECT and side-effects. Approximately a third did not feel they had freely consented to ECT even when they had signed a consent form. Clinician-led research evaluates these findings to mean that patients trust their doctors, whereas user-led work evaluates similar findings as showing inadequacies in informed consent. CONCLUSION: Neither current nor proposed safeguards for patients are sufficient to ensure informed consent with respect to ECT, at least in England and Wales.

Electroconvulsive Therapy↗
PubMedDate not supplied

Recruitment of subjects for clinical trials after informed consent: does gender and educational status make a difference?

CONTEXT: Researchers and investigators have argued that getting fully informed written consent may not be possible in the developing countries where illiteracy is widespread. AIMS: To determine the percentage of patients who agree to participate in a trial after receiving either complete or partial information regarding a trial and to find out whether there were gender or educational status-related differences. To assess reasons for consenting or refusing and their depth of understanding of informed consent. SETTINGS AND DESIGN: A simulated clinical trial in two tertiary health care facilities on in-patients. METHODS AND MATERIAL: An informed consent form for a mock clinical trial of a drug was prepared. The detailed / partial procedure was explained to a purposive sample of selected in-patients and their consent was asked for. Patients were asked to free list the reasons for giving or withholding consent. Their depth of understanding was assessed using a questionnaire. Chi-square test was used for statistical analyses. RESULTS: The percentages of those consenting after full disclosure 29/102 (30%) and after partial disclosure 15/50 (30%) were the same. There was a significant (p=0.043) gender difference with a lesser percentage of females (30%) consenting to participation in a trial. Educational status did not alter this percentage. Most patients withheld consent because they did not want to give blood or take a new drug. Understanding of informed consent was poor in those who consented. CONCLUSIONS: The fact that only one-third of subjects are likely to give consent to participate in a trial needs to be considered while planning clinical trials with a large sample size. Gender but not educational status influences the number of subjects consenting for a study. Poor understanding of the elements of informed consent in patients necessitates evolving better methods of implementing consent procedures in India.

Adult↗
PubMed2001

Preimplantation genetic diagnosis (PGD), a collaborative activity of clinical genetic departments and IVF centres.

Preimplantation genetic diagnosis (PGD) requires the combined efforts of geneticists and workers in the field of reproductive medicine. This was studied on the basis of a questionnaire, sent to 35 members of the PGD Consortium of the European Society of Human Reproduction and Embryology (ESHRE). A reply was obtained from 20 centres. They represent the majority of activities in the field of PGD in the world. It is obvious that many of the activities (in vitro fertilisation, embryo culture and biopsy) take place in IVF units while others (counselling and diagnosis) are the responsibility of genetic diagnostic centres. The distances between both units vary considerably. In all but one centre sex determination is offered. Aneuploidy screening is offered in 13 out of 20 centres. PGD of translocations and other structural chromosome abnormalities is offered in all but one centre. The number of monogenic diseases offered varies considerably. In comparison to prenatal diagnosis PGD is more expensive. The majority of these costs are due to the IVF or ICSI procedure. The charges for PGD vary between about 600 euro and 4000 euro. In 16 out of 20 centres the parents to be must sign an informed consent form.

Aneuploidy↗
PubMed1998

A school-based Chlamydia control program using DNA amplification technology.

OBJECTIVES: Chlamydia trachomatis is the most prevalent bacterial sexually transmitted disease (STD) in the United States, with the highest rates reported among adolescents. Chlamydia has severe consequences including pelvic inflammatory disease and infertility, and is believed to be a cofactor in human immunodeficiency virus transmission. Given that chlamydia is predominantly asymptomatic, most cases are identified through routine screening in health care settings. Over time, screening and treatment appear to be associated with a decrease in the prevalence of disease in areas with consistent chlamydia control programs. The new availability of sensitive and specific urine tests for chlamydia (polymerase chain reaction [PCR] and ligase chain reaction [LCR]) provides the opportunity to screen large numbers of at-risk youth in a noninvasive manner. We used PCR/LCR testing to investigate the feasibility of a school-based chlamydia control program and to determine the prevalence of chlamydia infection among junior and senior high school students. DESIGN: At three junior/senior high schools, all students, regardless of symptoms or sexual history, were given the opportunity to be tested for chlamydia using urine-based PCR or LCR testing. Only students with parental consent were eligible. Parents could not obtain test results, except if their children told them. During the five 3-week testing periods, throughout the day, classes were escorted to the testing area and each student was individually counseled regarding the opportunity to participate in the testing. SETTING: Three urban public schools in Louisiana. PARTICIPANTS: A total of 1933 students in grades 7 through 12, including 861 girls and 1072 boys. INTERVENTION: All students were informed about the test and taught about chlamydia during the homeroom period. Students were asked to provide a first-void urine specimen of not more than 30 mL. Specimens were refrigerated and delivered to the laboratory on the same day. Infected students were counseled and offered treatment with azithromycin, 1 g orally. They were also referred for or offered additional STD and human immunodeficiency virus testing. Infected students were asked to refer their sex partners to the city STD clinic for treatment. MAIN OUTCOME MEASURE: Prevalence of C trachomatis infection by grade and gender. RESULTS: Parental consent was obtained for 2849 (86.9%) of the 3278 matriculated students in grades 7 through 12. Fifty-one parents (1.6%) returned consent forms refusing permission for their child to participate in this screening and treatment program. The remaining 378 (11.5%) could not be reached by mail or telephone. Among all students with consent, 1933 (67.8% of those consented and 59.0% of those matriculated) were tested. Girls were less likely to be tested than boys (861/1363 [63. 2%] vs 1072/1465 [73.2%]). The overall prevalence of C trachomatis was 6.5%, with rates among girls more than twice that of boys (9.7% vs 4.0%). Generally, rates of infection increased with age. The prevalence rates among boys were for 7th grade, 2/208 (1%); 8th grade, 2/196 (2%); 9th grade, 10/236 (4.2%); 10th grade, 12/185 (6. 5%); 11th grade, 8/146 (5.5%); and 12th grade, 9/101 (8.9%). For boys 15 to 19 year old, the prevalence of chlamydia was 5.7%. Among girls, the prevalence rates were 7th grade, 0/105 (0%); 8th grade, 11/166 (6.6%); 9th grade, 23/218 (10.6%); 10th grade 23/146 (15.8%); 11th grade, 13/118 (11%); and 12th grade, 13/107 (12.1%). Among girls 15 to 19 years old, 12.7% were infected. Of 126 infected students, treatment was provided to 111 (88%). For this project, the laboratory cost of LCR testing was $17.76 per test. Without considering clinical staff time to collect the specimens, the average laboratory cost per infected student identified was $272. For students 15 to 19 years of age, of whom 104 (8.9%) of 1170 were infected, the laboratory cost was $200 per case identified. CONCLUSION: (ABSTRACT TRUNCATED)

Adolescent↗
PubMed1999

Informed consent documents for BRCA1 and BRCA2 screening: how large is the readability gap?

The decision to undergo testing for the BRCA1 and BRCA2 mutations, which are associated with an increased risk of breast and ovarian cancer, can have long-term consequences on women's lives. Women who decide to undergo such testing are required to sign informed consent documents, which indicate that they understand the test and its risks and benefits. These documents are generally written for advanced-level readers. However, the reading abilities of many women are substantially lower than the level of the consent forms, resulting in a 'readability gap'. This disparity suggests that women may not fully understand the documents they are asked to sign. The 'readability gap' poses the serious issues about informed consent, raising questions about institutional review boards and the effectiveness of the documents that are currently in use.

Adolescent↗