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PubMed2006

Does waiver of written informed consent from the institutional review board affect response rate in a low-risk research study?

BACKGROUND: Requiring written informed consent for a minimal-risk survey may result in limited participation rates. METHODS: Data from a cross-sectional survey of 177 older patients (87 blacks and 90 whites) with hypertension enrolled in the managed care Medicare risk product were used to assess participation rates pre- and postwaiver of written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization. Prior to the waivers being granted, patients were contacted two times via mail with an introductory letter and an informed consent document. Those who completed and returned the informed consent document were administered the questionnaire. After 6 weeks, a waiver of written informed consent and HIPAA authorization was obtained from the Institutional Review Board. Nonparticipants were reapproached and asked to complete the questionnaire. Participation rates were recorded before and after receiving the waivers. RESULTS: Participation rates increased from 21.5% in the prewaiver period to 57.4% in the postwaiver period (p < .001). Prewaiver participation differed by demographic subgroup and was higher among whites (26.7%) versus blacks (16.1%; p = .087), men (31.6%) versus women (16.7%; p = .024), and participants > or = 75 years old (28.4%) versus < 75 years old (14.6%; p = .025). In contrast, the postwaiver participation rate did not differ significantly across race, gender, or age subgroupings. Significant increases in participation rates from the pre- to the postwaiver time period were noted within each demographic subgroup (all p < .01). CONCLUSIONS: We identified a substantial increase in participation rates postwaiver of written informed consent and HIPAA authorization in a minimal-risk survey. The need for written documentation for minimal-risk surveys may negatively impact recruitment of blacks, women, and patients < 75 years old.

Cross-Sectional Studies↗
PubMed1998

Informed consent in a multicultural cancer patient population: implications for nursing practice.

Obtaining informed consent, an ethical obligation of nurses and other health care providers, occurs routinely when patients make health care decisions. The values underlying informed consent (promotion of patients' well-being and respect for their self-determination) are embedded in the dominant American culture. Nurses who apply the USA's cultural values of informed consent when caring for patients who come from other cultures encounter some ethical dilemmas. This descriptive study, conducted with Latino, Chinese and Anglo-American cancer patients in a large, public, west-coast clinic, describes constraints on the informed consent process in a multicultural setting, including language barriers, the clinical environment, control in decision making, and conflicting desired health outcomes for health care providers and patients, and suggests some implications for nursing practice.

Asian↗
PubMed2005

Informed consent for emergency surgery in infants and children.

The informed consent process for emergency surgery in children poses a challenge for pediatric surgeons because the child and his/her surrogates (usually parents) must make medical decisions in a relatively short period. The unique circumstances of a surgical emergency create potential barriers to achieving the central goals of the informed consent process, respect for patient autonomy and beneficence. The purpose of this review is to provide a practical guide for pediatric surgeons on the informed consent process as it applies to emergency surgery in pediatric patients. We will also discuss innovative methods of preoperative education that can be adopted in the emergency setting and highlight areas in which further research might help to improve this important aspect of surgical care.

Child↗
PubMed1996

[The legibility of written informed consent forms].

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

Forms and Records Control↗
PubMed2004

Comparison of the informed consent process for randomized clinical trials in pediatric and adult oncology.

PURPOSE: To compare the informed consent processes for phase III pediatric and adult oncology clinical trials in view of the critical importance of human subjects protection in both pediatric and adult cancer care. Findings are discussed in terms of the opportunities for improving pediatric and adult oncology informed consent. PATIENTS AND METHODS: A total of 219 subjects are reported on. Adult oncology patients made up 36.1% (n = 79) of the sample. Pediatric surrogates made up the remaining 63.9% (n = 140). Subjects in both studies were observed and audiotaped in conversation with their oncologists, and interviewed afterwards. Comparisons between the adult and pediatric subjects were done using chi(2) statistics and t tests. RESULTS: Differences between the pediatric and adult informed consent processes were found. Adult oncology decision makers were, on average, more fully informed and more actively engaged by their oncologists. Pediatric decision makers were, however, given more information about survival/cure, randomization, and voluntariness. Comprehension difficulties were more frequent among pediatric decision makers. Suggestions for improvement are made in view of the differences between adult and pediatric oncology research environments. CONCLUSION: Ongoing efforts to improve the ethical framework of clinical cancer research need to take into account the key differences between pediatric and adult oncology informed consent. More research needs to be done to explore the differences between adult and pediatric informed consent processes in oncology.

Adult↗
PubMed2000

Norway: valid (as opposed to informed) consent.

The traditional concept of "informed" consent may be too restrictive; "valid" consent may be a more manageable criterion. Norway's 1999 Patients' Rights Act comes into force on Jan 1, 2001. This essay asks if this new legislation is compatible with this concept of valid consent--and concludes that it is.

Adolescent↗
PubMed1995

Informed consent for upper gastrointestinal endoscopy.

Informed consent for upper gastrointestinal endoscopy requires that the patient understands the nature of, and reason for, the proposed procedure, and that he or she is given adequate time to deliberate and ask questions. In a prospective study, 200 outpatients completed questionnaires immediately before, and one day after, endoscopy, which assessed satisfaction with information provided by: (a) the referring doctor, (b) a standard information sheet sent out two to four weeks before endoscopy, and (c) the endoscopist. The first 100 patients were asked to read and sign a standard consent form immediately before the endoscopy. In the second 100 patients, a new endoscopy consent form that was simpler and easier to read than the standard form was sent out with the information sheet. Patients were directed to sign the new consent form before arriving at the unit only if they had no further questions. Overall, the indication for the endoscopy, and how it would be done, were explained clearly by the referring doctor in 79% and 68% of cases, respectively. Of the first 100 patients, only 54% had read the standard consent form in the endoscopy unit before signing it. In contrast, of the second 100 patients, the new form sent with the information sheet was read by 95%, and signed by 88% before coming to the unit. Furthermore, 84% found the new form easier to read and understand than the standard form. In our unit, roughly one quarter of patients referred for endoscopy are not adequately informed about the procedure. In contrast with the standard consent form, a simple endoscopy consent form sent out with the information sheet is preferred by most patients, and safeguards against patients undergoing endoscopy without informed consent.

Adult↗
PubMed1997

Epidural analgesia for labour and delivery: informed consent issues.

OBJECTIVE: Many anaesthetists believe that informed consent for epidural analgesia during labour is inadequate. Patients are perceived to be poorly informed and unable to cope with the information given during labour for informed consent. We reviewed these two hypotheses: A) to define complications for which patients want clear information: B) to quantify the influence of pain, anxiety, opioid premedication, and the importance of level of education, on a patient's level of satisfaction with regard to the consent process: and C) to assess how satisfactory epidural pain relief correlates with satisfaction with the consent process. METHODS: Sixty patients were surveyed during the first two months after vaginal delivery by two interviewers. Questions related to demographics, severity of labour pain, level of satisfaction with the epidural anaesthetic, risk of complications and satisfaction with information received were either categorical or scored on a scale from 0 to 10. RESULTS: All epidural related complications were considered important to disclose (8.4/10). The level of satisfaction with the consent process was 8.1/10. Patient satisfaction was not affected by opioid premedication, anxiety, pain score, education group or level of pain relief. CONCLUSION: Patients indicated they should be informed of all possible complications associated with epidural analgesia, regardless of severity or risk. In contrast to reports in the literature, non disclosure of serious risks during labour was not acceptable to parturients.

Adult↗
PubMed1998

Informed consent in patients with acute abdominal pain.

BACKGROUND: This study aimed to establish perceptions of informed consent in patients undergoing surgery for acute abdominal conditions. METHODS: A prospective observational study was carried out using a structured questionnaire-based interview technique in patients undergoing surgery for acute abdominal conditions. Main outcome measures were to establish the effects of pain and preoperative analgesia on informed consent, patient comprehension of planned surgery and the degree of discussion of potential side-effects and complications. RESULTS: Thirty-one of 49 patients perceived that pain did not interfere with their ability to give informed consent. Forty of 48 stated that preoperative analgesia did not impair their ability to give informed consent. Forty-two understood why an operation was being planned but 28 patients stated that there had been no preoperative discussion of any potential side-effects or complications of surgery. CONCLUSION: In this study the majority of patients perceived that they retained the ability to give informed consent despite the effects of pain and analgesia. Although the majority of patients understood why an operation was being planned there is a clear need for improved discussion of potential side-effects and complications.

Abdominal Pain↗
PubMed1998

Informed consent and the law.

Securing informed consent, though vital to any defense, will not shield a practitioner from a malpractice claim. That is because courts generally hold that patients cannot consent to negligent treatment.

Dentists↗
PubMed1998

Waiver of informed consent: a survey of emergency medicine patients.

Changes to Federal regulations pertaining to waiver of informed consent for acute care research were debated by the research and regulatory communities for more than 2 years before being finalized in October of 1996. Input from the general public was limited. This survey investigated the opinions of emergency medicine patients concerning waiver of informed consent for acute care research. A convenience sample of 212 patients were approached at a tertiary care academic urban emergency department. Seventy-three percent approved of waiver of informed consent if the absolute risks were minimal (50% if the absolute risks were greater than minimal but the incremental risks were minimal). Educational status and certain aspects of the patient's current health status (but not age, race, or gender) significantly affected the results. While most emergency medicine patients would want to be enrolled in a study if they had a serious illness and were unable to give informed consent, a significant percentage of patients would not want to be enrolled regardless of the degree of risk or availability of a family member to speak on their behalf. Waiver of informed consent for emergency research is an ethical dilemma pitting individual rights against societal needs and physician parentalism. A better understanding of what patients consider appropriate may help in resolving this dilemma.

Acute Disease↗
PubMed2005

Informed consent: a stepping stone in risk management.

This article discusses 1 facet of risk management: informed consent. It provides a basis from which the concept of risk management has evolved to the current understanding of informed consent. It develops the concept of informed consent through discussion of the elements that make up this integral part of risk management. It should be noted that, as with any legal concept, local legal counsel should be consulted, because state law is it applies to informed consent may vary.

Costs and Cost Analysis↗
PubMed2003

[Patients' perspective on the quality of informed consent into psychopharmacological treatment in schizophrenia and depression].

BACKGROUND: Respect for autonomy and the right to self-determination require informed consent of patients before any medical procedure. So far the majority of empirical studies on informed consent deal mainly with single aspects e. g. delivery and recall of information and legal questions from a physicians' perspective. In our study we examine the quality of informed consent to psychopharmacological treatment from the perspective of patients with schizophrenia and depression in a German university department of psychiatry. METHODS: Face to face interviews using a structured questionnaire by a research psychiatrist. The participants taking part in this study were inpatients diagnosed with schizophrenia and depression. All patients received medication for their condition. RESULTS: Half of the patients rated the information they received and the process of informed consent positive. Only a minority recalls information regarding the aim and the risks of the treatment. 20 % indicated that they have been informed about alternative treatment options. A quarter of the patients did not know that they had a right to refuse any treatment. CONCLUSION: Compared with studies including patients with somatic illnesses the participants in our study judge the process of informed consent rather critical. The results need to be discussed in the light of the special aspects of psychopharmacological treatment and different cultural and institutional settings.

Adolescent↗
PubMed2005

Research conditions that qualify for emergency exception from informed consent.

Medical research involving critically ill and injured subjects unable to provide informed consent can only be conducted under federal regulations that attempt to balance the need to develop lifesaving treatments with protection of research subjects' rights. Regulators, researchers, and medical ethicists have all struggled to define the conditions under which an emergency exception from informed consent is appropriate. Although research has been successfully conducted under the current regulations, confusion remains regarding the meaning of the regulations, the applicable conditions, and the best ways to balance the needs of future patients and the rights of research subjects. In May 2005, at the Academic Emergency Medicine Consensus Conference "Ethical Conduct of Resuscitation Research," a breakout session was held on the research conditions that qualify for the emergency exception from informed consent process. Several recommendations emerged: 1) The definition of "life-threatening condition" should be broadly interpreted to include serious disability as well as death. 2) Existing therapies should be considered "unsatisfactory," even if partially effective, when serious risk of morbidity or mortality remains even with the best available treatment or when the adverse effects of the best available treatment are serious. 3) Research with the emergency exception should be performed only if sufficient evidence exists that the proposed intervention has a reasonable chance of benefit. 4) More evaluation is needed to determine the degree to which the current rules impede research. 5) Application of the current regulatory framework for abbreviated or waived consent in emergency research should be encouraged. 6) Further study should also address variability among institutional review boards, the goals of community involvement, and how best to engage and educate the public in research efforts using emergency exception from informed consent.

Community-Institutional Relations↗
PubMed1999

[An analysis of patient information sheets for obtaining informed consent in clinical trials].

BACKGROUND: The written information provided to the potential participants in a clinical trial must have certain qualitative and quantitative characteristics to reach the ethical requirements governing the theory of the informed consent. MATERIAL AND METHODS: In a sample of 101 clinical trial protocols approved in two Spanish university general hospitals, the following items were evaluated: a) the amount and quality of the written information given to the patient, in accordance with the established in the Spanish legislation; b) the formal readability of this written forms, by means of the Flesch method, and c) the level of complexity of the vocabulary, by means of the number of non-comprehensible words for two volunteers unaware of the health professions, with high studies. RESULTS: The balance of benefits and risks, the identification and the way of contact with the main investigator, the description of the alternative treatments and the specification of the compensations in case of lesions were the items with highest noncompliance. The mean global readability by means of the index of Flesch was of -12.7 (text with a high level of complexity). The mean percentage of words non-comprehensible for the volunteers that analyzed the texts was 0.3%. CONCLUSIONS: The written form of information provided to the patient in the clinical trials developed in Spain has serious deficiencies, either in their formal readability (complexity of the linguistic structure) or in the amount and quality of the information that provides. These deficiencies could have a wrong influence in the appropriate obtention of the informed consent from the patients.

Analysis of Variance↗
PubMed2006

[Informed consent in gynecology and obstetrics].

OBJECTIVE: A systematic review of recent available literature on the topic of informed consent, evaluation of the terminus a quo and the creation of theoretical basis for execution of the process of informed consent in clinical practice with attention to specific aspects in gynecology and obstetrics. TYPE OF STUDY: Review of literature. SETTING: Mother and Child Care Institute Prague, Chair of Gynecology and Obstetrics, IPVZ, Prague. METHODS: Review of publications on the given topic and implementation of general principles of medical ethics in the area of gynecology and obstetrics. RESULTS: The branch of gynecology and obstetrics brings about various controversial clinical situations, which arise from specific features of the branch. The informed consent is an integral part of the diagnostic-therapeutic process and precondition of the correct (lege artis) procedure. The adequate agreement with the therapy should be informed, free and competent. It prevents ethical crisis in conditions of an ethical conflict. The paper defines the content and structure of the informed consent and draws attention to its technical prerequisites so as to fulfill the truthfulness and legal validity. CONCLUSION: The informed consent is an important part of communication between the physician and the patient. The physician provides a complex, qualified, truthful and complete information. A competent patient accepts this kind of information and decides, based on full understanding, when and in what form, undergoes the recommended procedure or refuses it.

Conflict of Interest↗
PubMed2006

Informed consent in cardiac surgery: is it truly informed?

OBJECTIVE: To develop a validated questionnaire to measure how informed patients are when giving consent for elective coronary artery bypass grafting. METHODS: We developed a questionnaire covering the domains described in the consent guidelines published by the General Medical Council. The questionnaire was developed for use in face-to-face interviews as opposed to a self-administered questionnaire. Interviews were conducted after the patients had given consent for surgery. A total of 41 patients were interviewed. To validate the questionnaire we tested the interobserver reliability by using four different interviewers and the construct validity by comparing it with area deprivation index and with predicted intelligence quotient scores obtained from the National Adult Reading Test. RESULTS: The correlation of the ranking of the questions between the interviewers was satisfactory (Spearman's rank correlation coefficient, rs = 0.84-0.89). The total questionnaire scores correlated well with predicted intelligence quotient scores (rs = 0.48) but not with area deprivation index (rs = 0.01). Questions with the worst scores were those related to mortality, morbidity, alternative treatment options and their relative success rates and risks. CONCLUSIONS: We have developed a validated questionnaire which tests patient's level of knowledge with respect to surgical myocardial revascularisation. Our study identified areas of informed consent where the minimal level of knowledge is below the recommended level. The questionnaire could be used in audits and clinical trials in patients undergoing coronary artery bypass grafting. It could be used as a tool to measure the effectiveness of patient education programmes. With appropriate changes, this instrument could also be applied in other fields of medical intervention, which require patients to give informed consent.

Adult↗