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PubMed2001

Beyond informed consent: the ethical design of pain research.

In the wake of the rapid development of medical research over the past 50 years, investigators, clinicians, and ethicists have raised numerous concerns about the ethical conduct of research. Perhaps the single most important protective mechanism to emerge from the fray has been the requirement of informed consent. Certainly it has the longest history. However, even though informed consent has become the most widely recognized mechanism of protecting human subjects in research, there are limits to what the informed consent process can accomplish. Another, and more far-reaching, way to protect human subjects involved in research is to ensure that the study design is as consistent as possible with patients' preferences and goals. That is, pain investigators have a significant opportunity to improve the ethical rigor of their work by designing a study that offers a subject what is a reasonable balance of risks and benefits. This article suggests some specific ways in which investigators may design research that is more consistent with patient preferences. We describe several aspects of the ethical design of clinical pain research that appear to be important to patients, including the potential benefits for subjects, the benefits for future patients, the risks and burdens of research participation, and the voluntariness of a subject's choice whether to enroll. We conclude by discussing ways in which the ethical design of research might make the informed consent process more robust.

Journal Article↗
PubMed1995

Informed consent for research: a study to evaluate readability and processability to effect change.

BACKGROUND: Ninety million Americans are reported to have low literacy skills, and the problems associated with illiteracy permeate all areas of our society, including medical research. The purpose of this study was to determine the readability and comprehensibility of human research informed consent forms using established reading comprehension processes. Further, if comprehension problems were present in the forms, the study sought to identify the exact nature of these difficulties and identify specific areas where the forms could be rewritten to increase readability and understanding. METHODS: All human research informed consents approved by Hartford Hospital in 1993 were evaluated by a Readability and Processability Form (RPF) based on reading research, including the Fry Scale which yields an approximate grade reading level. The RPF assigned points to each of the 20 areas of analysis according to strict scoring criteria, and target scores were established by the authors in consultation with the hospital. RESULTS: Seventy-six informed consent forms were evaluated, and neither the Fry score or the RPF score was in the target range. Ninety-six percent of the forms were found to have readability levels higher than the target level (8th grade). The mean readability and processability score was 46, resulting in the classification, Minimally Adequate/Needs Improvement. (The target range was Good, 61-100.) A question by question analysis of each of the 20 checklist items on the RPF identified important aspects of text writing style that were scored as Unacceptable or Poor. CONCLUSIONS: The descriptive data indicates that there were problems with the readability of the informed consent documents studied. The prescriptive portion of this study provides researchers with information on specific areas where their forms need to be studied and rewritten. The comprehension problems found in this study may alert others to similar problems and may provide the basis for other institutional review boards (IRBs) to study their consent forms in order to ensure that the interests of both the patient and the researcher are protected and that the obtained consent is truly informed.

Comprehension↗
PubMed2005

Informed consent in ENT. Patient's judgement about a specific consensus form.

The concept of informed consent was first used in the 60's. The meaning of this term is the need of a preliminary and valid consensus that places the doctor in an authorised condition whereby he is able to carry out his work. Notwithstanding the importance and delicacy of this topic and the potentially serious consequences, there is not, as yet, universal behaviour, on the part of doctors, regarding the mode of information and documentation on how the patient be informed. In a previous article, the authors outlined the best approach, on the part of the doctor in regard to the patient, in order to obtain valid informed consent. In particular, the specific information for each disease was proposed and this was not limited only to aspects related to type of treatment and possible risks, but thorough, with regard to adhering to the logical course (case history, objective tests, instrumental diagnosis carried out, etc.) that led the doctor to a certain diagnosis and a description of the proposed treatment possibilities as well as the treatment modalities excluded, with relative reasons. The study was designed in such a way as to define the degree of acceptance that this informative method has on the patients. This was achieved by means of a questionnaire filled in by 254 patients hospitalised in our department, about to undergo surgery. Judgement was substantially positive, in that, > 70% of patients agreed that the information was quite or very good, and 90% considered it sufficient or better. This demonstrates that even those subjects who received little information, were, in fact, satisfied with that given. The patient/doctor relationship was also judged positive. The patients felt that it was important to be kept informed about their condition, regardless of the form (written or spoken). In conclusion, the outcome of the questionnaire demonstrates the appreciation. on the part of the patients, regarding the procedure of information used in seeking consensus.

Adolescent↗
PubMed2002

Capacity to provide informed consent for participation in schizophrenia and HIV research.

OBJECTIVE: The degree to which people with psychiatric symptoms and cognitive dysfunction can provide informed consent to participate in research is a controversial issue. This study was designed to examine the capacity of subjects with schizophrenia and subjects with HIV to provide informed consent for research participation and to determine the relationships among cognitive dysfunction, psychiatric symptoms, and decisional capacity. METHOD: Twenty-five men and women with a DSM-IV diagnosis of schizophrenia and 25 men and women with HIV were recruited. The groups were compared in terms of neuropsychological functioning, psychiatric symptoms, and ability to provide informed consent to a hypothetical drug trial. RESULTS: Eighty percent of the subjects with schizophrenia and 96% of the HIV-positive subjects demonstrated adequate capacity to consent to the hypothetical drug trial, but subjects in the schizophrenia group had significantly lower scores on two of the four aspects of decisional capacity. For the subjects with schizophrenia, neuropsychological functioning and psychiatric symptoms (e.g., apathy and avolition), but not psychotic symptoms (e.g., hallucinations and delusions), were significantly associated with decisional capacity. CONCLUSIONS: The majority of subjects who are recruited and willing to participate in schizophrenia or HIV research will have adequate capacity to provide consent. Cognitive dysfunction and the symptoms shown to be associated with impaired decisional capacity are not unique to schizophrenia and may occur with many other forms of illness. These findings underscore the importance of considering how decisional capacity will be assessed in all types of research, regardless of the specific condition being studied.

Adolescent↗
PubMed1997

Informed consent in the elderly: assessing decisional capacity.

Informed consent is a process involving both patient rights and professional responsibilities. A nurses discomfort with an elderly person's ability to make a fully informed choice can be a source of ethical conflict. Assessing mental capacity in this vulnerable patient population is a necessary function of respecting patient autonomy.

Aged↗
PubMed1989

Informed consent in emergency research. Prehospital thrombolytic therapy for acute myocardial infarction.

Can the conscious patient in the midst of a medical emergency provide adequate informed consent for a clinical research protocol? Adequate consent is crucial to the ethical conduct of clinical trials, including those performed in emergency settings. We examine the problem of emergency informed consent. As an illustrative case, we discuss a pilot trial of prehospital thrombolytic therapy for myocardial infarction. Federal regulations for clinical research do not provide clear guidelines on emergency research in the conscious patient. Clinical investigators currently approach emergency consent in four ways: (1) avoid such research, (2) omit the consent process, (3) obtain deferred consent, or (4) obtain customary consent. We suggest a fifth alternative, two-step consent, which permits the conduct of emergency research while protecting the rights of the emergency research subjects. Such a process may serve as an alternative solution for future studies faced with the problem of informed consent in emergencies.

Emergencies↗
PubMed1994

Informed consent: what do patients want to know?

Informed consent is an important aspect of surgery, yet there has been little inquiry as to what patients want to know before their operation. This study has questioned 50 patients within 3 months of an ENT (ear, nose and throat) operation. We found that most were happy to allow doctors to determine their treatment but they wanted to know about their condition, the treatment, and the important side effects. Fifty per cent of patients admitted worrying about some aspect of their recent surgery. More than two-thirds thought signing a consent form primarily signified agreement to undergo treatment and that it was a legal document; 54% thought there was an important medico-legal aspect. Over half thought information sheets would be reassuring, one-third thought they would provoke anxiety and 8% thought they would frighten them from having surgery. Closer examination of the answers to our questions showed that those who were most worried about aspects of their surgery had a higher mean anxiety score, as did those who thought an information sheet would be either frightening or anxiety provoking. However, a higher anxiety score was not associated with a desire to know less about the proposed treatment.

Adolescent↗
PubMed2006

Informed consent and refusal of treatment: challenges for emergency physicians.

Due to the distinctive features of the hospital emergency department and its patients, emergency physicians confront special challenges in respecting patient rights to informed consent to treatment. After a brief review of the doctrine of informed consent and of its significance in the emergency department, this article will examine three specific challenges for informed consent and refusal of treatment in emergency medicine: (1) assessing patient decision-making capacity, (2) performing procedures on the newly dead, and (3) making treatment decisions for patients in legal custody.

Emergency Medicine↗
PubMedDate not supplied

Autonomy, privacy and informed consent 4: surgical perspective.

This is the fourth article in a four-part series that considers the issues of patient autonomy, privacy and informed consent. The article discusses these issues in the context of surgical patients and their nurses. There is an abundance of references to issues of autonomy and informed consent within the healthcare literature, although there are few empirical studies investigating these issues within practice. The issue of privacy has been somewhat less explored than that of autonomy or consent, particularly in the UK literature. This article reports the findings of a Scottish study that formed part of a multisite comparative study funded by the European Commission. A convenience sample of surgical patients (n = 282) and their nurses (n = 260) participated in the study. Data were collected by means of a self-completion questionnaire for both patients and nursing staff. Results indicated that there are significant differences in patient and staff perceptions on issues of patient autonomy, privacy and informed consent. However, the most marked difference in perceptions of patients and staff were found on the information-giving element of the autonomy subscale. Implications for nursing practice, education and research are highlighted.

Humans↗
PubMed2005

Information required to provide informed consent for endoscopy: an observational study of patients' expectations.

BACKGROUND AND STUDY AIMS: The aim of this study was to determine how much information patients require about the risk of complications in order to provide informed consent to undergo endoscopy. PATIENTS AND METHODS: Endoscopic complications and their consequences were discussed with consecutive patients who had undergone endoscopy. The patients were asked how common each complication would have to be for them to require information about the complication before providing adequately informed consent. RESULTS: Data were obtained from 150 gastroscopy patients (51% male, median age 55.5 years) and 150 colonoscopy patients (60% male, median age 54.4 years). Patients in both groups were more likely to want to know about major rather than minor complications at a lower level of risk (P < 0.001 at a risk greater than one in 1000). Similar proportions of gastroscopy patients (n = 29, 19%) and colonoscopy patients (n = 21, 14 %) wanted to know about all possible complications, no matter how inconsequential or rare. Colonoscopy patients were less likely to want no information about any complications than gastroscopy patients (n = 1, 0.7% and n = 15, 10%, respectively; P < 0.001). CONCLUSIONS: The information patients require in order to provide informed consent is very variable. Many appear to make a judgement about the need for information depending on the perceived severity of the complication, but some want information about all complications, irrespective of risk and severity. The level of risk at which they require this information is likely to be higher than the level used by doctors who are obtaining consent from patients. The process may be improved by providing procedure-specific information leaflets that offer information regarding common and serious complications.

Access to Information↗
PubMed1996

Conflicts between physicians and patients in non-elective cesarean delivery: incidence and the adequacy of informed consent.

A study was undertaken in 372 consecutive patients undergoing non-elective cesarean delivery to explore the incidence and nature of conflicts between physician and patient surrounding the decision to undergo non-elective cesarean delivery; to examine the adequacy of informed consent at the time of non-elective cesarean delivery; and to describe the importance of a preventive ethics approach to non-elective cesarean delivery. During a 6-month interval, all patients who underwent non-elective cesarean delivery and their physicians were asked to take part in a survey in the early postpartum period concerning their response to recommendations for cesarean delivery. The survey included demographics as well as questions pertaining to informed consent and the presence and nature of patient-physician conflict. Of the 326 patients who were interviewed, 319 (98%) agreed to the recommendation for non-elective cesarean delivery and 7 patients (2%) initially disagreed. Reasons for disagreeing included: feared surgery (4 of 7), needed husband's approval (1 of 7), and questioned the medical necessity of surgery (2 of 7). In all 7 cases of initial disagreement, cesarean delivery was eventually performed with the patient's consent. The mean age of patients who initially disagreed was younger (24.7 +/- 6) than that of those who agreed (31.0 +/- 4 [p < 0.05]). Conflicts were present in 7 of 113 clinic patients and 0 of 213 private patients (p < 0.05). Of those surveyed, 26 (8.7%) indicated that they did not have adequate input in the decision for non-elective cesarean delivery. Patients with inadequate input expressed significantly more concerns with regard to the effect of surgery on their own health (p < 0.05) as well as its effect on the baby (p < 0.05). Our findings suggest that even though the incidence of physician-patient conflict about non-elective cesarean delivery was quite low, a significant number of patients (1 in 12) may have reservations concerning the informed consent process at the time of non-elective cesarean delivery. Patients with reservations are more likely to have greater concerns with regard to maternal and fetal risks, suggesting that a more detailed risk disclosure prior to the procedure is warranted for all pregnant patients. Perhaps by incorporating the preventive strategies discussed, the adequacy of informed consent and therefore the patient's autonomy could be enhanced, thus diminishing patient reservations and preventing physician-patient conflict in the intrapartum period.

Adult↗
PubMed2006

Informed consent, capitation, and conflicts of interest in clinical trials: views from the field.

BACKGROUND: The beliefs of research team members about informed consent practices are not well studied, especially in regard to financial aspects of research such as capitation fees. Sponsors of research offer capitation fees for the enrollment of subjects, and although this money is intended to cover the costs of the research it can sometimes be used in other ways. There is no clear consensus about whether this financial aspect of trials should be part of the informed consent process or whether it represents a potential conflict of interest. METHODS: We presented several hypothetical cases to members of the American College of Surgeons Oncology Group (ACOSOG) at a semi-annual meeting. ACOSOG is a federally funded clinical trials group evaluating surgical and adjuvant methods of cancer treatment. The meeting included surgeons, nurses, case managers, and others involved in clinical surgical trials. RESULTS: We found that most respondents believed that it would be a violation of the protocol to enroll a subject who showed lack of recall about the study. Most respondents also favored disclosure of capitation fees, especially if those fees went into discretionary accounts, but there was some disagreement about the benefit of that disclosure to potential participants. CONCLUSIONS: This study shows the need for greater work in ensuring that research team members share common understandings about informed consent. It also shows that most of these research team participants are prepared to make more disclosure about financial aspects of research than current standards in fact require.

Attitude of Health Personnel↗
PubMed2002

Informed consent for total hip arthroplasty: does a written information sheet improve recall by patients?

OBJECTIVE: To ascertain whether a written information sheet is acceptable to patients and improves recall of the consent interview. DESIGN: Prospective randomised controlled study using questionnaires, comparing a group of patients given information in a written sheet with appropriate explanation to a group given verbal information alone. SETTING: A specialist orthopaedic surgery unit. PATIENTS: The test group was 126 patients undergoing revision or primary total hip arthroplasty; 65 patients were given information verbally, 61 patients were given written information. OUTCOME MEASURE: Patients' recall of information given, tested with a questionnaire completed on admission (mean of 18 days later). RESULTS: The patients receiving written information scored significantly higher (48% correct answers) than the patients receiving verbal information (38% correct answers). CONCLUSIONS: Written information sheets contribute to the process of informed consent. As patients' recall of information is generally poor, the sheets may also be useful medicolegally, as a permanent record of what was discussed.

Arthroplasty, Replacement, Hip↗
PubMed1997

Informed consent for patient care--VA. Final rule.

This document amends VA medical regulations concerning informed consent for patient care. It describes the requirements for obtaining and documenting informed consent. It also describes the types of treatments or procedures for which the patient's or surrogate's signature on a VA-authorized form is required and establishes a list and priority of surrogates authorized to act on behalf of patients who lack decision-making capacity. Further, it establishes an internal decision-making process for patients who lack decision-making capacity and who have no authorized surrogate. This is intended to protect patient rights and ensure that the patient (or the patient's surrogate or representative) receives sufficient information to make an informed health-care decision. authorized form is required and establishes a list and priority of surrogates authorized to act on behalf of patients who lack decision-making capacity. Further, it establishes an internal decision-making process for patients who lack decision-making capacity and who have no authorized surrogate. This is intended to protect patients rights and ensure that the patient (or the patient's surrogate or representative) receives sufficient information to make an informed health-care decision.

AIDS Serodiagnosis↗
PubMed1999

Informed consent for short-stay surgery.

This study in the context of short-stay surgery is based on a definition according to which informed consent consists of five elements: consent, voluntariness, disclosure of information, understanding and competence. The data were collected in four district hospitals in southern Finland by using a structured questionnaire. The population consisted of short-stay and one-day surgery patients (n = 107). Data analysis was based on statistical methods. The results indicated some problems in the realization of informed consent. Most commonly, consent was expressed by voluntary admission. Most patients had indicated their voluntary consent by making their decision independently. There were also certain problems with information. The respondents were least well informed about the drawbacks of anaesthesia and about alternative forms of treatment. The patients had not understood all the information they had received; problems of understanding were greatest with information about the advantages and disadvantages of anaesthesia. Problems were also reported with competence. These patients had the most difficulty in assessing the advantages and drawbacks of different treatments and anaesthesia.

Adult↗
PubMed2001

Informed consent? A child's right to autonomy.

There is a need for legal clarification of the concept of informed consent in minors. Paediatric nurses need to take a more active role in advocating for the 'Gillick competent' minor. The concept of informed consent continues to provide challenges for practice in paediatric nursing. Informed willing consent in 'Gillick competent' minors requires working effectively in partnership with the child, family and multidisciplinary team.

Child↗
PubMed2002

Informed consent for clinical photography.

The question of (informed) consent to medical photography has long been a vexed one. This paper briefly considers key landmarks in the debate, and examines in detail the evolution of the Addenbrooke's NHS Trust policy Photography and Video Recordings of Patients: Confidentiality and Consent, Copyright and Storage. The impact of the 1998 Data Protection Act, the Department of Health's Model Policy on Consent, and the implications of wider access to digital photography are discussed together with their integration into the Addenbrooke's policy.

Computer Security↗
PubMed2003

Problem areas in the understanding of informed consent for research: study of middle-aged and older patients with psychotic disorders.

RATIONALE: Optimizing the abilities of individuals with psychiatric disorders to provide meaningful informed consent for research has become a heightened concern for psychiatric researchers. OBJECTIVES: We examined a post-consent test of comprehension given to older patients with psychotic disorders to identify problem areas in the understanding of informed consent for research. METHODS: One hundred and two middle-aged and older outpatients with schizophrenia or related psychotic disorders and twenty normal comparison subjects were administered a 20-item questionnaire to assess their comprehension of consent for a low-risk research protocol after receiving either a routine (paper-based) or an enhanced (computerized, structured slide show incorporating greater review) consent procedure. Data on individual questions were analyzed. RESULTS: Patients had more difficulty than normal comparison subjects on open-ended questions, including those asking about study procedures, time involved, and potential risks and benefits. Among patients, the enhanced procedure was associated with better performance on questions about potential risks and time required than the routine procedure. CONCLUSIONS: Problem areas in the understanding of informed consent, such as study procedures and potential risks and benefits, should be the focus of attempts to improve the consent process for patient participants with severe mental illness. Research also should be done to clarify how best to assess understanding of consent, since the wording of questions likely affects the responses.

Biomedical Research↗