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PubMed1997

Participants' understanding of the process of psychological research: informed consent.

Sixty-five undergraduates participating in a wide range of psychological research experiments were interviewed in depth about their research experiences and their views on the process of informed consent. Overall, 32% of research experiences were characterized positively and 41% were characterized negatively. One major theme of the negative experiences was that experiments were perceived as too invasive, suggesting incomplete explication of negative aspects of research during the informed consent process. Informed consent experiences were viewed positively 80% of the time. However, most of the participants had a limited view of the purpose of informed consent: less than 20% viewed the process as a decision point. Results suggest a number of common pitfalls to standard informed consent practices that have not generally been recognized. Results are discussed in terms of both ethical and methodological implications. Suggestions for improving the informed consent process are also provided.

Attitude↗
PubMed1991

Hide-and-seek or show-and-tell? Emerging issues of informed consent.

This article reviews key philosophical and legal underpinnings of mental health professionals' obligation to obtain informed consent from consumers of their services. The basic components of informed consent are described, and strategies for clinically and ethically appropriate methods of obtaining informed consent are discussed. Emerging issues in informed consent involving duty to assess and protect against client dangerousness, obligations to third parties, and issues of deception are considered as well. The article proposes that part of the process of obtaining informed consent is the cultivation of a treatment environment that emphasizes beneficence and client autonomy.

Altruism↗
PubMed1991

Hypothetical contractarianism and the disclosure requirement problem in informed consent.

Two of the more deeply problematic issues surrounding the doctrine of informed consent are providing a justification for the practice of informed consent and providing an account of the nature and amount of information that must be disclosed in order for informed consent to take place. This paper is concerned with the latter problem, the problem of disclosure requirements, but it deals with this problem in a novel way; it approaches the problem by asking what fully informed and fully rational agents would agree to under certain hypothetical conditions. In general terms I juxtapose the hypothetical contractarianism found in Rawls' A Theory of Justice with that found in Gauthier's Morals By Agreement and ask what their respective hypothetical contractors would agree to with respect to choosing a particular standard of disclosure to govern the practice of informed consent. In more specific terms a contrast is made between what a Rawlsian agent behind a veil of ignorance would choose as compared to what, in Gauthier's terms, an ideal actor making an Archimedean choice would choose. The idea of an Archimedean point, and the subsequent choice made from that point, although technically identified by Rawls, originated with Archimedes of Syracuse.

Altruism↗
PubMed2005

A preliminary study of interactive questioning methods to assess and improve understanding of informed consent among patients with schizophrenia.

Growing recognition of the inadequacy of traditional methods of providing informed consent, especially for individuals vulnerable to impaired decisional capacity, has spurred recent interest in how to assess and improve components of consent-related decision making. In this preliminary study, we aimed to compare different methods of interactive questioning during presentation of research consent information among patients with schizophrenia. Patients were randomized to receive either standard administration (SA) of a consent form or one of two interactive questioning methods: Corrective Feedback (CF), in which the correct answer was provided following the participant's response, or Errorless Learning (EL), in which correct answers were provided just prior to the question. The MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) was used to measure understanding, appreciation, reasoning, and expression of a choice following presentation of the consent form. There was no significant effect of condition (SA vs. EL vs. CF) on any of the components of decisional capacity. Understanding scores measured during the consent process were higher than those measured afterward, but the two scores were highly correlated. Thus, the results of this randomized study suggest that interactive questioning neither helped nor harmed understanding, appreciation, or reasoning among patients with schizophrenia. Other considerations, however, may favor use of such methods in the consenting process.

Adult↗
PubMed1998

Information preferences, reading ability, and emotional changes in outpatients during the process of obtaining informed consent for autologous bone-marrow transplantation.

BACKGROUND: The complexity of autologous bone marrow transplantation (ABMT) imposes increased demands for disclosure of information to patients. This study describes the information preferences, reading ability, and emotional balance (affect) of adult patients at the time of outpatient informed consent. METHODS: Thirty patients were enrolled. The Derogatis Affects Balance Scale was used to determine each patient's emotional status before and after outpatient informed consent. The Information Styles Questionnaire was used to measure information preferences, and the Wide Range Achievement Test was used to measure reading ability. RESULTS: Every patient had at least average reading ability. Almost 90% of the patients preferred maximum amounts of detailed information. A significant change in total affectivity was seen after informed consent (p = 0.005), and the predominant pattern of change was decreases in both positive and negative affects, with a significant improvement in the positive-affects ratio. CONCLUSION: ABMT candidates tend to read well and prefer maximum amounts of information. The informed consent process is associated with significant change in the balance between positive and negative patient emotions, and the dominant pattern is neutralization of both the positive and the negative emotions. This neutralization is more pronounced for the negative emotions, suggesting that the informed consent process may make patients feel better overall.

Adolescent↗
PubMed1991

Are research participants truly informed? Readability of informed consent forms used in research.

Researchers typically attempt to fulfill disclosure and informed consent requirements by having participants read and sign consent forms. The present study evaluated the reading levels of informed consent forms used in psychology research and other fields (medical research; social science and education research; and health, physical education, and recreation research). Two standardized measures of readability were employed to analyze a randomly selected sample (N = 108) of informed consent forms used in Institutional Review Board-approved research projects at a midwestern university during the 1987-1988 academic year. Results indicate that informed consent forms are typically written at a higher reading level than is appropriate for the intended population and that there are no consistently significant differences in readability among areas of research or between college student and noncollege student participants. Due to the unacceptably high reading level of the consent forms, one must question whether participants can comprehend the information contained in the consent form.

Adolescent↗
PubMed1999

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.

Cognition↗
PubMed2004

Informed consent for invasive medical procedures from the patient's perspective.

BACKGROUND: Written informed consent is not obtained uniformly for invasive medical procedures in critically ill patients across America. The general consent-to-treat is used by some institutions in lieu of separate, procedure-by-procedure consent. OBJECTIVES: To determine whether hospitalized patients recall the general consent-to-treat and to ascertain their preferences regarding informed consent for invasive medical procedures. METHODS: A questionnaire was administered to patients admitted to a 325-bed community teaching hospital. RESULTS: Of 265 patients who participated in the study, only 8% correctly recalled all of the elements of the general consent-to-treat. One hundred twelve respondents (42.3%) trusted their doctors to perform necessary medical procedures, "as long as they were told what was going to happen and why the medical procedure was needed." These patients were older (67 vs 62 years, P = 0.02) and were less likely to hold college or advanced degrees (33% vs 44%, P = 0.04). One hundred fifty-three patients wanted to know the important benefits, risks and alternatives, and to give written permission for performance of medical procedures. On further questioning, 29 (19%) of 153 patients responded that no medical procedure should be done without getting consent first. Forty-three (28%) thought procedures with complications in < 1% of cases should not require consent, while nine (6%) thought consent should be required at a threshold of 10% complications. One hundred patients (65%) responded that procedures with small and nonserious risks (i.e., IV's, bladder catheters) should not require separate written consent. CONCLUSIONS: The general consent-to-treat is not recalled well by hospitalized patients and is unlikely to suffice as informed consent for invasive medical procedures. A majority of patients do not want to have invasive procedures without first giving their informed consent.

Adult↗
PubMed1997

Informed consent: patients' and junior doctors' perceptions of the consent procedure.

The important task of obtaining informed consent is often left to the most junior member of the surgical team, whose understanding of the surgical procedures involved may be limited. Little is known about patients' and junior doctors' satisfaction with the consent procedure, which was studied with the use of questionnaires. The vast majority of patients (95%) were satisfied with the explanation given to them prior to obtaining consent although 45% thought that the doctor who signed the consent form would be performing the surgery. Thirty-seven per cent of the junior doctors questioned admitted to obtaining consent for procedures of which they had little understanding. The majority of both junior doctors and patients felt that the surgeon performing surgery should sign the consent form. Junior doctors cannot be expected to obtain informed consent for procedures they do not fully understand and patients's; expectations must be taken into consideration if the seemingly inexorable rise in medico-legal litigation is to be halted.

Attitude of Health Personnel↗
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↗
PubMed2002

[Patterns of information and informed consent procedures. Study of the Ethical Commission of the ANMCO].

A survey on patterns of information and informed consent procedures during daily clinical practice has been performed by the Ethical Commission of ANMCO. A structured questionnaire (38 questions) was sent to the 653 cardiological units of the National Health Service in Italy. Four hundred and eighty (73.5%) were received. The following variables were considered to evaluate differences in the answers from the various cardiological units: geographical site, presence or absence of an in-patient department, a cath-lab, and of cardiac surgery facilities. Independent predictors of returning questionnaires were: geographical site (Northern Italy vs Central and Southern) and the presence of a cath-lab. Informed consent forms were provided in 53% of instances, while in 40% a free comment about the topic of informed consent was sent. Statistically significant differences in the answers were found about physicians' and nurses' role, ways of information, qualitative and quantitative risk estimates, other persons' role, models of consent forms and procedures of obtaining consent. Free comments and informed consent forms did not allow a statistical analysis. However, they still provided sufficient material to identify specific patterns of how cardiologists deal with the informed consent process. The distinction between the two phases of information and consent was rarely clear. Information or educational material was often mixed with consent forms. While some still showed a paternalistic approach, or else considered informed consent as a formal act, others demonstrated a deep understanding of the significance of the concept of informed consent. A widespread need of guidelines and standard patterns resulted.

Ethics↗
PubMed1999

Barriers to informed consent.

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

Clinical Trials as Topic↗
PubMed2005

Informed consent for anesthesia: survey of current practices in Japan.

Anesthesia requires informed consent because it is an invasive procedure with certain risks. However, the state of informed consent for anesthesia in Japan remains unclear. The purpose of this survey was to examine the state of informed consent for anesthesia in Japan. A questionnaire was sent to all hospitals certified by the Japanese Society of Anesthesiologists (n = 854). The questionnaire consisted of four sections: explanation of the anesthesia, method of documentation, consent for anesthesia, and other information such as the hospital's size. A total of 504 (59.0%) questionnaires were completed and returned. At 96.7% of hospitals, an anesthesiologist would explain the scheduled anesthesia. Most departments provide an explanation of dental damage, malignant hyperthermia, and nausea/vomiting. Explanation of anesthesia was standardized at 59.0% of hospitals. A written description was handed out to patients routinely at 61.3% of hospitals. Although consent for anesthesia was obtained at more than 90% of departments, only 59.9% of departments would keep records of having obtained consent. This survey found that the explanation of anesthesia varied among hospitals and was not standardized in Japan. Further attention is needed on how to improve the documentation of informed consent.

Anesthesia↗
PubMed1996

Informed consent and tardive dyskinesia. Long-term follow-up.

Informed consent allows patients to make treatment decisions based on the best possible information. The current study examines the long-term impact of the informed consent process on schizophrenic patients. Patients were administered a baseline questionnaire and were given an information form, which was read aloud to them by the investigator. Patients were re-administered the questionnaire at 4 weeks and were randomly assigned to no review (single-session group) or a review of the information (educational review group). All patients were administered the questionnaire at 2-year follow-up. Both the single session and the educational review process significantly increase the schizophrenic patient's knowledge about the benefits and risks of neuroleptic medication. No previous study has examined the impact of informed consent for antipsychotic medication at 2-year follow-up.

Antipsychotic Agents↗
PubMed2004

Interventions to improve research participants' understanding in informed consent for research: a systematic review.

CONTEXT: Available data suggest that prospective research participants may frequently not understand information disclosed to them in the informed consent process. Little is known about how understanding can be improved. OBJECTIVE: To review research on interventions to improve research participants' understanding of information disclosed in the informed consent process. DATA SOURCES AND STUDY SELECTION: A search of MEDLINE was performed using the terms informed consent and clinical research and informed consent and (comprehension or understanding) from 1966 to March 2004 , which included randomized controlled trials, longitudinal trials, and controlled trials with nonrandom allocation that compared the understanding of research participants who had undergone only a standard informed consent process to that of participants who had received an intervention to improve their understanding. A comprehensive bibliography of empirical research on informed consent published in January 1999 was also reviewed, as were personal files and all issues of the journals IRB and Controlled Clinical Trials. DATA EXTRACTION: Study design, quality criteria, population characteristics, interventions, and outcomes for each trial were extracted. The statistical significance of the interventions' effects on understanding were noted, as were mean scores for understanding for each group of each trial. For those trials that measured the secondary outcomes of satisfaction and willingness to enroll, results were also summarized. DATA SYNTHESIS: Thirty studies described 42 trials that met inclusion criteria. Of 12 trials of multimedia interventions, 3 showed significant improvement in understanding. Of 15 trials of enhanced consent forms, 6 showed significant improvement in understanding (all P<.05), but 5 of 6 trials were of limited quality, casting doubt on their practical relevance. Of 5 trials of extended discussion, 3 showed significant improvement in understanding (all P<.001) and 2 showed trends toward improvement (P=.054 and P=.08). Of 5 trials of test/feedback, all showed significant improvement in understanding (all P<.05) but were flawed in that they may have mistaken rote memorization for improvement in understanding. Another 5 trials were put into a miscellaneous category and had varying impact on understanding. Some demographic factors, particularly lower education, were associated with less understanding. Satisfaction and willingness to enroll were never significantly diminished by an intervention . CONCLUSIONS: Efforts to improve understanding through the use of multimedia and enhanced consent forms have had only limited success. Having a study team member or a neutral educator spend more time talking one-on-one to study participants appears to be the most effective available way of improving research participants' understanding; however, further research is needed.

Biomedical Research↗
PubMed1990

Liberty and tardive dyskinesia: informed consent to antipsychotic medication in the forensic psychiatric hospital.

This paper addresses informed consent to antipsychotic medication of those incarcerated in a forensic psychiatric hospital. The ways in which the unique setting of the forensic psychiatric hospital impinge upon the three components of informed consent--information, voluntariness, and competency--are explored. Special attention is given to the risk-benefit ratio of receiving antipsychotic medication in terms of the liberty interests at stake--freedom of movement, that is, the effects of tardive dyskinesia, and freedom of space, that is, release from the forensic psychiatric facility.

Dyskinesia, Drug-Induced↗
PubMed1992

Informed consent: is it a myth?

The issue of informed consent at it relates to neurosurgical professional malpractice liability and litigation has been of concern for 20 years or more. The problem persists, and the subject has been addressed by providing patient education with full disclosure regarding neurosurgical procedures. In the process of imparting informed consent, the authors studied the effectiveness of specific neurosurgical health care teaching. One hundred six persons undergoing anterior cervical fusion or lumbar laminectomy were instructed by a neurosurgeon and clinical nurse specialist with a master's degree in neurosurgery. Written testing was performed in each case immediately after a formal teaching session before surgery. Questions were simple and covered only four general topics: 1) diagnosis and surgical techniques; 2) operative risks; 3) postoperative care; and 4) goals and benefits relating to surgery. The mean score on testing immediate retention of information revealed a 43.5% overall performance rate. When patients were tested approximately 6 weeks later, the score dropped to 38.4%. This was statistically significant (chi 2, P less than 0.05). The authors encourage the concept of patient education. The data in the current study, however, suggest that the reasonable and prudent neurosurgeon making a concerted effort at patient education, with the assistance of a professional educator, cannot necessarily expect accurate patient or family recall or comprehension. Fulfillment of the doctrine of informed consent by neurosurgeons may very well be mythical.

Adult↗