Informed consent: assessment of comprehension

OBJECTIVE: The authors designed and evaluated a structured and rigorous informed consent procedure involving subjects with schizophrenia. METHOD: Informed consent forms were read and explained to 49 schizophrenic patients participating in ongoing clinical treatment research trials. The subjects answered a questionnaire relating to each research protocol. Protocol procedures were reiterated until the patients answered 100% of the questions correctly. Subjects were asked the same questions 7 days later to ascertain how much of the information they had retained. RESULTS: The patients' median score on the first trial of the informed consent questionnaire was 80% correct. To achieve 100% correct responses, 53% of the patients required a second trial of the questionnaire, and 37% of them required three or more trials. Scores improved between the first trial and the trial on day 7. Ninety-six percent of the subjects felt adequately informed, 66% reported participating in the research protocol for personal reasons, and 34% reported participating at the suggestion of others. CONCLUSIONS: These findings demonstrate that when adequate informed consent procedures are established, schizophrenic research subjects are able to understand and retain critical components of informed consent information.     

A program of quality improvement in transfusion safety. Experience at Saint-Camille Hospital

Because of concerns about competence and voluntariness, the mentally disordered constitute a vulnerable population in the context of nontherapeutic biomedical research and, as such, are in need of protection. Despite others' concern about protecting the mentally disordered, their decision-making potential should also be respected and maximized, allowing such individuals to consent to participate in experiments subject to an evaluation of their competence to make such a decision. Competent mentally disordered persons who anticipate future incapacity should be able to issue research directives or durable powers of attorney whereby they can provide explicit consent to participate in nontherapeutic research. When he or she becomes incompetent, a substitute decision maker should be able to provide consent on behalf of the mentally disordered person within established parameters. Nontherapeutic experimentation with the mentally disordered should be permitted, but only within the boundaries of ethical permissibility delineated by legislated guidelines. At present, the legal status of substituted consent for nontherapeutic procedures is uncertain and requires legislation, which in addition to legalizing such consent, would provide guidelines for substitute decision makers and for the creation of research directives. These guidelines should include restrictions on the scope of research, obligations of researchers, rights of subjects, and responsibilities of research ethics committees (RECs). In all cases, the voluntary and informed consent of the person or substitute decision maker must be obtained.     

Informed consent in family therapy research: Ethical dilemmas and practical problems.

Presents several scenarios that illustrate the ethical and practical issues involved in conducting family therapy research. The 3 elements of informed consent, identified in the Belmont Report (1979) as information, comprehension, and voluntariness, are discussed. Guidelines for applying the American Psychological Association ethical principles (see record 1982-04246-001) from a systems-sensitive perspective are offered. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

The informed consent process in older patients who developed delirium: a clinical epidemiologic study

PURPOSE: Delirium, defined as an acute, fluctuating disorder of attention and cognition, is a serious and increasingly common problem for hospitalized older persons. Delirium poses unique ethical challenges for the informed consent process, notably the preservation of patient autonomy in the face of potentially fluctuating decision-making capacity. To clarify these issues, we examined the informed consent process in a group of hospitalized older patients who developed delirium. PATIENTS: Eighty-four hospitalized patients aged >70 years who developed delirium during hospitalization at a large urban teaching hospital. METHODS: We conducted a clinical epidemiologic investigation of informed consent in 173 medical and surgical procedures performed in 84 patients. Clinical researchers carried out detailed cognitive evaluation of patients on or near the consent date. A separate blinded researcher extracted medical record information on the procedures and informed consent process variables. RESULTS: Of 173 procedures, 33 (19%) had no documentation of any consent, and 34 (20%) used surrogate consent. There were no documented assessments of competency/ decisional capacity; cognitive assessments were done in 7 (4%) cases, and legal consults in 2 (1%) cases. Discussion of potential risks of the procedure with patient or surrogate were documented in 61 (35%) cases. In multivariable analysis, independent predictors for failure to obtain consent were presence of delirium (adjusted odds ratio [OR] = 2.7, 95% confidence interval [CI] 1.3, 5.3) and less invasive procedure (OR = 5.0, CI 2.0, 12.8). Although cognitive impairment predicted surrogate use, we found that 47% of cases with substantial impairment did not involve use of a surrogate, whereas surrogates signed for 4% of cases with normal mental status near the time of consent. CONCLUSIONS: Our results highlight the ethical challenges that delirium poses for the informed consent process, including the high rate of no consent, lack of cognitive and decisional capacity assessment, and inconsistent surrogate use.     

Ethical issues in informed consent with substance abusers.

Alcohol and drug abusers present issues that complicate the informed consent process. The present study examined the practices of federally funded clinical investigators in obtaining informed consent from alcohol and drug abusers. Ninety-one (51%) researchers completed a 27-item survey on informed consent issues. The majority of investigators (57%) recruited participants susceptible to coercion; most used procedures to minimize coercion. Two thirds of researchers used objective means to determine competence to give consent and comprehension of consent forms. Virtually all investigators had policies to deal with suicidality, homicidality, or reports of child abuse; less than 1/2 informed participants of these limits to confidentiality. Almost 50% of investigators had dealt with intoxicated or suicidal participants; 12% had encountered homicidal participants; and 23% had encountered child abuse or neglect. Half of the sample used collateral data sources; about 1/2 of these obtained written informed consent from collaterals. Guidelines for informed consent with substance abusers are suggested. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Use, content, and readability of written informed consent forms for treatment.

Questionnaires were sent to 196 psychologists in private practice. Of the 104 (53%) respondents, 28.8% reported using written consent forms. The major reason cited for not using them was a preference for oral agreements. The content of the forms dealt primarily with issues regarding fees and not with information that satisfies the requirements of informed consent, such as risks of treatment and alternative treatments. The average readability for the consent forms returned was the "difficult" range, equivalent to an academically oriented magazine. Therapists need to evaluate their practices regarding informed consent, in order to increase clients' autonomy and their understanding of information provided. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

In case of emergency: no need for consent

The Food and Drug Administration (FDA) is amending its current informed consent regulations to permit harmonization of the Department of Health and Human Services' (DHHS) policies on emergency research and to reduce confusion on when such research can proceed without obtaining an individual subject's informed consent. This regulation provides a narrow exception to the requirement for obtaining and documenting informed consent from each human subject, or his or her legally authorized representative, prior to initiation of an experimental intervention. The exception would apply to a limited class of research activities involving human subjects who are in need of emergency medical intervention but who cannot give informed consent because of their life-threatening medical condition, and who do not have a legally authorized person to represent them. FDA is taking this action in response to growing concerns that current rules are making high quality acute care research activities difficult or impossible to carry out at a time when the need for such research is increasingly recognized.     

A guide to understanding informed consent

Anesthesia providers are expected to provide information to the patient during the preanesthesia interview that enables the patient to make informed choices. Adequate disclosure during the informed consent process ensures the equalization of the practitioner/patient relationship and the decision-making rights of the patient. Both certified registered nurse anesthetists (CRNAs) and anesthesiologists are not only legally required to provide information that will allow a patient to make an informed judgment about how to proceed with various anesthetic modalities but are also obligated by their standards of practice. This article informs the CRNA about the principles of informed consent so that they can better understand their role in the informed consent process.     

Ethical Issues in Couple and Family Research.

Federal regulations, ethical standards, and state laws governing ethics do not adequately address important issues in couple and family research. Including multiple family members, particularly dependent minors, in research requires the special application of fundamental ethical issues, such as confidentiality, privacy, and informed consent. The sensitive, commingled nature of couple and family information necessitates clear policies about data ownership and disclosure. Researchers need to have respect for the family as a unit and to evaluate benefits versus harms for the family as well as for individuals. This article highlights areas of potential concern and ambiguity related to abuse reporting and Certificates of Confidentiality and also addresses ethical issues with observational data, intervention studies, longitudinal designs, and computer-assisted research. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Panel discussion: problems of the specialist's duty to inform the patient (author's transl)

The obligation of the physician to inform the patient--which he has to prove in case of a suit--is based on the patient's right of self-determination. This self-decision information was subject of the panel discussion. Not discussed in detail were the information concerning diagnosis and prognosis, and the instruction of the patient regarding his conduct postoperatively and during medical treatment. Not considered was the so-called malpractice and negligence respectively. Medical liability suits are increasing for various reasons and are frequently directed at a failure to inform the patient becuase the patient is often unable to prove a negligence of the physician ("surrogate liability"). The dimension of the duty of disclosure (complete information--no information at all) is discussed in general and with special regard to the Ear-Nose- and Throat field. Special questions are answered regarding otoplasty, middle ear surgery, transplantations, extension of laryngeal surgery without prior informed consent, paranasal sinus and rhino-basis operations as well as surgery in minors and foreigners. In cases of non-vital indication and particularly in plastic-cosmetic procedures and outsider methods the requirements for informed consent are particularly important. The so-called rate of complications has perhaps a relative, but never an absolute meaning, and even this only in connection with the other circumstances of an individual case. The evidence of an adequate informed consent which must be included in a physician--patient-dialogue is most convincing by means of a written consent and the additional signature of a witness, perhaps also of the patient. The value, the problems and even the risks of an information based only on forms or brochures is discussed in detail. The panel discussion from the four points of view of the organizers should be no means confuse the otorhinolaryngologist. It should inform him about the medicolegal aspects of his activity and protect him from avoidable burdens.     

A monoclonal antibody shows discrete cellular and subcellular localizations of mGluR1 alpha metabotropic glutamate receptors

Informed consent is a process of communication between a health care provider and patient that educates the patient as to the patient's needs and the potential solutions for those needs, and leads to the endorsement of a health care treatment plan. A claim of lack of informed consent may be brought by a patient when there is a perceived failure in the disclosure of adequate information to make a reasoned decision whether to consent to treatment. This article provides the foundation of the informed consent doctrine, delineates the essential elements of a lack of informed consent claim, and identifies the parties and their roles in the informed consent process.     

Privacy and confidentiality in the publication of pedigrees: a survey of investigators and biomedical journals

CONTEXT: Pedigree diagrams efficiently communicate family information to genetics investigators; however, the publication of pedigrees poses a risk to the privacy and confidentiality of individuals depicted in the diagrams. Two sets of authoritative guidelines have been published to protect the privacy and confidentiality of subjects, but the influence of these guidelines on publication practices for pedigrees is unknown. OBJECTIVE: To determine the attitudes, practices, and experiences of investigators and journals with respect to privacy and confidentiality concerns in the publication of pedigrees. DESIGN: Investigators who have published pedigrees and editors of 26 biomedical journals were surveyed. Journals were reviewed for content in their "information for authors" sections and for documentation of informed consent in articles containing pedigrees. OUTCOME MEASURES: Practices regarding confidentiality and privacy reported by investigators and editors. RESULTS: Of 226 surveys sent to investigators, 177 were returned (78% response rate). Sixty-one investigators (36%) stated that family members were not informed that their pedigree would be published; 131 (78%) do not obtain informed consent specifically for pedigree publication and only 12 (28%) of the 43 who obtained consent obtained consent from all family members depicted. Thirty-two individuals (19%) reported having altered published pedigrees and 14 (45%) of 31 who had altered pedigrees stated that alterations were not disclosed to journals. Of the 14 journals that responded (54% response rate), only 3 reported written policies for managing potentially identifying information. Two journals reported having asked authors to alter pedigrees and 3 stated they had permitted alterations. A review of 5 genetics journals over a 2-year period revealed no documentation of consent for pedigree publication. CONCLUSIONS: Current practices in the publication of pedigrees do not conform with established recommendations and risk the privacy and confidentiality of subjects, often without informed consent. Attempts to address this problem through the alteration of data are being used, although this practice impairs the integrity of scientific communication.     

Ethical standards as an independent variable in psychological research.

Discusses recent proposals concerning ethical standards for psychological research. An experiment was conducted using a simple, typical verbal conditioning task in which the E said "good" when the S began a sentence with either "I" or "we." The nonethical group of 14 male undergraduates was selected and run under current procedures: they were informed only that the experiment involved "sentence construction." The ethical group of 14 Ss was selected and run under conditions of full disclosure of the experiment's purpose and hypotheses. Ss were allowed to participate or not under complete informed consent. Ss in the nonethical group significantly conditioned in a positive direction, while those in the ethical group conditioned in a negative direction (p     

Informed consent: The effects of clarity and specificity on disclosure in a clinical interview.

Replicated and extended the findings of T. Muehleman et al (1985) that informing clients of the limits of confidentiality is not necessarily detrimental to disclosure. 32 single mothers (approximate mean age 34 yrs) were assigned to 1 of 3 groups receiving an informed consent form prior to a clinical interview. The forms differed in the amount of specificity and clarity of information pertaining to the limits to confidentiality. Results indicate that when the limits to confidentiality were conveyed in a clear and specific manner, there was no decrease in disclosure. Contrary to these findings, 27 clinical psychologists who were surveyed predicted that increasing clarity and specificity of information concerning the limits to confidentiality would lead to decreased disclosure by the interviewees. (25 ref) (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Legal and ethical considerations of informed consent

The law of informed consent remains ineffective at resolving patient comprehension issues primarily because differing interpretations exist regarding who is responsible for the duty to inform. Court cases continue to set precedents for practicing physicians and other health care providers; however, other measures can be applied for effectual patient advocacy. Health care personnel should rewrite typical consent forms in simpler terms, use larger print, and create duplicate copies. If patients are given copies of the permits they sign, the can reread the forms at home when they are more comfortable. For true autonomy to exist in informed consent for surgical procedures, consent forms should contain patients' primary languages whenever possible, or an adequate interpreter should be made available. Surgeons, nurses, and other health care providers must become aware of their responsibilities related to informed consent for treatment. It is necessary for health care personnel to develop and use effective communication techniques and remember that although some patients are more visually attuned to new information, other patients may benefit more from listening or reading. The cases in this article show that a patient's autonomy is part of the informed consent process and the duty to inform the patient lies with the person performing the procedure. A more important issue, however, involves the patient's comprehension of the information given, because without it, the patient cannot achieve true autonomy in making decisions. Ensuring that all elements of informed consent are met to obtain informed consent will result in fewer malpractice claims, greater patient satisfaction, and an improved professional image. Nevertheless, nurses should make themselves aware of the state laws in which they practice, including their nurse practice acts. They then should advocate for patient rights by encompassing all elements of informed consent.     

Control of direction of flagellar rotation in bacterial chemotaxis

PURPOSE: To assess the policies and practices of nuclear medicine facilities as regards ventilation-perfusion (V-P) imaging in pregnant patients suspected of having pulmonary embolus. MATERIALS AND METHODS: Surveys were mailed to physician-directors of 1,000 randomly selected facilities at which nuclear imaging studies are performed. Information gathered included use of V-P imaging in pregnant patients, written policies, informed consent procedures, and modifications of standard protocols. RESULTS: Of the 1,000 surveys mailed, 327 (33%) completed surveys were returned. Of these 327 respondents, 220 (67%) reported that they perform V-P imaging in pregnant patients suspected of having pulmonary embolus. Of these 220 respondents, 115 (52%) routinely obtain informed consent, and 170 (77%) modify their standard V-P imaging protocol for pregnant patients. The most common modification (135 [79%] of 170 respondents) was reduction of the perfusion agent dose. Reported practice patterns for written policies, informed consent, and modifications did not show statistically significant trends among respondents in varying practice settings or geographic locations. CONCLUSION: Most respondents perform V-P imaging in pregnant patients suspected of having pulmonary embolus, with considerable variability in their policies and practices.     

Monitoring clinical research: an obligation unfulfilled

The revelation that data obtained for the US-based National Surgical Adjuvant Breast and Bowel Project (NSABP) from subjects enrolled at H?pital Saint-Luc in Montreal was falsified has eroded public trust in research. Institutions can educate researchers and help prevent unethical research practices by establishing procedures to monitor research involving human subjects. Research monitoring encompasses four categories of activity: annual reviews of continuing research, monitoring of informed consent, monitoring of adherence to approved protocols and monitoring of the integrity of data. The authors describe characteristics of research projects that may call for monitoring procedures in each category. The form taken by such monitoring depends on the nature of the protocol. Although appropriate research monitoring requires substantial investment of personnel and financial resources, it is required under guidelines regulating research involving human subjects in Canada. Research monitoring is a step forward in re-establishing public confidence in medical research.     

Informed consent with suicidal patients: Rethinking risks in (and out of) treatment.

Informed consent is uniformly accepted as essential to the treatment process. However, the relevant literature has not discussed issues of risk specific to suicidal patients, nor has such information routinely been included in the informed consent process. The implications of including suicide-specific risk information in the informed consent process is discussed and examples provided. (PsycINFO Database Record (c) 2010 APA, all rights reserved)