An alternative rationale for informed consent by human subjects.

Discusses the conscientious researcher's objection to the special emphasis placed on informed consent and proposes an alternative rationale for consent. If the special emphasis on informed consent derives from a distrust of researchers, then the underlying relationship between professionals and the community at large has broken down. However, since research, by definition, involves something that the expert does not yet understand, there is no reason to trust the judgment of the expert over that of the layperson. Therefore, Ss must be able to make a decision of whether or not to participate that is based on as much information as the researcher can provide. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Material risks and informed consent to psychotherapy.

The article by R. T. Hare-Mustin et al (see record 1979-26958-001) dealing with client rights and informed consent (IC) and the article by L. Everstine et al (see record 1980-31031-001) dealing with confidentiality and IC in psychotherapy articulate ethical concerns that have not received the amount of attention their importance deserves and requires. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Confidentiality, ethics, and informed consent.

Comments on the article Protecting confidentiality rights: The need for an ethical practice model by Mary Alice Fisher (see record 2007-19520-001). In Fisher's excellent and much-needed article, she rightly implied that when discussing ethical dilemmas, psychologists may find themselves saying "consult an attorney" almost as often as they find themselves saying, "consult a fellow psychologist." Fisher's article was meant to turn the ship so to speak, by providing psychologists with a foundation for thinking clearly about confidentiality issues--a foundation that does not use legal arguments as primary building blocks. The above being said, we offer comments about four issues that we hope will add to the fine ideas expressed by Fisher. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Risks of alcohol consumption in laboratory studies involving human research participants.

Research protocols that include alcohol consumption raise a number of critical issues with regard to potential risks to research participants, researchers, and institutions. This article seeks to highlight some of these issues by presenting some of the potential risks and discussing relevant dimensions and parameters of these risks. Risks to individual research participants are the primary focus of concern, but consideration of risks associated with aspects of the experimental, contextual, and institutional setting are also considered. The authors conclude with recommendations for individuals conducting studies involving alcohol consumption by human research participants. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Evaluation of Institutional Review Board review and informed consent in publications of human research in critical care medicine

OBJECTIVE: To examine the frequency of obtaining Institutional Review Board (IRB) approval and informed consent in critical care research. DATA SOURCES AND DATA EXTRACTION: One-year retrospective review of original critical care research in humans published in seven journals, including American Journal of Respiratory and Critical Care Medicine, Chest, Critical Care Medicine, Intensive Care Medicine, The Journal of the American Medical Association, Lancet, and The New England Journal of Medicine. Studies were examined for general information (country/state where the research was performed, affiliation of the hospital to a medical school, and whether the work was supported by a grant and specifically by a pharmaceutical company), approval by IRB, method of consent, design of research, and interventions involved in the study. DATA SYNTHESIS: Two hundred seventy-nine studies were reviewed, 124 (44%) of which were conducted in the United States. Two hundred forty-three (87%) studies were performed in a university institution, 96 (34%) studies were supported by a grant, and 23 (24%) studies were supported by a pharmaceutical company. In 66 (24%) studies, there was no evidence of IRB review and informed consent approval. IRB approval was obtained but the method of consent was not specified in 36 (13%) studies. No significant differences were found in obtaining IRB approval and informed consent between research conducted in the United States (n=71, 57%) or outside the United States (n=92, 59%). Grant support was obtained in ten (9%) of the 116 studies not fully approved, compared with 70 (50%) of the 140 studies that obtained full approval (p < .05). All studies (23) supported by the pharmaceutical industry were fully approved. CONCLUSIONS: Many published studies in critical care lack IRB approval and/or informed consent. All research supported by the pharmaceutical industry was fully approved. The findings raise ethical concerns about critical care research.     

Emergency medicine and the development of the Food and Drug Administration''s final rule on informed consent and waiver of informed consent in emergency research circumstances

The quality of dental unit water is of considerable importance since patients and dental staff are regularly exposed to water and aerosols generated from the dental unit. The unique feature of dental chair water lines is the capacity for rapid development of a biofilm on the dental water supply lines combined with the generation of potentially contaminated aerosols. The biofilm, which is derived from bacteria in the incoming water and is intrinsically resistant to most biocides, then becomes the primary reservoir for continued contamination of the system. Dental water may become heavily contaminated with opportunistic respiratory pathogens such as Legionella and Mycobacterium spp. The significance of such exposure to patients and the dental team is discussed. There is at the present time, no evidence of a widespread public health problem from exposure to dental unit water. Nevertheless, the goal of infection control is to minimise the risk from exposure to potential pathogens and to create a safe working environment in which to treat patients. This paper evaluates the range of currently available infection control methods and prevention strategies which are designed to reduce the impact of the biofilm on dental water contamination, and are suitable for use in general practice. Bacterial load in dental unit water can be kept at or below recommended guidelines for drinking water (less than 200 colony forming units/ml) using a combination of readily available measures and strict adherence to maintenance protocols. Sterile water should be employed for all surgical treatments.     

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)     

Getting meaningful informed consent from older adults: a structured literature review of empirical research

OBJECTIVES: To perform a structured literature review of the published empirical research on informed consent with older adults in order to make recommendations to improve the informed consent process and to highlight areas needing further examination. DESIGN: Relevant literature was identified by searching electronic databases (AGELINE, BIOETHICSLINE, CancerLit, Ethics Index, Health, LegalTrac, MEDLINE, PAIS International, PsycInfo, and Sociofile). Studies were included if they were reports of primary research data about informed consent and, if patients or other subjects were used, older subjects were included in the sample. Data related to the aspect of informed consent under study (recruitment, decision-making capacity, voluntariness, disclosure of information, understanding of information, consent forms, authorization, and policies and procedures) were abstracted and entered into a specially designed database. MEASUREMENTS: Characterization of the population, age of subjects, setting, whether informed consent was being studied in the context of research or treatment, study design, the nature of outcome or dependent variables, independent variables (e.g., experimental conditions in a randomized controlled trial or patient/subject characteristics in a nonrandomized comparison), and results according to the aspect of informed consent under study. RESULTS: A total of 99 articles met all the inclusion criteria and posed 289 unique research questions covering a wide range of aspects of informed consent: recruitment (60); decision making capacity (21); voluntariness (6); disclosure (30); understanding (139); consent forms (7); authorization (11); policies (13); and other (2). In the secondary analyses of numerous studies, diminished understanding of informed consent information was associated with older age and fewer years of education. Older age was also sometimes associated with decreased participation in research. Studies of disclosure of informed consent information suggest strategies to improve understanding and include a variety of novel formats (e.g., simplified, storybook, video) and procedures (e.g., use of health educators, quizzing subjects, multiple disclosure sessions). CONCLUSIONS: A systematic review of the published literature on informed consent reveals evidence for impaired understanding of informed consent information in older subjects and those with less formal education. Effective strategies to improve the understanding of informed consent information should be considered when designing materials, forms, policies, and procedures for obtaining informed consent. Other than empirical research that has investigated disclosure and understanding of informed consent information, little systematic research has examined other aspects of the informed consent process. This deficit should be rectified to ensure that the rights and interests of patients and of human subjects who participate in research are adequately protected.     

Facilitating informed consent for outpatient psychotherapy: A suggested written format.

Although the responsibility of psychologists to inform clients fully about psychotherapy is clear, an adequate procedure for doing so is not. We present a written format designed to facilitate the informed consent process. The format is a series of questions that clients have a right to ask and has several advantages over narrative forms: It preserves clients' rights to refuse information, it is less overwhelming, it fosters conversation between therapist and client, and it is readable. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Epidural analgesia for labour and delivery: informed consent issues

We analyzed the clade distribution of B and E in HIV-1 isolates in Japan by a nested PCR method using 5'-CCCACAAGATTTAAATATG-3' of the gag gene as clade B primer and 5'-CCCACAAGATTTAAACTCC-3' of the gag gene as clade E primer. Seventy-two anti-HIV-1 confirmatory positive serum samples were collected during a period of 1991-1996 in two hospitals in Yokohama City. Peripheral blood mononuclear cells were obtained from the buffy coat of these samples and extracted DNA were used for nested PCR. The 72 cases comprised of 11 Japanese hemophiliacs, 14 Japanese male homosexuals, 19 Japanese male heterosexuals, 5 Japanese female heterosexuals and 23 Thai female heterosexuals. Of these 36 were clade B and 35 were clade E and one case showed positive PCR results for both B and E primers. Almost all male Japanese hemophiliacs and homosexuals in our sample have clade B, while the female Thai heterosexuals have clade E, irrespective of the year of isolation. As for Japanese male heterosexuals, through 1993, clade B was predominant but since 1994, the predominate clade switched to clade E. Although the number of Japanese female heterosexuals in our sample is small, clade B was isolated in 2 cases even after 1994.     

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)     

The World War II plutonium experiments: contested stories and their lessons for medical research and informed consent

During the Second World War medical researchers around the USA injected 18 hospital patients with radioactive plutonium in order to learn its effects on the body. Two documents, a newspaper account and a university committee report, tell divergent stories of the scientists and patients involved in that experiment. This article uses those documents-plutonium narratives-as a catalyst for exploring the problematic representation of past human experimentation, assumptions of moral progress in medical research, and the nature of informed consent today. Informed consent is shown to be an evolving process and discursive practice that cannot be understood apart from its historical and cultural embeddedness.     

Creating a link between research and practice.

Reviews the book, Understanding Research in Clinical and Counseling Psychology by J. C. Thomas; M. Hersen (Eds.) (see record 2003-02257-000). This is a research methods textbook written primarily for clinical and counseling students and would be useful for any students who are planning on pursuing a helping vocation, or for current practitioners. Targeted for this specific audience, it bridges the gap between research and practice by describing clear links between the two throughout the text. Even though this is an edited book, with different authors for each chapter, the writing across the chapters is similar, and thus is easy to read and understand. The authors' foci on bridging this gap sets this text apart from other available research textbooks. The most prominent difference with this text is the use of examples. The emphasis of the examples is on aspects of research that are relevant and important to the field of psychology. The 16 chapters are divided into four sections: Research Foundations, Research Strategies, Research Practice, and Special Problems. Each section has a different scope, which creates structure and links between the various topics. The gap between research and practice can be vast and difficult to close for many practitioners. The book keenly focuses on the issue of closing this gap by presenting research concepts interwoven with practice issues. (PsycINFO Database Record (c) 2011 APA, all rights reserved)