Injuries to research subjects A survey of investigators

A task force of the Department of Health, Education, and Welfare conducted a survey aimed at estimating the incidence of research-related injuries, with a view to determining the feasibility of compensating subjects injured during research. The data were obtained by telephone from 331 investigators conducting research on nearly 133,000 human subjects over the past three years. Eighty-five investigators reported at least one injury. Of the 4957 reported injuries, 3926 were classified as trivial, and 974 as temporarily disabling; of 57 injuries resulting in death or permanent disability, one disabling stroke, not clearly related to the research, occurred three days after a non-therapeutic procedure; the rest resulted from treatments expected to benefit the patients directly, usually cancer chemotherapy. The data suggest that the risks of participation in nontherapeutic research may be of no greater than those of everyday life, and in therapeutic research, no greater than those of treatment in other settings.     

Ethical review of multi-centre research: a survey of local research ethics committees in the south Thames region

We reported a 63-year-old woman with myotonic dystrophy (MD), who had frequent swallowing disturbances and died from suffocation asphyxia. Her esophagus on CT image 30 minutes after taking semi-solid meal showed dietary remnants in the middle portion of esophagus with entire esophageal dilatation. At autopsy, there was marked atrophy in the striated muscles in the upper part and smooth muscles in the lower part of the esophagus. The site of dietary stagnation on CT image was identical to the atrophic smooth muscle layer seen at autopsy. We speculate that one of the causes of esophageal motor dysfunctions is smooth muscle atrophy. The dietary stagnation in the esophagus may increase a risk of the asphyxia. Therefore we need to keep patients at the straight position during and after dietary ingestion to prevent respiratory problems.     

Structure and practice of institutional review boards in the United States

OBJECTIVE: The institutional review board (IRB) is a critical element in the protection of patients' and subjects' rights with regard to their participation in research protocols. The purpose of this study was to describe the structure and current practices of IRBs in the United States. METHODS: A self-administered questionnaire was mailed to the IRB chair of each U.S. hospital with a capacity of at least 400 beds (n = 907). The survey contained 21 questions outlining committee size and structure, review of research proposals, and policies concerning scientific misconduct. Chairs also were asked what advice they would offer a young investigator preparing a proposal for submission. RESULTS: A total of 488 surveys (54%) were returned; 447 of the responding institutions had an IRB committee. Committees had an average of 14 members, representing 27 medical specialties. Orthopedics had the least IRB representation (10% of committees), followed by emergency medicine (12%) and ophthalmology (15%). The majority of research proposals go through 5 specific steps once submitted for review. Common reasons for proposal rejection were improperly designed consent form (54%), poor study design (44%), unacceptable risk to subjects (34%), ethical or legal reasons (24%), and scientific merit (14%). When a research proposal is rejected, 86% of the responding IRBs assist the investigator in making appropriate revisions. Although a number of IRBs (17%) have dealt with scientific misconduct allegations, only 58% have a written policy regarding research integrity. CONCLUSION: Despite variations in committee structure and representation, IRBs have similar procedures for governing research. Investigators should be familiar with these procedures and are encouraged to discuss their proposal with an IRB representative prior to formal review.     

Ethical and legal aspects of survey research.

Sample surveys have been received as legal evidence since 1940. Judges have given weight to sample survey research in reaching decisions. Among the problems involved is the legal pressure to disclose names of respondents—a violation of the principle of confidentiality and anonymity under which much survey research is conducted. "It is the purpose of the present paper to call to the attention of relevant professional associations the need for guidance on this ethical and legal issue." Under what conditions should names of respondents be disclosed? Major sections are: The scientist in court, The dilemma, Estimating reliability, A case study. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Scope of hypnosis education in academia: results of a national survey

Nutritional husbandry of captive wild ruminants often requires feeding these animals a supplemental diet to enhance their health, reproductive performance, and productivity. Although supplemental diets for wild ruminants are commercially available, few have been evaluated in controlled intake and digestion trials. Voluntary intake, digestive efficiency, nitrogen retention, and gross energy utilization of pronghorn (Antilocapra americana), mule deer (Odocoileus hemionus), mountain sheep (Ovis canadensis), mountain goats (Oreamnos americanus), and wapiti (Cervus elaphus) consuming a high-energy, high-protein pelleted supplement were compared. Voluntary intake of dry matter, energy, and nitrogen were similar (P > 0.34) between mountain goats and mountain sheep and consistently lower (P < 0.03) for these species than for pronghorn, mule deer, and wapiti. Differences in digestive efficiency among species were inversely related to dry matter intake rates. Apparent digestibility of dry matter, organic matter, and neutral-detergent fiber was 10-20% higher for mountain goats and mountain sheep than for the other species (P < 0.04). Although these findings suggest a superior digestive efficiency for mountain goats and mountain sheep, species comparisons are inconclusive because of the confounding effects of season and ambient temperature on voluntary intake and digestion. Under the conditions of this experiment, the diet tested was safe, nutritious, and highly palatable. Protein and energy concentrations appear to be sufficient to meet or exceed known nutritional requirements of captive wild ruminants.     

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 regulations and their impact on research practice.

Examined the impact on experimental results of ethical procedures such as informed consent, freedom to withdraw, and constraints on the use of deception by surveying the frequency of these practices in studies published in 9 social psychology journals (e.g., Journal of Personality and Social Psychology), 7 from 1979 and 3 from 1983 (1 journal was surveyed twice). Results show that the proportion of studies that reported obtaining informed consent or explicitly giving Ss the freedom to withdraw was negligible and that the practice of deception has not been reduced by ethical regulations. The percentage of social psychological studies that used deception increased monotonically over the past 3 decades. Although recent data show a slight decline, the extremity of some deceptions does not seem to have moderated. Reports of debriefing Ss have generally increased; however, most investigators still do not report this practice, and few describe what Ss are told. It is argued that detailed reporting of these practices should be required and expected in all published research. (82 ref) (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Outcomes research: a review

PURPOSE: The purpose of this article is to review the history of the medical outcomes movement as well as the methodologies used in outcomes research. CONCEPT: Outcomes research refers to a genre of clinical investigation that emphasizes the measurement of patient health outcomes, including the patient's symptoms, functional status, quality of life, satisfaction with treatment, and health care costs. RATIONALE: Outcomes research evolved from studies that demonstrated the presence of wide geographic variations in the practice of medicine and surgery. Such differences in utilization were unaccompanied by any discernible difference in patient outcomes. With escalating health care costs, there has been a growing interest in measuring the outcomes of medical intervention to determine the quality and appropriateness of medical care. DISCUSSION: Outcomes may be measured both directly and indirectly, over differing periods of time, and with varying degrees of objectivity, reliability, and validity. Current research has focused on quality of life issues, which include the extent to which a patient's usual or expected physical, emotional, and social well-being have been affected by a medical condition or treatment. The true value of health care can be determined only by a systematic examination of patient outcomes. To accomplish this goal, methods are required that are relatively unfamiliar to many clinical researchers. Future clinical research should include patient-oriented outcome measures that would otherwise focus solely on physiological or anatomic outcomes. Such information will be essential in determining which medical and surgical treatment strategies should be abandoned and which will gain acceptance in the future.     

Ethical dilemmas in psychological practice: Results of a national survey.

Surveyed 294 randomly selected psychologists who were members of Division 29 (Psychotherapy) of the American Psychological Association (APA) on the choices they would make in the face of specific ethical dilemmas. Ss were presented 10 vignettes, each representing a potential problem of professional ethics. They were asked to indicate their preferred resolution to the dilemma and their primary reason for choosing this alternative. Ss were also asked to rate the frequency with which they encountered each of 17 ethical/legal issues in their clinical practices and to rate each issue's severity. Ss also described dilemmas that they themselves had experienced in practice. Results show that the degree of consensus on the appropriate response to the 10 dilemmas varied considerably. Highest consensus was achieved on such issues as duty to warn potential victims of violence and avoidance of difficult bartering relationships. Lowest consensus was achieved on such issues as advertising practices and the boundaries of competence. Assessments of their own and their colleagues' competence and propriety were among the most troubling issues to Ss. It is suggested that work to further develop graduate course work in ethics should be pursued, with attention to real-world ethical problems involving confidentiality, competence, and colleagues' behavior. (12 ref) (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Active–alert hypnosis: Replication and extension of previous research.

Compared levels of hypnotic responsiveness resulting from 4 induction procedures: (a) verbal active-alert induction alone, (b) bicycle pedaling alone, (c) verbal active-alert induction plus bicycle pedaling, and (d) traditional relaxation induction. Ss were 48 undergraduates. Stanford Hypnotic Susceptibility Scale scores indicated that the verbal induction plus pedaling procedure was significantly more effective than either the verbal- or pedaling-alone procedures. There were no significant differences in scores produced by the verbal plus pedaling and traditional relaxation inductions. Findings are consistent with A. M. Ludwig's (1966) proposal that there exists a range of stimulation necessary for the maintenance of normal waking consciousness and that levels of stimulation above or below that range are conducive to the production of altered states of consciousness. (10 ref) (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Present status of psychological research and training in hypnosis.

Anonymous questionnaires on training and research in hypnosis were returned by 54 of 55 psychology department chairmen with approved clinical psychology training programs and 39 of 85 American Medical Association approved medical schools. 8 psychology departments and 2 medical schools have courses in hypnosis. Unless the "psychological profession is more active in protecting its rights to research and clinical use of a methodology which is basically psychological, it may find itself legally excluded from the field." (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Ethical and social issues in prenatal sex selection: a survey of geneticists in 37 nations

In a recent 37-nation survey of 2903 geneticists and genetic counselors, 29% would perform prenatal diagnosis (PND) for a couple with four girls who want a boy and would abort a female fetus. An additional 20% would offer a referral. The percentage who would perform PND in the United States (34%) was exceeded only by Israel (68%), Cuba (62%), Peru (39%), and Mexico (38%). In all, 47% had had requests for sex selection. There appears to be a trend toward honoring such requests since a similar survey in 1985. This paper discusses reasons for this trend and the ethical dilemmas of refusing patient requests in societies where individual autonomy is stressed.     

The institutional review board as a mirror of scientific and ethical standards

Decisions by institutional review boards (IRBs) are presumed to reflect the norms and standards of the scientific community. Such criteria have shifted as changes have occurred in experimental interventions and protocols, codes of federal regulatory agencies, norms among investigators, and expectations of participants. The tension created by shifting norms and standards raises two questions: (a) Should IRBs evaluate the scientific (e.g., design) features of the proposed research, and (b) should consistent standards be expected even in areas that are in constant flux (e.g., AIDS research)? We discuss these questions and propose a mechanism to keep IRBs abreast of emergent issues and sensitized not only to the costs of doing research but also to the costs of not doing it.     

Memory and hypnosis: Implications for the use of forensic hypnosis.

I review arguments regarding hypnosis in forensic investigations, offer procedures of a nonhypnotic nature to enhance memory recall, and suggest guidelines for hypnosis in criminal cases. The effects of hypnosis on memory, as well as the concomitant dangers regarding those effects, are discussed. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Two types of delinquents and their institutional adjustment.

Tested a typology classifying 326 incarcerated delinquent boys as buoyant or beset, depending on their level of anxiety and depression at intake. Findings reveal that the two types of boys differed in some aspects of life history and personality, that the buoyant type adjusted better to the institution's group-oriented treatment program, and that buoyant and beset boys responded differentially to some components of the treatment. Implications are drawn regarding the usefulness of the typology for guiding differential treatment. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

The antisaccade: a review of basic research and clinical studies

The ability to suppress reflexive responses in favor of voluntary motor acts is crucial for everyday life. Both abilities can be tested with an oculomotor task, the antisaccade task. This task requires subjects to suppress a reflexive prosaccade to a flashed visual stimulus and instead to generate a voluntary saccade to the opposite side. This article reviews what is currently known about the neural structures and processes which are involved in the performance of this task. Current data show that a variety of brain lesions, neurological diseases and psychiatric disorders result in errors, i.e. prosaccades towards the stimulus, in this task. Brain imaging studies have shown that a widely distributed cortical and subcortical network is active during the generation of antisaccades. These findings are discussed and the potential of the antisaccade task for diagnostic purposes is evaluated.