Pyogenic liver abscesses in patients with malignant disease: a report of 52 cases treated at a single institution

OBJECTIVE: To generate baseline data about the experiences of researchers applying to five or more local research ethics committees (LRECs) for ethical review. The new multi-centre review system will be compared with these data. DESIGN: Ninety-seven researchers, whose status as multicentre researchers was unclear, were identified from various sources in the South Thames Region. They were each sent a questionnaire asking for their views on the substance of ethical review and their experiences of the process of ethical review. RESULTS: Of the completed questionnaires, 24 fitted the multicentre criteria of applying to five or more LRECs. Responses showed dissatisfaction with LRECs' treatment of the scientific aspects of research, but satisfaction with aspects relating to consent and protection of patients' welfare. Respondents experienced great difficulty in the administration of the process of ethical review. CONCLUSIONS: The need for a new system of ethical review for multi-centre research is beyond doubt. It remains to be seen whether it will be an improvement.     

Medical research and the ethics committee. A questionnaire study among project leaders in the health region 4

All 159 principal investigators whose projects had been assessed by the biomedical research ethics committee in Health Region 4 (Central Norway) during 1986-92 were asked to complete a questionnaire about medical research ethics and the work of the ethics committee. Their answers about scientific fraud and misconduct have been published previously. This paper reports how the 119 respondents (70% of those addressed) regard the role and work of the ethics committees and how they perceived the committee's assessment of their own project. A majority agreed that medical ethics committees are an important part of the scientific community (90%), that scientific quality is an important ethical element of any project (85%), and that researchers put more effort into their study protocol as they knew it would be assessed by an ethics committee (85%). More than 70% agreed that the committee's comments were useful and relevant, but a majority of these agreed only partly. The results are discussed in relation to the characteristics of the investigators.     

Medical investigators' views about ethics and fraud in medical research

The objective of this study was to ascertain the views and attitudes of medical investigators on medical ethics, and ethics and fraud in medical research. We sent postal questionnaires to all principal investigators whose study protocols had been assessed by their regional medical ethics committee for biomedical research (mid-Norway) in the years 1986-92 (n = 159). The response rate was 70% (n = 119). Some 80% agreed that ethical considerations had influenced their research and 12% that they would have had ethical scruples today about some of their previous projects. One in ten agreed that they might have achieved better results if they could have paid less attention to ethics. About 70% of the respondents found that the committee's comments were useful and relevant, but most agreed only in part. Around 85% agreed fully or in part that scientific quality is an important ethical element of any project and that researchers put more effort into their study protocol when they knew it would be evaluated by an ethics committee. One in six (18%) respondents agreed fully or in part that they had been exposed to scientific misconduct. Also, 27% knew about one or more cases of fraud or misconduct while 42% stated that this knowledge was not public. We concluded that ethics in medicine and medical research have an important and increasing role among investigators with little or no theoretical background and training in ethics. Scientific fraud and misconduct in medicine is a growing concern among researchers, who welcome a professional body that can manage allegations and cases of fraud.     

Comment on Gilbert.

Comments on the article by S. J. Gilbert (January, 1983) regarding the work of institutional review boards and the ethics of research with human subjects. Gilbert argues that until researchers can learn to take ethical issues in research seriously as ethical and not merely political problems, those same researchers are likely to be mystified by objections to their protocols. The solution is not to psychologize the committees, but for psychologists to do some honest reflection on the ethics of their own research. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

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.     

Intersubunit structure within heterodimers of medium-chain prenyl diphosphate synthases. Formation of a hybrid-type heptaprenyl diphosphate synthase

The later work of Wittgenstein (1953) takes language and meaning as arising in use. A local 'grammar' is created. Ethical/research awarding committees have developed, and clashing, meanings about what constitutes 'good' research. The fixed rule language game of the committee is implicitly powerful because it is part of well-rehearsed societal narratives which equate science and knowledge. This creates a force on the qualitative researcher to conform to the authoritative grammar which it is difficult to counter. In these circumstances, qualitative researchers may choose to inhabit two, parallel research universes by 'storying' their research proposal according to the audience. But a question arises as to whether ethical approval has been gained when a 'Trojan horse' approach is used. Moving between worlds involves the researcher living with a dual identity. The postmodernist movement away from structure, form and singular truth is seen as setting a context for a new archaeology of knowledge which transcends good/bad dichotomies in relation to research. The qualitative researcher is encouraged to enter into dialogical communication with committees with the hope that a shared grammar may emerge.     

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.     

Written patient information. Analysis of Danish biomedical research programs]

All patients involved in biomedical research must, according to the Helsinki II declaration, receive complete verbal and written information about the project. Valid consent must be based on adequate information. This study analyses all of the 225 written patient information sheets submitted for approval to the regional research ethical committee covering the three southernmost counties in Jutland (Denmark) during the years 1989 and 1990. Linguistic analysis shows that the information is written in a difficult style with a median readability index of 48.2. It is generally recommended that information directed to the general public should have a readability index below 40 (approximately the level of the popular press). Analysis of information content shows that several important pieces of information are often missing: for instance, information about the name of the leader of the research and about the fact that the relationship with the institution will not be adversely affected by a refusal to participate in the research programme.     

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.     

Inhibition of Corynebacterium parvum-primed and lipopolysaccharide-induced hepatic necrosis in rats by selective depletion of neutrophils using a monoclonal antibody

The use of hospital ethics committees or infant care review committees has been recommended for difficult decision making. In a survey of military and civilian neonatologists, ethics committees had been established in 27 of their 28 hospitals and fewer than 50% had infant care review committees. Despite the frequently of potential cases for committee review, they were seldom consulted. Inquiry into the educational background of respondents revealed that at least 62% of neonatologists had received ethics education during their professional careers. Most made difficult decisions in conjunction with parents or used a multidisciplinary patient care conference. The use of these conferences antedated any federal regulations. Sixty-seven percent indicated that the Baby Doe regulations had affected neither their thinking about ethical issues nor their practice. In 13 different hypothetical cases in delivery room, intensive care nursery, and long-term care settings, the provision of comfort care, limited care, or withdrawal of support was noted by a sizable percentage of neonatologists; exceptions included meningomyelocele and trisomy 21. The need for ethics committee input in decision making for neonates is questionable.     

Medical research ethics 50 years after Nuremberg

50 years ago, in Nuremberg, 23 German doctors were accused of crimes against humanity. The anniversary is a solemn reminder of the dark origins of medical research ethics. Many researchers today believe that the medical experiments carried out under Hitler "vaccinated" postwar researchers against abuse. A review of the practices of postwar research shows that the "vaccination" had limited effect and that there is no reason to believe that the events which took place under Hitler were unique and will never happen again. After the war various measures were introduced to protect research subjects: informed consent, self regulation and independent research ethics committees. The measures have undoubtedly limited the abuse of subjects substantially. Nevertheless, in the Armed Forces, where abuse has been most rampant after the war, informed consent is not always practised and independent review is seldom carried out. With the support of grant institutions, journals and industry the protection of research subjects can be improved. It is recommended that medical faculties arrange an annual commemoration of the victims of medical research in order to raise consciousness and awareness among teachers and students.     

Being ethical in organizational research.

Suggests that even a researcher guided by moral intentions and learned in the code of ethics of the American Psychological Association is unprepared for the challenge of being ethical in organizational research. When dealing with persons in situ, in their normal role relations with others, ethical dilemmas arise from the researcher becoming entangled in a network of multiple roles and in the ambiguous and conflicting expectations derived from them. This article describes research with organized Ss and proposes role theory as a means for understanding ethical dilemmas in organizational research and for guiding the creation of research relationships with participants in which to address and moderate these dilemmas. It is proposed that research training and a code of ethics be developed that help researchers establish means for dealing with dilemmas in which there are no ethical solutions except those resting on the ad hoc consent of all parties. (26 ref) (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Ethics of practice: The beliefs and behaviors of psychologists as therapists.

There is an absence of comprehensive, systematically gathered data concerning psychologists' beliefs about and compliance with ethical principles. Furthermore, we know little about which resources are valued as effective in guiding appropriate behavior. Survey data were collected from 456 APA Division 29 members regarding the degree to which they engaged in each of 83 behaviors and the degree to which they considered each behavior to be ethical. These data were categorized and examined in terms of five principles derived from the Hippocratic oath (avoiding harm, competence, avoiding exploitation, respect, and confidentiality) as well as two additional principles (informed consent; social equity and justice). Twelve of the behaviors were very difficult for participants to evaluate on the basis of ethics. Seven of the 83 behaviors were practiced by over 90% of the participants; 16 by fewer than 10%. Colleagues, the APA Ethical Principles, and internship training were rated as the most helpful resources in guiding behavior; state and federal laws, published research, and local ethics committees were rated least helpful. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

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.     

Implications of socio-cultural contexts for the ethics of clinical trials

BACKGROUND: Health technology assesment (HTA) requires scientifically rigorous experimentation involving patients as subjects. HTA itself is required so that treatment given to patients will be both effective and efficient; this requirement is itself ethical in nature. At the same time it is essential that the methods used in HTA are ethically sound. Most healthcare researchers agree that the most effective and soundest method for assessing treatments is the randomised controlled trial (RCT). However, some researchers believe that the RCT is unethical, either in essence, or for use in some forms of medical research and HTA. Furthermore, many patients seem unable to understand the principles and purposes of the RCT, a factor which is highly detrimental for the validity of informed consent. Informed consent is the key to the ethics of medical research, both in most theories and in all codes of research conduct. Many RCTs therefore risk being unethical in practice, even if ethical in principle. AIM OF REPORT: To survey the main objections to the RCT and its alternatives. To assess the philosophical and methodological basis of these objections, and of the methods recommended for addressing them. To identify areas where objections are founded in social or cultural factors normally overlooked in ethical argument about the RCT methodology. To identify alternative arguments or methods which might resolve ethical conflicts in this area. HOW THE RESEARCH WAS CONDUCTED: The methods used were adapted from systematic reviews in medicine. Systematic searches of Medline, Psychlit and Sociofile CD-ROM databases; hand-searches of the major journals in general medicine and surgery, medical ethics and philosophy; and searches of books were carried out. The literature survey was restricted to articles published or abstracted in English. A database of the most relevant and useful materials was compiled, and is accessible on the Internet (http://www.liv.ac.uk/sdthomps/page1.html). RESEARCH FINDINGS: UNDERSTANDING RCTS AND THEIR ALTERNATIVES: There is some evidence of difficulty in understanding the aims and methods of RCTs, and some disquiet about elements of the RCT methodologies. These objections are well known and much discussed, and concern the use of placebo, the continuation of trials after significant differentials in benefit or harm are apparent, and randomisation. CULTURAL OR RELIGIOUS OBJECTIONS: There was an absence of evidence of cultural or religious objections to randomisation, placebo or other kinds of controlled prospective trials. This most likely reflects an absence of research rather than absence of objections. (ABSTRACT TRUNCATED)     

Are research ethics committees behaving unethically? Some suggestions for improving performance and accountability

The results of recent empirical investigations in research synthesis imply that research ethics committees are behaving unethically by endorsing new research which is unnecessary and by acquiescing in biased under-reporting of research which they have approved. The performance and accountability of research ethics committees would be improved if they required those proposing research to present systematic reviews of relevant previous research in support of their applications; to summarise the results of these reviews in the information prepared for potential participants; to register new controlled trials at inception; and to ensure that the results of these trials are made publicly available within a reasonable period of time after completion of data collection.     

Using deception ethically: Practical research guidelines for researchers and reviewers.

This article reviews highlights in the literature on existing recommendations for ethical use of deception in psychological research. We conclude that ethical guidelines and aspirational statements set out by research policies and advisory panels on ethics must eventually be operationalized into concrete terms when introducing deception into a research design. Specific directives for using deception are especially important for new researchers developing projects and also for university/departmental reviewers who are being asked to evaluate the ethical standing of proposed research. We offer a checklist designed to cultivate the understanding of junior researchers and to facilitate the review process by instantiating the relevant general guidelines into a set of Y/N questions about intended research. Finally, the article presents empirical data from researchers and ethics reviewers who provided end-user evaluations of the tool. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Professional integrity in clinical research

In response to public concern over abuses in human medical experimentation, the dominant approach to the ethics of clinical research during the past 30 years has been regulation, particularly via institutional review board review and approval of scientific protocols and written consent forms. However, the effectiveness of regulatory mechanisms in ensuring the ethical conduct of clinical research is limited. Little attention has been devoted to the nature and role of professional integrity of physician investigators, a conscientious framework for guiding investigators in the socially important but morally complex activity of clinical research. Professional integrity is vital in forging an ethically sound relationship between investigators and patient volunteers, a relationship that differs in important ways from the patient-physician relationship in standard clinical practice. We examine critically 2 models of the moral identity of physician investigators, the investigator as clinician and the investigator as scientist; in neither of these 2 models can the physician investigator eliminate completely the moral conflicts posed by clinical research. The professional integrity of physician investigators depends on a coherent moral identity that is proper to the enterprise of clinical research. The roles of clinician and scientist must be integrated to manage conscientiously the ethical complexity, ambiguity, and tensions between the potentially competing loyalties of science and care of volunteer patients.     

Clinical hepatology and pharmacoepidemiology: a pending multidisciplinary approach

A healthy 19-year-old United States college student volunteer in a clinical research program underwent a bronchoscopy and died as a result of acute lignocaine toxicity. The major contributing factor in the tragedy was that the research protocol failed to specify an upper dose limit for lignocaine spray, although previous versions of the protocol had done so. We look at the implications of this case for Australian institutional ethics committees.     

Accountability of state licensing committees.

Asserts that state psychology licensing committees should be accountable to the public and to the profession. Focus is on the licensing committee in one state which misused a grandfather clause written to include licensing for graduates of schools not approved by the American Psychological Association. The committee used the clause to exclude graduates of approved universities. (PsycINFO Database Record (c) 2010 APA, all rights reserved)