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PubMed2005

A summary of important documents in the field of research ethics.

Today's researchers are obligated to conduct their studies ethically. However, it often seems a daunting task to become familiar with the important ethical codes required to do so. The purpose of this article is to examine the content of those ethical documents most relevant to the biomedical researcher. Documents examined include the Nuremberg Code, the Declaration of Helsinki, Henry Beecher's landmark paper, the Belmont Report, the U.S. Common Rule, the Guideline for Good Clinical Practice, and the National Bioethics Advisory Commission's report on research protections for the mentally ill.

Advance Directives↗

PubMed2000

Incomplete recovery among endogenously depressed patients: an ethological analysis.

The paper reports on an ethological study comparing the behavior of hospitalized endogenously depressed (N = 11) and nonpsychiatrically ill control (N = 11) subjects hospitalized for somatic illnesses. All subjects participating in the study signed the Helsinki Declaration of 1964 for protection of human research subjects. Findings include: a) for the first hospital week behavioral differences between the two subject groups were highly significant with the most robust finding being the reduced frequency of social interaction among depressed subjects, b) an increase in communication among depressed subjects over the course of hospitalization but a decline of communication and an increase of self-activity among controls, and c) significant behavior profile differences between the two subject groups at the time of hospital discharge. The findings suggest that clinically remitted depressives are not fully recovered and socially capable when discharged from the hospital.

Adult↗

PubMed2000

The complement regulators C1 inhibitor and soluble complement receptor 1 attenuate acute lung injury in rabbits.

Because activation of the complement system plays a major role in the pathogenesis of acute lung injury, the availability of new specific complement inhibitors represents a promising therapeutic approach. In the present study we investigated pulmonary edema formation and pulmonary artery pressure (PAP) in acute complement-induced lung injury for possible therapeutic impact of the complement regulators C1 inhibitor and soluble complement receptor 1. Eighteen isolated and ventilated rabbit lungs were perfused with pooled normal human serum (NHS, final concentration 35%) in Krebs-Henseleit buffer in a recirculating system. Lung weight gain and PAP were continuously recorded. Complement activation was blocked by the addition of C1 inhibitor (1.0 U/mL, n = 6) or sCR 1 (2.0 microg/mL, n = 6). Lungs that received NHS without inhibitors served as controls (n = 6). This study was performed according to the Helsinki Declaration and approved by the local government. Application of NHS resulted in an increase of PAP within 20 min from 8+/-2 to 42+/-6 mmHg, which was significantly (P < 0.05) decreased by C1-Inh (25+/-5 mmHg) and sCRI (20 +/-3 mmHg). Moreover, pulmonary edema formation after NHS, as assessed by overall weight gain, was reduced by both C1-Inh and sCR1, compared with controls. These findings were paralleled with significantly decreased thromboxane release rates and reduced tissue deposition of C3c and C5b-9. C1 inhibitor and sCR1 attenuate the complement-induced pulmonary capillary leakage and PAP increase, indicating the protective effect of complement inhibition in isolated perfused rabbit lungs.

Animals↗

PubMed2004

Patient care versus research: does clinical research provide individual benefit to patients enrolled in trials?

PURPOSE OF THE REVIEW: Historically, clinical research and patient care have long been intertwined. Until the mid-1970s, physicians in both North America and Europe considered that research on their patients was an integral part of the care that they delivered to them. In the United States, it was after the recommendations of the Belmont report, in 1979, that both medical activities were clearly separated. But, in Europe, the concept of "individual direct benefit from research" is still prevailing in some national legislation. RECENT FINDINGS: The revision of the Declaration of Helsinki and the implementation of a European directive (in 2001) on clinical research in Member States' national laws have prompted a reappraisal of the distinction of research with and without individual benefit. Several recent articles have shown that this concept is flawed for several reasons: first, the commitment of a physician to his patient is inherently different in these two situations; second, it masks the possible conflict of interest, which can be financial or not; third, it perpetuates the "therapeutic conception" and reduces the obligation for a physician-investigator to implement supplemental procedures aimed at enhancing the safety of study patients. SUMMARY: The European directive on clinical research, voted on in 2001 and still in the process of being implemented in national laws of the European Union Member States, mandates clarification of these issues. All European investigators are concerned because the framework of regulations governing clinical research will be markedly altered. The replacement of the distinction between research with and without direct benefit by the evaluation of the risk/benefit ratio by ethics committees is one of the most important changes that is due to happen soon.

Clinical Trials as Topic↗

PubMed2001

Randomised placebo-controlled trials and HIV-infected pregnant women in developing countries. Ethical imperialism or unethical exploitation?

The maternal-fetal HIV transmission trials, conducted in developing countries in the 1990s, undoubtedly generated one of the most intense, high profile controversies in international research ethics. They sparked off a prolonged acrimonious and public debate and deeply divided the scientific community. They also provided an impetus for the revision of the Declaration of Helsinki--the most widely known guideline for international research. In this paper, I provide a brief summary of the context, outline the arguments for and against the controversial use of placebo controls, and focus on particular areas that I believe merit further discussion or clarification. On balance, I argue that the researchers failed in their duties to protect the best interests of their research subjects, and to promote distributive justice. I discuss the difficulties of obtaining valid consent in this research context, and argue that it is unethical to inform women of their HIV status without at least offering them prophylactic treatment for their unborn children. A global view of justice, which endorses international equity, cannot be squared with international research guidelines that allow 'local conditions' to define the scope of duty to the control group. Finally, I suggest that the heated debate reflects a tension, if not an outright war, between two conflicting meta-ethical systems, or incommensurable paradigms, that underpin scientific research involving human subjects.

Developing Countries↗

PubMed1997

Immunity and health after bereavement in relation to coping.

Coping was examined as an intervening variable between the stressor of bereavement and its effects on subjective health and immunity in thirty-nine recently bereaved Norwegian women. Coping was defined as: "positive response outcome expectancies". Data were collected approximately one month after the death of the husband, and twelve months thereafter. Data collected were: expected coping success (self-scoring), subjective health (UHI), anxiety and depression (GWB), and immunoglobulins (IgA, IgM, IgG) with components (C3, C4). Statistics were: frequencies, paired t-test, ANOVA, and MANOVA. Permissions and confidentiality were in accordance with the Helsinki-declaration. Coping was found to be related strongly to health and to health changes. Few relations were found between immunity and health. Coping, health, and anxiety and depression formed a triangle of interrelations. It was concluded that coping defined as "positive response outcome expectancies" may be a predictor of the adaptational outcome after a crisis.

Adaptation, Psychological↗

PubMed2001

Four forward-looking guidance points.

Four key guidance points in the UNAIDS guidance document, Ethical Considerations in HIV Preventive Vaccine Research, are compared with analogous statements in three other recently issued documents dealing with international research. Those documents are: the Declaration of Helsinki, as revised in 2000; the report of the U.S. National Bioethics Advisory Commission, issued in 2001; and a current (2001) draft revision of the 1993 CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects. The four guidance points compared with statements on similar issues on the other three documents are Guidance Point 2, which deals with making available a safe and effective vaccine after trials are completed; the second half of Guidance Point 4, which requires that the desired outcome should benefit the population from which research participants are drawn; Guidance Point 11, which discusses what should be provided to a control group in a vaccine trial; and Guidance Point 16, which addresses the care and treatment to be provided for trial participants who become infected with HIV during the trial. The analysis and comparison concludes that the UNAIDS guidance points are at least as ethically sound as analogous points in these other documents, and for the most part are ethically superior in providing greater benefits to research participants and to others. Nevertheless, they are subject to the criticism that they are too 'aspirational' and not sufficiently 'pragmatic'.

AIDS Vaccines↗

PubMed2005

Analysis of some Filipino perspectives on ethical issues in multi-country collaborative research: a case of deep listening.

The discussion on ethical issues, it is said, should not be confined to experts but should be extended to patients and local communities, because of the real need to engage stakeholders and non-stakeholders alike not only in carrying out any biomedical research project, but also in the drafting and legislation of bioethics instruments. Several local and inter-country consultations have already been conducted in furtherance of this goal, but there is much left to be desired in them. The consultations may have helped in articulating local principles, but not in making the instruments embody these principles. As such, instruments turn incompossible, i.e. the principles and actions they legitimate are not performable. In an ethnographic study conducted in the Philippines, for example, paragraphs 29 and 30 of the Declaration of Helsinki and CIOMS guidelines 8 and 15 are construed as not only contradictory to one another but also to local principles. This problem can be solved by taking deliberate steps to ensure that consultations are grounded in ethnographic data about local principles, which the instruments would embody. A steering committee can be of help in gathering ethnographic data, in conducting consultations at the local level, and in providing a venue for discourse on various bioethical issues.

Anthropology, Cultural↗

PubMed1999

Ethics and clinical trials.

The current reference guideline about ethics in clinical trials is the Declaration of Helsinki of human rights in medical research. Three major principles are emphasised: respect of the patient to accept or not to participate in a trial, the constraints and the presumed risks must be acceptable for patients included in a study, and vulnerable subjects should not participate in studies. The investigator is responsible for obtaining a free and well-informed consent from patients before their inclusion in a study. Where possible, a new drug should always first be compared to placebo in order to prove its superiority. Else, a small-sized trial comparing a new drug versus a reference treatment can lead to an erroneous conclusion of absence of difference. Moreover, good results or improvement are obtained in at least 30% of cases with placebo, whatever the disease. The use of placebo is unethical in life-threatening diseases and when an effective proved drug exists. The use of placebo is ethical in severe diseases with no efficient drug, in some severe diseases even when an active reference treatment is available, and in all moderate and functional diseases. In order to detect flawed studies, most journals now ask for any manuscript submitted and reporting results of a randomised clinical trial to join a checklist in order to verify the quality of the trial. Finally, it remains the responsibility of the doctor to decide whether or not a protocol is ethical, to participate or not and to include patients or not.

Advertising↗

PubMed2004

The ethics of research related to health care in developing countries.

The Ethics of Research Related to Health Care in Developing Countries by the Nuffield Council on Bioethics makes a number of innovative recommendations that depart from codes such as the Declaration of Helsinki. It recommends that standards of care might be relativised to the standard of that nation. It recommends that very good reasons need to be given for not giving post-trial access to medications but recognises that there may be justifiable instances of this. It is the view of the authors that these and other recommendations of the report are sensible pieces of advice given the complexities of the developing world.

Clinical Trials as Topic↗

PubMed2006

Xenotransplantation: a bioethical evaluation.

Allograft shortage is a formidable obstacle in organ transplantation. Xenotransplantation, the interspecies transplantation of cells, tissues, and organs, or ex vivo interspecies exchange between cells, tissues, and organs is a frequently suggested alternative to this allograft shortage. As xenotransplantation steadily improves into a viable allotransplantation alternative, several bioethical considerations coalesce. Such considerations include the Helsinki declaration's guarantee of patients' rights to privacy; political red tape that may select for undermined socioeconomic groups as the first recipients of xenografts; industry incentives in xenotransplantation investments; conflicts of interest when a clinician supervises a patient as a research subject; the psychosocial impact of transplantation on the xenograft recipient, and the rights of animals. This review illuminates these issues through a conglomeration of expert opinion and relevant experimental studies.

Animal Rights↗

PubMed1990

[The doctrine of free and informed consent: its ethical and legal foundations and its applications in research and practice of psychiatry].

This article briefly examines the ethical and legal foundations for the doctrine of informed consent in medical research and practice. The doctrine is based upon the importance of respecting the individual's autonomy and his right to self-determination. The article also reviews the development of the doctrine of informed consent based on its recent application. The authors cite the Nuremburg Code and the Helsinki Declarations and particularly the media denunication of several scandals in the United States during the late 1960s, when Henri Beecher's name figured prominently. The effects of informed consent in psychiatry are examined specifically, as well as the consequences for psychiatric research, on subjects who are able to give their consent, as well as those who are unable to do so. As for its effects on clinical practice, the paper discusses the right of the hospitalized patient to refuse treatment, and informed consent and the risks for patients treated with neuroleptics of developing tardive dyskinesia. The authors conclude that in psychotherapy the concept of informed consent cannot be taken for granted.

Antipsychotic Agents↗

PubMed2000

Ethics of medical research in developing countries: the role of international codes of conduct.

Many statisticians work with informal codes of ethics, and are probably unaware of the existence or content of rules which have been drawn up to govern statistical practice. Medical statisticians will be aware of codes of conduct for medical research, and most codes of professional ethics have some dependence on evidence. Statisticians, therefore, have a valuable contribution to make to debates on ethics which concern scientific soundness, data and perceptions of risk. A lively debate on the revision of the widely respected Declaration of Helsinki, to reflect issues arising from research in developing countries, particularly HIV research, centres on questions of study design, data analysis and assessment of risk. Collectively owned multiprofessional work requires each of the various professions to take responsibility for the conduct of the research, and the impact that it might have. Statisticians share important responsibilities in maintaining ethical medical research in all countries.

Developing Countries↗

PubMed1999

The principles of medical ethics and medical research.

In this paper I discuss the application of the principles of medical ethics and of medical research to the case of children and others whose consent to treatment and to research is problematic. Public health depends substantially on the possibility of ongoing research into all conditions which affect the health of the people. Constraints on this research are therefore a public health issue. Moreover and more importantly the possibility of predictive testing and indeed of screening for health-relevant conditions is an important public health tool, and limitations on the use of this tool are of great significance to public health medicine. Having considered the particular problems created by research and predictive testing on children for late-onset conditions I go on to discuss research on those whose consent is problematic more generally. I conclude with radical recommendations for the reform of The Declaration of Helsinki and of the International Ethics Guidelines for Biomedical Research Involving Human Subjects, prepared by the Council for International Organizations of Medical Sciences (CIOMS).

Adult↗

PubMedDate not supplied

Clinical research in developing countries: recent moral arguments.

During the 1990s, bioethicists raised questions about certain clinical trials conducted in developing countries. These inquiries led to revisions in the Declaration of Helsinki and recommendations from the US National Bioethics Advisory Commission. This article raises doubts about the original questions and subsequent recommendations. It is possible that impractical solutions have been proposed for nonexistent ethical problems.

Advisory Committees↗

PubMed2005

[Ethical conflicts in research with human subjects].

The Declaration of Helsinki (2000) helped trigger a major debate on many ethical aspects of research with human subjects. Topics under discussion include the use of placebos, the application of equipoise, the distinction between research ethics and clinical ethics, and the difference between therapeutic and non-therapeutic trials. This article supports tenets that serve to protect patients involved in research, especially in those aspects concerning maintenance of best existing therapy, the rejection of using placebos, support of equipoise, the assurance that required medication shall be available beyond the termination of the research project, and that appropriate compensation will obtain to host communities inasmuch as they may have facilitated and supported the project. The current proposal of introducing a double ethical standard, aspirational for developed countries and pragmatic for poor nations, should be rejected, since it contravenes the universalizability of prescriptive ethics.

Conflict of Interest↗

PubMed2005

Squamous cell carcinoma presenting as an endodontic-periodontic lesion.

BACKGROUND: Regardless of advances in diagnosis and treatment during the past 40 years, the overall 5-year survival rates for oral and oropharyngeal squamous cancers have only slightly improved and remain around 50%. Thus, the early diagnosis and treatment of carcinoma by health care providers are essential in achieving a good prognosis. We report a case of invasive squamous cell carcinoma that presented as a benign endodontic-periodontic lesion with a 7-mm periodontal pocket on tooth #15 in a 40-year-old, non-smoking woman. The subsequent management of the case is also discussed. The study was conducted in accordance with the Helsinki Declaration of 1975, as revised in 2000. METHODS: Our patient was seen for a comprehensive periodontal examination including a periodontal charting, occlusal analysis, study casts, electronic pulp test for tooth #15, and complete mouth periapical radiographs. As there was a periapical radiolucency, an endodontic consultation was obtained. A periodontal flap surgical procedure was performed on teeth #13 to #15, and as there was bone erosion into the maxillary sinus, a biopsy of the soft tissue was submitted to the local hospital for histological analysis. RESULTS: The biopsied lesion was diagnosed as invasive, moderately differentiated squamous cell carcinoma with focal spindle and clear cell differentiation (grade II to III of IV). Bone invasion was also identified. The treatment of the carcinoma involved a hemimaxillectomy with the removal of the maxillary left posterior teeth. The patient remained free of tumor for 5 years after the initial presentation. CONCLUSIONS: Patient education and periodic oral cancer examinations by dental professionals are necessary to reduce diagnostic delay and improve prognosis. This case report emphasizes the important role of dental professionals, especially periodontists and endodontists, of being aware that squamous cell carcinoma may manifest itself clinically and/or radiographically as a common periodontal or endodontic lesion.

Adult↗

PubMed2005

Papillon-Lefèvre syndrome: a successful outcome.

BACKGROUND: Papillon-Lefèvre syndrome (PLS) is a rare autosomal recessive condition manifested clinically by hyperkeratosis of the palms and soles and rapidly progressive periodontitis resulting in loss of deciduous and permanent teeth. This case report describes the clinical periodontal findings and treatment of a 10-year-old male patient with PLS. The patient provided informed consent, and the study was conducted in accordance with the Helsinki Declaration of 1975, as revised in 2000. METHODS: Upon initial presentation, a full periodontal examination was completed. Conventional probing depths, clinical attachment levels (CAL), gingival index (GI), and plaque index (PI) were measured prior to initial therapy, which involved oral hygiene instruction and scaling and root planing. At reevaluation, initial treatment proved unsuccessful, and a surgical approach with concomitant systemic antibiotic therapy was implemented. In addition, the patient's dermatologist treated his palmoplantar keratoderma with systemic retinoids. Subsequently, the patient was placed on a strict 3-month maintenance protocol and was evaluated over a period of 1 year. RESULTS: Initial treatment with mechanical therapy, oral hygiene instruction, frequent recalls, and systemic antibiotics did not yield efficacious results. However, with the addition of surgical treatment, a favorable clinical outcome was obtained. CONCLUSIONS: Numerous treatment regimens for the periodontal disease seen in PLS can be found in the literature. We demonstrate successful treatment of the periodontal disease seen in this condition using mechanical therapy, systemic antibiotics, and surgical modalities; over a period of 1 year, we were able to achieve significant reductions in gingival inflammation and erythema.

Amoxicillin↗