Ethical report

In general, the quality of social/ethical reporting falls below that of environmental reporting. In addition, the lack of standards creates difficulties with comparability. With limited agreement over the nature of social indicators or how to measure social performance there is a pressing case for greater convergence of the standard setters in this area. 

Clinical trials must be conducted in accordance with the principles of Good Clinical Practice (GCP). GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Its purpose is twofold ... 

If the events are classified as Suspected Unexpected Serious Adverse Reactions (SUSARs) that are fatal or life-threatening, the sponsor must then report them to the Ethics Committee and the Competent Authority within 7 days. Other SUSARs must be reported within 15 days. The sponsor must also inform all other investigators involved in the trial. The Competent Authority is required to enter the information... 

In addition to the expedited reporting described above, sponsors shall submit, once a year throughout the clinical trial, or on request, a safety report to the Competent Authority and the Ethics Committee. This should cover SUSARs, other serious adverse reactions, and an analysis of the subjects safety during the course of the trial. 

The sponsor must inform the Competent Authority and the Ethics Committee of the end of a trial within 90 days of its completion. The sponsor will then prepare a trial report, where the data are analysed and assessed, with conclusions presented. 

Under US regulations, each institution conducting research with human subjects must have its own IRB. These perform the same functions as the Independent Ethics Committees in Europe, and should contain at least five members, one of which should be independent of the institution. There should be available a mixture of scientific and non-scientific expertise capable of assessing research proposals from legal, ethical and scientific perspectives. The IRB must grant written authorisation to the investigator before a study can commence. They are also responsible for on-going reviews of research, and must report to the FDA ... 

Unlike human trials. Institutional Review Boards/Independent Ethics Committees are not involved, while informed consent is only required from the owner of the trial animals. In addition to the standard items associated with human trials, aspects such as management and housing of animals, diet and disposal of trial animals and their produce should be included in the trial protocol. Studies may be blinded from the investigators in order to avoid bias in the reporting of animal observations. 

ADR reporting may be either voluntary or obligatory. Spontaneous reporting by health professionals is often favoured, since it is very difficult to make reporting compulsory. But in many countries, considerations of ethical responsibility and/or technical expediency have inclined governments to make reporting mandatory for the holders of marketing authorizations. 

The need for and ethics of cancer therapy with radiopharmaceuticals are now being carefully discussed. The success in diagnosis of cancer using "Tc has provoked interest in the possibility of cancer therapy with radiorhenium. Even if complete recovery from the disease has not yet been achieved, positive changes in the quality of life (in about 80% of all patients) were reported by rhenium treatment for bone metastases. 

The main pre-clinical species used for pharmacokinetic studies are the rat, mouse and dog. An examination of the Biosys database for 2000 and 2001 shows that of the abstracted papers, 6334 mapped to the subject heading Pharmacokinetics . Of these, the vast majority (70%) were studies on humans. Studies on rats constituted 14% of the reports, mice 7.5% and dogs 3.4% (Table 6.2). Nonhuman primates can also be important pharmacokinetic models, but ethical and practical considerations severely limit studies in these animals such that, within the same period, they represented less than 0.5% of the abstracted reports on PK. 

Blowfield, M. (1999). Ethical Trade A Review of Developments and Issues. Unpublished report for NRI, University of Greenwich, UK. 

House of Commons (1999). Ethical Trading, Sixth Report of the Trade and Industry Committee, The Stationery Office, London. 

Some 40 countries have cleared irradiated foods of certain types for human consumption, or have given provisional clearance. Large scale ( 104 tons per year) irradiation of potatoes has been approved in Japan, and very large scale ( 105 tons per year) irradiation of grains has been reported from the former Soviet Union for insect control. However, it must be admitted that clearances with associated legal complications have come slowly in most countries, and even today there are ongoing debates regarding the ethics and economics of food irradiation. 

The terminology used in this Standard is slightly different from the others in that it is appropriate for the particular discipline. For example, the term, referral laboratories in paragraph 4.5 of ISO 15189 is used in a slightly different sense to the comparable clause in ISO/IEC 17025. Included in this section are consultants who may provide a second opinion. If the referral laboratory is an external laboratory, to which samples are submitted for a supplementary or confirmatory examination procedure and report, it is much the same as a contract laboratory in ISO/IEC 17025. There is an extra Annex in this Standard which covers the ethics applicable to laboratory medicine. 

In in vivo studies, an important issue is the quality of ECG recordings and the methods used for the analysis. A few years ago, a survey reported on the practice in the pharmaceutical industry to assess the potential for QT prolongation and concluded that the majority view in the industry is not necessarily best practice [153]. After this publication, a lot of work has been done to improve the performance of in vivo models, although it should be acknowledged that their cost (together with some ethical considerations on the rational use of animals) makes them unsuitable for large-scale screening. 

Since the Kefauver-Harris Amendmenf was adopted in 1962, pharmaceutical manufacturers have been held responsible by the FDA for providing new medications fhaf are bofh safe and effective. In addition to the Kefauver-Harris Amendment, the Belmont Report (written in 1979), established the ethical principles and guidelines for conducting research. The FDA requires that clinical trials be conducted in compliance with a protocol that has been... 

The Belmont Report s principle of beneficence refers to the need to ensure that all aspects of a study are designed to obtain the desired knowledge in a way that maximizes benefits and minimizes risks to the participants. The principle of beneficence also means that a risk-benefit analysis must be performed on every proposed study. In determining if fhis ratio is ethical, consideration must be given to the impact on both the participants and society. 

The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Department of Health, Education, and Welfare, Washington, DC, April 18, 1979. 

Venous blood samples are collected from clinical subjects after approval by the regulatory authorities for the evaluation of medicines and the local ethical committees for the sampling and the experiments to be performed. The identities of the clinical subjects are blinded. The collection should contain samples of healthy infants or children of both genders and minorities, with at least five clinical subjects per group. If adverse event reactions are to be studied, the collection should also contain at each time-point of the study one group of clinical subjects who were reported to experience adverse events after vaccination. The clinical subjects are vaccinated intramuscularly with one dose of the vaccine at 3, 5, and 12mo of age. Samples are collected at 3 mo before the first vaccination and at 6 and 13 mo, with the second samples taken after their second vaccination at 5 mo of age and the third vaccination at 12mo of age, respectively. 

---