Implementation Of Good Clinical Practice Research Articles

Expert consensus on key issues of quality control in clinical trials of new drugs of traditional Chinese medicine

Since "the implementation of good clinical practice"(GCP), especially after 2015, the overall quality of new drug cli-nical trials in China has made significant progress, but compared with developed countries, there are still some obvious quality problems in clinical trials in China. Clinical trials of new drugs of traditional Chinese medicine are an important part of clinical trials of new drugs in China. In addition to some common problems in all clinical trials, there are also some special quality problems. In terms of security data, such as the collection of human safety data is not standardized, the management and judgment of unexpected serious adverse reactions(SUSAR) were not professional and timely, the relationship between adverse events and trial drug was not fully judged by investigator, In terms of effective data, such as primary efficacy outcome of the scale cannot be traced, TCM syndrome data cannot meet the requirements of "source data" in the revised GCP and the quality of traditional Chinese medicine placebo is not high, in terms of overall quality system construction, the sponsors and research institutions have not established a quality assurance system that conforms to the characteristics of new drug research of traditional Chinese medicine, etc. The quality of clinical trials of new drugs of traditional Chinese medicine is based on the current GCP and ICH-GCP in China, we should also consider the characteristics of clinical trials of new traditional Chinese medicine drugs, and formulate targeted quality control measures according to the characteristics of these new drugs of traditional Chinese medicine, to improve the overall quality of clinical trials of new drugs of traditional Chinese medicine in China, which has important strategic significance for promoting the research and development of new drugs of traditional Chinese medicine in China.

Lessons learnt from the COVID-19 crisis: Regulatory aspects linked to human research and product authorisation

The governmental measures instigated in connection with the COVID-19 pandemic have presented new challenges concerning the approval and conduct of clinical trials with medicinal products in Switzerland and the implementation of good clinical practice (GCP) and good pharmacovigilance practices (GVP) inspections. This article discusses various regulatory aspects of study approval, conduct, and inspections that have been affected by the pandemic and summarises lessons learnt in these areas.

Implementation of Good Clinical Practice in Early COVID-19 Pandemic

Implementation of Good Clinical Practice in Early COVID-19 Pandemic

Clinical application research through reflection, interpretation and new understanding - a hermeneutic design.

The implementation of theoretical knowledge in clinical practice and the implementation of good clinical practice into theory have been of interest in caring science for the last 30years. The aim of this article was to elaborate and discuss a methodology named clinical application research. The method is grounded in a hermeneutical design inspired by Gadamer's philosophy. The methodology, clinical application research, has been used in a research project A life in dignity and experiences from the researchers forms the bases for the elaboration and discussion. The project was performed in collaboration with residents, family caregivers and healthcare providers at six nursing homes in Scandinavia. The material for this article is based on the previous research, that is the results from 10 different articles showing the meaning of dignity and indignity in daily life in nursing homes. Data were generated from 56 individual interviews and 18 focus-group interviews with a total of 40 staff members with five to eight participants at every interview session. By reflection, interpretation and new understanding our results provide knowledge about dignity and how to preserve dignity for older people in an appropriate ethical way. The methodology was relevant for the research project A life in dignity and relevant to caring practice in nursing homes as it opens new possibilities and new ways of thinking when performing dignified care to older people.

Estimated date of discharge for surgical admission: a way forward

Estimated date of discharge for surgical admission: a way forward Anil Bagul, Duff M Bruce Department of General Surgery, Aberdeen Royal Infirmary, Foresterhill, Aberdeen, UK Introduction: The Planned Care Improvement Programme has highlighted the importance of developing a robust framework that supports the implementation of good clinical practice in the National Health Service. An important aspect of this process is the efficient management of patient discharge. Early prediction of an estimated date of discharge (EDD) may enable a structured discharge process. Aims: To examine how accurately clinical staff predict a date of discharge and to identify factors that may result in discrepancies between predicted and actual date. Design: Data was collected prospectively for all admissions to a general surgical ward at the Aberdeen Royal Infirmary. Patients were allocated an EDD upon admission by the most senior medical staff on the post-admission ward round. Assessment and analysis: Surgical wards were piloted as areas supported by operational support to achieve EDD for all patients. Wards visited showed variable results. Results: Forty-six (44.2%) medical staff correctly predicted the discharge date. Eighteen (11.4%) patients were discharged prior and 64 (40.5%) after their EDDs; of these 64, 12 (21.8%) had multiple factors causing the delay. Measurement of improvement was assessed by the number of patients with an accurate EDD and reasons causing a delay to discharge. Conclusion: Extra unit referrals projected most delays, indicating a need for changes in the referrals system. This study highlights some of the causes for discrepancies and areas where system changes may influence the length of hospital stay. EDD has a positive impact on length of hospital stay. Keywords: date of discharge, hospital stay, planned care improvement, planned discharge

Economic aspects in the management of diabetes in Italy

BackgroundDiabetes mellitus (DM) is a chronic-degenerative disease associated with a high risk of chronic complications and comorbidities. The aim of this study is to estimate the average annual cost incurred...

Characteristics of anticancer drug studies registered on the Chinese Clinical Trial Registry (ChiCTR) from 2007 to 2015.

This research aims to examine the basic and methodological characteristics of anticancer drug studies registered on the Chinese Clinical Trial Registry (ChiCTR) and explores the progress of implementation of good clinical practice (GCP) and the challenges it poses for anticancer drug research in China. The studies from 2007 to 2015 were downloaded from the ChiCTR and those involving anticancer drugs with evaluation of the main dimensions. The numerical trend of the studies registered each year was analyzed. Chi-square tests were performed to test for significant differences between different funding sources, types of drug and study phases. Six hundred and four anticancer drug studies were collected. The overall number of anticancer drug studies was increased. Significant differences could be seen in the dimensions of multicentre study (P = 0.000), participant number (P = 0.029) and randomization procedure (P = 0.005) for the three funding sources. There were significant differences in the dimensions of multicentre study (P = 0.001), participant number (P = 0.025), collecting samples from participants (P = 0.006), and randomization procedure (P = 0.009) between different kinds of drugs. There were also significant differences in the dimension of participant number (P = 0.025) and randomization procedure (P = 0.016) between different study phases. There are problems with study registry criteria and study type classification method. Also, within the studies researched, heterogeneity exists for various dimensions. Different sources of funding, distinct types of drug and disparate phases of study lead to significant differences in certain dimensions of anticancer drug studies.

Vaccination Age Changing from Infancy and Childhood to Adolescence and Adulthood: An In-Dispensable Approach in Immunization Programs

Objectives: Despite the positive effects of vaccines on control of many infectious diseases, they are not completely safe. The purpose of this article is to draw attention to the problems associated with newborns and infants immunization. Methods: For each subject, a review of electronic sources was carried out in the PubMed and Google Scholar using appropriate key words. Results: For different reasons including: the differences between the immune systems of newborns/children and adults, sever adverse events and inefficacy of vaccines, deceptive advertising and inadequate parental awareness about vaccines and vaccination; newborns and children are at risk and accordingly a decline in public confidence is observed. Conclusions: The revision of vaccination age changing (at least for some vaccines) in order to maintain newborns/children's health and to prevent the return of infectious diseases is required. To achieve this goal, new retrospective and prospective studies to reassess the safety, efficacy, quality and protection duration of vaccines, proper implementation of good clinical practice, establishment of a network vaccine safety database by collaboration of international organizations, vaccine manufacturers and academic centers for sharing of information and enhancement of awareness of healthcare professionals and people about immunization at global level are needed.

PDB31 - Economic Aspects in the Management of Diabetes in Italy

Background Diabetes mellitus (DM) is a chronic-degenerative disease associated with a high risk of chronic complications and comorbidities. The aim of this study is to estimate the average annual cost incurred by the Italian National Health Service (NHS) for the treatment of DM stratified by patients' comorbidities. Moreover, the model estimates the economic impact of implementing good clinical practice for the management of patients with DM. Methods Data were extrapolated from administrative database of the Marche Region and specific inclusion and exclusion criteria were developed from a clinical board in order to estimate patients with DM only, DM+1, DM+2, DM+3 and DM+4 comorbidities (cardiovascular disease, neuropathy, nephropathy and retinopathy). Regional data were considered a good proxy for implementing a previously developed cost-of-illness (COI) model from Italian NHS perspective already published. A scenario analysis was considered to estimate the economic impact of good clinical practice implementation in the treatment of DM and its comorbidities in Italy. Results The model estimated an average number of patients with DM per year in the Marche region of 85.909 (5.5% of population) from 2008 to 2011. The mean costs per patients with DM only, DM+1, DM+2, DM+3 and DM+4 comorbidities were €341, €1,335, €2,287, €5,231 and €7,085 respectively. From the Italian NHS perspective, the total economic burden of DM in Italy amounted to €8.1. billion/year (22% for drugs, 74% for hospitalization and 4% for visits). Scenario analysis demonstrates that the implementation of good clinical practice could save over €700 million per year. Conclusions This model is the first study that considers real world data and COI model to estimate the economic burden of DM and its comorbidities from the Italian NHS perspective. Integrated management of the patients with DM could be a good driver for the reduction of the costs of this disease in Italy.

International clinical practice guidelines for the treatment and prophylaxis of venous thromboembolism in patients with cancer

Guidelines addressing the management of venous thromboembolism (VTE) in cancer patients are heterogeneous and their implementation has been suboptimal worldwide. To establish a common international consensus addressing practical, clinically relevant questions in this setting. An international consensus working group of experts was set up to develop guidelines according to an evidence-based medicine approach, using the GRADE system. For the initial treatment of established VTE: low-molecular-weight heparin (LMWH) is recommended [1B]; fondaparinux and unfractionated heparin (UFH) can be also used [2D]; thrombolysis may only be considered on a case-by-case basis [Best clinical practice (Guidance)]; vena cava filters (VCF) may be considered if contraindication to anticoagulation or pulmonary embolism recurrence under optimal anticoagulation; periodic reassessment of contraindications to anticoagulation is recommended and anticoagulation should be resumed when safe; VCF are not recommended for primary VTE prophylaxis in cancer patients [Guidance]. For the early maintenance (10 days to 3 months) and long-term (beyond 3 months) treatment of established VTE, LMWH for a minimum of 3 months is preferred over vitamin K antagonists (VKA) [1A]; idraparinux is not recommended [2C]; after 3-6 months, LMWH or VKA continuation should be based on individual evaluation of the benefit-risk ratio, tolerability, patient preference and cancer activity [Guidance]. For the treatment of VTE recurrence in cancer patients under anticoagulation, three options can be considered: (i) switch from VKA to LMWH when treated with VKA; (ii) increase in LMWH dose when treated with LMWH, and (iii) VCF insertion [Guidance]. For the prophylaxis of postoperative VTE in surgical cancer patients, use of LMWH o.d. or low dose of UFH t.i.d. is recommended; pharmacological prophylaxis should be started 12-2 h preoperatively and continued for at least 7-10 days; there are no data allowing conclusion that one type of LMWH is superior to another [1A]; there is no evidence to support fondaparinux as an alternative to LMWH [2C]; use of the highest prophylactic dose of LMWH is recommended [1A]; extended prophylaxis (4 weeks) after major laparotomy may be indicated in cancer patients with a high risk of VTE and low risk of bleeding [2B]; the use of LMWH for VTE prevention in cancer patients undergoing laparoscopic surgery may be recommended as for laparotomy [Guidance]; mechanical methods are not recommended as monotherapy except when pharmacological methods are contraindicated [2C]. For the prophylaxis of VTE in hospitalized medical patients with cancer and reduced mobility, we recommend prophylaxis with LMWH, UFH or fondaparinux [1B]; for children and adults with acute lymphocytic leukemia treated with l-asparaginase, depending on local policy and patient characteristics, prophylaxis may be considered in some patients [Guidance]; in patients receiving chemotherapy, prophylaxis is not recommended routinely [1B]; primary pharmacological prophylaxis of VTE may be indicated in patients with locally advanced or metastatic pancreatic [1B] or lung [2B] cancer treated with chemotherapy and having a low risk of bleeding; in patients treated with thalidomide or lenalidomide combined with steroids and/or chemotherapy, VTE prophylaxis is recommended; in this setting, VKA at low or therapeutic doses, LMWH at prophylactic doses and low-dose aspirin have shown similar effects; however, the efficacy of these regimens remains unclear [2C]. Special situations include brain tumors, severe renal failure (CrCl<30 mL min(-1) ), thrombocytopenia and pregnancy. Guidances are provided in these contexts. Dissemination and implementation of good clinical practice for the management of VTE, the second cause of death in cancer patients, is a major public health priority.

A refined estimate of the malaria burden in Niger

BackgroundThe health authorities of Niger have implemented several malaria prevention and control programmes in recent years. These interventions broadly follow WHO guidelines and international recommendations and are based on interventions that have proved successful in other parts of Africa. Most performance indicators are satisfactory but, paradoxically, despite the mobilization of considerable human and financial resources, the malaria-fighting programme in Niger seems to have stalled, as it has not yet yielded the expected significant decrease in malaria burden. Indeed, the number of malaria cases reported by the National Health Information System has actually increased by a factor of five over the last decade, from about 600,000 in 2000 to about 3,000,000 in 2010. One of the weaknesses of the national reporting system is that the recording of malaria cases is still based on a presumptive diagnosis approach, which overestimates malaria incidence.MethodsAn extensive nationwide survey was carried out to determine by microscopy and RDT testing, the proportion of febrile patients consulting at health facilities for suspected malaria actually suffering from the disease, as a means of assessing the magnitude of this problem and obtaining a better estimate of malaria morbidity in Niger.ResultsIn total, 12,576 febrile patients were included in this study; 57% of the slides analysed were positive for the malaria parasite during the rainy season, when transmission rates are high, and 9% of the slides analysed were positive during the dry season, when transmission rates are lower. The replacement of microscopy methods by rapid diagnostic tests resulted in an even lower rate of confirmation, with only 42% of cases testing positive during the rainy season, and 4% during the dry season. Fever alone has a low predictive value, with a low specificity and sensitivity. These data highlight the absolute necessity of confirming all reported malaria cases by biological diagnosis methods, to increase the accuracy of the malaria indicators used in monitoring and evaluation processes and to improve patient care in the more remote areas of Niger. This country extends over a large range of latitudes, resulting in the existence of three major bioclimatic zones determining vector distribution and endemicity.ConclusionThis survey showed that the number of cases of presumed malaria reported in health centres in Niger is largely overestimated. The results highlight inadequacies in the description of the malaria situation and disease risk in Niger, due to the over-diagnosis of malaria in patients with simple febrile illness. They point out the necessity of confirming all cases of suspected malaria by biological diagnosis methods and the need to take geographic constraints into account more effectively, to improve malaria control and to adapt the choice of diagnostic method to the epidemiological situation in the area concerned. Case confirmation will thus also require a change in behaviour, through the training of healthcare staff, the introduction of quality control, greater supervision of the integrated health centres, the implementation of good clinical practice and a general optimization of the use of available diagnostic methods.

Practices, patients and (im)perfect data--feasibility of a randomised controlled clinical drug trial in German general practices.

BackgroundRandomised controlled clinical (drug) trials supply high quality evidence for therapeutic strategies in primary care. Until now, experience with drug trials in German general practice has been sparse. In 2007/2008, the authors conducted an investigator-initiated, non-commercial, double-blind, randomised controlled pilot trial (HWI-01) to assess the clinical equivalence of ibuprofen and ciprofloxacin in the treatment of uncomplicated urinary tract infection (UTI). Here, we report the feasibility of this trial in German general practices and the implementation of Good Clinical Practice (GCP) standards as defined by the International Conference on Harmonisation (ICH) in mainly inexperienced general practices.MethodsThis report is based on the experience of the HWI-01 study conducted in 29 German general practices. Feasibility was defined by 1) successful practice recruitment, 2) sufficient patient recruitment, 3) complete and accurate data collection and 4) appropriate protection of patient safety.ResultsThe final practice recruitment rate was 18%. In these practices, 79 of 195 screened UTI patients were enrolled. Recruitment differed strongly between practices (range 0-12, mean 2.8 patients per practice) and was below the recruitment goal of approximately 100 patients. As anticipated, practice nurses became the key figures in the screening und recruitment of patients. Clinical trial demands, in particular for completing symptom questionnaires, documentation of source data and reporting of adverse events, did not agree well with GPs' documentation habits and required support from study nurses. In many cases, GPs and practice staff seemed to be overwhelmed by the amount of information and regulations. No sudden unexpected serious adverse reactions (SUSARs) were observed during the trial.ConclusionsTo enable drug trials in general practice, it is necessary to adapt the setup of clinical research infrastructure to the needs of GPs and their practice staff. Risk adaption of clinical trial regulations is necessary to facilitate non-commercial comparative effectiveness trials in primary health care.Trial RegistrationTrial registration number: ISRCTN00470468

New perspective and new challenges in clinical trial regulation in Italy.

Since 2004 the European Directive 2001/20/EC concerning the implementation of good clinical practice in the conduct of clinical trials on medicinal products has become operative in Italy (Decreto legislativo 24 giugno 2003, n. 211). It is therefore the intention of the Ministry of Health to obtain through an intelligent application of the recent national decree clear indications on how to conduct and to monitor transparent and useful clinical trials and to best exploit the results emerging from clinical studies in our country, both and equally from "commercial" and "non commercial" clinical studies. Using data coming from the National Register on Clinical Trials, we have observed that the absolute number of clinical research has significantly increased raising 845 interventional trials in 2008. Even if the total number of researches seems to have a positive trend and the well designed clinical trials remain the most reliable way to get unbiased information, probably we need to integrate clinical trial data with other type of clinical research, in order to better manage the post-marketing uses. Furthermore, a new pathway for "from clinical trials to the market" has to be explored through a scientific debate among the scientific community.

New perspective and new challenges in clinical trial regulation in Italy

Summary. Since 2004 the European Directive 2001/20/EC concerning the implementation of good clinical practice in the conduct of clinical trials on medicinal products has become operative in Italy (Decreto legislativo 24 giugno 2003, n. 211). It is therefore the intention of the Ministry of Health to obtain through an intelligent application of the recent national decree clear indications on how to conduct and to monitor transparent and useful clinical trials and to best exploit the results emerging from clinical studies in our country, both and equally from “commercial” and “non commercial” clinical studies. Using data coming from the National Register on Clinical Trials, we have observed that the absolute number of clinical research has significantly increased raising 845 interventional trials in 2008. Even if the total number of researches seems to have a positive trend and the well designed clinical trials remain the most reliable way to get unbiased information, probably we need to integrate clinical trial data with other type of clinical research, in order to better manage the post-marketing uses. Furthermore, a new pathway for “from clinical trials to the market” has to be explored through a scientific debate among the scientific community.

Das Genehmigungsverfahren klinischer Prüfungen von Arzneimitteln bei den Bundesoberbehörden

Since 2004, clinical trials of medicinal products have to be approved by the federal authorities in Germany. Authorization is necessary in addition to the favorable opinion of the concerned ethics committee. This procedure has undoubtedly resulted in larger expenditures with respect to time and costs of planning and conducting of clinical trials. However, the implementation of Good Clinical Practice has also increased both safety for the trial subjects and validity of the data. The most important laws and regulations, definitions, the procedures for submitting a clinical trial application as well as subsequent amendments are described and further information is provided.

Regulation (EC) No 1901/2006 on medicinal products for paediatric use &amp; clinical research in vulnerable populations

Before any medicinal product is authorised for use in adults, it must undergo extensive pharmaceutical consistency and stability tests, toxicological tests and clinical trials to ensure that it is of high quality, safe and effective.The same approach may not always be applied to medicinal products used to treat children.Studies showed that over 50% of the medicinal products used in children may not have been tested for use in this age group. The absence of suitable authorised medicinal products to treat conditions in children results from the fact that pharmaceutical companies do not adapt medicinal products to the needs of the paediatric population. This leaves health care professionals with no alternative other than to use medicinal products "off-label" and to use unauthorised products with the associated risks of inefficacy and/or adverse reactions.The Regulation (EC) No 1901/2006 sets up a system of requirements, rewards and incentives, together with horizontal measures, to ensure that medicinal products are researched, developed and authorised to meet the therapeutic needs of children.The Regulation is addressed to:1. The pharmaceutical industry by setting out the legal framework for receiving rewards and incentives by conducting clinical trials in the paediatric population.2. The Member States to set out to support research into, and the development and availability of, medicinal products for paediatric use.3. The Community as funds for research into medicinal products for the paediatric population shall be provided for in the Community budget in order to support studies relating to medicinal products or active substances not covered by a patent or a supplementary protection certificate.The legal framework for conducting clinical trials, including children/minors, is set up in Directive 2001/20/EC, the Clinical Trials Directive (CTD), for the European Union (EU). The CTD establishes specific provisions regarding conduct of clinical trials, including multi-centre trials, on human subjects involving medicinal products and in particular relating to the implementation of good clinical practice. Compliance with this good practice provides assurance that the rights, safety and well-being of trial subjects are protected, and that the results of the clinical trials are credible. The CTD is addressed to all investigators conducting clinical trials including clinical trials in the paediatric population and had to be applied accordingly.In the framework of the authorisation of medicinal products regulated by the Regulation (EC) No 726/2004 and Directive 2001/83/EC as amended and the CTD, and additional implementing Directives and guidelines, the new Regulation (EC) No 1901/2006 is an important new piece of legislation focusing on the requirements to improve the situation for the paediatric population.All Regulations/Directives to be found:

La recherche biomédicale en France : ce qui a changé depuis 2004

The public health law passed in 2004 is the implementation into French law of the European Clinical Trial directive 2001/20/EC on the implementation of good clinical practice in conducting clinical trials on medicinal products for human use. This law goes further than the European directive since it reconsiders all the components related to all fields of biomedical research. It has (i) standardized communication with the authorities (French Drug Agency/French Health Authority and the Ethics Committee); (ii) reinforced protection to participants in clinical trials and modified the information delivered to participants and how their informed consent is obtained; (iii) added risk-benefit assessment; and (iv) increased transparency for the public.

Maintaining data integrity in a rural clinical trial

Clinical trials conducted in rural resource-poor settings face special challenges in ensuring quality of data collection and handling. The variable nature of these challenges, ways to overcome them, and the resulting data quality are rarely reported in the literature. To provide a detailed example of establishing local data handling capacity for a clinical trial conducted in a rural area, highlight challenges and solutions in establishing such capacity, and to report the data quality obtained by the trial. We provide a descriptive case study of a data system for biological samples and questionnaire data, and the problems encountered during its implementation. To determine the quality of data we analyzed test-retest studies using Kappa statistics of inter- and intra-observer agreement on categorical data. We calculated Technical Errors of Measurement of anthropometric measurements, audit trail analysis was done to assess error correction rates, and residual error rates were calculated by database-to-source document comparison. Initial difficulties included the unavailability of experienced research nurses, programmers and data managers in this rural area and the difficulty of designing new software tools and a complex database while making them error-free. National and international collaboration and external monitoring helped ensure good data handling and implementation of good clinical practice. Data collection, fieldwork supervision and query handling depended on streamlined transport over large distances. The involvement of a community advisory board was helpful in addressing cultural issues and establishing community acceptability of data collection methods. Data accessibility for safety monitoring required special attention. Kappa values and Technical Errors of Measurement showed acceptable values. Residual error rates in key variables were low. The article describes the experience of a single-site trial and does not address challenges particular to multi-site trials. Obtaining and maintaining data integrity in rural clinical trials is feasible, can result in acceptable data quality and can be used to develop capacity in developing country sites. It does, however, involve special challenges and requirements.

Emergency Research without Consent under Polish Law

Although Directive 2001/20/EC of the European Parliament and of Council of 4 April 2001 on the approximation of the laws regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use does not contain an exception for emergency situations, and requires the informed consent of a legal representative in all cases where research is conducted on legally competent individuals who are unable to give informed consent, in Poland, emergency research can be conducted without consent. Polish regulations on emergency research can hardly be treated as a result of intentional legislative policy. Our provisions arise from multiple and sophisticated interpretations of different regulations that govern medical experiments on human subjects and clinical trials. These interpretations can be summarized as follows: (1) There are two categories of medical experiments: therapeutic and non-therapeutic experiments. Emergency research without consent may be conducted in the category of therapeutic experiment only (therapeutic experiment consists of the introduction by the physician of new or only partially proven diagnostic, therapeutic or preventive methods in order to achieve direct benefit to the health of the patients, and it can be carried out when hitherto applied methods were ineffective or their effectiveness was insufficient). (2). Emergency research may be conducted without consent if there is a situation of great urgency in which the research subject's life is in danger and there is no possibility of obtaining immediate consent from the research subject him or herself, or from his or her legal representative or guardianship court, and the research subject has not refused to give consent for the participation in an emergency therapeutic experiment. The legal representative or guardianship court shall be provided with all the relevant information concerning subject's participation in an experiment as soon as possible. All projects of emergency research with intent to be done without the research subject's consent must be approved by an independent bioethics committee. Because these five requirements seem to provide insufficient protection for a subject's autonomy and rights it is necessary to add to them two other conditions: (1) the emergency research could not be conducted using other research participants capable of giving informed consent; and (2) informed consent for continued participation in the emergency research shall be obtained from either the participant him or herself or the legally authorized representative as soon as possible (requirement of obtaining deferred consent). A consolidated single Act that will govern all aspects of medical experiments on human subjects, including emergency research, should be prepared and enacted as soon as possible.

Current Status of the Implementation of Good Clinical Practice in China

If a medical institution in China wishes to carry out clinical studies on humans they must first gain accreditation from the relevant regulatory department of the State Council.