Analysis of problems and countermeasures faced by the ethics committee in the context of the 2020 version Good Clinical Practice / 中华医学科研管理杂志

Objective:According to the requirements set forth by the " regulations on the management of drug clinical trial institutions" and the 2020 version of Good Clinical Practice, problems faced by the construction of Institutional Review Board (hereinafter referred to as the IRB) in the implementation of the filing system is solved.Methods:According to the study of laws and regulations, combined with problem analysis during the early construction of IRB, problems during the IRB filing are identified and analyzed.Results:The IRB faced many problems that including the organizational structure, continuing review, informed consent and multicenter ethical review. We can gradually improve the ability of ethical review through continuous in-depth study of relevant laws and regulations, so as to ensure the scientific validity and ethical acceptability of drug clinical trials.Conclusions:It is of great significance for the high-quality development of IRB to improve its organizational structure, optimize its review mechanism and improve its review efficiency.

Tools and processes for tracking IRB approvals as a coordinating center for large multicenter clinical research networks

RTI International, San Francisco, CA, USA

RTI International, Research Triangle Park, NC, USA

RTI International, Rockville, MD, USADepartment of Oncology, King Abdul Aziz Medical City for National Guard, Riyadh, Saudi Arabia

Ulm University –Faculty of Medicine, Ulm, Germany

University of ThePeople, Pasadena, CaliforniaDepartment of Anaesthesia, Konaseema Institute of Medical Science, Amalapuram, Andhra Pradesh, India

Department of Pharmacology, Konaseema Institute of Medical Science, Amalapuram, Andhra Pradesh, IndiaDiscipline of Physiotherapy, Faculty of Health Sciences, The University of Sydney, Sydney, Australia

Physiotherapy Department, College of Applied Medical Science, Taif University, Taif, Saudi Arabia

Charles Perkins Centre, Prevention Research Collaborati on, School of Public Health, The University of Sydney, Sydney, Australia

School of Public Health, The University of Sydney, Sydney, Australia

IRB review points for studies utilizing paraffin blocks archived in the pathology laboratory / 영남의대학술지

In the personalized medicine era, utilizing paraffin blocks in pathology archives for investigating human diseases has come into the limelight. This archived material with clinical data will reduce the research time and could prevent new patient recruitment to obtain tissue for research. However, the clause indicating the necessity of consent from human material providers in the Korean Bioethics and Safety Act has made the Institutional Review Board (IRB) deny permission to use paraffin blocks for research without consent, and alternatively to get the same before starting an experiment. Written consent may be waived off in studies using paraffin blocks with anonymous status or conditions not linked to personal information by applying the paragraph 3, article 16 of the current Bioethics and Safety Act. Also, the IRB should recommend researchers to preserve the blocks as medical records of patients in long-term archives.

Understanding of Essential Elements Required in Informed Consent Form among Researchers and Institutional Review Board Members

Informed consent process remains a constant challenge in clinical research.  The aim of the present study was to evaluate the understanding of researchers and members of Institutional Review Boards (IRBs) regarding the essential elements of an Informed Consent Form (ICF) as required by internationally recognized regulations.  Using 8 case studies to illustrate basic ethical elements, the study consisted of 107 participants, mainly from the Asia Pacific and African regions.  The results showed that most of the participants had general knowledge regarding the essential elements required in an ICF. However, the issues of confidentiality of data and payment for study participation proved to be problematic for some participants, accounting for 35% and 28% of all incorrect answers respectively.  This suggests that participants’ understanding of the underlying concepts of the required ICF elements is limited.  Ethical training of researchers and IRB members, particularly in the Asia Pacific and African regions, concerning valid informed consent is still needed.

Understanding of Essential Elements Required in Informed Consent Form among Researchers and Institutional Review Board Members

The process of informed consent remains a constant challenge in clinical research. The aim of the present study was to evaluate the understanding of researchers and members of Institutional Review Boards (IRBs) regarding the essential elements of an Informed Consent Form (ICF) as required by internationally recognized regulations. Using eight case studies to illustrate basic ethical elements, the study involved 107 participants, mainly from the Asia Pacific and African regions. The results showed that most of the participants had general knowledge regarding the essential elements required in an ICF. However, the issues of confidentiality of data and payment for study participation proved to be problematic for some participants, accounting for 35% and 28% of all incorrect answers respectively. This suggests that participants’ understanding of the underlying concepts of the required ICF elements is limited. Ethical training of researchers and IRB members, particularly in the Asia Pacific and African regions, concerning valid informed consent is still needed.

Institutional Review Board (IRB): its role and responsibility in making research ethical.

ABSTRACT: This is a review article prepared as a part of the assignment in the educational activity and training on research ethics titled “Ethical and Regulatory Aspects of Clinical Research” arranged by the Bangladesh Bioethics Society (BBS), Dhaka, Bangladesh, in collaboration with the Department of Bioethics of National Institutes of Health (NIH), Bethesda, Maryland, USA, through video conferencing between September 25 and November 13 of 2013. The search was confined to ‘Google’, ‘HINARI’ and ‘PubMed’ published articles. Besides, some guidelines on roles and responsibilities of Institutional Review Board (IRB) were taken into consideration. Key words used for searching were ‘institutional review board’, ‘ethical review committee’ and ‘ethical research’. A total of 18 journal articles and some guidelines were selected for this writing. The systemic review from the databases revealed some important discussions on research, ethical research, roles and responsibilities of IRB/ERC and its challenges, and national/institutional research strategies.

Effect of Rosiglitazone on Insulin Resistance and ROS . IKK Signaling Pathway in Vascular Endothelial Cells / 医药导报

Objective To explore the protective effect of rosiglitazone on insulin resistance( IR)induced by high glucose in vascular endothelial cells and its possible mechanism. Methods Human umbilical vein endothelial cells( HUVECs) was divided into 3 groups:the normal control group cultivated in DEME medium with 5. 5 mmol·L-1 glucose;the high glucose group( HG)cultivated in DEME medium with 33 mmol · L-1 glucose for 24 h after the IR model was set up;the rosiglitazone group cultivated in DEME medium with 33 mmol·L-1 glucose and 10 μmol·L-1 of rosiglitazone for 24 h after the IR model was set up. The cell viability,nitric oxide(NO),endothelin-1(ET-1),mitochondrial membrane potential,reactive oxygen species ( ROS),p-IKK and IkBa protein levels were detected. Results Compared with the normal control,the cell viability,the level of NO and the mitochondrial membrane potential were decreased,levels of ET-1 and ROS increased,p-IKK expression was up-regulated,and IκBα expression was down-regulated in HG group(all P〈0. 01). Rosiglitazone reversed these changes in a time-dependent manner(P〈0. 05). Conclusion Rosiglitazone has the protective effect on insulin resistance induced by high glucose in vascular endothelial cells via inhibiting ROS/IKK signaling pathway.

Discussion on Special Ethical Issues in Clinical Research of Traditional Chinese Medicine / 世界科学技术-中医药现代化

The eastern and western medicine have different thinking mode under different philosophy. This article discussed on special ethical issues which were encountered in the clinical research of traditional Chinese medicine (TCM) and different from western medicine. The connotation of ethical review should also be adapted to the characteristics of TCM. This paper discussed these problems, and put forward the idea that ethical review system should be built according to TCM characteristics. Standards for TCM ethical review should be established in order to promote the research progress of TCM and maintain the legitimate rights of TCM subjects.

A Study on Management and Report of Adverse Event in Clinical Trials

BACKGROUND: This research is to identify the difficulties occuring in the course of managing the adverse events and the adverse event related standard operating procedure in the regulation of each institutional review board. METHODS: In order to identify the issues of the management of adverse events of each institution, this research surveyed the IRB administrators in fifty two university hospitals nation-wide. This survey is conducted among one chairman and one IRB member from the IRB members per each IRB who have experience in reviewing adverse events. The survey also includes investigators and sponsors who engage in reporting adverse events. RESULTS: The result of this survey demonstrates that the objects and the terms of adverse event reports provided by the Standard Operating Procedure and the KGCP of each institution are not very different from each other. However, according to the survey, any cases reported to the IRBs, although they are not specified as the object of reports in the institution, have been reviewed by the IRB members. To sum up the results of the survey, the major issues include ambiguous regulations on adverse event reports and reviews, the use of different report formats for each institution, and the difficulty with evaluating the causal relationship with Investigational Product. CONCLUSION: It is necessary to develop concrete and specified guidelines on the objects and the terms of reports, the standard for the causal relationship and the adequate measures for adverse events after review and to standardize the format of adverse event reporting.

Institutional Review Board (IRB) Mutual Recognition Program and Its Feasibility in Korea

BACKGROUND: The use of Cooperative Institutional Review Board (Co-IRB) has become subject to continuous discussion. As a result, leading mainly by the Korea Association of Institutional Review Boards (KAIRB), "IRB mutual recognition program (MR-IRB)" was proposed. However operational methods of the program are still controversial. The object of this research is to examine domestically feasible scope and operation methods of MR-IRB by conducting survey. METHODS: 71 survey data was collected from chairman or specialist of each IRB and 29 IRB members of one institution running Central IRB was included. RESULTS: 76.5 % of respondents selected phase 3 multi-national, multi-center clinical Sponsor Initiated Trial as a suitable subject of MR-IRB, but only 50 % supported Investigator initiated trials, and answered early-stage clinical trials such as phase 1 clinical trials or biological agent trials are unsuitable due to relatively insufficient knowledge on risk level. In order to operate MR-IRB, standardized review criteria and agreement of institutions in building mutual trust is essential. Also it was learned from the survey that the most desirable way to adopt MR-IRB is to be initiated by the representing organization such as KAIRB based on mutual trust from institutional agreement. CONCLUSION: MR-IRB was recognized as one of Co-IRB. A suitable subjects of MR-IRB were preferred the phase 3 multi-national, multi-center clinical sponsor initiated trials to all kinds of clinical trials. This study suggests that based on real operation experience from MR-IRB pilot study, further study should be conducted to analyze pros and cons of MR-IRB and identify domestically eligible model to facilitate MR-IRB.

Human Studies on Functional Foods: How They Are Regulated

Along with the steady growth of health functional food (HFF) markets, research evaluating the human effects of HFF has been expanding. In this study, we investigated the regulatory and management system of human study on HFF in the USA, Japan and UK, and the Korean domestic regulations on HHF, medicines, medical devices, cosmetics and biotechnology in order to improve the domestic management system. In these four countries, institutional review board (IRB) or research ethics committee (REC) approvals are required for on human study of HHF, but regulatory and management systems differ from country to country. In the USA, human studies on HFF for structure/function claims do not require the FDA's prior approval but clinical trials of the disease treatment effects of HHF require prior approval from the FDA. In the USA, IRBs are managed by the Department of Health and Human Services (DHHS) rather than the FDA, and IRBs in those institutions which would execute the clinical trials requiring prior approval from the FDA or human studies funded by the USA federal government are required to be registered on the DHHS. In the UK, although the government does not require prior approval of human study, authorized RECs managed by the National Research Ethics Service (NRES) and other independent RECs review the human study. In Japan, human study for HFF must conform with "Ethical guidelines for epidemiological research" and IRB registration has not been required. In Korean domestic regulations, the responsibilities, compositions, functions and operations of IRBs on medicines, medical devices and biotechnology are legally specified, but not those of IRB on HHF. These foreign statuses for the management of human study on HFF and comparisons with Korean regulations are expected to be used as basic data to improve the domestic legal system.

A Study on Bioethical Consideration to Prospective Clinical Research Papers published in Journal of Korean Society of Emergency Medicine

PURPOSE: There is increasing concern about ethical conduct of human research in the field of medicine. The purpose of this study was to assess the ethical review process by institutional review boards for human research articles published in the journal of Korean Society of Emergency Medicine. METHODS: We reviewed human research papers published in the journal of Korean Society of Emergency Medicine from the 1st edition, 1990 to the 6th edition, 2006. A checklist was used to review the articles. RESULTS: The total number of prospective clinical research paper was 250. Among them, there were 63 papers (25.2%) in which the obtaining of informed consent was described in the article. Only two studies (0.8%) published in the journal were noted to have IRB approval. Invasive techniques were employed in 134 studies (53.6%). Among the 134, only 22 (16.4%) mentioned that informed consent taken was given during the study. Studies which may have involved discrimination totaled 21 (8.4%), and the number of studies that may have violated the patients' right to privacy was 20 (8%). The number of studies that may have a conflict of interest but was not declared was 12 (4.8%). CONCLUSION: There should be greater concern about the ethical conduct of research in studies with human research subjects in the journal of the Korean Society of Emergency Medicine.

Re-analyze of The Institutional Review Board / 中国医学伦理学

This article is the second one of the series articles about three kinds of ethics committee. The author will expound the background, definition, organization, function and significance respectively of the Institutional Review Board.

Discussion on How to Be a Chairperson of Institutional Review Board/Ethics Committee / 中国医学伦理学

The IRB/EC chairman plays an important role in the work of an IRB/EC.He must in part be an enthusiastic leader and expert on medicine,legal regulations,ethical issues and management.The main purpose of IRB/EC chairman is to help inspire IRB/EC members to perform their ethical review work well in IRB/EC without being interfered by outside factors.