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.

A study to assess the completeness of informed consent documents for biomedical research on human participants submitted to the institutional ethics committee of a tertiary care hospital

Background: Informed consent is an essential pre-requisite for research on human participants. However, many studies have shown that informed consent documents (ICDs) are incomplete and lack many of the essential elements. The objective of the study was to assess the completeness of ICDs submitted to an institutional ethics committee (IEC) against the Indian Council of Medical Research (ICMR) ethical guidelines for biomedical research on human participants.Methods: This is a retrospective cross-sectional study. The ICDs submitted to the IEC during the period from January 2015 to December 2017 were reviewed for completeness, with the help of a checklist which is based ICMR ethical guidelines for biomedical research on human participants 2006.Results: A total of 212 ICDs were reviewed during the study period. More than 50% of the ICDs have clearly explained many of the essential elements like nature and purpose of the study (62.3%), voluntary participation (98.6%), procedures (68.9%), risks (71.2%), benefits (92.9%), alternative treatments (60.7%), maintaining confidentiality (99.1%), no loss of benefits on withdrawal from the study (87.8%) and contact details of principal investigator (99.5%). However, the other essential elements of the ICD are either not mentioned or not clearly explained.Conclusions: This study has shown that although majority of the ICDs submitted for review by the IEC have mentioned many of the essential elements, some of the elements like contact details of Chairman of IEC, future use of sample, compensation for trial related injury and provision of counseling for consent of genetics testing have not been stated.

III. The role of the Research Ethics Committees in the regulation of Pharma-Sponsored studies

Participants of Pharma-sponsored research are exposed to risks, benefits, and uncertainties that do not occur in other forms of clinical studies. Ethics committees represent the subjects’ first line of protection. This responsibility begins with the study review and ends after all study subjects finish the intervention. The objective of this paper is to review the most common controversial issues found in Pharma-sponsored studies. Potential solutions are proposed to prevent or resolve the polemical aspects. However, different challenges will be faced in the near future (e.g., when new therapies reach their late stage of development). All parties involved in research should work together to guarantee the protection of participants, the paramount principle on which clinical investigation is based. Pharma-sponsored research is a crucial driver to develop and implement innovative approaches to improve the informed consent process and the execution of the studies.

II. The research ethics involving vulnerable groups

Abstract Vulnerability in research occurs when the participant is incapable of protecting his or her interests and therefore, has an increased probability of being intentionally or unintentionally harmed. This manuscript aims to discuss the conditions that make a group vulnerable and the tools and requirements that can be used to reduce the ethical breaches when including them in research protocols. The vulnerability can be due either to an inability to understand and give informed consent or to unequal power relationships that hinder basic rights. Excluding subjects from research for the only reason of belonging to a vulnerable group is unethical and will bias the results of the investigation. To consider a subject or group as vulnerable depends on the context, and the investigator should evaluate each case individually.

Discussion of the site visit strategy of Institutional Review Board / 中华医学科研管理杂志

Objective To discuss appropriate strategies of site visits in ethical committees ,to enhance the supervision of clinical trials effectively ,and standardize the implementation of clinical research .Methods In consideration of the lack of de-tailed normative description of site visit in ethical guidelines and relevant articles ,as well as the varying degrees of implementa-tion and understanding of site visits among different ethical committees .This article discussed the procedures ,contents and considerations of site visit based on the analysis of numerous site visits cases conducted .Results Site visit is one of the crucial procedures to more comprehensive ,in-depth and truly understanding of the implementation of clinical trials .It is helpful to help sponsors/investigators enhance awareness and compliance with the good clinical practice .It also helps to correct problems time-ly during the implementation process to assure the standardized implementation of follow-up studies ,and finally ,effectively protect the rights and interests and safety of subjects .Conclusions Standardized and efficient site visit strategy of the ethical committee is one of the important regulatory strategies in the implementation of clinical trials and is an effective supplement to the regular review of ethical materials .

Placebo Controlled Trials: Interests of Subjects versus Interests of Drug Regulators

The use of placebo-controlled trials in situations where established therapies are available is considered ethically problematic since the patients randomised to the placebo group are deprived of the beneficial treatment. The pharmaceutical industry and drug regulators seem to argue that placebo-controlled trials with extensive precautions and control measures in place should still be allowed since they provide necessary scientific evidence for the efficacy and safety of new drugs. On the other hand, the scientific value and usefulness for clinical decision-making may be much higher if the new drug is compared directly to existing therapies. As such, it may still be unethical to impose the burden and risk of placebo-controlled trials on patients even if extensive precautions are taken. A few exceptions do exist. The use of placebo-controlled trials in situations where an established, effective and safe therapy exists remains largely controversial.

Analysis of the Influential Factors of Medical Staff's Cognition on Medical Ethics Review / 中国医学伦理学

Objective:To analyze the influential factors of medical staff's cognition on medical ethics review in Wuhan municipal medical institutions,and thus to provide suggestions for strengthening the ethical construction.Methods:Aquestionnaire survey was conducted among medical staff.Chi-square test and Logistic regression method were performed to analyze the influential factors of medical staff's cognition on medical ethics review.Results:The results showed that medical staff's cognition on medical ethics review was affected by the technical tide,education background,whether had received ethical education,the cognition on ethics committees and whether the medical institution had established ethics committee.With higher technical titles,they thought more necessity to establish ethics committees and conduct ethical review of the clinical applications of new technology and new business.Those with higher technical titles and had read the ethical propaganda materials thought it more necessary to conduct ethical review of the clinical application of new technology and new business and the ethical review of biomedical research involved human beings.Conclusions:The medical institution should embody the establishment and standardization of ethical committees into the hospital assessment management system,as a necessary condition for the application of research projects and achievement awards.Also,it should conduct medical ethics training for all medical staff.Only those passed the examination can enter into the research and clinical operation with certificates,which can protect the medical ethics education into practice.It should strengthen the medical staff's cognition on ethical review,constantly innovate the operation rules and management system based on following the basic ethical review principles,and constantly improve the medical ethical review mechanism.

Ethical Review Gist of Clinical Trials Regarding Medical Apparatus and Instruments / 中国医学伦理学

Objective:To explore the principles and elements of ethical review of clinical trials regarding medical apparatus and instruments.Methods:This paper introduced Beijing Anzhen Hospital's requirements on considerations for the vulnerable,acquisition of informed consent,the researchers' qualification and experiment design,during ethical review of clinical trials regarding medical apparatus and instruments.Results:Institution review board of Beijing Anzhen Hospital designed principles and standard operating procedures for ethical review of clinical trials regarding medical apparatus and instruments.Conclusion:Ethical review of clinical trials regarding medical apparatus and instruments now is more scientifically standardized,and has become an important approach for the protection of subjects' rights and interests.

Institutional Board Review for Clinical Investigations on Inflammatory Bowel Diseases: A Single-Center Study

BACKGROUND/AIMS: The growing volume and the diversity of clinical research has led to related laws and regulations as well as the Institutional Review Board (IRB) approval process becoming more stringent. To conduct clinical research efficiently and while following regulations, information about the IRB approval process and feedback is important for investigators. This has yet to be studied. METHODS: We included 381 gastrointestinal disease research proposals (79 with inflammatory bowel disease [IBD], and 302 with non-IBD) reviewed by the IRB of Severance Hospital between January 2009 and December 2013. We retrospectively analyzed research characteristics including research risk levels, results of initial reviews, frequencies of continuing review, numbers of IRB comments, frequencies of IRB comments, and durations from submission to approval. RESULTS: Investigators' decisions on risk level were higher in the IBD group than in the non-IBD group (P<0.05). Results of initial reviews, frequencies of continuing reviews, the numbers of IRB review comments, and durations from submission to approval were not different between the two groups, but IRB decisions on risk level were higher in the IBD group (P<0.05). In subgroup analysis, the number of IRB comments from initial review on informed consent forms and procedures as well were quest of more information were significantly higher in the IBD group than in the non-IBD group (P<0.001 and 0.01, respectively). CONCLUSIONS: In Korea, rare diseases such as IBD require more information for the IRB process due to their distinct characteristics. IBD researchers should develop research protocols more carefully and make their research as subject-friendly as possible.

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 Bioethics and Safety Act in medical research

The ethics of medical research is an important area of physician ethics. Physicians are called to respect the life, health, and personality of human subjects. In contrast to other ethical fields, physician ethics, including the ethics of medical research, does not rely on the good faith of physicians alone; ethics and the law are intermingled. While respecting international norms related to medical ethics, individual countries have expanded legal interventions into medical research. The United States has regulated the research of human subjects receiving federal funding through the Common Rule. In Korea, legal interventions for human subjects protection have been applied to a limited extent in clinical trials under the Pharmaceutical Affairs Act and the Medical Devices Act in Korea. On January 29, 2004, the Bioethics and Safety Act was enacted, requiring embryo research institutes, gene banks, and gene therapy institutions to establish Institutional Review Boards. On February 1, 2012, the Bioethics and Safety act was completely revised, which was a significant turning point in medical ethics in Korea. Structural differences between the Common Rule of the United States and the Bioethics and Safety Act of Korea are as follows. First, the Bioethics and Safety Act shall be applied regardless of the presence or absence of government funding. Thus the Bioethics and safety act has a more comprehensive and compulsory effect than the Common Rule. Second, under the Bioethics and Safety Act, the Ministry of Health and Welfare has direct supervision over institutional review boards, rather than supervision of the research organization itself. This differs from the Common Rule, which regards the research organization as the counterpart to the government. Third, the Bioethics and Safety Act regulates the study of derivatives of human bodies, in addition to research on human subjects. The Bioethics and Safety Act has the following problems. First, it mandates that researchers, instead of IRBs, record and store data concerning medical research. Second, the Act does not provide a specific definition of "minimal risk". Third, as the Act does not allow the exemption of informed consent of children under the age of 18 even if specific prerequisites are met as in the case of adults, research involving children will atrophy significantly in Korea.

Mission and Operation of Institutional Review Board / 영남의대학술지

An institutional review board (IRB) should independently safeguard the right, safety, and well-being of all clinical trial subjects. It should consist of members who are qualified and experienced to review and evaluate the science, medical aspects, and ethics of the proposed trial. They have to pursue continuing efforts to improve the standards of review. The levels of review include the full board review, expedited review, continuing review, or exempt from review, while the levels of decision-making include approval, conditional approval, deferred approval, and disapproval. Investigators must follow the approved protocols and regulations honestly, and it is the IRB's mission to audit clinical trial sites as well.

Mission and Operation of Institutional Review Board / 영남의대학술지

An institutional review board (IRB) should independently safeguard the right, safety, and well-being of all clinical trial subjects. It should consist of members who are qualified and experienced to review and evaluate the science, medical aspects, and ethics of the proposed trial. They have to pursue continuing efforts to improve the standards of review. The levels of review include the full board review, expedited review, continuing review, or exempt from review, while the levels of decision-making include approval, conditional approval, deferred approval, and disapproval. Investigators must follow the approved protocols and regulations honestly, and it is the IRB's mission to audit clinical trial sites as well.

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.

Institutional review board (IRB) and ethical issues in clinical research / 대한마취과학회지

Clinical research has expanded tremendously in the past few decades and consequently there has been growing interest in the ethical guidelines that are being followed for the protection of human subjects. This review summarizes historical scandals and social responses chronologically from World War II to the Death of Ellen Roche (2001) to emphasize the lessons we must learn from history. International ethical guidelines for studies with human subjects are also briefly described in order to understand the circumstances of clinical research. The tasks and responsibilities of the institutions and investigators in human subject research to preserve the safety and welfare of research subjects are summarized. Next, several debated ethical issues and insights are arranged as controversial topics. This brief review and summary seeks to highlight important arguments and make suggestions to institutional review boards (IRBs) to contribute to the future evolution of ethics in clinical research as we advance forward.

Current issues on a standard for surrogate pregnancy procedures / 대한생식의학회지

While Korea does not have any legal statement on surrogacy, treatments are carried out in practice. As a result, every Institutional Review Board (IRB) of each fertility clinic faces an ethical predicament in reviewing each case. There is a need to arrange the institutions' own standards of surrogate pregnancy procedures before the establishment of national or professional regulation. This article examines the legal, social, and medical issues of surrogacy to help IRBs to judge their cases.

The Suggestions for Improving the Institutional Review Board (IRB) in Clinical Trials: Focusing on Continuing Management

As Korea has increasing number of clinical trials in recent years, institutional review boards (IRBs) are facing new challenges. The IRB should review submitted documents and supervise clinical trials from the beginning to the end to protect human subjects. Although most IRBs invest much time and efforts to initial review, they rarely conduct proper continuing management at the moment. The purpose of this article is to describe challenges involving continuing management, which includes unanticipated problems, subject's complaints, site visit, and continuing review, and to provide suggestions for improving it. Above all, institutions should perceive the importance of continuing management and they should provide sufficient manpower and resources for the management.

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.