Ethical Concern in International Qualitative Health Research

Sue Turale 질적연구학회 2007 질적연구 Vol.8 No.2

This paper is based on an invited keynote address to the Qualitative Health Research Conference held at Ewha Womans University, Seoul, Korea, June 20­23, 2007. Some important ethical issues in international qualitative research are highlighted to encourage researchers to contribute to the development of better international guidelines and strategies to ensure the protection and privacy of research participants, including those from developing countries. The author reflects on these issues, drawing on literature, her research experience, and learning experiences an editor of a international journal. The literature reveals a small but growing international body of knowledge about the ethical concerns of qualitative researchers. However, there is a serious lack of debate about how the health professions can ensure that international qualitative research is undertaken in an ethical framework that fits within socio­cultural­legal norms of engaging countries, and particularly the host country. Researchers from different countries have different mindsets, cultures, languages, as well as differing levels of research and educational training. They also have different levels and standards of training in the ethical aspects of research. This may cause both actual and potential moral problems, damage to both researchers and the researched, and undermine scholarly activity and integrity.

Government Initiatives for Research Ethics During COVID-19 Pandemic in Korea

Park Young Su,Kim Ock-Joo 대한의학회 2024 Journal of Korean medical science Vol.39 No.12

Background: Despite the growing necessity for government-led policy changes on clinical research ethics during pandemic, the scope of previous literature is limited to Korean government’s pandemic response strategies or reflections of research ethics at the level of institutions and academic societies. This paper examines the proactive policy changes and responses by the South Korean government in addressing the challenges and issues of research ethics against the backdrop of the urgency of rapid development and emergency supply of medical products during the coronavirus disease 2019 (COVID-19) pandemic. Methods: We conducted searches of various government documents, using predetermined keywords related to research ethics and integrity during the COVID-19 pandemic. Only documents issued by governments or public institutions were included. A total of 24 documents were selected for analysis. They were divided into two phases: the first phase for urgent response (January 2020–February 2021) and the second phase (March 2021–February 2023) for long-term preparedness. Results: The Korean government recommended several measures of research governance to accelerate the ethical review of COVID-related research to be shortened less than one week: the joint operation of Institutional Review Boards (IRBs), exempted or expedited review by a special review committee, guidelines for urgent reviews, and designation of the Korean Academy of Medical Sciences as the supervising agency for the Clinical Trial Safety Support Institution as well as the Central IRB. It allowed temporary non-face-to-face methods for informed consent process (telephone explanations and a photo of the original signed consent) and clinical trials (telephone counselling and prescription, proxy prescription, and drug delivery and supply to clinical trial participants, and online ethics training). Conclusion: As a result of South Korea’s commitment to ethical principles in their pandemic response, the medical system did not experience collapses due to the pandemic, and pandemic research was conducted with careful ethical considerations. The pandemic ethics immunization during the Middle East respiratory syndrome epidemic in 2015 laid the foundation for prompt government initiatives that ensured both pandemic research ethics and pandemic response ethics.

독일에서의 인간대상 의학연구에 있어 윤리위원회의 역할과 기능

구인회(Ku In-Hoe) 한국생명윤리학회 2004 생명윤리 Vol.5 No.1

In the field of medical research on humans, the ethics committees have an important role. They ensure the necessary protection of the subjects and contribute to quality assurance in medical research. Opinions of the Committee do not have the force and effect of law and may not be relied upon as an absolute defense to a charge of ethical misconduct. Originally established as an instrument of ethical self-guard in the medical profession, the ethics committee soon advanced to a statutory institution and is now on the way to becoming the body charged with judicial control in medical research. This development implies the need for changes in both position and function of the ethics committee, but these have not been made with due consideration for all the developments there have been. The existing uncertainties are hampering medical research, which is in the interests of neither the public nor the actual medical research. Owing to the different and obscure legal arguments used, it has not been possible to make any definitive decision on the legal standing of decisions made by ethics committees. It seems obvious that these problems cannot be solved unless the work of ethics committees can be based on a clear and reliable legal basis regulating the judicial nature of the committees' decisions, the composition of the actual committees and the procedures they are to follow in reaching their decisions. With regard to the existing regulations, this might be best achieved by integrating the work of the ethics committees into the approval procedures of an administrative authority. When a committee member has a conflict of interest in relation to a project under review, or could be seen to have a conflict of interest, that member should withdraw from the meeting.

자율적 연구윤리 기구로서 기관생명윤리위원회의 역할과 과제

백수진(Sujin Baik),김현철(Hyeon Cheol Kim) 국가생명윤리정책원 2020 생명, 윤리와 정책 Vol.4 No.1

생명윤리법의 기관위원회 제도는 연구기관에 설치하고 연구기관 내에서 연구계획서 심의, 연구대상자 보호를 비롯한 연구윤리에 관한 관리를 수행하기에 적합하도록 설계되어 있다. 즉, 연구기관 스스로 기관위원회를 통해 내부 연구 수행을 관리하는 이른바 ‘자율규제’ 체계를 채택하고 있다. 그런데 이런 자율규제는 한편으로 연구 수행과 가장 가까운 거리에서 윤리적 문제들을 즉시 관리할 수 있다는 장점이 있는 반면에, 기관 내부의 이해관계에서 자유롭기 어렵고 기관위원회의 규제 역량이 부족하면 있으나 마나 한 존재로 전락하기 쉽다는 치명적인 단점을 가지고 있다. 그럼에도 불구하고 필자들은 연구자의 학문 연구에 대한 자유를 보장하고 윤리성을 확립하여 연구에 대한 신뢰를 확보하기 위해서는 이러한 기관 내에 있으면서도 적절한 독립성과 전문성을 갖는 기관위원회의 역할이 중요하며, 이를 위한 역량을 지원하고 관리하는 것이 결과적으로 윤리적 연구 환경을 조성하는 길이라 생각한다. 이를 위해 이 글에서는 기관위원회 제도의 한계로 첫째, 생명윤리법에서는 기관위원회가 그 기관의 연구를 모두 관장할 수 있는 위상을 갖도록 하는 강제 장치가 제도화되어 있지 않다는 점. 둘째, 획일적 기관위원회 설치 의무가 현실의 연구환경을 적절히 반영하기 어렵다는 한계가 있다는 점. 셋째, 기관위원회 심의와 운영을 위한 역량을 갖춘 기관위원회 위원장, 위원, 행정인력이 아직 부족하다는 현실적인 한계가 있다는 점을 지적하고 이에 대한 제언으로 구체적인 기관위원회 및 위원을 위한 역량 관리 방안과 기관위원회 제도화 개선 방안을 제시하고자 한다. The Institutional Bioethics Committee System authorized by the Bioethics Act was designed to be implemented in research institutes for the management and oversight of ethical conduct of research, including review of research plans and protection of research subjects within the institutes. In other words, the research institute itself adopts a system of self-regulation that manages the conduct of internal research through the institutional committee. While self-regulation has the advantage of affording oversight and management of ethical issues at a close distance to the site where the research is conducted, internal interests may influence the institution’s regulatory capacity through the institutional committee. Nevertheless, with adequate independence and expertise within the institutional committees, research institutions can ensure the freedom of researchers to conduct independent research while assuring ethical principles and maintaining trust in the research process. In this article, I examine the limitations of the institutional committee system and suggest ways to improve the current situation. First, in the Bioethics Act, there are no provisions to ensure that the institutional committee achieves the status to supervise all of the institution’s research. Second, the requirement to establish an institutional committee within all research institutions is hindered by a lack of clarity regarding the actual research environment of many institutions. Third, practical considerations further limit system development because of a shortage of qualified institutional committee chairpersons, members, and administrative personnel with the expertise to deliberate and manage the institutional committee effectively. To address these concerns, I present a plan to improve the institutionalization of research ethics committees and strengthen competency management plans for specific institutional committees and members.

기관생명윤리위원회(IRB) 심의 미준수에 대한 관리 방안 검토

정은주,백수진 한국의료윤리학회 2020 한국의료윤리학회지 Vol.23 No.1

Since 2013, with the expansion of Institutional Bioethics Committees (IBCs), the ethical review and management of research on human subjects has greatly increased throughout South Korea. During this same time, a number of ethical lapses, including certain researchers failing to comply fully with the law or making false statements on their IBC applications, have attracted media attention. Although these scandals have helped to highlight the importance of ethical guidelines in research on human subjects, they have been quickly forgotten and have not led to any lasting changes or solutions. In order to prevent these incidents from occurring, new policy proposals are needed. Among these should be a plan to improve the IBC review/approval process in order to ensure that all research-related activities, from the beginning to the end of the research cycle, follow proper guidelines. Toward that goal, this article examines, and makes recommendations concerning the IBC review/approval process, which is the starting point of responsible research. The article examines the purpose and limitations of the Bioethics and Safety Act, reviews domestic and foreign laws and policies on IBC review duties, with a focus on 45CFR46 in the US, and finally suggests measures that could be adopted to better manage IBC non-compliance in Korea. On this last point, this article makes three recommendations: (1) a preventative measure for strengthening IBC education and related capacities through an IBC governance organization; (2) a measure to link and activate existing policies for research funding at academic institutions; and (3) a measure for registering and sharing research and IBC approval information. 2013년 이후 기관생명윤리위원회(IRB) 설치 의무 확대를 통해 연구에 대한 심의 및 관리가 제도화되었지만, 그 운영의 적절성에 대해 생각해 보게 하는 법률 미준수 또는 IRB 심의 관련 허위 기재 등의 연구윤리 문제가 사회적인 이슈가 된 바 있다. 일련의 스캔들로 연구의 윤리적 수행에 대한 중요성이 부각되고 있음에도 불구하고, 지금까지 이러한 사건·사고는 발생 이후 잠시 주목을 받고 관리 방안 필요성이 대두되다가 명확한 대안 없이 잊히는 과정을 반복해왔다. 사회 변화와 과학기술발전이 급격한 현재 연구 환경에서는 발생 가능한 윤리적 이슈가 지금보다 더 다양하고 위협적일 수 있으며, 과거의 과오를 되풀이하지 않기 위해서라도 연구 관련 발생 가능한 윤리적 문제와 이를 준수하지 않을 때 관리 가능한 정책적 대안이 고려되어야 한다. 이 중에서도 IRB 심의는 연구의 윤리적 시작과 안전은 물론, 진행과 종료를 담보하는 과정으로, 심의 관련 미준수를 제도적으로 관리하는 방안 마련은 중요하다. 심의 미준수에 대한 관리 체제의 결여는 연구의 윤리성과 신뢰성을 책임져야 하는 해당 기관과 기관위원회의 기반을 잃게 하고, 연구자의 불찰을 낳는 과정을 되풀이하도록 하기 때문이다. 이에 따라, 본 글은 책임 있는 연구의 시작점인 IRB 심의를 중점으로 연구자의 자율적 심의 및 연구 수행과 관리에 대한 생명윤리법의 취지와 한계를 살펴보고, 우리와 유사하게 기관 내 IRB를 설치·운영하고 있는 미국의 IRB 심의에 대한 법률과 관련 정책을 검토하였다. 그리고 국내에서 연구자의 심의 미준수를 예방하고 관리할 수 있는 방안으로 전담 관리 기구를 통한 상담 및 교육과 역량 강화를 지원하는 ‘예방적 관리’와 연구 및 학술 관리 기관의 정책 연계와 활성화를 통한 ‘정책적 관리’, 그리고 연구 및 승인 정보의 등록과 공유를 통한 ‘시스템적 관리’ 방안을 모색해 보았다. 본 글에서 제안한 방안이 향후 IRB 심의 준수 관리뿐 아니라 생명윤리 및 안전 관리 체계를 적절한 방향으로 확립하는 데 도움이 되기를 기대한다.

간호학 연구의 윤리적 접근

정인숙 한국간호과학회 2015 Journal of Korean Academy of Nursing Vol.45 No.3

Purpose: This paper was written to introduce methods of using the research ethics committee (RES) from requesting the initial reviewto reporting the close-out for nursing researchers. Methods: General ethical principles were described by reviewing the ‘Bioethics andSafety Act’ and other related guidelines, and constructing some questions and answers. Results: The results were composed of threeparts; definition of RES, steps in using RES, and archiving. The 7 steps for using RES were; identifying whether the study needed to bereviewed, by the RES identifying whether the study could be exempted, requesting the initial review after preparing documents, requestingthe re-review, requesting an amendment review, requesting a continuing review and reporting the close-out. Conclusion:Nursing researchers need to receive RES approval before starting nursing research involving human subjects. Nursing researchers areurged to use the steps reported in this paper to receive RES approval easily and quickly.

커뮤니케이션 연구와 연구윤리 문제

정동훈(Donghun Chung) 한국언론학회 2006 한국언론학보 Vol.50 No.3

The present paper focused on research ethics in communication field which has not been paid attention. Two organizations are mainly dealing with research ethics in science: Institutional Review Board(IRB) reviews research projects which involve human subjects and Office of Research Integrity(ORI) investigates cases of scientific misconduct. However, only few schools have these bodies at the institutional level in Korea. Indeed, social science has ignored the importance of the systemized processes and official organizations to use human subjects for behavioral research. Therefore, this research emphasized on the necessity of the Research Ethics Committee(REC) in the Korean Society for Journalism and Communication Studies. The necessity came from historically ethical issues, and various cases were dealt with as examples. Finally, the role and system of REC were suggested.

유네스코 '생명윤리와 인권보편선언'의 권고사항과 국내 실천을 위한 제언

이인영 한남대학교 과학기술법연구소 2006 과학기술법연구 Vol.12 No.1

In October 2005, the General Conference of UNESCO adopted by acclamation the Universal Declaration on Bioethics and Human Rights. Member States committed themselves and the international community to respect and apply the fundamental principles of bioethics set forth within a single text. Universal Declaration addresses ethical issues related medicine, life science and associated technologies as applied to human beings, taking into account their social, legal and environmental dimensions. Together with the Declaration, the General Conference of UNSCO adopted a resolution which calls upon Member States to make any effort to take appropriate steps to ensure the follow-up to the Declaration. Last year some serious accidents in relation to bioethics and research ethics occurred in Korea. We should consider new approaches to social responsibility to ensure that progress in science and technology contributes to secure human dignity and human rights. Also we should take all appropriate measures, whether of a legislative, administrative or other character, to give effect to the principles set out in this Universal Declaration. First of all, we should recognize that the ethical issues raised by the rapid advances in science and their technological applications should be examined with the respect to the human dignity and human rights. And then, we should promote professionalism, honesty and integrity and transparency in ethical decision making in particular declarations of all conflicts of interest and appropriate sharing of knowledge. Persons and professionals concerned and society as whole should be engaged in informed pluralistic public debate. Secondly, independent and multidisciplinary ethics committees should be established in order to provide advice and appropriate assesment on ethical problems. In advancing scientific research and medical practice, the benefits to research participants and patients should be maximized and any possible harm to such individuals should be minimized. The ethical committees should functionally fulfill its tasks. Thirdly, we should endeavor to foster bioethics education and training and encourage information dissemination programmes about bioethics. In particular young people are provided the useful and vivid understanding of the ethical implications in relation to science, environment and human life. Also, researchers and research assistant are provided the better bioethics education and training in order to promote integrity in scientific and biomedical research. We should monitor institutional investigations of research misconduct and facilitates the responsible conduct of research through educational, preventive, and regulatory activities.

How to Deal with the Concept of Authorship and the Approval of an Institutional Review Board When Writing and Editing Journal Articles

허선 대한임상검사정도관리협회 2020 Journal of Laboratory Medicine And Quality Assuran Vol.42 No.2

This paper examined the concept of ‘authorship,’ the ‘approval of an institutional review board (IRB),’ and the authorship dispute and IRB issues resolution process. Descriptions were based on international guidelines and the literature on research and publication ethics. ‘Authorship’ entails a promise among co-authors, and as such, outsiders should not be involved. Usually, authorship disputes stem from internal researcher conflict, especially in cases involving the ghost author issue. Qualifying as an author is based on the four criteria recommended by the International Committee of Medical Journal Editors: substantial contributions, drafting the work, final approval, and agreement to be accountable for all aspects of the work. However, these criteria vary according to the academic category. Furthermore, author taxonomy has been introduced to clarify each author’s role. Author order also entails a promise among co-authors. The IRB may exempt studies on human subjects or human derivatives that are not related to subjects’ safety or do not utilize subjects’ personal information from review or from obtaining informed consent. At the core of medical journals’ research and publication ethics issues, such as authorship and the IRB’s approval, is a commitment to ensuring ‘the safety and privacy of subjects and patients.’ Given the importance of this principle, research and publication ethics issues are due considerable attention.

Protection of Personal Information in Medical Journal Publications

Sun Huh 대한신경중재치료의학회 2019 Neurointervention Vol.14 No.1

It aimed to present the definition of personal information based on Korean laws that protect personal information and the process of protection of personal information in journal publishing based on the guidelines of the International Committee of Medical Journal Editors and Committee of Publication Ethics. Two Korean laws relate to the protection of personal information in human subject research: the Personal Information Protection Act and the Bioethics and Safety Act. These laws were enacted to prevent the unauthorized use of Koreans’ personal information including medical information. Personal information can be divided into personally identifiable information including resident registration numbers and sensitive information including health information. To protect personal information in journal publishing, institutional review board (IRB) approval and obtaining informed consent from patients is recommended or mandatory in clinical studies. However, retrospective chart reviews may be exempted from IRB approval, while obtaining informed consent is recommended for all case reports. Journal policies may vary with regard to whether a copy of the informed consent form is collected from authors, since the Committee of Publication Ethics guideline does not specifically recommend collecting it. In discussions of adopting clinical data-sharing policies, transfer of data including nonidentifiable personal information to another country is an unresolved issue. Furthermore, a public data repository site should be established in Korea for data to be deposited. To protect subjects’ privacy and to prevent legal issues potentially arising from privacy concerns, editors and publishers should do their best to publish articles with appropriate oversight on subjects’ personal information.