With the growing amount of clinical research, regulations and research ethics are becoming more stringent. This trend introduces a need for quality assurance measures for ensuring adherence to research ethics and human research protection beyond Institutional Review Board approval. Audits, one of the most effective tools for assessing quality assurance, are measures used to evaluate Good Clinical Practice and protocol compliance in clinical research. However, they are laborious, time consuming, and require expertise. Therefore, we developed a simple auditing process and (...) evaluated its feasibility and effectiveness. The screening audit was developed using a routine audit checklist based on the Severance Hospital’s Human Research Protection Program policies and procedures. The measure includes 20 questions, and results are summarized in five categories of audit findings. We analyzed 462 studies that were reviewed by the Severance Hospital Human Research Protection Center between 2013 and 2017. We retrospectively analyzed research characteristics, reply rate, audit findings, associated factors and post-screening audit compliance, etc. Investigator reply rates gradually increased, except for the first year. The studies were graded as “critical,” “major,” “minor,” and “not a finding”, based on findings and number of deficiencies. The auditors’ decisions showed fair agreement with weighted kappa values of 0.316, 0.339, and 0.373. Low-risk level studies, single center studies, and non-phase clinical research showed more prevalent frequencies of being “major” or “critical”. Inappropriateness of documents, failure to obtain informed consent, inappropriateness of informed consent process, and failure to protect participants’ personal information were associated with higher audit grade. We were able to observe critical GCP violations in the routine internal audit results of post-screening audit compliance checks in “non-responding” and “critical” studies upon applying the screening audit. Our screening audit is a simple and effective way to assess overall GCP compliance by institutions and to ensure medical ethics. The tool also provides useful selection criteria for conducting routine audits. (shrink)

Giải quyết biến đổi khí hậu và ô nhiễm môi trường đang và sẽ là thách thức lớn của nhân loại trong thế kỷ 21. Con người không còn nhiều thời gian để sửa chữa, phục hồi đưa hệ sinh thái môi trường (tự nhiên) trở về trạng thái an toàn. Trong khi các nỗ lực trong thời gian qua chưa thực sự hiệu quả thì COP26 mở ra cơ hội lớn để nhân loại tiến gần đến mục tiêu kiềm (...) chế nhiệt độ của trái đất không vượt quá 1.5 độ C. Mặc dù Việt Nam cùng với 146 quốc gia trên thế giới đã có cam kết mạnh mẽ nhất trong việc giảm phát thải vào năm 2050, tuy nhiên việc cụ thể hóa cam kết thông qua các giải pháp sáng tạo là rất quan trọng. Sử dụng (áp dụng, vận dụng) hệ sáng tạo 3D và nguyên lý bán dẫn giá trị, tác giả đề xuất hệ sinh thái “giải pháp trụ cột” cần thực hiện gồm có tăng cường thông tin, truyền thông, nghiên cứu khoa học về môi trường (biến đổi khí hậu, ô nhiễm môi trường...); xây dựng, chuyển đổi và nâng cao văn hóa và môi trường; đẩy mạnh phát triển kinh tế gia tăng phúc lợi; xây dựng (chuyển đổi) lớp doanh nhân có văn hóa, trách nhiệm môi trường; tăng cường mở rộng sự hợp tác quốc tế về mọi mặt đặc biệt là trong lĩnh vực kinh tế, truyền thông và khoa học; và thực thi các giải pháp nêu trên một cách kỷ luật. (shrink)

No consensus yet exists on how to handle incidental fnd-ings in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are fndings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. This paper reports recommendations of a two-year project group funded by NIH to study how to manage IFs in genetic and genomic research, as well as imaging research. We conclude that researchers (...) have an obligation to address the possibility of discovering IFs in their protocol and communications with the IRB, and in their consent forms and communications with research participants. Researchers should establish a pathway for handling IFs and communicate that to the IRB and research participants. We recommend a pathway and categorize IFs into those that must be disclosed to research participants, those that may be disclosed, and those that should not be disclosed. (shrink)

This paper reports our analysis of the ELSI Virtual Forum: 30 Years of the Genome: Integrating and Applying ELSI Research, an online meeting of scholars focused on the ethical, legal, and social implications (ELSI) of genetics and genomics.

Despite its widespread existence, the adaptive role of aneuploidy (the abnormal state of having an unequal number of different chromosomes) has been a subject of debate. Cellular aneuploidy has been associated with enhanced resistance to stress, whereas on the organismal level it is detrimental to multicellular species. Certain aneuploid karyotypes are deleterious for specific environments, but karyotype diversity in a population potentiates adaptive evolution. To reconcile these paradoxical observations, this review distinguishes the role of aneuploidy in cellular versus organismal evolution. (...) Further, it proposes a population genetics perspective to examine the behavior of aneuploidy on a populational versus individual level. By altering the copy number of a significant portion of the genome, aneuploidy introduces large phenotypic leaps that enable small cell populations to explore a wide phenotypic landscape, from which adaptive traits can be selected. The production of chromosome number variation can be further increased by stress‐ or mutation‐induced chromosomal instability, fueling rapid cellular adaptation. (shrink)

Examining the subtle forms of aggression, violence, and harassment that occur in our society and manifest in institutions and places of work, the expert contributors collected here describe the experience of social marginalization and expose how vulnerable individuals work to navigate exclusionary climates. This volume explores how bodies disrupt the status quo in multiple contexts and locations; provides insights into how institutions are structured and how practices that may cause harm are maintained; and, finally, considers progressive and proactive alternatives. This (...) book will be a key resource for academics and professionals in education, sociology, nursing, law, business and political science, as well as organizations and policymakers grappling with aggression in the workplace. (shrink)

플라톤과 아리스토텔레스로 대표되는 희랍철학 사상 에 관한 17인의 공동논문집.

재야지도자이자 한국의 정신적인 지도자였던 고 함석 헌 선생과 장준하 등 한국 지성인들과의 만남을 소개 했다.