Development proposals of Human Research Protection Program

Communication And Coordination ◽

Human Participants ◽

Background: China’s ethics committees alone are unable to meet the growing need for human participant protection. Several scandals in recent years indicate weaknesses in the protection of human participants in China. Objectives: The aim of the study is to summarize the status and problems of human research protection program in China and to explore its establishment proposals at national and hospital levels. Research design: To conduct literature retrieval, Chinese National Knowledge Infrastructure, Chinese Biomedical Document Database, and English databases Web of Science and PubMed were searched; laws, guidelines, and regulations were also searched on web by Google and Chinese search engine Baidu. Ethical considerations: No data were collected from human participants, and ethical review was not required. Findings: There are problems for China’s Human Research Protection Program, such as weak relevant legal systems, insufficient administrative supervision, and incompetent ethics committee capacities. To fully protect human participants, China should promote the development of Human Research Protection Program, which can formulate ethics-related laws, improve regulations for the protection of the safety and rights of human participants, strengthen supervision, and enforce compensation for human participants. Owing to the frequency with which human participants are recruited in hospitals in China, hospitals can utilize existing ethics committees and establish data and safety monitoring committees, quality control, fund and contract management, and conflict of interest management offices. Discussion: As a growing program, it remains necessary to learn from the experience of developed countries with high ethics standards and reformulate them to fit China’s conditions to explore potential future development. The program will also be an experience for other developing countries. Conclusion: Human Research Protection Program can strengthen communication and coordination among various hospital departments to effectively protect the rights and welfare of human participants.

Human research ethics committees members: ethical review personal perceptions

Bioethics News ◽

10.1007/s40592-021-00130-8 ◽

2021 ◽

Author(s):

Boris Handal ◽

Chris Campbell ◽

Kevin Watson ◽

Marguerite Maher ◽

Keagan Brewer ◽

...

Keyword(s):

Research Ethics ◽

Ethics Committees ◽

Ethical Review ◽

Research Ethics Committees ◽

Human Research ◽

Human Research Ethics ◽

Personal Perceptions

The Status of Hospital Ethics Committees in Pennsylvania

Cambridge Quarterly of Healthcare Ethics ◽

10.1017/s0963180198001145 ◽

1998 ◽

Vol 7 (1) ◽

pp. 104-107 ◽

Cited By ~ 6

Author(s):

ELLEN L. CSIKAI

Keyword(s):

Health Care Organizations ◽

Ethics Committees ◽

Ethical Review ◽

American Hospital ◽

American Hospital Association ◽

Current State ◽

Hospital Ethics Committees ◽

Common Response ◽

The Status ◽

Hospital Ethics

Interdisciplinary hospital ethics committees have been the most common response to the mandates for ethical review procedures set forth by the Joint Commission for the Accreditation of Health Care Organizations (JCAHO, 1995 Standards), the American Hospital Association, and within institutions themselves. A 1989 national survey reported that 60% of hospitals had ethics committees. However, little is still known about the current state of these committees in hospitals, their composition, what functions are performed, or what issues are discussed.

Problems and development strategies for research ethics committees in China’s higher education institutions

Journal of Medical Ethics ◽

10.1136/medethics-2020-106768 ◽

2020 ◽

pp. medethics-2020-106768

Author(s):

Jiyin Zhou

Keyword(s):

Higher Education ◽

Research Ethics ◽

Administrative Support ◽

Higher Education Institutions ◽

Human Head ◽

Ethics Committees ◽

Developed Countries ◽

Research Ethics Committees ◽

The Usa ◽

Human Participants

The establishment of research ethics committees (REC) in China’s higher education institutions (HEI) is lagging far behind western developed countries. This has at least partly directly led to anomie in scientific research ethics, as seen in the recent controversies involving a proposed human head transplant and gene-edited babies. At present, the problems for REC in China’s HEI include lack of regulation, informal ethics reviews, lack of supervision and insufficient ethics review capacity. To counteract these problems, suggested measures include mandatory formation of formal ethics committee, administrative support from HEI, ethics approval letter prior to funding application, formulation of regulations and standard operating procedures, selecting and training for members and independent consultants, training for secretaries and staff, ethics training for investigators, and learning from the experience of HEI outside of China, such as the USA and Canada. The establishment of REC in China’s HEI will greatly enhance the overall quality of ethics reviews in China. In addition to better protecting the rights and welfare of human participants, it is also conducive to maintaining the reputation of China’s HEI.

Human Research Protection Program in Mokdong Hospital

The Ewha Medical Journal ◽

10.12771/emj.2015.38.3.95 ◽

2015 ◽

Vol 38 (3) ◽

pp. 95 ◽

Cited By ~ 1

Author(s):

Ivo Kwon

Keyword(s):

Human Research ◽

Enhancing Graduate Practicum Project Development and Selection at Schools of Public Health: A Case Study

Pedagogy in Health Promotion ◽

10.1177/2373379919842232 ◽

2019 ◽

Vol 6 (3) ◽

pp. 196-202

Author(s):

Kristen Cribbs ◽

Susanna Lynch ◽

Marita LaMonica ◽

Chioma Amadi ◽

Ashish Joshi

Keyword(s):

Public Health ◽

Experiential Learning ◽

Doctoral Students ◽

Administrative Database ◽

Learning Program ◽

Health Seeking ◽

Human Research ◽

Schools Of Public Health ◽

Experiential learning is a core competency of curricula across accredited U.S. schools of public health, helping students to hone diverse skill sets that will enable them to readily join the workforce and contribute to solving complex public health problems. At the City University of New York (CUNY) Graduate School of Public Health and Health Policy (SPH), all master’s and doctoral students are required to complete a practicum during their degree programs; yet practicum development and selection processes are often overlooked. To enhance the experiential learning program and Human Research Protection Program processes surrounding student practica at the CUNY SPH, researchers mined an administrative database and analyzed characteristics of practicum projects undertaken by graduate students. Findings from this novel study will facilitate policy and procedural changes within the SPH Office of Experiential Learning, which oversees the practicum program, and across SPH offices, including the Human Research Protection Program, to promote an optimal, student-centered practicum experience. Additionally, these analyses will serve as a model for other schools of public health seeking to develop, refine, and strengthen their practicum programs.

Toward Effective Human Research Protection: The Current Status and Limitations of the Human Research Protection Program in Korea

Korean Journal of Medical Ethics ◽

10.35301/ksme.2017.20.2.163 ◽

2017 ◽

Vol 20 (2) ◽

pp. 163-175

Author(s):

Junho Jung ◽

정세희 ◽

Ock-Joo Kim ◽

Jeong-Hyun Kim

Keyword(s):

Current Status ◽

Human Research ◽

COMPLEXITIES OF MEDICAL RESEARCH IN DEVELOPING COUNTRIES: STANDARD OF CARE: RESPONSIBILITIES OF ETHICS COMMITTEES

Pakistan Journal of Public Health ◽

10.32413/pjph.v7i2.48 ◽

1970 ◽

Vol 7 (2) ◽

pp. 117-121

Author(s):

Inayat Ullah Memon

Keyword(s):

Developing Countries ◽

Ethical Issues ◽

Standard Of Care ◽

Ethics Committees ◽

Developed Countries ◽

Biomedical Ethics ◽

Western World ◽

For Profit ◽

Eastern Hemisphere ◽

Human Participants

Increased awareness of human rights particularly those of vulnerable and emphasis on protection of less strong from stronger groups, have extended the limits of biomedical ethics where human participants are involved in the research. Inequalities amongst various global groups and subgroups in respect to financial resources and healthcare with increased collaborative biomedical research, particularly for-profit institutions have raised ethical issues one being the standard of care in research in developing countries. Emergence of newer and complex infectious diseases and resurgence of older ones in recent past has prompted Western world to undertake research in the Eastern hemisphere of the globe. But it has generated complex and various ethical dilemmas. Ethics demands that enrollees of research in developing countries not only be judiciously remunerated but outcomes of the studies be directly beneficial and affordable to them along with provision of parallel benefits. The core point of discussion amongst various partners is the selection from possible choices of standard of care to human participants in less developed countries. While some authors have argued for alternate standards whereas others suggest to compromise on this demand in particular conditions with permission from Ethics Committees. These suggestions, besides empowering the ERCs have put more burden on them to prepare guidelines and resolve the encountered issues where presently available guidelines are inadequate or insufficient. This work provides in-depth discussion and analyses possible alternatives to this complex dilemma.

Ethical Considerations for safeguarding human participants in pandemic research: a rapid review protocol

HRB Open Research ◽

10.12688/hrbopenres.13053.2 ◽

2020 ◽

Vol 3 ◽

pp. 22

Author(s):

Lydia O'Sullivan ◽

Ronan P. Killeen ◽

Peter Doran ◽

Rachel K. Crowley

Keyword(s):

Ethics Committees ◽

Rapid Review ◽

Ethical Review ◽

Institutional Research ◽

Ethical Considerations ◽

The Public ◽

Global Pandemic ◽

Review Protocol ◽

Human Participants ◽

Short Timeframe

COVID-19 is a respiratory disease caused by a coronavirus, designated SARS-CoV-2, which is responsible for a global pandemic in 2020. Public interest in this disease has led to the publication of thousands of articles in the medical literature in a very short timeframe. It is imperative that medical research into COVID-19 is conducted quickly and safely, and that due reference is given to the ethical considerations enshrined in the ICH GCP guidelines, according to the Declaration of Helsinki. In order to review the reporting of ethical considerations in these papers, we hereby propose a protocol for a systematic review of COVID-19 papers up to April 14 th 2020. The search criteria proposed for the review are based upon what would be a reasonable search conducted by a lay member of the public with access to PubMed.gov. Institutional Research Ethics Committees (RECs) face significant challenges in providing thorough and timely ethical review during the COVID-19 pandemic. It is proposed to publish the findings of this rapid review along with a summary of an institutional REC response to the challenges of reviewing and approving clinical research proposals in the time of a pandemic.