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

2017 ◽  
Vol 20 (2) ◽  
pp. 163-175
Author(s):  
Junho Jung ◽  
정세희 ◽  
Ock-Joo Kim ◽  
Jeong-Hyun Kim
Keyword(s):  
Current Status ◽  
Human Research ◽  
Human Research Protection Program ◽  
Human Research Protection

Development proposals of Human Research Protection Program

2020 ◽  
pp. 096973302095211
Author(s):  
Jiyin Zhou ◽  
Dan Liu
Keyword(s):  
Ethics Committees ◽  
Developed Countries ◽  
Ethical Review ◽  
Human Research ◽  
The Status ◽  
Human Participant ◽  
Human Research Protection Program ◽  
Communication And Coordination ◽  
Human Participants ◽  
Human Research Protection

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.

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

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 ◽  
Human Research Protection Program ◽  
Human Research Protection

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.

Establishing a Human Research Protection Program in a Combatant Command

2008 ◽  
Vol 64 (Supplement) ◽  
pp. S9-S13 ◽  
Author(s):  
Laura R. Brosch ◽  
John B. Holcomb ◽  
Jennifer C. Thompson ◽  
Paul R. Cordts
Keyword(s):  
Human Research ◽  
Human Research Protection Program ◽  
Human Research Protection

scholarly journals Developing Quality and Efficiency of Institutional Review Board Review Under a Human Research Protection Program at a Leading Hospital in Central Southern China: A Descriptive Analysis of the First Three Years

2021 ◽  
pp. 155626462199565
Author(s):  
Xiaomin Wang ◽  
Jessica Hahne ◽  
Lun Li ◽  
Kaveh Khoshnood ◽  
Guoping Yang ◽  
...  
Keyword(s):  
Conflicts Of Interest ◽  
Southern China ◽  
Descriptive Analysis ◽  
Institutional Review Board ◽  
Serious Adverse Events ◽  
Human Research ◽  
Institutional Review ◽  
Institutional Review Board Review ◽  
Human Research Protection Program ◽  
Human Research Protection

This study analyzes the Institutional Review Board (IRB) quality and efficiency at a leading hospital in Central Southern China, under the first three years of a Human Research Protection Program (HRPP). We conducted a descriptive, retrospective analysis from 2015 through 2017. We extracted characteristics from the protocol archive in duplicate. Of 396 protocols submitted, 98% were approved. Mean protocol review time decreased from 23 to 15 calendar days, 344 serious adverse events SAEs were reviewed, and 93 conflicts of interest (COIs) were disclosed. IRB quality and efficiency mechanisms improved. Remaining needs include increased monitoring of COIs and unanticipated problem involving risks to subjects or others, distinctions between research types, and cooperation with specialized committees.

Rethinking Local Institutional Review Board (IRB) Review at State Health Departments: Implications for a Consolidated, Independent Public Health IRB

2012 ◽  
Vol 40 (4) ◽  
pp. 997-1007 ◽  
Author(s):  
David Perlman
Keyword(s):  
Public Health ◽  
Human Subjects ◽  
Public Health Practice ◽  
Institutional Review Board ◽  
Institutional Review Boards ◽  
Human Research ◽  
Institutional Review ◽  
Or Practice ◽  
Human Research Protection Program ◽  
Human Research Protection

A number of unique problems plague human research protection efforts at United States (US) State and Territorial Departments of Health (DOHs). The first problem is related to the number of Institutional Review Boards (IRBs) operated by and Federalwide Assurances (FWAs) held by DOHs. The lack of these two essential regulatory human research protection program mechanisms points to a possible inadequacy of infrastructure at DOHs for protecting human subjects. The second and third problems are related to the use and interpretation of research protection laws and regulations at DOHs. Parsing public health activities into research or practice (1) can be vexing and (2) likely produces variability in (a) how individual DOHs make the determination between research and practice and (b) the outcomes of such decisions for the same or similar projects. A related problem is that DOH or Institutional Review Board (IRB) officials might misclassify public health practice activities as research (and vice versa), which can have costly, adverse consequences.

Assessing the Quality and Performance of Human Research Protection Programs to Guide Compliance Oversight Activities

2018 ◽  
Vol 13 (3) ◽  
pp. 270-275
Author(s):  
Min-Fu Tsan ◽  
Yen Nguyen
Keyword(s):  
At Risk ◽  
Performance Metrics ◽  
Human Subjects ◽  
Program Performance ◽  
Human Research ◽  
Performance Metric ◽  
Human Research Protection Program ◽  
And Performance ◽  
Incident Rates ◽  
Human Research Protection

Routine on-site reviews should focus primarily on facilities that are at risk of harming human subjects. Using human research protection program performance metric data from 107 facilities, we defined a facility to be at risk when one of its noncompliance/incident rates was among the top three highest rates of that performance metric. Based on 14 performance metrics with noncompliance and incidents in 2017, 27 facilities were identified to be at risk. These 27 facilities at risk, while constituting only 25% of all facilities, contributed to 70% ± 25% ( M ± SD; range = 32%-100%) of all reported noncompliance/incidents. Thus, performance metric data can be used to guide compliance oversight activities.

Sign in / Sign up

Export Citation Format

Share Document