Human Subjects Research Protections

Baumann, John R.; Mullins-Owens, Heather; Russell, David W.; Waltz, Amy C.

doi:10.1016/b978-0-12-420058-6.00001-0

Cited by 2 publications

(5 citation statements)

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“…procedures in order to ensure that the research is conducted in an ethical manner [7,8]. Considering the last reference above "Ethical Manner" brings up the key question of "What constitutes a manner as "Ethical" or "Nonethical" when our world is such a diverse place that includes different cultures, diverse perspectives, different religious believes, vast differences in political and governmental systems and finally different healthcare systems with different levels of structures, support and set societal responsibilities from each stakeholder's side across the world.…”

Section: Research Ethics Committees -Role Structure and Function Arou...mentioning

confidence: 99%

Ethics & Governance of Research: Focus on Research Ethics Committees globally, disparities across regions and the understanding of the structures and systems in place for publicly available information

Tzermpinou

2023

Bioethica

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This publication presents the findings of the Research submitted for the degree of MRes in Bioeconomy Biotechnology & Law that was conducted in May 2022 at the International Hellenic university in Thessaloniki, Greece. The original research purpose was to gather information on the coherence or disparities that exist in the current environment within the established ethics committees on the country or regional level. Several elements were taken into consideration on their structural systems in place in terms of: governance, standard operating procedures, trainings, and reporting systems (internal but as well as external)] but the outcome of this research serves also as a baseline as “the outcome of a person’s understanding (author) on the current environment based on publicly available information” to reach to the desired result which is to establish a clear understanding on the current procedures of the ethics committees from a person without extensive knowledge or constant exposure to their inner environment. Therefore, there are two elements that were simultaneously under research. This article presents the results based on the findings of this research but as well the barriers (limitations and restraints) contributing to their understanding. The author provides closing recommendations on the organizational level but as well on a fundamental level to provide alignment but as well as a request for clarity on the existing publicly available information in a manner that is easy to understand to the simple reader which contributes to transparency on research.

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Section: Research Ethics Committees -Role Structure and Function Arou...mentioning

confidence: 99%

Ethics & Governance of Research: Focus on Research Ethics Committees globally, disparities across regions and the understanding of the structures and systems in place for publicly available information

Tzermpinou

2023

Bioethica

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“…However, IRBs can also be used as used a tool to protect the university's reputation and as such serve additional functions (cf. Baumann et al, 2015; Hedgecoe, 2016; White, 2007).…”

Section: Introductionmentioning

confidence: 99%

“…At large research institutions, IRBs are usually part of Human Subject Research Protections Programs (HRPPs) (cf. Baumann et al, 2015). HRPPs include more than the IRB committee such as “the institutional official, other compliance committees […], grants/contracts offices, […], and a host of activities beyond the review of individual studies” (Baumann et al, 2015, p. 2).…”

Section: Introductionmentioning

confidence: 99%

“…Baumann et al, 2015). HRPPs include more than the IRB committee such as “the institutional official, other compliance committees […], grants/contracts offices, […], and a host of activities beyond the review of individual studies” (Baumann et al, 2015, p. 2). At LACs, IRBs might be the only visible and/or publicly listed committee focusing on HSR.…”

Section: Introductionmentioning

confidence: 99%

“…Therefore, at LACs, a variety of questions related to research that are not technically under the purview of the IRB might be directed to the IRB, nonetheless. In contrast, some HRPPs at larger institutions have staff members in charge of implementing education for the research community, including courses about “regulatory basics for new investigators, and special topic discussions such as conducting research with vulnerable populations, adverse event reporting, and safety monitoring for more experienced investigators” (Baumann et al, 2015, p. 14). While some have lamented the bureaucratization of ethics approvals (Wynn, 2016), IRBs at LACs have the potential to be a centralized source of education and information to students about ethical research conduct.…”

Section: Introductionmentioning

confidence: 99%

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Human Subjects Research Guidelines for Undergraduate Researchers: An Analysis of Institutional Review Board (IRB) Websites at Top Liberal Arts Colleges in the United States

Miguel

Noy

2023

Journal of Empirical Research on Human Research Ethics

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Teaching students about the ethics of Human Subject Research (HSR) should be a fundamental component of students’ education about research. In this article, we analyze the Institutional Review Board (IRB) websites of top-ranked Liberal Arts Colleges (LACs) to examine their framing of HSR carried out by undergraduate students. Our descriptive quantitative analysis from 50 top-ranked LACs in the United States indicates that a majority of IRB websites provide information about undergraduate research, and most include information about students’ classroom-based research. Our qualitative content analysis of a subsample of ten colleges’ IRB websites provides information on how they inform and educate about issues including informed consent and highlight different resources for students including their research advisor, and disciplinary standards. We conclude by discussing recommendations for IRBs in their accessibility to undergraduates.

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Human Subjects Research Protections

Cited by 2 publications

References 4 publications

Ethics & Governance of Research: Focus on Research Ethics Committees globally, disparities across regions and the understanding of the structures and systems in place for publicly available information

Ethics & Governance of Research: Focus on Research Ethics Committees globally, disparities across regions and the understanding of the structures and systems in place for publicly available information

Human Subjects Research Guidelines for Undergraduate Researchers: An Analysis of Institutional Review Board (IRB) Websites at Top Liberal Arts Colleges in the United States

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