Browsing by Subject "Institutional Review Boards"

Now showing 1 - 3 of 3
  • Thumbnail Image
    Item
    Challenges in institutional ethical review process and approval for international multicenter clinical studies in lower and middle-income countries: the case of PARITY study
    (Frontiers Media, 2024-11-05) Lopez-Baron, Eliana; Abbas, Qalab; Caporal, Paula; Agulnik, Asya; Attebery, Jonah E.; Holloway, Adrian; Kissoon, Niranjan Tex; Mulgado-Aguas, Celia Isabel; Amegan-Aho, Kokou; Majdalani, Marianne; Ocampo, Carmen; Pascal, Havugarurema; Miller, Erika; Kanyamuhunga, Aimable; Tekleab, Atnafu Mekonnen; Bacha, Tigist; González-Dambrauskas, Sebastian; Bhutta, Adnan T.; Kortz, Teresa B.; Murthy, Srinivas; Remy, Kenneth E.; Global Health Subgroup of the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network; Pediatrics, School of Medicine
    Background: One of the greatest challenges to conducting multicenter research studies in low and middle-income countries (LMICs) is the heterogeneity in regulatory processes across sites. Previous studies have reported variations in requirements with a lack of standardization in the Institutional Review Board (IRB) processes between centers, imposing barriers for approval, participation, and development of multicenter research. Objectives: To describe the regulatory process, variability and challenges faced by pediatric researchers in LMICs during the IRB process of an international multicenter observational point prevalence study (Global PARITY). Design: A 16-question multiple-choice online survey was sent to site principal investigators (PIs) at PARITY study participating centers to explore characteristics of the IRB process, costs, and barriers to research approval. A shorter survey was employed for sites that expressed interest in participating in Global PARITY and started the approval process, but ultimately did not participate in data collection (non-participating sites) to assess IRB characteristics. Results: Of the 91 sites that sought IRB approval, 46 were successful in obtaining approval and finishing the data collection process. The survey was completed by 46 (100%) participating centers and 21 (47%) non-participating centers. There was a significant difference between participating and non-participating sites in IRB approval of a waiver consent and in the requirement for a legal review of the protocol. The greatest challenge to research identified by non-participating sites was a lack of research time and the lack of institutional support. Conclusions: Global collaborative research is crucial to increase our understanding of pediatric critical care conditions in hospitals of all resource-levels and IRBs are required to ensure that this research complies with ethical standards. Critical barriers restrict research activities in some resource limiting countries. Increasing the efficiency and accessibility of local IRB review could greatly impact participation of resource limited sites and enrollment of vulnerable populations.
  • Thumbnail Image
    Item
    The Establishment of Institutional Review Boards in the U.S. Background History
    (2021-08-31) Schneider, William H.
    Prior to the twentieth century, research ethics were primarily governed by individual conscience and professional codes of conduct. Whether and how humans might be investigated, however, has always been subject to the laws and customs of the society and government at the time. For many reasons, in the second half of the twentieth century, an elaborate set of rules and regulations about research were established by the American government to protect individual and public interests. What follows is a discussion of why federal rules and regulations were established, including the Institutional Review Boards. Originally written April 29, 2005; updated August 31, 2021.
  • Thumbnail Image
    Item
    Oral History and Human Subject Research: A Roundtable and Community Conversation on the Current State of Risks, Regulations, and Ethics Reviews
    (2024-11-02) Bravent, Jay-Marie; Boyd, Douglas A.; Dilger, Kirsten; Pieczko, Brandon T.; Terry, Kopana
    The COVID-19 pandemic has highlighted the interconnections between public health research and oral history. The 2022 Nelson Memo and 2018 EU GDPR have raised awareness about research data, public access, retention, and transparency. As research protocols utilizing interview procedures have increased, so too have the risks associated with interviewees speaking publicly about political and social issues. Threats and targeting of ethnic groups, undocumented immigrants, libraries, and the LGBTQA+ community grow, along with worries about social media shaming or job loss for interviewees. AI. Deep fakes. Identity theft. As the importance of oral history in this shifting research context and public spotlight continues to grow, projects must increasingly adhere to data privacy protections, retention guidelines, transparency regulations, and ethics review. Social science and humanities research protocols must meet new criteria from peer-reviewed journals, Institutional Review Boards, institutional research and legal office reviews, federal agencies, and funding organizations. How can oral history researchers and practitioners adapt and support each other? How should interviewers prepare, train, and anticipate new levels of peer review and public scrutiny? How do we navigate the different legal and institutional interpretations of “exclusion” and “exemption”? All while preserving academic freedom and open repository access to oral history interviews? Join us for a discussion of the current state (and future) of oral history within the frameworks of human subject research review, data requirements, government regulations, cultural literacy guidelines, and best practices for ensuring protections for interviewees.