Journal of AIDS & Clinical Research

Bonnie Bender

Publications

• Research Article
  Regulatory and Ethical Approval Timelines for HIV Vaccine Studies: An Analysis of International AIDS Vaccine Initiative (IAVI) Sponsored Studies in East and Southern Africa
  Author(s): Prince Bahati, Zablon Omungo, Bonnie Bender and Josea RonoPrince Bahati, Zablon Omungo, Bonnie Bender and Josea Rono
  
  Background: There has not been a systematic analysis of factors affecting ethics and regulatory timelines of HIV Vaccine trials and epidemiologic studies in Eastern and Southern Africa. We analyzed regulatory and ethics approval timelines and associated factors for HIV vaccine clinical trials and epidemiologic studies in Kenya, Uganda, Rwanda, South Africa and Zambia using data collected from seven Clinical Research Centers (CRCs) from 2001 to 2015. Methodology: Staff responsible for regulatory issues at CRCs provided archived data on ethical and regulatory review time-frames which were then validated with the sponsor central database. A semi structured questionnaires was administered to establish qualitative information on perceived factors affecting efficiency of approval processes and potential solutions. Quantitative data analysis was conducted using Excel. Qualitative data were .. Read More»
  DOI: 10.4172/2155-6113.1000676

  Abstract PDF