The Middle East Research Ethics Training Initiative (MERETI) was established in 2005, and aims to help enhance research ethics capacity in the Middle East by offering educational programs in health research ethics. Three MERETI trainees attended the 2015 Advancing Ethical Research Conference in Boston through PRIM&R’s scholarship program, and blogged about their experience on the MERETI Network. Below we have included some of their thoughts on the conference, along with links to their full blogs.
From Latifa Adarmouch: “I found [the pre-conference program Quality Assurance/Quality Improvement (QA/QI) in Human Subjects Research] very interesting, because it showed theoretically and practically how a QA/QI program allows combining ethical principles and regulatory requirements to promote research compliance and oversight quality; and thus enhance human subjects’ protection at the institutional level. Two key elements were of particular interest to me: First, there should be an emphasis on the relevance of establishing HRPPs to ensure optimal research oversight at the institutional level that cannot be achieved only by establishing an REC. Second, when considering QA/QI programs, quality assurance constitutes a first level that needs to be implemented before efforts at quality improvement; QA is thus a prerequisite for QI activities.” Read Latifa’s blog.
From Salma Ait Batahar: “What’s new in human subject research protection? That is what the last presentation discussed [during the pre-conference program Institutional Review Board (IRB) 101]. We have witnessed an increase of research conducted on the internet, the use of mobile device research and an increase in social media research. These types of studies raise issues about data security and the assurance of privacy and confidentiality. The data security issue requires: an institutional policy for securing data, the IRB’s use of consultants with expertise in security and the protocols need to include details about the collection, the transfer, and storage of data that protects confidentiality.” Read Salma’s blog.
From Marwan Falaefel: “Dr. Michael Turik [senior medical director for clinical pharmacology at Lilly Research Laboratories and vice chair of the Indiana University Ethical Review Board] discussed [during Panel I: From Ideal to Real: Post-Trial Access, Expanded Access, and Use of Ancillary Treatments in Global Studies] provisions for access to the study drug (if shown to be beneficial) to participants. While the primary goal should be rapid regulatory approval in the areas from which participants were recruited, provisions should also be made for access to the study drug prior to regulatory approval. Dr. Turik raised a number of lingering questions, such as 1) What type of post-trial access should be considered: the study drug (when proven to be effective in the trial) or the active comparator when the study drug is proved to be ineffective?; 2) What should be the duration of this access?; and 3) do other stakeholders have an obligation to share in the provision of post-trial access?” Read Marwan’s blog. [Editor’s note: Marwan also presented a poster abstract at the conference. PRIM&R members can access it in the Knowledge Center. Conference attendees can access the proceedings from these and all AER15 sessions here (requires a pass code which was provided prior to the conference).]