Elvira Rohland, Senior Health Research Ethics Administrator at Stellenbosch University’s Faculty of Medicine and Health Sciences (FMHS), has just returned from the United States where she participated in the prestigious Institutional Review Board Internship Programme of the US National Institutes of Health (NIH).
The programme is offered only once a year to a select group of participants, and from 28 August to 29 December 2016, Rohland had the opportunity to join the programme. The FMHS’s Head of Research Ethics Administration, Dr Nicola Barsdorf, supported Rohland – who has a wealth of experience in research ethics – as an ideal candidate for the internship, and encouraged her to apply.
The NIH Department of Bioethics is one of America’s preeminent centres for bioethics scholarship and training, with staff consisting of bioethicists and philosophers. Training is offered to future bioethicists, as well as biomedical researchers and clinical providers. In addition, the Department provides high-quality ethics consultation services.
By participating in the internship programme, Rohland hoped to gain a better understanding of the research regulatory environment in the United States, which applies to the international studies submitted to the Health Research Ethics Committee (HREC) at Stellenbosch University. As part of her role at the university, she processes all local and international research submissions that involve human participants.
“I wanted the opportunity to take coursework, and attend workshops and seminars to increase my current scope of knowledge,” Rohland says. “One key interest was to learn more about appropriate serious adverse event (SAE) reporting. This includes the urgency with which certain SAEs should be reviewed, the ability to distinguish whether SAEs are submitted within the required reporting period, and decision making in terms of post-approval documents.”
Rohland gained valuable insights into these topics, as she had hoped. She also learnt more about the systems and processes used for the protection of human subjects, and successfully completed the Human Subjects Research Course.
She is excited to now apply this valuable knowledge to her work at Stellenbosch University. In the process, the Faculty of Medicine and Health Sciences has taken another leap forward in terms of its bioethics standards and procedures.
Caption: Elvira Rohland, Senior Health Research Ethics Administrator recently participated in the prestigious Institutional Review Board Internship Programme of the US National Institutes of Health (NIH).