A researcher wishes to conduct a retrospective observational study on the health records of patients at a particular hospital who recently underwent a cardiovascular surgery in the past year. The researcher would be looking for correlations between long-term complications arising from the surgery and an array of risk factors indicated in the patients’ charts – weight, smoking habits, reported exercise, hypertension levels, etc. – with the goal of using the results to tailor follow-up care based on personalized risk factors. The records of all 822 patients who underwent cardiovascular surgery at that hospital in the past year would be accessed in the course of the study. The researcher requests a waiver of consent from her IRB, on the grounds that the risk is minimal (data will be kept secure within the hospital’s servers) and the study would be impracticable without the waiver (It may be difficult to contact all 822 patients or their families, and some may not consent, potentially leading to a significantly biased sample and thus results that could not be generalized).

Developed for use at the February 2016 CENTRES workshop on the Human Biomedical Research Act. © 2016 National University of Singapore.

Questions for Discussion

1. Does the study qualify as minimal risk?
2. Is the study really impracticable without consent? What factors, more generally, should be considered when determining practicability?
3. Should the IRB grant the request for a waiver of consent? (See especially Schedule 5)