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 […]

The purpose of the study is to determine whether intensive, short term reflex training methods on the performance of proficient amateur players of fast paced action online video games (based on actions per minute) can be enhanced to the level of professional players. Actions per minute (APM) is a measurement of a player’s load handling capacity and is one of the metrics for judging player skill. A casual player can hit 50 APM; an experienced player, 75 APM; a proficient player 150 APM; and professional players can get up to 500–600 APM.   A sample of 40 secondary school students who are proficient players (150 APM) of a fast paced action online video game are randomly assigned to two groups. 20 students will be assigned to the intensive, short term training group and 20 students to the control group. The students in the training group will follow a daily one-hour […]

Kurt is a teacher in Germany. He has been asked to join a large research project that is looking at the genetics of cardiovascular disease. This will involve giving a DNA sample, answering a questionnaire and allowing details of his treatment to be given to the researchers. This study will directly help clinicians decide which drug to give to those patients who are enrolled in the study. Researchers at the local hospital where Kurt is being treated, in collaboration with a team of researchers from a European university and a medical sciences institute in China, are conducting the study.   Kurt has been asked to give a broad consent that will allow the researchers to keep the DNA sample and information for use in suitably approved future research projects. This will save them the expense of coming back for consent for each new research project. He can choose whether researchers […]

Transcranial direct current stimulation (tDCS) is a non-invasive procedure in which electrodes are placed on someone’s head to stimulate various regions via electric currents. While most uses for the procedure are clinical, a researcher is trying to develop a tDCS kit for personal use among healthy individuals. The kit is designed to improve general moods by stimulating the pleasure centres of the brain. While prior studies have not seen much efficacy in improving mood via tDCS, those studies relied on relatively low frequency currents and targeted different regions of the brain compared to this study. The proposed experiment is a randomized sham-controlled trial to test the effect of the device on subjects’ self-reported mood. Participants in one arm will receive the actual tDCS procedure, while subjects in another arm will be given a sham procedure (the same device pressed on their heads, but it is not actually turned on).   […]

An IRB approved a study aiming to assess whether weekly back massages could relieve the pain of patients recovering from spinal surgery. A group that received the back massages would be compared with a group that did not. The initial protocol stated that the primary outcome measure would be self-reported pain levels. As the study was about to begin, however, a researcher read a newly-published article that indicated back massages may also have an effect on patients’ ability to carry out everyday tasks. The researcher therefore added a set of questions to participants concerning how well they can manage such tasks.   Developed for use at the February 2016 CENTRES workshop on the Human Biomedical Research Act. © 2016 National University of Singapore.   Questions for Discussion Does the new outcome measure qualify as a deviation from the study protocol? (See section 22) Is the researcher required to send the […]

This randomised controlled trial is designed to test the relationship between maternal nutrition and offspring health. Participants are women planning to conceive in the near future. All participants will receive a nutritional packet they are to dissolve in water and consume twice daily throughout their pregnancy. Both control and experimental packets contain micronutrients; the experimental packet contains, in addition, probiotics and myo-inositol (a naturally-occurring nutrient). The effect of the intervention on a variety of health outcomes for the mother and offspring will be measured, including: glucose tolerance, gestational diabetes incidence, breast milk micronutrient profile, birthweight, cardiometabolic profile, gut bacteria profile, and neurocognitive development.   Developed for use at the February 2016 CENTRES workshop on the Human Biomedical Research Act. © 2016 National University of Singapore.   Questions for Discussion Is this study within the scope of the Human Biomedical Research Act?