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?

A group of Singaporean students who are concerned with the long-term health effects of smoking want to study the effectiveness of behavioural therapies in helping secondary school students quit smoking. Posters will be put up on notice boards at 10 secondary schools inviting students who want to quit smoking to register their interest to participate in the study by attending a free talk on smoking cessation at a designated venue. 50 students attending the talk will be invited to participate in the study and attend a series of behavioural therapy sessions. Six months after the end of the therapy sessions, participants will be interviewed by phone to find out whether they have ceased smoking. A further follow-up will be carried out 12 months after the end of the therapy sessions.   Developed for use at an October 2016 CENTRES workshop on the Social, Behavioural and Educational Research. © 2016 National […]

An ongoing study aims to measure the long-term effect of regular consumption of specially-formulated protein milkshakes on the match performance of adult football players at a local community club. One of the researchers, however, misunderstood the meaning of ‘adult’ and recruited several 18 year olds into the study. They have been consuming the shakes and had their performance monitored for several weeks. The PI discovers the error, and must decide what course of action to take.   Developed for use at the February 2016 CENTRES workshop on the Human Biomedical Research Act. © 2016 National University of Singapore.   Questions for Discussion What should the researcher, her IRB and/or her research institution do? Who has been or could be exposed to liability under the Act, and under what potential penalties?