An employee at institution A, a physical therapy centre, wishes to conduct an investigation into the effects of a new massage technique developed by the employee on relieving pain in individuals who suffer from chronic back problems. Institution A does not routinely conduct human subjects research, and as such is not registered as a research institution with Ministry of Health (MOH) and has no IRB. The employee will be collaborating with institution B, a hospital with a patient pool that would be recruited into the study; the employee of Institution A would visit patients at Institution B and administer the massage. Furthermore, a researcher at institution C, a university, is interested in collaborating with the employee to design the study, analyse the results and write it up for publication. Both institutions B and C have IRBs; B is registered with MOH as a research institution. Institutions A and B are […]

A student wishes to replicate Milgram’s famous conformity study, with a slight modification. Subjects will be informed they and another volunteer are participating in a teaching intervention test. Subjects are told that they will be a “tester” and other volunteer will be a “learner” given a series of questions, and the tester are to press a button to administer an electric shock whenever the learner gets a question wrong. Shocks escalate in strength as more questions are answered incorrectly. Unbeknownst to the tester, the learners are actors; no shocks are actually delivered, though the learner will call out in pain as if they have been shocked. As the testing progresses, the learner will progressively give incorrect answers as shocks escalate. When the tester suggests that the learner has had enough, a study coordinator will instruct the tester to continue and assure them that everything is fine. The study will cease […]

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 […]

In order to better understand online bullying triggers, a group of researchers will recruit secondary school students who are social media users. Researchers will first approach students at school with a questionnaire concerning online harassment on social media sites. Among those who report at least one instance of online harassment in the past year (and with further permission of their parents) researchers will invite them to participate in more in-depth study. In this more in-depth phase, researchers will be given access to view the student’s social media platform on which the harassment occurred. The researchers will study the initial circumstances surrounding the harassment, in order to ascertain the proximate causes of such harassment.   Developed for use at an October 2016 CENTRES workshop on the Social, Behavioural and Educational Research. © 2016 National University of Singapore. All rights Reserved.   Questions for Discussion What are the main forms of subject […]

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?