HP 320 GLOBAL HEALTH QUIZZES | GRADED A

1. A protocol coming before an REC has received scientific review. When reviewing the protocol the REC identifies additional scientific issues relatin… 2. Which of the following are examples of issues relating to research design which may have ethical implications: (select all that apply) 3. The choice of a placebo as a comparator in research when an established effective intervention exists is controversial 5. When considering if the proposed sample size for a study has ethical implications, an REC may wish to consider: 6. A REC reviews a protocol for a randomized control trial of a novel treatment where it is proposed that the control group receives a placebo. The fo… 7. A REC may consider the following to be a valid justification for the use of deception in research: 8. Guideline 11 of the International Ethical Guidelines for biomedical research involving human subjects, CIOMS (2002) states that a placebo may be us… o the study purpose is to determine if there is an effective alternative to a proven treatment that is currently unavailable in the location where the research is proposed o the research is low risk and the risks of being in the placebo group are minor and short-lived o the proven treatment cannot be used as a comparator because it would not yield scientifically reliable results that are relevant to the health needs of the study population o the alternative being studied is proven to be safe and effective then it will be made reasonably available to the population 1. When reviewing a protocol RECs should consider: o whether risks of harm have been minimized o the magnitude of the potential harm as well as the risk it will occur o whether the potential benefits of the research outweigh the potential risks o whether the population bearing the risk of research is also likely to benefit from any knowledge gained in the research