Topic: Super Sperm Clinical Trial
Answer the following questions after you read all the attached files carefully
1- Does the clinical trial research application have to aIDress every part of the National Statement Research Merit and Integrity Guidelines 3.3.3 and 3.3.4 before Human Research Ethics committee (HREC) can approve the application?
Select one or more
a. No, because there are different types of clinical trials, and one or more of Guidelines might not apply to particular clinical trial application.
b. In general yes, but the interpretation and application of these Guidelines can be adapted to any particular clinical trial application.
c. Yes.
2- What types of clinical trial does the SuperSperm Vitamins application describe?
Select one or more
a.Phase IV
b.Phase II
c.Phase II / III
d.Phase I / II / III
e.Phase I / II
f.Phase III
g.Phase I
3-Does the SuperSperm Vitamins clinical trial application meets the Guideline that refer to research merit and integrity? Which of the following statements are correct?
Select one or more
a.Yes.it meets the Guideline that requires research to be directed to answering a specific question or questions.
b.Yes, because the SuperSperm application aIDresses 3.3.3 a,b,c and d adequately and appropriately.
c.Yes. it meets the Guideline that requires research to test a scientifically valid hypothesis.
d.No, because the SuperSperm application does not aIDress one or more 3.3.3 or 3.3.4 adequately or appropriately.
4-Does the proposed benefit justify the risk? Which of the following statement are correct?
Select one or more
a. No, because Guideline 3.3.10 the use of placebo has not been aIDressed adequately.
b. No, the prospect of benefit arising from the research has been exaggerated.
c. Yes, the proposed benefit justifies the risk because no significant adverse reaction were observed in the pilot study so risk of harm is unlikely, whereas the potential benefit of likelihood of successful pregnancy is increased.
d. The SuperSperm application does not provide sufficient information for assessment of relative benefit or risk.
5-Does the SuperSperm application aIDress the monitoring Guidelines described in 3.3.20 ? Which of the following statements are correct?
Select one or more
a .Meets a, b and c but not d.
b. Meets a and d
c. Meets a, but whether it meets b or not is open to interpretation and discussion.
d. Meets a, b and d but not c.
e. No, it doesnt meet any
