Expression of Sex hormones receptors and their prognostic value in urothelial bladder carcinoma

1.      What are these numbers: Institute: 107 and Department: 117

2.      Study Type: stated as “Interventional”, while the study is observational

3.      The primary objective already includes the secondary objective, so it should be removed from the primary.

4.      “Does this protocol involve the use of substances that may pose any health risk” the question here is about risk to the patients and not risk to the investigators, so the answer should be “NO”. Protection of the investigator is the role of the occupational health Program and not the IRB.

5.      Blocks:

o   It is not clear to me whether the blocks are already collected and done or will be collected from patients after the approval of the study.

o   It is not clear whether the blocks are de-identified or not.

o   The source of the blocks is stated as laboratory, which laboratory and is the lab part of the research?

o   mitigation strategies to protect the biospecimen from being exposed to spoilage or spreading infection is not stated

6.      “Consenting is not feasible in this research”

o   Please explain first the source of the blocks

o   “consenting is not feasible” for only 30% of the patients, so why waiver for all?.

o   Did the investigator submit a request for waiver of consent?

7.      How will the study assess the relation to the prognosis? It is not mentioned in the methodology