[Minutes, Clinical Research Subpanel Meeting]

instance. Any future 'Mood or any further patient that would be involved in
the study would require informed consents, etc in the future. The panel
would need the letter from the Principal Investigator documenting that this
was done in accordance with WHO guidelines. The decision of the IRB is as
follows: The panel approves the retrospective work which was done pending
receipt of the letter indicating that WHO guidelines have been adhered to.
For any more patients or for more blood drawings, we would need to see a
protocol and informed consent (written in English) and any necessary international collaborative documents that would be required.
Stipulations
1. Provide a letter to the IRB indicating that WHO guidelines have been
adhered to.
2. If more patients or blood drawings are taken, submit a protocol and
informed consent, written in English, for full IRB Review. Include
any necessary international collahration document(s) or OPPR guidelines
that would also be required.