This is the first formulation of the ASSERT statement. I invite input from you, IRB members, investigators, trialists, research sponsors, editors, and any other interested party. Please send me comments concerning the statement and checklist, and its associated elaboration; suggestions for additional items that should be included in the statement or checklist; and any general comments, suggestions or criticisms you may have. I will devote careful attention to them.

If you are interested in becoming a member of a Working Group on the Statement, please contact me at : howard.mann@hsc.utah.edu