IRB appoval

I have to get an approval from DUKE IRB for me to get money from the army grant I got last year. This approval is essentially telling the exchequer that the project will involve human subjects and that it will be my responsibilty to make sure that the protocol I use on the subjects is safe for them etc. This is a tedious process and takes a lot of "bandwidth". Here's how they try to be instructive and helpful in some way. I found it quite interesting - to say the least:

Common Consent Form Errors

• Use "study drug" not "study medication" when the drug is investigational and also when a placebo is used. The word "medication" or "medicine" should only be used if the drug is commercially available for that particular condition.

• Do not use "treatment” or “therapy”" if a placebo is involved or if an investigational drug is involved. Words to use in place of include, “study drug regimen” or “study procedure.”

• Use "study doctor" (more understandable to a lay person) instead of “principal investigator."

• Do not capitalize "sponsor."

• Define the word "placebo" when first used. Examples of placebo definitions are: “sugar pill," "inactive substance," "inactive substance in the same form as the active drug."

• Use "research study," instead of "trial."

• Use the word "subject" throughout instead of “patient” since this is research. However, it is applicable to use “patient” if you are referring to the person prior to his/her entering the study.

• When a placebo and active drug are involved, clarify for the subject that when the consent refers to the study drug, the study drug means "placebo or active drug."

• Begin the consent form with, "You are being asked to take part in this research study because (insert condition here)" and then information about what is research.

• Do not use the word “invite” (for example, “You are invited to participate in a research study.”) Instead use, “You are being asked to participate in a research study because (insert condition here).”

• When describing randomization for 2 groups use, “like the flip of a coin,” for more than 2 groups, use "like drawing numbers from a hat."

• Do not use i.e. or etc., use instead, "for example," "so forth."

• Do not use CAPS or bold items unnecessarily. For example, “WE CANNOT AND DO NOT GUARANTEE OR PROMISE THAT YOU WILL RECEIVE ANY BENEFITS FROM THIS STUDY.

• If the FDA may approve the study drug while the research study is in process, let subjects know if they will be responsible for paying for the study drug if it is approved.

• Use lists instead of strings of items.

• Use simple vocabulary – swallow a pill vs. oral administration