11 June 2009

Protocol modifications

As you may well know, any proposed change to an already approved human subject research protocol, measures, or informed consent document during the period of IRB approval must be submitted to the IRB for review and approval before that change commences.

We in HARPO, on the behalf of our reviewers, ask that you highlight any proposed wording changes in the application form, consent documents, recruitment fliers, etc. in yellow and underline and attach those changed documents to this form. This will assist the reviewer with understanding the changes investigators are planning to make.

See http://www.umbc.edu/research/HARPO/IRB/IRBpostapproval.html#modifications for more information.

No comments: