HomeLeadershipInstitutional Review BoardForms, Instructions, and Information21 Amendments Most Frequent Errors

Most Frequent Errors for Amendments

1. Executing changes to an approved research protocol without submitting an amendment or prior to receiving approval of an amendment.

2. Not reading the instructions on the website for amendments.

3. Using an old form.

4. Not answering all the questions on the Amendment form.

5. Not clearly stating how the proposed changes will affect risk to subjects. If the researcher believes the change will not affect risk, failing to describe why the changes will not affect risk.

6. Not signing the form.

7. Not using track changes or highlighting changes in the protocol and/or informed consent document (ICD).

8. Not amending the most recent, approved protocol. If the protocol has been previously amended, “accept” the changes approved through previous amendments so that ONLY those changes related to the current amendment are highlighted

9. Not updating the date on the protocol.

10. For full protocol research, not requesting additional subjects when the approved number has been exhausted.

11. When adding additional investigators, not including their human subjects protection training and resumes.

12. When adding non-USAFA investigators, not ensuring that an appropriate institutional or individual agreement is in place.

13. Numerous errors both typographical and grammatical. Spell check is NOT ENOUGH.

14. Not writing out all acronyms before using the abbreviated form (e.g. write out Department of Behavioral Sciences and Leadership before using the abbreviation DFBL).

15. Making inquiries to HRPP Support Personnel that are incomplete or inappropriate. Inquiries must include the protocol title and number and must be from a named investigator.

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