Ethical Issues

THE WEDNESDAY ACCRUALNET POST (5-7-13): Top 12 Informed Consent Dings

Last Updated: May 7, 2013



Ellen Richmond's Image

In reviewing data monitoring reports over the years, I've noticed that certain mistakes related to informed consent forms can be snags for even the most experienced sites.  Some policies are stricter at some institutions than others but my observation is that the mistakes are universal and using a last minute checklist might be all it takes to avoid the 12 most common “dings”.  Let us know if you would add any to the top 12

1.       Expired Consent Forms - Be sure the consent form that the participant signs is the most recent IRB-approved version. Once the IRB approves a revised consent form to replace a previous consent form, the previous consent form can no longer be used. To prevent using unapproved/outdated consent documents, consider printing the current version directly or shortly before starting the informed consent process.

2.       No IRB Approval Stamp - Be sure the signed consent form has the IRB dated stamp of approval.

3.       Staff Fills In Consent Date - Be sure the participant (or his/her legally acceptable representative) personally signs and prints his name on the consent form along with the correct date.

4.       Red Ink - (This one's really bad.) Use only blue or black ink when completing the consent document.

5.       White-out, etc. - If the participant or study personnel make an error, the error should be corrected by drawing a signal line through the error.

6.       Research Nurse Witness - If a witness’s signature is required (e.g., when the participant or his/her legal representative is unable to read), an impartial witness should be present during the entire informed consent process. Be sure that the witness is not part of the research team.

7.       Non-consenter Signature - Make sure that the PI/designee signature line has been signed by the person who actually obtained the participant’s consent, if required at your institution.

8.       Missing Pages - Retain the entire original, signed consent forms for at least three years after study termination.  Do not give the original to the participant.

9.       Giving Original to Participant - Provide a copy of the complete consent document to each participant.

10.     Auto - Charting of Consent Process - Document the consent process in the participant’s chart including more than just an indication that the subject signed and received a copy of the consent.

11.    Changing Consent Before IRB Approval - -Do not cross through incorrect or outdated information and do not add new information. (You have to submit an amendment form for IRB review and approval prior to implementing any changes to the consent form.)

12.   Lack of Staff Role Delegation Approval - If required, ensure all personnel involved with recruitment and obtaining informed consent have completed training and have been approved by the IRB to participate in the protocol.

Hope this list is helpful.  


Also, from the AccrualNet Team:  Happy Nurses Week to all nurses in the AccrualNet community!

Sona Thakkar's Image

Great list, Ellen! Who knew that basic "dotting i's and crossing t's" types of dings were the most common. This doesn't even get at the content IN the consent. That's another whole area where a checklist would be helpful to ensure that the appropriate content was included for potential participants.

Please Login or Register to post comments.