2. Basic Informed Consent Training: Part II
Training for Investigators and Research Staff

3. True or False
False
A subject does not need to be provided with a copy of their signed informed consent form.

4. According to HHS Regulations 45 CFR 46.117:
A copy of the informed consent document shall be given to the person signing the form
According to the TTUHSC El Paso HRPP Manual
The Principal Investigator shall maintain all original consent documents

5. Multiple Choice C
Exculpatory language is _______ on an informed consent form:
Always allowed
Only allowed when followed by a thorough explanation from the Principal Investigator or staff
Never allowed

6. According to HHS Regulations 45 CFR 46.116:
The inclusion of any exculpatory language in informed consent through which the subject is made to waive, or appear to waive, any of the subject's legal rights is prohibited

7. True or False
False
Any clinical staff member can obtain informed consent from a participant. This includes medical assistants, nurses, and doctors.

8. According to the TTUHSC El Paso HRPP Manual
Only authorized study personnel may obtain informed consent from a participant.
Authorized study personnel consist of faculty and staff that have been delegated duties by the Principal Investigator.

9. Common Informed Consent Problems and Solutions

10. Presentation Content Common Informed Consent Process problems
Common Informed Consent form mistakes
Strategies to improve Informed Consent compliance
Why follow the rules?

11. Common Informed Consent Form (ICF) Mistakes
Incorrect version of the ICF
Expired ICFs
Altered ICFs
Non-IRB approved ICFs

12. Can You Spot What’s Wrong?

13. Common Informed Consent Process Mistakes
Missing/incorrect signatures
Unauthorized signatures
Incorrect/missing dates and times
No subject copy
Giving away the original
No “AM/PM”
Unnecessary witnesses

14. Common Informed Consent Process Mistakes cont’d
Missing initials
Signing the wrong line
Scribbling out errors
Pre-signing ICF
Parents name in place of their child’s name
No “mother/father” on HIPAA

15. Can You Spot What’s Wrong?

16. Strategies to Improve Informed Consent Compliance Process
Don’t save different versions
Always print from iRIS
Submit changes to IRB
Obtain IRB approval

17. Strategies to Improve Informed Consent Compliance Mistakes
Ensure that you know where to sign before beginning
Show subjects where to sign after consenting
Explain to subjects how to sign
Observe as the subjects sign
Know when a witness is needed vs when they are not
Review the consent a second time after completion
Make sure you have the original document
Provide a full copy of signed document to subject

18. Strategies to Improve Informed Consent Compliance Mistakes cont’d
Ensure that you know where the parent will sign
Have you or subjects line through, initial and date errors
Don’t use white-out
Don’t pre-sign the ICF
Sign soon after the subject
Use the same watch to tell time
Review the consent again before photocopying it
File the original ICFs in a consistent and safe place

19. Why Follow the Rules?

20. Why Follow the Rules?
To be in compliance with federal and institutional regulations
To maximize the safety of the research subject
To demonstrate study integrity

21. Questions?