1. Research Informed Consent
Kristin Bialobok, MSN, RN, CCRC, CCRA
Director
Office of Research Education and Regulatory Management

2. Purpose of Consent ? Prospective Subject Will ..
Understand nature of research
Be informed of purpose, risks, and benefits, and
alternative therapies
Make a Voluntary Decision about Participation

3. What rules do I follow? Federal Regulations Institutional Policy
21CFR Part 50
45CFR Part 46
Sponsor Request
ICH Good Clinical Practice Guidelines
E6 4.8

4. Is Informed Consent Always Essential?
EXCEPTIONS:
IRB has granted a waiver of consent
Life-threatening condition and
Inability to communicate with the subject and
Time is insufficient to obtain consent from subject’s legal representative and
There is no alternative method of approved therapy
Must Be Followed By
notification of the IRB within 5 days
review and evaluation of test article use by another physician
obtain consent ASAP.

5. Research Consent Process
Consent Document
Consent Discussion

6. THE INFORMED CONSENT DOCUMENT

7. Research Consent Document
21 CFR Basic Elements of IC

8. Research Consent Document
21 CFR Additional Elements

9. Research Consent Document
Readability
Language that is easily understood
Language must be appropriate to the population being studied
Language translators should be qualified and IRB authorized
Consider comprehension as well as readability
Limit medical terminology
Avoid informal speech

10. Research Consent Document
IRB
Informed Consent
(final version)
Sponsor PI

11. INFORMED CONSENT DISCUSSION

12. Who has the Authority to Obtain Research Consent?
What do the regulations say?
Silent
What does ICH GCPs say?
4.1.5 – “the investigator should maintain a list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties.”
What does the institution say?
Consideration: Nurse Practice Act

13. Informed Consent Process
Discussion between the physician and the participant.
Review of information by research nurse/coordinator.
All questions and concerns addressed.
No exculpatory language
Minimal chance of coercion/undue influence
Allow adequate time
Signatures obtained.

14. Informed Consent and Screening Procedures
Informed consent must be obtained prior to any protocol specific testing being conducted.
If protocol specific testing done the same day as informed consent document signed, must be clear documentation of the chronological order in the medical record.

15. COMPLETING THE INFORMED CONSENT DOCUMENT

16. Completing the Document
All blank spaces completed
No additions or deletions
Signatures obtained
FDA 21CFR 50- The patient or authorized representative shall sign and
date the informed consent.
OHRP 45 CFR 46- ….signed by the patient or legally authorized
representative.
ICH GCP E6 4.8 – …the informed consent should be signed and
personally dated by the subject or legally authorized
representative.
Institutional Policies

17. Completing the Document
Document distribution
FDA 21CFR 50- A copy of Informed Consent shall be given to the patient
or representative.
OHRP 45 CFR 46- A copy shall be given to the person signing the form.
ICH GCP E6 4.8 – The subject should receive a copy of the signed and
dated written informed consent form…
Institutional Policies

18. Completing the Document
When do you need a witness?
When presenting the informed consent document orally
Use of a short form
If required by the IRB
Who can be the witness?
ICH GCP – Impartial witness – a person who is independent of the trial, who cannot be unfairly influenced by people involved in the trial, who attends the informed consent process…

19. DOCUMENTING THE INFORMED CONSENT PROCESS

20. DOCUMENTING THE PROCESS
Protocol number or name of study
Alternative treatment options discussed.
A statement that the protocol, and the informed consent were reviewed with the participant, including the risks and benefits of the study.
Time for questions to be asked and answered.
Description of the participant’s decision
Copy of consent was given to the participant
DOCUMENTING THE PROCESS

21. RE-CONSENTING
Participants must be informed of new information that may affect their willingness to take part in the research.

22. CONSENTING MINORS

23. the parent/s or legal guardian
CONSENTING MINORS
Minor
Per state law – Texas=Under 18 years old
informed consent
process
(on the child’s behalf)
the parent/s or legal guardian
Participant under 18 y

24. CONSENTING MINORS Depending on the type of research, the IRB
may make provisions for “assent” of children.
Assent
“A child’s affirmative agreement to be a participant in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.”
Need to specifically ask for the institution’s policy before auditing.

25. MDACC Flow Chart – Consenting Minors
Age >/=18 No
Yes
Subject and Person obtaining consent sign the ICD
Parent/Guardian, witness, and Person obtaining consent sign the ICD
Child Age 7-12 – Verbal Assent Only
Child Age – Written Assent Required

26. Non-English Speaking Participants

27. Non-English Speaking Participants
Ideal is to use consent translated to participant’s native language
45 CFR (b) - “Short form written consent document…”

28. What do we look for as auditors?
Does ICD contain all required elements?
Was ICD used for participant the most current IRB approved document at time of enrollment?
Is a the ICD present in the participant’s medical record?
Is a copy of the ICD present in the investigator’s file?
Are all blank spaces completed?

29. What do we look for as auditors?
Does writing appear that participant signed and dated ICD?
Is witness’s signature and date present, if needed?
Is person’s who obtained consent signature and date present?
Was delegation of authority to obtain consent appropriate?
Do all date on the consent match?
If dates do not match is explanation present in the on-study progress note?

30. What do we look for as auditors?
Is full informed consent process documented in progress note?
Is participant a minor?
If minor, is assent portion of the ICD completed?
Is participant Non-English speaking?
If Non-English speaking was institutional policy followed?

31. FDA Inspections and Informed Consent Statistics
% of the clinical investigators/sites inspected were cited for informed consent related issues.
% of the investigators/sites who received OAI (Official Action Indicated) letters included informed consent citations.
Good Clinical Practice A Question & Answer Reference Guide May 2008

32. Practice Time