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

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

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

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.

Research Consent Process Consent Document Consent Discussion

THE INFORMED CONSENT DOCUMENT

Research Consent Document 21 CFR 50.25 - Basic Elements of IC

Research Consent Document 21 CFR 50.25 - Additional Elements

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

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

INFORMED CONSENT DISCUSSION

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

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.

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.

COMPLETING THE INFORMED CONSENT DOCUMENT

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

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

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…

DOCUMENTING THE INFORMED CONSENT PROCESS

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

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

CONSENTING MINORS

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

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.

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 13-17 – Written Assent Required

Non-English Speaking Participants

Non-English Speaking Participants Ideal is to use consent translated to participant’s native language 45 CFR 46.117(b) - “Short form written consent document…”

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?

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?

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?

FDA Inspections and Informed Consent Statistics 2007- 11% of the clinical investigators/sites inspected were cited for informed consent related issues. 2007- 32% 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

Practice Time