Presentation on theme: "Research Informed Consent Kristin Bialobok, MSN, RN, CCRC, CCRA Director Office of Research Education and Regulatory Management."— Presentation transcript:
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 ICH Good Clinical Practice Guidelines E6 4.8 Institutional Policy Sponsor Request 21CFR Part 50 45CFR Part 46
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. Is Informed Consent Always Essential?
Research Consent Process oConsent Document oConsent Discussion
THE INFORMED CONSENT DOCUMENT THE INFORMED CONSENT DOCUMENT
Research Consent Document 21 CFR Basic Elements of IC
Research Consent Document 21 CFR Additional Elements
Research Consent Document 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 readabilityConsider comprehension as well as readability Limit medical terminologyLimit medical terminology Avoid informal speechAvoid informal speech Readability
Research Consent Document Informed Consent (final version) IRB PI Sponsor
INFORMED CONSENT DISCUSSION
Who has the Authority to Obtain Research Consent? What do the regulations say? What do the regulations say? Silent Silent What does ICH GCPs say? What does ICH GCPs say? – “the investigator should maintain a list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties.” – “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? What does the institution say? Consideration: Nurse Practice Act
o Discussion between the physician and the participant. o Review of information by research nurse/coordinator. o All questions and concerns addressed. o No exculpatory language o Minimal chance of coercion/undue influence o Allow adequate time o Signatures obtained. Informed Consent Process
o Informed consent must be obtained prior to any protocol specific testing being conducted. o 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. Informed Consent and Screening Procedures
COMPLETING THE INFORMED CONSENT DOCUMENT
Completing the Document oAll blank spaces completed oNo additions or deletions oSignatures obtained FDA 21CFR 50- The patient or authorized representative shall sign and date the informed consent. ICH GCP E6 4.8 – …the informed consent should be signed and personally dated by the subject or legally authorized representative. Institutional Policies OHRP 45 CFR 46- ….signed by the patient or legally authorized representative.
Completing the Document oDocument distribution FDA 21CFR 50- A copy of Informed Consent shall be given to the patient or representative. ICH GCP E6 4.8 – The subject should receive a copy of the signed and dated written informed consent form… Institutional Policies OHRP 45 CFR 46- A copy shall be given to the person signing the form.
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 oProtocol number or name of study oAlternative treatment options discussed. o A statement that the protocol, and the informed consent were reviewed with the participant, including the risks and benefits of the study. oTime for questions to be asked and answered. oDescription of the participant’s decision oCopy of consent was given to the participant
RE-CONSENTING Participants must be informed of new information that may affect their willingness to take part in the research.
Minor Per state law – Texas=Under 18 years old Participant under 18 y the parent/s or legal guardian informed consent informed consent process process (on the child’s behalf) (on the child’s behalf)
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.
Yes No Age >/=18 Subject and Person obtaining consent sign the ICD Parent/Guardian, witness, and Person obtaining consent sign the ICD MDACC Flow Chart – Consenting Minors Child Age 7-12 – Verbal Assent Only Child Age – Written Assent Required
Non-English Speaking Participants
Ideal is to use consent translated to participant’s native language 45 CFR (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?
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? What do we look for as auditors?
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