Presentation on theme: "Research Informed Consent"— Presentation transcript:
1Research Informed Consent Kristin Bialobok, MSN, RN, CCRC, CCRADirectorOffice of Research Education and Regulatory Management
2Purpose of Consent ? Prospective Subject Will .. Understand nature of researchBe informed of purpose, risks, and benefits, andalternative therapiesMake a Voluntary Decision about Participation
3What rules do I follow? Federal Regulations Institutional Policy 21CFR Part 5045CFR Part 46Sponsor RequestICH Good Clinical Practice GuidelinesE6 4.8
4Is Informed Consent Always Essential? EXCEPTIONS:IRB has granted a waiver of consentLife-threatening condition andInability to communicate with the subject andTime is insufficient to obtain consent from subject’s legal representative andThere is no alternative method of approved therapyMust Be Followed Bynotification of the IRB within 5 daysreview and evaluation of test article use by another physicianobtain consent ASAP.
5Research Consent Process Consent DocumentConsent Discussion
7Research Consent Document 21 CFR Basic Elements of IC
8Research Consent Document 21 CFR Additional Elements
9Research Consent Document ReadabilityLanguage that is easily understoodLanguage must be appropriate to the population being studiedLanguage translators should be qualified and IRB authorizedConsider comprehension as well as readabilityLimit medical terminologyAvoid informal speech
12Who has the Authority to Obtain Research Consent? What do the regulations say?SilentWhat 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
13Informed Consent Process Discussion between the physician and the participant.Review of information by research nurse/coordinator.All questions and concerns addressed.No exculpatory languageMinimal chance of coercion/undue influenceAllow adequate timeSignatures obtained.
14Informed 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.
16Completing the Document All blank spaces completedNo additions or deletionsSignatures obtainedFDA 21CFR 50- The patient or authorized representative shall sign anddate the informed consent.OHRP 45 CFR 46- ….signed by the patient or legally authorizedrepresentative.ICH GCP E6 4.8 – …the informed consent should be signed andpersonally dated by the subject or legally authorizedrepresentative.Institutional Policies
17Completing the Document Document distributionFDA 21CFR 50- A copy of Informed Consent shall be given to the patientor 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 anddated written informed consent form…Institutional Policies
18Completing the Document When do you need a witness?When presenting the informed consent document orallyUse of a short formIf required by the IRBWho 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…
20DOCUMENTING THE PROCESS Protocol number or name of studyAlternative 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 decisionCopy of consent was given to the participantDOCUMENTING THE PROCESS
21RE-CONSENTINGParticipants must be informed of new information that may affect their willingness to take part in the research.
23the parent/s or legal guardian CONSENTING MINORSMinorPer state law – Texas=Under 18 years oldinformed consentprocess(on the child’s behalf)the parent/s or legal guardianParticipant under 18 y
24CONSENTING 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.
25MDACC Flow Chart – Consenting Minors Age >/=18NoYesSubject and Person obtaining consent sign the ICDParent/Guardian, witness, and Person obtaining consent sign the ICDChild Age 7-12 – Verbal Assent OnlyChild Age – Written Assent Required
27Non-English Speaking Participants Ideal is to use consent translated to participant’s native language45 CFR (b) - “Short form written consent document…”
28What 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?
29What 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?
30What 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?
31FDA 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