informed consent process patrick herbison, med, cip research compliance manager office of human...
DESCRIPTION
Regulations – Common Rule 45 CFR Must obtain consent Sufficient time No coercion In an understandable language Can’t make subject waive rights Can’t release PI, sponsor, institution from liability Elements of consentTRANSCRIPT
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Informed Consent ProcessPatrick Herbison, MEd, CIPResearch Compliance ManagerOffice of Human Research (OHR)[email protected]
These slides contain summaries of regulations (mainly 45 CRF 46) and OHR Policies. Please follow the full regulations and policies.
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Topics • ‘Normal Consent’• Variations• Waivers/Alterations• Assent• Surrogate Consent• Physically Unable to Sign• Witnesses• Short Forms• Translations• Consent Amendments/Re-Consent
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Regulations – Common Rule45 CFR 46.116• Must obtain consent• Sufficient time• No coercion• In an understandable language• Can’t make subject waive rights• Can’t release PI, sponsor, institution from liability• Elements of consent
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Regulations – Common Rule45 CFR 46.117
•Usual Process•Written, IRB approved consent•Signed by the subject•Copy given to the subject•Opportunity for the subject to read consent
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Regulations – Common RuleNotice of Proposed Rulemaking (NPRM)• Simplify the consent form
• Specimens are identifiable – Broad consent for future use• Define exclusion categories• Re-define exempt categories• Fewer waivers of consent for research with specimens• Single IRB Review• Eliminate continuing review for expedited and closed
studies• Common rule to cover all studies at institutions that
receive federal funding
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Regulations – Common Rule45 CFR 46.116• Elements of Consent (8 Basic Elements)• Study involves research• Purpose• Duration• Procedures• Experimental procedures• Risks• Possible benefits
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Regulations – Common Rule45 CFR 46.116• Elements of Consent (8 Basic Elements)• Alternatives• Confidentiality• Compensation/Treatment in case of injury• Contact info (study, injury, rights as a research
subject)• Voluntary participation• Not participate or withdraw without penalty
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Regulations – Common Rule45 CFR 46.116• Elements of Consent (6 Additional Elements)• Unforeseeable risks to subject, unborn child• Termination without consent• Cost• Early termination consequences and procedures• Significant new findings• Number of subjects
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Role of the IRB• To Ensure:• Appropriate consent will be obtained• Approve the consent based on Common Rule (New, Continuing Review, Amendments)• Approve all patient materials• Require amendments and re-consent
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Waivers - 45 CFR 46•Waiver of requirement to obtain informed consent or alteration of consent• No more than minimal risk• Will not adversely affect the rights and welfare of
the subjects• Couldn’t do study without waiver or alteration• When possible, the subjects will be given
information after participation
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Waivers - 45 CFR 46
•Waiver of requirement to obtain a signed consent form• If either apply:• The consent would be the only record
linking subject to a sensitive study• No more than minimal risks and consent
is not usually required for any of the procedures
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Waivers and Alterations – IRB Forms•OHR-2: Describe consent requirements – IRB will decide if appropriate•OHR-3: If you think subject authorization to collect PHI should be waived•OHR-5: If de-identified health information is being collected
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Assent – OHR-8C•Used for studies involving children/impaired adults•Used for long term situations• Assent cannot be done without consent!
Consent Form
Assent Form
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Assent – OHR-8C• Parent/Guardian is consented the usual way• Parent/Guardian signs the consent• For the patient, the process is the same as consent but simplified• Patient signs the assent• Children 7 – 17 should be given the opportunity to assent or if they can understand, use the consent form(TJU Policy 506)
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Surrogate Consent – OHR-8B•Used for studies involving incapacitated/impaired adults•Used for short term situations•Use approved consent form•OHR-8B replaces consent form signature pageConsent
FormOHR-8B
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Surrogate Consent – OHR-8B•OHR-8B gives priority of surrogates• If able, the patient consents as well•Obtain assent or consent if patient later becomes able
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Physically Unable to Sign ConsentOHR Policy IC 705• Subject is physically unable (e.g. paralyzed), not
mentally unable• The subject’s name and date of signature may be written
in• The subject may make their mark or thumbprint if able• There must be a witness• Include the following note on the signature page of
consent:• The subject is physically unable to sign the consent
form. All pages of the consent form were reviewed with the subject, who voluntarily consented to participate in this study.
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Witnesses•Generally required if:• The only language the subject speaks and understands is English, but the subject cannot read English• The subject is blind• The subject cannot physically sign the consent form• The short form process will be used
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Witnesses• Impartial, cannot be study personnel•Must be present for the entire consent discussion• Should be available throughout the study
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Short Form Consent – OHR-8S - English• A form stating that consent has been
explained verbally•Use the short form and a summary (usually the full consent)
Short Form
OHR-8S
Consent Form
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Short Form Consent – OHR-8S - English•Need an impartial witness (it cannot be
study personnel but can be the translator)• Short form is signed by the patient and the witness• The summary (consent) is signed by the witness, person obtaining consent and investigator• Patient is given copies of both
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Short Form Consent – OHR-8S - English• Short form = 2 forms + 5 signatures +
Witness vs.• Regular Consent = 1 form + 3 Signatures
• Easier to make a short consent form (use OHR-8A – Consent Form for Blood Draw) • Contact the IRB Before Using!
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TranslationsThe standard requirements from 45
CRF 46.116 and 46.117
1. Informed consent should be documented by the use of a written consent form
2. Consent forms must be written in a language understandable to the subject
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Translations
Translated
Short Form
OHR-8S
EnglishConsent
Form
Translated Consent
Form
Non-English Speaking Subject
Expected
Not Expected
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Translations – Not Expected•Use the short form in subject’s language and English consent• The short form explains that consent has been explained verbally• Both must be approved by the IRB before use• Several languages on the OHR forms page (OHR-8S)
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Translations – Not Expected• Need an impartial witness and translator fluent in
both languages• The translator can be the witness but neither can be
study personnel• Both must be present for the entire consent
discussion• Both should be available throughout the study
• Same short form requirements discussed previously• Short form is signed by the patient and the witness• The summary (consent) is signed by the witness,
person obtaining consent and investigator• Patient is given copies of both
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Translations – Not Expected• After consent with the short form, the full consent
should be translated and the subject re-consentedTranslate
dShort Form
OHR-8S
EnglishConsent
Form
Translated Consent
Form
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Translations – Expected• The consent form should be translated and approved by the IRB• Translated documents need documentation of accuracy• For individuals, submit translator’s name and qualifications to the IRB• Translation agencies will provide documentation of accuracy
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Consent Amendments• From 45 CFR 46.116: The subject will be
informed of any change that may affect the subject’s willingness to continue participation (changes to any of the elements of consent).
• Who can ask for changes to the consent and re-consent:• Sponsor• PI• Study Personnel• IRB• Other
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Re-Consent• The study team makes the recommendation on the OHR-12• The IRB agrees or modifies and includes the requirement on the approval page.
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Recommendations• A method to ensure most current, IRB approved consent is used•Use a checklist to document the consent process
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Questions?