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Informed Consent Process Patrick Herbison, MEd, CIP Research Compliance Manager Office of Human Research (OHR) patrick.herbison@jefferson.edu. These slides contain summaries of regulations (mainly 45 CRF 46) and OHR Policies. Please follow the full regulations and policies. Topics.
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Informed Consent ProcessPatrick Herbison, MEd, CIPResearch Compliance ManagerOffice of Human Research (OHR)patrick.herbison@jefferson.edu These slides contain summaries of regulations (mainly 45 CRF 46) and OHR Policies. Please follow the full regulations and policies.
Topics • ‘Normal Consent’ • Variations • Waivers/Alterations • Assent • Surrogate Consent • Physically Unable to Sign • Witnesses • Short Forms • Translations • Consent Amendments/Re-Consent
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
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
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
Regulations – Common Rule45 CFR 46.116 • Elements of Consent (8 Basic Elements) • Study involves research • Purpose • Duration • Procedures • Experimental procedures • Risks • Possible benefits
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
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
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
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
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
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
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
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)
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 page OHR-8B Consent Form
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
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.
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
Witnesses • Impartial, cannot be study personnel • Must be present for the entire consent discussion • Should be available throughout the study
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
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
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!
Translations The standard requirements from 45 CRF 46.116 and 46.117 • Informed consent should be documented by the use of a written consent form • Consent forms must be written in a language understandable to the subject
Translations Non-English Speaking Subject Not Expected Expected Translated Consent Form Translated Short Form OHR-8S English Consent Form
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)
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
Translations – Not Expected • After consent with the short form, the full consent should be translated and the subject re-consented Translated Short Form OHR-8S English Consent Form Translated Consent Form
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
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
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.
Recommendations • A method to ensure most current, IRB approved consent is used • Use a checklist to document the consent process