Informed Consent Process Patrick Herbison, MEd, CIP Research Compliance Manager Office of Human Research (OHR) 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 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 consent

Regulations – Common Rule 45 CFR Usual Process Written, IRB approved consent Signed by the subject Copy given to the subject Opportunity for the subject to read consent

Regulations – Common Rule Notice 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 Rule 45 CFR Elements of Consent (8 Basic Elements) Study involves research Purpose Duration Procedures Experimental procedures Risks Possible benefits

Regulations – Common Rule 45 CFR 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 Rule 45 CFR 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!

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

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 Consent OHR 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 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 and 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

Translations Non-English Speaking Subject ExpectedNot Expected

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

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 : 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

Questions?