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 pageConsent

FormOHR-8B

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!

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

Translations

Translated

Short Form

OHR-8S

EnglishConsent

Form

Translated Consent

Form

Non-English Speaking Subject

Expected

Not 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-consentedTranslate

dShort Form

OHR-8S

EnglishConsent

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

Questions?