April 11, 2023April 11, 2023

The Process of Informed ConsentThe Process of Informed Consent

Amy Blakeslee, BS, CIP, CCRPHIC Lead CoordinatorYale University School of Medicine

Amy Blakeslee, BS, CIP, CCRPHIC Lead CoordinatorYale University School of Medicine

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What is the HIC?What is the HIC?

Institutional Review Board (Called HIC-Human Investigation Committee at Yale)

Committee whose primary responsibility is to protect the rights and welfare of human research participants.

Governed by Federal Regulations (OHRP and FDA)

Also by Belmont Report (Ethical Principles of Justice, Beneficence and Respect for Persons)

Institutional Review Board (Called HIC-Human Investigation Committee at Yale)

Committee whose primary responsibility is to protect the rights and welfare of human research participants.

Governed by Federal Regulations (OHRP and FDA)

Also by Belmont Report (Ethical Principles of Justice, Beneficence and Respect for Persons)

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What is Informed Consent?What is Informed Consent?

• Example of Ethical Principle of Respect for Persons

• Not a document, but a process

• Starts at initial contact (e.g. recruitment)

• Example of Ethical Principle of Respect for Persons

• Not a document, but a process

• Starts at initial contact (e.g. recruitment)

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• Continues through study participation

• an informed participant is better able to adhere to the protocol and therefore provide evaluable data

• research staff members are obligated to share any new information related to subject’s participation (i.e. newly identified side effects, etc)

• Continues through study participation

• an informed participant is better able to adhere to the protocol and therefore provide evaluable data

• research staff members are obligated to share any new information related to subject’s participation (i.e. newly identified side effects, etc)

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Informed Consent

The Document

Informed Consent

The Document

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All subjects must receive a copy of

the ICF document for their

records• Many participants will refer back to it or

take it to show to a loved one

• USE THE CORRECT (HIC approved!) VERSION

• NO crossing out/white out—no changes of ANY type without HIC approval

All subjects must receive a copy of

the ICF document for their

records• Many participants will refer back to it or

take it to show to a loved one

• USE THE CORRECT (HIC approved!) VERSION

• NO crossing out/white out—no changes of ANY type without HIC approval

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• Written/signed consent may be waived under certain circumstances—this must be approved by HIC on a case-by-case basis

• Investigators must keep a copy of the signed consent document for their records (in a secure location)

• Written/signed consent may be waived under certain circumstances—this must be approved by HIC on a case-by-case basis

• Investigators must keep a copy of the signed consent document for their records (in a secure location)

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Elements-Required by Federal Regulations and HIC policy (see Yale template handout)

Elements-Required by Federal Regulations and HIC policy (see Yale template handout)

• Involves research

• Explain purpose of research

• Expected duration of participant’s involvement

• Description of procedures (***In LAY terms***--see handout)

• Involves research

• Explain purpose of research

• Expected duration of participant’s involvement

• Description of procedures (***In LAY terms***--see handout)

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Elements-Required (cont’d)Elements-Required (cont’d)

• Differentiate between experimental and standard procedures

• Description of Risks/Discomforts

• Description of Benefits (**Does NOT include Payments to Subjects)

• Disclose Alternatives

• Differentiate between experimental and standard procedures

• Description of Risks/Discomforts

• Description of Benefits (**Does NOT include Payments to Subjects)

• Disclose Alternatives

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Elements-Required (cont’d)Elements-Required (cont’d)

• Confidentiality Section

• In Case of Injury

• Whom to contact with questions

• Voluntary Participation—free to withdraw at ANY time

• Confidentiality Section

• In Case of Injury

• Whom to contact with questions

• Voluntary Participation—free to withdraw at ANY time

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Industry sponsored researchIndustry sponsored research

• Sponsors usually provide a template to be used; however the HIC must approve the final version and it must follow the HIC guidelines

• This is not a ‘contract’ between the participant and the company-both the document and process are meant to inform participants

• Sponsors usually provide a template to be used; however the HIC must approve the final version and it must follow the HIC guidelines

• This is not a ‘contract’ between the participant and the company-both the document and process are meant to inform participants

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Informed Consent

The Process

Informed Consent

The Process

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• Handing a participant the consent document and asking them to read and ask questions is NOT Informed Consent

• Verify participant knows diagnosis before proceeding with process (If a treatment study)

• Handing a participant the consent document and asking them to read and ask questions is NOT Informed Consent

• Verify participant knows diagnosis before proceeding with process (If a treatment study)

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Should be a discussion which covers what is contained in the documentShould be a discussion which covers what is contained in the document

• Try to keep it short (people will tune out at a certain point)

• Tailor presentation to audience. You may want to think about your most unsophisticated relative—what would you like them to know if THEY were the participant

• Don’t assume people know jargon/acronyms

• Try to keep it short (people will tune out at a certain point)

• Tailor presentation to audience. You may want to think about your most unsophisticated relative—what would you like them to know if THEY were the participant

• Don’t assume people know jargon/acronyms

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• Participants should be given ample time to consider options, ask questions and be allowed to take the information home to consider options

• Pay attention to verbal and non-verbal cues both by YOU and by the person

• Participants should be given ample time to consider options, ask questions and be allowed to take the information home to consider options

• Pay attention to verbal and non-verbal cues both by YOU and by the person

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Verify person understands information presentedVerify person understands information presented

• Consider giving a ‘quiz’ after explaining study and before participant signs

• Consider giving a ‘quiz’ after explaining study and before participant signs

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Consent AddendumsConsent Addendums

• Very useful when new information has been identified

• Used to provide currently enrolled subjects about new information (side effects, etc)

• The Committees seem to be moving toward requiring an addendum

• HIC has developed a template, available on our website

• Very useful when new information has been identified

• Used to provide currently enrolled subjects about new information (side effects, etc)

• The Committees seem to be moving toward requiring an addendum

• HIC has developed a template, available on our website

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Special PopulationsSpecial Populations

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MinorsMinors• Under 18 cannot sign Consent form (Unless

pregnant female consenting for research related to pregnancy or on fetus OR under 18 parent consenting for research on child)

• Minors sign an assent form (should have separate assents for different age ranges eg-7-12, 13-17)

• Parents sign permission form

• Child declining participation trumps parent agreeing unless HIC determines child assent not required

• Under 18 cannot sign Consent form (Unless pregnant female consenting for research related to pregnancy or on fetus OR under 18 parent consenting for research on child)

• Minors sign an assent form (should have separate assents for different age ranges eg-7-12, 13-17)

• Parents sign permission form

• Child declining participation trumps parent agreeing unless HIC determines child assent not required

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Non-EnglishNon-English

• According to regulations, the document MUST be in a language understandable to the participant and must contain the same elements as English version—can be a ‘short form’

• Consent should be obtained by someone fluent in the participant’s language.

• This should NOT be a family member

• According to regulations, the document MUST be in a language understandable to the participant and must contain the same elements as English version—can be a ‘short form’

• Consent should be obtained by someone fluent in the participant’s language.

• This should NOT be a family member

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Non-English (cont’d)Non-English (cont’d)

• Finalize the English version before having it translated.

• Talk to the translator.

• All translators listed on the HIC website must meet certain criteria.

• Finalize the English version before having it translated.

• Talk to the translator.

• All translators listed on the HIC website must meet certain criteria.

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Decisionally ImpairedDecisionally Impaired

• May be cognitively impaired, unconscious, mentally disabled, temporarily impaired

• Informed Consent discussion should happen with next of kin/surrogate OR legally authorized representative

• When possible, participant’s assent should also be obtained—may be after the research related activities have occurred in the case of participants who are temporarily impaired

• May be cognitively impaired, unconscious, mentally disabled, temporarily impaired

• Informed Consent discussion should happen with next of kin/surrogate OR legally authorized representative

• When possible, participant’s assent should also be obtained—may be after the research related activities have occurred in the case of participants who are temporarily impaired

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And now a word about HIPAA….

And now a word about HIPAA….

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• HIPAA RAF (Research Authorization Form) IS NOT a consent form

• authorization to use and release Protected Health Information for research purposes records to those entities listed on the RAF

• Consider using a Compound consent form which incorporates HIPAA language into consent form

• HIPAA RAF (Research Authorization Form) IS NOT a consent form

• authorization to use and release Protected Health Information for research purposes records to those entities listed on the RAF

• Consider using a Compound consent form which incorporates HIPAA language into consent form

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Questions?Questions?

• HIC website: http://info.med.yale.edu/hic/

• OHRP website: http://www.hhs.gov/ohrp/

• FDA website

http://www.fda.gov/

• HIC 785-4688

• HIC website: http://info.med.yale.edu/hic/

• OHRP website: http://www.hhs.gov/ohrp/

• FDA website

http://www.fda.gov/

• HIC 785-4688