IRB Webinar 11/13/2014. To recognize how to conduct an adequate informed consent process in adults and children To learn how to manage the process.

ICF ProcessIRB Webinar 11/13/2014

Objectives

To recognize how to conduct an adequate informed consent process in adults and children

To learn how to manage the process in special situations

To identify things to avoid when documenting the process

Topics Introduction Steps in the consent process Informed Consent Process (ICP) in Adults, special

considerations:o Does not speak Englisho Illiterate or Visually impairedo LAR in cases where subject cannot consent

ICP in Children, special considerations :o Child and parents do not speak Englisho Use of short form

Scenarios

Introduction

The are three elements involved in a successful participant enrollment. The elements include:o The informed consent form (ICF or ICD)o ICPo Consent documentation

Interdependent Elementso Poor documents undermine the process and vice versao Documenting the use of a poor form/process is GIGO

Steps in the consent process1. Provide enough information to

weigh risks/benefits of participation

2. Facilitate comprehension of the information

3. Give opportunities for Q&A4. Help with documentation5. Continue to provide

information: Ongoing process

ICP video

ICP in Adults: Special Consideration

Participants who do not speak English Use of a translated ICF or short

form Oral translation of the English

language consent form is presented

There MUST be a translator There must be a witness to the

oral presentation

ICP in Adults: Special Consideration

Participants who do not speak English If using a short form, you may use

IRB approved short forms or submit an amendment for your own forms

If the IRB has not approved enrollment of non-English speaking subjects, an amendment will be required. o Include this in your original

submission!

ICP in Adults: Special Consideration

Participants who do not speak English (cont.) Subject (or LAR)

o Signs short form Investigator

o Signs ICF Translator

o Signs nothing (unless acting as witness) Witness

o Signs short form and ICF

ICP in Adults: Special Consideration

Illiterate or Visually impaired Person obtaining consent

o Reads entire form aloudo Documents subject unable to read

Opportunity for discussing questions and concerns is vital. o Repeating and explaining portions of the

Informed Consent Document.o Cover the document in stages.

ICP in Adults: Special Consideration

Illiterate or Visually impaired Requires a witness to verify

o Process took placeo Subject indicates understandingo Subject consented to participate.

“Making their mark” is sufficient.o Names and telephone contact numbers

for the study PI and the IRB Office should still be provided.

Legally authorized representative (LAR) considerations LAR = An individual authorized under law to consent on behalf

of a subject to participate in the procedure involved in the research

Research involving medical treatmento If an adult, make sure person is of sound mind and body, conscious,

mentally unimpaired and physically able to read and/or hear and understand; and has not been declared to be legally incompetent.

o If they are not, you need to use a LAR

ICP in Adults: Special Consideration

Legally authorized representative (LAR) considerations Research not involving medical

treatmento If an adult, you may not use a LAR if

the research does not involve medical treatment, unless there is a legal document (e.g. power of attorney that is specific for research).

ICP in Adults: Special Consideration

ICP in Children

Assent, not consent Verbal or Written Assent? If the parent of the child does not

speak English, do not use the child as the translator. You need a translator and the use a translated ICF or short form.

ICP in Children 1 or 2 parent signatures per IRB

approval letter If child is accompanied to the visit by

someone other than his/her parent, consider the following:o Medical research: Obtain legal

documentation. o Non-medical: you may not enroll subject

unless there is legal documentation specific to research consent.

ICP in ChildrenIf child is accompanied to the visit by someone other than a parent, consider the following: Medical research

o If minor is accompanied by grandparent or other relative that may be considered a LAR, ask why parent did not attend visit. • If parents are not available, but are the legal guardians (e.g. overseas for a

long period), make every effort to contact parent and make sure they agree with participation before adding child to study.

• If parents are not available/not able to serve as legal guardian (e.g., incapacitated), then family member may enroll child but should provide legal documentation to the study team.

o In general, if using a legal guardian, obtain legal documentation.

Scenarios You are doing a Phase II cancer trial study, and a non-English

speaking patients is eligible for it. The patient arrives alone to the clinic and speaks Mandarin. You do not have an ICF or short form approved. Which option is correct?

A. You may use the IRB short form in Mandarin. You did not have that approved before but the document is an IRB approved short form.

B. Have them sign the English version but get a translator from the hospital to sign as a witness.

C. Submit an amendment to select the option of enrolling non-English speaking subjects and use the IRB approved short form.

Scenarios You are doing a Phase II cancer trial study, and a non-English

speaking patients is eligible for it. The patient arrives alone to the clinic and speaks Mandarin. You do not have an ICF or short form approved. Which option is correct?

A. You may use the IRB short form in Mandarin. You did not have that approved before but the document is an IRB approved short form.

B. Have them sign the English version but get a translator from the hospital to sign as a witness.

C. Submit an amendment to select the option of enrolling non-English speaking subjects and use the IRB approved short form.

Scenarios You are approved to enroll non-English speaking subjects in

your pediatric, medical trial. You want to enroll a non-English speaking, 14 year-old child into the trial. What are the documents and procedures needed in this case (select the right option)

A. I need to translate the assent form, but not the ICF as I would be using a translator.

B. I need to use the short form (already approved by IRB) and use a translator for both the consent and assent.

C. I need to translate both documents (assent and ICF). I do not need to use a translator as the documents are already translated.

Scenarios You are approved to enroll non-English speaking subjects in

your pediatric, medical trial. You want to enroll a non-English speaking, 14 year-old child into the trial. What are the documents and procedures needed in this case (select the right option)

A. I need to translate the assent form, but not the ICF as I would be using a translator.

B. I need to use the short form (already approved by IRB) and use a translator for both the consent and assent.

C. I need to translate both documents (assent and ICF). I do not need to use a translator as the documents are already translated.

Scenarios You have talked to a parent about her child participating in a

non-medical trial. The day of the enrollment visit, the grandparent accompanies the child and say that the parent is not available.

A. You may not enroll the child unless the ICP is already approved by IRB (verbal consent).

B. You talked to the parent already, so the child can be enrolled by the grandparent.

C. You may not enroll unless the parent agrees to come the next day and sign the form again after child finishes with participation.

Scenarios You have talked to a parent about her child participating in a

non-medical trial. The day of the enrollment visit, the grandparent accompanies the child and say that the parent is not available.

A. You may not enroll the child unless the ICP is already approved by IRB (verbal consent).

B. You talked to the parent already, so the child can be enrolled by the grandparent.

C. You may not enroll unless the parent agrees to come the next day and sign the form again after child finishes with participation.

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IRB Contacts:

Please call the QA and Education team Maria G. Davila

(404)712-0724 or [email protected] Shara Karlebach

(404)712-0727 or [email protected] Kevin Wack

(404)712-5220 or [email protected] Sean Kiskel

(404)712-0766 or [email protected]

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Questions?