 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 in special situations  To identify things to avoid when documenting the process

 Introduction  Steps in the consent process  Informed Consent Process (ICP) in Adults, special considerations: o Does not speak English o Illiterate or Visually impaired o LAR in cases where subject cannot consent  ICP in Children, special considerations : o Child and parents do not speak English o Use of short form  Scenarios

 The are three elements involved in a successful participant enrollment. The elements include: o The informed consent form (ICF or ICD) o ICP o Consent documentation  Interdependent Elements o Poor documents undermine the process and vice versa o Documenting the use of a poor form/process is GIGO

1. Provide enough information to weigh risks/benefits of participation 2. Facilitate comprehension of the information 3. Give opportunities for Q&A 4. Help with documentation 5. Continue to provide information: Ongoing process

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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

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!

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

Illiterate or Visually impaired  Person obtaining consent o Reads entire form aloud o 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.

Illiterate or Visually impaired  Requires a witness to verify o Process took place o Subject indicates understanding o 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 treatment o 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

Legally authorized representative (LAR) considerations  Research not involving medical treatment o 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).

 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.

 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.

If 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.

 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.

 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.

 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.

 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.

 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.

 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.

Please call the QA and Education team  Maria G. Davila (404) or  Shara Karlebach (404) or  Kevin Wack (404) or  Sean Kiskel (404) or 23

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