ICF Process - Emory University

ICF Process - Emory University

ICF Process IRB 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 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 Introduction

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 Steps in the consent process 1. 2.

3. 4. 5. Provide enough information to weigh risks/benefits of participation Facilitate comprehension of the information Give opportunities for Q&A Help with documentation 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 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.

ICP in Adults: Special Consideration 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.

ICP in Adults: Special Consideration 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 ICP in Adults: Special Consideration 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). 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 Children 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. 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. B. C.

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

B. C. 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. Have them sign the English version but get a translator from the hospital to sign as a witness. 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. B. C. I need to translate the assent form, but not the ICF as I would be using a translator. I need to use the short form (already approved by IRB) and use a translator for both the consent and assent. 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. B. C. I need to translate the assent form, but not the ICF as I would be using a translator. I need to use the short form (already approved by IRB) and use a translator for both the consent and assent. 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. B. C. You may not enroll the child unless the ICP is already approved by IRB (verbal consent). You talked to the parent already, so the child can be enrolled by the grandparent. 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. B. C. You may not enroll the child unless the ICP is already approved by IRB (verbal consent). You talked to the parent already, so the child can be enrolled by the

grandparent. You may not enroll unless the parent agrees to come the next day and sign the form again after child finishes with participation. 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] 23 Questions? 24

Recently Viewed Presentations

  • California Exonerees Health and Well-Being Project

    California Exonerees Health and Well-Being Project

    BackgroundAdditional Risks Associated With Wrongful Conviction . When the wrongfully convicted are freed from incarceration, they may spiral into poverty, depression, and substance use and misuse. Exoneree experiences can often resemble that of military veterans and torture survivors who suffer...
  • Energy Release From Macronutrients - Yola

    Energy Release From Macronutrients - Yola

    Intramuscular stores (fat or glycogen) are depleted . During the recovery phase (post exercise) fats and carbs from the diet will go to restoring those levels. High intensity exercise can lead to fat loss depletion of glycogen & glycogen stores...
  • Learn what's new with Microsoft Office 365 connectors

    Learn what's new with Microsoft Office 365 connectors

    Connectors in the inbox, including management UI - OWA only. Actionable Messages via Connectors (Groups and inbox) - OWA only. Actionable Messages via SMTP - OWA only. Broad rollout within the next few weeks. Available soon. Connectors in the inbox...
  • Présentation PowerPoint

    Présentation PowerPoint

    Réforme des subventions aux énergies fossiles. ODD : MFI PROPOSES. Le potentiel du financement innovant est encore largement inexploité. Les ressources mobilisées grâce à des initiatives de financement innovant du développement représentent en moyenne 2 milliards USD par an.
  • Setting-up projects in the framework of the EPO's co ...

    Setting-up projects in the framework of the EPO's co ...

    The PATLIB (Patent Library) Network in Europe Heidrun Krestel European Affairs, Member States 19 May 2010 Presentation overview Landscape of the European PATLIB network PATLIBs' innovation support services for users EPO's collaboration with and support for the European PATLIB network...
  • North Carolina Society of Enrolled Agents

    North Carolina Society of Enrolled Agents

    North Carolina Society of Enrolled Agents * Examination Collection Appeals Common opportunities to represent a taxpayer North Carolina Society of Enrolled Agents * Enrolled Agents have the authority to prepare any type of tax return and may represent any taxpayer...
  • Structure-Function Relationships in the Enantioselective ...

    Structure-Function Relationships in the Enantioselective ...

    Structure-Activity Relationships in Enantioselective Oxidations of Alcohols by PdII Complexes Smith (Robert J.) Nielsen Jason M. Keith, William A. Goddard III
  • Efficient XML Query Processing - Carleton University

    Efficient XML Query Processing - Carleton University

    BLAS: An Efficient XPath Processing System Zhimin Song Advanced Database System Professor: Dr. Mengchi Liu