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Informed Consent: Process, Document, and Waiver Criteria Guiding Principles The Belmont Report – Respect For Persons People are autonomous agents and should be treated with respect Informed consent must be freely and voluntarily given Those of diminished capacity require additional protections Informed Consent What it is: Ongoing ‘process’ of communication and understanding Voluntary agreement between subject and investigator (absence of pressures/coercion) What it isn’t: A piece of paper A one time conversation Elements Statement that the study involves research Purpose Duration of participation Treatments/Procedures Probability for random assignment Aspects that are experimental Subject’s responsibilities Foreseeable risks/benefits Elements (cont.) Alternative treatment(s) Compensation/treatment for injury Payment/expenses Confidentiality conditions Monitor, auditor, and REC access Subject’s identity not revealed in publications Notification of relevant/significant and (new) information Elements (cont.) A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable (when appropriate) Foreseeable reasons for termination Approximate sample size Voluntary nature of participation 6 Elements (cont.) Consequences of discontinuing research participation (when appropriate) Contact person(s) for questions About the research About subjects’ rights In the event of research-related injury 7 Informed Consent Document Written document that includes all applicable elements E.g., OHRA Consent Templates Readability and Comprehension Consent documents must be in language that is understandable to participants Must be approved by the IRB and/or local ethics board Additional Considerations Parental/legal guardian permission for minors Minor assent affirmative agreement to participate in research Surrogate Consent Obtain consent from illiterate persons Use of a witness Use of a subject advocate Documentation of Informed Consent Valid IRB approved written consent form Signed and dated participant or legally authorized representative person who obtained informed consent Retain original signed/dated document for study file Provide subjects with a copy (unless waived by the IRB) Use Enrollment Log as additional documentation When To Obtain Consent Prior to the start of any study procedures After sufficient time is allowed for participants to discuss with family, friends, and other physicians Throughout individual’s participation in the study Investigator is required to inform subject of relevant/significant (new) findings and to ensure that they are still willing to participate IRB or sponsor, may require that the subject sign an updated consent form For minors, when they reach the local age of majority Who Can Obtain Consent Principle Investigator (PI) or Co-Investigator Qualified by training and experience Knowledgeable about informed consent process Knowledgeable about protocol Knowledgeable about local culture and their customs If others, persons must be approved by IRB PI to document, e.g., Delegation of Responsibility Log Responsibility of PI to ensure informed consent obtained and documented Waiver of the Requirement to Obtain Informed Consent Research involves no more than minimal risk to the subjects; Waiver or alteration will not adversely affect the rights and welfare of the subjects; Research could not practicably be carried out without the waiver or alteration; Whenever appropriate, the subjects will be provided with additional pertinent information after participation. Waiver of the Requirement to Document Informed Consent Non-FDA regulated research that involves no more than minimal risk: The only record linking subject/research would be the consent and the principal risk would be harm resulting from a breach of confidentiality OR The research presents no more than minimal risk to subjects and involves no procedures for which written consent is normally required Compliance Checklist Was informed consent obtained from each subject prior to the start of any study procedure(s)? Was an IRB approved consent form (IRB validation stamp in footer) used to consent each subject? Was the consent form used for each subject a copy of the most recently approved version (check valid dates)? Is the consent form on file for each subject the original signed and dated version (not a photocopy)? Are all pages of the consent form on file for each subject? Compliance Checklist (cont.) Did all subjects receive a copy of their signed and dated consent form? Is there documentation to support that all subjects received a copy of their signed and dated consent form? Is subject identification (written or imprinted with hospital card) on all pages of the consent form? Did each subject sign and date the consent form for him/herself? (excluding IRB approved surrogate/parental consent) Compliance Checklist (cont.) Did an IRB approved study representative obtain consent for all subjects? Did the IRB approved study representative obtaining consent sign and date for him/herself? Did the subject and study representative enter the same date on the consent form? Are all consent forms free of any handwritten changes/corrections (e.g. updated physician contact telephone number)? Compliance Checklist (cont.) Are original copies of all IRB approved consent forms on file (maintain electronically or in study’s Regulatory Binder)? Is the number of subjects who have signed the consent form (i.e. enrolled) less than the target enrollment goal approved by the IRB?
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