![]() ![]() The consent form must include the required elements and optional elements under the federal regulations. The NIH IRB will accept and approve an ICF that differs from the NIH templates, provided that the document contains all of the required, and any applicable optional elements, as required by the HHS Common Rule (45 CFR 46) and if applicable, FDA regulations (21 CFR 50), and it is well written. Rewriting model consent forms from Sponsors to attempt to fit the NIH consent form templates often results in consents that do not satisfy regulatory or NIH requirements. What if the sponsor or study group has provided a model consent, or you are submitting a consent to an external IRB? If you have questions whether a consent addendum is the appropriate mechanism for notifying existing subjects of a change, please contact the IRBO for guidance. Do not use a consent addendum if there are extensive changes or new risks – instead subjects should be re-consented with a modified consent document. The consent addendum can be used to facilitate discussion with subjects since the changes/new findings are the only focus of the document. When just a limited number of existing subjects need to be informed of specific minor changes (rather than having them sign a modified consent document), e.g., a change in planned procedure, or when follow up will be extended.However, this information does not pertain to all subjects who are, or will be newly, enrolled. When just a limited number of existing subjects need to be informed of significant new findings developed during their participation that may impact their willingness to continue in the study.The consent addendum should only be used for subjects who are currently taking part in an NIH IRB-reviewed study and have already signed the original consent.Įxamples of when a consent addendum may be used are as follows: What if I only need to provide new study information to a limited number of previously enrolled subjects or inform enrolled subjects of a minor change? NIH Consent Template for use NIEHS CRU.docx radiation risk language and GINA language) those sections are noted in the document.įor any questions about the use of this language in your consent, please contact of Consent Language: There is some language inserted which cannot be altered (e.g. The examples serve as a starting point and should be modified as necessary to match the requirements of the specific study. To expedite approval of the study consent forms, study teams should use these examples. This document, called the “consent library” is found below. The IRB has assembled a compendium of procedure descriptions and their associated risks from consent forms. NCI Using Online and Manual Readability Tools to Assess the Reading Level of Informed Consent DocumentsĬenter for Disease Control and Prevention (CDC) Health Literacy Website Plain Language: Getting Started or Brushing Up (information and checklists via NIH webpage or pdf)Ĭommunicating Risks and Benefits: An Evidence-Based User’s Guide (FDA) NCI Checklist to Develop Easy-to-Read Informed Consent Documents How to Use Simpler Words and Phrases (a resource) How to Write Using Active Voice (preferred) vs. NCI Risk Terms Library MICROMEDEX Scientific Terms (Informed Consent Terms for Risks Spreadsheet)Ĭommon Terminology Criteria for Adverse Events (Systems Based Lay Terms for Adverse Events Spreadsheet) Side Effect Tables of Common Oncology Drug Regimens.Side Effect Tables for Common Oncology Drugs.Edit, revise, and edit again - until the document is clear and concise.Have someone without a medical background, who is unfamiliar with the study, review the consent form.Target the reading level as close as possible to Grades 6 - 8.Both the descriptions of the procedures, and the associated risks, may be modified and adapted to match each study's specific requirements, with a few exceptions which are noted in the document The IRB does not intend that investigators must use the exact wording for most procedures. The document can be downloaded as an MS Word file. The IRB has compiled a document entitled Consent Librarywhich includes Plain Language descriptions of procedures and corresponding risk information.Refer to the PRISM Readability Toolkit which contains information about the principles of Plain Language, and examples for improving readability.Use Plain Language instead of technical terms.which can be used to control formatting Adhere to the template design specified int the MS Word Style Sheet - margins, type size, font choices, use of bold, etc. ![]() Follow the instructions in the NIH IRB's template.To create clear, simple consent documents: Getting your Consent Form (ICF) Approved Quickly ![]()
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