University of Tulsa TU IRB知情同意书(ICF)使用说明 - 请选择适用的同意要素与附加要素样本

Sep 1, 2026

University of Tulsa Institutional Review Board（TU IRB）知情同意书（ICF）填写使用说明，提供完成同意表模板的关键步骤与写作规则。说明要求研究者阅读各章节标题后的蓝色/斜体或方括号指引，只删除被允许的部分；其余黑色规定文字必须保留。文案应使用简洁明了的二人称语言，符合受试者理解水平，并在适用情形下按需加入“Additional Elements of Informed Consent”及其他补充同意请求。说明还强调从TU IRB网页获取最新版本、以及涉及受试者报酬时需按TU Controller要求提供必要识别信息（并提示相应保密段落变更）。

LanguageEnglish

CategoryForms

FormatDOCX

Pages4

Reading Time2 min

AccessFree to download

General Instructions for Using Consent Forms

Selecting the appropriate informed consent form

Using consent form templates correctly

Language, length, and participant-friendly writing

Additional consent requests and consent elements

When to add additional elements of consent

The University of Tulsa Institutional Review Board (TU IRB) INFORMED CONSENT FORM (ICF) GENERAL INSTRUCTIONS * ADDITIONAL CONSENT ELEMENTS/SAMPLES PLEASE READ BEFORE COMPLETING THE CONSENT FORM TEMPLATE SELECT THE INFORMED CONSENT(S) APPROPRIATE FOR YOUR STUDY: HYPERLINK "https://utulsa.edu/wp-content/uploads/2019/01/TU-IRB-General-ICF-v1.14.2019.docx" \h General Informed Consent Form – For adult subjects (18 years or older) HYPERLINK "https://utulsa.edu/wp-content/uploads/2019/07/Sample-General-ICF.pdf" \h Sample General ICF HYPERLINK "https://utulsa.edu/wp-content/uploads/2019/01/TU-IRB-Online-ICF-v1.14.2019.docx" \h Online Informed Consent Form – For online research of adult subjects (18 years or older) when you can waive documentation of consent (not collecting signed forms) HYPERLINK "https://utulsa.edu/wp-content/uploads/2019/07/Sample-Online-ICF.pdf" \h Sample Online ICF HYPERLINK "https://utulsa.edu/wp-content/uploads/2019/01/TU-IRB-Parent.Guard_.LAR-ICF-v1.14.2019.docx" \h Parent/Guardian/LAR Informed Consent Form – For adult parent/guardian of a minor subject OR a Legal Authorized Representative (LAR) of an adult subject with cognitive impairment. This form MUST be accompanied with an Assent Form if the minor or cognitive impaired adult subject is able to consent. HYPERLINK "https://utulsa.edu/wp-content/uploads/2019/07/Sample-Parent-Guardian-ICF.pdf" \h Sample Parent/Guardian ICF HYPERLINK "https://utulsa.edu/wp-content/uploads/2019/01/TU-IRB-Minor-Assent-Form-v1.14.2019.docx" \h Assent Form – For minor subjects (under 18 years old) OR adult subjects with cognitive impairment and MUST be accompanied with a Parent/Guardian/LAR ICF. HYPERLINK "https://utulsa.edu/wp-content/uploads/2019/07/Sample-Assent-Form.pdf" \h Sample Assent Form Debrief and Second Consent Form – For adult subjects (18 years or older) with an element of deception HYPERLINK "https://utulsa.edu/wp-content/uploads/2019/07/Sample-Debrief-and-Second-ICF.pdf" \h Sample Debrief & Second ICF HYPERLINK "https://utulsa.edu/wp-content/uploads/2019/01/TU-IRB-Broad-Consent-v1.14.2019.docx" Broad Consent Form – It is an optional alternative to the informed consent requirements and ONLY used to store, maintain, and/or use identifiable private information or identifiable bio-specimens for secondary research use (where the identifiable data was collected from either a research study other than the proposed future research or from a non-research purpose). GENERAL INSTRUCTIONS FOR USING CONSENT FORMS Follow the blue, italicized and/or bracketed [ ] instructions after the title headings of each section on all consent/assent forms. ONLY delete: the blue, italicized and/or bracketed [ ] instructions at the top of each section OR when you’ve been given a choice of statements to use in a section and then delete the rest. Most black text is REQUIRED language and needs to remain in that section. You can delete entire sections of the Informed Consent Form ONLY WHEN instructions explicitly state that you may delete the section, if not applicable to your study: *[This section can be deleted if not applicable to your study] Write in clear and concise simple language and keep forms as short as possible. Tailor the language to your participants’ needs, using simple words that your potential participants will understand. If your prospective subjects are the general adult public, use language/vocabulary not above 8th grade reading level. Write in the 2nd person as if they are standing right in front of you and you are answering their questions (“you” are being asked to…“your” responses…) The last page of this form has Additional Consent Requests to copy and paste over to your consent form whenever applicable. Examples of research activities that require an additional signature approval include: audio or visual recordings for research purposes or for public use, future contact of participants, etc. If you are paying human subjects any

FAQs

如何选择适合本研究的知情同意书(ICF)版本？

根据研究对象特征（成人、线上研究、父母/监护人或LAR、未成年/认知障碍成人等）选择对应的ICF类型；每种表单在说明中均给出适用情形与样本链接。

填写同意/附同意表模板时，哪些内容可以删除？

仅可删除每个章节标题后方括号或蓝色/斜体指引中明确允许删除的部分；若未明确说明可删除，章节中的大段黑色规定文字需要保留。

在什么情况下需要增加知情同意书的附加要素（Additional Elements of Informed Consent）？

当本研究适用说明所列的附加同意要素清单时，需要在同意书中加入“Additional Elements of Informed Consent”标题，并按要求提供对应信息。

若向人体受试者支付超过25美元的报酬，需要注意什么？

若通过支票/现金或礼品卡支付金额超过25美元，TU Controller’s Office要求提供必要识别信息以便发放或追踪；此时同意书的保密(Confidentiality)部分必须告知参与者将被要求提供姓名、地址和社会安全号码以获得补偿。

Sep 1, 2026

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