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同意/同意检查表使用检查表确保正确提交。
同意/同意检查表
研究者审查非治疗性研究同意/同意表的核对表
a) Required Consent/Assent Forms
_____ 1. Is there an Adult Consent Form (studies involving adults age 19 and
above)?
_____ 2. 是否有家长同意书（涉及未成年人的研究）？
_____ 3. Is there a Guardian Consent Form (studies involving incompetent
subjects)?
_____ 4. 是否有儿童同意书（涉及6-12岁未成年人的研究）？
_____ 5. 是否有青少年同意书（涉及13-18岁未成年人的研究）？
b) Review of Consent form Format and Style
_____ 1. Is the consent form printed on appropriate University of Nebraska at
Kearney
stationery?
_____ 2. Is each element of informed consent identified by the required subheading
in 大胆的类型 (research that is minimal risk or greater)?
_____ 3. 知情同意的要素是否按正确顺序排列？
_____ 4. Does each element contain only content relevant information without
unnecessary repetition.
_____ 5. 同意书是用第二人称写的吗？
_____ 6. 语言是否符合相应的教育水平？
_____ 7. 是否所有复杂的术语都有适当的定义/简化？
c) Review of the Elements of Informed Consent
_____ 1. Is the scientific title of the study the same as the title listed on the IRB
application form?
_____ 2. 同意书是否有IRB标准的参与邀请？
_____ 3. Is the Basis for Subject Selection clearly stated with only major
inclusion/exclusion criteria listed?
_____ 4. Is there a clear statement of the scientific purpose of the research which is
not directed toward the subject?
_____ 5. Are all procedures applied to subjects, including method of subject
assignment, explained clearly and sequentially?
_____ 6. Is the description of Potential Risks and Discomforts complete, adequately
explained and presented using the required format?
_____ 7. 是否充分解释了风险保障？
_____ 8. 对受试者的潜在益处的陈述是否现实/可支持？
_____ 9. 对社会的潜在利益的陈述是否现实/可支持？
_____ 10。 是否有关于参与的其他选择的声明？ (required for
studies involving compensation in the form of academic credit)
_____ 11. Are any economic incentives/rewards for participation clearly stated in the
Financial Compensation section?
_____ 12。 Is the standard In Case of Emergency Contact Procedure statement
present?
(required for more than minimal risk studies)
_____ 13. Is the standard Emergency Care and Compensation in Case of Injury
statement present? (required for more than minimal risk studies)
_____ 14. 保密保证是否清楚和完整？
_____ 15。 Is the standard IRB statement concerning the Rights of Research Subject
present?
_____ 16。 Is the standard IRB Voluntary Participation and Withdrawal statement
present?
_____ 17. Are the correct standard IRB concluding consent statement present for the
subject, investigator and the witness (if required)?
_____ 18。 是否有注明日期的受试者、调查员和证人签名空白？
_____ 19。 Is the name and office phone number of the investigator(s) placed at the
end of the form?
_____ 20。 Is the day/night phone numbers of the investigator(s) present (required
for more than minimal risk studies)?
d) Review of Parental/Guardian Consent Form
_____ 1. 家长/监护人同意书是否以代理同意书形式书写？
e) Review of Youth Assent Forms
_____ 1. Is the language written at the level of the youngest prospective subject
in the youth age range (13-18)?
_____ 2. Is each element of youth assent identified by the correct subheading?
(research that is minimal risk or greater)
_____ 3. 青春同意的要素是否按正确的顺序排列？
_____ 4. Is the required consultation with parents statement included as the second
part of the Invitation to Participate?
f) Review of Child Assent Form
_____ 1. Is the language written at the level of the youngest prospective subject
in the child age range (6-12)?
_____ 2. Are the elements of child assent arranged in the correct sequence and
identified by a number?
_____ 3. Is the required consultation with parents statement included as part of the
Invitation to Participate?
