知情同意指引

All protocols submitted to the IRB must utilize an appropriate (and approved) recruitment 同意程序与所涉及的风险相一致. 这是责任 of the PI and research staff to ensure that proper informed consent has been obtained 来自所有研究参与者. 必须征得未成年人的同意. 同意形式 are typically much briefer than consent forms, and the language must be appropriate 参与者的年龄.

同意指南:

Unless a waiver of documentation of informed consent is requested (see below), all research projects involving human subjects require a consent form signed by both the 研究者和研究对象.

The human subjects in your project must participate willingly, having been adequately 了解研究情况. 如果你项目中的人类受试者是脆弱的 人口(我.e. prisoners, cognitively impaired individuals, or minors), special 需要保护措施. 请联系IRB办公室了解更多信息.

Except where noted, written informed consent must contain all sections described in 的模板.

放弃同意文件

Under certain circumstances the IRB may waive the need for a signed consent from a 研究参与者. 本同意文件的豁免可在 下列情形:

1. When the research presents no more than minimal risk and involves procedures that do not require written consent when performed outside of a research setting.
2. The consent document is the only record linking the subject with the research.
3. The research can not be carried out without the waiver 的同意 When the principal research risks are those associated with breach of confidentiality.

请注意: The absence of a signed consent document DOES NOT release the researcher from obtaining 受试者同意参加本研究. 参与者应注意 that they are in a research study, who is conducting the study and for what reason, 他们的参与是自愿的. 一种方法是附加一个同意类型 document with the pertinent information (“elements 的同意”), and indicate that 完成调查即表示同意参与. 个人也可以给予 要随身携带的研究信息. 在知情同意的情况下 must be obtained verbally, oral instructions and the script detailing exactly what 会不会对参与者说很重要.

A waiver of documentation 的同意 may be requested by checking the appropriate box in the IRB initial application, and explaining why the request is being made, i.e. which of the above criteria applies, and how subjects will be provided the elements 的同意.

Protocols granted a waiver of documentation of informed consent must employ an information 登记受试者时填写. 所有资料表应包括以下内容:

1. 调查人员姓名及所属组织.
2. A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental.
3. A clear of any reasonably for-seeable discomforts or risks which the subject might 参与项目期间的偶遇.
4. A clear description of any benefits to the subject or to which may reasonably be expected 从研究来看.
5. A statement describing how confidentiality or records identifying the subject will 保持.
6. A statement that participation is voluntary, that refusal to participate involves no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may withdraw or discontinue participation at any time without penalty 或丧失当事人有权享有的利益. 这应该包括告知 the participant of what will be done with the data that has already been collected 停止参与后.
7. An explanation of whom to contact for answers pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related 对主体的伤害. 调查人员必须提供他们的姓名，电话号码，和 email address where they can be contacted for information about the study. Dr. Melany Puglisi， IRB主席，irb@csu.Edu，必须列为参与者的联系人 has questions or concerns about their rights or treatment as a research subject.
8. An information sheet does NOT include space for a research subject to sign their name. Rather, a statement should be included that states (or along the lines of) "By completing and returning the attached survey you are giving your voluntary consent to participate 在研究." All information sheets used to enroll subjects must be photocopies of stamped and dated information sheet(s) issued by the IRB at the time of a study's 批准.

使用受保护的健康信息和HIPAA隐私规则

Some healthcare data (Protected Health Information or PHI) is protected by the HIPAA 隐私规则.

欲了解更多信息，请访问http://www.美国卫生和公众服务部.gov / ocr /隐私/ hipaa /理解/特殊/研究/索引.html

Any investigator using Protected Health Information must complete the Responsible Conduct of 研究 (RCR) module on Information Privacy and Security - Health Privacy 模块.

样本知情同意模板

Note that these templates all meet the New Common Rule guidelines which went into 地点2019年1月21日.

1. Sample Consent for Adult Participants in an Experimental Study or Survey (.医生)
2. 14-17岁儿童同意书样本(.医生)
3. 7-13岁儿童同意书样本(.医生)
4. 家长许可信样本(.医生)
5. 网上调查同意书样本(.医生)
6. 焦点小组同意书样本(.医生)
7. 访谈同意书样本(.医生)
8. 豁免研究同意书样本(.医生)