IRB：申请程序和说明

研究生 : Step 1 is to identify a faculty or staff director or collaborator, as all student projects must be supervised by a faculty or staff PI. 一起填写下面的表格。

协议的应用程序 : The IRB is accountable to federal policy to evaluate human-participants research using the criteria of beneficence, justice, 和 respect for persons. To facilitate this evaluation, investigators are required to complete, submit, 和 receive approval for a Research 协议的应用程序 prior to initiating any data collection. The Research 协议的应用程序 is a fillable form that requests key information required for IRB review. In the majority of cases in which a protocol is returned for revision, the problem is that incomplete or inconsistent information has been provided. Thus, investigators are encouraged to describe the research protocol in sufficient detail so the IRB can evaluate

• 招募参加者（司法）

• 激励或潜在的强迫参与（尊重人）

• 获得知情同意参与的程序（尊重）

• 保障保密及私隐的措施（尊重）

• 参与者将被要求做什么（慈善）

• 参与的风险和收益（慈善）

• 让受试者明白参与是自愿的（尊重）

The information 和 justification required for approval is increased for protocols that involve vulnerable populations (children, prisoners, pregnant women), deception, collection of identifiable information (particularly information covered under HIPAA or FERPA), or procedures that involve more than minimal risk.

知情同意 : For almost every study, investigators are required to inform potential participants fully of the procedures that will be expected of them, the time requirements, why they were selected for possible participation 和 how many other people are being recruited, any potential risks 和 benefits, the degree to which their information will remain confidential, the alternatives to participation, the procedures 和 any penalties for discontinuing participation, 和 whom to contact with questions, concerns, or to discuss problems. Only after this information is presented to potential participants 在适当的阅读水平上 can a participant consent to be tested.

同意书范本提供了所需的信息。 Investigators are encouraged to adapt this model consent document for their purposes.

Note that the requirement that each participant provide informed consent does 不 mean that each participant must physically sign a consent form. If the research involves minimal risk 和 the greatest threat to confidentiality is the participant’s name on a consent form, for instance, investigators can request 放弃同意文件 (i.e., informed consent is still required, but no physically signed consent form will be collected).

要求放弃同意文件的准则:

• The signature on the informed consent document would be the only record linking the subject to the research 和 the principal risk of harm to the subject would be a breach of confidentiality. For example, for research on sensitive topics, such as domestic violence or illegal activities; 或

• The research presents no more than minimal risk of harm to subjects 和 involves no procedures for which written consent is normally required outside the research context. For example, minimal risk research that involves surveys/interviews conducted via telephone or online; 或

• Where the participants are members of a cultural group in which signing forms is not a normal/acceptable practice.

要求放弃或更改同意的准则:

• 这项研究对受试者的风险不超过最低限度；

• 在没有豁免或更改的情况下，研究无法实际进行；

• 放弃或变更不会对标的的权利和福利产生不利影响； 和,

• Where appropriate, the subjects will be provided with additional information about their participation. Note: The intent of this waiver criterion is to require debriefing for participants in deception research

• If the research involves identifiable private information or identifiable biospecimens, this research could not be carried out practicably without using the information/specimen in an identifiable form.

For research with children (people under the age of 18) or individuals with diminished intellectual capacity, assent from the participant 和 informed consent from the parent or guardian is typically required.

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