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Process for Obtaining Informed ConsentThe 同意书 does not by itself constitute 知情同意. 而, the 同意书 should serve as a guide by which the researcher explains 知情同意 with prospective subjects.
The 同意书 does not by itself constitute 知情同意. 而, the 同意书 should serve as a guide by which the researcher explains 知情同意 with prospective subjects.
During the process of 知情同意, all 同意书的内容 should be carefully, patiently, and clearly explained to the prospective subject. 除了, the researcher should frequently assess the prospective subject’s understanding by asking appropriate questions. During the process for enrolling a subject in non-免除 research, the investigator should explain to the subjects their 作为研究参与者的权利. The explanation of a research subject’s rights is considered an adjunct to 知情同意 and demonstrates the commitment of both the researcher and the university to the conduct of human subject research with the highest integrity and skill possible. The IRB encourages researchers to provide their subjects with a written copy of the 研究对象的权利.
The following are general guidelines for writing the 同意书, the required elements that should be included in all 同意书s, and the characteristics of each element based on level of risk with samples.
文具
识别
Style
可读性
长度
格式
辩解的语言
同意书的存放
研究的题目
执行概要
邀请参与
选科依据
研究目的
程序说明
潜在的风险和不适
对研究对象的潜在好处
对社会的潜在利益
保密保证
研究对象的权利
Voluntary Participation and Withdrawal
知情同意文件
调查人员的身份.
豁免同意书 research should include the above elements as necessary.
Consent forms for all non-免除 research must contain these additional elements:
参与的替代方案
金融义务
参与补偿
In Case of Emergency Contact Procedure
Emergency Care and Compensation in Case of Injury.
Characteristics of the Adult Consent Form for 免除 Research
Characteristics of the Adult Consent Form for Non-Therapeutic Research that is Less Than Minimal Risk
Characteristics of the Adult Consent Form that is Minimal Risk
Characteristics of the Adult Consent Form that is Greater than Minimal Risk
Surveys that are completely anonymous do not need separate written 知情同意 because completion of the survey implies consent. 同样的, phone interviews that are anonymous do not need written consent because completing the interview implies consent. However, the information typically given on a 同意书 (例如, 关于数据使用的信息, 保密保证, phone numbers to contact in case of dissatisfaction with treatment by researchers) must be included in the cover letter or opening remarks. 一些 免除 projects may ethically require 知情同意 (written or oral). If, 在研究者看来, 这项研究需要知情同意, the method used to obtain it should be described in the IRB application, and any written 同意书s or scripts to obtain oral consent should be submitted. If the investigator does not believe that an 免除 study requires written 知情同意, it should be stated and justified in the protocol.
研究项目满足 免除 criteria may not require documented written 知情同意. Projects in educational settings that meet all of the 免除 conditions may not require parental consent; however, the investigator and/or school personnel may decide that parental 知情同意 和孩子 同意 应该得到. Groups such as 4-H and other club meetings may be considered as educational settings.
The IRB may waive the requirement of a signed 同意书 if: (a) the research is subject to the approval of state or local government and is designed to study public service programs and the study could not be carried out without the waiver, or (b) the research involves minimal risk, would not adversely affect the rights of the participants, and it could not be carried out without the waiver.
Before submitting your protocol and consent documents to the IRB, be sure to review the 同意/同意检查表.
