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加快加快 reviews are used for research presenting minimal risk to non-vulnerable participants or less-than-minimal risk to vulnerable participants.
加快 reviews are used for research presenting minimal risk to non-vulnerable participants or less-than-minimal risk to vulnerable participants.
加快 reviews do not require a convened meeting of the IRB. The director or chair of the IRB chooses a limited number of board members to review the protocol. The IRB members receive the protocol and return their comments to the director, who notifies the principal investigator of the results of the review. Note: 加快 reviewers 不能 disapprove a protocol; it would then be referred to a full-board meeting of the IRB.
Research involving no more than minimal risk and in which the involvement of (non-vulnerable) participants is in one or more of the following categories may be reviewed through the 加快 review procedure:
1. Studies requiring the collection of biological materials: hair and nail clippings, in a non-disfiguring manner; deciduous teeth; permanent teeth if patient care indicates a need for extraction; excreta and external secretions including sweat and uncannulated saliva; blood samples by venipuncture, in amounts not exceeding 450 milliliters in an eight-week period and two or less times per week, from participants 19 years of age or older and who are in good health and not pregnant.
2. Recording of data from participants 19 years of age or older using noninvasive procedures routinely employed at clinical practice (participants less than 19 years of age may be used with parental consent). This includes the use of physical sensors that are applied either to the surface of the body or at a distance and do not involve input of matter or significant amounts of energy into the participant or an invasion of the participant's privacy. It also includes such procedures as weighing, 感官敏锐度测试, 心电描记法, 脑电描记法, 温度记录, detection of naturally occurring radioactivity, 诊断回波描记术, 和electroretinography. It does not include exposure to electromagnetic radiation outside the visible range (例如, x射线, 微波).
3. Moderate exercise by healthy volunteers. (Use the ASCM's Guidelines for Exercise Testing and Prescription.)
4. Research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required.
5. Voice recordings made for research purposes such as investigations of speech defects.
6. Research that uses videotape or film recordings, such as investigations of husband-wife or parent-child interaction. Studies that involve audio recordings of interviews also fall into this category. (If audio tape recording is to facilitate accurate record keeping and will be erased following transcription, 它可能符合豁免审查的资格)
7. 对现有资料的研究, 文档, 记录, 病理标本, or diagnostic specimens in which the existing data contain the individual’s name or other identifying information. 这一类 不包括 studies of publicly authored 文档, 比如报纸文章, 小说, 艺术作品, or other materials that may be subjected to content analysis.
8. Research on the behavior or characteristics of individuals or groups that may involve minor stress, 不舒服, 或尴尬. 例子包括:
9. Experiments in which participants are deceived about the purpose of the research may be reviewed as 加快 or Full Board. Most research which involves deception 不能 be reviewed as exempt. Note: subjects must be debriefed about the real purpose of the study afterward. 参与者 不能 be deceived about the degree of potential risk or 不舒服 involved in the study.
