IRB FAQ
IRB FAQ
Frequently Asked Questions by Faculty, Students, and Staff Conducting Research with Human Participants
以下答案旨在帮助学生和其他首次申请机构审查委员会(IRB)审查请求的申请人.
1) What is the IRB?
伯明翰南方大学机构审查委员会(澳门新葡京官网 IRB)的成立是为了保护研究中的人类受试者，保护他们的权利，促进对研究受试者的道德和负责任的对待.
平衡计分卡伦理委员会政策要求所有在平衡计分卡主持下进行的涉及人类受试者的研究必须在数据收集阶段开始之前由伦理委员会审查和批准. The 澳门新葡京官网 IRB upholds and applies the ethical principles of The Belmont Report and operates in compliance with federal law outlined in the Code of Federal Regulations Title 45 Part 46 (45 CFR 46), in compliance with state laws and College policies.
Completion of the appropriate training course at The Collaborative Institutional Training Initiative (CITI) Program is a prerequisite for IRB review. You are encouraged to complete your training immediately. 如果您在申请审核之前完成培训课程，整个申请过程将会容易得多.
2) How do I know if I should submit an application to the IRB?
The IRB reviews proposals that constitute research, as defined by the U.S. Department of Health and Human Services, Code of Federal Regulations and the Belmont Report. Research, according to The Belmont Report, "designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships). 研究通常以正式的协议来描述，该协议规定了一个目标和一套旨在达到该目标的程序." In the Code of Federal Regulations (45 CFR 46.102) research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Human subjects, sometimes referred to as participants, are living individuals 调查人员(无论是专业人员还是学生)在研究过程中获得的信息: (1)通过干预或与个人互动获得的数据或(2)可识别的私人信息.
3) You may be wondering why your research needs to be reviewed. 伯明翰南方学院致力于研究的道德行为，并已采用的道德标准 The Belmont Report. 下面摘编的贝尔蒙特报告中的原则和应用为理解审查的必要性提供了背景. 该报告阐明了在人类受试者研究环境中应用的伦理原则，并以一般方式解释了这些原则如何适用.
Guiding Principles and Applications from the Belmont Report
Principle: Respect for Persons. incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. 因此，尊重人的原则分为两个独立的道德要求:承认自主权的要求和保护自主权减少的人的要求.
Application: Informed Consent. Respect for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them. This opportunity is provided when adequate standards for informed consent are satisfied.
Principle: Beneficence. 以合乎道德的方式对待人，不仅要尊重他们的决定并保护他们不受伤害, but also by making efforts to secure their well-being. Such treatment falls under the principle of beneficence. “善行”一词通常被理解为涵盖超越严格义务的善意或慈善行为. In this document, beneficence is understood in a stronger sense, as an obligation. 在这个意义上，已经制定了两个一般规则作为慈善行为的补充表达: (1) do not harm and (2) maximize possible benefits and minimize possible harms.
Application: Assessment of Risks and Benefits. The assessment of risks and benefits requires a careful arrayal of relevant data, including, in some cases, alternative ways of obtaining the benefits sought in the research. Thus, 评估既提供了机会，也有责任收集有关拟议研究的系统和全面的信息. 对于研究者来说，这是一种检查所提议的研究是否设计得当的手段. For a review committee, it is a method for determining whether the risks that will be presented to subjects are justified. 对于未来的受试者，评估将有助于决定是否参加. Furthermore, this benefit must outweigh the risks.
Principle: Justice requires that people be treated fairly. Researchers should not take from research participants without giving back.
Application: Selection of Subjects. Just as the principle of respect for persons finds expression in the requirements for consent, and the principle of beneficence in risk/benefit assessment, 公正原则提出了在研究对象的选择中应有公平的程序和结果的道德要求.
4) What is taken into account in the review process?
Based on the principles and applications of The Belmont Report and 45 CFR 46, a wide array of factors is considered by the 澳门新葡京官网 IRB during a review of proposed research. 您将被要求提供有关知情同意和受试者选择的文件. One of the most important factors, related to the principle of beneficence, is the design or protocol of the research project. 平衡计分卡审核委员会批准/不批准决定的一个关键因素是基于权衡研究的利益(如上所述)与参与者的风险. All research projects pose some risk of harm to participants so the weight assigned to risk in any review is never zero. However, if the design of the research project is flawed then hypotheses cannot be tested, research questions cannot be answered and no contribution to generalizable knowledge is possible. The benefit side of the benefit to reward ratio is given a weight of zero. In this circumstance, even though risk to subjects is minimal, the proposed research will not be approved.
It is important that research proposals submitted for review clearly articulate the potential benefits of the research, provide sufficient information regarding the design of the research so that the capacity of the research to provide the benefit is established, and that risks to subjects are clearly identified and addressed.
5) What about the population under study?
Different rules apply to research with the general population versus research that may involve vulnerable populations including children, pregnant women, prisoners and the cognitively impaired. Contact the IRB Chair if your research involves a vulnerable population.
6) What are the different levels of review?
The levels of review are exempt, expedited, and full.
Level 1:
Exempt Review
Certain research projects may be exempt from review. 一位有经验的IRB成员将对豁免审查请求进行审查，并确定拟议的研究是否符合条件. 拟议的研究必须满足两个标准，以便有资格通过豁免程序进行审查.
- The research must not pose greater than minimal risk 定义为日常生活中通常遇到的身体或心理伤害的概率和程度的伤害, or in the routine medical, dental, or psychological examination of healthy persons.
- 研究必须至少属于下列联邦法规规定的豁免类别之一.
- Education research
- Surveys, interviews, educational tests, public observations (that do not involve children)
- Studies of public officials
- Analysis of previously-collected, anonymous data
- Public benefit or service program
- Consumer acceptance, taste, and food quality studies
If you believe your research satisfies one of the exempt categories above, you may submit a request for exemption by completing the appropriate form. The IRB will review requests for exemption and decide if exemption is warranted. If exemption is not granted, it will be necessary to apply for expedited or full review.
Level 2:
Expedited Review
联邦法规定义的快速审查允许IRB主席(或由主席指定的有经验的成员或IRB小组委员会)评估和批准特定类型的研究. 进行快速审查的审查员可以行使IRB的所有权力，但不得否决一项研究. When a board member or subcommittee cannot approve the research under expedited review, the study is referred to the full Committee for review.
In order to qualify for review via expedited procedures two criteria must be met: (1) The research must not pose greater than minimal risk to participants; and (2) it must fall into at least one of the expedited categories defined by the federal regulations. 快速审查程序不适用于研究项目，如果确定受试者和/或他们的回答被合理地解释为使他们面临刑事或民事责任风险或损害受试者的财务状况, employability, insurability, reputation, or be stigmatizing, 除非实施合理和适当的保护措施，使与侵犯隐私和违反保密有关的风险不大于最小风险.
Federally-defined Expedited Categories:
- Clinical studies of drugs and medical devices only when certain conditions are met
- Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture in certain populations and within certain amounts
- Prospective collection of biological specimens for research purposes by noninvasive means
- 通过临床实践中常规使用的无创程序(不涉及全身麻醉或镇静)收集数据, excluding procedures involving x-rays or microwaves.
- Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes
- Collection of data from voice, video, digital, or image recordings made for research purposes
- Research on individual or group characteristics or behavior or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies
- Continuing review of research previously approved by the 澳门新葡京官网 IRB
Level 3:
Full Committee Review
不属于豁免或加速审查类别的拟制人体受试者研究必须提交委员会全面审查. Submission deadlines and meeting dates for the IRB are posted on the Schedule of Meetings page.