IRB常见问题解答

教师常见问题解答, 学生, 工作人员 Conducting Research with Human Participants

The answers below are intended to assist students 和 other first time applicants with the Institutional 审查委员会 (IRB) Request for Review.

1)什么是IRB?

The Birmingham-南部 College Institutional 审查委员会 (365英国上市官网 IRB) was established to safeguard human subjects in research by protecting their rights 和 promoting the ethical 和 responsible treatment of research subjects.

365英国上市官网 IRB policy requires that all research involving human subjects conducted under the auspices of 365英国上市官网 must be reviewed 和 approved by the IRB before the data gathering phase may commence. The 365英国上市官网 IRB upholds 和 applies the ethical 原则 of 贝尔蒙特报告和 operates in compliance with federal law outlined in the 联邦法规第45卷第46部分 (45 CFR 46), in compliance with state laws 和 College policies.

Completion of the appropriate training course at The Collaborative Institutional Training Initiative (CITI) Program 是IRB审查的先决条件. You are encouraged to complete your training immediately. The entire application process will be much easier if you complete the training course before working on the Request for Review.

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 和 Human Services, Code of Federal Regulations 和 the Belmont Report. 研究表明贝尔蒙特报告, "designates an activity designed to test an hypothesis, 允许得出结论, thereby to develop or contribute to generalizable knowledge (expressed, 例如, 在理论, 原则, 关系陈述). Research is usually described in a formal protocol that sets forth an objective 和 a set of procedures designed to reach that objective.《365英国上市官网》(45 CFR 46.102) 研究是指系统的调查, 包括研究开发, 测试与评估, designed to develop or contribute to generalizable knowledge.

Human subjects, sometimes referred to as participants, are 个人生活 about whom an investigator or investigators (whether professional or student) in the course of research obtain: (1) data through intervention or interaction with the individual or (2) identifiable private information.

3) You may be wondering why your research needs to be reviewed. Birmingham-南部 College is committed to the ethical conduct of research 和 has adopted the ethical st和ards of 贝尔蒙特报告. The 原则和 applications found in 贝尔蒙特报告 excerpted below provide context for underst和ing the need for review. The report articulates ethical 原则 to be applied in the human subjects research setting 和 explains in a general way how the 原则 apply.

Guiding Principles 和 Applications from the Belmont Report

原则: 尊重他人. incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, 和第二, that persons with diminished autonomy are entitled to protection. The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge autonomy 和 the requirement to protect those with diminished autonomy.

应用程序: 知情同意. 对人的尊重要求主体, 到他们有能力的程度, be given the opportunity to choose what shall or shall not happen to them. This opportunity is provided when adequate st和ards for informed consent are satisfied.

原则: 善行. Persons are treated in an ethical manner not only by respecting their decisions 和 protecting them from harm, but also by making efforts to secure their well-being. Such treatment falls under the principle of beneficence. The term "beneficence" is often understood to cover acts of kindness or charity that go beyond strict obligation. In this document, beneficence is understood in a stronger sense, as an obligation. Two general rules have been formulated as complementary expressions of beneficent actions in this sense: (1) 不伤害和 (2) maximize possible benefits 和 minimize possible harms.

应用程序: 风险和收益评估. The assessment of risks 和 benefits requires a careful arrayal of relevant data, 包括, 在某些情况下, alternative ways of obtaining the benefits sought in the research. 因此, the assessment presents both an opportunity 和 a responsibility to gather systematic 和 comprehensive information about proposed research. For the investigator, it is a means to examine whether the proposed research is properly designed. 评审委员会, it is a method for determining whether the risks that will be presented to subjects are justified. For prospective subjects, the assessment will assist the determination whether or not to participate. Furthermore, this benefit must outweigh the risks.

原则: 正义要求人们被公平对待. Researchers should not take from research participants without giving back.

应用程序: 科目选择. Just as the principle of respect for persons finds expression in the requirements for consent, the principle of beneficence in risk/benefit assessment, the principle of justice gives rise to moral requirements that there be fair procedures 和 outcomes in the selection of research subjects.

4) What is taken into account in the review process?

的原理和应用贝尔蒙特报告和 45 CFR 46, a wide array of factors is considered by the 365英国上市官网 IRB during a review of proposed research. You will be asked to provide documentation regarding informed consent 和 the selection of subjects. 最重要的因素之一, 仁慈的与仁慈原则有关的, is the design or protocol of the research project. A key factor in the approval/disapproval decision by the 365英国上市官网 IRB is based on weighing the benefits of the research (as defined above) against the risks to participants. 所有的研究项目都会带来一些问题危害风险 to participants so the weight assigned to risk in any review is never zero. 然而, if the design of the research project is flawed then hypotheses cannot be tested, research questions cannot be answered 和 no contribution to generalizable knowledge is possible. The benefit side of the benefit to reward ratio is given a weight of zero. 在这种情况下, 尽管对实验对象的风险很小, 提议的研究不会被批准.

它是重要的那项研究建议提交审查 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, that risks to subjects are clearly identified 和 addressed.

研究对象的情况如何?

Different rules apply to research with the general population versus research that may involve 弱势群体包括 children, pregnant women, prisoners 和 the cognitively impaired. 联系 IRB的椅子 if your research involves a vulnerable population.

6)有哪些不同层次的复习?

审查的级别是免除, 加快, 完整的.

1级:

免除审查

Certain research projects may be 免除 from review. An experienced member of the IRB will conduct a review of the Request for 免除审查和 determine if the proposed research qualifies. There are two criteria the proposed research must satisfy in order to qualify for review via 免除 procedures.

研究不得超过 最小的风险 of harm defined as of the probability 和 magnitude of physical or psychological harm that is normally encountered in daily life, 或者在日常医疗中, 牙科, or psychological examination of healthy persons.

The research must be classified into at least one of the 免除 categories defined by federal regulations 和 listed below.

教育研究

Surveys, 面试s, educational tests, public observations (that do not involve children)

公职人员研究

Analysis of previously-collected, anonymous data

公共利益或服务项目

Consumer acceptance, taste, food quality studies

If you believe your research satisfies one of the 免除 categories above, you may submit a request for 免除ion by completing the appropriate form. The IRB will review requests for 免除ion 和 decide if 免除ion is warranted. If 免除ion is not granted, it will be necessary to apply for 加快 or 完整的 review.

2级:

加快审查

Expedited review as defined by federal regulations allows the IRB chairperson (or an experienced member or a subcommittee of the IRB designated by the chairperson) to evaluate 和 approve specific types of research. Reviewers conducting an 加快 review may exercise all of the authority of the IRB except that they may not disapprove a study. When a board member or subcommittee cannot approve the research under 加快 review, the study is referred to the 完整的 Committee for review.

In order to qualify for review via 加快 procedures two criteria must be met: (1) 研究不得超过最小的风险 to participants; 和 (2) it must fall into at least one of the 加快 categories defined by the federal regulations. An 加快 review procedure is not applicable for research projects where identification of the subjects 和/or their responses is reasonably construed to place them at risk of criminal or civil liability or be damaging to the subjects financial st和ing, 就业能力, 可保险性, 声誉, 或者被污名化, unless reasonable 和 appropriate protections will be implemented so that risks related to invasion of privacy 和 breach of confidentiality are no greater than 最小的风险.

联邦政府定义的加急类别:

Clinical studies of drugs 和 medical devices only when certain conditions are met

用手指棒采集血样, 跟贴, 耳朵贴, or venipuncture in certain populations 和 within certain amounts

Prospective collection of biological specimens for research purposes by noninvasive means

Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves.

涉及材料(数据)的研究, 文档, 记录, (或标本)已收集, 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, 面试, 口述历史, 焦点小组, 项目评估, 人为因素评价, 或者质量保证方法

Continuing review of research previously approved by the 365英国上市官网 IRB

3级:

全体委员会审查

Proposed human subject research which does not fall into either the 免除 or 加快 review categories must be submitted for 完整的 committee review. Submission deadlines 和 meeting dates for the IRB are posted on the Schedule of Meetings page.