院校检讨委员会

聘委会的三个主要关注事项是:

• whether legally informed consent is obtained from research participants;
• whether the benefits of the research outweigh the risks to the participant; and
• 参与者是否被欺骗.

The principles governing the IRB are primarily derived from the following sources:

• 院校检讨委员会服务
• National Institute of Health’s Regulations and Ethical Guidelines
• 美国卫生部 and 人类服务s’ Office for Human 研究 Protections (OHRP)
• National Cancer Institute’s Protecting Participants in Clinical Trials

The IRB assesses the ethical aspects of human subjects research proposed by its students, 教师, 和工作人员.  更具体地说, the IRB ensures that the benefits of the research outweigh the risks to the participants in that research, that the participants are in no way deceived during the research process, and that participants indicate their informed consent to such research by signing (and/or having a parent or legal guardian sign) a suitable consent form.

IRB结构

The IRB is composed of at least four “core” members taken from several of the academic divisions of the College. The IRB Chair must have served at least two years as a core member. Core positions are held by individuals who are involved in research or have firsthand knowledge of human subjects research.

A member’s knowledge of such research is defined as having an understanding of procedural issues involved in human subjects research or having experience adjudicating human subject applications. At least one additional member must be from a discipline not typically involved in human subjects research (e.g. fine arts, literature, mathematics, physics, etc.). At least one member of the Board must be from the local community. Additional members are selected to maintain a minimum of eight (8) board members.

The Chair and core members of the Board are selected by the Provost. The other members are selected by the IRB  Chair in consultation with the Provost.

IRB培训

Investigators new to human subjects research are encouraged to go over the training modules available at the following websites.

• 美国卫生部 & 人类服务
• Collaborative Institutional Training Initiative

Before submitting 文档 to the IRB for review, obtain a certificate of completion of the “调查人员的责任 & “知情同意”培训.

IRB审查程序

Title 45 Part 46 of the HHS Policy for Protection of Human 研究 Subjects outlines the IRB procedures for review of research. 使用以上作为指导方针, the YHC IRB has established three levels of review 免除, 快速和全面的审查.

1. 免除

研究 dealing with the following are exempt from IRB review. Nevertheless, investigators do need to submit the “Application for 免除 Status” form. The final decision that a certain research is exempt rests on the IRB.
a. 研究 on regular and special instructional strategies or research on the effectiveness of or the comparison among instructional techniques, 课程, 或者课堂管理方法.
b. 研究 involving the use of educational tests (cognitive, 诊断, 资质, 成就), 自愿调查程序, voluntary interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human participants can be identified, directly or through identifiers linked to the participant; and (ii) any disclosure of the human participants’ responses outside the research could reasonably place the participants at risk of criminal or civil liability or be damaging to the participants’ financial standing, 就业能力, 或声誉.
c. 研究 involving the use of educational tests (cognitive, 诊断, 资质. 成就), 调查程序, interview procedures or observation of public behavior that is not exempt under (2) above if: (1) the human participants are elected or appointed public officials or candidates for public office; or (ii) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
d. 研究 involving the collection or study of existing data, 文档, 记录, 病理标本, 或者诊断标本, if these sources are publicly available or if the information is recorded by the investigator in a manner that participants cannot be identified, directly or through identifiers linked to the participants.
e. 研究 and demonstration projects which are conducted by or subject to the approval of State or Federal Department or Agency heads, 它们是用来研究的, 评估, or otherwise examine: (1) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs, (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
f. Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency, or the Food Safety and Inspection Service of the U.S. 农业部.

The IRB chair will notify the principal investigator about the outcome of the exempt application which would be either:

• 豁免“按提交”
• 修改后豁免
• Not exempt- a non-exempt application must be submitted

The IRB chair will notify the PI about the necessary changes.

2. 加快

If an application fails to qualify as exempt, the PI needs to seek IRB approval using the non-exempt application form. The research may qualify for expedited review if
a. Minor changes in previously approved research during the period (of one year or less) for which approval is authorized.
b. 收集:头发和指甲剪报, in a nondisfiguring manner; deciduous teeth; and permanent teeth if patient care indicated need for extraction.
c. Collection of excreta and external secretions including sweat, uncannulated唾液, 分娩时取出胎盘, and amniotic fluid at the time of rupture of the membrane prior to or during labor.
d. Recording of data from participants 18 years of age or older using noninvasive procedures routinely employed in clinical practice. 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 (e.g.， x射线，微波).
e. 静脉穿刺采集血液样本, in amounts not exceeding 450 ml in an eight-week period and no more often than two times per week, from participants 18 years of age or older and who are in good health and not pregnant.
f. Collection of both supra- and subgingival plaque and calculus, provided the procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques.
g. 健康志愿者适度运动
h. The study of existing data, 文档, 记录, 病理标本, 或者诊断标本.
i. 研究 on individual or group behavior or characteristics of individuals, 比如对知觉的研究, 认知, 博弈理论, 或者测试开发, where the investigator does not manipulate participants’ behavior and the research will not involve stress to participants.
j. 研究 on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required.
就像豁免案例一样, the expedited application may be approved as submitted, approved with changes or may be considered for full review. The IRB chair will notify the PI of the results of the expedited application and the next course of action.

3. 完整的检查

If the application fails or does not qualify for the expedited review, it will be considered for full review by the IRB committee. 在众多的ion will be considered at the following IRB meeting, unless the next meeting is within a week of the receipt of the application. If it is the latter case, the application would be considered at the meeting after the next. 在众多的i提交的文件可以被批准, 经过修改或者在极端情况下, may be denied by the IRB if it fails to meet the standards of ethical research.

Policy Regarding Appeals and Non-Compliance

In situations where an application has been denied by the IRB on the ground that it fails to meet the ethical standards of research, the PI could reappeal to the IRB regarding such a decision. Such requests should be made in writing to the IRB chair with two weeks of the IRB decision. The request should justify why the PI thinks that such a decision is necessary and may supply additional 文档. The IRB would deliberate on the issue at its next meeting. The PI may be asked to be present at this meeting to clarify any issues.

The IRB reserves the right to monitor research by YHC 教师, staff and students. If there is a report of non-compliance or if the committee has sufficient reasons to believe that a certain research is being carried out without the proper ethical guidelines the following would occur.

• The IRB would intervene and try to resolve the issue such that it follows the guidelines established by the IRB for ethical research.
• 如果以上失败, the matter would be reported to the academic advisor, chief of staff or dean of 教师 for students, 教职员工.