IRB：常见问题

我如何决定是否需要提交IRB协议？
所有 研究 involving 人类参与者 should be approved by the IRB prior to data collection; however, there are many data-collection or data-analysis activities that 做 不 meet the criteria for 研究 or 人类参与者. Check the Definitions page to determine whether your proposed activity fits the criteria.

我想在课堂上收集数据来判断一种教学方法是否有效。 这需要IRB审查吗？
Data that are collected for quality-control or quality evaluation reasons 做 不 qualify as 研究. Instructors are permitted to engage in activities within the classroom that they believe will promote learning, and are permitted to measure the outcomes or effects of these activities without IRB review. However, an instructor 可能 subsequently want to describe these activities or outcome data in a professional presentation or publication--at which point the measures become part of 研究 rather than 指令, and thus 做 require IRB review and approval.

I want my students to conduct demonstration 研究 projects so they can learn about 研究 methods or statistics. 这需要IRB审查吗？
Classroom demonstration projects for the purpose of 指令 and learning 做 不 require IRB review or approval. However, if those projects produce data that may contribute to generalizable knowledge (e.g., get submitted for presentation or publication), the study qualifies as 研究 and require IRB review and approval.

我在上面读到课程项目不需要IRB审查。 What qualifies as a “class project”?
Individual or group 类项目 are designed for 指令al purposes only. The primary purpose is 不 to answer some 研究 question, but rather is to develop one or more particular 研究 skills. For instance, a sociology professor 可能 require you to ask five friends to answer some questions so you can learn how to interview a focus group. A statistics professor 可能 get you to ask friends some questions so that your class has some data to analyze as you learn the statistical procedures. These types of pedagogical activities are 不 designed to produce generalized knowledge about a 研究 question. 它们不需要IRB审查； however, in assigning and supervising these 类项目, the instructor accepts additional responsibilities for ensuring that (a) no potential participant feels coerced; (b) confidentiality and privacy are ensured; (c)参与者的风险最小； and (d) potential participants are fully informed about the purpose of the activity so that they can consent. If the instructor is unwilling or unable to ensure these protections of 人类参与者 in class projects—or is unsure about whether the activity constitutes a class project—the instructor should consult the IRB by emailing irb@covenant.edu 在活动开始之前.

我的毕业论文算是一个课程项目吗？ 是否需要IRB审查？
Most Capstone projects 做 不 involve interaction with 人类参与者, and so they 做 不 require IRB review. Other Capstone projects for which the data are archival, historical, or public 做 不 typically require IRB review: The data were originally collected from 人, but you will 不 be interacting with those 人 in any way. Capstone projects that 做 involve interaction with 人类参与者 but that are considered oral histories, single-case studies, or biographies typically 做 不 require IRB approval. They are about the individual 人, rather than using information from the 人 to learn generally about a group of 人. It is still required, of course, to treat these individuals in ethical ways, reflecting respect for 人, beneficence, and justice. If you are unclear about how to 做 this, consult the IRB 之前 beginning your interviews.

Capstone projects that involve collection of data from even a small sample of 人 for purposes of generalizable knowledge—so as to ascertain the answer to some 研究 question in a way that 可能 generalize beyond the sample—almost always 做 require IRB review and approval. Even if you 做 不 plan to publish or report your findings publically or professionally, the inclusion of the results from human-participants’ data in a Capstone is itself considered archival, and is sufficient to require IRB approval. If you are testing a small group of participants (e.g., international students) in hopes of learning something about international students’ perceptions and experiences of campus life, this is potentially generalizable knowledge and thus 研究 by the Common-Rule definition, which would require IRB approval 之前 you begin. If you are unclear about whether your Capstone project requires IRB review, consult the IRB 之前 beginning your study.

For my capstone project, I want to interview faculty members to write about their experiences integrating faith and scholarship. 这需要IRB审查吗？
口述历史和新闻活动不需要IRB审查或批准。 They are about individual 人 or events and are 不 intended to be generalized to other 人 or events. However, case studies, focus groups, and interviews with individuals on attitudes, opinions, or behaviors that are intended to generalize to other 人 做 meet the criteria for 研究 and 做 require IRB review and approval.

我有一个经过批准的研究方案。 我如何增加一些学生作为研究助理？
研究小组成员应在原始研究方案申请表上列出。 Changes to the 研究 team, including new investigators (faculty, staff or student) or removal of members of the 研究 team (e.g., students who graduate) should be submitted by email to irb@covenant.edu, together with 做cumentation of appropriate CITI training for each new member of the 研究 team. Submit a revised Informed Consent form if the personnel amendment alters the approved form. The IRB 必须 review and approve personnel changes 之前 those personnel can begin working on the study.

我有一个经过批准的研究方案，但我想做一些修改。 How 做 I amend my protocol?
Your approved protocol is your contract with the IRB: You have indicated exactly what you will 做, and the IRB has approved only the procedures you described. In most cases, it is easy to get approval for changes in the procedure, unless those changes alter the risk to participants; however, you 必须 get IRB approval 之前 deviating from the approved protocol. To submit a protocol amendment, edit the approved Research Protocol Application, highlighting in some way all changes, or append a statement describing the proposed changes (e.g., increasing participant numbers, changing recruitment procedures or populations, altering 研究 procedures). Submit the amendment request to irb@covenant.edu.

My 研究 appears to qualify as 免除, so can I begin the study without IRB review?
所有 activities that meet the definition of 研究 with 人类参与者 requires IRB review and approval 之前 the study can begin. 免除 做 不 mean “做 不 require review” but rather “免除 from annual review after approval.” The IRB determines whether a protocol meets the criteria for 免除 versus expedited versus full-board review.

是否所有的研究都要求参与者签署知情同意书？
Participants should typically be informed of study details and should consent to be included in the study, but this 做 不 necessitate a signed consent form. Indeed, investigators can request a 放弃同意文件 if the study meets specific criteria (see IRB Application Procedures page). Online surveys may use “click here if you consent to participate” and phone interviews may involve verbal consent, for example; a 放弃同意文件 is required anytime participants will 不 physically sign a paper consent form. In rare cases, 研究 may necessitate a request for 放弃同意或更改同意 (see IRB Application Procedures page for more information).

焦点小组有特殊的规则吗？
When participants are tested in a group, the consent form needs to state that the 研究 team can不 ensure confidentiality of responses. Although focus-group members should be encouraged to treat discussions as confidential, the investigators can only guarantee their own compliance with this requirement.

什么是“第三方信息”？
Suppose a 研究er interviewed students about their classroom experience, and the students reported information about Dr. Prof’s behavior. Unless Dr. Prof has consented to be included in the study, this would be considered third-party information and can不 be used in the 研究. Similar instances would include when family members are asked to report on a focal individual’s attitudes or actions without that person’s knowledge or consent, or athletes asked about the recruitment actions of a specific coach. If the information is private and individually identifiable, then the third party is considered a human subject. The investigators 必须 either redact that information from the data, inform and consent the third party, or request and receive a waiver of consent.

Can a student submit a 研究 protocol as principal investigator without a faculty PI?
No, all 威尼斯人平台 研究 proposals 必须 include at least one faculty or staff member who accepts responsibility for supervising the student investigator(s).

什么是“不良事件”？如果发生了，我该怎么办？
In preparing the Research Protocol Application, investigators 必须 describe the risks of participation. An adverse event is any unexpected occurrence during the course of an approved 研究 protocol that either causes physical or psychological harm, or increases the risk of physical or psychological harm, or results in a loss of privacy and/or confidentiality to a 研究 participant or others (such as family members). Examples of adverse events include, but are 不 limited to: a participant in study becomes nauseous or experiences an injury; a member of the 研究 team loses a USB drive that contains identifiable project data; a participant experiences unexpected psychological distress (e.g., begins to cry) when describing an incident; a 研究er accidentally discloses in conversation that a mutual acquaintance visited the lab to participate in a study. 不良事件必须立即报告给IRB通过 irb@covenant.edu . 内部审查委员会将调查并确定纠正措施。

What 做 it mean when the protocol application says I need to justify my 研究 population (e.g., if you are testing a vulnerable population) and my sample size (i.e., expected number of 人 you will test)?
“证明”不仅仅意味着解释或描述； rather, you need to state how you know that your population or sample is the appropriate one. For instance, how did you estimate the number of participants that you will need for the study? How 做 you know that number is adequate to achieve the goals and scientific/societal benefits you have described? How 做 you know that it isn’t too many participants—more than you need to achieve the objectives of the project, so that you are multiplying the (even minimal) risk unnecessarily. You 可能 justify your sample size on the basis of personal experience with studies of similar designs, on published work by others who used similar 研究 designs, on the basis of disciplinary convention, using power analysis or a similar statistical procedure, or in other ways. Note that convenience (e.g., “I propose to test 30 participants, because there are 30 students in the class”) or practical considerations may be important, but they typically are inadequate as justifications. Similarly, if your 研究 proposes to test children, prisoners, pregnant women, individuals with diminished decision-making or mental capacities, or individuals who are vulnerable for reasons of economic or educational disadvantage), you 必须 justify why this specific population is appropriate for the study and what additional protections will be provided.

Can 研究ers who are 不 Covenant employees or students collect data at Covenant College?
是的，在极少数情况下。 See the 威尼斯人平台调查-守门人政策 for more details.

What if I have concerns about whether a 研究er is engaged in unapproved 研究, or is appropriately following approved 研究 procedures?
Questions, concerns, or reports of suspected noncompliance should be reported to irb@covenant.edu or directly to a member of the IRB. This information can be submitted anonymously, but all such reports 必须 be submitted in writing. The IRB will investigate suspected noncompliance and will determine whether corrective action is required.