What is the IRB Short Answer the Institutional

What is the IRB? Short Answer: the Institutional Review Board

What is the IRB? Long Answer: a committee whose purpose is to protect the rights and welfare of human subjects in research, in particular by considering the ethical implications of proposed research projects and experiments. The IRB is composed of faculty members from various disciplines, as well a member external to the university.

What is the governing principle behind our approach to research? From Dr. Henry Beecher’s “Ethics of Clinical Research, ” 1966: “A particularly pernicious myth is the one that depends on the view that ends justify means. A study is ethical or not at its inception. ”

What are the main questions an IRB asks of an application? Is the research based on voluntary consent? Is the research based on informed consent? Does the research involve deception? Does the research involve vulnerable populations? Will the research subjects be paid? Are there mechanisms to ensure the anonymity of the research subjects? • Will the research provide a clear benefit? • Does the research contain the potential to enact harm on the participants? • • •

The Belmont Principles • Respect for persons (recognizes a person’s right to protection, autonomy, privacy) • Beneficence (not just “do no harm, ” but more like “do unto others…”) • Justice (research does not systematically include or exclude a particular population)

Let’s get practical—who should apply? All research connected with members of the Park University community must be reviewed and approved by the IRB. The Park University IRB defines "research" as a systematic investigation— including research development, testing and evaluation—involving a living individual about whom you obtain: • data through intervention or interaction, INCLUDING surveys and interviews, and/or • identifiable private information in a form associable with that individual.

Can you say that again? Yes, I’d love to. Here’s another way to think of it: If you are a member of the Park University community and intend to conduct research that involves human participants, either on campus or elsewhere, you must have your research plans reviewed and approved by the IRB prior to the initiation of your project. Researchers who are not affiliated with Park University who intend to conduct research involving members of the Park University community as participants are also required to secure Park University IRB approval prior to beginning their research.

An interesting wrinkle: what about observation? Observation—that is, a project that involves watching people, but not interacting with them —is exempt if the observer focuses on public behavior.

Great—so that means I can observe people anywhere that’s technically public, right? • Not really. The Park IRB uses this circumscribed definition of public behavior: Public behavior is behavior occurring without the intervention of the researcher, and which the individual could reasonably expect to be observed. Observation of reactions to "staged" events and of behavior occurring in private settings (e. g. , at home, in a bathroom stall) or in settings in which individuals have reasonable expectations of a limited audience (e. g. , classrooms, meetings of identified groups) is not exempt. Adapted from US Department of Health and Human Services Code of Federal Regulations, 45 CFR 46. 101(b)(2)

We don’t have a medical school. So how often does institutional research using human subjects come up? We process about 100 applications a year, in areas like • • Psychology Criminal Justice Education Sociology Legal Studies Athletic Training Business And even Spanish, History, Design

How do I apply? To go to the IRB page under My. Park, click on “Resources, ” and then the “Institutional Review Board” link. Select “IRB application” on left tool bar and complete the application. Please review “Forms” including the Informed Consent Checklist. Questions? Contact IRBchair@park. edu

Is it really that easy? Well, usually. In addition to the application, you’ll need an informed consent form. And in some instances, the form will direct you to fill out other supplementary forms. This will happen if • Your research is funded • Your project involves international research • You’re seeking a waiver of informed consent • You intend to seek the assent of a child

What happens then? Scenario One The Chair will read the IRB application and he/she may decide that it’s EXEMPT. This happens if the project • Involves normal educational practices, like classroom management surveys, comparisons on instructional technique, etc. • The research involves the collection and study of existing data • The research involves basic “taste-testing” style surveys of products approved by the FDA • The research is sponsored by governing agencies, and involves basic survey practices

What happens then? Scenario Two The Chair may read your application and decide it should be EXPEDITED. This means one member of the IRB will review your application and make a determination on behalf of the board. These reviews occur when • The research presents no more than minimal risk to the subjects • The collection of data is routine, standard, and non-invasive • The research continues the research of a project that has already been approved • The research involves individual or group characteristics or behavior • The research does not involve any of the elements of Full Board Review research

What happens then? Scenario Three The Chair or another member may read the application and decide that a Full Board Review is required. This occurs when the research project • Involves vulnerable populations (children, prisoners, the mentally handicapped, etc. ) • Involves payment to subjects • Involves more than minimal risk to subjects • Does not meet the criteria for exempt or expedited review

Outcomes In Scenario One, you will get a letter from the IRB stating that your research is exempt; you will carry on with your research outside the oversight of the IRB. In Scenarios Two and Three, you will get a letter from the IRB stating whether your research project has been approved or disapproved. If it has been approved, you may proceed with your project. If it has been disapproved, you will receive detailed information as to why that happened, and you will be able to reapply as soon as you have corrected the necessary elements.

And that’s it (pretty much). Questions? Feel free to e-mail the IRB Chair at irbchair@park. edu