Faculty running or supervising research studies with people should go through the following online trainings provided by the Office of Human Research Protections (OHRP)–the federal agency with oversight on these activities:
Training through these courses is required for the college to maintain compliance. The certificates are good for 3 years–keep them for your records and email a copy to irb@mica.edu.
To maintain our state and federal compliance, the college is required to collect information on–and assess for oversight–all projects that meet the federal definition of Human Subjects Research. Our tool for capturing this data is the IRB PreReview Decision Tree.
Entries in the Decision Tree begin the oversight process and are part of the official record of the project. The amount of oversight needed will be determined by your answers to these questions.
Students doing thesis, capstone, or other independently directed projects with people should have their planned work assessed for oversight. You can prepare your students for this process by helping them develop certain information about their projects within your curriculum. If your students can answer the following questions about their project, they should be ready for submission:
1) Please provide a brief description of your study. What are you looking to assess through this project? What method are you using to assess this?
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Note if you are working with existing data or your method for collecting data.
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If you are partnering with a community organization, government agency, or business please identify them here.
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Identify if working with a high-risk population is essential to your study (eg-the study is only on minors; the study is only on the elderly).
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Additionally, please use this space to identify a co-PI (Principal Investigator) should you have a lead partner on the project.
2) A Human Subject is defined as a living individual about whom an investigator (whether professional or student) is conducting research. Are you doing either of the following?
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Obtaining information through intervention or interaction with the individual, and using, studying, or analyzing that information?
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Obtaining, using, studying, analyzing, or generating identifiable private information?
3) Generalizable Knowledge is knowledge that is expressed in theories, principles, or statements of relationships that can be applied to our experiences.
Activities designed to contribute to generalizable knowledge draw general conclusions, inform policy, or generalize findings beyond a single individual or an internal program.
The information is collected to share with others in a discipline/field and makes a broad statement (conclusion) about a group of people, procedures, programs, etc.
Are any of the following true for your project?
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Intending for the information to inform the theoretical framework of your field or any other established body of knowledge;
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The primary beneficiaries of the study are other researchers, scholars, and practitioners in the field of study;
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Note: This is referring to beyond the "classroom" if the study is for a class.
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The results are intended for publication, presentation, or other distribution to inform the field of study or practice; and/or
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Note: Again, beyond the classroom.
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The results are intended to be replicated in other settings.
These questions reflect some of what students will encounter in the Decision Tree. Depending on their answers, they will be prompted to provide additional information on the specifics of their project. It is important that students answer the questions thoroughly and consistently, as the entry becomes part of the official record of the activity. If you or your students have any questions please reach out to irb@mica.edu.