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HPU Institutional review board

HPU Institutional review board. Board Members. Dr. Kimberly Wear Chair Department of Psychology Dr . Virginia McDermott School of Communication; Director of Master’s Program in Strategic Communication Dr . Kimberly Reich Department of Exercise Science Dr . Kimberly Titus

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HPU Institutional review board

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  1. HPU Institutional review board

  2. Board Members • Dr. Kimberly Wear Chair Department of Psychology • Dr. Virginia McDermott School of Communication; Director of Master’s Program in Strategic Communication • Dr. Kimberly Reich Department of Exercise Science • Dr. Kimberly Titus Department of Mathematics and Computer Science • Dr. Jane Bowser School of Education; Chair Dept. of Specialized Curriculum and Instructional Technology • High Point community member

  3. Website http://www.highpoint.edu/academics/IRB HPU IRB Policies & Procedures Decision Charts Training Protocol Application Form Protocol Continuing Review/Study Closure Form Informed Consent Examples

  4. Faculty Researchers

  5. How do I know if I need to apply? • Research, as stated in The Belmont Report “designates an activity designed to test a hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationship). • Research is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective.

  6. Teaching Activity vs. Research Activity

  7. How do I apply? • Read • HPU IRB Policies • HPU IRB Procedures • Department Policies & Procedures • Protocol Application Form • Human Research Participants Training • Informed Consent

  8. Is the research eligible for Exemption? Yes if, • The data, documents, records, or specimens already exist and either: • The subjects cannot be identified in the research data or indirectly, and no one can track the subjects' identities, or • The sources of data are publicly available. • For research not involving vulnerable subjects or sensitive topics, the researcher observes public behavior, conducts interviews or surveys, or uses educational tests and either: • subjects cannot be identified directly or indirectly, or • the data could not harm subjects if they were made public, nor, if subjects give information about others, is inadvertent disclosure likely to harm others, or • federal statute completely protects all subjects' confidentiality, or • all respondents are candidates or elected or appointed public officials. • In an educational setting, the research or evaluation concerns normal educational practices. • Taste and food quality studies with safe and wholesome foods.

  9. Is the research eligible for Expedited Review? • Cannot be expedited: • Research submitted to a funding agency (including High Point University) except when the proposal is a minor revision of a previously approved protocol and is still within the year of authorization; • Research involves more than minimal risk; • Subjects can be identified. • May or may not be appropriately expedited: • Research with vulnerable subjects • Research on sensitive topics

  10. Submission Process • Submit protocol application, informed consent, supporting documentation, training certificate(s) to IRB Chair (electronic preferred will need page one with original signatures) • IRB Chair reviews all protocol applications for completeness • If approved at another institution, IRB Chair reviews protocol application • If Exempt, IRB Chair or one member reviews protocol application • If Expedited, two IRB members are assigned to review the protocol application. IRB Chair will summarize reviewer comments/questions and correspond with investigator(s) • If Full Board Review is required, all members of the IRB will review the protocol application and a meeting will be convened

  11. As a Faculty Supervisor, what concerns should I have? • Faculty is responsible party • All persons involved in data collection must have Human Participants Training • Individual protocol applications or umbrella protocol applications

  12. After I receive approval for my research, what else do I do? • One year to the day of approval, a report must be filed with the IRB Chair. • If the study is complete, file a study closure form. • If the study is ongoing, • File a continuing review form. • Make sure you have a current training certificate on file for anyone working on the project. • A status report will be required (publications, etc.) • If the study was approved for more than one year, • File a continuing review form. • Make sure you have a current training certificate on file for anyone working on the project. • A status report will be required (publications, etc.)

  13. Questions? Thank you!

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