HPU INSTITUTIONAL REVIEW BOARD

Board Members• Dr. Kimberly Wear Chair

Department of Psychology

• Dr. Virginia McDermottSchool of Communication; Director of Master’s Program in Strategic Communication

• Dr. Kimberly ReichDepartment of Exercise Science

• Dr. Kimberly TitusDepartment of Mathematics and Computer Science

• Dr. Jane BowserSchool of Education; Chair Dept. of Specialized Curriculum and Instructional Technology

• High Point community member

Website

http://www.highpoint.edu/academics/IRB

HPU IRB Policies & ProceduresDecision Charts

TrainingProtocol Application Form

Protocol Continuing Review/Study Closure FormInformed Consent

Examples

FACULTY RESEARCHERS

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.

Teaching Activity

vs. Research Activity

How do I apply?

• Read • HPU IRB Policies• HPU IRB Procedures• Department Policies & Procedures

• Protocol Application Form

• Human Research Participants Training

• Informed Consent

Is the research eligible for Exemption?Yes if,

1. The data, documents, records, or specimens already exist and either: a) The subjects cannot be identified in the research data or indirectly, and no one can track

the subjects' identities, or b) The sources of data are publicly available.

2. For research not involving vulnerable subjects or sensitive topics, the researcher observes public behavior, conducts interviews or surveys, or uses educational tests and either:

a) subjects cannot be identified directly or indirectly, or b) 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 c) federal statute completely protects all subjects' confidentiality, or d) all respondents are candidates or elected or appointed public officials.

3. In an educational setting, the research or evaluation concerns normal educational practices.

4. Taste and food quality studies with safe and wholesome foods.

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

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

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

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.)

Thank you!

QUESTIONS?