1. Institutional Review Board Issues for Classroom Research Sharon McWhorter IRB Administrator, The University of Akron (With assistance from Phil Allen, IRB Chair)

2. Definitions Research: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalized knowledge Human Subject: A living individual about whom an investigator conducting research obtains  data through the intervention or interaction with the individual  identifiable private information

3. Why does the IRB exist? … to protect the rights and welfare of persons recruited for participation in research … to advance an organizational culture and infrastructure that supports the highest ethical standards in research with human participants … to ensure compliance with federal regulations under Department of Health & Human Services Regulations (45 CFR 46)

4. IRB Penalties Loss of Federal Funds if found to be in violation of federal guidelines  This includes federal financial aid funding! Shut –down of research projects at your institution

5. Levels of Review Convened meeting of the full IRB  Greater than minimal risk  Vulnerable population (e.g., prisoners)  Sensitive issues (e.g., substance abuse) Expedited  No more than minimal risk & for minor changes in approved protocol  Meets one of expedited categories Exempt  No more than minimal risk (anonymous)  Meets one of exemption categories

6. Criteria for IRB Approval Risks to subjects are minimized. Risks are reasonable in relation to benefits. Selection of subjects is equitable. Informed consent obtained and documented. Subjects’ safety is monitored, if appropriate. Privacy and confidentiality of subjects is maintained. Additional safeguards are included for vulnerable populations.

7. Key Documents Belmont Report – Ethical Principals and Guidelines Title 45, Code of Federal Regulations, Part 46 (45 CFR 46) – Department of Health & Human Services FDA Standards – for clinical trials

8. Consent Issues Student records are protected under FERPA  For ‘proactive” studies, obtain consent from students to access their data for the specific research purposes. List all information that will be required (GPA, other grades, high- school class standing)  For “retroactive” situations, use a “link-list” in which the identity of student is protected but the data from the class and the data needed from the Registrar can be linked  There are variations among IRBs and institutions concerning how this is done—consult with your local IRB for specifics