Institutional Review Board Issues for Classroom Research

Sharon McWhorter IRB Administrator, The University of Akron

(With assistance from Phil Allen, IRB Chair)

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 obtainsdata through the intervention or

interaction with the individual identifiable private information

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)

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 projectsat your institution

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

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.

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

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