IRB TRAINING

WHAT IS IRB?Work with a partner to answer these

questions…

• 1. What does IRB stand for?

• 2. Why is the IRB important?

• 3. What are the steps to have your research project certified by the IRB?

WHAT DOES IRB STAND FOR?

Institutional Review Board

WHY IS THE IRB IMPORTANT?

• Protect the rights and welfare of people involved in research

• Reviews plans for research involving human subjects

• Institutions that accept research funding from the federal government must have an IRB to review all research involving human subjects (even if a given research project does not involve federal funds).

• Federal Law

• Unethical research done on humans such as the Tuskegee Study

WHY DO WE HAVE AN IRB?

• 1. Respect for Persons

• Volunteer, privacy, informed

• 2. Beneficence

• Risks are justified by benefits to individual or society

• 3. Justice

• Equal distribution of risks and benefits

3 PRINCIPALS

• Full Board Review: • The application will be considered by either the Biomedical (if an intervention is involved) or

Social and Behavioral committee• Each committee meets once per month – so this process takes time!• Studies going to Full Board will be those that:

• Focus on vulnerable population groups (children/ prisoners)• Include invasive sample collection• Pose greater than minimal risk to participants

• Expedited Review:• The application will be passed to a single Designated Reviewer, who then makes a

recommendation to the Chair• Studies undergoing Expedited review will be those that:

• Secondary data that contains identifiers• Primary data collection from adults

• Exempt Review:• IRB can determine that an application is exempt from review

• Uses public access secondary data with no identifying information

TYPES OF IRB REVIEW

• Should follow the format and include the sections recommended by the IRB

• Title of project• Principal Investigator• Sponsor’s Name• Introduction/ Purpose• Procedures• Risks• Benefits• Confidentiality• Compensation• Contact Persons

CONSENT FORMS

• http://www.compliance.iastate.edu/irb/

• Fill out Application for Approval

• Website includes

• IRB checklist

• Consent Form Layouts

• Review process information

IRB AT IOWA STATE

IS EVERYBODY IRB CERTIFIED?

SCENARIOS

PROBLEM AREA PARAGRAPH

DUE: TOMORROW

• State the problem you are addressing

• Introduce the problem

• Why it is a problem ?

• Whom is it a problem for?

WHAT TO INCLUDE

Example 1

Example 2

Example 3