Unit 3: IRB Basics

Question 1

Purpose of IRB

Answer 1

1. Safety
2. Confidentiality
3. Risks are commensurate with potential benefits

Question 2

IRB Basics

Answer 2

Each Institution has its own IRB Comprised of 5 members with varied backgrounds in research expertise(1 member must have a nonscientific background, 1 member must not be affiliated with the institution)

Question 3

Level 1: Exempt (from review) (IRB Levels of Review)

Answer 3

• Research involving typical educational practices
• Survey/interview procedures not involving sensitive areas of behavior
• Observations of public behavior
• Data does not contain Protected Health Information

Question 4

Level 2: Expedited (IRB Levels of Review)

Answer 4

• Projects with minimal risk that record minimal to noninvasive data
• Example: effects of moderate exercise in healthy persons

Question 5

Level 3: Full Review (IRB Levels of Review)

Answer 5

• Projects with moderate to high risks

- Lower-risk procedures in children or other vulnerable populations unable to provide consent

Question 6

Researcher Information

Parts of the IRB Application

Answer 6

• Names
• Addresses
• Qualifications

Question 7

Proposed Research Description(Parts of the IRB Application)

Answer 7

• Project Title
• Description (Rationale, background literature review, hypothesis, research design, etc.)
• Step-by-Step Description (frequency, duration & location of each procedure)

Question 8

Type of Review (Parts of the IRB Application)

Answer 8

Checklist to determine what level of review is needed

Question 9

Participants (Parts of the IRB Application)

Answer 9

• Description
• Vulnerable Populations
• Selection of Participants (Inclusion/exclusion criteria, recruitment, type of data collecting, etc.)

Question 10

Consent (Parts of the IRB Application)

Answer 10

Process and document

Question 11

Benefits/Risks (Parts of the IRB Application)

Answer 11

Description and explanation of reasonable expectations of the study

Question 12

Parts of the IRB Application

Answer 12

• Researcher Information
• Proposed Research Description
• Type of Review
• Participants
• Consent
• Protected Health Information Checklist
• Benefits/Risks
• Training Certificate and Signatures

Question 13

Consent Documents (IRB Supporting Documents)

Answer 13

• Consent Document(s)
• Assent Document(s)
• PHI documents (if applicable)
• Debriefing Statements (if applicable)

Question 14

Recruiting Documents (IRB Supporting Documents)

Answer 14

• Advertisements,
• Poster,
• Flyers,
• Scripts,
• Emails,
• Social Media Posts,
• Letters, etc.

Question 15

Study Instruments (IRB Supporting Documents)

Answer 15

• Survey,
• Questionnaires,
• Interview Guides,
• Tests,
• Photographs, etc.

Question 16

Letters (if applicable) (IRB Supporting Documents)

Answer 16

• Permission Letters,
• MOU’s,
• Letters Of Support, or
• Other Assurances Of Collaboration

Question 17

Grants (if applicable) (IRB Supporting Documents)

Answer 17

Grant Proposal

Question 18

CITI – Training (IRB Supporting Documents)

Answer 18

• Evidence of human subjects protection training

- Required for all principal investigators