IRB Protocol Workshop Class

General Protocols

100

What is the primary purpose of the HRP-503 General template?

It is used for clinical trials, interventional studies, or studies with patient interaction.

200

Why is the HRP-503 General template more detailed than other templates?

Because it is designed for studies requiring more regulatory and compliance information due to direct patient interaction.

300

Which section allows researchers to outline the research workflow?

• The "Procedures Involved" section.

400

What type of study does the HRP-503 General template often involve?

More-than-minimal-risk studies requiring detailed descriptions of patient consent and data handling.

500

How does the HRP-503 General template differ in consent requirements compared to the Surveys and Interviews template?

The HRP-503 General template requires detailed written consent processes due to patient interaction, while the Surveys and Interviews template often relies on simplified or implied consent mechanisms for non-invasive studies.

Surveys and Interviews

100

What type of research is the HRP-503 Surveys and Interviews template designed for?

Non-invasive studies such as surveys, interviews, focus groups, and observations.

200

What feature differentiates the Surveys and Interviews template from the General template?

It includes formatted sections with checkboxes for easier completion.

300

What is the focus of the "Procedures Involved" section in the Surveys and Interviews template?

How surveys, interviews, or observations will be conducted.

400

How does this template simplify data collection explanations?

By using pre-formatted sections and checkboxes for standardized answers.

500

What are two key reasons for using the HRP-503 Surveys and Interviews template instead of the HRP-503 General template?

• The study involves non-invasive procedures like surveys or focus groups.
• The template’s checkbox formatting simplifies study design for these specific methodologies.

Record Data Studies

100

What is the HRP-503 Record Data template used for?

Studies analyzing medical records or data retrospectively or prospectively without patient interaction.

200

Why does this template often require a waiver of consent?

Because there is no direct patient interaction, and the study involves secondary data.

300

What makes the Record Data template longer and more detailed than the Medical Record Review template?

It accounts for a broader range of research types, including federally funded or multi-site studies.

400

What is a key difference in consent requirements between Record Data and General templates?

• Record Data studies often ask for a full waiver of consent, while General templates involve direct consent processes.

500

In what scenarios should you not use the HRP-503 Record Data template, and what alternative should be chosen instead?

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  • Do not use the Record Data template if the study is federally funded or involves multi-site research.
  • Instead, use the HRP-503 General template for such studies, as it provides the required regulatory detail and flexibility.

Medical Record Review

100

What is the primary purpose of the HRP-503 Medical Record Review template?

For retrospective chart reviews within UCD and not federally funded.

200

How many sections does the Medical Record Review template have?

Only four sections.

300

What is the main restriction for using the Medical Record Review template?

It must be used only for studies involving UC Davis EMR data and not federally funded.

400

Why is this template more simplified than the Record Data template?

• Because it is targeted specifically for chart review studies with minimal customization.

500

What are the potential risks of using the HRP-503 Medical Record Review template incorrectly for a study that does not meet its specific criteria?

• The study may face delays or rejection during IRB review if it involves federally funded or multi-site research.
• Inadequate documentation could result in non-compliance with IRB standards or regulatory requirements.

IRB Basics

100

What does IRB stand for?

Institutional Review Board.

200

Why is a protocol required for IRB review?

It outlines the scientific method and ensures a well-designed study.

300

What is IRBNet?

• A platform used for submitting protocols and study documents for IRB review.

400

What is the code name for the general protocol template?

HRP-503.

500

What are three key elements that must be included in any protocol submitted to the IRB to ensure approval?

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  1. A detailed description of the study’s procedures and methodology.
  2. A plan for maintaining data confidentiality and addressing potential risks.
  3. Clear consent processes tailored to the study’s level of risk and participant interaction.