Is IRB Approval Required?

IRB approval is required regardless of the site

of the study or the source of funding (if there is funding).

Which type of research does not need to get an IRB approval?

Publicly available data

do not require IRB review. Examples: census data, labor statistics. Note: Investigators should contact the IRB if they are uncertain as to whether the data qualifies as “publicly available.”

How do I know if I need IRB approval?

IRB review and approval is required for projects that:

Meet the definition of research

.

Involve human subjects

and. Include any interaction or intervention with human subjects or involve access to identifiable private information.

What happens if you don’t get IRB approval?

What’s the worst that can happen if I don’t get IRB approval? Aside from potential ethical implications for the subjects and for the researcher, bypassing IRB review brings other risks: Students: …

Degrees will not be awarded for work based on research involving human subjects

that was not approved by the IRB.

Do you always need IRB?

Yes.

All research must be reviewed by the IRB

. If the project is minimal risk, then it may qualify for exemption or be handled in an expedited review by the IRB. The specific decision rests with the IRB or with an administration official named by your institution, not with the investigator.

What are IRB requirements?

Under FDA regulations, an IRB is an appropriately

constituted group that has been formally designated to review and monitor biomedical research involving human subjects

. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research.

How long is IRB approval?

How long does IRB review take? An

expedited or exempt review may take about two weeks

. Studies requiring convened review may take three or more weeks. The PI has a significant influence on the length of time between submission and approval.

How do I get an IRB approval?

1. Step 1: Determine if your project requires IRB approval. …
2. Step 2: Complete the Mandatory Online Certification for Researchers. …
3. Step 3: Complete the IRB Research Project Application. …
4. Step 4: Prepare the Informed Consent Document(s) …
5. Step 5: Submit Proposal Form.

What documents need IRB approval?

• Application.
• Consent Document(s)
• Recruitment Materials.
• Study Instrument(s)
• Permission Letters (if applicable)
• Certificate of Education (if not already on file)
• Grant proposal narrative (if applicable)
• The application materials have been made into one PDF.

Can you publish without IRB approval?

Please note,

IRB approval cannot be granted retroactively

, so research conducted for a classroom assignment without IRB approval can never be used as the basis for a publication. If there is a possibility that it might be used for a future publication, it is advisable to seek IRB approval.

What does the IRB review?

The IRB reviews

the proposals before a project is submitted to a funding agency to determine if the research project follows the ethical principles and federal regulations for the protection of human subjects

. The IRB has the authority to approve, disapprove or require modifications of these projects.

What are the three levels of risk in research?

The risks to which research subjects may be exposed have been classified as

physical, psychological, social, and economic

. Physical Harms Medical research often involves exposure to minor pain, discomfort, or injury from invasive medical procedures, or harm from possible side effects of drugs.

Why does IRB take so long?

Do you need IRB approval for systematic reviews?

Reviews, meta‐analyses, or descriptions of educational materials do not involve human subjects and

do not require IRB review

.