IRB
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Inital

The WVDE IRB conducts three types of initial reviews depending upon the level of risk inherent in your proposed project.


Typical Review Periods for Each Category of Initial Review

Type of Initial Review

Description
(See WVDE IRB Manual for Explicit Details)

Time Period for Continuing Review Approval

Exempt

Minimal risk* studies that meet exemption criteria

Up to 10 business days or 2 weeks

Expedited

Minimal risk* studies that meet expedited criteria

Up to 15 business days or 3 weeks

Full Board

Studies posing more than minimal risk* or that otherwise do not meet exemption/expedited criteria

Up to 25 business days or 5 weeks

*minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

 

All initial reviews require a completed IRB Research Application and an IRB PI Information and Certification Form. Note that, you must also include proof that you have completed the necessary education requirements or your application will not be considered. The following forms are required for each category of review:


Required Forms by Category of Initial Review

REQUIRED FOR ALL REVIEWS

Additional Forms Required for:

OPTIONAL FORMS

Exempt Review

Expedited Review

Full Board Review

IRB Research Application

IRB Exempt Status Application Checklist

IRB Expedited Review Application Checklist

 

IRB Co-Investigator Information and Certification Form*

IRB PI Information and Certification Form

 

 

 

IRB Request for Waiver of Informed Consent**

*This form is required when your project includes more than one investigator or individual who will have access to data/collect data from research participants. Proof of completion of education requirements is required for all co-investigators.
**This form is required when your project does not propose to utilize an informed consent procedure or when you plan to use such a procedure, but not to obtain written or recorded documentation of informed consent.

 

Investigators should be aware that additional documentation may be required depending upon the specific details of a project. This documentation may include the following:


Additional Documentation Requirements

Other Documentation

When necessary

Resources

Proposed Informed Consent Forms

In nonexempt studies, consent forms may be required

Informed Consent Checklist:
(http://www.hhs.gov/ohrp/policy/consentckls.html)

Sample Informed Consent Form Language

Sample General Public Consent Form Language

Draft Data Collection Instruments

If proposing new data collection instruments (e.g., surveys, interview protocols, etc.)

Guidance Under Construction

Grant Application/Proposal for Project

If your project is funded by an external grant.

N/A

Proof of Completion of Education Requirements

For any principal or co-investigator included on the project

See the Education section of this website