How to Submit for IRB Review
IRB Resources:
Do you have a study that requires premium attention with personalized oversight to ensure accelerated timelines?
How Do I Submit for IRB Review?
To submit your study for IRB review, you need to submit an IRB application requesting ethical review. A complete application typically includes the application form, the draft consent form, study protocol, investigator qualifications, recruitment materials, and any support documents.
Submit in three easy steps with WCG IRB Connexus:
Log into WCG IRB Connexus (or set up an account if you don’t have one).
Follow the prompts to input the necessary information to get your study review started.
Easily upload supporting docs, including protocol, informed consent, and investigators’ brochure.
About WCG IRB Connexus
WCG IRB Connexus is a revolutionary IRB submission and review portal built from the ground up based on feedback from end users like you.
The result? Dramatic improvements to the things that matter most: ease of use, speed of submission, and complete visibility into the status and timelines of your reviews — all in one place.
Have questions before you submit?
What happens when I submit my study?
Board Review
Once you’ve completed your submission, it will be checked for completeness and prepared for review by our AAHRPP-accredited board. These ethical review boards include specialized review boards for biosafety research, oncology research, and clinical pharmacology research.
- WCG IRB’s review boards meet daily, up to 20 times per week.
- WCG IRB staff will begin reviewing your submission within one business day.
Board Review Determination
Determination: Disapprove
The board issues a “disapprove” determination when the initial, continuing, or modification submission does not meet the criteria for approval and the IRB considers the research to have extensive deficiencies. When the IRB makes this determination, it will summarize its reasons and recommendations, if any.
When the Board makes a “disapprove” determination on a change in research, the change cannot be implemented. The Board expects the research will continue as previously approved.
You may request reconsideration of a “disapprove” determination and provide additional information to the board for consideration. The investigator may appear before the Board in person or via teleconference, if desired.
Determination: Defer
The board issues a “defer” determination when the criteria for approval have not been met based on the information provided. The Board will request further information in order to make a determination. Learn more about a “defer” determination and your next steps here.
Determination: Conditionally Approve
The board issues this determination when your initial, continuing, or modification submission will meet the criteria for approval with minor or prescriptive changes or requirements.
You’ll receive written notification of the conditions promptly after the review.
Once you submit the requested information, your submission will be re-reviewed.
When the re-review is complete and all information is confirmed, you will receive your approval documents.
Important! The study, change in research, or other submitted material is not approved until we confirm that any/all of the condition(s) are satisfied. You are not authorized to begin research-related activities until you receive final approval documents.
Determination: Approve
The board issues an “approve” determination when your initial, continuing, or modification submission meets the criteria for approval.
When the approval is based on board-required consent form modifications, we’ll provide a finalized consent form with the required modifications.
We’ll usually communicate approval with a Certificate of Action (COA).
Outcome Documentation
Once your study has been reviewed, we’ll prepare and send the outcome documents to you and all designated contacts (in WCG IRB Connexus or WCG IRBNet), including:
- Certificate of Action (this will convey the Board’s action as well as any special Board determinations, requirements, or other necessary information).
- Copy of the Board-approved consent form (when applicable), ready for use.
- Description of the changes to the consent form (depending on the type and extent of the Board’s changes).
- Explanatory notices relevant to the review.
Common IRB Submission Mistakes
How Can I Avoid Incomplete Documentation in My Submission?
Failing to attach necessary files delays review processes. You must include all recruitment materials, surveys, and interview guides. Double-check your application packet before submitting, so every required document is present.
What Are the Most Common Consent Form Errors?
Researchers frequently utilize outdated templates or overly technical jargon. Prevent this issue by writing informed consent documents in simple, easy-to-understand terms. Always incorporate mandatory elements like risks, benefits, along with compensation details, so participants fully understand what involvement entails.
How Do Inconsistencies Affect the Review Process?
Discrepancies between main application forms and attached documents create board confusion. Ensure descriptions of study procedures, team members, plus recruitment methods match across all submitted materials.
Why Is Missing Trainings/Credentials a Problem?
Institutional Review Boards require proof that research personnel understand ethical guidelines. When team members lack mandatory credentials, such as Collaborative Institutional Training Initiative (CITI) programs, committees halt approvals. Verify current certifications for everyone prior to submission.
What Details Do I Need to Provide Regarding Data Security?
Vague explanations regarding participant information protection often lead to pushback. Outline storage methods plus security protocols clearly. Additionally, apply terms like anonymous versus confidential correctly and accurately describe privacy measures.
How Detailed Should My Study Procedures Be?
Lack of detail prevents review boards from fully grasping what participants will experience. Outline subject journeys explicitly. Highlight specific activities, time commitments, alongside physical locations involved during the research phase.
How Should I Handle Requested Modifications from the Board?
Ignoring requested changes causes significant delays. When reviewers ask for revisions, respond directly to every single point. Provide clear explanations showing how you updated protocol attachments, ensuring they meet compliance requirements.
Can I Begin Recruiting Participants Before Receiving Final Approval?
Commencing recruitment early is a major violation. You cannot begin recruitment or data collection until receiving formal written board approval. Wait for official notices to protect subjects while maintaining regulatory compliance.
What Must I Do if My Study Procedures Change After Initial Approval?
Failing to report procedural updates represents a serious mistake. Submit an amendment whenever research plans change. Always wait upon board clearance before implementing new methods in the field.
Have questions about IRB review or Connexus before you submit?
Contact us:
Have you already submitted your study for IRB review with WCG and have questions? Please contact us at clientcare@wcgclinical.com, and we’d be happy to assist!