Materials Required for Initial Review

The following is a general list of items required by WCG IRB to begin the review process for a research study. 

Items Required for All Initial Review Requests 

• Initial Review Submission Form: Use ClinSphere^® eReview Manager or IRBNet for study submissions.
• Protocol: If you’re unsure of what requirements are needed for a Protocol document, please see the WCG whitepaper here. For protocol templates, there are multiple online options, including the WCG Protocol Assistant, Word template documents and Protocol writing tool from NIH.  
• Current Professional License for PI, showing the expiration date.

(Federal regulations do not recognize coprincipal investigators; therefore, if two PIs plan to share oversight of a single study, the Board requires a completed submission form for each investigator and holds each individually responsible for the conduct of the entire study.)

• Curriculum Vitae (CV) for principal investigator.  

Consent Form (If WCG IRB has not already approved one). Please submit consent forms as Microsoft Word compatible files (.doc, .docx, .rtf).

Other Materials to be Provided to the Participants which are not included in the protocol, such as advertisements, questionnaires, participant diaries, etc. (Any commercially available validated instruments cited in the protocol that are used without modification are not listed individually on the approval letter. However, approval of the protocol does extend to the uses of such industry standard forms as described in the approved protocol.)

Submitters will benefit from submitting advertising and other recruitment materials with the initial review submission, as later submissions incur a fee for review. Please review the guidance in the section of this Guide outlining best practices for submitting ads and other subject facing materials.

For Drugs, Biologics, and Food Supplements

• Investigator’s drug brochure (in most cases).
• Background information for food supplements.
• Documentation from sponsor or FDA verifying the IND (Investigational New Drug) number, if one is required for the research. If an IND is not required, provide the reason why in writing.

For Device Studies:

• Device manual is required for device studies (also called “Instructions for Use”) and ONE of the following:
  • Unredacted FDA letter granting the Investigational Device Exemption (IDE); OR
  • Letter from sponsor stating that the study is a non-significant risk device study and the basis for that determination; (unredacted) OR 
  • Documentation of why the investigation is exempt from the IDE requirements under 21 CFR § 812.2(c) (such as the PMA approval letter/number or 510(k) clearance letter/number) or otherwise exempt.
• Physicians seeking approval to use a Humanitarian Use Device (HUD) for treatment, not part of a research study, may use the form titled Clinical Use of a Humanitarian Use Device (HUD) (HRP-284) designed for such review requests.