Changes to Research / Additional Document Submissions

General Information
How to submit a protocol change
How to submit a consent form modification
How to request a reconsideration
How to submit a change of principal investigator
Additional changes which require notification to WIRB
Checklist of requirements for submitting changes in research
Sending the request to WIRB

Whenever a change to the protocol or consent form is proposed, the change must be reviewed and approved by WIRB before being implemented, unless a serious safety concern requires immediate implementation by the investigator.

Use the WIRB Change in Research/Subject Recruitment Submission Form to submit requests for review of changes to protocols, consent forms or subject materials; review of new consent forms and subject materials or review of new or modified recruitment materials. Use of the Change in Research/Subject Recruitment Submission Form is optional, but its use is strongly recommended to facilitate the review of submitted materials.

• How to submit a protocol change


Requests for review of protocol changes must include the exact text of the amendment, administrative change, or other revision to the protocol, a summary of changes, rationale for the change, and a copy of the WIRB-approved consent form with the proposed changes clearly marked (if applicable). Proposed changes to the consent form may be "redlined" into an electronic copy of the consent form or handwritten on a copy of the current WIRB-approved consent form. WIRB does not recommend marking changes with a highlighter alone, as the highlighting can be lost or obscure information when the document is scanned into WIRB's electronic workflow system.

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• How to submit a consent form modification


Requests for consent form modifications should consist of the WIRB Change in Research/Subject Recruitment Submission Form (or a cover letter explaining the request), an updated 1572 (if applicable), and a copy of the WIRB-approved consent form with proposed changes clearly marked. Proposed changes to the consent form may be "redlined" into an electronic copy of the consent form or handwritten on a copy of the current WIRB-approved consent form. WIRB does not recommend marking changes with a highlighter alone, as the highlighting can be lost or can obscure information when the document is scanned into WIRB's electronic workflow system.

Requests for review can be sent to WIRB online, by mail, fax, or e-mail (clientservices@wirb.com) and should reference the sponsor protocol number, WIRB study number, and name(s) of applicable investigator(s).

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• How to request a reconsideration


Requests for a reconsideration of a Board action should be accompanied by a rationale for the request. Additional information may allow the Board to favorably respond to the request. There is no additional fee for reconsiderations of disapproved items. Likewise, reconsiderations of board-directed modifications to consent forms and other subject materials or recruitment materials do not incur additional fees if the reconsideration is in regard to the language originally reviewed by the Board. If new or alternate language is submitted, the Change to Research fee applies.

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• How to submit a change of principal investigator


The Board requires written confirmation from the sponsor that the change is acceptable and has been approved, a letter from the old investigator relinquishing responsibility for the study (or an explanation for why this is not available), and a letter from the new investigator accepting responsibility for the study. The sponsor is required to select investigators under 21 CFR 312.53(a).

Also submit a WIRB Initial Review Submission Form, license and CV for the new investigator (unless current versions are already on file with WIRB), a modified 1572 (when applicable), and a request to modify the existing consent form to reflect the new investigator's name and contact information (when applicable).

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• Notify WIRB of changes of address or telephone for the investigator or the site(s). (If you are adding a site or moving to a new site, complete a WIRB Additional Site form for each new or updated location and forward to us.)
• Notify WIRB of changes of address, or telephone for study or sponsor contacts
• Notify WIRB of transfers of subjects (please include the reason for the transfer, to whom the subject is transferring, and documentation of sponsor approval of transfer)
• Notify WIRB of increases in the number of subjects allowed at the specific investigator site (indicate if a consent form change is needed)

Minor administrative changes sent to the investigator from the sponsor generally should be submitted to WIRB for review as "Administrative Letters" or "Administrative Changes." This type of change might consist of sponsor notifications of changes to the status of the protocol (such as completion of enrollment, completion of a cohort, ending development of a test article).

The list above is not an exhaustive listing of the changes in research that may need to be reported to WIRB. If you are in doubt about submitting a particular item, contact WIRB's Client Services at 1-800-562-4789 or e-mail clientservices@wirb.com.

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Checklist of requirements for submitting changes in research

Protocol Changes (Amendments, Administrative Changes, etc.):
Submit:

• A signed copy of the protocol amendment, revision or administrative letter (if applicable).
• A summary of changes and rationale for the new amendment to the protocol (if WIRB has already received the protocol amendment, you may submit the protocol amendment title page and signature page only).

• A copy of the WIRB approved consent form with changes marked. Please note any changes to addresses or phone numbers. Address changes should be accompanied by an updated 1572 (if applicable).

• Have any of these recruitment materials been previously approved by WIRB?
  *If yes, please attach a copy of the previously-approved item(s).
• If you are submitting a Public Service Announcement, please indicate if it will be announcer-read (verbatim) or taped.
• Are you submitting any recruitment materials that reference a web site?
  *If yes, you must attach a hard copy of the recruitment sections of the web site for WIRB review (do not include study-specific materials for studies approved by another IRB).
• If you are submitting screening materials, describe the screening plan on the WIRB Screening Procedures Information Form. WIRB reviews screening materials in the same fashion as consent documents.
• WIRB's requirements for screening scripts are listed at the bottom of the Screening Procedures Information form.

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