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

We recommend use of WIRB's "smart form" online submission tool. Click on the "WIRBNet LOGIN" button in the upper right corner of this screen to establish an account and start using it.

Submitting via the smart form can significantly reduce the number of questions you have to answer about your submission. It also features a safe and secure process for uploading your submission documents, and provides general guidance about what type of documentation is required for various types of review requests.

Users who submit online receive an e-mailed confirmation that WIRB has received their submission. It includes a reference number that will facilitate discussions of the submission with WIRB staff. The confirmation e-mail also serves as an official WIRB acknowledgement of receipt.


Use the WIRB Change in Research and Subject Recruitment (Ads) Submission Form (smart form or paper form) to submit requests for review of changes to protocols, consent forms or subject materials (ads); review of new consent forms and subject materials or review of new or modified recruitment materials. Use of the Change in Research and Subject Recruitment (Ads) 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, the 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 should be "redlined" into an electronic 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.

As of January 1, 2009, all requests for changes to previously approved consent forms must be submitted in one of two ways: The changes can be submitted using the currently approved WIRB consent form with only the new changes tracked in redline format, OR the changes can be detailed in a document specifying the requested changes.

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• How to submit a consent form modification


Requests for consent form modifications should consist of the WIRB Change in Research and Subject Recruitment Submission Form (smart form version or paper form), an updated 1572 (if applicable), and a copy of the WIRB-approved consent form with proposed changes clearly marked (or a document specifying the requested changes). Changes sent to WIRB on the sponsor’s template consent form will not be accepted. Proposed changes to the consent form should be "redlined" into an electronic 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. In general, a statement justifying changes is very helpful and can reduce the need for WIRB to contact sites for explanations. Whenever revisions are requested to previously Board-approved language, the submission must include a rationale.

We recommend using the “smart” online form available via the WIRBNet Login button on wirb.com. The “smart form” submission is generally a shorter process because it dynamically omits questions that are not relevant, based on the answers you provide about the research. Requests for review can also be submitted to WIRB online from its web site, mailed, faxed or e-mailed ( clientservices@wirb.com). Submissions should reference the sponsor protocol number, WIRB study number, and name(s) of applicable investigator(s).

After January 1, 2009, whenever WIRB receives a request for a revised consent form in any format other than the two formats described above, the submission will be returned to the submitter with a request that the changes be sent to WIRB as described above.

If the changes are to be submitted for a multi-site study , the same changes might have already been approved by WIRB for another site. If you agree to accept the changes already approved, the review will take place more quickly. You can contact WIRB Client Services to determine if pre-approved language exists for your change in research.

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• How to request a reconsideration


Requests for a reconsideration of a Board action must 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 (as a smart form, or as a paper form using the Investigator Submission Form for Multi-Center Protocols), 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, report the change to us via a change in research smart form submission, or download and 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 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 only). .
• A signed copy of the protocol amendment, revision or administrative letter (if applicable)

• 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 via a change in research smart form submission, or download and complete 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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