WIRB News

Review of Individual Research Locations

Beginning April 1, 2008, Certificates of Approval issued by WIRB will cite the individual research location addresses that have been approved for the investigator.

The research site information required by WIRB at initial review remains the same. However, in order to conduct the review of changes to research locations after initial review, WIRB requires additional information about any new locations where subjects will be seen. WIRB’s Change in Research Submission Form has been updated to include a “Change in Research – Additional Site Form” that solicits information about new research location(s).

Any time an investigator provides WIRB with updated research site information (via a letter, revised box 3 of the 1572, etc.) for an open research study where subjects are seen, a “Change in Research - Additional Site Form” must be completed and provided to WIRB for each additional or changed site. This form is not required for changes to administrative locations (sites where no subjects are seen). The Board will review the information and, if approved, issue a Certificate of Approval citing approval of the new location(s).

If a consent form has been approved for the research, WIRB will also issue an updated consent form that reflects the new location(s).

Copies of the “Change in Research – Additional Site Form” may be downloaded from the Download Forms page of the WIRB website (www.wirb.com), or you may request a copy via fax, e mail or postal mail by contacting a WIRB Client Service Representative at 1-800-562-4789 or e-mailing clientservices@wirb.com.

Thank you for using WIRB and for joining us in our pursuit of continuous improvement.

WIRB is pleased to announce WIRBNet, an on-line information portal designed to provide expanded submission detail, enhanced tracking features and the secure download of approval documents. WIRBNet liberates users from the limits of time zones, phone calls and e-mails.

In order to access confidential research review information, users are given a personal account with a user name and password.

Once logged on, users may select from the following options:

• WIRBNet Tracking (to view the details of research in progress and research pending review)
• Online Submissions (to allow the secure upload of review materials to WIRB)
• View Rights Account Management (to grant view rights to study coordinators and other research-related staff who need access to the information)

“WIRBNet Tracking” presents a list of the protocols to which the user is associated. Users may then click on a protocol to see detail about specific investigator reviews, continuing review report forms, protocol variances, and site adverse event reporting, all of which may be printed or exported to an Excel spreadsheet.

“Now you and your study team can have real time access to current information about research submissions to WIRB whenever you might need it.

Simplified Text of California Experimental Subjects’ Bill of Rights

In order to help sites in California comply with California State regulations, WIRB attaches the California Experimental Subject’s Bill of Rights to consent forms for sites in California. Up until recently, the text WIRB included was copied directly from the applicable portion of California’s Health & Safety Code.

However, the Health & Safety Code does not require subjects be provided with the information verbatim as outlined in the statute, so WIRB recently developed a simplified version of the text. Before adopting it, WIRB presented it to the California Attorney General. The Attorney General provided feedback, and WIRB has now adopted language that is acceptable to both the members of WIRB and the California Attorney General.

Beginning in September 2007, the simplified language will be added to new consent forms for sites in California. The text in existing, approved consent forms will not be changed.

Additions to the Certificate of Approval

In July 2007, WIRB added new information to its Certificates of Approval.

All Certificates now display the Site Status Reporting frequency and Continuing Review Frequency:

The Continuing Review field indicates the frequency with which the Board conducts Continuing Study Review. Click here for more information about WIRB’s study renewal processes and requirements.

The Site Status Reporting field indicates how often the site is required to complete a Continuing Review Report form. Click here for more information about WIRB’s continuing review reporting requirements.

Certificates of Approvals for WIRB’s Canadian panel (Panel 10) also include two additional fields:

• A field indicating that panel 10 is WIRB’s Canadian Panel:

• A set of attestation statements congruent with those in Health Canada’s Research Ethics Board Attestation form (REBA):

  In respect of the identified clinical trial, I certify, as chair of this Research Ethics Board that:

  1. The membership of this Research Ethics Board complies with the membership requirements for Research Ethics Boards defined in Part C Division 5 of the Food and Drug Regulations, Part 4 of the Natural Health Products Regulations, and the Tri-Council Policy Statement (TCPS);
  2. This Research Ethics Board carries out its functions in a manner consistent with Good Clinical Practices; and
  3. This Research Ethics Board has reviewed and approved the clinical trial protocol and informed consent form for the trial which is to be conducted by the qualified investigator named above at the specified clinical trial site. This approval and the views of this Research Ethics Board have been documented in writing.

Because the content of WIRB’s Certificate of Approval for Canadian sites is now congruent with the content of Health Canada’s Research Ethics Board Attestation form, sites are no longer required to submit REBA forms with their review requests and WIRB will no longer complete REBA forms for new review requests.

New Online Submission Feature

WIRB is pleased to announce a new Online Submission feature of our WIRB.com website. Many of our customers have asked for a better way to transmit documents to us. The Online Submission feature will let you upload documents to us through a safe and secure process.

To use this feature, simply click the ‘Online Submission’ button on the WIRB.com webpage and follow the easy directions. You can access the site at www.wirb.com

The general steps are:

1. Select the type of submission you wish to make
2. Upload your individual documents to the site
3. Complete the ‘Submitter Information’ page.
4. Click the ‘Finalize Submission’ button
5. Receive your confirmation page (and email) that includes your Submission Number.

The confirmation means that WIRB has received and can begin processing your submission. You can reference your Submission Number in any communication with our Client Services team. Note that your confirmation email can serve as an official “Acknowledgement of Receipt.” You will still receive a separate tracking number once we create the work order to review your submission.

We are pleased to provide this new service to you, and we hope that this – and other initiatives we are working on – help reduce the time needed for IRB review.

Please let us know if you have any questions, comments or suggestions.

Pediatric Assent Changes

In response to suggestions from WIRB’s pediatric panel chairman, and several IRB chairs at prominent children’s research centers around the country, the Board is implementing a new approach to obtaining and documenting child assent. The new approach to assent would eliminate the requirement to obtain signatures of minors on the consent form or an assent form. Instead, the current signature lines for minors will be replaced with a set of statements to be certified by the person conducting the assent discussion, verifying the minor subject’s understanding and assent. Below is an example of the proposed assent section.

This approach to assent is widely used at children’s hospitals around the country and meets the regulatory requirements for documentation of assent under 21 CFR 50.55(g) and 45 CFR 46.408(e). Please note that this does not change in any way the requirement to obtain assent. Rather, it only changes the manner in which the assent is documented.

The Board will be implementing this new approach to obtaining and documenting assent from minors in the near future. This new approach will be applied to new research only; unless specifically requested to do so, we will not apply it retroactively. We would like to alert you to this change in process at WIRB, and would appreciate any feedback or concerns on the proposed process. Please address your questions and concerns to David Forster JD, Vice President, Compliance at 360-252-2428.

Below is a copy of the assent section that would be incorporated into the signature section of the main consent form. When a separate assent form is submitted to WIRB, the Board will consider whether to modify the assent form into an age appropriate information sheet to be provided to the minor to aid in the assent discussion.

ASSENT SECTION:
Statement of person conducting assent discussion:

1. I have explained all aspects of the research to the subject to the best of his or her ability to understand.
2. I have answered all the questions of the subject relating to this research.
3. The subject agrees to be in the research.
4. I believe the subject’s decision to enroll is voluntary.
5. The study doctor and study staff agree to respect the subject’s physical or emotional dissent at any time during this research when that dissent pertains to anything being done solely for the purpose of this research.

__________________________ ____________
Signature of Person Conducting / Date
Assent Discussion

Statement of Parent/Guardian:
My child appears to understand the research to the best of his or her ability and has agreed to participate.

______________________ ______________
Signature of Parent/Guardian / Date

Changes to WIRB's Consent Form Approval Stamp

This month WIRB's approval stamp is slimming down. Consent form approval stamps will no longer specify "Olympia, WA."

Our headquarters continue to be located in Olympia, but our increasing review of international research has prompted us to eliminate the Olympia reference from our approval stamps.

Though it is a small change, the elimination also contributes to our overall effort to keep our consent forms as concise as possible for the subjects who read them.

WIRB Announces Full Reaccreditation

WIRB is pleased to announce that the Association for the Accreditation of Human Research Protection Programs (AAHRPP) has renewed WIRB’s fully accredited status.

The Association for the Accreditation of Human Research Protection Programs (AAHRPP) “seeks not only to ensure compliance, but to raise the bar in human research protection by helping institutions reach performance standards that surpass the threshold of state and federal requirements.” On April 28, 2003, WIRB was the first independent IRB to be issued full accreditation by AAHRPP.

Every three years accredited institutions must re-submit an accreditation application to request renewal of their accreditation.

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