WIRB News

Confirmation of WIRB Registration with DHHS/FDA (September 2009)
IRB Registration Requirements News (July 2009)
Updated Unanticipated Problems Reporting (February 2009)
Requirements for Changes in Research (December 2008)
Review of Individual Research Locations (April 2008)
WIRB Launches New Authenticated Web Site February 4, 2008
New, Simplified Text of California Experimental Subjects’ Bill of Rights (September 2007)
Additions to the Certificate of Approval (July 2007)
New Online Submission Feature (June 2007)
Pediatric Assent Changes (June 2007)
Changes to WIRB's Consent Form Approval Stamp (May 2007)
WIRB Announces Full Reaccreditation (September 2006)

Confirmation of WIRB Registration with DHHS/FDA

The update/renewal of WIRB's organization (IORG) registration, submitted
electronically, has been processed. The registration is listed on the OHRP website at http://ohrp.cit.nih.gov/search/search.aspx. Our IRB registration number is IRB00000533, parent organization number is IORG0000432. The expiration date of WIRB's Registration is
9/16/2012.

The notification e-mail that WIRB received from HHS is available for download here: http://www.wirb.com/download/confirmation_of_registration.pdf.

IRB Registration Requirement News (July 2009)

From: Office for Human Research Protections (OHRP)
[mailto:OHRP-L@LIST.NIH.GOV]On Behalf Of Irene Stith-Coleman
Sent: Wednesday, July 08, 2009 7:34 AM
To: OHRP-L@LIST.NIH.GOV
Subject: Effective Date of New OHRP Institutional Review Board Registration Requirements Approaching

On July 14, 2009, the new Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) regulations requiring registration of institutional review boards (IRBs) that were published in the Federal Register on January 15, 2009 (74 FR 2399 and 74 FR 2358) will go into effect. The Office for Human Research Protections’ (OHRP’s) IRB registration system will be compatible with the requirements of both the HHS and FDA regulations.

The HHS IRB registration requirements were added as a new subpart E to the HHS protection of human subjects regulations (45 CFR part 46). Subpart E requires all IRBs that review human subjects research conducted or supported by HHS and that are designated under an assurance of compliance approved for federalwide use (i.e, a Federalwide Assurance (FWA)) by OHRP to register with HHS. Required IRB registration information includes: contact information for the person providing the registration information; approximate numbers of all active protocols and active protocols involving research conducted or supported by HHS; and, approximate number of full- time equivalent positions devoted to the IRB’s administrative activities.

For any IRB currently registered with OHRP, the institution or organization operating the IRB must submit all information required under HHS regulations at subpart E of 45 CFR part 46 by the current expiration date previously assigned by OHRP or within 90 days of any changes regarding the contact person who provided the IRB registration information or the IRB chairperson, whichever comes first. Institutions or organizations operating IRBs currently registered with OHRP that review FDA-regulated research will need to update registration information to include FDA-specific information once the registration rule is effective. For IRBs that only review FDA-regulated research, an initial registration is required. [For questions regarding registration of IRBs that review FDA-regulated research, see FDA contact information below].

For any IRB not currently registered with OHRP, the IRB must be registered with OHRP before being designated on an FWA and reviewing research conducted or supported by HHS.

Note that beginning on July 14, 2009, institutions and organizations needing to register a new IRB, or update or renew an existing IRB registration, must do so electronically via the OHRP website at http://ohrp.cit.nih.gov/efile/ unless the institution or organization lacks the ability to register its IRBs electronically. OHRP’s current electronic IRB registration submission system is being updated so that it corresponds to the requirements of both IRB registration rules. The updated registration system will “go live” on July 14, 2009. In addition, the Office of Management and Budget (OMB) recently approved the information collection requirements in both rules. Thus, beginning on July 14, 2009, IRB registration information for both rules will be collected on the OMB-approved modified IRB registration form (OMB No. 0990- 0279), which will be posted on the OHRP website.

In order to implement the changes required to update the system for registering an IRB electronically via the OHRP website, the system will be shut down during the period of July 8 through July 13. During that period, new IRB registrations, or updates to, and renewals of, existing IRB registrations cannot be submitted, nor can they be processed by OHRP. In addition, individuals will not be able to access the list of OHRP registered IRBs on the OHRP website; or view IRB registration documents received by OHRP during the last 60 days.

The final IRB registration rule that was published in January as the new
http://edocket.access.gpo.gov/2009/E9-588.htm. The FDA IRB registration final rule (new 21 CFR 56.106) can be accessed at http://edocket.access.gpo.gov/2009/E9-682.htm.

For further information on OHRP’s IRB registration requirements contact Irene Stith-Coleman, Ph.D., Office for Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852, telephone (240) 453-6900, email Irene.Stith-Coleman @hhs.gov

For further information on FDA's IRB registration requirements contact Jean Toth-Allen, Ph.D., Good Clinical Practice Program, Office of the Commissioner, Food and Drug Administration, 5600 Fishers Lane, HF-34, Room 16-85, Rockville, MD 20857, telephone (301) 827-1585, email jean.toth-allen@fda.hhs.gov

Updated Unanticipated Problems Reporting (February 2009)

Click here to view an audio video presentation outlining WIRB's current expectations for the reporting of unanticipated problems.

In follow up to guidance issued by OHRP and the FDA (links to the guidance are provided below) regarding the reporting of unanticipated problems to IRBs, Western Institutional Review Board (WIRB) has revised its reporting requirements for adverse events and protocol violations. Under the new requirements, fewer adverse events and protocol violations will need to be reported, but those that do meet the reporting criteria will need to be reported on the appropriate WIRB reporting form and will require additional information. The forms are designed to collect all the relevant information needed for the Board to evaluate the report.

As of April 1, 2009, all reports of unanticipated problems involving risks to subjects or others must be submitted on the appropriate WIRB reporting form available on the Download Forms page of www.WIRB.com.

Reports that are not submitted on the appropriate reporting form and those that are incomplete will generally be returned to the submitter with a description of the WIRB reporting requirements and guidance encouraging the submitter to resubmit with the required analysis.

Adherence to these reporting requirements will help WIRB to focus on issues where subject rights, welfare or safety are at risk. If you have any questions, please contact us.

Links to the new guidance:

http://www.wirb.com/download/FDA_AE_guidance_01-2009_(final).pdf http://www.wirb.com/download/OHRP_guidance.pdf

Requirements for Changes in Research (December 2008)

WIRB continuously tries to reduce the time it takes to complete reviews of submissions. We have found that review of changes to consent forms takes less time when the changes are documented on the consent form that was previously approved by WIRB. Changes sent to WIRB on the sponsor's template or another rendition of the consent form are often difficult to transfer onto the version of the consent form currently approved by WIRB.

In order to improve efficiency and reduce errors, effective January 1, 2009, WIRB will require all requests for changes in previously approved consent forms to 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 handwritten on the form,

• The changes can be detailed in a document specifying the requested changes.

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.

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 this change in research at the following:

Review of Individual Research Locations (April 2008)

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 Launches New Authenticated Web Site February 4, 2008

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 (September 2007)

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 (July 2007)

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 (June 2007)

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 (June 2007)

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 (May 2007)

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 (September 2006)

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.

Click the link below to view previous WIRB News items:

WIRB News Archives