WIRB News Archives

January 2006
2006 Initial Review Submission Form Available January 1, 2006

Approximately once a year, WIRB reviews its Initial Review Submission Form and makes revisions. All year long we consider what changes in the regulatory environment need to be reflected in the form, consider feedback provided by Board members and staff, and feedback from customers who have taken the time to tell us what worked or didn’t work well for them.

Our 2006 version will be available on the web site the last week of December 2005, and includes some changes we are excited to see accomplished. This year we have actually eliminated some questions! We hope our changes will help simplify the process of completing the form.

• In addition to eliminating some questions, we have broken out the “additional sites” listing onto its own page, so that investigators with multiple sites can more easily copy and complete the questions for all their additional sites.
• We have also eliminated the signature line on the last page, to facilitate the process of sending the form to us via e-mail.
• We have added question 1f to help us better identify and serve investigators who do research at institutions which have special requirements for their WIRB studies.
• If you submit audio-visual materials to WIRB for review, please note the change to question 32. We are no longer able to review recordings and other audio-visual materials at initial review without a script. Contact Client Services if a script is unavailable.
• Please also note the updated human subject protection training requirements in question 10. Based on WIRB’s AAHRPP accreditation, in June of 2005 we implemented new requirements for human subjects protection training by members of the research team. Our requirement is for all members of the research team who will be interacting with subjects to have training in human subjects protections. This is in recognition that as clinical trials become more complex, it is ever more important to ensure all members of the research team are aware, and trained, on issues regarding the protection of subjects in research. Unfortunately, the wording in our 2005 version of the submission form was not entirely clear, and some interpreted our requirement as only pertaining to the investigator. For 2006 the wording of the question has been updated to more accurately communicate our requirement that all members of the research team who interact with subjects have training.

WIRB will continue to accept the 2005 version of the form until March 31, 2006, but beyond that date, submitters will be asked to complete and submit the 2006 version (the revision date of 01-2006 is located in the lower left hand corner of the form). A copy of the new form may be downloaded from the Download Forms page, or you may request a copy by contacting a WIRB Client Services 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 in the protection of human research subjects.

February 2006
Memorial Announcement

Western Institutional Review Board mourns the loss of Chair Designee and Board Member, Michael K. Schmidt. Mr. Schmidt was appointed to the Board April 1, 2002, and passed away February 22, 2006.

October 2005
Investigator Confirmation of Board Requirements

DHHS regulation 45 CFR 46.109(d) states “An IRB shall notify investigators and the institution in writing of …. modifications required to secure IRB approval of the research activity....” Based on this regulation, effective October 1, 2005, investigators approved for new research studies are required by WIRB to confirm their acceptance of the requirements imposed by the Board. No action is required for studies approved prior to October 1, 2005.

Enrollment may not commence until the investigator has accepted the Board’s requirements and sent the signed form to WIRB.

• If the Board’s requirements are acceptable, the investigator should sign the form and send it to WIRB. Enrollment may commence once the form is sent. Sites should retain a signed and dated copy of the form for their records along with confirmation of having sent the form (fax confirmation, copy of e-mail, etc.)

• If one or more of the Board’s requirements are not acceptable, mark the applicable box, provide explanatory comments, and return the form to WIRB. Enrollment may not commence.
  

It is VERY IMPORTANT that sites return the form to WIRB in a timely manner whether the investigator finds the requirements acceptable or not.

Contact us if you have questions.

September 2005
Good Clinical Practice Training Offered

We are pleased to announce WIRB is offering a half-day GCP training class entitled, Today's Good Clinical Practice Requirements, at the Harbor Court Hotel in Baltimore, on Saturday, October 15, 2005. This activity has been approved for 4.25 hours of Category 1 CME credit.

Click here for information on seminars hosted by WIRB.

August 2005
Legally Authorized Representatives (LARs) in Research

The laws regulating who can consent for adults who lack the capacity to consent for themselves are defined at the state level and vary from state to state.  Persons who can consent for adults who lack the capacity to personally provide informed consent are often known as Legally Authorized Representatives (LARs).

Starting August 1, 2005, investigators receiving WIRB approval to conduct a new protocol allowing for the inclusion of adults who lack the capacity to personally provide consent may look forward to receiving a letter from WIRB describing their state's laws regarding Legally Authorized Representatives.

Letters will not be routinely sent with approvals of changes in research or to new sites requesting approval for protocols which WIRB reviewed prior to August 1, 2005, but Client Services can provide active sites with a copy of the information upon request.

Click here for WIRB contact information

July 2005
WIRB Welcomes Another Group of Fellows

This July WIRB welcomed its fifth group of international fellows. The newest group includes two representatives from Thailand, one from Taiwan and one from the Philippines. For more information about the WIRB International Fellows Program, click here.

July 2005
Updated Ten Day Serious Adverse Event (SAE) Form

In July, WIRB made a change to its Ten Day Serious Adverse Event reporting form. Though unrelated adverse events do not have to be submitted to WIRB, a “Not Related” checkbox was restored to the form so that sites that are required by their sponsor, institution or internal SOPs to report unrelated SAEs to their IRB can clearly identify the unrelated SAEs as such.

WIRB is continuously evaluating the effectiveness of its forms and makes frequent improvements to them. The current versions are always available on WIRB’s web site. To ensure that they’ve used the latest and best version, we encourage sites to make a habit of downloading forms from www.wirb.com whenever they need to fill one out.

Click here to go the Download Forms page and download the current forms

May 2005
Re-designed Web Site

Welcome to the re-designed WIRB web site. We have updated and expanded the information available on our web site. Among the new features:

• The new site now allows users to bookmark and return to specific pages on the site.
• Information is collected and organized according to each type of user's needs (for example, "Information for Subjects," "Information for Investigator / SMO," etc.)
• A new "Quick Links" toolbar is now available from all screens allowing users to immediately move to the search page, the Download Forms page or the IRB submission information pages from anywhere on the web site.
• Links in the footer of each page allow quick and convenient access to frequently used screens.

February 2005
Memorial Announcement

Western Institutional Review Board honors the legacy of Kenneth Partlow, M.D. Dr. Partlow died unexpectedly on January 23, 2005, at eighty-seven years old, leaving a distinguished legacy of leadership and service to his community. He was the first Chairman of Western IRB when WIRB was founded over thirty-six years ago. He remained a member of WIRB until his death. His loss to us is beyond measure and we will remember him always.

Dr. Ken Partlow was a third generation practicing physician in Olympia, Washington, and is followed by the fourth generation. There has been a Dr. Partlow practicing medicine in Olympia since the late nineteenth century continuing into the twenty-first century. Dr. Partlow was the first full-time board certified pathologist to make Olympia his home base. He founded Olympia Medical Laboratory and Black Hills Pathology.

A memorial service will be held at St. John's Episcopal Church in Olympia on February 10, 2005, at 2:00 P.M.

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May 2004
New Chair Appointed
Dr. Angela Bowen, President of WIRB, announces the appointment of Theodore D. Schultz, J.D. as Chairman of Western IRB. Mr. Schultz has served on the Board since 1972 and has served as Panel Chair for five years. Mr. Schultz succeeds Mr. William C. Jacobs who has served as Board Chair for the last four years. Mr. Jacobs will continue his responsibilities as Chair of Panel 12 and has recently been appointed as Director of the WIRB International Fellows Program.

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Winter 2003
Investigator Training for Medical Research

One-Day Intensive Course

WIRB continues to offer the Investigator Training for Medical Research course and will be in:

• Orlando, Florida, June 6, 2003,
• Cleveland, Ohio, July 25, 2003, and
• St. Louis, Missouri, November 7, 2003.

This course qualifies for continuing education credits and is designed for investigators and potential investigators, as well as staff members involved in clinical research.

Participants become familiar with the following clinical research topics:

• Events that influenced human subject protection regulations
• Key governing regulations
• Investigators' ethical responsibilities
• Investigator regulatory responsibilities and legal obligations
• Drug development process

For more details, call 800-562-4789 or go to the Investigator Training page.

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May 2003
WIRB FIRST INDEPENDENT TO ACHIEVE ACCREDITATION FOR WORK SAFEGUARDING RIGHTS OF HUMAN RESEARCH SUBJECTS

OLYMPIA - May 1, 2003 - The Western Institutional Review Board (WIRB), Olympia, Wash., the oldest independent entity in the nation whose oversight safeguards the rights and welfare of human research subjects, is now the first such independent board to achieve national accreditation. The citation was announced by the Association for the Accreditation of Human Research Protection Programs (AAHRPP), in Washington, D.C.

Angela J. Bowen, M.D., founder and president of WIRB, said the award was a tribute to the 220 employees at the WIRB Olympia campus and to more than 100 review board members who have performed oversight of clinical investigations in more than 30 nations and in all 50 U.S. states.

"We are an independent, ethical review board dedicated to the protection of human research subjects, with no affiliation with any sponsor, pharmaceutical company, contract research organization or government agency," she said.

Now in its 35th year, WIRB has provided review of the research conducted by more than 10,000 independent investigators, as well as research taking place in universities, medical schools and medical centers. WIRB currently provides oversight for some 3,300 research projects at 7,000 sites with the mission to "protect the rights and welfare of the human research subject."

The primary mission of review boards, commonly called Institutional Review Boards (IRBs), is to safeguard the rights and welfare of human test subjects - both before and during their involvement in a medical research study. These impartial review panels perform the job of risk/benefit assessment - ensuring that the risks are both minimized and fairly disclosed to study participants when testing drugs, vaccines, or medical devices. IRBs have the authority to approve, require modifications to, or disapprove the proposed study protocols and consent forms for research, which will involve human subjects. In addition, IRBs must review and approve or disapprove the investigator for the research. Once approved, the IRB must monitor the progress of ongoing research.
The AAHRPP organization, responding to public and political scrutiny of research involving human participants, seeks to raise the bar in human research protection by helping institutions attain standards that surpass state and federal requirements. The WIRB accreditation process involved months of documentation assembly by WIRB, an extensive self-assessment process and a lengthy on-site evaluation with complete access to staff and facilities by AAHRPP.

Recognizing WIRB as "a leader in clinical research reviews," the Washington State Senate unanimously passed a resolution acknowledging WIRB's receipt of AAHRPP accreditation. The accreditation established a "gold seal", as described by the Senate, "signifying adherence to rigorous standards for human protection, ensuring consistency and uniformity among all institutions conducting biomedical, behavioral, and social sciences research; and that WIRB strives to ensure that risks of scientific advancement never outweigh the value of human life…"

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June 2002
Annual Training Seminar

WIRB's 2002 Annual Training Seminar will be a departure from our customary format. We will join the Fred Hutchinson Cancer Research Center and the University of Washington in hosting a regional OHRP/FDA/VA Human Subjects Protection Conference at the Bell Harbor Convention Center in Seattle, Washington, on August 15-16, 2002. More information on this important conference is available at the Fred Hutchinson web site.

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April 2002
How Do You Receive Your Documents From WIRB?

Did you know that WIRB can fax or e-mail your documents to you? You could receive your documents via fax or e-mail as many as two days earlier than documents sent via overnight mail.

If you ask WIRB to fax or e-mail your study documents to you, the documents are sent immediately after they are completed. Hard copies of the documents then follow in the mail. Most sponsors will authorize drug shipments and subject enrollment based upon receipt of faxed or e-mailed study documents.

WIRB can set up a different method of document distribution for each contact associated with the study. Investigators can be faxed, while sponsor or CRO contacts receive their documents via e-mail and the SMO gets their courtesy copy in the mail.

If you are interested in this service, please contact Client Services at 1-800-562-4789 or by e-mail at clientservices@wirb.com.

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March 2002
Initial Review Submissions

WIRB is pleased to announce its revised submission form for initial review. The new submission form is designed to improve the Board's ability to protect the rights and welfare of subjects by requesting additional information related to subject safety. The new form is also designed to request information in a more direct, user-friendly style.

The appearance of the form has been updated. The form is now available in .PDF format and a new fillable Word 2000 format. Each question is numbered for easy reference and questions on similar topics have been grouped together.

As you complete the form, you may find it useful to use the new checklist on page 8. The new checklist summarizes the supporting documents requested in the body of the form. This form will improve WIRB's ability to provide timely, accurate review services to investigators. We expect our customers will find the form more straightforward and easier to complete. If you have questions regarding submissions to WIRB, please contact Client Services at 1-800-562-4789 or by e-mail at clientservices@wirb.com.

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February 2002
International Research Review

The Western Institutional Review Board has offered international research review services since 1986. WIRB has reviewed research for sites in a variety of countries, including:

• The Bahamas
• The Dominican Republic
• The Dutch Caribbean
• Germany
• Ireland
• Japan
• The People's Republic of China
• Poland
• The Slovak Republic
• South Africa
• Tunisia
• United Kingdom
• Vietnam

• Brazil
• Chile
• Costa Rica
• Ecuador
• Guatemala
• Mexico
• Panama

• When study data is expected to be submitted to the U.S. FDA;
• When a local ethics review committee is not available; or
• When a supplement to local ethics review is desired.

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• CCRC - Certified Clinical Research Coordinator
• CCSA - Certified Checkpoint System Administrator
• CLS - Clinical Laboratory Scientist
• CNE - Certified Novell Engineer
• CPA - Certified Public Accountant
• CQA - Certified Quality Auditor
• CQM - Certified Quality Manager
• JD - Doctor of Jurisprudence
• MAAA - Member of the American Academy of Actuaries
• MCP - Microsoft Certified Professional
• MCSE - Microsoft Certified Systems Engineer
• MD - Doctor of Medicine
• MHA - Masters of Hospital Administration
• MS - Masters of Science
• PhD - Doctor of Philosophy
• PHR - Professional of Human Resources
• RN - Registered Nurse

In addition to the experience and knowledge combined in the degrees and certifications mentioned above, WIRB is also pleased to announce that 21 staff members have passed the CIP (Certified IRB Professional) exam. This certification for IRB professionals is highly valued and provides formal recognition of knowledge of IRB functions and human subject protection systems. By bringing all of these people together, WIRB is able to present a range of experience and services to our clients. We do this in order to offer our clients the best independent IRB review available, with expert ethical, medical and scientific representatives. Due in part to some of the factors mentioned above, WIRB is able to offer a variety of services to our clients, including local review in Canada and South America, non-local, centralized review throughout the United States, and international review, when requested. If you are interested in learning more about WIRB, please contact client services at clientservices@wirb.com or at 1-800-562-4789.

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December 2001
WIRB Establishes a Canadian Board
Release by Cynthia M. Dunn, M.D., Vice President, Operations

Effective September 1, 2001, amendments to the Canada Food and Drug Regulations include specific requirements regarding Research Ethics Boards conducting the review of Phase 1 to Phase 3 drug trials. In consideration of this new regulation, the Western Institutional Review Board (WIRB) is pleased to announce the establishment of a Canadian Board. The WIRB Canadian Board will conduct reviews in compliance with Canadian regulatory requirements, ICH and US FDA. Reviews will also be to WIRB standards.

The well-credentialed Board and its consultants possess a broad range of expertise in the medical and social sciences, ensuring high quality reviews. The Canadian Board is fully supported by WIRB's headquarters in Olympia, WA.

Additional information regarding WIRB's international review services is available by contacting Client Services at (800) 562-4789 or by visiting our web site at www.wirb.com. WIRB looks forward to continuing to serve your research review needs.

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November 2001
WIRB Employees and the Certified IRB Professional (CIP) Examination.

WIRB is proud to announce that eight (8) employees have been certified as CIPs. In addition, nineteen (19) more employees took the CIP examination in October 2001, and are currently awaiting their results.

The Council for Certification of IRB Professionals (CCIP), an affiliate of Applied Research Ethics National Association (ARENA), endorses the concept of voluntary, periodic certification by examination for all IRB (Institutional Review Board) professionals. Certification is one part of a process called credentialing. Certification focuses specifically on the individual and is an indication of current knowledge in a specialized area of practice. Certification for IRB professionals is highly valued and provides formal recognition of knowledge of IRB functions and human subject protection systems.

The Certification Program is sponsored by the Council for Certification of IRB Professionals (CCIP), an affiliate of ARENA. The Certification Examination for IRB Professionals is administered for the CCIP by the Professional Testing Corporation (PTC).

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