Institutional Review Board

Institutional Review Board

Western IRB Review for Multi-center, Industry Sponsored Research
In January 2004, Charles R. Drew University (CDU) signed a contract with the Western Institutional Review Board (WIRB) located in Olympia, Washington to serve as the IRB of record for all multi-center, industry sponsored research to be conducted on CDU campus.

CDU/WIRB Liaison
The Office for the Protection of Human Subjects is the administrative office for the IRB and is located in Bldg. F. This office will coordinate sending an invoice to the sponsor for IRB review; review the pre-approval internal CDU process, transmission of new applications to WIRB. For approved WIRB studies, documents requesting any changes, amendments, or modifications will also be administratively handled by this office.

Pre-Review Submission Forms

When an application is submitted to the CDU/WIRB Office, it must contain the following completed, signed forms with the appropriate attachments:

WIRB REQUIREMENTS:

  • WIRB Initial Review Submission Form
  • Protocol (date: __________ ) 
  • Complete grant application, if submitted to a Federal agency.
  • DEA and Medical Licenses for Principal Investigator
  • Medical Licenses for all Sub-Investigators (if applicable)
  • Curriculum Vitae for Principal Investigator and all Sub-Investigators
  • Signed FDA Form 1572, if applicable, with WIRB listed as the IRB (date: )
  • Informed consent form using WIRB template
  • Advertisements (How many? ) , questionnaires, subject diaries, etc.
  • Investigator's Drug Brochure (dates for those included: ________________)
  • Background Information for Food Supplements
  • Documentation from sponsor or FDA verifying the IND number (if applicable).  If the IND is not required, provide a written reason.
  • If a DEVICE study, provide device manual  and ONE of the following:  unredacted FDA approval letter for IDE, OR sponsor letter stating that it is a non-significant risk device study, OR a justification of why the investigation is exempt from IDE requirements under 21CFR812.2(c) or otherwise exempt.
  • HIPAA Authorization/Waiver (see the WIRB web site http://www.wirb.com/ for additional information on HIPAA and to download forms for waivers of authorization).

    WIRB Forms: http://www.wirb.com/


CDU REQUIREMENTS:

  • Internal Authorization Form
  • Financial Disclosure Form
  • Certification of education in research ethics and the protection of human subjects and HIPAA for all research staff.
  • Copy of the Subjects Bill of Rights
  • Radioactive Drug Research Committee Approval and/or Biohazards and Safety Committee Approval (if applicable)
  • LA County Research Oversight Committee Form
  • If outside facilities or agencies are used as research sites, letters of agreement. These letters must be on the facility's letterhead. If these facilities have an IRB, include a copy of the letter of approval for this study.
  • Authorization statement for conducting research signed by 1) Department head or 2) Director of Participant and Clinical Interactions Resources (PCIR)

    CDU Forms: Please inquire Dawna Masterson at 323-563-5902.

 

CDU/WIRB Pre-Approval Process

  • Prepayment of WIRB/CDU Fees
    The pre-approval process begins with contacting Dawna Masterson, Policy and Regulatory Analyst, Office for the Protection of Human Subjects at Charles Drew University at (323) 563-5902. To avoid any delays, it is advisable to discuss your plans to conduct a multi-center, industry sponsored research study on campus early. CDU requires the WIRB expenses to be prepaid. Some industry sponsors require several weeks upon receipt of a written invoice before payment is initiated and sent to the University.
    Cost for WIRB services will vary. It is reasonable to anticipate the sum to collect from the sponsor will be about $2400 for initial review ($1750) with two amendments ($570 for both). An invoice will be prepared for the industry sponsor. Please provide the 1) name of the industry sponsor, 2) industry sponsor address and 3) any known contact information.
  • Preparing the CDU/Western IRB Forms
    Concurrently, to the sending of the invoice, the Investigator should prepare the WIRB documents and the CDU internal documents as described above. The Investigator will be notified once the check from the industry sponsor has been received. The Investigator should submit the WIRB forms and the CDU forms for an administrative review by the CDU's Office for Protection of Human Subjects located in Building F. If the CDU's internal submission is deficient in any documentation, signature of approval or any other concern, the investigator will be contacted by written correspondence. A courtesy email will also be sent to the Investigator. Important Note: Please verify signature of Departmental review approval or PCIR approval on CDU's authorization form, before submitting to the CDU/WIRB.

CDU/WIRB Fees [as of April 2008]

New Research Submission ($1750)

  • New protocol/research review

Multicenter Studies, Additional Investigators ($825 each person)

  • Site specific consent forms
  • Site specific recruitment materials

Research Study Year 2 and Beyond ($825 for each site)

  • Continuing review (annual renewal) at each site

Changes Made to Research Study ($285 for each site)

  • Protocol amendments/revisions
  • Consent form modifications
  • New or updated recruitment/retention materials
  • Change to research locations
  • Increased subject enrollment level
  • Site prepared translations
  • Other changes to research

Amendment to Change Investigator/Add Co-investigator ($825 for each site)

Videoconference ($350)

Teleconference ($150)

IRB Study Transfer ($550)

  • Review of IRB and study records for research in progress.  Initial review fees also apply.


Generic Non-Protocol Related Materials ($550)

  • e.g. Regulatory exempt determination, site pre-screening consent forms, generic advertising, centralized call screening or recruitment scripts

WIRB Translations Services (Variable per English word)

  • Minimum translator charge $150 + change to research fee

IRB Written Consent Form (Variable $150/hour)

  • Minimum charge $450

Miscellaneous Fees

  • US Government Express Mail + handling charges
  • CDU administrative charges
  • Sending the IRB Documents to Western IRB office

    After successful completion of all internal documents for CDU, the research submission packet is ready to be sent to the Western IRB administrative office in Olympia, Washington. The Investigator will be notified by email or telephone contact when the documents are completed and ready for submission directly to WIRB. The Investigator may retrieve the prepared IRB documents and return to his/her office for mailing.

    Mailing Address:

    Western Institutional Review Board
    3535 7th Ave., SW
    Olympia, Washington 98502
    Telephone Number: (360) 252-2500

    Or, the Investigator may have the CDU IRB administrative office mail the documents using the US Government, Express Mail for the cost of $30.00, no later than 2 pm, Monday - Friday. The Investigator will be notified by email or telephone contact when the WIRB submission was mailed. Upon request, a copy of the receipt can be faxed to the Investigator.
  • Western IRB Response to the Documents

    The Investigator and the CDU IRB administrative office will be notified when the packet is received by WIRB and how to track the study during the WIRB review process. The Investigator should contact the WIRB directly with any questions or concerns regarding the review of the study. WIRB telephone number is (360) 252-2500.

    At the time of initial review, WIRB will determine the duration of the approval period and any reporting requirements placed upon the investigator. This determination is based on the level of risk to potential subjects. Additionally, WIRB will require the investigator to report his or her study status, on a quarterly basis to WIRB. There is no charge for the quarterly reporting.
  • Western IRB Second Year Approval and Beyond

    Continuing review by Western Institutional Review Board (WIRB) routinely includes interim progress reports, as directed by the Board, review of proposed changes to research, adverse event reports, review of any protocol deviations, visits to the research site, and annual review of the research. At the end of the first year of the study, if the Investigator informs WIRB that the study is still ongoing, WIRB will process the Continuing Review, which will issue approval for the second year. WIRB will automatically generate the Continuing Review Report forms directly to the Investigator for completion and subsequent return to WIRB. The continuing review form must be filled out completely and returned to WIRB in a timely manner. Even if the site has not started enrolling subjects, the continuing review form must be completed and returned to WIRB so that the Board is informed of the study's status at the site.

    WIRB/CDU will assess a fee of $825 for the second year's approval. CDU requires the WIRB expenses to be prepaid. It is reasonable to anticipate the sum to collect from the sponsor will be $825 for annual renewal, and $285 per year for consent or protocol changes. Some industry sponsors require several weeks upon receipt of a written invoice before payment is initiated and sent to the University. Please ensure plenty of time between the study's expiration date and time to solicit funds from the Industry sponsor.

    WIRB has a full-time staff of more than 150 provide support services. A toll-free telephone line (800-562-4789, USA, Canada & Puerto Rico) is available 24-hours a day to assist study subjects. WIRB has on-site staff able to assist callers in several languages, as well as supplemental support from AT&T translation services.

Fees Charges for Research Study Year 2 and Beyond ($825 for each site)

  • Continuing review (annual renewal)
  • Western IRB Amendments to Consent and Protocol

    Investigators must submit the exact text of an amendment or other revisions to the protocol and any proposed changes to the consent document to WIRB. WIRB/CDU will assess a fee of $285 for an amendment. CDU requires the WIRB expenses to be prepaid. Some industry sponsors require several weeks upon receipt of a written invoice before payment is initiated and sent to the University. Please ensure plenty of time between the study's required amendment and time to solicit funds from the Industry sponsor. When there are numerous changes to the research protocol, a summary of the changes is requested. If the amendment does require a change to the approved consent form, please list each specific change. You may include a copy of the most recently WIRB-approved consent form, with legible, hand-written changes to that form. The changes cannot be implemented until approved by the WIRB Board. "Change in Research" and other forms can be obtained from the WIRB website at www.wirb.com

    Fees for Changes Made to Research Study
    $285 - Amendment to Protocol/modification to Subject

$825 - Amendment to change Investigator/ add Co-Investigator

$500 - Administrative Change to Subject Consent Form

  • Protocol amendments/revisions
  • Consent form modifications
  • New or updated recruitment/retention materials
  • Change to research locations
  • Increased subject enrollment level
  • Site prepared translations
  • Other changes to research
  • Adverse Events Reports of adverse events (AEs) should be made to WIRB from both sponsors and investigators, and are subsequently categorized by severity and source by WIRB staff. All adverse events are screened initially by a trained WIRB staff member to identify the protocol, study, and investigator numbers. All adverse event reports are reviewed by a WIRB Board member.
    AEs are entered in a database and a copy of the report is filed by drug name. All investigator correspondence is retained by Western Institutional Review Board as required by regulations. The reviewing physician determines -- based on the information in the AE report and the current subject consent form -- if subjects should be notified verbally of the AE or if consent form modifications may be necessary. Recommended changes are then submitted to the Board for consideration. Both the Sponsor and Investigator(s) are notified of any Board action or consent form change resulting from an AE report.
    Whenever an unexpected AE that involves risks to human subjects or others occurs at a WIRB approved investigator site, it should be reported to WIRB using the established reporting procedure. Instructions and report forms can be found on the "Download Forms" section of the www.wirb.com
    If you have any further questions, contact the Charles Drew University, Office for the Protection of Human Subjects, located on campus in Building F, telephone number (323) 563-5902. Or, Western IRB, 3535 7th Ave., SW, Olympia, Washington 98502- 2029; telephone number (360) 252-2500 or fax number (360) 252-2498.