Established in 1989, Southwest Independent Institutional Review Board, Inc. (SIIRB) is a national Institutional Review Board (IRB) specializing in the review of Ophthalmic research. SIIRB consists of a unique, diverse group of individuals bound by the commitment to protect the rights and welfare of clinical research subjects by ensuring compliance with all applicable federal and state 
regulations, including Food and Drug Administration (FDA) and the Office of Human Research Protection (OHRP) guidance. SIIRB abides by the International Committee on Harmonisation (ICH) Guidelines and Good Clinical Practice (GCP) guidelines. These members are highly qualified with significant knowledge and experience in ethical principles, legal precedents and scientific methodology. In addition the board has consulting Ophthalmologist in each subspecialty.
The purposes of this guide are to:
• inform sponsors / investigators / CROs of requirements for protocol submissions necessary to facilitate the review process;
• outline the Board’s requirements for investigators conducting a study in which SIIRB is the reviewing IRB.
MULTI-SITE/CENTRAL IRB
The Board is available to conduct multi-site reviews or act as the “Central IRB” on studies within the United States.
SUBMISSION DOCUMENTS
Each study submission must include all documents listed on the SIIRB checklist. All questions must be answered in full. All submission documents are available on the SIIRB web site in an electronic format.
(Refer to http://www.siirb.com/Forms/tabid/240/Default.aspx.)
IRB NUMBER
SIIRB assigns an IRB number to your study when it is received. The IRB number will remain the same throughout the study. Please reference the IRB number on all correspondence or calls
TURN-AROUND-TIME
The standard turn-around-time for review of a protocol and consent document is less than one week.
BOARD MEETINGS
The Board meets at least weekly on Thursdays. Due to some holiday weeks and other unforeseen conflicts the Board may not meet every Thursday.
The Board must receive all new study submissions no later than Friday 4:00 p.m. CST, one week prior to a Thursday meeting date to avoid additional fees.
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RECRUITMENT MATERIALS
You must submit all advertisements and recruitment materials for review and obtain approval prior to using the materials. Recruitment materials include, but are not limited to, newspaper television and radio advertisements, subject letters, web sites, posters, scripts for phone screens, newsletters, brochures, prescreening questionnaires, prescreening consent documents, and Doctor to Doctor letters. Research sites should inform prospective study subjects of all studies for which they are eligible.
AMENDMENTS AND/OR REVISED CONSENT DOCUMENTS
You must submit all amendments or changes to the protocol to the Board for review and obtain approval from the Board prior to implementing the proposed amendment or change. .
All revisions to an informed consent document must be submitted to the Board, including those not resulting from an amendment (e.g., an increase in compensation, an addendum, additional safety information). You must submit a copy of the most recent SIIRB approved informed consent document with all changes.
REVISED INVESTIGATOR’S BROCHURE
SIIRB requires that each revised investigator’s brochure (IB) be submitted in a timely manner.
INVESTIGATOR RESPONSIBILITIES
The Belmont Report
Each investigator should be familiar with the Belmont report. This report was issued in 1979 and outlines the basic ethical principles and guidelines for research involving human subjects. Refer to the FDA web site:
http://www.fda.gov/oc/ohrt/belmont.html
Good Clinical Practice
• Investigators are responsible for conducting clinical research in accordance with Good Clinical Practice. For further information about Good Clinical Practice, review the following sections of the Code of Federal Regulations:
• Title 21 Part 50 (Informed Consent): http://www.access.gpo.gov/
• nara/cfr/waisdx 99/2 1cfr50 99.htm
• Title 21 Part 56 (Institutional Review Boards): http://www.access.gpo.gov/nara/cfr/waisidx 99/2 1cfr56 99.html
• Title 21 Part 312 (Investigational New Drug Application): http://www.access.gpo.gov/nara/cfr/waisidx 99/2 1cfr312 99.html
• Title 21 Part 812 (Investigational Device Exemption): http:/www.access.gpo.gov/nara/cfr/waisdx 99/2 1cfr812 99.html
• Title 21 Part 54 (Financial Disclosure): http://www.access.gpo.gov/nara/cfr/waisidx 99/2 1cfr54 99.html
Food and Drug Administration (FDA) Information Sheets
Investigators should be familiar with the FDA Information Sheets. They provide guidance on many topics, including, for example, recruitment materials, subject compensation, and obtaining informed consent. (Refer to http://www.fda.gov/oc/ohrt/irbs/.)
OBTAINING INFORMED CONSENT
Each potential research subject must be provided with a complete and understandable explanation of the study and an opportunity to have all questions answered. The written consent must be obtained from a fully informed subject or subject’s representative who is legally authorized to give consent, if applicable.
NON-ENGLISH SPEAKING SUBJECTS
When a site considers a non-English speaking subject for enrollment, it must have the approved informed consent document translated into the language that the subject can read and understand. The translation must be completed by a professional translation service that will certify the translation is a true and accurate translation of the current SIIRB approved English version. The site must then submit the translated version to the Board. The same procedures must be followed for revisions to the non-English consent document. It is the responsibility of the site to request an updated version of any informed consent document that has been translated. For California sites, the translated California Subject’s Bill of Rights should also be submitted, (Refer to http://www.siirb.com/Forms/tabid/240/Default.aspx.)
SERIOUS ADVERSE EVENT/SAFETY REPORTS
• SIIRB requires that all serious adverse events (SAEs) be submitted promptly (within 10 business days of the investigator’s knowledge of the event) to SIIRB. (Refer to SAE Report Form on our web site, http://www.siirb.com/Forms/tabid/240/Default.aspx.) The death of a subject must be reported immediately to SIIRB. The Board will review the SAEs. The FDA does not require IRBs to acknowledge receipt of an SAE or a Safety Report.
UNANTICIPATED PROBLEMS INVOLVING RISK TO HUMAN SUBJECTS OR OTHERS
Federal regulations require the investigator to report unanticipated problems involving risk to human subjects or others to the reviewing IRB. Any unanticipated problem involving risk to human subjects or others must be reported to SIIRB promptly after the investigator becomes aware of this event. Examples of unanticipated problems involving risk to human subjects include, but are not limited to, breaches of subject confidentiality, unanticipated additional cost to study subjects, unanticipated legal risk to a subject, and/or adverse events of increased frequency or severity.
SIGNIFICANT PROTOCOL DEVIATIONS
The Board requires the investigator to report significant protocol deviations promptly to the Board. Significant protocol deviations include any deviation that significantly affects the safety of the subjects or the scientific quality of the study.
The SIIRB Significant Protocol Deviation Form must be completed and submitted to SIIRB. Refer to http://www.siirb.com/Forms/tabid/240/Default.aspx.)
REVISIONS TO 1572s / NON-
IND/DEVICE STUDIES FORM
If revisions to the 1572 or Non-IND/Device Forms are necessary (e.g., change of Principal Investigator, addition of location (s), change in IRB, etc.), revisions must be submitted to SIIRB. Additions or changes to clinical laboratories do not need to be submitted to SIIRB.
CONTINUING REVIEW
Federal regulations prohibit the Board from approving a study for any period greater than one year; however, the Board may approve a protocol for a period of less than one year. If your study will last beyond one year or the approval period is for less than one (1) year, you must fill out a Continuing Review Report Form in its entirety and submit it at least 1 month prior to the expiration date noted on the original approval letter. The Board must have adequate time to conduct the review.