1PURPOSE
1.1This document describes the procedures for the initial intake of items from investigators intended for review by the Human Subjects Division (HSD) or the University of Washington (UW) Institutional Review Board (IRB).
2POLICY
2.1Each incoming item is marked with the date received at HSD, if it is not already indicated on the item(as, for example, occurs with a printed email).
2.2Applications concerning new projects are assigned to an IRB or HSD staff member on the following basis:
2.2.1Exempt requests and Human Subjects Research determinations. They are assigned to an HSD staff person based on the investigator’s department.
2.2.2Expedited review (“Minimal Risk” applications). They are assigned to an expedited reviewer based on the investigator’s department.
2.2.3Applications requiring full IRB review. All other applications are assigned to a full IRB by an Assistant Director of Operations,on the following basis and sequence:
2.2.3.1Nature of risks to subjects. If there are more than minimal physical risks to subjects, the application will be assigned to a biomedical IRB. Otherwise, it will be assigned to a social/behavioral IRB.
2.2.3.2Specific methodologies, topics or subject populations. Research involving certain specific methodologies, topics, or subject populations is generally assigned to the same IRB, based on IRB member expertise. For example, one UW IRB reviews all research involving the emergency medicine exception to informed consent.
2.2.3.3Principal investigator, Department, School or College. After the above factors are considered, the assignment system aims to ensure that all research from a specific investigator, department, school or college is consistently assigned to the same IRB (based on IRB member experience and knowledge).
2.3Items for already-approved projects are assigned to the same IRB that has been responsible for the most recent reviews. In rare circumstances it is necessary to temporarily or permanently transfer an item to a different IRB. The transfer is performed as a separate procedure, after the initial intake, by other staff. (See SOP Transfer to Another UW IRB.)
3DEFINITIONS
3.1None
4RESPONSIBILITIES
4.1The HSD staff person fulfilling the role of Submission Intake Coordinator performs these procedures, except as noted below.
5PROCEDURE: Paper items
5.1All items are routed upon receipt to the Submission Intake Coordinator, who performs the following procedures.
5.2Checking for completeness.
5.2.1The following issues are checked for completeness.
5.2.1.1Correct number of copies, as indicated on each form.
5.2.1.2Required signatures, as indicated in the SOP Signatures on IRB Forms.
5.2.1.3Current versions of forms.
5.2.2Incomplete items. The Submission Intake Coordinator contacts the investigator or study contact person about incorrect versions of forms or to obtain missing signatures or items. Missing copies are made at HSD or (if a large item) requested from the investigator or study contact.
5.3Stamping. Items are not to be stamped if they are incomplete.
5.3.1Date stamping. The date an item is received at HSD is stamped, if the item is not already marked (for example, an item is a printed email).
5.3.1.1The date in the stamp should be correct and legible.
5.3.1.2The stamp is placed in the upper right hand corner of the document, for items with no date box. Whenever possible, the date stamp is placed so as to not cover any information on the document.
5.3.1.3The first page of all application forms, and the first page of all supporting materials attached to an application, are stamped.
5.4Highlighting. The following items have highlighting applied as indicated.
5.4.1Application forms. The copy “type” is highlighted (e.g., Master, Committee, Investigator). There is no Committee copy for items that are reviewed by the expedited process or by HSD staff.
5.4.2Closure/Do Not Renew forms. The submission reason (“Close IRB application”) is highlighted.
5.4.3Serious Adverse Event reports. “AE/Safety Report” is highlighted on both copies, and “Researcher” is highlighted on one copy.
5.5Collating. Copies are collated into complete sets, if they do not arrive already collated.
5.5.1Each set is clipped together.
5.5.2The Master Copy is always placed on top of the other copies.
5.5.3The complete set of copies is clipped together.
5.6IRB assignment.
5.6.1The IRB assignment is made as described above in Sections 2.2 and 2.3.
5.6.1.1When an investigator lists more than one department, the assignment is based on the nature of the project and the department of the Department Chair who signed the application.
5.6.2The Submission Intake Coordinator makes all assignments except for applications for new projects that require full IRB review. Assignments for full convened IRB review for new applications are made by the Assistant Director of Operations.
5.6.3The IRB assignment is marked on the face page of each copy of an application form, and in the HSD database.
5.7Data entry. A record is created in the HSD database (“DORA”), following the procedures and data entry steps described in the DORA Reference Manual.
5.8Capturing email addresses. This step applies only to submissions for which a new record must be created in DORA for the lead researcher and/or the study contract person (i.e., for people who are not already listed in the DORA database).
5.8.1The Submission Intake Coordinator provides the HSD Information Manager with the first name, last name, and email address of the new person.
5.8.2The HSD Information Manager adds the name and email address to the subscription list for the HSD e-Newsletter.
5.9Distribution. The items are distributed to the appropriate staff member/teams, to perform pre-review.
6PROCEDURE: Email items
6.1HSD does not generally accept applications by email, though HSD staff may grant exceptions in some circumstances (such as a researcher who is currently out of the country and needs to submit a Status Report). However, a significant portion of correspondence occurs by email. For all items related to determinations, pre-review, IRB review, new information, complaints, inquiries or other study-related items:
6.1.1Print the item.
6.1.2If the date received is not indicated, stamp the receipt date in the upper right hand corner of the first page.
6.1.3Complete any appropriate data entry (see DORA Reference Manual).
6.1.4Handle appropriately for the item, as described in other SOPs (for example, the SOP on Modifications). All items related to an IRB application/file become part of the IRB file. (See SOP IRB Records.)
7MATERIALS
7.1SOP Transfer to Another UW IRB
7.2SOP Signatures on IRB Forms
7.3DORA Reference Manual
7.4SOP IRB Records
8REFERENCES
8.145 CFR 46.115 and 21 CFR 56.115
Version 1.2 / 1639Implemented / 12/09/2013 / Page 1 of 4