Exemption Type

 

The Exemption Type maintenance document allows you to create and edit standard types of research exemptions used for protocol compliance.  It is used to establish and maintain numeric codes and textual description values which are stored in database tables.  This data serves as reference information that is made available for display and selection in various areas of the system, including other e-docs.

One of six categories of exempt research specified by the Common Rule (45 CFR 46.101(b).  Categories of research (primarily educational, behavioral, social science and research involving existing data, medical records, and pathological specimens) that present little or no risk to the research participants. Research that qualifies for "Exemption from IRB Review" must meet one of six categories outlined in the Common Rule (e.g. 45 CFR 46.101(b) and should not involve vulnerable research participants except under unique situations. 

On the Special Review page of the KC Proposal Development e-doc, you select an Exemption Type when the proposal involves human subjects.

Existing Value Modification:  These values are defined by the CFR.

Document Layout

Figure 1054 Exemption Type Maintenance Document Example Layout

Edit Exemption Type Codes Section

The Edit Exemption Type Codes section of the Exemption Type maintenance document is a unique section that allows you to specify and maintain the details associated with the reference table record in fields.  It displays two required fields and one optional field that let you specify each type of exemption to be used for reference and selection in the system.

 

Table 718 Exemption Type Maintenance Document - Edit Exemption Type Codes Section Field Descriptions

Field	Description
Exemption Type	Required.  Enter a numeric value to uniquely identify the exemption type in the system.  Enter the code value that uniquely defines this particular type of exemption in the system for reference and identification.  One of six categories of exempt research specified by the Common Rule (45 CFR 46.101(b).   This becomes a read-only field after saving the document and cannot be edited.
Exempt #	Required.  Enter an alphanumeric value (for example, E1) to represent the exemption type detail.  Enter the alphanumeric characters that serve as the unique number of this individual exemption.  One of six categories of exempt research specified by the Common Rule (45 CFR 46.101(b).
Detailed Description	Enter the full textual description of the exemption.  Enter text that thoroughly explains the purpose and meaning of the exemption type code.  Click within the text box (or press the tab  key from a previous field) to relocate the cursor to the field, and then type (or paste from virtual clipboard) to enter text in the box as necessary to provide the appropriate information.  Click the add note  icon to view/edit/paste text in a new browser window, then click the continue button to return to the text entry field in the document.

Examples

Figure 1055 Exemption Type Maintenance Document Example Values

Common Features

This maintenance document includes the following features that are common to most KC maintenance documents:

Table 719 Links to Common Maintenance Document Component Instructions

Common Maintenance E-Doc Component	Cross-Reference Links To Usage Instructions
Document Header	For more information, see “Header Area” on page 99 in E-Doc Fundamentals.
Document Overview Section	For more information, see “Document Overview” on page 103 in Common E-Doc Tabbed Sections.
Notes and Attachments Section	For more information, see “Notes and Attachments” on page 104 in Common E-Doc Tabbed Sections.
Ad Hoc Recipients Section	For more information, see “Ad Hoc Recipients” on page 106 in Common E-Doc Tabbed Sections.
Route Log Section	For more information, see “Route Log” on page 107 in Common E-Doc Tabbed Sections.
Action Buttons	For more information, see  “Action Buttons” on page 81 in Selection, Entry and Action Tools.

Process

For information about searching for, initiating, editing, copying, submitting, saving, closing, canceling, and/or routing a maintenance document, see “Common Maintenance E-Doc Operations” on page 129 in the Overview section.