The investigator is required to enter information about alternate database or literature searches they have performed when they plan to use procedures that cause more than momentary pain and distress.
Alternate Search Required? The investigator can select Yes or No to the question “Does the protocol involve procedures which cause more than momentary pain and distress”. If the research involves procedures that cause more than momentary pain and distress (typically procedures with pain category D and E), the investigator must search for procedures that cause lesser pain and distress and provide the same research outcome. If the investigator selects Yes the investigator can then provide details about the databases searched. If the investigator selects No the investigator does not have to provide any information about alternate database searches and can save and move on to other protocol sections.
The system makes it mandatory for the investigator to select Yes or No for the question “Does the protocol involve procedures which cause more than momentary pain and distress” prior to submission of the IACUC protocol. If a value is not chosen, a data validation error is generated by the system when the investigator tries to submit the protocol. |
Figure 838 Protocol Document, The Three R’s – Alternate Search Required
Table 437 Protocol Document, The Three R’s, Alternate Search Required
Field |
Description |
Does the protocol involve procedures which cause more than momentary pain and distress |
Select one of the following choices: Yes/No. Use the drop-down menu by clicking the down arrow to display the list, and then click on an item in the list to highlight and select it to populate the box with your selection. |
Alternate Searches: This section becomes visible when the investigator responds Yes to the question “Does the protocol involve procedures which cause more than momentary pain and distress”. It allows the investigator to provide detailed information about the databases they searched, the keywords used in the search and additional details.
Figure 839 Protocol Document – The Three R’s – Alternate Searches
Table 438 Protocol Document, The Three R’s, Alternate Searches
Field |
Description |
Date |
Required field. Enter or select the date the database search was performed. Click the calendar icon to select, or type in mm/dd/yyyy format to populate the box with the desired date. |
Databases |
Required field. Specify the databases you performed a search on for less painful procedures
• Select the databases from the list of databases in the Available panel. After selecting a database name, use the right pointing arrow to move the database from the Available panel to the Selected panel. To deselect a database that is within the Selected panel, select it and use the left pointing arrow to move the database name from the Selected panel back to the Available panel. Multiple databases can be selected by an investigator.
• You can manually enter database names that are not in the Available panel. Enter the database name in the Other data entry box. Click the add button and the database name entered in the Other data entry box will appear in the Selected panel. Once the database name appears in the Selected section, use the left pointing arrow to deselect and move it to the Available panel OR use the use the right pointing arrow to move the database from the Available panel to the Selected panel
|
Years |
Required field. Specify the publication years or date range that the literature search was performed against. To enter the years searched or the date range, 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. |
Keywords |
Required field. Specify the keywords that were used in performing the database search. To enter the keywords, 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. |
Comments |
Provide a summary of the database search performed and describe whether less painful procedures were found and if so reasons for using or not using the less painful procedures. To enter comments, To enter the years searched or the date range, 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. |
Action |
Required. Click the add button after you’ve made your selections to cause the database to be added as a numbered row in the table below. For previously-added database lines, click delete to remove the line, if needed. For more information about basic line item functionality, see “Common Line Item Operations” in Common E-Doc Operations. |