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.
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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 |
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 |
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
•
You can manually enter database names that are not in the Available
panel. Enter the database name in the Other
|
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 |
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 |
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 |
Action |
Required. Click the add
|