The Special Review section contains information pertaining to reviews required for regulatory compliance. Types may be identifies, their approval status is recorded, and relevant protocol number, and key date information is displayed, along with access to any comments provided by reviewers. A special review refers to a grant proposal that requires additional review by an institutional committee or official (for example, for proposals that include the use of Biohazard Materials in research).
Figure 307 Institutional Proposal Document, Special Review Page – Special Review Section Example
Table 173 Institutional Proposal Document, Special Review Page – Special Review Section Column Descriptions
Field |
Description |
Add |
The line where you make your entries and selections and click the add button, which adds them as numbered line items below. |
Type |
Required. The type indicates which special
review, if any, is relevant to the document (proposal/award/irb).
Type selections include use of animal usage, biohazard materials,
foundation relations, human participants, international relations,
radioactive isotopes, recombinant DNA, space changes, TLO PR-Previously
Reviewed, TLO Review – no conflict (A), TLO Review – potential conflict
(B2), TLO Reviewed – no conflict (B1).Click the down arrow |
Approval Status |
|
Protocol Number |
The unique identifier assigned to the protocol
submitted for regulatory review. The protocol # is the number assigned to
the protocol submitted by the PI to the institution's relevant committee
(e.g. IACUC, IRB, etc.). A unique number assigned by the institution
and/or compliance committee to a specific research Protocol. Type the
value if known in the box, otherwise, search for and select it and
populate the box automatically by using either the lookup |
Application Date |
The date the protocol was submitted to the
regulatory committee. The application date is the date the PI submitted a
protocol/request for permission to the relevant institutional
committee/person for special Review. Enter the date in mm/dd/yyyy format or select it
using the date selector by clicking on the calendar icon |
Approval Date |
The date the protocol was approved by the
regulatory committee. The approval date is the date the protocol/request
for permission was approved by the relevant institutional
committee/person. Enter the date in mm/dd/yyyy format or select it
using the date selector by clicking on the calendar icon |
Expiration Date |
The date, after which, the existing protocol expires.
Enter the date in mm/dd/yyyy format or select it from the calendar
selector to specify the date this special review will expire. Enter
the date in mm/dd/yyyy
format or select it using the date selector by clicking on the calendar icon |
Exemption # |
One of six categories of exempt research specified by the Common Rule (45 CFR 46.101(b). If the proposed project is exempt, as defined by the different institutional committees, an exemption number is generally issued, and is entered into this field. Scroll the spin box to view the list items from which to select. |
Comments |
Type to enter internal notes relevant to the protocol or special review item. |
Actions |
After line items have been added, they may be removed by clicking the delete button. |