Special Review

The Special Review page contains information pertaining to reviews required for regulatory compliance. Types may be identified and their approval status is recorded along with the relevant protocol number, key information, and any comments provided by reviewers. A special review refers to an award that requires additional review by an institutional committee or official, for example, proposals that include the use of Biohazard Materials in research.

Figure 320 Award Document, Special Review Page – Special Review Section Example

Field	Description
Type	Required. The type of special review relevant to the document. Type selections include use of: Animal Usage Biohazard materials Human Subjects International Programs Radioactive Isotopes Recombinant DNA Space Change Export Control Conflict of Interest
Approval Status	Required. The status of the special review type. Approval statuses include: Pending Approved Not Yet Applied Exempt Link to IRB
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 WVU’s relevant committee (e.g., IRB, IACUC). A unique number assigned by the institution and/or compliance committee to a specific research protocol. Currently, human subject research protocols are the only type of protocols that can be connected to an award and are therefore viewable.
Application Date	The date the PI submitted a protocol/request for permission to the relevant regulatory committee for special review.
Approval Date	The date the protocol/request for permission was approved by the relevant regulatory committee for special review.
Expiration Date	The date an existing protocol expires.
Exemption #	One of six (6) categories of exempt research specified by the Common Rule (45 CFR 46.101(b)). If the proposed project is exempt, an exemption number is generally issued and should be entered into this field.
Comments	Internal notes relevant to the protocol or special review item.

Table 118 Institutional Proposal Document, Special Review Page – Special Review Section Column Descriptions

Add Special Review Lines

Only OSP Administrators have the ability to add Special Review lines. All other users will have view only access.

The Type and Approval Status are required fields to add a special review to a proposal. Click on the drop-down menu to select the appropriate special review types that are relevant to this proposal in the Type field. Click on the drop-down menu in the Approval Status field to select the status of the previously-selected type. Enter all information known about the protocol and comments regarding the special review. In the Protocol Number field, search for the protocol number for any human subject research protocols by clicking the search icon to use the Protocol Lookup feature or type in the protocol number for all other special review types, if known. If known, enter the Application Date in the text box in MM/DD/YYYY format or select the date by clicking on the calendar icon. If known, enter the Approval Date in the text box in MM/DD/YYYY format or select the date by clicking on the calendar icon. If known, enter the Expiration Date in the text box in MM/DD/YYYY format or select the date by clicking on the calendar icon. Select the appropriate exempt number from the spin box in the Exemption# field. Type within the text box to enter internal notes in the Comments field. After all selections have been made, click the add button to add the review entry as a numbered line item. To remove a line item, click the delete button.

Searching Protocols

To search for human subject research protocols within WVU+kc, click the search icon in the Protocol Number to use the Protocol Lookup feature. Enter information within the search fields provided. If searching for all protocols submitted by a particular investigator, it may be useful to utilize the wildcard search by entering the investigator’s last name in the Investigator field and searching. For example, if searching for a protocol submitted by Dr. Bluebeard, enter *bluebeard* in the Investigator field and all of Dr. Bluebeard’s protocols will be displayed in the search results. Refine the search for Dr. Bluebeard if the type of protocol is known, by selecting a type in the Protocol Type field such as NHSR, Exempt, Expedited, or Full Board.

For more information about searching, see Search Tips quick reference guide.

Figure 273 Award Document– Protocol Lookup Page