Sterling Institutional Review Board

	Please note this important information regarding changes affecting Sponsors/CROs and Principal Investigators.

1. Full Board Review

The Sterling Board meets once per week (typically on Wednesday or Thursday) to review the ethical considerations associated with new and continuing research studies. Please see the Board Meeting Calendar for specific meeting dates.

New studies and changes in Sterling IRB-approved research that affect participant risk should be submitted by mail, email or fax and received by Sterling IRB at least 5 business days prior to the meeting.


		Please note: The Sterling IRB administrative staff works closely with clients to meet deadlines, particularly those that do not fall within the usual study submission timeline. The staff makes every effort to resolve any questions or concerns prior to the Board meeting to ensure timely approval.

After the meeting, the contact person for the study is notified of the results within 24 hours and written documentation is sent to the site(s) typically within 48 hours (2 business days). A PDF of the approval document is emailed to the contact person for the study (or mailed upon request).

2. Expedited Review

Expedited review commonly takes place in the case of recruitment materials, informed consent document revisions and minor protocol amendments. Expedited review is only appropriate for study modifications that require no more than minimal risk to the study participants, as well as the initial approval of research that meets specific requirements as outlined by OHRP, the Office for Human Research Protections:

http://www.hhs.gov/ohrp/humansubjects/guidance/expedited98.htm

If Sterling determines that a document qualifies for expedited review, the Sterling Chairman or designee will review the document and determine an action. If the Chairman or designee approves the document for expedited review, an approval document will be mailed to the site(s) typically within 48 hours (2 business days) of that determination. A PDF of the approval document will be emailed to the contact person for the study (or mailed upon request).

For further information or if you have any questions,
call 1-888-636-1062 (toll-free) or email .