IRB Services

Informed Consent Services

Sitero IRB can assist you with development and editing of informed consent/assent documents specific to your study or site.

If you need assistance drafting or editing the informed consent/assent or would like more information, please contact us.

Sitero IRB On-Call

Sitero IRB can convene a meeting outside of the regularly scheduled meeting times specifically for your project.

The Sitero IRB On-Call™ Board will convene within 24 hours’ notification and meet all federal requirements for a duly-constituted IRB meeting.

Translation Services

Sitero IRB can provide certified translations of all study documents related to the initial and continuing review of your project.

Sitero Consulting Services

Sitero IRB can assist you with development and editing of informed consent/assent documents specific to your study or site.

If you need assistance drafting or editing the informed consent/assent or would like more information, please contact us.

Sitero IRB Institutional Services

Sitero will work closely with your local IRB so your institution can leverage the expertise of our Board and the deep-bench knowledge of our staff.

Sitero provides a turn-key compliance solution that provides seamless outsourcing of your local IRB operations with a material reduction in your HRPP operating costs.

Sitero Consulting & Staffing Services

Sitero IRB can offer services that include Protocol Development, Site Audits, and Human Research Protection Program (HRPP) evaluation for academic research institutions, hospital systems, and practice-based research programs. Clinical Quality Assurance (CQA), GxP Training, Regulatory Affairs, and other specialized consulting services are also available.

We can also provide interim experienced IRB professionals and IRB Members in order to keep your HRPP program operational with minimal disruption.

SMART IRB & Reliance Agreements

Sitero IRB is a participating member of SMART IRB. SMART IRB is a flexible master reliance agreement designed to harmonize and streamline the IRB review process for multisite studies while ensuring the highest level of protection for research participants.

Sitero IRB can serve as the IRB of record for practice-based research programs, academic institutions, and hospital systems if there is no local IRB with jurisdiction or the local IRB has jurisdiction but defers its jurisdiction to Sitero IRB in writing through an authorization agreement.

Investigators who conduct research at institutions with a local IRB and are asking for Sitero IRB coverage should be aware of any obligations or limitations that may require the use of that institution’s IRB.