Institutional Review Board Services

Pursuant to the authority of FAR 13.106-1(b)(1)(i), the Contracting Officer

may solicit from one source if the Contracting Officer determines that the

circumstances of the contract action deem only one source is reasonably

available. The Agency for Healthcare Research and Quality (AHRQ), intends

to issue a sole source to:

Advarra, Inc.

6940 Columbia Gateway Drive, Suite 110

Columbia, MD 21046

In accordance with the Federal Policy for the Protection of Human Subjects

("Common Rule"), HHS regulations 45 CFR 46 states that all federal funded

research grants or projects must be reviewed by an institutional review

board (IRB) and that the IRB must be registered with the Department of

Health and Human Services (HHS) Office of Human Research Protections

(OHRP). In order to remain in compliance with HHS regulations, Agencies

with a federal wide assurance (FWA) must therefore designate and register

at least one IRB with OHRP to perform the ethical review their research

functions.

Advarra (previously called Chesapeake IRB) has provided IRB review

services for AHRQ intramural research activities since at least 2004. AHRQ

would like to continue its association with Advarra due to their familiarity

with health services research AHRQ intramural researchers’ conduct, from

previous review of AHRQ studies.

Due to the complexity of the issues related to the agencies' IRB review and

human subjects applicability, in person interactions and meetings are

sometimes required. In addition, the majority of AHRQ's, Advarra, Inc.

has the credentials and qualifications required to review this unique

database.

A selection of another vendor could possibly delay the review of research

projects and as a result of having to train a vendor about AHRQ's databases

and research projects and ensure that they are knowledgeable regarding

HHS federal regulations, 45 CFR 46, agency would not be able to

continue with projects that they have been working on for years due to a

lack of knowledge involving the projects by a new vendor selection.

Consequently, all efforts in previous research could possibly be nullified.

Research projects involving human subjects and/or patient identifiable data

are required to be reviewed annually.

This notice of intent is not a request for competitive proposals. A

determination by the Government as to whether or not to compete this

proposed contract action based upon responses to this notice is solely

within the discretion of the Government. Interested parties regarding this

sole source action may contact the contract specialist, Bob Zuhlke, via email at

Robert.Zuhlke@ahrq.hhs.gov  no later than the time and date specified in the posting.