Technical and Logistical Support for IRB Review 2020

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. staff 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 staff 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, Kori Best, [email protected] no later than the time and date specified in the posting.