SUPPORT SERVICES FOR THE ALL OF US RESEARCH PROGRAM INSTITUTIONAL REVIEW BOARD (IRB)

Notice ID:

NIHODM9000012022

Department/Ind. Agency:

HEALTH AND HUMAN SERVICES, DEPARTMENT OF

Sub-tier:

HEALTH AND HUMAN SERVICES, DEPARTMENT OF

Sub Command:

NATIONAL INSTITUTES OF HEALTH OLAO

Office:

NATIONAL INSTITUTES OF HEALTH OLAO

All Dates/Times are:

(utc-05:00) eastern standard time, new york, usa

Updated Published Date:

jan 06, 2022 04:44 pm est

Original Published Date:

0000-00-00 00:00:00

Updated Response Date:

jan 14, 2022 03:00 pm est

Original Response Date:

jan 14, 2022 03:00 pm est

Inactive Policy:

15 days after response date

Initiative:

• None***--***

Product Service Code:

r499 - support- professional: other

NAICS Code:

541611 - administrative management and general management consulting services

Original Set Aside:

Background The All of Us is supported and overseen by the National Institutes of Health (NIH).The program is the result of NIH’s Precision Medicine Initiative Working Group of the Advisory Committee to the Director, which concluded its work in 2015. The program is conducted by numerous awardees across the U.S. Compliance with Federal regulations pertaining to the conduct of human subject’s research and with the principles underpinning those regulations is paramount to ensure trust in the Program and its aims. With a diverse network of sites and partners working toward the common goals of the Program, there is a need for centralized support for compliance and monitoring of research to ensure consistent approaches across the U.S. Compliance and monitoring activities include, but are not limited to, monitoring site activities for protocol compliance, support in reporting of adverse incidents to the program and central Institutional Review Board (IRB), coordination of annual review for site activities, and assisting in the management of changes in research. Centralizing support for the performance sites engaged in the research program limits regulatory and compliance risk to the Program and its participants. The All of Us Research Program IRB serves as the IRB of record for all protocols received the Precision Medicine Initiative (PMI) will pioneer a new model of patient-powered research that promises to accelerate biomedical discoveries and provide clinicians with new tools, knowledge, and therapies to select which treatments will work best for which patients. A critical part of PMI is the All of Us Research Program led by the National Institutes of Health (NIH). Sources Sought Information The Department of Health and Human Services National Institutes of Health (NIH}, Office of Acquisition and Logistics Management (OALM}, Office of Logistics and Acquisition Operations (OLAO) is seeking qualified business concerns, 8(a) small businesses, Woman-owned, small disadvantaged businesses, HUB Zone small businesses and Service-disabled Veteran small business concerns fully accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) possessing the capabilities to fulfill this requirement. The intended procurement will be classified under North American Industry Classification Code (NIAICS) 541611; CLASSIFICATION CODE 541611 Administrative Management and General Management Consulting Services THIS IS A SOURCES SOUGHT ONLY. This Sources Sought is issued solely for information and planning purposes – it does not constitute a Request for Proposal (RFP) or a promise to issue an RFP in the future. Interested parties’ responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. This request for information does not commit the Government to contract for any supply or service whatsoever. Further, the NIH All of Us Research Program Office is not at this time seeking proposals and will not accept unsolicited proposals. The anticipated period of performance for the contract is a base twelve-month period, plus four (4) twelve-month option periods for a total not to exceed period of sixty months. THIS IS NOT A REQUEST FOR PROPOSAL OR COST PROPOSAL Interested parties responding to this market survey must provide a capability statement demonstrating their full Accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) to perform the following work, and experience, expertise and available resources to perform the various tasks of this requirement. Interested parties are requested to respond to this Sources Sought with a capability Statement relevant to the requirement. The capability statement and any other information furnished must be in writing and must contain material in sufficient detail to allow NIH to determine of the interested party can meet all the requirements. Information submitted is to be pertinent and specific to the technical requirements identified above and demonstrate your firm’s ability to provide all personnel and resources necessary to provide all of the services identified. Interested party’s capability statements shall include: Interested parties are advised that the U.S. Government will not pay for any information or administrative costs incurred in response to this Sources Sought; all costs associated with responding to this Sought Sources will be solely at the interested party’s expense. Not responding to this RFI does not preclude participation in any future RFP, if any is issued. Intresed parties should submit their capability statments via email to this address: Bestj@od.nih.gov.

6011 EXECUTIVE BLVD., SUITE 503L

BETHESDA , MD 20892

USA

Primary Point of Contacts:

John Best