Human Research Protection Program

Added: Aug 28, 2014 3:54 pm This is a sources sought notice to determine the availability of potential small business sources capable of providing human research protection program support services for the Bureau of Medicine and Surgery in direct support of the Department of Navy (DON) Human Research Protection Program (HRPP). THE DESCRIPTIVE INFORMATION CONTAINED IN THIS SOURCES SOUGHT REFLECTS CURRENT KNOWLEDGE AS OF THIS PRINTING. THESE FACTS MAY BE UPDATED OR REVISED IN THE ACTUAL REQUEST FOR PROPOSALS, WHEN ISSUED.



The Surgeon General (SG) of the Navy serves as the sole authority for the execution and oversight of the DON HRPP. The DON HRPP is responsible for ensuring that DON-sponsored research involving human subjects complies with applicable federal regulations, DoD directives, DON instructions, and policies.

The DON HRPP is responsible for oversight of approximately 1,300 research protocols for studies being conducted in over 150 stateside and overseas locations within the DON and in the civilian sector. The purpose of this requirement is to obtain non personal HRPP support services that will include such tasks as supporting the development and maintenance of DON HRPP guidance documentation by providing senior subject matter expertise in applied research ethics and human research protection; providing assistance to DON HRPP in reviewing and assessing the compliance of DON commands, institutions, and extramural collaborators with applicable federal regulations, DoD directives, DON instructions, and policies on the protection of human subjects in research, and the level of knowledge of the command/institution HRPP staff and IRB members; oversight and monitoring of clinical research in an academic, private and military setting, prompt assistance and expertise on human research protection issues to DON commands and institutions; assisting the DON HRPP Training and Education Specialist develop and conduct education and training for DON HRPP internal staff and DON commands, institutions, and extramural performers conducting human subjects research; administrative support to DON HRPP; and program management and analysis, budget and information system support.







A Firm Fixed Price (FFP) non-personal services contract is anticipated that will consist of a one year base period and four, one year option periods. The North American Industrial Classification System (NAICS) code for this acquisition is 541690 and the size standard is $14 million. Offerors possessing the requisite skills, resources and capabilities necessary to perform the stated requirement are invited to respond to this source sought notice via the submission of an executive summary, no more than five (5) pages in length. Responses must use twelve point Times New Roman font.



The submission should include the following information: 1) company name, address, and point of contact with corresponding phone number and e-mail address 2) DUNS number, business size and classification 3) relevant corporate experience information.

Relevant corporate experience information is defined as experience (within the past five years) that is of the same or similar services to that which is described herein and a technical description of ability to meet the requirement (2 references). The corporate experience should include the applicable contract number, total number of FTE, contract period of performance, a brief description of the services provided AND the relevancy of the services to the proposed HRPP requirement. A customer point of contact with corresponding telephone number and e-mail address should also be included.



A brief description of the capability and resources should accompany the references and address technical competencies and organizational experience relative to the key task areas.

Standard brochures and/or paraphrasing of the Source Sought Notice will not be considered sufficient to demonstrate the capabilities of an interested party.



All submissions are required to be submitted via e-mail to laura.mattiford@navy.mil no later than 1:00pm (local time/Philadelphia, PA) on 3 September 2014. Please direct any questions concerning this Sources Sought Notice to Laura Mattiford at laura.mattiford@navy.mil