Research Support Services

1. 1. The period of performance for this non-severable contract will involve research support services over a twenty-four (24) month period of performance consisting of a twelve (12) month base period of performance from 10 June 2021 to 09 June 2022 and one (1) additional twelve-month option, if the option is exercised. The Contracting Officer may exercise options only after determining that (1) funds are available and (2) the requirement covered by the option fulfills an existing Government need.

1. 1. Performance of this contract does not require or authorizes access to classified information; therefore; a DD254 is not applicable.

1. 1. This contract does not include personal services. Additionally, health care workers and/or clinical positions are not required; therefore, indemnification and medical liability insurance (FAR 52.237-7) is not applicable.

1. 1. There is human research involved with this effort; therefore, this task order will require the Contractor to possess a human subjects research assurance certification. The Department of Defense (DoD) is responsible for Contractor oversight of compliance with 32 CFR Part 219, Protection of Human Subjects; and the Government personnel responsible for such oversight is the Command’s Human Research Protection Official as defined by DFAR 252.235-7004, Protection of Human Subjects. All research shall be determined to be compliant with federal and Department of Defense regulations for protecting human subjects.  All studies similarly need to be compliant with the requirements of the HIPAA Privacy Rule.  Further, evolving human subject protection regulations need to be investigated and training plans developed to educate researchers as to their human subject responsibilities.  Contractor shall support appropriate/applicable Institutional Review Board (IRB) functions and HIPAA Privacy Office.  Such support shall include analyzing research protocols to determine compliance with relevant human subject protection regulations and drafting administrative correspondence detailing review proceedings and findings.  Support shall also include development of educational materials, monitoring of research, and database development for tracking of research protocols.

There is no animal research involved with this effort.