PART 835 - RESEARCH AND DEVELOPMENT CONTRACTING

Authority: 38 U.S.C. 7303; 40 U.S.C. 121(c); 41 U.S.C. 1702 and 48 CFR 1.301 through 1.304.

Source: 87 FR 70748, Nov. 21, 2022, unless otherwise noted.

      835.001-70 Veterans Affairs (VA) definitions.

      835.003-70 VA policy.

      835.003-71 Research misconduct.

      835.003-72 Protection of human subjects.

      835.003-73 Animal welfare.

      835.003-74 Facilities.

      835.003-75 Acknowledgement of support and disclaimer.

      835.010 Scientific and technical reports.

835.001-70 Veterans Affairs (VA) definitions.

Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalized knowledge.

Research impropriety refers to noncompliance with the laws, regulations, and policies regarding human subject protections, laboratory animal welfare, research safety, research laboratory security, research information security, and research misconduct. It does not encompass improper procedures or conduct in areas outside of the mandate of the Office of Research Oversight (ORO) (e.g., waste, fraud, abuse, or fiscal mismanagement).

Research misconduct means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.

VA facility means a component of the VA national health care system, such as a VA Medical Center, VA Health Care System, or VA Medical and Regional Office Center.

835.003-70 VA policy.

(a) Pursuant to 38 U.S.C. 7303, VA is authorized to carry out a program of medical research in connection with the provisions of medical care and treatment to Veterans.

(b) The Office of Research Oversight (ORO) serves as the primary Veterans Health Administration (VHA) office that advises the Under Secretary for Health on all compliance matters related to -

(1) Human subject protections;

(2) Laboratory animal welfare;

(3) Research safety;

(4) Research laboratory security;

(5) Research information security;

(6) Research misconduct; and

(7) Other research improprieties.

835.003-71 Research misconduct.

The contracting officer shall insert the clause at 852.235-70, Research Misconduct, in all research and development (R&D) solicitations and contracts.

835.003-72 Protection of human subjects.

The contracting officer shall insert the clause at 852.235-71, Protection of Human Subjects, in all research and development (R&D) solicitations and contracts.

835.003-73 Animal welfare.

The contracting officer shall insert the clause at 852.235-72, Animal Welfare, in all research and development (R&D) solicitations and contracts.

835.003-74 Facilities.

If the contracting officer determines that the facilities to be assigned to perform effort on a research and development (R&D) contract are critical to the success of the R&D effort, the contracting officer shall insert the clause at 852.235-73, Facilities, in the solicitation and contract.

835.003-75 Acknowledgement of support and disclaimer.

The contracting officer shall insert the clause at 852.235-74, Acknowledgement of Support and Disclaimer, in all research and development (R&D) solicitations and contracts.

835.010 Scientific and technical reports.

The contracting officer shall insert the clause at 852.235-75, Scientific and Technical Reports, in all research and development (R&D) solicitations and contracts.