Definitions for Chapters 16, 17, and 18

Sponsored research: Research funded by external entities through a grant or contract that involves a specified statement of work (e.g., the research proposal) with a related transfer of value to the sponsor, including clinical trials involving investigational drugs, devices or biologics. (See Stanford University Research Policy Handbook, 13.3 Specialized Categories of Sponsored Projects.)

Stanford sponsored research: Sponsored research conducted at Veterans Affairs Palo Alto Health Care System (VAPAHCS), Stanford University, Stanford Hospital and Clinics (SHC) and Lucile Packard Children’s Hospital (LPCH) through a grant or contract with Stanford University. A “grant” is sponsored research that has few if any contractual terms other than those designating the research to be supported by the funding.

Palo Alto Institute for Research and Education (PAIRE) sponsored research: Sponsored research conducted at VAPAHCS through a grant or contract between PAIRE and external sponsors.

VA research: Research conducted at VAPAHCS through Veterans Administration research awards (see VHA Directive 1200 Research and Development.)

16.1 Agreement Includes Protection for Research Participants

Section revised: 3/13/13

STANFORD has and follows written policies and procedures setting forth the ethical standards and practices of the Human Research Protection Program. Relevant policies and procedures are made available to Sponsors, Researchers, Research Staff, research participants, and the Institutional Review Board, as appropriate. (AAHRPP Element I.1.D)

In Stanford and PAIRE sponsored research, Stanford University and PAIRE address the protection of research participants by:

· Including in their standard contract templates a provision that the sponsor acknowledges and understands that the STANFORD HRPP is applicable to all human participant research. See:

- Stanford University (Office of Sponsored Research (OSR)) Clinical Study Agreement template (Section 19),

- Office of Technology Licensing (OTL) Sponsored Research Agreement template (Appendix 2), and

- VA Cooperative Research And Development Agreement (CRADA) template (Human Subjects paragraph)

· Asking for the inclusion of such a provision in any proposed contract that does not use their standard templates

· Including in the cover letter accepting and acknowledging the grant an equivalent statement regarding the HRPP in grants to Stanford University.

Additionally, the IRB will review the proposed consent form and delete any provision that requires a participant to waive or appear to waive any legal rights (i.e., exculpatory provisions).

16.2 Provision Addressing Medical Care for Participants

Section revised: 3/13/13

Stanford has a written agreement with the Sponsor that addresses medical care for research participants with a research-related injury, when appropriate. (AAHRPP Element I.8.A)

Stanford University, SHC and LPCH

· In Stanford sponsored research, medical care for participants is addressed by:

· Including in its standard contract template a provision that the sponsor provides for the cost of diagnosis, care and treatment of any undesirable side effects, adverse reactions, illness or injury to a participant, without regard as to the fault of the sponsor (see Stanford University Clinical Trials/Study Agreement template (Subject Injury section))

· Asking for the inclusion of such a provision in any proposed contract that does not use Stanford University’s standard template

· Including the substance of any such provision in the consent form (see Stanford University consent form template)

· Including a statement in the consent form that participants do not waive any liability rights for personal injury by signing the consent form

VAPAHCS and PAIRE

In VA research at VAPAHCS, medical care for participants is addressed by complying with the applicable VA laws and policy that currently:

· Require pursuant to 38 CFR 17.85 that the VA provide free medical care to both veteran and non-veteran participants for those injuries, except for: (a) treatment for injuries due to noncompliance with study procedures, or (b) research conducted for VA under a contract with an individual or a non-VA institution

· Require pursuant to 38 USC 1151 that if a participant who is a veteran be eligible for dependency and indemnity compensation for a qualifying additional disability or a qualifying death in the same manner as if such additional disability or death were service-connected, if the disability or death was not the result of willful misconduct and was caused by hospital care, medical or surgical treatment, or examination furnished to the participant and the proximate cause of the disability or death was either; (a) carelessness, negligence, lack of proper skill, error in judgment, or similar instance of fault on the part of the department in furnishing the hospital care, medical or surgical treatment, or examination; or (b) an event not reasonably foreseeable

· Allowing pursuant to 28 USC 1346(b) and 2671-2680 claims under the Federal Torts Claims Act for both veteran and non-veteran participants who consider the VA to be at fault for their injuries.

In research at VAPAHCS, PAIRE in its sponsored agreements addresses medical care for participants by:

· Abiding by the same laws and policy as specified above for VAPAHCS (see VA Cooperative Research And Development Agreement (CRADA) templates (section 12.3 Costs of Subject Injury))

On behalf of VAPAHCS and PAIRE, the IRB requires that the VA Protocol Director include a statement in the VA consent form:

· Explaining the above-described possible benefits for participants, and

· Explaining that participants do not waive any liability rights for personal injury by signing the consent form. See VAPAHCS consent form template.