2.1 Inventions [Patent Law]

• Patent Laws. 35 U.S.C. §§ 102, & 200 – 212.

• Inventions by Government employees. Executive Order 10096, January 24, 1950.

• Executive Department-wide regulations on Government employee inventions. 37 C.F.R. Part 501.

• VA regulations on VA employee inventions (consistent with Part 501). 38 C.F.R. §§ 1.650 – 1.663.

2.2 Data [Copyright Law]

• Copyright Laws. 17 U.S.C. §§ 101 – 810.

2.3 Equipment

• An NPC may accept gifts and grants to support VA research. 38 U.S.C. § 7364 (a)(1).

• Residual funds {and by implication equipment purchased therewith] will be used to support VA research. VHA Handbook 1200.177j.

• Use and display of VA seal and flag. 38 C.F.R. § 1.9.

• Prohibition on endorsing products or services or giving appearance of governmental approval. 5 C.F.R. § 2635.702.

• Human Subjects Protocols must be approved by IRB. 38 C.F.R. Part 16

• The R&D Committee is the local committee charged with oversight of all R&D activities within a VA facility. VHA Directive 1200. (It is this committee’s approval of an IRB-approved research project that makes it “VA approved research”. However, the R&D committee has no authority to approve a study if the IRB disapproved it).

5.1 No Reciprocal Sponsor - Institution Indemnity

• An NPC may not give assurances that conflict with Federal law or enter into agreements that purport to supercede or are contrary to Federal law. VHA Handbook 1200.17 ¶ 6 c. & d.

5.3 FTCA Coverage in Lieu of Insurance

• VA is an executive department of the United States. 38 U.S.C. § 301 (a).

• The Federal Tort Claims Act governs how negligence claims may be brought against the United States and its agencies. 28 U.S.C. §§ 1346 (b) & 2671 – 2680.

5.4 Medical Malpractice Insurance

• NPC should purchase sufficient liability insurance. VHA Handbook 1200.17 ¶ 6e.

5.5 Providing Treatment for Research-Related Injuries

• VA shall provide necessary medical treatment to research subjects for injuries resulting from research participation. 38 C.F.R. § 17.85.

• The Medical Care Recovery Act authorizes VA to collect from negligent third parties the cost of VA care. 42 U.S.C. §§ 2651 – 2653.

• FDA requirements for safety reports (adverse event notification) on investigational new drugs. 21 C.F.R. § 312.32

• Access to Federal agency records(and exceptions to that access) is governed by the Freedom of Information Act (FOIA). 5 U.S.C. § 552. Note that FOIA does not apply to records kept by an NPC.

• VA regulations relating to FOIA. 38 C.F.R. §§ 1.550 – 1.559.

[All Confidentiality & Disclosure Laws Except FOIA]

• VA claims are confidential (includes all records on veterans and their dependants. 38 U.S.C. § 5701.

• VA regulations relating to the VA confidentiality statute. 38 C.F.R. §§ 1.500 – 1.527.

• Privacy Act regulates the collection, maintenance, use and dissemination of personal information by Federal agencies. 5 U.S.C. § 552a.

• VA regulations relating to the Privacy Act. 38 C.F.R. §§ 1.575 – 1.584.

• Additional protections are extended to medical records dealing with drug abuse, alcoholism or alcohol abuse, HIV infection, and sickle cell anemia. 38 U.S.C. § 7332.

• VA regulations relating to section 7332. 38 C.F.R. §§ 1.460 – 1.469.

• Health Insurance Portability and Accountability Act of 1996 (HIPAA). Public Law 104 – 191 (August 21, 1996).

• The HIPAA Privacy Rule is a body of regulations authorized by Pub. Law 104 – 191. They establish a foundation of Federal protections for the privacy of protected health information. The Rule does not replace Federal, State or other law that grants individuals even greater privacy protection. 45 C.F.R. Parts 160 & 164.

• If the results of commercially sponsored projects are generally published in a form available to the interested public, it constitutes scientific research in the public interest within the meaning of section 501(c)(3). IRS Revenue Ruling 76-296.

• For work to be carried on in the public interest, the results of the research must be made available to the public on a nondiscriminatory basis, IRS Publication 557, Page 24, Scientific Organizations.

• VA follows the Common Rule for the protection of human subjects. 38 C.F.R. Part 16.

• VHA Manual M-3, Part I, Chapter 9 (October 30, 1992).

• Good Clinical Practice: Consolidated Guideline, 62 FR 25692, May 9, 1997.  FDA’s position is that the ICH Good Clinical Practice (GCP) guidelines are guidance and as such are not legal requirements subject to enforcement by FDA or other U.S. authorities.  (This was reiterated in an April 15, 2003, letter from Richard M. Campanelli, Director, Office of Civil Rights, Department of Health and Human Services to Stan Crosley, Chair, International Pharmaceutical Privacy Consortium.).  

• VA System of Records 34 VA 12 “Veteran, Patient, Employee and Volunteer Research and Development Project Records”. 66 Federal Register 16705 – 16707, March 27, 2001. 

• Protection of Human Subjects. 38 C.F.R. Part 16.

• VA is an executive department of the United States. 38 U.S.C. § 301 (a).

• The Secretary of Veterans Affairs has authority to prescribe all rules and regulations to carry out laws he administers. 38 U.S.C. § 501 (a).

• NPC may not enter into agreements that purport to supercede or are contrary to Federal Law. VHA Handbook 1200.17 ¶ 6d.

• Authority and purpose of NPC to conduct and facilitate approved research. 38 U.S.C. §§ 7361 & 7362.

• VA is an executive department of the United States. 38 U.S.C. § 301 (a).

• NPC may not enter into agreements that purport to supercede or are contrary to Federal Law. VHA Handbook 1200.17 ¶ 6d.

• Federal & State laws, court cases, regulations, and more – www.findlaw.com

• United States Code, Code of Federal Regulations, Federal Register, Congressional Record and more – www.gpoaccess.gov

• NAVREF legal resources – www.navref.org/legal/main.htm

• VHA forms and publications – www.va.gov/publ/direc/health/

• HIPPA Privacy Rule, FAQs and more – www.hhs.gov/ocr/hipaa

• VA Research & Development – Technology Transfer Program – www.vard.org

• Google search engine for government sites – www.google.com/unclesam