References

1. National Bioethics Advisory Commission, “Research Involving Human Biological Materials: Ethical Issues and Policy Guidance” (1999), Chapter 3: Current Guidance on the Use of Human Biological Materials in Research, page 56.
2. The term “patient data” is used in this survey to represent all medical and health information derived from human tissue samples, regardless of whether such information is obtained in a clinical or research setting and regardless of whether such information is taken from healthy individuals or “patients.” Use of the term “patient data” parallels many state statutes that refer to information in the patient medical record, but the intention here is to cover information beyond that which is included in the medical record. When reference is made to individually identifiable data, this will be specified.
3. While the Common Rule only applies to human subjects research that is federally funded or conducted, many research institutions have agreed to subject all of their research activities to its requirements.
4. 45 C.F.R. 46.101(a) establishes the scope of the Federal Policy for Protection of Human Subjects. Seventeen federal agencies have adopted Subpart A as their policy for protection of human research subjects in research that is federally funded or conducted.
5. 45 C.F.R. 46.102.
6. More information about the federal regulations for human subjects protection can be found at: http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm and http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?F R=50.3
7. Office for Human Research Protections, DHHS, Guidance on the Use of Expedited Review Procedures (2003), http://www.hhs.gov/ohrp/humansubjects/guidance/exprev.htmHRP
8. More information about the specifics of OHRP’s policy on Expedited Review of Research Protocols can be found at: http://ohrp.osophs.dhhs.gov/humansubjects/guidance/expedited98.htm.
9. Health Insurance Portability and Accountability Act of 1996 (HIPAA), Public Law No. 104-191, Section 264 (1996); Standards for Privacy of Individually Identifiable Health Information, 45 C.F.R. Section 160 (2002), 45 C.F.R. Section 164 subparts A, E (2002).
10. Health Insurance Portability and Accountability Act of 1996.
11. This report does not address the details of HIPAA implementation and compliance, but further information can be obtained from: http://privacyruleandresearch.nih.gov. To view the complete final Privacy Rule, see: http://www.hhs.gov/ocr/hipaa/finalreg.html.
12. Section 160.203(b). A standard, requirement, or implementation specification adopted under this subchapter that is contrary to a provision of State law preempts the provision of State law. This general rule applies, except if the provision of state law relates to the privacy of individually identifiable health information and is more stringent than a standard, requirement, or implementation specification adopted under subpart E of part 164 of this subchapter.
13. 45 C.F.R. 46.101(f).
14. National Bioethics Advisory Commission, “Research Involving Human Biological Materials: Ethical Issues and Policy Guidance” (1999), Chapter 3: Current Guidance on the Use of Human Biological Materials in Research, page 56.
15. North Dakota Century Code, Chapter 23-01.3, Health Information Protection Act.
16. These laws are often aimed at preventing the use of personal medical information to deny insurance coverage or employment and to prevent discrimination or stigmatization. A handful of states directly addressed the issue of commercial use of genetic information, often stating that medical information and/or genetic information may not be sold.
17. See Colorado.
18. Alaska Statutes 21.07.040(b)(2)(A)(B).
19. Vermont Statutes Annotated, Title 18, Section 1852(10). The patient has the right to be advised if the hospital proposes to engage in or perform human experimentation affecting the patient’s care or treatment. Participation by patients in clinical training programs or in the gathering of data for research purposes shall be voluntary. The patient has the right to refuse to participate in such research projects.
20. Annotated Code of Maryland Code; 4-303; 4-304(a).
21. Oregon Revised Statutes Annotated, Medical Records, 192.525.
22. Minnesota Statutes Annotated, Section 144.335 subd. 3a(d).
23. Minnesota Statute Annotated, Section 144.335 subd. 3a(d).
24. Connecticut General Statutes, Section 19A-490B.
25. As of April 2003, over 30 states have enacted some form of legislation governing the use and disclosure of genetic information. Sixteen states require informed consent to perform or require a genetic test or in order to obtain genetic information about an individual. Twenty-five states require informed consent to disclose genetic information, and some of these specify the type of written authorization required to disclose genetic information. Six states require individual permission to retain genetic information.
26. Arizona, Arkansas, Colorado, Delaware, Georgia, Louisiana, Maryland, Massachusetts, Missouri, Nebraska, New Jersey, New Mexico, New York, North Dakota, Oklahoma, Oregon, Rhode Island, South Carolina, Texas, Vermont, and Virginia permit research uses of genetic information under certain specified conditions.
27. Massachusetts General Laws Annotated, Section 70g. Genetic Information and Reports Protected As Private Information; Prior Written Consent for Genetic Testing.
28. Nebraska Revised Statutes 77-5519, Genetic test, defined.
29. Louisiana Revised Statutes Annotated, 22: 213.7.
30. McKinney’s Consolidated Laws of New York Annotated, Section 79-l(2).
31. Arkansas Code Annotated 20-35-103: All stored tissues, including blood, that arise from surgery, other diagnostic or therapeutic steps, or autopsy may be disclosed for genetic or other research studies, if: (A) The patient’s name or social security number is not attached to or included with the specimen; or (B) The patient’s name or social security number is attached to or included with the specimen and the patient has given informed written consent to the disclosure. Oklahoma Statutes, Title 36, Chapter 1, Article 36, Section 3614.4–Genetic Research Studies Nondisclosure Act: All stored tissues, including blood, that arise from surgery, other diagnostic or therapeutic steps, or autopsy may be disclosed for genetic or other research studies if informed consent has been obtained. (“Informed consent may be included in a section of the consent for treatment, admission to a hospital or clinic, or permission for an autopsy and no other consent shall be required.”)
32. Michigan Compiled Laws Annotated, Genetic Test–Informed Consent 333.17520; Nebraska Revised Statute 71-1,104.01.
33. Code of Laws of South Carolina “Privacy of Genetic Information Act,” Section 38-93-10.
34. South Dakota Codified Laws 34-14-22.
35. New Jersey Statutes Annotated 10:5-43.
36. Vernon’s Texas Statutes and Codes Annotated, Article 9032, Prohibited Use of Genetic Information.
37. Arizona Revised Statutes, 12-2802.
38. Arizona Revised Statutes, 20-448.02.
39. Colorado Revised Statutes Annotated, 10-3-1104.7.
40. Florida Statutes Annotated, Title XLIV, 760.40. Genetic testing; informed consent; confidentiality.
41. Georgia Code Annotated, Sections 33-54-1 and 33-54-6.
42. Louisiana Revised Statutes Annotated, 22:213.7(E).
43. In the recent decision by a federal court in Florida, the judge decided that this statute addressing ownership of the results of DNA analysis did not mean that individuals who voluntarily contributed blood and tissue samples for research purposes retained an ownership interest in the sample or in the resulting patented research product. Daniel Greenberg, Fern Kupfer, Frieda Eisen, David Green, Canavan Foundation, Dor Yeshorim, And National Tay-Sachs And Allied Diseases Association, Inc., Plaintiffs, v. Miami Children’s Hospital Research Institute, Inc., Variety Children’s Hospital, Inc. D/B/A Miami Children’s Hospital, And Reuben Matalon, Defendants. Case Number: 02-22244-Civ-Moreno, United States District Court For The Southern District Of Florida, Miami Division, 2003 U.S. District, Lexis 8959, May 29, 2003.
44. Annotated Code of Maryland, Human Subject Research, 13-2002.
45. West’s Annotated Code of Virginia, Section 32.1-162.16.
46. McKinney’s Public Health Law, Section 2440-6.
47. Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Maryland, Massachusetts, Minnesota, Mississippi, Montana, Nevada, North Carolina, New Hampshire, New Jersey, North Dakota, Oregon, Rhode Island, Tennessee, Texas, Vermont.
48. Delaware, Hawaii, Maryland, Massachusetts, Minnesota, Montana, North Carolina.
49. 45 C.F.R. 46.102(f).
50. West’s Revised Code of Washington 70.02.050(g).
51. Minnesota Statutes Annotated, 144.335.
52. Vernon’s Texas Statutes and Codes Annotated, 602.053.
53. Annotated California Civil Code, Section 56-56.05(f).
54. Annotated California Civil Code, Section 56.10(d).
55. Annotated California Civil Code 24170.
56. According to Department of Health and Human Services (HHS) human subjects regulations at 45 C.F.R. 46.103, every institution engaged in human subjects research supported or conducted by DHHS must obtain an Assurance of Compliance approved by the Office for Human Research Protections (OHRP). Historically, OHRP has approved three basic types of assurances: Multiple Project Assurance (MPA), Cooperative Project Assurance (CPA), and Single Project Assurance (SPA). All MPAs approved by OHRP were designated for federalwide use.
57. The data will comprise a limited data set under HIPAA.
58. Arizona Revised Statutes, Title 12, Chapter 19, Genetic Testing, 12-2801, Definitions.
59. Code of Alabama, Insurance Code Sections 27-53-2 and 27-53-1-4.
60. McKinney’s Consolidated Laws of New York Annotated, Section 79-l.
61. McKinney’s Public Health Law, Protection Of Human Subjects, Section 24402446.
62. Oregon Revised Statutes Annotated, Medical Records, 192.525.
63. Oregon Revised Statutes Annotated, Genetic Privacy Act, 192.533.
64. Oregon Revised Statutes Annotated, 192.537
65. Moore v. Regents of the University of California, et.al., 499 U.S. 936, 111 S. Ct. 1388, 113 L.Ed. 2d 444, (1991).
66. Daniel Greenberg, Fern Kupfer, Frieda Eisen, David Green, Canavan Foundation, Dor Yeshorim, And National Tay-Sachs And Allied Diseases Association, Inc., Plaintiffs, v. Miami Children’s Hospital Research Institute, Inc., Variety Children’s Hospital, Inc. D/B/A Miami Children’s Hospital, And Reuben Matalon, Defendants. 264 F.Supp.2d, 1064 (May 29, 2003).

NIH Publication No. 05-5628
Printed November 2004