Liability for Institutional Review Boards: From regulation to litigation

Journal of Legal Medicine

Volumn 25, Issue 2, 2004, Pages 131-184

  Resnik, David B ^a,b  

^a EAST CAROLINA UNIVERSITY   (United States)

^b Univ Hlth Syst of E Carolina   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GOVERNMENT; HEALTH CARE; HUMAN; LAW SUIT; LEGAL ASPECT; LEGAL LIABILITY; NEGLIGENCE; POLICY; PROFESSIONAL STANDARD; REVIEW; THEORETICAL STUDY; BIOMEDICAL AND BEHAVIORAL RESEARCH; EPIDEMIOLOGY; GOVERNMENT REGULATION; LEGAL APPROACH; MALPRACTICE; RISK; STANDARD; UNITED STATES;

BIOMEDICAL AND BEHAVIORAL RESEARCH; LEGAL APPROACH;

CAUSALITY; ETHICS COMMITTEES, RESEARCH; FEDERAL GOVERNMENT; GOVERNMENT REGULATION; HUMANS; LIABILITY, LEGAL; MALPRACTICE; PUBLIC POLICY; RISK; UNITED STATES;

EID: 3142700643     PISSN: 01947648     EISSN: None     Source Type: Journal    
DOI: 10.1080/01947640490457451     Document Type: Review

References (301)

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2. Id. at ii-iii.
3. Id. at iii-iv.
4. Eliot Marshall, Review Boards: A System in Jeopardy?, 280 SCIENCE 1830 (1998).
5. Eliot Marshall, HHS Plans to Overhaul Clinical Research Rules, 288 SCIENCE 1315 (2000).
6. Beverly Woodward, Challenges to Human Subject Protections in US Medical Research, 282 J.A.M.A. 1947 (1999).
7. George Annas, Why We Need a National Human Experimentation Agency, 1 ACC. RES. 293 (1999).
8. Jeremy Sugarman, The Role of Institutional Support in Protecting Human Research Subjects, 75 ACAD. MED. 687 (2000).
9. Eliot Marshall, Gene Therapy on Trial, 288 SCIENCE 951, 951 (2000).
10. ROBERT LEVINE, ETHICS AND THE REGULATION OF CLINICAL RESEARCH 6 (2d ed. 1988).
11. Marshall, supra note 9, at 952.
12. Id. at 954-55.
13. Id. at 953.
14. Bruce Agnew, Financial Conflicts Get More Scrutiny in Clinical Trials, 289 SCIENCE 266 (2000).
15. Gelsinger Complaint (2002), at http://www.sskrplaw.com/links/healthcare2. html.
16. Gelsinger Settlement Press Release (2002), at http://www.sskrplaw.com/ gene/pressrelease.html.
17. Eliot Marshall, Volunteer's Death Prompts Review, 292 SCIENCE 2226 (2001).
18. Dale Keiger & Sue De Pasquale, Trials and Tribulations, 54 JOHNS HOPKINS MAG. 1 (2002).
19. Johns Hopkins Medical Institutions, Settlement with Roche Family (2002), at http://www. hopkinsmedicine.org/press/2001/OCTOBER/011011.htm.
20. Grimes v. Kennedy Krieger Inst., Inc., 782 A.2d 807 (Md. 2001).
21. Id. at 818.
22. I b i d.
23. I b i d.
24. I b i d.
25. Loretta Kopelman, Pediatric Research Regulations Under Legal Scrutiny: Grimes Narrows Their Interpretation, 30 J. LAW, MED. & ETHICS 38 (2002).
26. 2002 WL 535045 (N.D. Okla. 2002).
27. I b i d.
28. Robertson Complaint at http://www.sskrplaw.com/gene/robertson/complaint- new.html.
29. Id. ¶ 223.
30. 2002 WL 535045.
31. David Malakoff, Flawed Cancer Study Leads to Shake-Up at Univ. of Oklahoma, 289 SCIENCE 706 (2000).
32. Geslinger Complaint, supra note 15.
33. Vida Foubister, Lawsuits Have Doctors Wary, But Not Quitting Yet, AM. MED. NEWS 1 (Apr. 16, 2001).
34. 2002 WL 32124953 (W.D. Wash. 2002).
35. Guckin Complaint, at http://www.sskrplaw.com/gene/guckin.html; Wade Complaint, at http://www. sskrplaw.com/gene/cordy.html.
36. Guckin Complaint, at http://www.sskrplaw.com/gene/guckin.html; Wade Complaint, at http://www. sskrplaw.com/gene/cordy.html.
37. Sheer Complaint, at http://www.sskrplaw.com/gene/scheer.pdf; Hamlet Complaint, at http://www. sskrplaw.com/gene/hamletcomplaint.pdf.
38. Sheer Complaint, at http://www.sskrplaw.com/gene/scheer.pdf; Hamlet Complaint, at http://www. sskrplaw.com/gene/hamletcomplaint.pdf.
39. Robert Levine et al., Institutional Review Board: A Crisis in Confidence, 134 ANN. INT. MED. 161 (2001); William Burman et al., Breaking the Camel's Back: Multi-Center Clinical Trials and Local Institutional Review Boards, 134 ANN. INT. MED. 152 (2001).
40. Robert Levine et al., Institutional Review Board: A Crisis in Confidence, 134 ANN. INT. MED. 161 (2001); William Burman et al., Breaking the Camel's Back: Multi-Center Clinical Trials and Local Institutional Review Boards, 134 ANN. INT. MED. 152 (2001).
41. NATIONAL BIOETHICS ADVISORY COMMISSION, ETHICAL AND POLICY ISSUES IN RESEARCH INVOLVING HUMAN SUBJECTS (2001); Donna Shalala, Protecting Research Subjects - What Must Be Done, 343 NEW ENG. J. MED. 808 (2000).
42. NATIONAL BIOETHICS ADVISORY COMMISSION, ETHICAL AND POLICY ISSUES IN RESEARCH INVOLVING HUMAN SUBJECTS (2001); Donna Shalala, Protecting Research Subjects - What Must Be Done, 343 NEW ENG. J. MED. 808 (2000).
43. LEVINE, supra note 10, at 331.
44. Id. at 332.
45. Id. at 333-34.
46. Jesse Goldner, An Overview of the Legal Controls on Human Experimentation and the Regulatory Implications of Taking Professor Katz Seriously, 38 ST. LOUIS U. L. J. 63, 96 (1993). The National Research Act was codified and amended as 42 U.S.C. §§ 201 to 300aaa-13 (1988).
47. NATIONAL COMMISSION FOR THE PROTECTION OF HUMAN SUBJECTS IN BIOMEDICAL AND BEHAVIORAL RESEARCH, BELMONT REPORT (1979).
48. LEVINE, supra note 10, at 334.
49. JEREMY SUGARMAN ET AL., ETHICS OF RESEARCH WITH HUMAN SUBJECTS: SELECTED POLICES AND RESOURCES 35 (1998).
50. 45 C.F.R. § 46.107 (1991).
51. I b i d.
52. I b i d.
53. I b i d.
54. I b i d.
55. I b i d.
56. I b i d.
57. Id. § 46.109.
58. Id. § 46.111.
59. Id. § 46.109.
60. I b i d.
61. LEVINE, supra note 10, at 33-34.
62. 45 C.F.R. § 46.113 (1991).
63. Michael Morse et al., Monitoring and Ensuring Safety During Clinical Research, 285 J.A.M.A. 1201 (2001).
64. Required Education for the Protection of Human Subjects, in NATIONAL INSTITUTES OF HEALTH GUIDE (2002), available at http://grantsl.nih.gov/grants/ guide/notice-files/NOT-OD-00-039.html.
65. More information on IRB accreditation is available at http://www.primr.org/.
66. See http://www.aaalac.org/.
67. 45 C.F.R. § 46.115 (1991).
68. OFFICE OF INSPECTOR GENERAL, supra note 1.
69. 953 F.2d 638 (4th Cir. 1992).
70. I b i d.
71. Halikas v. University of Minnesota, 856 F. Supp. 1331 (D. Minn. 1994).
72. Id. at 1333.
73. Id. at 1334-36.
74. JOHN DIAMOND ET AL., UNDERSTANDING TORTS 50 (2d ed. 2000).
75. Id. at 258-77.
76. Id. at 118-43, 231-32.
77. 644 N.E.2d 1214 (111. App. 1995).
78. Id. at 1216.
79. I b i d.
80. I b i d.
81. Id. at 1218 (citing 21 C.F.R. §§ 50 & 56).
82. Id. at 1219.
83. Id. at 1221.
84. Sherman Health Systems web site (2002), at http://www.shermanhealth.com.
85. See infra notes 253-79 and accompanying text.
86. 1997 WL 570909 (E.D. Pa. 1997).
87. Id. at *6-7.
88. Id. at *3 (citing 21 C.F.R. § 56 (1997)).
89. Id. at *4 (citing 21 C.F.R. § 56 (1997)).
90. DIAMOND ET AL., supra note 70, at 93-98.
91. Jerold E. Rothkoff, Litigating Nursing Home Abuse and Neglect Cases, 214 N.J. LAWYER 12 (2002).
92. Id. at 14.
93. DIAMOND, supra note 70, at 231-32.
94. Dumont v. Teets, 262 P.2d 734 (Colo. 1953).
95. 45 P.3d 936 (Or. 2002).
96. Id. at 937.
97. Id. at 938.
98. I b i d.
99. Id. at 943.
100. 386 P.2d 430 (Or. 1963).
101. Id. at 430.
102. I b i d.
103. Id. at 433.
104. Tara L. Eyer & Clarence C. Kegel, Jr., Confidentiality of School Personnel Matters and Due Process Restrictions on the School Board: Developing Rational Policies, Balancing Interests, and Resolving a Recurrent Dilemma, 101 DICK. L. REV. 325 (1997).
105. Timothy P. Glynn, The Limned Liability of Negligent Supervision, Retention, Hiring and Infliction of Emotional Distress Claims in Employment Discrimination Cases in Minnesota, 24 WM. MITCHELL L. REV. 581 (1998).
106. 813 So. 2d 341 (La. 2002).
107. Id. at 341-46.
108. Id. at 349.
109. I b i d.
110. 802 So. 2d 967 (La. App. 2001).
111. I b i d.
112. Id. at 970.
113. 73 S.W.3d 131 (Tenn. App. 2001).
114. Id. at 133.
115. Id. at 135 (citing TENN. CODE ANN. § 29-20-201.107 (2000)).
116. 169 F. Supp. 2d 21 (D. Conn. 2001).
117. I b i d.
118. 114 767 S.W.2d 296 (Ark. 1989).
119. Id. at 297 (citing ARK. CODE ANN. § 19-10-305 (1987)).
120. JOHN CALAMARI & JOSEPH PERILLO, THE LAW OF CONTRACTS 643 (4th ed. 1998).
121. I b i d.
122. Id. at 649-50.
123. 364 P.2d 685 (Cal. 1961).
124. 21 P.3d 452, 462-63 (Haw. 2001).
125. Id. 122 2002 WL 32124953.
126. I b i d.
127. Id. 125 636 F.2d 46 (3d Cir. 1980).
128. DIAMOND ET AL., supra note 70, at 50-51.
129. Id. at 50-66.
130. Id. at 93-94.
131. Id. at 95-96.
132. See Mary Anderlink & Nannette Elster, Lawsuits Against IRBs: Accountability or Incongruity?, 29 J. LAW, MED. & ETHICS 220, 226 (2001); Kenneth De Ville, The Role of Litigation in Human Research Accountability, 9 Acc. RES. 23 (2002).
133. See Mary Anderlink & Nannette Elster, Lawsuits Against IRBs: Accountability or Incongruity?, 29 J. LAW, MED. & ETHICS 220, 226 (2001); Kenneth De Ville, The Role of Litigation in Human Research Accountability, 9 Acc. RES. 23 (2002).
134. Grimes, 782 A.2d at 847-49.
135. Id. at 818-19.
136. 45 C.F.R. § 46.
137. 637 F. Supp. 1463 (M.D.N.C. 1986).
138. Id. at 1475.
139. I b i d.
140. See Kus, 644 N.E.2d at 1216; Gregg, 1997 WL 570909.
141. See BARUCH BRODY, THE ETHICS OF BIOMEDICAL RESEARCH: AN INTERNATIONAL PERSPECTIVE 197-212 (1998); Alexander Capron, Human Experimentation, in MEDICAL ETHICS 135 (Robert Veatch ed., 2d ed. 1997) ; LEVINE, supra note 10, at 37-76 & 95-155; Karine Morin, The Standard of Disclosure in Human Subject Experimentation, 19 J. LEGAL MED. 157 (1998).
142. See BARUCH BRODY, THE ETHICS OF BIOMEDICAL RESEARCH: AN INTERNATIONAL PERSPECTIVE 197-212 (1998); Alexander Capron, Human Experimentation, in MEDICAL ETHICS 135 (Robert Veatch ed., 2d ed. 1997) ; LEVINE, supra note 10, at 37-76 & 95-155; Karine Morin, The Standard of Disclosure in Human Subject Experimentation, 19 J. LEGAL MED. 157 (1998).
143. See BARUCH BRODY, THE ETHICS OF BIOMEDICAL RESEARCH: AN INTERNATIONAL PERSPECTIVE 197-212 (1998); Alexander Capron, Human Experimentation, in MEDICAL ETHICS 135 (Robert Veatch ed., 2d ed. 1997) ; LEVINE, supra note 10, at 37-76 & 95-155; Karine Morin, The Standard of Disclosure in Human Subject Experimentation, 19 J. LEGAL MED. 157 (1998).
144. See BARUCH BRODY, THE ETHICS OF BIOMEDICAL RESEARCH: AN INTERNATIONAL PERSPECTIVE 197-212 (1998); Alexander Capron, Human Experimentation, in MEDICAL ETHICS 135 (Robert Veatch ed., 2d ed. 1997) ; LEVINE, supra note 10, at 37-76 & 95-155; Karine Morin, The Standard of Disclosure in Human Subject Experimentation, 19 J. LEGAL MED. 157 (1998).
145. 562 P.2d 1192 (Or. 1977).
146. Id. at 1197.
147. Id. at 1198.
148. OR. REV. STAT. § 483.456(2) (1975).
149. James, 562 P.2d at 1198.
150. Id. at 1200.
151. I b i d.
152. 580 A.2d 1115 (Pa. Super. 1990).
153. Id. at 1120.
154. Id. (citing PA. CONS. STAT. ANN. § 6308 (1988)).
155. Id. at 1121.
156. Id. at 1120.
157. The United States Supreme Court often applies the plain meaning rule. See, e.g., K Mart Corp. v. Cartier, Inc., 486 U.S. 281, 291-92 (1988). State courts also use the plain meaning rule. See, e.g., Hill v. Conway, 463 A.2d 232 (Vt. 1983). But see People v. Gilbert, 324 N.W.2d 834 (Mich. 1982) (challenging the view that statutory language is ever free of ambiguity).
158. Bailey v. United States, 516 U.S. 137, 142 (1995).
159. I b i d.
160. But see Ancheff v. Hartford Hosp., 799 A.2d 1067 (Conn. 2002) (challenges the admissibility of the Belmont Report as evidence in a medical malpractice case on the grounds that its probative value does not outweight its prejudicial effect; the court also criticized the Report on the grounds that it was too vague and philosophical).
161. Skidmore v. Swift & Co., 323 U.S. 134, 140 (1944).
162. United States v. Mead Corp., 533 U.S. 218, 227-28 (2001).
163. OHRP, for example, publishes and updates its Institutional Review Board Guidebook (2002), available at http://ohrp.osophs.dhhs.gov/irb/irb_guidebook. htm. The FDA also publishes Guidance Documents (2002), at http://www.fda.gov/ cder/guidance.
164. 45 C.F.R. § 46.111(a) (1991).
165. 67 S.W.3d 453 (Tex. App. 2002).
166. Id. at 453-54.
167. Id. at 457-58.
168. DIAMOND ET AL., supra note 70, at 51-53.
169. I b i d.
170. I b i d.
171. Stephen G. Gilles, On Determining Negligence: Hand Formula, Balancing, the Reasonable Person Standard, and the Jury, 54 VAND. L. REV. 813 (2001).
172. 166 227 N.W.2d 21 (Neb. 1975).
173. Id. at 25-26.
174. 159 F.2d 169, 173 (2d Cir. 1947).
175. Id. at 173.
176. Gilles, supra note 165.
177. DAN DOBBS & PAUL HAYDEN, TORTS AND COMPENSATION (2001).
178. 439 S.E.2d 829, 831-32 (S.C. 1993).
179. 430 S.E.2d 129 (Ga. App. 1993).
180. Flowers v. Torrance Mem. Hosp. Med. Center, 35 Cal. Rptr. 2d 685 (Cal. 1994).
181. DIAMOND ET AL., supra note 70, at 103-05.
182. Flowers, 35 Cal. Rptr. 2d at 687-88. See also Advincula v. United Blood Servs., 678 N.E.2d 1009, 1017-18 (Ill. 1996).
183. Flowers, 35 Cal. Rptr. 2d at 687-88.
184. Smith v. Methodist Hosps. of Memphis, 995 S.W.2d 584, 589 (Tenn. App. 1999).
185. 2 TRIALS OF WAR CRIMINALS BEFORE THE NUREMBERG MILITARY TRIBUNALS UNDER CONTROL COUNCIL LAW No. 10, THE NUREMBERG CODE 170-71 (1949); WORLD MEDICAL ASSOCIATION, DECLARATION OF HELSINKI (2001); WORLD HEALTH ORGANIZATION, INTERNATIONAL ETHICS GUIDELINES FOR BIOMEDICAL RESEARCH INVOLVING HUMAN SUBJECTS (1993).
186. 2 TRIALS OF WAR CRIMINALS BEFORE THE NUREMBERG MILITARY TRIBUNALS UNDER CONTROL COUNCIL LAW No. 10, THE NUREMBERG CODE 170-71 (1949); WORLD MEDICAL ASSOCIATION, DECLARATION OF HELSINKI (2001); WORLD HEALTH ORGANIZATION, INTERNATIONAL ETHICS GUIDELINES FOR BIOMEDICAL RESEARCH INVOLVING HUMAN SUBJECTS (1993).
187. 2 TRIALS OF WAR CRIMINALS BEFORE THE NUREMBERG MILITARY TRIBUNALS UNDER CONTROL COUNCIL LAW No. 10, THE NUREMBERG CODE 170-71 (1949); WORLD MEDICAL ASSOCIATION, DECLARATION OF HELSINKI (2001); WORLD HEALTH ORGANIZATION, INTERNATIONAL ETHICS GUIDELINES FOR BIOMEDICAL RESEARCH INVOLVING HUMAN SUBJECTS (1993).
188. Joan H. Krause, Reconceptualizing Informed Consent: Informed Consent in an Era of Health Care Cost Containment, 85 IOWA L. REV. 309 (1999).
189. Id. at 317-21.
190. Robertson, 2002 WL 535045.
191. I b i d.
192. I b i d.
193. 42 U.S.C. § 1983.
194. Robertson, 2002 WL 535045.
195. I b i d.
196. I b i d.
197. I b i d.
198. 997 F. Supp. 1380, 1383 (E.D. Wash. 1998).
199. Wright, 2002 WL 32124953.
200. Id. 193 Grimes, 782 A.2d at 849.
201. Id. at 858.
202. 874 F. Supp. 796 (S.D. Ohio 1995).
203. Id. at 803.
204. Id. at 805.
205. Id. at 806-19.
206. Id. at 820.
207. Id. (quoting the Nuremberg Code).
208. Id. at 821.
209. 997 F. Supp. 1380, 1383 (E.D. Wash. 1998).
210. 203 Id. at 1384.
211. BRODY, supra note 138.
212. See, e.g., http://www.miami.edu/citireg/.
213. DIAMOND ET AL., supra note 70, at 205.
214. Id. at 230-31.
215. Summers v. Tice, 199 P.2d 1 (Cal. 1948).
216. I b i d.
217. See Mitchell v. Gonzalez, 1 Cal. Rptr. 2d 913 (Cal. 1991); Vincent v. Fairbanks Mem. Hosp., 862 P.2d 847 (Alaska 1993).
218. 45 C.F.R. § 46.111 (1991).
219. Id. § 46.116.
220. 737 P.2d 661 (Wash. 1987).
221. Id. at 661.
222. Id. at 666.
223. 45 C.F.R. §§ 46.109, 46.113 (1991).
224. Anjou v. Boston Elevated Ry. Co., 94 N.E. 386 (Mass. 1911).
225. DIAMOND ET AL., supra note 70, at 229.
226. Id. at 231-32.
227. ROBERT HAMILTON, THE LAW OF CORPORATIONS 1-19 (2000).
228. Rudeck v. Wright, 709 P.2d 621 (Mont. 1985).
229. DIAMOND ET AL., supra note 70, at 213-15.
230. Id. at 214.
231. Overseas Tankship (U.K.), Ltd. v. Morts Dock and Eng'g Co., Ltd., App. Cas. (The Wagon Mound No. 1) 1 All E.R. 404 (1961).
232. I b i d.
233. Marshall, supra note 9, at 951.
234. 64 F.2d 193 (6th Cir. 1933).
235. Bigbee v. Pacific Tel. & Tel. Co., 665 P.2d 947 (Cal. 1983).
236. DIAMOND ET AL., supra note 70, at 242.
237. I b i d.
238. Robertson Complaint, supra note 28, ¶ 135.
239. Gelsinger Complaint, supra note 15, ¶¶ 89-92.
240. GREG PENCE, CLASSIC CASES IN MEDICAL ETHICS 240 (2d ed. 1995).
241. DIAMOND ET AL., supra note 70, at 263.
242. Id. at 265.
243. Id. at 263-65.
244. Id. at 267-69. Under pure comparative fault, the plaintiff's damage award is reduced by the plaintiff's percentage of fault. Under modified comparative fault, the plaintiff's recovery is reduced by his or her fault up to 50%, with recovery prohibited if plaintiff's fault is greater than 50%. See, e.g., IND. CODE ANN. § 34-51-2-6 (West 1999).
245. Id. at 267-69.
246. Knight v. Jewett, 11 Cal. Rptr. 2d 2, 14 (Cal. 1992).
247. Balthazor v. Little League Baseball, Inc., 72 Cal. Rptr. 2d 337 (Cal. App. 1998).
248. 991 F. Supp. 747 (D. Md. 1997).
249. Id. at 749.
250. Brady v. Ralph M. Parsons Co., 609 A.2d 297, 301 (Md. 1992).
251. DIAMOND ET AL., supra note 70, at 270.
252. Id. at 271.
253. I b i d.
254. 42 U.S.C. § 11111 (a)(1) (1986).
255. MARK HALL, ET AL., HEALTH CARE LAW AND ETHICS 182-85 (1999).
256. 696 N.E.2d 707 (111. App. 1998).
257. Robin Wilson, Hospital Ethics Committees as the Forum of Last Resort: An Idea Whose Time Has Not Come, 76 N.C. L. REV. 353 (1998).
258. MONT. CODE ANN. § 37-2-201 (1995).
259. Hill, 73 S.W.3d at 131.
260. Seminole Tribe of Florida v. Florida, 517 U.S. 44 (1996).
261. DIAMOND ET AL., supra note 70, at 278.
262. DOBBS & HAYDEN, supra note 171, at 393-94.
263. I b i d.
264. 28 U.S.C. §§ 2671-2680 (2002).
265. Id. § 2680(a).
266. 42 U.S.C. § 1983 (1871).
267. Scheuer v. Rhodes, 416 U.S. 232, 239-41 (1974).
268. Robertson, 2002 WL 535045.
269. Id. at * 3.
270. Id. (citing Barney v. Pulsipher, 143 F.3d 1299, 1309 (10th Cir. 1998)).
271. Id. at *4.
272. I b i d.
273. OKLA. STAT. tit. 51, § 155 (2001).
274. In re Cincinnati, 874 F. Supp. at 801.
275. I b i d.
276. Id. at 818.
277. Id. at 819.
278. Id. at 820. 272 See, e.g., Regents of the Univ. of California v. Doe, 519 U.S. 425 (1997); Emberg v. University of Maryland Univ. Coll. Asian Div., 3 F. Supp. 2d 1127 (D. Hawaii 1998); O'Hara v. Indiana Univ. of Pennsylvania, 171 F. Supp. 2d 490 (W.D. Pa. 2001).
279. David W. Hartmann, Volunteer Immunity: Maintaining the Vitality of the Third Sector of Our Economy, 10 U. BRIDGEPORT L. REV. 63 (1989).
280. See, e.g., Trotter v. School Dist. 218, 733 N.E.2d 363 (Ill. App. 2000) (immunity for volunteers at a public school); Sewickley Twnsp. Volunteer Fire Co. No. 3 v. First Nat'l Bank of Herminie, 8 Pa. D. & C. 4th 297 (Pa. Com. Pl. 1990) (immunity for volunteer firefighters).
281. DIAMOND ET AL., Supra note 70, at 231-32.
282. See Jones v. Westernaires, Inc., 876 P.2d 50, 54 (Colo. App. 1993) (discussing the definition of volunteer in various statutes).
283. Cincinnati Ins. Co. v. Rose, 612 N.E.2d 819 (Ohio Com. Pl. 1992); Baxter v. Hog Valley Volunteer Fire Dept., Inc., 669 So. 2d 285 (Fla. App. 1996).
284. The Copernicus Group, located in Research Triangle Park, North Carolina, is an independent IRB. It advertises that it follows FDA regulations and will review a research proposal within 72 hours of submission. See http://www.copernicusgroup.com/.
285. Jackson v. Metropolitan Edison Co., 419 U.S. 345, 347 (1974).
286. SSKR&P Law Offices, at http://www.sskrplaw.com/gene/index.html (last visited Sept. 8, 2003).
287. Wright v. The Fred Hutchinson Cancer Res. Cen., 2001 WL 1782714 (2001).
288. Anderlink & Elster, supra note 130, at 226.
289. David Klingman et al., Measuring Defensive Medicine Using Clinical Scenario Survey, 21 J. HEALTH POLITICS, POL'Y & LAW 185, 186-87 (1996).
290. REBECCA DRESSER, WHEN SCIENCE OFFERS SALVATTON 49-50 (2002).
291. Id. at 59-60.
292. Anderlink & Elster, supra note 130, at 221-22.
293. I b i d.
294. PENCE, supra note 233, at 240.
295. I b i d.
296. DeVille, supra note 130, at 17, 20.
297. Id. at 21.
298. DOBBS & HAYDEN, supra note 171, at 2-3.
299. DeVille, supra note 130, at 34.
300. Anderlink & Elster, supra note 130, at 225.
301. Id. at 226.