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Dealing with Conflicts of Interest in Biomedical Research: IRB Oversight as the Next Best Solution to the Abolitionist Approach

Published online by Cambridge University Press:  01 February 2021

Jesse A. Goldner
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In the summer of 1995, Thomas W. Parham went to his physician, Peter Arcan, for an ordinary check up. During his visit, Dr. Arcan suggested that Mr. Parham join a clinical trial studying a new drug to shrink enlarged prostates. Mr. Parham was confused because he never had prostate problems, but Dr. Arcan stated that the drug might prevent future difficulties. When asked why he joined the study, Mr. Parham stated, “I just followed his advice, just like if he said to take two aspirin instead of one. He’s a doctor and I’m not.”

Mr. Parham should not have been entered into the study because he had been hospitalized a year earlier due to a chronic slow heart rate, a clear study-exclusion criterion that would disqualify him from being a subject in the protocol. However, Dr. Arcan sought an exemption from the drug company stating that Mr. Parham’s heart rate was only “mildly slow,” failing to report the prior hospitalization. After Mr. Parham began taking the study medication, he complained of fatigue, a symptom of a slow heart rate. Within weeks, after requesting to be taken off the study, he was hospitalized and a pacemaker was implanted for his slow heart rate. The drug’s manufacturer, SmithKline Beecham P.L.C., was paying Dr. Arcan $1,610 for each patient enrolled in the study. The fee covered study expenses, but was sufficient to give the recruiting physician a profit for each subject enrolled.

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Article
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Journal of Law, Medicine & Ethics , Volume 28 , Issue 4 , Winter 2000 , pp. 379 - 404
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Copyright © American Society of Law, Medicine and Ethics 2000

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References

K. Eichenwald and G. Kolata, Drug Trials Hide Conflicts for Doctors, New York Times, May 16, 1999, at A1.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
D. Nelson and R. Weiss, Penn Researchers Sued in Gene Therapy Death, Washington Post, Sept. 19, 2000, at A3 [hereinafter cited as Nelson and Weiss, Penn Researchers Sued].Google Scholar
R. Weiss and D. Nelson, Methods Faulted in Gene Test Death, Teen Too Ill for Therapy, Probe Finds, Washington Post, Dec. 8, 1999, at A1.Google Scholar
J. Brainard and D.W. Miller, U.S. Regulators Suspend Medical Studies at 2 Universities, Chronicle of Higher Education, Feb. 4, 2000, at A30.Google Scholar
R. Weiss, FDA Halts Experiences on Genes at University: Probe of Teen's Death Uncovers Deficiencies, Washington Post, Jan. 22, 2000, at A1.Google Scholar
D. Nelson and R. Weiss, Penn Ends Gene Trials on Humans, Washington Post, May 25, 2000, at A1 [hereinafter cited as Nelson and Weiss, Penn Ends Gene Trial].Google Scholar
B. Gose, U. of Pennsylvania, Doctors, and Ethicist are Named in Suit Over Gene-Therapy Death, Chronicle of Higher Education, Sept. 29, 2000, at A34.Google Scholar
Nelson and Weiss, Penn Researchers Sued, supra note 7.Google Scholar
Id.Google Scholar
Nelson and Weiss, Penn Ends Gene Trial, supra note 11.Google Scholar
S. Hensley, Targeted Genetics Genovo Deal Leads to Windfall for Researcher, Wall Street Journal, Aug. 10, 2000 at B12.Google Scholar
Nelson and Weiss, Penn Ends Gene Trial, supra note 11.Google Scholar
Id.Google Scholar
Gose, supra note 12.Google Scholar
A. Schneider, U. of Pennsylvania Settles Lawsuit Over Gene-Therapy Death, Chronicle of Higher Education, Nov. 6, 2000.Google Scholar
Bodenheimer, T., Uneasy Alliance-Clinical Investigator's and the Pharmaceutical Industry (Health Policy Report), N. Engl. J. Med., 342 (2000): 153944, at 1539.Google Scholar
Id.Google Scholar
Id.Google Scholar
Angell, M., Is Academic Medicine for Sale? (Editorial), N. Engl. J. Med., 342 (2000): 151618, at 1517.CrossRefGoogle ScholarPubMed
See text at notes 197217 infra.Google Scholar
See, for example, Eichenwald and Kolata, supra note 1; K. Eichenwald and G. Kolata, A Doctor's Drug Studies Turn Into Fraud, New York Times, May 17, 1999, at A1; V. Kiernan, Financial Ties May Taint Researchers Judgment, Chronicle of Higher Education, Jan. 23, 1998, at A18.Google Scholar
D.F. Thompson, Understanding Financial Conflicts of Interest (Sounding Board), N. Engl. J. Med., 329 (1993): 57376, at 573.Google Scholar
Id.Google Scholar
J. Katz, Human Experimentation and Human Rights, Saint Louis University Law Journal, 38 (1993): 754, at 14.Google Scholar
Id. at 15.Google Scholar
Id. See also J.A. Goldner, An Overview of Legal Controls on Human Experimentation and the Regulatory Implications of Taking Professor Katz Seriously, Saint Louis University Law Journal, 38 (1993): 64134, at 120 [hereinafter cited as Goldner, Legal Controls on Human Experimentation].Google Scholar
Id.Google Scholar
Thompson, supra note 27, at 573.Google Scholar
Id.Google Scholar
Delgado, R. and Leskovac, H., Informed Consent in Human Experimentation: Bridging the Gap Between Ethical Thought and Current Practice, UCLA Law Review, 34 (1986): 67130, at 91.Google ScholarPubMed
Kassirer, J.P. and Angell, M., Financial Conflicts of Interest in Biomedical Research, N. Engl. J. Med., 329 (1993): 57071.CrossRefGoogle ScholarPubMed
Emanuel, E.J. and Steiner, D., Institutional Conflict of Interest (Sounding Board), N. Engl. J. Med., 332 (1995): 26267, at 263.CrossRefGoogle ScholarPubMed
TUNA is a procedure used to treat prostate disorders. T.M. Burton, Urodollars: A Prostate Researcher Tested Firm's Product and Sat on Its Board, Wall Street Journal, Mar. 19, 1998, at A1.Google Scholar
Id.Google Scholar
Id.Google Scholar
Dr. Oesterling pled no contest to a felony charge of fraud after it was discovered that he had been double and triple billing for his trips and had not reported research money to the university. Id.Google Scholar
Id.Google Scholar
D. Vergano, Drug Trials vex Medical Ethics American Experts put Testing by Private Companies Under a Microscope, USA Today, Aug. 8, 2000, at 9D; see also Eichenwald and Kolata, supra note 1.Google Scholar
Finkel, M.J., Should Informed Consent Include Information on How Research is Funded?, IRB, 13, no. 5 (1991): 13, at 1. Currently, the Department of Health and Human Services provides little guidance on recruitment. However, a recent OIG report recommended the development of such recruitment guidelines. See Office of Inspector General, Recruiting Human Subjects: Pressures in Industry Sponsored Clinical Research (June 2000): 179, at 33 [hereinafter cited as OIG Report, Pressures in Industry Sponsored Clinical Research].CrossRefGoogle ScholarPubMed
Shimm, D.S. and Spece, R.G., Conflict of Interest and Informed Consent in Industry-Sponsored Clinical Trials, Journal of Legal Medicine, 12 (1991): 477513, at 482.CrossRefGoogle ScholarPubMed
Roizen, R., Why I Oppose Drug Company Payment of Physician/Investigators on a Per Patient/Subject Basis, IRB, 10, no. 1 (1988): 910, at 9.CrossRefGoogle ScholarPubMed
Shimm and Spece, supra note 45, at 482. Still another source states that pharmaceutical companies sometimes pay doctors as much as 6,000 per patient. See also S. Kaplan and S. Brownlee, Dying for a Cure: Why Cancer Patients Often Turn to Risky Experimental Treatments And Wind Up Paying With Their Lives, U.S. News & World Report, Oct. 11, 1999, at 34. It is not clear whether remuneration levels cited by commentators are in net or gross.Google Scholar
Shimm and Spece, supra note 45, at 482.Google Scholar
Id. See Roizen, supra note 46, at 9. See also OIG Report, Pressures in Industry Sponsored Clinical Research, supra note 44, at 25.Google Scholar
Shimm and Spece, supra note 45, at 482.Google Scholar
Office of Inspector General, Recruiting Human Subjects: Sample Guidelines for Practice (June 2000): 123, at 8 [hereinafter cited as OIG Report, Sample Guidelines for Practice].Google Scholar
Some investigators indicate that sponsors continually cut initial study budgets, so bonuses help sites recoup the costs of conducting the trials. See OIG Report, Pressures in Industry Sponsored Clinical Research, supra note 44, at 17.Google Scholar
See OIG Report, Sample Guidelines for Practice, supra note 51, at 8.Google Scholar
OIG Report, Pressures in Industry Sponsored Clinical Research, supra note 44, at 1214.Google Scholar
Id. at 13.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
See OIG Report, Pressures in Industry Sponsored Clinical Research, supra note 44, at 2526.Google Scholar
L.B. Andrews, Money Is Putting People at Risk in Biomedical Research, Chronicle of Higher Education, Mar. 10, 2000, at B4.Google Scholar
Shimm and Spece, supra note 45, at 482.Google Scholar
Id.Google Scholar
Maher, E.A., An Analysis of Finder's Fees in Clinical Research, Canadian Medical Association Journal, 150 (1994): 25256, at 252.Google ScholarPubMed
DeRenzo, E.G., Coercion in the Recruitment and Retention of Human Research Subjects, Pharmaceutical Industry Payments to Physician-Investigators, and the Moral Courage of the IRB, IRB, 22, no. 2 (2000): 15, at 2.CrossRefGoogle ScholarPubMed
Eichenwald and Kolata, supra note 1.Google Scholar
Maher, supra note 63, at 255.Google Scholar
Id. at 25556.Google Scholar
Lind, S.L., Finder's Fees for Research Subjects, N. Engl. J. Med., 323 (1990): 19295, at 193.CrossRefGoogle ScholarPubMed
Id.Google Scholar
Campbell, E.G., Louis, K.S., and Blumenthal, D., Looking a Gift Horse in the Mouth: Corporate Gifts Supporting Life Sciences Research, JAMA, 279 (1998): 99599, at 995.CrossRefGoogle ScholarPubMed
The study surveyed 2,167 faculty who conducted research. The survey asked the researchers to rate research-gifts as essential, very important, important, not very important, or not at all important to the progress of their research. Id. at 997.Google Scholar
Id. at 998.Google Scholar
Id. at 997.Google Scholar
Orlowski, J.P. and Wateska, L., The Effects of Pharmaceutical Firm Enticements on Physician Prescribing Patterns: There's no Such Thing as a Free Lunch, Chest, 102 (1992): 27073.CrossRefGoogle ScholarPubMed
Id.Google Scholar
Id. at 273.Google Scholar
Healy, B. et al., Conflict-of-Interest Guidelines for a Multicenter Clinical Trial of Treatment After Coronary Artery Bypass-Graft Surgery (Special Report), N. Engl. J. Med., 320 (1989): 94951, at 950.CrossRefGoogle ScholarPubMed
Hilgartner, S., Research Fraud, Misconduct and the IRB, IRB, 12, no. 1 (1990): 14, at 4.CrossRefGoogle ScholarPubMed
Id.Google Scholar
Macklin, R., Due and Undue Inducements: On Paying Money to Research Subjects, IRB, 3, no. 5 (1981): 16, at 1, 4. The risk-to-benefit ratio must be balanced or shown to be in a favorable ratio. See National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, DHEW Pub. No. (OS) 780012, (Washington, D.C.: U.S. Gov't Printing Office, 1978) [hereinafter cited as The Belmont Report]. Thus, offering patients money, as an inducement to participation in a study with high levels of risk, would violate principles of justice and accepted norms regarding the risk-benefit analysis.CrossRefGoogle ScholarPubMed
Hilgartner, supra note 78, at 4.Google Scholar
Stelfox, H. et. al., Conflict of Interest in the Debate over Calcium-Channel Antagonists, N. Engl. J. Med. 338 (1998): 10106. For a discussion of other studies demonstrating that financial conflicts of interest have an impact on the conclusions reached by researchers in published articles, see National Institutes of Health, Conference on Human Subject Protection and Financial Conflicts of Interest, Transcript at 1314 (August 15, 2000) [hereinafter cited as National Institutes of Health, Transcript, Aug. 15, 2000].CrossRefGoogle ScholarPubMed
V. Kiernan, supra note 26.Google Scholar
Id.Google Scholar
Id.Google Scholar
Scientific Journals Rarely Acknowledge Authors Potential Conflicts, Study Finds, Chronicle of Higher Education, Feb. 5, 1999, at A39.Google Scholar
See G. Blumenstyk, Medical Journal Reviews Its Policies After Author's Potential Conflict is Reported, Chronicle of Higher Education, Oct. 8, 1999, at A24. See also D. Orentlicher and M.K. Hehir, II, Advertising Policies of Medical Journals: Conflicts of Interest for Journal Editors and Professional Societies, Journal of Law, Medicine & Ethics, 27 (1999): 113118.Google Scholar
Blumenstyk, supra note 87.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Scientific Journals Rarely Acknowledge Authors Potential Conflicts, Study Finds, supra note 86.Google Scholar
Katz, supra note 29, at 37. See also Delgado and Leskovac, supra note 35, at 104.Google Scholar
Goldrick, B.A., Larson, E., and Lyons, D., Conflict of Interest in Academia, Image: Journal of Nursing Scholarship, 27 (1995): 6569, at 66.Google ScholarPubMed
Delgado and Leskovac, supra, note 35, at 104.Google Scholar
Goldner, J.A., The Unending Saga of Legal Controls Over Scientific Misconduct: A Clash of Cultures Needing Resolution, American Journal of Law & Medicine, 24 (1998): 293343, at 343.Google ScholarPubMed
See 35 U.S.C. 200 et. seq. (1980). See also National Institutes of Health, Transcript, Aug. 15, 2000, supra note 82, at 49. See also text at notes 123127 infra.Google Scholar
Angell, supra note 24.Google Scholar
National Institutes of Health, A 20-20 View of Invention Reporting to the National Institutes of Health (visited Oct. 30, 2000) <http://grants.nih.gov/grants/guide/notice-files/not95-003.html>..>Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Andrews, supra note 60, at 2.Google Scholar
Id.Google Scholar
Id. at 3.Google Scholar
In fact, there is no mention of conflicts of interest in the legislative history of the Act.Google Scholar
Inglehart, J.K., Rapid Changes for Academic Medical Centers, N. Engl. J. Med., 332 (1995): 40711, at 408.Google Scholar
Id. See also P.D. Fox and J. Wasserman, Academic Medical Centers and Managed Care: Uneasy Partners, Health Affairs, (Spring 1993): 8593, at 89.Google Scholar
Id.Google Scholar
Johnson, A., Current Trends in Faculty Personnel Policies: Appointment, Evaluation and Termination, Saint Louis University Law Journal, 44 (2000): 81112, at 88.Google Scholar
Id.Google Scholar
Id.Google Scholar
Taken from materials presented by Annette Johnson, Saint Louis University Health Law Symposium, April 1999. Materials on file with author.Google Scholar
See, for example, C. Hilton et al., A Relative-value-Based System for Calculating Faculty Productivity in Teaching, Research, Administration, and Patient Care, Academic Medicine (1997): 78793, at 79293. For example, at Louisiana State University School of Medicine in New Orleans, physicians receive points for writing grants and publishing an abstract or manuscript. Id. Under the university's scheme, a physician has the opportunity to receive 4,150 points based on research projects, out of a total 14,612 possible points. Id. Thus, almost one-third of the total points may be obtained by participating in research; salary levels, in turn, reflect the total number of points awarded. Id.Google Scholar
Angell, supra note 24, at 1517.Google Scholar
Leskovac, H., Ties that Bind: Conflicts of Interest in University-Industry Links, U.C. Davis Law Review, 17 (1984): 895923, at 895.Google Scholar
Id. at 899.Google Scholar
Edgar, H. and Rothman, D.J., The Institutional Review Board and Beyond: Future Challenges to the Ethics of Human Experimentation, Milbank Quarterly, 73, no. 4 (1995): 489506, at 500.CrossRefGoogle ScholarPubMed
Id. at 499500.Google Scholar
Id. at 500.Google Scholar
W.L. Geary, Protecting the Patent Rights of Small Businesses Does the Bayh-Dole Act Live Up to its Promise? AIPLA Quarterly Journal, 20 (1992): 1034, at 18. See also R.K. Yoshinaka, Too Much of a Good Thing? Public Access to Medical Research in Washington After Paws v. U.W, Washington Law Review, 70 (1995): 92952, at 939. See text at notes 99104 supra.Google Scholar
Id.Google Scholar
Id.Google Scholar
Andrews, supra note 60, at 2.Google Scholar
Angell, supra note 24.Google Scholar
Blake, D.A., The Opportunities and Problems of Commercial Ventures: The University View, in Biomedical Research, in Porter, R.J. and Malone, T.E., eds., Biomedical Research: Collaboration and Conflict of Interest (Baltimore: John Hopkins University Press, 1992): 8892, at 8889.Google Scholar
Id. This is true even though the Bayh-Dole Act gives sponsoring universities intellectual property rights to inventions stemming from federally funded research.Google Scholar
Bok, D., Business and the Academy, Harvard Magazine, 83 (1981): 2335, at 26.Google ScholarPubMed
Emanuel and Steiner, supra note 37, at 263.Google Scholar
Maatz, C.T., University Physician-Researcher Conflicts of Interest: The Inadequacy of Current Controls and Proposed Reform, High Technology Law Journal, 7 (1992): 13788, at 155.Google ScholarPubMed
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id. at 156.Google Scholar
Id. at 156.Google Scholar
Id.Google Scholar
See Financial Disclosure by Clinical Investigators, 63 Fed. Reg. 5,233 (1998); Objectivity in Research, 60 Fed. Reg. 35,810 (1995); and Investigator Financial Disclosure Policy, 59 Fed. Reg. 33,308 (1994).Google Scholar
See Financial Disclosure by Clinical Investigators, 21 C.F.R. 54.1(a) (1998) and Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding is Sought, 42 C.F.R. 50.601 (1996).Google Scholar
See Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding is Sought, 42 C.F.R. 50.606 (1996).Google Scholar
Financial Disclosure by Clinical Investigators, 59 Fed. Reg. 48,708 (1994).Google Scholar
Id. Federal support is not necessary for the FDA regulations to be applicable. The FDA regulations apply to any FDAregulated article. NIH Regulatory Burden v. Human Subjects Protection Workgroups Report (visited at December 6, 2000) <http://grants.nih.gov/grants/policy/regulatoryburden/humansubjectsprotection.htm>..>Google Scholar
Id.Google Scholar
Financial Disclosure by Clinical Investigators, 21 C.F.R. 54.4 (1998).Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id. at 54.4(c).Google Scholar
Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding is Sought, 42 C.F.R. 50.604 (1996).Google Scholar
Id. See also Investigator Financial Disclosure Policy, 59 Fed. Reg. 33,31112 (1994); F-D-C Reports, Final PHS Conflict-of-Interest Rule Sets 10,000/5% Disclosure Threshold, Harmonizes With NSF Reg, The Blue Sheet, July 12, 1995.Google Scholar
Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding is Sought, 42 C.F.R. 50.604 (1996). See also Investigator Financial Disclosure Policy, 59 Fed. Reg. 33,31112 (1994); F-D-C Reports, Final PHS Conflict-of-Interest Rule Sets 10,000/5% Disclosure Threshold, Harmonizes With NSF Reg, The Blue Sheet, July 12, 1995.Google Scholar
The NSF and PHS guidelines are virtually identical. The main difference between the two is that, while all research funded by PHS is subject to the PHS guidelines, the NSF policy only applies to institutions accepting NSF grant funds that have more than 50 employees. See M. Barnes and S. Krauss, Conflicts of Interest in Human Research: Risks and Pitfalls of Easy Money in Research Funding, BNA's Health Law Reporter, 9, no. 35 (2000): at 1385.Google Scholar
Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding is Sought, 42 C.F.R. 50.604 (1996). See also Investigator Financial Disclosure Policy, 59 Fed. Reg. 33,31112 (1994); F-D-C Reports, Final PHS Conflict-of-Interest Rule Sets 10,000/5% Disclosure Threshold, Harmonizes With NSF Reg, The Blue Sheet, July 12, 1995.Google Scholar
Id.Google Scholar
Id.Google Scholar
The PHS and NSF rules do not specify what type of mechanisms an institution should have in place in order to detect an investigator's failure to comply with the institution's conflictof-interest policy.Google Scholar
42 C.F.R. 50.606(a).Google Scholar
Id.Google Scholar
Id.Google Scholar
42 C.F.R. 50.606(c). The disclosure of financial conflicts of interest is required of all individuals presenting at Continuing Medical Education (CME) seminars.Google Scholar
42 C.F.R. 50.606(b).Google Scholar
Id.Google Scholar
Id.Google Scholar
The Post-CABG Clinical Trial was a multicenter, randomized, double blind study sponsored by the National Institutes of Health. Healy, supra note 77. See also Shimm and Spece, supra note 45, at 508.Google Scholar
Shimm and Spece, supra note 45, at 508.Google Scholar
F-D-C Reports, Conflict-of-Interest Guidelines Established By Researchers Conducting NHLBI-Sponsored Trial, The Blue Sheet, April 12, 1989.Google Scholar
Shimm and Spece, supra note 45, at 508.Google Scholar
Id.Google Scholar
Id.Google Scholar
A.S. Relman, Economic Incentives In Clinical Investigation, N. Engl. J. Med., 320 (1989): 93334, at 933.CrossRefGoogle Scholar
Id.Google Scholar
See American Society of Gene Therapy, Policy of The American Society of Gene Therapy on Financial Conflict of Interest in Clinical Research (visited Oct. 30, 2000) <http://www.asgt.org/policy/index.html>..>Google Scholar
Id.Google Scholar
See American Society of Gene Therapy, American Society of Gene Therapy Bylaws (visited Oct. 30, 2000) <http://www.asgt.org/bylaws.html>..>Google Scholar
Keratoconjunctivitis sicca is defined as inflammation of the cornea and conjunctiva [the membrane lining the eyelids]; a condition marked by hyperemia [an excess of blood] of the conjunctiva, thickening and drying of the corneal epithelium, and itching and burning of the eye. M. OToole et al., eds., Miller-Keane Encyclopedia and Dictionary of Medicine, Nursing, and Allied Health, 5th ed. (Philadelphia: W.B. Saunders, 1992): at 811.Google Scholar
Shimm and Spece, supra note 45, at 507.Google Scholar
Id. See also F-D-C Reports, Vitamin A Ophthalmic Ointment Studies By Tseng, et al., Violated Human Subject Protection Rules, NIH Finds, The Blue Sheet, March 8, 1989.Google Scholar
Id. at 50708.Google Scholar
Id. at 508.Google Scholar
M. Witt and L.O. Gostin, Conflict of Interest Dilemmas in Biomedical Research, JAMA, 271 (1994): 54751.CrossRefGoogle Scholar
Id. See also Shimm and Spece, supra note 45, at 508, n. 92.Google Scholar
See President and Fellows of Harvard College, Guidelines for Conflicts of Interest (visited Oct. 30, 2000) <http://www.hms.harvard.edu/integrity/guide.html>..>Google Scholar
Witt and Gostin, supra note 181, at 549.Google Scholar
Id.Google Scholar
Id.Google Scholar
Angell, supra note 24, at 1516.Google Scholar
K.S. Mangan, Harvard Medical School Will Keep Its Conflict-Of-Interest Policies, Chronicle of Higher Education, June 9, 2000, at A36.Google Scholar
Angell, supra note 24, at 1518.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
See Goldner, Legal Controls on Human Experimentation, supra note 31.Google Scholar
Id. at 101103. Institutional review boards also conduct continuing review of approved research to ensure that human-subject protections remain in place. See also R.J. Levine, Ethics & Regulation of Clinical Research (Baltimore : Urban & Schwarzenberg, 1981): 326. See also 21 C.F.R. 56.111(a)(2) and (4); 45 C.F.R. 46.111(a)(2) and (4).Google Scholar
See Goldner, Legal Controls on Human Experimentation, supra note 31, at 63, 90103.Google Scholar
See generally Office of Inspector General, Institutional Review Boards: Their Role in Reviewing Approved Research (June 1998): i15.Google Scholar
Id.Google Scholar
Id. at 911.Google Scholar
Id.Google Scholar
Office of Inspector General, Protecting Human Subjects: Status of Recommendations (April 2000): 125 [hereinafter cited as OIG Report, Status of Recommendations]. See also J. Brainard, NIH, FDA Should Do More to Protect Human Subjects in Research, Report Says, Chronicle of Higher Education, April 21, 2000, at A38.Google Scholar
OIG Report, Status of Recommendations, supra note 201, at 23.Google Scholar
IRBs: Facing a Crackdown, Center Watch, 7 (April 2000).Google Scholar
J. Manier, Rush is told why studies were halted, Chicago Tribune, Nov. 19, 1998, at A1.Google Scholar
P.J. Hilts, Safety Concerns Halt Oklahoma Research, New York Times, July 11, 2000, at F12.Google Scholar
J. Brainard, U.S. Regulators Call on 2 Universities to Suspend Studies Involving Prisoners, Chronicle of Higher Education, Sept. 15, 2000, at A26.Google Scholar
Office for Human Research Protections, OHRP Compliance Activities: Common Findings and Guidance (visited Oct. 30, 2000) <http://ohrp.osophs.dhhs.gov/references/findings.pdf>..>Google Scholar
See text at notes 720 supra.Google Scholar
E.T. Pound, Clinical trials halted Feds: Cancer study endangered patients, USA Today, July 10, 2000, at 1A.Google Scholar
E.T. Pound, A case study in how not to conduct a clinical trial, USA Today, July 10, 2000, at 15A.Google Scholar
R. Weiss and D. Nelson, U.S. Halts Cancer Tests in Oklahoma; Patient Protections Ignored, Agency Say, Washington Post, July 11, 2000, at A1.Google Scholar
J. Brainard, Spate of Suspensions of Academic Research Spurs Questions About Federal Strategy, Chronicle of Higher Education, Feb. 4, 2000, at A29 [hereinafter cited as Brainard, Spate of Suspensions]. See also J. Brainard, Agency Reassigns Head of Office That Oversees Human-Subjects Research, Chronicle of Higher Education, June 9, 2000, at A31 [hereinafter cited as Brainard, Agency Reassigns Head of Office].Google Scholar
Brainard, Spate of Suspensions, supra note 212.Google Scholar
Id.Google Scholar
J. Brainard, Physician May Lead New Human-Research Office, Chronicle of Higher Education, May 26, 2000, at A41. See also P. Healy, Government to Upgrade Power of Watchdog on Human-Subject Research, Chronicle of Higher Education, July 30, 1999, at A28.Google Scholar
Healy, supra note 215; Brainard, supra note 215.Google Scholar
R. Weiss, Panel Urges Major Upgrade for Medical Research Safety Office, Washington Post, June 4, 1999, at A16; Brainard, supra note 215.Google Scholar
Weiss, supra note 217.Google Scholar
Healy, supra note 215. See also J. Brainard, Director Named for New Office to Protect Human Research Subjects, Chronicle of Higher Education, June 16, 2000, at A30.Google Scholar
Brainard, Agency Reassigns Head of Office, supra note 212; J. Brainard, Will Fresh Face Bring a New Approach to Federal Protection of Human Subjects? Chronicle of Higher Education, July 21, 2000, at A21 [hereinafter cited as Brainard, Fresh Face].Google Scholar
Brainard, Fresh Face, supra note 220.Google Scholar
Id.Google Scholar
J. Brainard, Top Official Criticizes Protection of Humans in Research, Chronicle of Higher Education, Oct. 6, 2000, at A34.Google Scholar
Id.Google Scholar
National Institutes of Health, Conference on Human Subject Protection and Financial Conflicts of Interest, Transcript (August 16, 2000) [hereinafter cited as National Institutes of Health, Transcript, Aug. 16, 2000] (Statement of Greg Koski).Google Scholar
Brainard, Fresh Face, supra note 220.Google Scholar
Id.Google Scholar
Office for Human Research Protections, Statement of Greg Koski, Ph.D., M.D., Director, Office for Human Research Protections, Office of the Secretary, Department of Health and Human Services, for the Hearing on Human Subjects Protections in VA Medical Research Before The Subcommittee on Oversight and Investigations Committee on Veterans Affairs U.S. House of Representatives, Transcript (Sep. 28, 2000) (visited December 6, 2000) <http://ohrp.osophs.dhhs.gov/references/tkoski.htm> [hereinafter cited as OHRP, Statement of Greg Koski].+[hereinafter+cited+as+OHRP,+Statement+of+Greg+Koski].>Google Scholar
Brainard, supra note 215.Google Scholar
J. Brainard, Top Official Criticizes Protection on Humans in Research, Chronicle of Higher Education, Oct. 6, 2000, at A34.Google Scholar
OHRP, Statement of Greg Koski, supra note 228.Google Scholar
45 C.F.R. 46.111 (1991); 21 C.F.R. 56.111 (1991).CrossRefGoogle Scholar
21 C.F.R. 50.25 (1981); 45 C.F.R. 46.116(c) (1991); 45 C.F.R. 690.116(c) (1991).Google Scholar
Id. (emphasis added).Google Scholar
Protection of Human Subjects; Informed Consent, 46 C.F.R. 8942, 8947 (1981).Google Scholar
21 C.F.R. 50.20 (1981); 45 C.F.R. 46.116 (1991); 45 C.F.R. 690.116 (1991).Google Scholar
National Institutes of Health, Financial Conflicts of Interest and Research Objectivity: Issues for Investigators and Institutional Review Boards (June 5, 2000) (visited December 6, 2000) <http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-040.html>..>Google Scholar
Id.Google Scholar
Id.Google Scholar
Department of Health and Human Services, Human Subject Protection and Financial Conflicts of Interest: Conference, 65 Fed. Reg. 41,07302 (2000).Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
R.F. Weir and J.R. Horton, DNA Banking and Informed Consent Part 1, IRB, 17, no. 4 (1995): 14, at 3 [hereinafter cited as Weir and Horton, Part 1].CrossRefGoogle Scholar
Id.Google Scholar
Canterbury v. Spence, 464 F.2d 772, 786 (D.C. Cir. 1972).Google Scholar
Weir and Horton, Part 1, supra note 244, at 3.Google Scholar
Id.Google Scholar
B.R. Furrow et. al., Liability and Quality Issues in Health Care, 3rd ed. (St. Paul, Minnesota: West Publishing Co., 1997): at 381.Google Scholar
Delgado and Leskovac, supra note 35, at 88.Google Scholar
Halushka v. University of Saskatchewan, 53 D.L.R. 2d 436, 444 (Sask. 1965).Google Scholar
Delgado and Leskovac, supra note 35, at 90.Google Scholar
Of course, the subject's risk is not gratuitous if he or she is being compensated for time spent, or if he or she has contracted to receive a percentage of the profits if the research produces a commercially viable product. A subject, however, cannot be compensated for risk.Google Scholar
Goldner, Legal Controls on Human Experimentation, supra note 31, at 114.Google Scholar
Id., citing the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, DHEW Pub. No. (OS) 78-0012 (Washington, D.C.: U.S. Gov't Printing Office, 1978).Google Scholar
Delgado and Leskovac, supra note 35, at 92.Google Scholar
Id. at 91.Google Scholar
T.H. Murray, Who Owns the Body? On the Ethics of Using Human Tissues for Commercial Purposes, IRB, 8, no. 1 (1986): 15, at 4.CrossRefGoogle Scholar
Id.Google Scholar
M.A. Rodwin, Physicians Conflicts of Interest: The Limitations of Disclosure (Sounding Board), N. Engl. J. Med., 321, (1989): 14051409, at 1407 [hereinafter cited as Rodwin, Limitations of Disclosure]. See generally C.E. Schneider, The Practice of Autonomy: Patients, Doctors and Medical Decisions (New York: Oxford University Press, 1998).Google Scholar
Emanuel and Steiner, supra note 37, at 265.Google Scholar
Id.Google Scholar
Id.Google Scholar
Rodwin, Limitations of Disclosure, supra note 260, at 1405.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
M.A. Rodwin, Medicine, Money and Morals: Physicians Conflicts of Interest (New York: Oxford Press, 1993): at 215.Google Scholar
Id. at 216.Google Scholar
Id. at 5; Murray, supra note 258, at 5.Google Scholar
Roizen, supra note 46, at 9.Google Scholar
Id. at 9, citing H.M. Spiro, Mammon and Medicine: The Rewards of Clinical Trials, JAMA, 255 (1986): 11741175.CrossRefGoogle Scholar
Moore v. Regents of University of California, 793 P.2d 479 (Cal. 1990).Google Scholar
Id. at 481.Google Scholar
Id.Google Scholar
Id. at 482.Google Scholar
Id. at 485.Google Scholar
A.T. Corrigan, A Paper Tiger: Lawsuits Against Doctors for Non-Disclosure of Economic Interest in Patient's Cells, Tissues and Organs, Case Western Reserve Law Review, 42 (1991): 56597, at 584.Google Scholar
Murray, supra note 258, at 4.Google Scholar
Finkel, supra note 44, at 2.Google Scholar
Id.Google Scholar
Murray, supra note 258, at 4.Google Scholar
Frequently Asked Questions Concerning the Department of Health and Human Services Objectivity in Research Regulations and the National Science Foundation Investigator Financial Disclosure Policy, 61 Fed. Reg. 34,839 (1996).Google Scholar
Id.Google Scholar
Rodwin, Limitations of Disclosure, supra note 260, at 1405.Google Scholar
R.W. Garnett, Why Informed Consent? Human Experimentation and the Ethics of Autonomy, The Catholic Lawyer, 36 (1996): 455511, at 458.Google Scholar
Delgado and Leskovac, supra note 35, at 102.Google Scholar
See Office for Protection from Research Risks, Protecting Human Research Subjects: Institutional Review Board Guidebook (1993): at 3-443-45.Google Scholar
Tissue is generally removed during a medically necessary procedure. Very few protocols call for tissue removal in excess of what is medically necessary for the subject's particular malady.Google Scholar
A gift is defined as a voluntary transfer of property to another made gratuitously and without consideration. Bradley v. Bradley, 540 S.W.2d 504, 511 (Tex. Civ. App. 1976).Google Scholar
Murray, supra note 258, at 1, 3.Google Scholar
Id.Google Scholar
R.F. Weir and J.R. Horton, DNA Banking and Informed Consent Part 2, IRB, 17, nos. 56 (1995): 18, at 8 [hereinafter cited as Weir and Horton, Part 2].CrossRefGoogle Scholar
Id.Google Scholar
Id.Google Scholar
Id. at 2.Google Scholar
Id. at 8.Google Scholar
R. Levine, Research that Could Yield Marketable Products from Human Materials: The Problem of Informed Consent, IRB, 8, no. 1 (1986): 67, at 7.CrossRefGoogle Scholar
Bartolo, Tales of Informed Consent: Four Years on an Institutional Review Board, Health Matrix, 2 (1992): 193245, at 233.Google Scholar
Weir and Horton, Part 2, supra note 294, at 3.Google Scholar
Levine, supra note 299, at 6.Google Scholar
Id.Google Scholar
Id. at 7.Google Scholar
45 C.F.R. 46.116 (1991); 21 C.F.R. 50.20 (1981).CrossRefGoogle Scholar
Id. at 7.Google Scholar
7 C.F.R. 1.111 (2000). The Belmont Report states, it can be seen how conceptions of justice are relevant to research involving human subjects. For example, the selection of research subjects needs to be scrutinized in order to determine whether some classes (e.g., welfare patients, particular racial and ethnic minorities, or persons confined to institutions) are being systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied. The Belmont Report, supra note 80, at 5.Google Scholar
Roizen, supra note 46, at 10.Google Scholar
See National Institutes of Health, Conference on Human Subject Protection and Financial Conflicts of Interest, Transcript (August 15, 2000) [hereinafter cited as National Institutes of Health, Transcript, Aug. 15, 2000] (Statement of Susan Kornetsky).Google Scholar
Id. (Statement of Theodore J. Cicero).Google Scholar
B. Lo et al., Conflict of Interest Policies for Investigators in Clinical Trials, N. Engl. J. Med., 343 (2000): 16161620, at 1617.Google Scholar
S. Van McCrary et. al., A National Survey of Policies on Disclosure of Conflicts of Interest in Biomedical Research, N. Engl. J. Med., 343 (2000): 16211625, at 1623.CrossRefGoogle Scholar
National Institutes of Health, Transcript, Aug. 16, 2000, supra note 225 (Statement of Greg Koski).Google Scholar
See J.M. Drazen and G. Koski, To Protect Those Who Serve (Editorial), N. Engl. J. Med., 343, (2000): 16431645, at 1644.CrossRefGoogle Scholar
See Angell, supra note 24.Google Scholar
National Institutes of Health, Transcript, August 16, 2000, supra note 225 (Statement of Marcia Angell).Google Scholar
Id.Google Scholar
Id.Google Scholar
Id. See also Angell, supra note 24.Google Scholar
National Institutes of Health, Transcript, August 16, 2000, supra note 225 (Statement of Marcia Angell).Google Scholar
Id. (Statement of Greg Koski).Google Scholar