Hostname: page-component-8448b6f56d-xtgtn Total loading time: 0 Render date: 2024-04-24T19:36:53.066Z Has data issue: false hasContentIssue false

A Walk in the Park: A Case Study in Research Ethics

Published online by Cambridge University Press:  01 January 2021

Extract

Can researchers, interested in novel ways to assess HIV seroprevalence among populations which are otherwise hidden, collect condoms that have been discarded on the ground in a public sex environment (PSE) and test them for HIV? Does the Code of Federal Regulations address this question, and if not, what areas of research ethics might provide guidance to an IRB considering such a study? These questions arose as part of a preliminary study to test the feasibility of collecting discarded condoms from a public sex environment in Massachusetts, and testing contained semen for HIV. Although the methodology of this study is somewhat unusual, the questions raised are not. Researchers, who wish to use other types of abandoned samples such as discarded syringes, hair or saliva samples, or even excess biological samples, commonly confront similar issues, and the analysis utilized here could guide design and review of other studies.

Type
Symposium
Copyright
Copyright © American Society of Law, Medicine and Ethics 2009

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

The aims of this project are the following: To test the feasibility of innovative methods to increase knowledge about men who have sex with men (MSM) in public sex environments in order to better target outreach, education, and prevention efforts, and specifically, to review the ethical questions raised by collecting and testing anonymous samples without informed consent of the persons who discarded the condoms.Google Scholar
45 CFR §46.101 (1991).Google Scholar
45 CFR §46.102(f) (1991).Google Scholar
National Bioethics Advisory Commission, Research Involving Human Biological Materials: Ethical Issues and Policy Guidance, vol. 1 (Rockville, MD: U.S. Government Printing Office, 1999): At iii.Google Scholar
Office for Human Research Protection, U. S. Department of Health and Human Services, Guidance on Research Involving Coded Private Information or Biological Specimens, 2008, available at <http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.htm> (last visited January 9, 2009).+(last+visited+January+9,+2009).>Google Scholar
45 CFR §46.116(d) (1991).Google Scholar
Group on Ethical and Legal Issues Related to AIDS, Public Health Service Executive Task Force on AIDS, Policy on Informing Those Tested about HIV Serostatus, 1988, available at <http://www.hhs.gov/ohrp/humansubjects/guidance/hsd-c88jun.htm> (last visited January 9, 2009).+(last+visited+January+9,+2009).>Google Scholar
See National Bioethics Advisory Commission, supra note 4.Google Scholar
Meslin, E. Quaid, K., “Ethical Issues in the Collection, Storage, and Research Use of Human Biological Materials,” Journal of Laboratory and Clinical Medicine 144, no. 5 (2004): 229234; Clayton, E. W. Steinberg, K. K. Khoury, M. J. Thomson, E. Andrews, L. Kahn, M. E., “Informed Consent for Genetic Research on Stored Tissue Samples,” JAMA 274, no. 22 (1995): 1786–1792; Knoppers, B. M. L. Laberge, C. M., “Research and Stored Tissues: Persons as Sources, Samples as Persons?” JAMA 274, no. 22 (1995): 1806–1807.CrossRefGoogle Scholar
See National Bioethics Advisory Commission, supra note 4.Google Scholar
See Meslin, Quaid, , supra note 9.Google Scholar
Jones, D. G. Gear, R. Galvin, K. A., “Stored Human Tissue: An Ethical Perspective on the Fate of the Anonymous, Archival Material,” Journal of Medical Ethics 29, no. 6 (2003): 343347.CrossRefGoogle Scholar
Id.; Skene, L., “Who Owns Your Body? Legal Issues on the Ownership of Bodily Material,” Trends in Molecular Medicine 8, no. 1 (2002): 4849; Furness, P. N., “Research Using Human Tissues — A Crisis of Supply?” Journal of Pathology 195, no. 3 (2001): 277–284; Ashcroft, R., “The Ethics of Reusing Archived Tissue for Research,” Neuropathology and Applied Neurobiology, 26, no. 5 (2000): 408–411.CrossRefGoogle Scholar
Regidor, E., “The Use of Personal Data from Medical Records and Biological Materials: Ethical Perspectives and the Basis for Legal Restrictions in Health Research,” Social Science and Medicine 59 (2004): 19751984.CrossRefGoogle Scholar
See Ashcroft, , supra note 13; Grizzle, W. Grody, W. W. Noll, W. W. Sobel, M. E. Stass, S. A. Trainer, T., “Recommended Policies for Uses of Human Tissue in Research, Education, and Quality Control,” Archives of Pathology and Laboratory Medicine 123, no. 4 (1999): 296300.Google Scholar
See Knoppers, Laberge, , supra note 9; Furness, , supra note 12; Regidor, , supra note 14; Sade, R. M., “Research on Stored Biological Samples Is Still Research,” Archives of Internal Medicine 162, no. 13 (2002): 14391440.Google Scholar
See Regidor, , supra note 14.Google Scholar
See Jones, , supra note 12.Google Scholar
See Regidor, , supra note 14; Furness, , supra note 13.Google Scholar
See Meslin, Quaid, , supra note 9; Knoppers, , supra note 9; Jones, , supra note 12; Regidor, , supra note 14; Grizzle, , supra note 15; Sade, , supra note 16; Prime, W. Sobel, M. E. Herrington, C. S., “Utilization of Human Tissue in Breast Cancer Research,” Breast Cancer Research 2, no. 4 (2000): 237240; Pelias, M. Z., “Using Archived Tissue Samples: Anonymous Use and Informed Consent,” American Journal of Human Genetics 57, Supplement (1995): A298.Google Scholar
Wendler, D., “What Research with Stored Samples Teaches Us about Research with Human Subjects,” Bioethics 16, no. 1 2002: 3354.CrossRefGoogle Scholar
See Prime, , supra note 20; Wendler, , supra note 21; Knoppers, Laberge, , supra note 9; Jones, , supra note 12.Google Scholar
See Grizzle, , supra note 15.Google Scholar
45 CFR §164.508(c)(1) (2000).Google Scholar
45 CFR §164.502(d) (2000); 45 CFR §164.514(a)-(c) (2000).CrossRefGoogle Scholar
45 CFR §164.510(j)(2)(iii) (2000).Google Scholar
45 CFR §164.512(i)(1)(i) (2000).Google Scholar
See Wendler, , supra note 21.Google Scholar
See Jones, , supra note 12.Google Scholar
See Knoppers, , supra note 9; Skene, , supra note 13.Google Scholar
Rebbe, L. K. W., “Misrepresentation, Conversion, and Commercial Human Tissue Research,” Washington University Law Quarterly 66 (1988): 643669; Gitter, D. M., “Ownership of Human Tissue: A Proposal for Federal Recognition of Human Research Participants' Property Rights in Their Biological Material,” Washington and Lee Law Review 61 (2004): 257–343.Google Scholar
Moore v. Regents of the University of California, 793 P.2d 479 (Cal. 1990).Google Scholar
Greenberg et al. v. Miami Children's Hospital Research Institute Inc. et al., 264 F.Supp.2d 1064, 1074 (2003).Google Scholar
Washington University v. Catalona, 437 F.Supp.2d 985, 994 (2006).Google Scholar
Corpus Juris Secundum, Abandonment, §2 (1985) (footnotes and citations omitted).Google Scholar
Nuffield Council on Bioethics, Human Tissue: Ethical and Legal Issues, London, 1995.Google Scholar
Start, R. Brown, W. Bryant, R. J. Reed, M. W. Cross, S. S. Kent, G., “Ownership and Uses of Human Tissue: Does the Nuffield Bioethics Report Accord with Opinion of Surgical Inpatients?” BMJ 313, no. 7069 (1996): 13661368.CrossRefGoogle Scholar
Office of Technology Assessment, OTA-BA-337, New Developments in Biotechnology: Ownership of Human Tissues and Cells - Special Report (Washington, D.C.: U. S. Government Printing Office, 1987).Google Scholar
Skene, L., “Ownership of Human Tissue and the Law,” Nature Reviews Genetics 3, no. 2 (2002): 145148; Emson, H. E., “The Ethics and Legality of HIV Prevalence Studies: A Contrary View,” Health Law in Canada 12, no. 4 (1992): 95–96, 114.CrossRefGoogle Scholar
Coburn, D., “Guidelines on Ethical and Legal Considerations in Anonymous Unlinked HIV Seroprevalence Research,” Canadian Medical Association Journal 144, no. 12 (1991): 16031604.Google Scholar
See National Bioethics Advisory Commission, supra note 4; Ashcroft, , supra note 13.Google Scholar
See Coburn, , supra note 42; McHale, J., “Waste, Ownership and Bodily Products,” Health Care Analysis 8, no. 2 (2000): 123135.Google Scholar
Fairchild, A. L. Bayer, R., “Uses and Abuses of Tuskegee,” Science 284, no. 5416 (1999): 919921; Bayer, R., “The Ethics of Blinded HIV Surveillance Testing,” American Journal of Public Health 83, no. 4 (1993): 496–497.CrossRefGoogle Scholar
Id. (Bayer); Ploughman, P., “Public Policy Versus Private Rights: The Medical, Social, Ethical, and Legal Implications of the Testing of Newborns for HIV,” AIDS and Public Policy Journal 10, no. 4 (1995–1996): 182204.Google Scholar
See Bayer, , supra note 45.Google Scholar
Office for the Protection from Research Risks, Centers for Disease Control, HIV Seroprevalence Survey of Childbearing Women: Testing Neonatal Dried Blood Specimens on Filter Paper for HIV Antibody, Department of Health and Human Services, 1988.Google Scholar
Cal. Health & Safety Code §120990 (2007).Google Scholar
NY C.L.S. Pub Health §2781(6)(b) (1988).Google Scholar
See Emson, , supra note 41; Coburn, , supra note 42; Anonymous, , “Revised Guidelines on Ethical and Legal Considerations in Anonymous Unlinked HIV Seroprevalence Research,” Canadian Medical Association Journal 146, no. 9 (1992): 17431746; Sharpe, G., “The Ethics and Legality of HIV Seroprevalence Studies,” Health Law in Canada 11, no. 4 (1991): 102–118; Nicoll, A. Gill, O. N. Peckham, C. S. Ades, A. E. Parry, J. Mortimer, P., “The Public Health Applications of Unlinked Anonymous Seroprevalence Monitoring for HIV in the United Kingdom,” International Journal of Epidemiology 29 (2000): 1–10; Wan, L., “The Legality of Unlinked Anonymous Screening for HIV Infection: The U.S. Approach,” Health Policy 14, no. 1 (1990): 29–35; Scientific Committee of the Advisory Council on Aids, Unlinked Anonymous Screening for HIV Surveillance in Hong Kong 1990- 1996, Hong Kong Advisory Council on AIDS and the Centre for Health Protection, Department of Health, 1997, available at <http://www.info.gov.hk/aids/pdf/g51.pdf> (last visited December 31, 2008); Scientific Committee on AIDS, Unlinked Anonymous Screeing for HIV Surveillance in Hong Kong 1997–2004, Hong Kong Advisory Council on AIDS and the Centre for Health Protection, Department of Health, 2005, available at <http://www.27802211.com/ice/program/program13.htm> (last visited December 31, 2008).Google Scholar
World Health Organization, Unlinked Anonymous Screening for the Public Health Surveillance of HIV Infections: Proposed International Guidelines, Global Programme on AIDS, 1989, 17.Google Scholar
Levine, C., “Ethics, Epidemiology, and Women's Health,” Annals of Epidemiology 4, no. 2 (1994): 159165.CrossRefGoogle Scholar
See Fairchild, Bayer, , supra note 45; Bayer, , supra note 45.Google Scholar
Id. (Fairchild and Bayer); see Ploughman, , supra note 46; Snider, D. E., “Patient Consent for Publication and the Health of the Public,” JAMA 278, no. 8 (1997): 624626.Google Scholar
Bayer, R. Lumey, L. H. Wan, L., “The American, British and Dutch Responses to Unlinked Anonymous HIV Seroprevalence Studies: An International Comparison,” AIDS 4 (1990): 283290.CrossRefGoogle Scholar
See Bayer, , supra note 45.Google Scholar
See Clayton, , supra note 9; Knoppers, Laberge, , supra note 9; Furness, , supra note 13; Fairchild, , supra note 45; Ploughman, , supra note 46; De Zulueta, P., “The Ethics of Anonymised HIV Testing of Pregnant Women: A Reappraisal,” Journal of Medical Ethics 26 (2000): 2526.Google Scholar
DeWitte, J. Have, H. T., “Ownership of Genetic Material and Information,” Social Science and Medicine 45, no. 1 (1997): 5160; see Levine, , supra note 53; Zulueta, De, supra note 58.CrossRefGoogle Scholar
See Nicoll, , supra note 51; Scientific Committee of the Advisory Council on Aids, supra note 51.Google Scholar
Id. (Nicoll, ); Dondero, J. Pappaioanou, M. Curran, J. W., “Monitoring the Levels and Trends of HIV Infection: The Public Health Service's HIV Surveillance Program,” Public Health Reports 103, no. 3 (1988): 213220.Google Scholar
See Levine, , supra note 53; id. (Dondero, ); Boyd, K. M., “Institute of Medical Ethics: Working Party Report: HIV infection: The Ethics of Anonymised Testing and of Testing Pregnant Women,” Journal of Medical Ethics 16, no. 4 (1990): 173178.Google Scholar
See Levine, , supra note 53.Google Scholar
Wendler, D. Emanuel, E., “The Debate Over Research on Stored Biological Samples: What Do Sources Think?” Archives of Internal Medicine 162, no. 13 2002: 14571462; see Ploughman, , supra note 46; Levine, , supra note 53.CrossRefGoogle Scholar
See Snider, , supra note 55.Google Scholar
See Levine, , supra note 53.Google Scholar
Vernazza, P. L. Gresser, S. Koller, C. Osterwalder, J. J., “Condom Semen Samples for Unlinked Anonymous HIV Testing,” [letter] The Lancet 346 (1995): 962963; Sankary, T. M. Ichikawa, S. Kondo, M. Imai, M. Ohya, H. Kihara, M. Kihara, M., Sentinel Surveillance of HIV Molecular Clones in Condom Semen Samples from Clients of Female Prostitutes in Japan, paper presented at XI International Conference on AIDS, July 7-July 12, 1996; Vancouver, A. M. Worm, E. Lauritzen, I. P. Jensen, J. S. Christiansen, C. B., “Markers of Sexually Transmitted Diseases in Seminal Fluid of Male Clients of Female Sex Workers,” Genitourinary Medicine 73 (1996): 284–287.CrossRefGoogle Scholar
Amar, H. Ho, J. Mohan, A., “Human Immunodeficiency Virus Prevalence in Women at Delivery Using Unlinked Anonymous Testing of Newborns in the Malaysian Setting,” Journal of Paediatric and Child Health 35 (1999):6366.CrossRefGoogle Scholar
Embling, M. L. Monroe, K. W. Oh, M. K. Hook, E. W. III, “Opportunistic Urine Ligase Chain Reaction Screening for Sexually Transmitted Diseases in Adolescents Seeking Care in an Urban Emergency Department,” Annals of Emergency Medicine 36 (2000): 2832.CrossRefGoogle Scholar
Prevots, D. R. Allen, D. M. Lehman, J. S. Green, T. A. Petersen, L. R. Gwinn, M., “Trends in Human Immunodeficiency Virus Seroprevalence among Injection Drug Users Entering Drug Treatment Centers, United States, 1988–1993,” American Journal of Epidemiology 143 (1996): 733742.CrossRefGoogle Scholar
45 CFR §46.116(d) (1991); see also, 21 CFR §50.20, Food and Drug Administration, U.S. Department of Health and Human Services, “Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff. Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable,” 2006 (permitting limited use of previously stored samples for in vitro diagnostic device investigation, as long as the sample are completely anonymous).Google Scholar
Rosen, C., “Liberty, Privacy, and DNA Databases,” The New Atlantis: A Journal of Technology and Society (2003): 3752, available at <http://www.thenewatlantis.com/archive/1/rosen.htm> (last visited January 9, 2009); Joh, E. E., “Reclaiming Abandoned DNA: The Fourth Amendment and Genetic Privacy,” Northwestern University Law Review 100 (2006): 857–884.Google Scholar
Id. (Rosen).Google Scholar
Harmon, A., “Lawyers Fight Gene Material Gained on Sly,” New York Times, April 3, 2008, A1, at 14.Google Scholar
Kaye, D. H., “Science Fiction and Shed DNA,” Northwestern University Law Review: Colloquy 101 (2006): 6263.Google Scholar
See Sade, , supra note 16.Google Scholar