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IRB Decision-Making with Imperfect Knowledge: A Framework for Evidence-Based Research Ethics Review

Published online by Cambridge University Press:  01 January 2021

Emily E. Anderson  and
James M. DuBois
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Extract

Institutional Review Board (IRB) decisions hinge on the availability and interpretation of information. This is demonstrated by the following well-known historical example. In 2001, 24-year-old Ellen Roche died from respiratory distress and organ failure as a result of her participation in a study at Johns Hopkins Asthma and Allergy Center. The non-therapeutic physiological study, “Mechanisms of Deep Inspiration-Induced Airway Relaxation,” was designed to examine airway hyperresponsiveness in healthy individuals in order to better understand the pathophysiology of asthma. Participants inhaled hexamethonium, a chemical ganglionic blocker that was not FDA-approved for use as specified in the experimental protocol. Risks of inhaling hexamethonium, including lung damage, had been reported in the 1950s and ‘60s. An investigation conducted after Roche's death determined that the study's principal investigator had failed to adequately search the medical literature; the protocol submitted for IRB review cited articles indexed in online literature databases that went back only as far as the 1970s.

Type
Symposium
Information
Journal of Law, Medicine & Ethics , Volume 40 , Issue 4 , Winter 2012 , pp. 951 - 969
Copyright
Copyright © American Society of Law, Medicine and Ethics 2012

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References

Steinbrook, R., “Protecting Research Subjects – the Crisis at Johns Hopkins,” New England Journal of Medicine 346, no. 9 (2002): 716–720.CrossRefGoogle Scholar
Albanese, A., “Could Librarians’ Help Have Prevented Hopkins Tragedy?” Library Journal 126, no. 15 (2001): 16; Robinson, J.G. and Gehle, J.L., “Medical Research and the Institutional Review Board: The Librarian's Role in Human Subject Testing,” Reference Services Review 33, no. 1 (2005): 20–24.Google Scholar
See Steinbrook, , supra note 1.Google Scholar
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Ethical Principles and Guidelines for the Protection of Human Subjects of Research (Belmont Report), DHEW Publication OS78–0012, Washington, D.C., September 30, 1978.Google Scholar
See National Commission, supra note 4.Google Scholar
Sieber, J.E., “Empirical Research on Research Ethics,” Ethics and Behavior 14, no. 6 (2004): 397–412; Sieber, J.E., “The Evolution of Best Ethical Practices in Human Research,” Journal of Empirical Research on Human Research Ethics 1, no. 1 (2006): 1–2.CrossRefGoogle Scholar
Kon, A. A., “The Role of Empirical Research in Bioethics,” American Journal of Bioethics 9, no. 6-7 (2009): 59–65; Sugarman, J. and Sulmasy, D.P., eds., Methods in Medical Ethics, 2nd ed. (Washington, D.C.: Georgetown University Press, 2010).CrossRefGoogle Scholar
Candilis, P.J. Lidz, C.W., and Arnold, R.M., “The Need to Understand IRB Deliberations,” IRB: Ethics & Human Research 28, no. 1 (2006): 1–6.Google Scholar
Dickert, N. Emanuel, E., and Grady, C., “Paying Research Subjects: An Analysis of Current Policies,” Annals of Internal Medicine 136, no. 5 (2002): 368–73; Wolf, L.E., “IRB Policies Regarding Finder's Fees and Role Conflicts in Recruiting Research Participants,” IRB: Ethics & Human Research 31, no. 1 (2009): 14–19.CrossRefGoogle Scholar
Campbell, E.G. Weissman, J.S., and Clarridge, B. et al., “Characteristics of Medical School Faculty Members Serving on Institutional Review Boards: Results of a National Survey,” Academic Medicine 78, no. 8 (2003): 831–36; de Vries, R.G. and Forsberg, C.P., “What Do IRBs Look Like? What Kind of Support Do They Receive?” Accountability in Research 9, no. 3-4 (2002): 199–216; de Vries, R.G. and Forsberg, C.P., “Who Decides? A Look at Ethics Committee Membership,” HEC Forum 14, no. 3 (2002): 252–8; Hayes, G.J. Hayes, S.C., and Dykstra, T., “A Survey of University Institutional Review Boards: Characteristics, Policies, and Procedures,” IRB: Ethics and Human Research 17, no. 3 (1995): 1–6; Lemmens, T. and Thompson, A., “Noninstitutional Commercial Review Boards in North America: A Critical Appraisal and Comparison with IRBs,” IRB: Ethics & Human Research 23, no. 2 (2001): 1–12.CrossRefGoogle Scholar
Byrne, M.M. Speckman, J. Getz, K., and Sugarman, J., “Variability in the Costs of Institutional Review Board Oversight,” Academic Medicine 81, no. 3 (2006): 708–12; Catania, J.A. Wolf, L.E. Wertleib, S. Lo, B., and Henne, J., “Research Participants’ Perceptions of the Certificate of Confidentiality's Assurances and Limitations,” Journal of Empirical Research on Human Research Ethics 2, no. 4 (2007): 53–59; Speckman, J.L. Byrne, M.M., and Gerson, J. et al., “Determining the Costs of Institutional Review Boards,” IRB: Ethics and Human Research 29, no. 2 (2007): 7–13; Wagner, T.H. Cruz, A.M.E., and Chadwick, G.L., “Economies of Scale in Institutional Review Boards,” Medical Care 42, no. 8 (2004): 817–23.CrossRefGoogle Scholar
Burman, W. Breese, P., and Weis, S. et al., “The Effects of Local Review on Informed Consent Documents from a Multicenter Clinical Trials Consortium,” Controlled Clinical Trials 24, no. 3 (2003): 245–55; McWilliams, R. Hoover-Fong, J., and Hamosh, A. et al., “Problematic Variation in Local Institutional Review of a Multicenter Genetic Epidemiology Study,” JAMA 290, no. 3 (2003): 360–66; Silverman, H. Hull, S.C., and Sugarman, J., “Variability among Institutional Review Boards' Decisions within the Context of a Multicenter Trial,” Critical Care Medicine 29, no. 2 (2001): 235–41.CrossRefGoogle Scholar
Fisher, C.B. Kornetsky, S. Z., and Prentice, E.D., “Determining Risk in Pediatric Research with No Prospect of Direct Benefit: Time for a National Consensus on the Interpretation of Federal Regulations,” American Journal of Bioethics 7, no. 3 (2007): 5–10; Shah, S. Whittle, A. Wilfond, B. Gensler, G., and Wendler, D., “How Do Institutional Review Boards Apply the Federal Risk and Benefit Standards for Pediatric Research?,” JAMA 291, no. 4 (2004): 476–82.CrossRefGoogle Scholar
Brendel, D.H. and Miller, F. G., “A Plea for Pragmatism in Clinical Research Ethics,” American Journal of Bioethics 8, no. 4 (2008): 24–31.CrossRefGoogle Scholar
Abbott, L. and Grady, C., “A Systematic Review of the Empirical Literature Evaluating IRBs: What We Know and What We Still Need to Learn,” Journal of Empirical Research on Human Research Ethics 6, no. 1 (2011): 3–20.CrossRefGoogle Scholar
Id.Google Scholar
Edwards, S.J.L. Ashcroft, R., and Kirchin, S., “Research Ethics Committees: Differences and Moral Judgment,” Bioethics 18, no. 5 (2004): 408–27; Fost, N., “IRB Inconsistency: Be Careful What You Wish For,” American Journal of Bioethics Primary Research 2, no. 2 (2011): 37–38.CrossRefGoogle Scholar
Klitzman, R., “The Myth of Community Differences as the Cause of Variations among IRBs,” American Journal of Bioethics Primary Research 2, no. 2 (2011): 24–33; Pritchard, I.A., “How Do IRB Members Make Decisions? A Review and Research Agenda,” Journal of Empirical Research on Human Research Ethics 6, no. 2 (2011): 31–46.Google Scholar
Rid, A. Emanuel, E.J., and Wendler, E., “Evaluating the Risks of Clinical Research,” JAMA 304, no. 13 (2010): 1472–79; Pritchard, , supra note 18.CrossRefGoogle Scholar
See Klitzman, , supra note 18: at 29.Google Scholar
Fendrich, M. Lippert, A.M., and Johnson, T.P., “Respondent Reactions to Sensitive Questions,” Journal of Empirical Research on Human Research Ethics 2, no.3 (2007): 31–37; Rojas, A. and Kinder, B.N., “Effects of Completing Sexual Questionnaires in Males and Females with Histories of Childhood Sexual Abuse: Implications for Institutional Review Boards,” Journal of Sex & Marital Therapy 33, no. 3 (2007): 193–201.CrossRefGoogle Scholar
Luebbert, R. Tait, R. C. Chibnall, J.T., and Deshields, T. L., “IRB Member Judgments of Decisional Capacity, Coercion, and Risk in Medical and Psychiatric Studies,” Journal of Empirical Research on Human Research Ethics 3, no. 1 (2008): 15–24; Tait, R.C. Chibnall, J. T. Iltis, A.S. Wall, A., and Deshields, T. L., “Assessment of Consent Capability in Psychiatric and Medical Studies,” Journal of Empirical Research on Human Research Ethics 6, no. 1 (2011): 39–50.CrossRefGoogle Scholar
Anderson, E.E., “A Qualitative Study of Non-Affiliated, Non-Scientist Institutional Review Board Members,” Accountability in Research 13, no. 2 (2006): 135–55; Sengupta, S. and Lo, B., “The Roles and Experiences of Nonaffiliated and Non-Scientist Members of Institutional Review Boards,” Academic Medicine 78, no. 2 (2003): 212–18.CrossRefGoogle Scholar
Sirotin, N. Wolf, L.E., and Pollack, L.M. et al., “IRBs and Ethically Challenging Protocols: Views of IRB Chairs about Useful Resources,” IRB: Ethics & Human Research 32, no. 5 (2010): 10–19.Google Scholar
Rothstein, W.G. and Phuong, L.H., “Ethical Attitudes of Nurse, Physician, and Unaffiliated Members of Institutional Review Boards,” Journal of Nursing Scholarship 39, no. 1 (2007): 75–81; Anderson, , supra note 23.CrossRefGoogle Scholar
45 C.F.R. § 46.107 (1999).CrossRefGoogle Scholar
See Anderson, , supra note 23.Google Scholar
See Sirotin, , supra note 24.Google Scholar
Id.Google Scholar
Sackett, D.L. Rosenberg, W.M. Gray, J.A. Haynes, R.B., and Richardson, W.S., “Evidence Based Medicine: What It Is and What It Isn’t,” British Medical Journal 312, no. 7023 (1996): 71–72.CrossRefGoogle Scholar
Rosenberg, W.M. and Donald, A., “Evidence Based Medicine: An Approach to Clinical Problem-Solving,” British Medical Journal 310, no. 6987 (1995): 1122–26.CrossRefGoogle Scholar
Dawes, M. Summerskill, W., and Glasziou, P. et al., “Sicily Statement on Evidence-Based Practice,” BMC Medical Education 5, no. 1 (2005).CrossRefGoogle Scholar
Anderson, E.E. and DuBois, J.M., “The Need for Evidence-Based Research Ethics: A Review of the Substance Abuse Literature,” Drug and Alcohol Dependence 86, no. 2-3 (2007): 95–105; Beagan, B. and McDonald, M., “Evidence-Based Practice of Research Ethics Review,” Health Law Review 13, no. 2 & 3 (2005): 62–68; DuBois, J.M. Volpe, R.L., and Rangel, E.K., “Hidden Empirical Research Ethics: A Review of Three Health Journals from 2005 through 2006,” Journal of Empirical Research on Human Research Ethics 3, no. 3 (2008): 7–18; McDonald, M. and Cox, S., “Moving toward Evidence-Based Human Participant Protection,” Journal of Academic Ethics 7, no. 1 (2009): 1–16; Siminoff, L.A. Caputo, M., and Burant, C., “The Promise of Empirical Research in the Study of Informed Consent Theory and Practice,” HEC Forum 16, no. 1 (2004): 53–71; Solomon, M.Z., “Realizing Bioethics’ Goals in Practice: Ten Ways “Is” Can Help “Ought”,” Hastings Center Report 35, no. 4 (2005): 40–47; Sugarman, J., “The Future of Empirical Research in Bioethics,” Journal of Law, Medicine & Ethics 32, no. 2 (2004): 226–31; Sieber, , supra note 6.CrossRefGoogle Scholar
Cook, D.J. Jaeschke, R., and Guyatt, G.H., “Critical Appraisal of Therapeutic Interventions in the Intensive Care Unit: Human Monoclonal Antibody Treatment in Sepsis. Journal Club of the Hamilton Regional Critical Care Group,” Journal of Intensive Care Medicine 7, no. 6 (1992): 2752–82.CrossRefGoogle Scholar
DuBois, J.M., “What Counts as Empirical Research in Bioethics and Where Do We Find the Stuff?” American Journal of Bioethics 9, no. 6-7 (2009): 70–72, at 71.CrossRefGoogle Scholar
DuBois, J.M. Bante, H., and Hadley, W.B., “Ethics in Psychiatric Research: A Review of 25 Years of NIH-Funded Empirical Research Projects,” American Journal of Bioethics Primary Research 2, no. 4 (2011): 5–17.Google Scholar
Flory, J. and Emanuel, E.J., “Interventions to Improve Research Participants' Understanding in Informed Consent for Research,” JAMA 292, no. 13 (2004): 1593–1601; Sugarman, J. McCrory, D. C., and Powell, D. et al., “Empirical Research on Informed Consent. An Annotated Bibliography,” The Hastings Center Report 29, no. 1 (1999): S1–42; Siminoff, et al., supra note 33.CrossRefGoogle Scholar
Dunn, L.B. Nowrangi, M.A. Palmer, B.W. Jeste, D. V., and Saks, E.R., “Assessing Decisional Capacity for Clinical Research or Treatment: A Review of Instruments,” American Journal of Psychiatry 163, no. 8 (2006): 1323–34; Jeste, D.V. Palmer, B. W., and Appelbaum, P.S. et al., “A New Brief Instrument for Assessing Decisional Capacity for Clinical Research,” Archives of General Psychiatry 64, no. 8 (2007): 966–74.CrossRefGoogle Scholar
Katz, R.V. Wang, M.Q., and Green, B.L. et al., “Participation in Biomedical Research Studies and Cancer Screenings: Perceptions of Risks to Minorities Compared with Whites,” Cancer Control 15, no. 4 (2008): 344–51; Roberts, L.W. Hammond, Green K.A., and Hoop, J.G., “An Inverse Relationship between Perceived Harm and Participation Willingness in Schizophrenia Research Protocols,” American Journal of Psychiatry 161, no. 11 (2006): 2002–04; Russell, S.L. Katz, R.V., and Kressin, N.R. et al., “Beliefs of Women's Risk as Research Subjects: A Four-City Study Examining Differences by Sex and by Race/Ethnicity,” Journal of Women's Health 18, no. 2 (2009): 235–43.CrossRefGoogle Scholar
Taylor, P.J. Awenat, Y., and Gooding, P. et al., “The Subjective Experience of Participation in Schizophrenia Research: A Practical and Ethical Issue,” The Journal of Nervous and Mental Disease 198, no. 5 (2010): 343–8; Unguru, Y. Sill, A.M., and Kamani, N., “The Experiences of Children Enrolled in Pediatric Oncology Research: Implications for Assent,” Pediatrics 125, no. 4 (2010): E876-e83.CrossRefGoogle Scholar
Catania, J.A. Wolf, L.E. Wertleib, S. Lo, B., and Henne, J., “Research Participants’ Perceptions of the Certificate of Confidentiality's Assurances and Limitations,” Journal of Empirical Research on Human Research Ethics 2, no. 4 (2007): 53–59; Festinger, D.S. Dugosh, K. L. Croft, J.R. Arabia, P.L., and Marlowe, D.B., “Do Research Intermediaries Reduce Perceived Coercion to Enter Research Trials among Criminally Involved Substance Abusers?” Ethics & Behavior 21, no. 3 (2011): 252–59; Roberts, L.W. Warner, T.D. Anderson, C.T. Smithpeter, M.V., and Rogers, M.K., “Schizophrenia Research Participants' Responses to Protocol Safeguards: Recruitment, Consent, and Debriefing,” Schizophrenia Research 67, no. 2-3 (2004): 283–91.CrossRefGoogle Scholar
Dunn, L.B. Candilis, P.J., and Roberts, L.W., “Emerging Empirical Evidence on the Ethics of Schizophrenia Research,” Schizophrenia Bulletin 32, no. 1 (2006): 47–68.CrossRefGoogle Scholar
Ripley, E.B.D., “A Review of Paying Research Participants: It's Time to Move Beyond the Ethical Debate,” Journal of Empirical Research on Human Research Ethics 1, no. 4 (2006): 9–20.CrossRefGoogle Scholar
Dubois, J.M., “Hidden Data for Research Ethicists: An Introduction to the Concept and a Series of Papers,” Journal of Empirical Research on Human Research Ethics 3, no. 3 (2008): 3–5.CrossRefGoogle Scholar
Anderson, EE and Iltis, AS, “Assessing and Improving Research Participants’ Understanding of Risk: Potential Lessons From the Literature on Physician-Patient Risk Communication,” Journal of Empirical Research on Human Research Ethics 3, no. 3 (2008): 27–37.CrossRefGoogle Scholar
See Robinson, and Gehle, , supra note 2.Google Scholar
Jeste, D.V. Palmer, B. W., and Golshan, S. et al., “Multimedia Consent for Research in People with Schizophrenia and Normal Subjects: A Randomized Controlled Trial,” Schizophrenia Bulletin 35, no. 4 (2009): 719–29; Rubright, J. Sankar, P., and Casarett, D.J. et al., “A Memory and Organizational Aid Improves Ad Research Consent Capacity: Results of a Randomized, Controlled Trial,” American Journal of Geriatric Psychiatry 18, no. 12 (2010): 1124–32; Stunkel, L. Benson, M., and McLellan, L. et al., “Comprehension and Informed Consent: Assessing the Effect of a Short Consent Form,” IRB: Ethics & Human Research 32, no. 4 (2010): 1–9.CrossRefGoogle Scholar
Monshi, B., and Zieglmayer, V., “The Problem of Privacy in Transcultural Research: Reflections on an Ethnographic Study in Sri Lanka,” Ethics and Behavior 14, no. 4 (2004): 305–312.CrossRefGoogle Scholar
De Vries, R.O.B. and Gordijn, B., “Empirical Ethics and Its Alleged Meta-Ethical Fallacies,” Bioethics 23, no. 4 (2009): 193–201; Tancredi, L.R., “The Limits of Empirical Studies on Research Ethics,” Ethics and Behavior 5, no. 3 (1995): 217–36.CrossRefGoogle Scholar
See, for example <www.cochrane.org> (last visited December 10, 2012).+(last+visited+December+10,+2012).>Google Scholar
See McDonald, and Cox, , supra note 33.Google Scholar
See Dawes, , supra note 32, at 2.Google Scholar
See Dawes, , supra note 32, at 2.Google Scholar
Burris, S. and Davis, C., “Assessing Social Risks Prior to Commencement of a Clinical Trial: Due Diligence or Ethical Inflation?” American Journal of Bioethics 9, no. 11 (2009): 48–54.CrossRefGoogle Scholar
Festinger, D.S. Marlowe, D. B. Dugosh, K. L. Croft, J.R., and Arabia, P.L., “Higher Magnitude Cash Payments Improve Research Follow-up Rates without Increasing Drug Use or Perceived Coercion,” Drug and Alcohol Dependence 96, no. 1-2 (2008): 128–35; Thurstone, C. Salomensen-Sautel, S., and Riggs, P.D., “How Adolescents with Substance Use Disorder Spend Research Payments,” Drug and Alcohol Dependence 111, no. 3 (2010): 262–64.CrossRefGoogle Scholar
Dempsey, J.P. Back, S.E. Waldrop, A.E. Jenkins, L., and Brady, K.T., “The Influence of Monetary Compensation on Relapse among Addicted Participants: Empirical Vs. Anecdotal Evidence,” The American Journal on Addictions 17, no. 6 (2008): 488–90; DuBois, J.M. O'Leary, Callahan C., and Cottler, L., “The Attitudes of Females in Drug Court toward Additional Safeguards in HIV Prevention Research,” Prevention Science 10, no. 4 (2009): 345–52; Festinger, D.S. Marlowe, D.B., and Croft, J.R. et al., “Do Research Payments Precipitate Drug Use or Coerce Participation?” Drug and Alcohol Dependence 78, no. 3 (2005): 275–1; Oransky, M. Fisher, C.B. Mahadevan, M., and Singer, M., “Barriers and Opportunities for Recruitment for Nonintervention Studies on HIV Risk: Perspectives of Street Drug Users,” Substance Use & Misuse 44, no. 11 (2009): 1642–59; Slomka, J. McCurdy, S. Ratliff, E. Timpson, S., and Williams, M., “Perceptions of Financial Payment for Research Participation among African-American Drug Users in HIV Studies,” Journal of General Internal Medicine 22, no. 10 (2007): 1403–09.CrossRefGoogle Scholar
See Festinger, et al., 2008, supra note 55; Festinger, et al., 2005, supra note 56.Google Scholar
See Dempsey, et al. supra note 56.Google Scholar
See Thurstone, et al. supra note 55.Google Scholar
See DuBois, et al., 2009, supra note 56; Oransky, et al., supra note 56; Slomka, et al., supra note 56.Google Scholar
Byrne, M.M. Croft, J.R. French, M.T. Dugosh, K.L., and Festinger, D.S., “Development and Preliminary Results of the Financial Incentive Coercion Assessment Questionnaire,” Journal of Substance Abuse Treatment (2011) EPub ahead of print.CrossRefGoogle Scholar
See Festinger, et al., 2008, supra note 55; Festinger, et al., 2005, supra note 56.Google Scholar
See Festinger, et al., 2008, supra note 55.Google Scholar
See Dempsey, et al., supra note 56.Google Scholar
See Dempsey, et al., supra note 56; Thurstone, et al., supra note 55.Google Scholar
See Thurstone, et al., supra note 55.Google Scholar
See Oransky, et al., supra note 56; Slomka, et al., supra note 56.Google Scholar
See DuBois, et al., 2009, supra note 56.Google Scholar
See Oransky, et al., supra note 56; Slomka, et al., supra note 56.Google Scholar
See Festinger, et al., 2008, supra note 55; Festinger, et al., 2005, supra note 56.Google Scholar
Bean, S. Henry, B., and Kinsey, J.M. et al., “Enhancing Research Ethics Decision-Making: An REB Decision-Bank,” IRB: Ethics & Human Research 32, no. 6 (2010): 9–12.Google Scholar
Murphy, J. Scott, J., and Kaufman, D. et al., “Public Perspectives on Informed Consent for Biobanking,” American Journal of Public Health 99, no. 12 (2009): 2128–34.Google Scholar
Murphy, J. Scott, J., and Kaufman, D. et al., “Public Expectations for Return of Results from Large-Cohort Genetic Research,” American Journal of Bioethics 8, no. 11 (2008): 36–43.CrossRefGoogle Scholar
Pulley, J. Brace, M. Bernard, G., and Masys, D., “Attitudes and Perceptions of Patients Towards Methods of Establishing a DNA Biobank,” Cell and Tissue Banking 9, no. 1 (2008): 55–65; Brothers, K.B. Morrison, D. R., and Clayton, E. W., “Two Large-Scale Surveys on Community Attitudes toward an Opt-out Biobank,” American Journal of Medical Genetics 155, no. 12 (2011): 2982–2990.CrossRefGoogle Scholar
Haga, S. B. and O'Daniel, J., “Public Perspectives Regarding Data-Sharing Practices in Genomics Research,” Public Health Genomics 14, no. 6 (2011): 319–24; McGuire, A.L. Hamilton, J.A. Lunstroth, R. McCullough, L.B., and Goldman, A., “DNA Data Sharing: Research Participants’ Perspectives,” Genetics and Medicine 10, no. 1 (2008): 46–53.Google Scholar
Pentz, R.D. Billot, L., and Wendler, D., “Research on Stored Biological Samples: Views of African American and White American Cancer Patients,” American Journal of Medical Genetics 140A, no. 7 (2006): 733–39; Simon, C.M. L'Heureux, J., and Murray, J.C. et al., “Active Choice but Not Too Active: Public Perspectives on Biobank Consent Models,” Genetics in Medicine 13, no. 9 (2011): 821–31; See Murphy, et al., 2009, supra note 70.CrossRefGoogle Scholar
Lemke, A. A. Wolf, W. A. Hebert-Beirne, J., and Smith, M. E., “Public and Biobank Participant Attitudes toward Genetic Research Participation and Data Sharing,” Public Health Genomics 13, no. 6 (2010): 368–77; See Murphy, et al., 2009 at supra note 70; See Simon, et al., at supra note 70.CrossRefGoogle Scholar
Beskow, L.M. and Dean, E., “Informed Consent for Biorepositories: Assessing Prospective Participants' Understanding and Opinions,” Cancer Epidemiology Biomarkers and Prevention 17, no. 6 (2008): 1440–51.Google Scholar
Chen, D.T. Rosenstein, D. L. Muthappan, P. Hilsenbeck, S.G. Miller, F.G. Emanuel, E.J. Wendler, D., “Research with Stored Biological Samples: What Do Research Participants Want?” Archives of Internal Medicine 165, no. 6 (2005): 652–55; Malone, T. Catalano, P.J. O'Dwyer, P.J. Giantonio, B., “High Rate of Consent to Bank Biologic Samples for Future Research: The Eastern Cooperative Oncology Group Experience,” Journal of the National Cancer Institute 94, no. 10 (2002): 769–71.CrossRefGoogle Scholar
Beskow, L. M. Friedman, J. Y. Hardy, N. C. Lin, L., and Weinfurt, K. P.. “Simplifying Informed Consent for Biorepositories: Stakeholder Perspectives,” Genetics in Medicine 12, no. 9 (2010): 567–72.CrossRefGoogle Scholar
See Chen, et al., supra note 79; Malone, , et al., supra note 79.Google Scholar
See Beskow, and Dean, supra note 78; Murphy, et al., 2009, supra note 72; Simon, et al., supra note 72.Google Scholar
See Lemke, et al., supra note 77.Google Scholar
See Malone, et al., supra note 79; Murphy, et al., 2009, supra note 72; Pentz, et al., supra note 76.Google Scholar
Beskow, et al., 2010, supra note 80.Google Scholar
Abou-Nassar, K. Kovacs, M.J., and Kahn, S.R. et al., “The Effect of Dalteparin on Coagulation Activation During Pregnancy in Women with Thrombophilia: A Randomized Trial,” Thrombosis and Haemostasis 98, no. 1 (2007): 163–71; Brenner, B. Hoffman, R. Carp, H. Dulitsky, M., and Younis, J., “Efficacy and Safety of Two Doses of Enoxaparin in Women with Thrombophilia and Recurrent Pregnancy Loss: The Live-Enox Study,” Journal of Thrombosis and Haemostasis 3, no. 2 (2005): 227–29; Dendrinos, S. Kalogirou, I., and Makrakis, E. et al., “Safety and Effectiveness of Tinzaparin Sodium in the Management of Recurrent Pregnancy Loss,” Clinical and Experimental Obstetrics & Gynecology 34, no. 3 (2007): 143–45; Gris, J.C. Mercier, E., and Quéré, I. et al., “Low-Molecular-Weight Heparin Versus Low-Dose Aspirin in Women with One Fetal Loss and a Constitutional Thrombophilic Disorder,” Blood 103, no. 10 (2004): 3695–99; Laskin, C.A. Spitzer, K.A., and Clark, C.A. et al., “Low Molecular Weight Heparin and Aspirin for Recurrent Pregnancy Loss: Results from the Randomized, Controlled HEPASA Trial,” Journal of Rheumatology 36, no. 2 (2009): 279–87; Rodger, M.A. Kahn, S. R., and Cranney, A. et al., “Long-Term Dalteparin in Pregnancy Not Associated with a Decrease in Bone Mineral Density: Substudy of a Randomized Controlled Trial,” Journal of Thrombosis and Haemostasis 5, no. 8 (2007): 1600–06; Visser, J. Ulander, V.M., and Helmerhorst, F.M. et al., “Thromboprophylaxis for Recurrent Miscarriage in Women with or without Thrombophilia,” Thrombosis and Haemostasis 105, no. 2 (2011): 295–301.CrossRefGoogle Scholar
Bauersachs, R.M. Dudenhausen, J., and Faridi, A. et al., “Risk Stratification and Heparin Prophylaxis to Prevent Venous Thromboembolism in Pregnant Women,” Thrombosis and Haemostasis 98, no. 6 (2007): 1237–45; Dargaud, Y. Rugeri, L., and Vergnes, M.C. et al., “A Risk Score for the Management of Pregnant Women with Increased Risk of Venous Thromboembolism: A Multicentre Prospective Study,” British Journal of Haematology 145, no. 6 (2009): 825–35.Google Scholar
Bates, S.M. Greer, I.A., and Pabinger, I. et al., “Venous Thromboembolism, Thrombophilia, Antithrombotic Therapy, and Pregnancy: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition),” Chest 133, no. 6, Supp. (2008): 844S–86S; Duhl, A.J. Paidas, M. J., and Ural, S.H. et al., “Antithrombotic Therapy and Pregnancy: Consensus Report and Recommendations for Prevention and Treatment of Venous Thromboembolism and Adverse Pregnancy Outcomes,” American Journal of Obstetrics and Gynecology 197, no. 5 (2007): 457.e1–57.e21; Weintraub, A. and Sheiner, E., “Anticoagulant Therapy and Thromboprophylaxis in Patients with Thrombophilia,” Archives of Gynecology and Obstetrics 276, no. 6 (2007): 567–71.CrossRefGoogle Scholar
Id.Google Scholar
Coverdale, J.H. McCullough, L.B., and Chervenak, F.A., “The Ethics of Randomized Placebo-Controlled Trials of Anti-depressants with Pregnant Women: A Systematic Review,” Obstetrics & Gynecology 112, no. 6 (2008): 1361–68.CrossRefGoogle Scholar
45 C.F.R. § 46.204 (2006).CrossRefGoogle Scholar
See Beagan, and McDonald, , supra note 33; McDonald, and Cox, , supra note 33.Google Scholar
See Siroin, et al., supra note 24.Google Scholar
See DuBois, et al., supra note 33. Mustanski, B., “Ethical and Regulatory Issues with Conducting Sexuality Research with LGBT Adolescents: A Call to Action for a Scientifically Informed Approach,” Archives of Sexual Behavior 40, no. 4 (2011): 673–86.Google Scholar
See <www.aahrpp.org> (last visited December 10, 2012).+(last+visited+December+10,+2012).>Google Scholar
See <www.primr.org> (last visited December 10, 2012).+(last+visited+December+10,+2012).>Google Scholar
See DuBois, et al., 2009, supra note 35.CrossRefGoogle Scholar
45 C.F.R. § 46.107 (1999).Google Scholar
See DeVries, and Forsberg, , supra note 10.Google Scholar
See Sirotin, et al., supra note 24.Google Scholar
Beskow, L.M. Grady, C. Iltis, A.S. Sadler, J.Z., and Wilfond, B.S., “Points to Consider: The Research Ethics Consultation Service and the IRB,” IRB: Ethics & Human Research 31, no. 6 (2009): 1–9.Google Scholar
See DuBois, Volpe, , and Rangel, , supra note 33.Google Scholar
Committee on Assessing the System for Protecting Human Research Subjects, Board on Health Sciences Policy, Institute of Medicine, Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC, 2001; Federman, D.D. Hanna, K. E. Rodriguez, Lyman L., Responsible Research: A Systems Approach to Protecting Research Participants. Washington, DC, 2002.Google Scholar
See DuBois, Volpe, , and Rangel, , supra note 33.Google Scholar
See Albanese, , supra note 2; Robinson, and Gehle, , supra note 2.Google Scholar
See DuBois, , 2008, supra note 47.Google Scholar
See McDonald, and Cox, , supra note 33.Google Scholar
For examples see <www.cochrane.org> and <www.cebm.net> (last visited December 10, 2012).+and++(last+visited+December+10,+2012).>Google Scholar
See DuBois, Hadley, , and Bante, , supra note 36; Dunn, Candilis, , and Roberts, , supra note 42.Google Scholar
Rid, A. and Wendler, D., “A Proposal and Prototype for a Research Risk Repository to Improve the Protection of Research Participants,” Clinical Trials 8, no. 6 (2011): 705–15; See Abbott, and Grady, , supra note 15.CrossRefGoogle Scholar
See Pritchard, , supra note 18.Google Scholar
See Candilis, et al., supra note 8.Google Scholar
See Abbott, and Grady, , supra note 15.Google Scholar
See Abbott, and Grady, , supra note 15.Google Scholar
Taylor, H.A., “Moving Beyond Compliance: Measuring Ethical Quality to Enhance the Oversight of Human Subjects Research,” IRB: Ethics and Human Research 29, no. 5 (2007): 9–14; See Beagan, and McDonald, , supra note 33.Google Scholar