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

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Id.

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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.

See Klitzman , supra note 18: at 29.

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45 C.F.R. § 46.107 (1999).

See Anderson , supra note 23.

See Sirotin , supra note 24.

Id.

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Katz R.V. Wang M.Q. , and Green B.L. , “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. , “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.

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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.

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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.

See Robinson and Gehle , supra note 2.

Jeste D.V. Palmer B. W. , and Golshan S. , “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. , “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. , “Comprehension and Informed Consent: Assessing the Effect of a Short Consent Form,” IRB: Ethics & Human Research 32, no. 4 (2010): 1–9.

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See, for example <www.cochrane.org> (last visited December 10, 2012).

See McDonald and Cox , supra note 33.

See Dawes , supra note 32, at 2.

See Dawes , supra note 32, at 2.

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.

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.

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. , “Do Research Payments Precipitate Drug Use or Coerce Participation?” Drug and Alcohol Dependence 78, no. 3 (2005): 275–81; 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.

See Festinger , 2008, supra note 55; Festinger , 2005, supra note 56.

See Dempsey supra note 56.

See Thurstone supra note 55.

See DuBois , 2009, supra note 56; Oransky , supra note 56; Slomka , supra note 56.

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.

See Festinger , 2008, supra note 55; Festinger , 2005, supra note 56.

See Festinger , 2008, supra note 55.

See Dempsey , supra note 56.

See Dempsey , supra note 56; Thurstone , supra note 55.

See Thurstone , supra note 55.

See Oransky , supra note 56; Slomka , supra note 56.

See DuBois , 2009, supra note 56.

See Oransky , supra note 56; Slomka , supra note 56.

See Festinger , 2008, supra note 55; Festinger , 2005, supra note 56.

Bean S. Henry B. , and Kinsey J.M. , “Enhancing Research Ethics Decision-Making: An REB Decision-Bank,” IRB: Ethics & Human Research 32, no. 6 (2010): 9–12.

Murphy J. Scott J. , and Kaufman D. , “Public Perspectives on Informed Consent for Biobanking,” American Journal of Public Health 99, no. 12 (2009): 2128–34.

Murphy J. Scott J. , and Kaufman D. , “Public Expectations for Return of Results from Large-Cohort Genetic Research,” American Journal of Bioethics 8, no. 11 (2008): 36–43.

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.

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.

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. , “Active Choice but Not Too Active: Public Perspectives on Biobank Consent Models,” Genetics in Medicine 13, no. 9 (2011): 821–31; See Murphy , 2009, supra note 70.

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 , 2009 at supra note 70; See Simon , at supra note 70.

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.

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.

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.

See Chen , supra note 79; Malone , et al., supra note 79.

See Beskow and Dean supra note 78; Murphy , 2009, supra note 72; Simon , supra note 72.

See Lemke , supra note 77.

See Malone , supra note 79; Murphy , 2009, supra note 72; Pentz , supra note 76.

Beskow , 2010, supra note 80.

Abou-Nassar K. Kovacs M.J. , and Kahn S.R. , “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. , “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. , “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. , “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. , “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. , “Thromboprophylaxis for Recurrent Miscarriage in Women with or without Thrombophilia,” Thrombosis and Haemostasis 105, no. 2 (2011): 295–301.

Bauersachs R.M. Dudenhausen J. , and Faridi A. , “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. , “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.

Bates S.M. Greer I.A. , and Pabinger I. , “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. , “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.

Id.

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.

45 C.F.R. § 46.204 (2006).

See Beagan and McDonald , supra note 33; McDonald and Cox , supra note 33.

See Siroin , supra note 24.

See DuBois , 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.

See <www.aahrpp.org> (last visited December 10, 2012).

See <www.primr.org> (last visited December 10, 2012).

See DuBois , 2009, supra note 35.

45 C.F.R. § 46.107 (1999).

See DeVries and Forsberg , supra note 10.

See Sirotin , supra note 24.

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.

See DuBois Volpe , and Rangel , supra note 33.

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.

See DuBois Volpe , and Rangel , supra note 33.

See Albanese , supra note 2; Robinson and Gehle , supra note 2.

See DuBois , 2008, supra note 47.

See McDonald and Cox , supra note 33.

For examples see <www.cochrane.org> and <www.cebm.net> (last visited December 10, 2012).

See DuBois Hadley , and Bante , supra note 36; Dunn Candilis , and Roberts , supra note 42.

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.

See Pritchard , supra note 18.

See Candilis , supra note 8.

See Abbott and Grady , supra note 15.

See Abbott and Grady , supra note 15.

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.