Surrogate Consent for Research

Bibliography


Provided below in alphabetical order is a select bibliography on legally authorized representatives, surrogacy and surrogate consent for research. Most articles are abstracted on PubMed, the MEDLINE interface of MEDLINE’s producer, the U.S. National Library of Medicine. Click on the PMID for an article to be taken directly to PubMed’s indexed abstract and other information for the article. A separate Web browser page will open.

  1. Appelbaum, P.S. Involving Decisionally Impaired Subjects in Research: The Need for Legislation. American Journal of Geriatric Psychiatry, vol. 10, no. 2: 120-4, 2002. PMID: 11925272.
  2. Baumann, J. State Law Said Critical Policy Consideration in Trials With Decisionally Impaired Subjects (reporting results of webinar by Stone et al.). Medical Research Law & Policy Report, vol. 9, no. 8, 258, 2010. Contact for access or copy.
  3. Berg, J.W. Legal and Ethical Complexities of Consent with Cognitively Impaired Research Subjects: Proposed Guidelines. Journal of Law, Medicine and Ethics, vol. 24, no. 1: 18-35, 1996. PMID: 8925010.
  4. Black, B.S., Brandt, J., Rabins, P.V., Samus, Q.M., Steele, C.D., Lyketsos, C.G., and Rosenblatt, A. Predictors of Providing Informed Consent or Assent for Research Participation in Assisted Living Residents. American Journal of Geriatric Psychiatry, vol. 16, no. 1: 83-91, 2008. PMID: 18165463.
  5. Bravo, G., Dubois, M.-F., and Paquet, M. The Conduct of Canadian Researchers and Institutional Review Boards Regarding Substituted Consent for Research. IRB: Ethics & Human Research, vol. 26, no. 1:1-8, 2004. PMID: 15281211.
  6. Burns, K.E.A., Zubrinich, C., Marshall, J. & Cook, D. The ‘consent to research’ paradigm in critical care: Challenges and potential solutions. Intensive Care Medicine, 35, 1655-1658, 2009. PMID: 19582396.
  7. Chen, D.T., Case, L.D., Brott, T.G., Brown, R.D., Silliman, S.L., Meschia, J.F., and Worrall, B.B. Impact of Restricting Enrollment in Stroke Genetics Research to Adults Ablse to Provide Informed Consent. Stroke, vol. 39, no. 3: 831-837, 2008. PMID: 18258838.
  8. Chenaud, C., Merlani, P., Luyasu, S., and Ricou, B. Informed Consent for Research Obtained During the Intensive Care Unit Stay. Critical Care, vol. 10, no. 6: R170, 2006. PMID: 17156444.
  9. Ciroldi, M., Cariou, A., Adrie, C., Annane, D., Castelain, V., Cohen, Y., Delahaye, A., Joly, L.M., Galliot, R., Garrouste-Orgeas, M., Papzian, L., Michel, F., Barnes, N.K., Schlemmer, B., Pochard, F., and Azoulay, E. Ability of Family Members to Predict Patient’s Consent to Critical Care Research. Intensive Care Medicine, vol. 33, no. 5: 807-813, 2007. PMID: 17361388.
  10. Coppolino, M., and Ackerson, L. Do Surrogate Decision Makers Provide Accurate Consent for Intensive Care Research? Chest, vol. 119, no. 2: 603-612, 2001. PMID: 11171743.
  11. Criner, G.J. Framing the Forum: Medical Ethics in Large-Scale, Interventional Respiratory Clinical Trials. Proceedings of the American Thoracic Society, vol. 4, no. 2: 171-75, 2007. PMID: 17494726.
  12. Dreer, L.E., DeVivo, M.J., Novack, T.A., Krzywanski, S., & Marson, D.C. Cognitive predictors of medical decision-making capacity in traumatic brain injury. Rehabilitation Psychology, 53(4), 486-497, 2008.
  13. Fisher, C.B. Goodness-of-Fit Ethic for Informed Consent to Research Involving Adults with Mental Retardation and Developmental Disabilities. Mental Retardation and Developmental Disabilities Research Reviews, vol. 9, no. 1: 27-31, 2003. PMID: 12587135.
  14. Flaherty, M.L., Karlawish, J., Khoury, J.C., Kleindorfer, D., Woo, D. and Broderick, J.P. How important is surrogate consent for stroke research? Neurology [Epub ahead of print], 2008. PMID: 18753472.
  15. Harvey, S.E., Elbourne, D., Ashcroft, J., Jones, C.M., & Rowan, K. Informed consent in clinical trials in critical care: Experience from the PAC-Man study. Intensive Care Medicine, 32, 2020-2025, 2006. PMID: 17019555.
  16. Kim, S.Y.H., Appelbaum, P.S., Jeste, D.V., and Olin, J.T. Proxy and Surrogate Consent in Geriatric Neuropsychiatric Research: Update and Recommendations. American Journal of Psychiatry, vol. 161, no 5: 797-806, 2004. PMID: 15121642.
  17. Kim, S.Y.H., Kim, H.M., McCallum, C., and Tariot, P.N. What Do People at Risk for Alzheimer Disease Think About Surrogate Consent for Research? Neurology, vo. 65, no. 9: 1395-1401, 2005. PMID: 16275826.
  18. Kim, S.Y.H., Kim, H.M., Langa, K.M., Karlawish, J.H.T., Knopman, D.S., & Appelbaum, P.S. Surrogate consent for dementia research: A national survey of older Americans. Neurology, 72, 149-155, 2009. PMID: 19139366.
  19. Liddell, K., Bion, J., Chamberlain, D., Druml, C., Kompanje, E., Lemaire, F., Menon, D., Vrhovac, B., and Wiedermann, C.J. Medical Research Involving Incapacitated Adults: Implications of the EU Clinical Trials Directive 2001/20/EC. Medical Law Review, vol. 14, no. 3: 367-417, 2006. PMID: 16928731.
  20. Luce, J.M. California’s New Law Allowing Surrogate Consent for Clinical Research Involving Subjects with Impaired Decision-making Capacity. Intensive Care Medicine, vol. 29, no. 6: 1024-1025, 2003. PMID: 12861989.
  21. Luce, J.M. Informed Consent for Clinical Research Involving Patients with Chest Disease in the United States. Chest, 135(4), 1061-1068, 2009. PMID: 19349401.
  22. McClure, K.B., Delorio, N.M., Gunnels, M.D., Ochsner, M.J., Biros, M.H., and Schmidt, T.A. Attitudes of Emergency Department Patients and Visitors Regarding Emergency Exception from Informed Consent in Resuscitation Research, Community Consultation, and Public Notification. Academic Emergency Medicine, vol. 10, no. 4: 352-359, 2003. PMID: 12670849.
  23. Misra, S., Rosenstein, D., Socherman, R., and Ganzini, L. Bipolar Mania and Capacity to Consent: Recommendations for Investigators and IRBs. IRB: Ethics & Human Research, vol. 32, no. 1: 7-15, 2010. PMID: 20184219.
  24. Moscone, P., Poli, P., Giolo, A., and Apolone, G. How Italian Health Consumers Feel About Clinical Research: A Questionnaire Survey. European Journal of Public Health, vol. 15, no. 4: 372-379, 2005. PMID: 16014662.
  25. Noble, J.H. & Sharav, V.H. Protecting people with decisional impairments and legal incapacity against biomedical research abuse. Journal of Disability Policy Studies, 18(4), 230-244, 2008.
  26. Pinder, M., Tshukutsoane, S., Scribante, J., Piccolo, R., and Lipman, J. Critical Care Research and Pre-emptive Informed Consent: A Practical Approach used in Chris Hani Baragwanath ICU. Intensive Care Medicine, vol. 24, no. 4: 353-357, 1998. PMID: 9609414.
  27. Saks, E.R., Dunn, L.B., Wimer, J., Gonzales, M., and Kim, S. Proxy Consent to Research: The Legal Landscape. Yale Journal of Health Policy, Law & Ethics, vol. 8, no. 1: 37-92, 2008. PMID: 18564493.
  28. Scales, D.C., Smith, O.M., Pinto, R., Barrett, K.A., Friedrich, J.O., Lazar, N.M. et al. Patients’ preferences for enrolment into critical-care trials. Intensive Care Medicine, 35, 1703-1712, 2009. PMID: 19551372.
  29. Seckler, A.B., Meier, D.E., Mulvihill, M., and Cammer Paris, B.E. Substituted Judgment: How Accurate are Proxy Prediction? Annals of Internal Medicine, vol. 115, no. 2: 92-98, 1991. PMID: 2058868.
  30. Shalowitz, D.I., Garrett-Mayer, E., and Wendler, D. The Accuracy of Surrogate Decision Makers: A Systematic Review. Archives of Internal Medicine, vol. 166, no. 5: 493-497, 2006. PMID: 16534034.
  31. Shelton, A.K., Fish, A.F., Cobb, J.P., Bachman, J.A., Jenkins, R.L., Battistich, V., and Freeman, B.D. Surrogate Consent for Genomics Research in Intensive Care. American Journal of Critical Care, vol. 15, no. 5: 418-426, 2009. PMID: 19723862.
  32. Silveira, M.J., Kim, S.Y., Langa, K.M. Advance Directives and Outcomes of Surrogate Decision Making Before Death. New England Journal of Medicine, vol. 362, no. 13: 1211-18, 2010. PMID: 20357283.
  33. Silverman, H.J., Druml, C., Lemaire, F., and Nelson, R. The European Union Directive and the Protection of Incapacitated Subjects in Research: An Ethical Analysis. Intensive Care Medicine, vol. 30, no. 9: 1723-1729, 2004. PMID: 15232680.
  34. Silverman, H.J., Luce, J.M., and Schwartz, J. Protecting Subjects with Decisional Impairment in Research: The Need for a Multifaceted Approach. American Journal of Respiratory and Critical Care Medicine, vol. 169, no. 1: 10-14, 2004. PMID: 14695105.
  35. Smith-Tyler, J. Informed Consent, Confidentiality, and Subjects Rights in Clinical Trials. Proceedings of the American Thoracic Society, vol. 4, no. 2: 189-193, 2007. PMID: 17494730.
  36. Stocking, C.B., Hougham, G.W., Danner, D.D., Patterson, M.B., Whitehouse, P.J., and Sachs, G.A. Speaking of Research Advance Directives: Planning for Future Research Participation. Neurology, vol. 66, no. 9: 1361-1366, 2006. PMID: 16682668.
  37. Stone, T.H. Surrogate Consent for Research: Legal and Policy Considerations for Acute Respiratory Failure Research Involving Adults with Impaired Decision-making Capacity. Medical Research Law & Policy Report, 7(17): 556-563 (September 2008). Contact for access or copy.
  38. Strauss, D.H., and Flynn, L, Secretary’s Advisory Committee on Human Research Protections, HHS. Report of Subcommittee on the Inclusion of Individuals with Impaired Decision-Making in Research (July 15-16, 2008).
  39. Sulmassy, D.P., Terry, P.B., Weisman, C.S., Miller, D.J., Stallings, R.Y., Vettese, M.A., and Haller, K.B. The Accuracy of Substituted Judgments in Patients with Terminal Diagnoses. Annals of Internal Medicine, vol. 128, no. 8: 621-629, 1998. PMID: 9537935.
  40. Triebel, K.L., Martin, R.C., Nabors, L.B., & Marson, D.C. Medical decision-making capacity in patients with malignant glioma. Neurology, 73, 2086-2093, 2009. PMID: 20018637.
  41. Wendler, D., and Prasad, K. Core Safeguards for Clinical Research with Adults Who are Unable to Consent. Annals of Internal Medicine, vol. 135, no. 7: 514-523, 2001. PMID: 11578155.
  42. Wendler, D., Martinez, R.A., Fairclough, D., Sunderland, T., and Emanuel, E. Views of Potential Subjects Toward Proposed Regulations for Clinical Research with Adults Unable to Consent. American Journal of Psychiatry, vol. 159, no. 4: 585-591, 2002. PMID: 11925296.
  43. Wiedermann, C.J., Almici, M., Mangione, S., Giarratano, A., and Mayr, O. Clinical Research in Italy in Adult Patients Unable to Consent: After Implementation of the European Union’s Directive 2001/20/CE. Intensive Care Medicine, vol. 33, no. 2: 316-318, 2007. PMID: 17136516.

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