Informed Consent for Cancer Treatment and Research

Sandra A. Mitchell

ONF 2003, 30(5), 751-755. DOI: 10.1188/03.ONF.751-755

Jump to a section


    Angelos, P. (2000). Ethical issues in cancer patient care. Norwell, MA: Kluwer Academic Publishers.

    Berry, D.L., Dodd, M.J., Hinds, P.S., & Ferrell, B.R. (1996). Informed consent: Process and clinical issues. Oncology Nursing Forum, 23, 507-512.

    Clark, S. (2003). Informed consent without bureaucracy. Journal of Clinical Neuroscience, 10, 35-36.

    Dalla-Vorgia, P., Lascaratos, J., Skiadas, P., & Garanis-Papadatos, T. (2001). Is consent in medicine a concept only of modern times? Journal of Medical Ethics, 27, 59-61.

    English, D.C. (2002). Valid informed consent: A process, not a signature. American Surgeon, 68, 45-48.

    Jerrold, L. (2002). The limits of informed consent. American Journal of Orthodontics and Dento-facial Orthopedics, 121, 542-544.

    Leino-Kilpi, H., Valimaki, M., Arndt, M., Dassen, T., Gasull, M., Lemonidou, C., et al. (2000). Patient's autonomy, privacy and informed consent. Amsterdam: IOS Press.

    Loyal, L., & Tobias., J.S. (2001). Informed consent in medical research. London: BMJ Books.

    Manning, S.S., & Gaul, C.E. (1997). The ethics of informed consent: A critical variable in the self-determination of health and mental health clients. Social Work in Health Care, 25, 103-117.

    Neumann, J.L. (2001). Ethical issues confronting oncology nurses. Nursing Clinics of North America, 36, 827-841.

    O'Neill, O. (2003). Some limits of informed consent. Journal of Medical Ethics, 29, 4-7.

    Pape, T. (1997). Legal and ethical considerations of informed consent. AORN Journal, 65, 1122-1127.

    Rousseau, P. (2001). Ethical and legal issues in palliative care. Primary care: Clinics in office practice, 28, 391-400.

    Sims, J., & Miracle, V. (2002). Elements of an informed consent. Dimensions of Critical Care Nursing, 21, 242-245.

    Thall, P.F. (2002). Ethical issues in oncology biostatistics. Statistical Methods in Medical Research, 11, 428-448.

    Albrecht, T.L., Blanchard, C., Ruckdeschel, J.C., Coovert, M., & Strongbow, R. (1999). Strategic physician communication and oncology clinical trials. Journal of Clinical Oncology, 17, 3324-3332.

    Baylis, F., & Downie, J. (2001). Professional recommendations: Disclosing facts and values. Journal of Medical Ethics, 27, 20-24.

    Bjorn, E., Rossel, P., & Holm, S. (1999). Can the written information to research subjects be improved?: An empirical study. Journal of Medical Ethics, 25, 263-267.

    Butow, P.N., Dunn, S.M., & Tattersall, M.H. (2000). Denial, misinformation and the "assault of truth." In E. Bruera & R.K. Portenoy (Eds.), Topics in palliative care (4th ed., pp. 263-278). Oxford, UK: Oxford University Press.

    Calman, K.C. (2002). Communication of risk: Choice, consent, and trust. Lancet, 360, 166-168.

    Carrie, C., & Freeman, C. (2001). Are all consents really informed? International Journal of Radiation Oncology, Biology, Physics, 51, 287.

    Chan, Y., Irish, J.C., Wood, S.J., Rotstein, L.E., Brown, D.H., Gullane, P.J., et al. (2002). Patient education and informed consent in head and neck surgery. Archives of Otolaryngology and Head and Neck Surgery, 128, 1269-1274.

    Davis, T.C., Williams, M.V., Marin, E., Parker, R.M., & Glass, J. (2002). Health literacy and cancer communication. CA: A Cancer Journal for Clinicians, 52, 134-159.

    Fleissig, A., Jenkins, V., & Fallowfield, L. (2001). Results of an intervention study to improve communication about randomized clinical trials of cancer therapy. European Journal of Cancer, 37, 322-331.

    Fried, E. (2001). The therapeutic misconception, beneficence, and respect. Accountability in Research, 8, 331-348.

    Garrud, P., Wood, M., & Stainsby, L. (2001). Impact of risk information in a patient education leaflet. Patient Education and Counseling, 43, 301-304.

    Gattellari, M., Voigt, K.J., Butow, P.N., & Tattersall, M.H. (2002). When the treatment goal is not cure: Are cancer patients equipped to make informed decisions? Journal of Clinical Oncology, 20, 503-513.

    Holmes-Rovner, M., & Wills, C.E. (2002). Improving consent: Insights from behavioural decision research. Medical Care, 40(Suppl. 9), 30-38.

    Jefford, M., & Tattersall, M.H. (2002). Informing and involving cancer patients in their own care. Lancet Oncology, 3, 629-637.

    Lewis, D. (1999). Computer-based approaches to patient education: A review of the literature. Journal of the American Medical Informatics Association, 6, 272-282.

    Tattersall, M.H., & Butow, P.N. (2002). Consultation audio tapes: An underused cancer patient information aid and clinical research tool. Lancet Oncology, 3, 431-437.

    Tattersall, M.H., Gattellari, M., Voigt, K., & Butow, P.N. (2002). When the treatment goal is not cure: Are patients informed adequately? Supportive Care in Cancer, 10, 314-321.

    Wilt, T. (2002). Clarifying uncertainty regarding detection and treatment of early-stage prostate cancer. Seminars in Urologic Oncology, 20, 10-17.

    Weston, J., Hannah, M., & Downes, J. (1997). Evaluating the benefits of a patient information video during the informed consent process. Patient Education and Counseling, 30, 239-245.

    Ziegler, D.K., Mosier, M.C., Buenaver, M., & Okuyemi, K. (2001). How much information about adverse effects of medication do patients want from physicians? Archives of Internal Medicine, 161, 706-713.

    Aoki, Y., Nakagawa, K., Hasezawa, K., Tago, M., Baba, N., Toyoda, K., et al. (1997). Significance of informed consent and truth-telling for quality of life in terminal cancer patients. Radiation Medicine, 15, 133-135.

    Davis, M.P., & Dreicer, R. (2002). Revisiting truth and consequences: What to do when the patient doesn't want to know. Journal of Clinical Oncology, 20, 4403-4404.

    DeVita, M.A. (2001). Honestly, do we need a policy on truth? Kennedy Institute of Ethics Journal, 11, 157-164.

    Fins, J.J. (2001). Truth-telling and reciprocity in the doctor-patient relationship: A North American perspective. In E. Bruera & R.K. Portenoy (Eds.), Topics in palliative care (5th ed., pp. 81-105). Oxford, UK: Oxford University Press.

    Grassi, L., Giraldi, T., Messina, E.G., Magnani, K., Valle, E., & Cartei, G. (2000). Physicians' attitudes to and problems with truthtelling to cancer patients. Supportive Care in Cancer, 8, 40-45.

    Kashiwagi, T. (1999). Truth telling and palliative medicine. Internal Medicine, 38, 190-192.

    Yaniv, G. (2000). Withholding information from cancer patients as a physician's decision under risk. Medical Decision Making, 20, 216-227.

    Biehl, M., & Halpern-Felsher, B. (2001). Adolescents' and adults' understanding of probability expressions. Journal of Adolescent Health, 28, 30-35.

    Dunn, L.B., & Jeste, D. (2001). Enhancing informed consent for research and treatment. Neuropsychopharmacology, 24, 595-607.

    Gattellari, M., Butow, P.N., Tattersall, M.H., Dunn, S.M., & MacLeod, C.A. (1999). Misunderstanding in cancer patients: Why shoot the messenger? Annals of Oncology, 10, 39-46.

    Joffe, S., Cook, E.F., Cleary, P.D., Clark, J.W., & Weeks, J.C. (2001). Quality of informed consent in cancer clinical trials: A cross-sectional survey. Lancet, 358, 1772-1777.

    Raich, P.C., Plomer, K.D., & Coyne, C.A. (2001). Literacy, comprehension, and informed consent in clinical research. Cancer Investigation, 19, 437-445.

    Tattersall, M.H. (2001). Examining informed consent to cancer clinical trials. Lancet, 358, 1742-1743.

    Wirshing, D.A., Wirshing, W.C., Marder, S.R., Liberman, R.P., & Mintz, J. (1998). Informed consent: Assessment of comprehension. American Journal of Psychiatry, 155, 1508-1511.

    Appelbaum, P.S. (1998). Ought we to require emotional capacity as part of decisional competence? Kennedy Institute of Ethics Journal, 8, 377-387.

    Appelbaum, P.S., Grisso, T., Frank, E., O'Donnell, S., & Kupfer, D.J. (1999). Competence of depressed patients to consent to research. American Journal of Psychiatry, 156, 1380-1384.

    Auerwald, K.B., Charpentier, P.A., & Inouye, S.K. (1997). The informed consent process in older patients who developed delirium: A clinical epidemiological study. American Journal of Medicine, 103, 410-418.

    Baergen, R. (2002). Asessing the Competence Assessment Tool. Journal of Clinical Ethics, 13, 160-164.

    Carpenter, W.T., Gold, J.M., Lahti, A.C., Queern, C.A., Conley, R.R., Bartko, J.J., et al. (2000). Decisional capacity for informed consent in schizophrenia research. Archives of General Psychiatry, 57, 533-538.

    Christensen, K., Haroun, A., Schneiderman, L.J., & Jeste, D.V. (1995). Decision-making capacity for informed consent in the older population. Bulletin of the American Academy of Psychiatry and the Law, 23, 353-365.

    DeMarco, J.P. (2002). Competence and paternalism. Bioethics, 16, 231-245.

    DeRenzo, E.G., Conley, R.R., & Love, R.C. (1998). Assessment of capacity to give consent to research participation: State-of-the-art and beyond. Journal of Health Care Law and Policy, 1(1), 66-87.

    Fellows, L.K. (1999). Competency and consent in dementia. Journal of the American Geriatrics Society, 46, 922-926.

    Grisso, T., & Appelbaum, P.S. (1998). Assessing competence to consent to treatment: A guide for physicians and other health professionals. New York: Oxford University Press.

    Holzer, J.C., Gansler, D.A., Moczynski, N.P., & Folstein, M.F. (1997). Cognitive functions in the informed consent evaluation process: A pilot study. Journal of the American Academy of Psychiatry and the Law, 25, 531-540.

    Kim, S.Y., Karlawish, J.H., & Caine, E.D. (2002). Current state of research on decision-making competence of cognitively impaired elderly persons. American Journal of Geriatric Psychiatry, 10, 151-165.

    Limbie, I. (2001). Assessing competence in psychiatric contexts. Journal of Psychiatry and the Law, 29(1), 31-52.

    Marson, D., Chatterjee, A., Ingram, K., & Harrell, L. (1996). Toward a neurologic model of competency: Cognitive predictors of capacity to consent in Alzheimer's disease using three different legal standards. Neurology, 46, 666-672.

    Marson, D., Dymek, M., & Geyer, J. (2001). Informed consent, competency, and the neurologist. Neurologist, 7, 317-326.

    Miller, C.K., O'Donnell, D., Searight, R., & Barbarash, R.A. (1996). The Deaconess Informed Consent Comprehension Test: An assessment tool for clinical research subjects. Pharmaco-therapy, 16, 872-878.

    National Bioethics Advisory Commission. (1998). Research involving persons with mental disorders that may affect decision-making capacity. Report of the recommendations of the National Bioethics Advisory Commission. Rockville, MD: Author.

    Nelson, R.M., & Merz, J.F. (2002). Voluntariness of consent for research: An empirical and conceptual review. Medical Care, 40(Suppl. 9), V69-80.

    Oldham, J.M., Haimowitz, S., & Delano, S.J. (1999). Protection of persons with mental disorders from research risk: A response to the report of the National Bioethics Advisory Commission. Archives of General Psychiatry, 56, 688-693.

    Rao, G.S., & Blake, L.M. (2002). Decision-making capacity in the elderly. Primary Care Update, 9(2), 71-75.

    Rikkert, M.G., van den Bercken, J.H., ten Have, H.A., & Hoefnagels, W.H. (1997). Experienced consent in geriatrics research: A new method to optimize the capacity to consent in frail elderly subjects. Journal of Medical Ethics, 23, 271-276.

    Saks, E.R., & Behnke, S.H. (1999). Competency to decide on treatment and research: MacArthur and beyond. Journal of Contemporary Legal Issues, 10, 103-129.

    Tomoda, A., Yasumiya, R., Sumiyama, T., Tsukada, K., Hayakawa, T., Matsubara, K., et al. (1997). Validity and reliability of Structured Interview for Competency Incompetency Assessment Testing and Ranking Inventory. Journal of Clinical Psychology, 53, 443-450.

    Welie, J.V., & Welie, S.P. (2001). Patient decision making competence: Outlines of a conceptual analysis. Medicine, Health Care, and Philosophy, 4, 127-138.

    Welie, S.P. (2001). Criteria for patient decision making (in)competence: A review of and commentary on some empirical approaches. Medicine, Health Care, and Philosophy, 4, 139-151.

    Wilks, I. (1997). The debate over risk-related standards of competence. Bioethics, 11, 413-426.

    Charles, C., Gafni, A., & Whelan, T. (1999). Decision-making in the physician-patient encounter—Revisiting the shared treatment decision-making model. Social Science and Medicine, 49, 651-666.

    Charles, C., Whelan, T., Gafni, A., Willan, A., & Farrell, S. (2003). Shared treatment decision making: What does it mean to physicians? Journal of Clinical Oncology, 21, 932-936.

    Elwyn, G., Edwards, A., Mowle, S., Wensing, M., Wilkinson, C., Kinnersley, P., et al. (2000). Measuring the involvement of patients in shared decision-making: A systematic review of instruments. Patient Education and Counseling, 43, 5-22.

    Feldman-Stewart, D., Brundage, M.D., & Van Manen, L. (2001). A decision aid for men with early stage prostate cancer: Theoretical basis and a test by surrogate patients. Health Expectations, 4, 221-234.

    Freedman, T.G. (2002). "The doctor knows best" revisited: Physician perspectives. Psycho-Oncology, 11, 327-335.

    Lacey, M.D. (2002). The experience of using decisional support aids by patients with breast cancer. Oncology Nursing Forum, 29, 1491-1497.

    O'Connor, A., Drake, E., Fiset, V., Page, J., Curtin, D., & Llewellyn-Thomas, H. (1997). Annotated bibliography: Studies evaluating decision-support interventions for patients. Canadian Journal of Nursing Research, 29, 113-120.

    O'Connor, A., Tugwell, P., Wells, G., Elmslie, T., Jolly, E., Hollingworth, G., et al. (1998). A decision aid for women considering hormone therapy after menopause: Decision support framework and evaluation. Patient Education and Counseling, 33, 267-279.

    O'Connor, A., Tugwell, P., Wells, G., Elmslie, T., Jolly, E., Hollingworth, G., et al. (1998). Randomized trial of a portable, self-administered decision aid for postmenopausal women considering long-term preventive hormone therapy. Medical Decision Making, 18, 295-303.

    O'Connor, A.M., Rostom, A., Fiset, V., Tetroe, J., Entwistle, V., Llewellyn-Thomas, H.A., et al. (1999). Decision aids for patients facing health treatment or screening decisions: A systematic review. BMJ, 319, 731-734.

    Pierce, P.F., & Hicks, F.D. (2001). Patient decision-making behavior: An emerging paradigm for nursing science. Nursing Research, 50, 267-274.

    Rostom, A., O'Connor, A., Tugwell, P., & Wells, G. (2002). A randomized trial of a computerized versus an audio-booklet decision aid for women considering post-menopausal hormone replacement therapy. Patient Education and Counseling, 46, 67-74.

    Sullivan, M.D. (2002). The illusion of patient choice in end-of-life decisions. American Journal of Geriatric Psychiatry, 10, 362-364.

    Ubel, P.A. (2002). Is information always a good thing?: Helping patients make "good" decisions. Medical Care, 40(Suppl. 9), 39-44.

    Volk, R., Cass, A., & Spann, S.A. (1999). A randomized controlled trial of shared decision making for prostate cancer screening. Archives of Family Medicine, 8, 333-340.

    Whelan, T., Levine, M., Gafni, A., Sanders, K., Willan, A., Mirsky, D., et al. (1999). Mastectomy or lumpectomy? Helping women make informed choices. Journal of Clinical Oncology, 17, 1727-1735.

    Degner, L.F., Kristjanson, L.J., Bowman, D., Sloan, J.A., Carriere, K.C., O'Neil, J., et al. (1997). Information needs and decisional preferences in women with breast cancer. JAMA, 277, 1485-1492.

    Kenny, P., Quine, S., Shiell, A., & Cameron, S. (1999). Participation in treatment decision-making by women with early stage breast cancer. Health Expectations, 2, 159-168.

    McKneally, M.F., & Martin, D.K. (2000). An en-trustment model of consent for surgical treatment of life-threatening illness: Perspective of patients requiring esophagectomy. Journal of Thoracic and Cardiovascular Surgery, 120, 264-269.

    Robinson, A., & Thomson, R. (2001). Variability in patient preferences for participating in medical decision making: Implications for the use of decision support tools. Quality in Health Care, 10(Suppl. 1), 34-38.

    Sayers, G.M., Barratt, D., Gothard, C., Onnie, C., Perera, S., & Schulman, D. (2001). The value of taking an "ethics history." Journal of Medical Ethics, 27, 114-117.

    Benitez, O., Devaux, D., & Dausset, J. (2002). Audiovisual documentation of oral consent: A new method of informed consent for illiterate populations. Lancet, 359, 1406-1407.

    Bottrell, M.M., Alpert, H., Fischbach, R.L., & Emanuel, L.L. (2000). Hospital informed consent for procedure forms: Facilitating quality patient-physician interaction. Archives of Surgery, 135, 26-33.

    Comprehensive Working Group on Informed Consent in Cancer Clinical Trials for the National Cancer Institute. (1998). Recommendations for the development of informed consent documents for cancer clinical trials. Retrieved May 20, 2003, from

    Coyne, C., Xu, R., Raich, P., Plomer, K., Dignan, M., Wenzel, L., et al. (2003). Randomized, controlled trial of an easy-to-read informed consent statement for clinical trial participation: A study of the Eastern Cooperative Oncology Group. Journal of Clinical Oncology, 21, 836-842.

    Gribble, J.N. (1999). Informed consent documents for BRCA1 and BRCA2 screening: How large is the readability gap? Patient Education and Counseling, 38, 175-183.

    Horng, S., Ezekiel, E., Wilfond, B., Rackoff, J., Martz, K., & Grady, C. (2002). Descriptions of benefits and risks in consent forms for phase I oncology trials. New England Journal of Medicine, 347, 2134-2140.

    Silverman, H., Hull, S.C., & Sugarman, J. (2001). Variability among institutional review boards' decisions within the context of a multicenter trial. Critical Care Medicine, 29, 235-241.

    Agre, P., McKee, K., & Gargon, N. (1997). Patient satisfaction with an informed consent process. Cancer Practice, 5, 162-167.

    Annunziata, M.A., Foladore, S., Magri, M.D., Crivellari, D., Feltrin, A., Bidoli, E., et al. (1998). Does the information level of cancer patients correlate with quality of life? A prospective study. Tumori, 84, 619-623.

    Cox, K. (2002). Informed consent and decision-making: Patients' experiences of the process of recruitment to phases I and II anti-cancer drug trials. Patient Education and Counseling, 46, 31-38.

    Montgomery, C., Lydon, A., & Lloyd, K. (1999). Psychological distress among cancer patients and informed consent. Journal of Psychosomatic Research, 46, 241-245.

    Pope, J., Tingey, D., Arnold, J.M., Hong, P., Ouimet, J., & Krizova, A. (2003). Are subjects satisfied with the informed consent process? A survey of research participants. Journal of Rheumatology, 30, 815-824.

    Tomamichel, M., Sessa, C., Herzig, S., de Jong, J., Pagani, O., Willems, Y., et al. (1995). Informed consent for phase I studies: Evaluation of quantity and quality of information provided to patients. Annals of Oncology, 6, 363-369.

    Alderson, P. (1996). Equipoise as a means of managing uncertainty: Personal, communal and proxy. Journal of Medical Ethics, 22, 135-139.

    Cavalli, F., & Sessa, C. (1999). Current issues in phase I trials: New study designs and informed consent procedures. Annals of Oncology, 10(Suppl. 6), 147-148.

    Cheng, J.D., Hitt, J., Koczwara, B., Schulman, K.A., Burnett, C.B., Gaskin, D.J., et al. (2000). Impact of quality of life on patient expectations regarding phase I clinical trials. Journal of Clinical Oncology, 18, 421-428.

    Cox, K. (1999). Researching research: Patients' experiences of participation in phases I and II anti-cancer drug trials. European Journal of Oncology Nursing, 3, 143-152.

    Cox, K. (2000). Enhancing cancer clinical trial management: Recommendations from a qualitative study of trial participants' experiences. Psycho-Oncology, 9, 314-322.

    Cox, K., & Avis, M. (1996). Ethical and practical problems of early anti-cancer drug trials: A review of the literature. European Journal of Cancer Care, 5, 90-95.

    Daugherty, C.K. (1999). Impact of therapeutic research on informed consent and the ethics of clinical trials: A medical oncology perspective. Journal of Clinical Oncology, 17, 1601-1617.

    Daugherty, C.K., Ratain, M.J., Minami, H., Banki, D.M., Vogelzang, N.J., Stadler, W.M., et al. (1998). Study of cohort-specific consent and patient control in phase I cancer trials. Journal of Clinical Oncology, 16, 2305-2312.

    Edwards, S.J., Lilford, R.J., & Hewison, J. (1998). The ethics of randomized controlled trials from the perspectives of patients, the public and healthcare professionals. BMJ, 317, 1209-1212.

    Ellis, P.M. (2000). Attitudes towards participation in randomized clinical trials in oncology: A review of the literature. Annals of Oncology, 11, 939-945.

    Halpern, S. (2002). Prospective preference assessment: A method to enhance the ethics and efficiency of randomized controlled trials. Controlled Clinical Trials, 23, 274-288.

    Jenkins, V., Leach, L., Fallowfield, L., Nicholls, K., & Newsham, A. (2002). Describing randomization: Patients' and the public's preferences compared with clinicians' practice. British Journal of Cancer, 87, 854-858.

    Lambert, M.F., & Wood, J. (2000). Incorporating patient preferences into randomized clinical trials. Journal of Clinical Epidemiology, 53, 163-166.

    McCullough, L.B. (2002). Ethical issues in the use of tumor markers in clinical investigation of the management of bladder cancer. Urologic Oncology, 7(1), 35-37.

    Menikoff, J. (2003). The hidden alternative: Getting investigational treatments off-study. Lancet, 361, 63-67.

    Wright, J.R., Crooks, D., Ellis, P.M., Mings, D., & Whelan, T.J. (2002). Factors that influence the recruitment of patients to phase III studies in oncology: The perspective of the clinical research associate. Cancer, 95, 1584-1591.

    Austoker, J. (1999). Gaining informed consent for screening. BMJ, 319, 722-723.

    Chan, E.C., Vernon, S.W., O'Donnell, F.T., Ahn, C., Greisinger, A., & Aga, D.W. (2003). Informed consent for cancer screening with prostate-specific antigen: How well are men getting the message? American Journal of Public Health, 93, 779-785.

    Dunn, A.S., Shridharani, K.V., Lou, W., Bernstein, J., & Horowitz, C.R. (2001). Physician-patient discussion of controversial cancer screening tests. American Journal of Preventive Medicine, 20, 130-134.

    Federman, D.G., Goyal, S., Kamina, A., Peduzzi, P., & Concato, J. (1999). Informed consent for PSA screening: Does it happen? Effective Clinical Practice, 2, 152-157.

    Geller, G., Botkin, J.R., Green, M.J., Press, N., Biesecker, B.B., Wilfond, B., et al. (1997). Genetic testing for susceptibility to adult-onset cancer. The process and content of informed consent. JAMA, 277, 1467-1474.

    Geller, G., Strauss, M., Bernhardt, B.A., & Holtz-man, N.A. (1997). "Decoding" informed consent. Insights from women regarding breast cancer susceptibility testing. Hastings Center Report, 27(2), 28-33.

    McCullough, L.B. (2002). Ethical issues in the use of tumor markers in clinical investigation of the management of bladder cancer. Urologic Oncology, 7(1), 35-37.

    Miller, G. (2003). Clinical research with healthy volunteers: An ethical framework. Journal of Investigative Medicine, 51(Suppl. 1), S2-S5.

    O'Neill, O. (2001). Informed consent and genetic information. Studies in History and Philosophy of Biological and Biomedical Sciences, 32, 689-704.

    Thompson, I.M. (2003). Informed consent for prostate cancer screening—A call for equity in medical interventions. Urology, 61, 15-16.

    Wolf, A., & Schorling, J. (2000). Does informed consent alter elderly patients' preferences for colorectal cancer screening? Journal of General Internal Medicine, 15, 24-30.

    Fazel, S., Hope, T., & Jacoby, R. (2000). Effect of cognitive impairment and premorbid intelligence on treatment preferences for life-sustaining medical therapy. American Journal of Psychiatry, 157, 1009-1011.

    Friebart, S., & Kodish, E. (2002). The right to decide. Journal of Clinical Oncology, 20, 4115-4118.

    Huijer, M., & van Leeuwen, E. (2000). Personal values and cancer treatment refusal. Journal of Medical Ethics, 26, 358-362.

    Kissane, D.W. (2000). The challenge of informed consent. Journal of Pain and Symptom Management, 19, 473-474.

    Kyba, F.C. (2002). Legal and ethical issues in end-of-life care. Critical Care Clinics of North America, 14, 141-155.

    Ernst, E., & Cohen, M.H. (2001). Informed consent in complementary and alternative medicine. Archives of Internal Medicine, 161, 2288-2292.

    Hart, A. (2001). Randomized controlled trials: The control group dilemma revisited. Complementary Therapies in Medicine, 9, 40-44.

    Monaco, G.P., & Smith, G. (2002). Informed consent in complementary and alternative medicine: Current status and future needs. Seminars in Oncology, 29, 601-608.

    Parkman, C.A. (2002). Complementary therapies and informed consent. Case Manager, 13(1), 22-23.

    Agrawal, M., & Danis, M. (2002). End-of-life care for terminally ill participants in clinical research. Journal of Palliative Medicine, 5, 729-737.

    Broughton, S. (2002). A review of the literature: Interventions to maximize capacity to consent and reduce anxiety of women with learning disabilities preparing for a cervical smear test. Health Services Management Research, 15, 173-185.

    Casarett, D., Karlawish, J., Sankar, P., Hirschman, K.B., & Asch, D.A. (2002). Obtaining informed consent for cancer pain research: Do patients with advanced cancer and patients with chronic pain have different concerns? Journal of Pain and Symptom Management, 24, 506-516.

    Casarett, D.J., Karlawish, J.H., Henry, M.I., & Hirschman, K.B. (2002). Must patients with advanced cancer choose between a phase I trial and hospice? Cancer, 95, 1601-1604.

    Casarett, D.J., & Karlawish, J.H.T. (2000). Are special ethical guidelines needed for palliative care research? Journal of Pain and Symptom Management, 20, 130-139.

    Cimino, J. (2003). A clinician's understanding of ethics in palliative care: An American perspective. Critical Reviews in Oncology/Hematology, 46, 17-24.

    Dickens, B.M., & Cook, R.J. (2003). Challenges of ethical research in resource-poor settings. International Journal of Gynecology and Obstetrics, 80, 79-86.

    Fitzgerald, D., Marotte, C., Verdier, R.I., Johnson, W.D., & Pape, J.W. (2002). Comprehension during informed consent in a less-developed country. Lancet, 360, 1301-1302.

    Fouad, M.N., Partridge, E., Wynn, T., Green, B.L., Kohler, C., & Nagy, S. (2001). Statewide Tuskegee Alliance for clinical trials: A community coalition to enhance minority participation in medical research. Cancer, 91(Suppl. 1), 237-241.

    Knudson, P. (2002). Ethical issues in human subject research: Informed consent to participate in research. Archives of Medical Research, 33, 88-89.

    Luce, J. (2003). Is the concept of informed consent applicable to clinical research involving critically ill patients? Critical Care Medicine, 31(Suppl. 3), S153-S160.

    Schneider, K.A., Kieffer, S.A., & Patenaude, A.F. (2000). BRCA1 testing and informed consent in a woman with mild mental retardation. Journal of Genetic Counseling, 9, 411-416.

    Verhaak, C.M., Kraaimaat, F.W., Staps, A.C., & Van Daal, W.A. (2000). Informed consent in palliative radiotherapy: Participation of patients and proxies in treatment decisions. Patient Education and Counseling, 41, 63-71.

    Cuttini, M. (2000). Proxy informed consent in pediatric research: A review. Early Human Development, 60, 89-100.

    Gould, S.J., & Anthony, M.Y. (2002). Ethical dilemmas in seeking consent for a postmortem examination. Current Pediatrics, 12, 465-469.

    Halpern-Felsher, B., & Cauffman, E. (2001). Costs and benefits of decision: Decision-making competence in adolescents and adults. Applied Developmental Psychology, 22, 257-273.

    Kearney, N., & Miller, M. (2000). Elderly patients with cancer: An ethical dilemma. Critical Reviews in Oncology/Hematology, 33, 149-152.

    Kodish, E. (2003). Informed consent for pediatric research: Is it really possible? Journal of Pediatrics, 142, 89-90.

    Kodish, E.D., Pentz, R.D., Noll, R.B., Ruccione, K., Buckley, J., & Lange, B.J. (1998). Informed consent in the Childrens Cancer Group: Results of preliminary research. Cancer, 82, 2467-2481.

    Olechnowicz, J.Q., Eder, M., Simon, C., Zyzanski, S., & Kodish, E. (2002). Assent observed: Children's involvement in leukemia treatment and research discussions. Pediatrics, 109, 806-814.

    Smyth, R.L., & Weindling, A.M. (1999). Research in children: Ethical and scientific aspects. Lancet, 354, 21-24.

    Spinetta, J.J., Masera, G., Jankovic, M., Oppen-heim, D., Martins, A.G., Ben Arush, M.W., et al. (2003). Valid informed consent and participative decision-making in children with cancer and their parents: A report of the SIOP Working Committee on psychosocial issues in pediatric oncology. Medical and Pediatric Oncology, 40, 244-246.

    Sugarman, J., McCrory, D.C., & Hubal, R.C. (1998). Getting meaningful informed consent from older adults: A structured literature review of empirical research. Journal of the American Geriatric Society, 46, 517-524.

    Tait, A.R., Voepel-Lewis, T., Robinson, A., & Malviya, S. (2002). Priorities for disclosure of the elements of informed consent for research: A comparison between parents and investigators. Pediatric Anaesthesia, 12, 332-336.

    Vernon, B., & Welbury, J. (2002). Consent for the examination and treatment of teenagers. Current Pediatrics, 12, 458-462.

    Akabayashi, A., & Fetters, M.D. (1999). Family consent, communication and advance directives for cancer disclosure: A Japanese case and discussion. Journal of Medical Ethics, 25, 296-301.

    Barnes, D.M., Davis, A.J., Moran, T., Portillo, C.J., & Koenig, B.A. (1998). Informed consent in a multicultural cancer patient population: Implications for nursing practice. Nursing Ethics: An International Journal for Health Care Professionals, 5, 412-423.

    Corbie-Smith, G., Thomas, S.B., Williams, M.V., & Moody-Ayers, S. (1999). Attitudes and beliefs of African Americans toward participation in medical research. Journal of General Internal Medicine, 14, 537-546.

    Crow, K., Matheson, L., & Steed, A. (2000). Informed consent and truth-telling: Cultural directions for healthcare providers. Journal of Nursing Administration, 30, 148-152.

    Hamadeh, G.N., & Adib, S.M. (1998). Cancer truth disclosure by Lebanese doctors. Social Science and Medicine, 47, 1289-1294.

    Higginson, I.J., & Costantini, M. (2002). Communication in end-of-life cancer care: A comparison of team assessments in three European countries. Journal of Clinical Oncology, 20, 3674-3682.

    Horikawa, N., Yamazaki, T., Sagawa, M., & Nagata, T. (2000). Changes in disclosure of information to cancer patients in a general hospital in Japan. General Hospital Psychiatry, 22, 37-42.

    Kaufert, J.M. (1999). Cultural mediation in cancer diagnosis and end of life decision-making: The experience of Aboriginal patients in Canada. Anthropology and Medicine, 6, 405-421.

    Kawakami, S., Arai, G., Ueda, K., Murai, Y., Yo-komichi, H., Aoshima, M., et al. (2001). Physician's attitudes towards disclosure of cancer diagnosis to elderly patients: A report from Tokyo, Japan. Archives of Gerontology and Geriatrics, 33, 29-36.

    Macklin, R. (2000). Informed consent for research: International perspectives. Journal of the American Medical Women's Association, 55, 290-293.

    Mitchell, J.L. (1998). Cross-cultural issues in the disclosure of cancer. Cancer Practice, 6, 153-160.

    Pang, M.C. (1999). Protective truthfulness: The Chinese way of safeguarding patients in informed treatment decisions. Journal of Medical Ethics, 25, 247-253.

    Angelos, P., DaRosa, D.A., Bentram, D., & Sherman, H. (2002). Residents seeking informed consent: Are they adequately knowledgeable. Current Surgery, 59, 115-118.

    Angelos, P., DaRosa, D.A., Derossis, A.M., & Kim, B. (1999). Medical ethics curriculum for surgical residents: Results of a pilot project. Surgery, 126, 701-705.

    Cassells, J.M., Jenkins, J., Lea, D.H., Calzone, K., & Johnson, E. (2003). An ethical assessment framework for addressing global genetic issues in clinical practice. Oncology Nursing Forum, 30, 383-390.

    Loh, W.Y., Butow, P.N., Brown, R.F., & Boyle, F. (2002). Ethical communication in clinical trials: Issues faced by data managers in obtaining informed consent. Cancer, 95, 2414-2421.

    Roberts, L.W., Mines, J., Voss, C., Koinis, C., Mitchell, S., Obenshain, S.S., et al. (1999). Assessing medical students' competence in obtaining informed consent. American Journal of Surgery, 178, 351-355.

    Sulmasy, D.P., & Marx, E.S. (1997). Ethics education for medical house officers: Long-term improvements in knowledge and confidence. Journal of Medical Ethics, 23, 88-92.

    Ward, C. (2000). Informed consent in theory and practice: The new undergraduate curriculum. British Journal of Plastic Surgery, 53, 181-183.

    Aaronson, N.K., Visser-Pol, E., Leenhouts, G.H., Muller, M.J., van der Schot, A.C., van Dam, F.S., et al. (1996). Telephone-based nursing intervention improves the effectiveness of the informed consent process in cancer clinical trials. Journal of Clinical Oncology, 14, 984-996.

    Ahern, S.P. (2002). Research on informed consent: Investigator-developed versus focus group-developed consent documents: A VA cooperative study. Controlled Clinical Trials, 23, 534-535.

    Donovan, J., Mills, N., Smith, M., Brindle, L., Jacoby, A., Peters, T., et al. (2002). Improving design and conduct of randomized trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. BMJ, 325, 766-770.

    Edwards, S.J., Lilford, R.J., Thornton, J., & Hewison, J. (1998). Informed consent for clinical trials: In search of the "best" method. Social Science and Medicine, 47, 1825-1840.

    Joffe, S., Cook, E.F., Cleary, P.C., Clark, J.W., & Weeks, J.C. (2001). Quality of informed consent: A new measure of understanding among cancer research subjects. Journal of the National Cancer Institute, 93, 139-147.

    Lavori, P.W., Sugarman, J., Hayys, M.T., & Feussner, J.R. (1999). Improving informed consent in clinical trials: A duty to experiment. Controlled Clinical Trials, 20, 187-193.

    Merz, J.F. (2002). The ethics of research on informed consent. Controlled Clinical Trials, 23, 172-177.

    National Institutes of Health, Office of the Director. (1996). Informed consent research involving human participants. Retrieved May 20, 2003, from

    Peduzzi, P., Guarino, P.G., Donta, S.T., Engel, C.C., Clauw, D.J., & Feussner, J.R. (2002). Research on informed consent: Investigator-developed versus focus group developed consent documents. A VA cooperative study. Controlled Clinical Trials, 23, 184-187.

    Sugarman, J., McCrory, D.C., Powell, D., Krasny, A., Adams, B., Ball, E., et al. (1999). Empirical research on informed consent. An annotated bibliography. Hastings Center Report, 29(1), S1-42.

    Acuff, C., Bennett, B.E., Bricklin, P.M., Canter, M.B., Knapp, S.J., Moldawsky, S., et al. (1999). Considerations for ethical practice in managed care. Professional Psychology: Research and Practice, 30, 563-575.

    Anderson, D.C., Gomez-Mancilla, B., Spear, B.B., Barnes, D.M., Cheeseman, K., Shaw, P.M., et al. (2002). Elements of informed consent for pharmacogenetic research: Perspective of the pharmacogenetics working group. Pharmacogenetics Journal, 2, 284-292.

    Beskow, L.M., Burke, W., Merz, J.F., Barr, P.A., Terry, S., Penchaszadeh, V.B., et al. (2001). Informed consent for population-based research involving genetics. JAMA, 286, 2315-2321.

    Collins, J.F., & Sather, M. (2002). Regulatory issues for clinical trials in humans. Epidemiologic Reviews, 24, 59-66.

    Cornetta, K., & Smith, F. (2002). Regulatory issues for clinical gene therapy trials. Human Gene Therapy, 13(10), 143-149.

    Hirtz, D., & Fitzsimmons, L. (2002). Regulatory and ethical issues in the conduct of clinical research involving children. Current Opinion in Pediatrics, 14, 669-675.

    Illman, J. (2002). Cancer registries: Should informed consent be required? Journal of the National Cancer Institute, 94, 1269-1270.

    Karlawish, J.H.T., Fox, E., & Pearlman, R. (2002). How changes in health care practices, systems, and research challenge the practice of informed consent. Medical Care, 40(Suppl. 9), 12-19.

    Miller, F.G., & Rosenstein, D.L. (2002). Reporting of ethical issues in publications of medical research. Lancet, 360, 1326-1328.

    Rosoff, A.J. (1999). Informed consent in the electronic age. American Journal of Law and Medicine, 25, 367-286.

    Sade, R. (2003). Publication of unethical research studies: The importance of informed consent. Annals of Thoracic Surgery, 75, 325-328.

    Sankila, R., Martinez, C., Parkin, D.M., Storm, H., & Teppo, L. (2001). Informed consent in cancer registries. Lancet, 357, 1536.

    Stevens, P., & Pletsch, P. (2002). Informed consent and the history of inclusion of women in clinical research. Health Care for Women International, 23, 809-819.

    Sullivan, M. (2003). The new subjective medicine: Taking the patient's point of view on health care and health. Social Science and Medicine, 56, 1595-1604.