Salud y Fármacos

Una organización internacional sin ánimo de lucro para fomentar el acceso y el uso adecuado de medicamentos entre la población hispano-parlante

Artículos sobre ensayos clínicos y ética

Poblaciones vulnerables

Generales

Chen DT, Miller FG, Rosenstein DL. Enrolling decisionally impaired adults in clinical research. Medical Care 2002; 40 (Suppl. 9) V20-v29

Hawryluck L. People at the end of life are a vulnerable research population. Clinical Oncology 2004; 16(3): 225-226

Iltis AS, Wall A, Lesandrini J, Rangel EK, Chibnall JT. Federal interpretation and enforcement of protections for vulnerable participants in human research. Journal of Empirical Research on Human Research Ethics 2009; 4(1): 37-41

Justo, L (2004) Participatory research: A way to reduce vulnerability. American Journal of Bioethics 4(3):pp. 18-19.

Justo, L and Erazun, F (2005) In a marginal voice. From participatory to emancipatory research. Preprint.

Justo, L and Erazun, F and Villarreal, J (2004) La investigación participativa como derecho: ¿posibilidad o utopia?. Perspectivas Metodológicas 4(4):pp. 73-82.

Leavitt FJ. Is any medical reserch population not vulnerable? Cambridge Quarterly of Healthcare Ethics 2006; 15(1):81-88

Levine C, Faden RR, Grady C, Hammerschmidt D, Eckenwiler L, Sugarman J. The limitations of “vulnerability” as a protection for human research participants. American Journal of Bioethics 2004; 4(3):44-49

Lloyd CE, et al. Securing recruitment and obtaining informed consent in minority ethnic groups in the UK. BMC Health Services Research 2008; 8:68 www.biomedcentral.com/1472-6963/8/68

Mills EJ, Singh S. Health, human rights, and the conduct of clinical research within oppressed populations. Globalization and Health 2007; 3(10) http://www.globalizationandhealth.com/content/pdf/1744-8603-3-10.pdf

Oldham JM, Haimowitz S, Delano SJ. Protection of persons with mental disorders from research risk: a response to the report of the National Bioethics Advisory Commission. Archives of General Psychiatry 1999; 56: 688-693

Sachs GA. Position statement: informed consent for research on human subjects with dementia. American Geriatrics Society. http://www.americangeriatrics.org/products/positionpapers/infconsent.shtml

Sieber JE. Protecting the vulnerable: Who are they? Journal of Empirical Research on Human Research Ethics 2008; 3(1):1-2

Wrobel AJ, Shapiro NE. Conducting research with urban elders: issues of recruitment, data collection, and home visits. Alzheimer Disease and Associated Disorders. 1999; 13 (Supplement 1), S34-38

Yan EG, Munir KM. Regulatory and ethical principles in research involving children and individuals with developmental disabilities. Ethics and Behavior 2004; 14:31-49

Cáncer

Audrey S, Abel J, Blazeby JM, Falk S, Campbell R. What oncologists tell patients about survival benefits of palliative chemotehrapy and implications for informed consent: qualitative study. BMJ 2008;337:a752 http://www.bmj.com/cgi/content/abstract/337/jul31_3/a752

Agrawal M, grady C, Fairclough DL, Meropol NJ, Mainard K, Emanuel EJ. Patients’ decision-making process regarding participation in phase I oncology research. Journal of Clinical Oncology 2006; 24(27): 4479-4484

Barrett R. Quality of informed consent: measuring understanding among participants in oncology clinical trials. Oncology Nursing Forum 2005; 32(4): 751-755

Brown RF, Butow PN, Butt DG, Moore AR, Tattersall MH. Developing ethical strategies to assist oncologists in seeking informed consent to cancer clinical trials. Social Science and Medicine 2004; 58: 379-390

Cheng JD, Hitt J, Koczwara B, Schulman KA, Burnet CB et al. Impact of quality of life on patient’s expectations regarding phase I clinical trials. Journal of Clinical Oncology 2000; 18 (2): 421-428

Cox K. Researching research: patients’ experiences of participation in phase I and II anti-cancer drug trials. European Journal of Oncology Nursing 1999; 3:143-152

Coyne C, Xu R, Raich P, Plomer K, dignan M et al. 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 2003; 21: 836-842

Daugherty CK, Banik DM, Janish L, Ratain MJ. Quantitative analysis of ethical issues in phase I trials: A survey interview of 144 advanced cancer patients. IRB: Ethics and Human Research 2000; 22(3): 6-14

Daugherty C, Ratain MJ, Grochowski E et al. Perceptions of cancer patients and their physicians involved in phase I trials. Journal of Clinical Oncology 1995; 13:1062-1072

Estey E, Hoth D, Simon R, et al. Therapeutic response in phase I trials of antineoplasic agents. Cancer Treatment Report 1986; 70: 1105-1115

Flynn KE, Weinfurt KP, Seils DM, et al. Decisional conflict among patients who accept or decline participation in phase I oncology studies. Journal of Empirical Research on Human Research Ethics 2008; 3(3): 69-77

Gordon LA, Daugherty CK. Referral and decision-making among advanced cancer patients participating in phase I trials at a single institution. Journal of Clinical Ethics 2001; 12(1): 31-38

Hawryluck L. People at the end of life are a vulnerable research population. Clinical Oncology 2004; 16(3): 225-226

Helf PR, Champion VL, Eckles R, Johnson CS, Meslin EM. Cancer patients’ attittudes towards future research uses of stored human biological materials. Journal of Empirical Research on Human Research Subjects 2007; 2(3):15-22

Hortsmann E, McCabe M, Grochow L, Yamamoto S, et al. Risks and benefits of phase I oncology trials, 1991 through 2002. NEJM 2005; 352 (9): 895-904

Jenkins VA, Fallowfield LJ, Souhami A, Sawtell M. How do doctors explain randomised clinical trials to their patients? European Journal of Cancer, 1999; 35:1187-1193

Joffe S, cook EF, Cleary PD, Clarck JW, Weeks JC. Quality of informed consent in cancer clinical trials: A cross-sectional survey. Lancet 2001; 358(9295):1772-1777

Kass N, Taylor H, Fogarty L et al. Purpose and benefits of early phase cancer trials: what do oncologists say? What do patients hear?. Journal of Empirical Research on Human Research Ethics 2008; 3(3): 57-68

Kennedy BJ. Impact of Institutional Review Boards on cancer research. Journal of Bioethics 1984; 5(1): 27-32

Kupst M, Patenaude A, Wlaco G, Sterling C. Clinical trials in pediatric cancer: parental perspectives on informed consent. Journal of Pediatric Hematology and Oncology 2003; 25(1): 787-790

Lantos J. Informed consent: The whole truth for patients? Cancer 1993; 72:2811-2815

McCaskill-Stevens W, Pinto H, Marcus AC, Comis R, Morgan R, Plomer K, Schoentgen S. Recruiting minority cancer patients into cancer clinical trials: a pilot project involving the eastern cooperative oncology group and the national medical association. Journal of Clinical Oncology 1999; 17 (3):1029-1039

Miller M. Phase I cancer trials: A collusion of misunderstanding. The Hastings Center Report 2000; 30: 25-29

Miller M. Phase I cancer trials: A crucible of competing priorities. International Anesthesiology Clinics 2001; 39:13-33

Penman DT, Holland JC, Bahna GF, Morrow G, Schmale AH, Derogatis LR, Carnrike CL Jr, Cherry R. Informed consent for investigational chemotherapy: patients and physicians’ perceptions. Journal of Clinical Oncology 1984; 2(7):849-855

Roberts TG, Goulart BH, Squitieri L, Stallings SC et al. Trends in the risks and benefits to patients with cancer participating in phase I clinical trials. JAMA 2004; 292 (17): 2130-2140

Rodenhuis S, van den Heuvel WJ, Annyas AA, Koops HS et al. Patient motivation and informed consent in a phase I study of anticancer agent. European Journal of Cancer And Clinical Oncology 1984; 20: 457-462

Schutta KM, Burnett CB. Factors that influence patients’ decision to participate ina phase I cancer clinical trial. Oncology Nursing Forum 2000; 27: 1435-1438

Simes RJ, Tattersall MH, Coates AS et al. Randomised comparison of procedures for obtaining informed consent in clinical trials of treatment for cancer. BMJ 1986; 293:1065-1068

Siminoff LA, fetting JH. Effects of outcome framing on treatment decisions in the real world: impact of framing on adjuvant breat cancer decision. Medical Decision Making 1989; 9: 262-271

Simon CM, Siminoff LA, Kodish ED, Burant C. Comparison of informed consent process for randomized clinical trials in pediatric and adult oncology. Journal of Clinical Oncology 2004; 22(13):2708-2717

Smith TL, Lee JJ, Kantarjian HM, Legha SS, Raber MN. Design and results of phse I cancer clinical trials: three-year experience at MD Anderson Cancer Center. Journal of Clinical Oncology 1996; 14: 287-295

Tomamichel M, Jaime H, Degrate A, deJong J, Pagani O, Cavalli F. Proposing phase I studies: patients’, relatives’, nurses’ and specialists’ perceptions. Annals of Oncology 2000; 11: 289-294

Van Luijn HE, Aaronson NK, Keus RB, Musschenga AW. The evaluation of the risks and benefits of phase II cancer clinical trials by Institutional Review Board (IRB) membrs: a case study. Journal of Medical Ethics 2006; 32(3): 170-176

Von Hoff DD, Turner J. Response rates, duration of response, and dose response effect in phase I studies in antineoplasics. Investigational New Drugs 1997; 9: 115-122

Wagener DK, Sporer AK, Simmerling M, Flome JL, An D, Curry SJ. Human Participants challenges in youth-focused research: perspectives and parctices of IRB administrators. Ethics and Behavior 2004; 14(4):335-349

Cuidados intensivos

Chenaud C, Merlani P, Luyasu S, Ricou B. Informed consent for research obtained during the intensive care unit stay. Critical Care 2006; 10(6):R170

Cohen LM, Mccue JD, Green GM. Do clinical and formal assessments of the capacity of patients in the intensive care unit to make decisions agree? Archives of Internal Medicine 1993; 153:2481-2485

Silverman HJ, Luce JM, Lanken PN, Morris AH, Harabin AL, Oldmixon CF, Thompson BT, Bernard GR. Recommendations for informed consent form for critical care clinical trials. Critical Care Medicine 2005; 33(4):867-882

Mujeres

Holden C. Women abound in NHI trials. Science 2008; 322:219

Laguna Goya N, Andrés Rodríguez-Trelles. Participatción de las mujeres en los ensayos clínicos según los informes de la agencia española de medicamentos y productos sanitarios. Revista Española de Salud Pública 2008; 82:343-350. http://www.scielosp.org/pdf/resp/v82n3/breve.pdf

Mills E, Nixon S, Singh S, Dolma S, Nayyar A, Kapoor S. Enrolling women into HIV preventive vaccine trials: an ethical imperative but a logistical challenge. PloS Medicine 2006; 3(3)e94. http://medicine.plosjournals.org/archive/1549-1676/3/3/pdf/10.1371_journal.pmed.0030094-L.pdf

Pediatria

Aman MG, Farmer CA. Psychotropic medication research in children and adolescents: empirical findings and ethical implications. Journal of Empirical Ethics on Human Research Subjects 2008; 3(3): 39-47

Caldwell PHY, Murphy SB. Clinical trials in children. The Lancet 2004; 364:803-811

Gaillard P, Fowler MG, Dabis F, Coovadia H, Van der Horst C, van Rompay K, Ruff A, Taha T, Thomas T, de Vincenzi I, Newell ML for the Ghent IAS Working Group on HIV in Women and Children. Use of antirretroviral drugs to prevent HIV-1 transmission through breastfeeding: from animal studies to randomized clinical trials. Journal of Acquired Immune Deficiency Syndromes 2004; 35(2):178-187

Kipnis K. Several vulnerabilities in the pediatric research subject. Theoretical Medicine and Bioethics 2003; 24(2): 107-120

Kodish E. The art of medicine. Pediatric ethics: a repudiation of the Groningen protocol. The Lancet 2008; 371:892-3

Kupst M, Patenaude A, Wlaco G, Sterling C. Clinical trials in pediatric cancer: parental perspectives on informed consent. Journal of Pediatric Hematology and Oncology 2003; 25(1): 787-790

Lee KJ, Havens PL, Sato TT, Hoffman GM, Leuthner SR. Assent for treatment:Clinician knowledge, attitudes and practice. Pediatrics 2006; 118(2):723-730

Mezquita E. Los ensayos pediátricos han aumentado un 22 por ciento. Diario Medico, 1 de diciembre de 2009
www.diariomedico.com/2009/12/01/area-profesional/normativa/los-ensayos-pediatricos-han-aumentado-un-22-por-ciento

Millum J, Emanuel EJ. The ethics of international research with abandoned children. Science 2007; 318:1874-1875. http://www.sciencemag.org/cgi/content/summary/318/5858/1874

National Institutes of Health. Policy and guidelines on the inclusion of children as participants in research involving human subjects. Bethesda MD. www.grants.nih.gov/grants/guide/notice-files/not98-024.html

Niños cobaya: la polémica de los fármacos infantiles. La Razón, 27 de noviembre de 2009. www.larazon.es/noticia/ninos-cobaya-la-polemica-de-los-farmacos-infantiles

Pace C, Talisuna A, Wendler D. Quality of parental consent in a Ugandan malaria study. AJPH 2005; 95(7):1184-9

Parkes J, Kerr D, McDowell BC, Cosgrove AP. Recruitment bias in a population-based study of children with cerebral palsy. Pediatrics 2006; 118(4):1616-1622

Rogers AS, Schwartz DF, Weissman G, english A. A case study in adolescent participation in clinical research: Eleven clinical sites, one common protocol, and eleven IRBs. IRB 1999; 21(1):6-10

Simon CM, Siminoff LA, Kodish ED, Burant C. Comparison of informed consent process for randomized clinical trials in pediatric and adult oncology. Journal of Clinical Oncology 2004; 22(13):2708-2717

Spetie L, Arnold LE. Ethical issues in child psychopharmacology research and practice: emphasis on prescholers. Psychopharmacology 2007; 191 (1): 15-26

Sugarman J. Determining the appropriateness of including children in clinical research: how thick is the ice? JAMA 2004; 291(4):494-496

Tierney E, Aman MG, Stout DJ, Pappas K, Arnold E, et al. Parent satisfaction in a multi-site trial of risperidone in children with autism: A social valididty study. Psychopharmacology 2007; 191(1):149-157

Van Stuijvenberg M, Suur MH, De vos S, et al. Informed consent, parental awareness, and reasons for participating in a randomized controlled study. Archives of Disease in Childhood 2007; 171 (1): 86-91

Velázquez Armenta Y, Nava Ocampo AA. Factores que afectan la absorción de los medicamentos en niños. Revista Mexicana de Pediatría 2005; 72(3): 148-153. http://www.hospitalinfantiltamaulipas.gob.mx/cetox/ABSORCION%20DE%20MEDICAMENTOS.pdf

Vitiello B. Ethical considerations in psychopharmacological research involving children and adolescents. Psychopharmacology 2003; 171 (1): 86-91

Vitiello B, Aman M, Scahill L et al. Research knowledge among paretns of children participating in a randomized controlled trial. Journal of the American Academy of Child and Adolescent Psychiatry 2005; 46(12):1642-1650

Vitiello B, Jensen PS. Medication development and testing in children and adolescents: current problems, future directions. Archives of General Psychiatry 1997; 54(9):871-876

Vitiello B, Kratochvil C, Silva S, Curry J et al. Research knowledge among the participants in the treatment for adolescents with depression study (TADS). Journal of the American Academy of Child and Adolescent Psychiatry 2007; 46(12):1642-1650

Wagener DK, Sporer AK, Simmerling M, Flome JL, An D, Curry SJ. Human Participants challenges in youth-focused research: perspectives and parctices of IRB administrators. Ethics and Behavior 2004; 14(4):335-349

Wagner K, Martinez M, Joiner T. Youth and their parents’ attituted and experiences about participation in psychopharmacology treatment research. Journal of the American Academy of Child and Adolescent Pharmacology 2006; 16(3): 298-307

Walsh C, ross LF. Are minority children under or overrepresented in pediatric research? Pediatrics 2003; 112(4):890-895

Yan EG, Munir KM. Regulatory and ethical principles in research involving children and individuals with developmental disabilities. Ethics and Behavior 2004; 14:31-49

Prisioneros

Psiquiatria/salud mental

Aman MG, Farmer CA. Psychotropic medication research in children and adolescents: empirical findings and ethical implications. Journal of Empirical Ethics on Human Research Subjects 2008; 3(3): 39-47

Appelbaum PS, Roth LH, Lidz C. The therapeutic misconception: informed consent in psychiatric resarch. International Journal of Law and Psychiatry 1982; 5:319-329

Appelbaum PS, Roth LH. Competency to consent to research: a psychiatric overview. Archives of General Psychiatry 1982; 39(8):951-958

Appelbaum PS, Grisso T, Frank E, O’Donnell S, Kupfer DJ. Competence of depressed patients for consent to research. American Journal of Psychiatry 1999; 156:1380-1384

Carpenter WT Jr, Gold JM, Lahti AC, Queern CA, Conley RR, Bartko JJ, Kovnick J, Applebaum PS. Decisional capacity for informed consent in schizophrenia research. Archives of General Psychiatry 2000; 57:533-538

Chen DT, Miller FG, Rosenstein DL. Enrolling decisionally impaired adults in clinical research. Medical Care 2002; 40 (Suppl. 9) V20-v29

Dunn LB, Palmer BW, Keehan M, Jeste DV, Appelbaum PS. Assessment of therapeutic misconception in older schizophrenia patientes with a brief instrument. American Journal of Psychiatry 2006; 163(3):500-506

Dunn L, Lindamer L, Palmer B, Golshn S, Schneiderman L, Jeste D. Improving understanding of research consent in middle-aged and elderly patients with psychotic disorders. American Journal of Geriatric Psychiatry 2002; 10:142-150

Frank E, Novick DM, Kupfer DJ. Beyond the question of placebo controls: ethical issues in psychopharmacological drug studies. Psychopharmacology 2003; 171:19-26

Jollant F, Bellivier F, Leboyer M, Astruc B, Torres S, Verdier R, Castelnau D, Malafosse A, Coourtet P. Impaired decision making in suicide attempters. American Journal of Psychiatry 2005; 162(2):304-310

Luebbert R, Tair RC, Chibnall JT, Deshields TL. IRB member judgments of decisional capacity, coercion, and risk in medical and psychiatric studies. Journal of Empirical Research on Human Research Ethics 2008; 3(1):15-24

MacQueen KM, McLoughlin K, Alleman P, burke HM, Mack N. Partnering for care in HIV prevention trials. Journal of Empirical Research and Human Research Ethics 2008; 3(4): 5-18

Moser DJ, Schultz SK, Arndt S, Benjamin ML, Fleming FW, Brems CS, Paulsen JS, Appelbaum PS, Andreasen NC. Capacity to provide informed consent for participation in schizophrenia and HIV research. American Journal of Psychiatry 2002; 159:1201-1207

Oldham JM, Haimowitz S, Delano SJ. Protection of persons with mental disorders from research risk: a response to the report of the National Bioethics Advisory Commission. Archives of General Psychiatry 1999; 56: 688-693

Orchuela J. 2006. Denuncias por investigación de medicamentos sin consentimiento en hospital neuropsiquíatrico de mujeres. Boletín Fármacos 9(2): 126-129 www.saludyfarmacos.org/boletin-farmacos/boletines/abr2006/etica-y-medicamentos

Perlis RH, Perlis CS, Wu Y, Hwang C, Joseph M, Nierenberg AA. Industry sponsorship and financial conflict of interest in the reporting of clinical trials in psychiatry. American Journal of Psychiatry 2005; 162 (10):1957-1960

Prentice KJ, Gold JM, Carpenter WT. Optimistic bias in the perception of personal risk: patterns in schizophrenia. American Journal of Psychiatry 2005; 162(3):507-512

Roberts LW. Evidence-based ethics and informed consent in mental illness research. Archives of General Psychiatry 2000; 57(6):540-42

Roberts LW. Ethics and mental illness research. Psychiatric Clinics of North America 2002; 25:525-545

Roberts LW, Hammond KG, Hoop J. An inverse relationship between perceived harm and participation willingness in schizpphrenia research protocols. American Journal of Psychiatry 2006; 163 (11):2002-2004

Sachs GA. Position statement: informed consent for research on human subjects with dementia. American Geriatrics Society. http://www.americangeriatrics.org/products/positionpapers/infconsent.shtml

Tierney E, Aman MG, Stout DJ, Pappas K, Arnold E, et al. Parent satisfaction in a multi-site trial of risperidone in children with autism: A social valididty study. Psychopharmacology 2007; 191(1):149-157

Vitiello B. Ethical considerations in psychopharmacological research involving children and adolescents. Psychopharmacology 2003; 171 (1): 86-91

Vitiello B, Aman M, Scahill L et al. Research knowledge among paretns of children participating in a randomized controlled trial. Journal of the American Academy of Child and Adolescent Psychiatry 2005; 46(12):1642-1650

Vitiello B, Jensen PS. Medication development and testing in children and adolescents: current problems, future directions. Archives of General Psychiatry 1997; 54(9):871-876

Vitiello B, Kratochvil C, Silva S, Curry J et al. Research knowledge among the participants in the treatment for adolescents with depression study (TADS). Journal of the American Academy of Child and Adolescent Psychiatry 2007; 46(12):1642-1650

Wagner K, Martinez M, Joiner T. Youth and their parents’ attituted and experiences about participation in psychopharmacology treatment research. Journal of the American Academy of Child and Adolescent Pharmacology 2006; 16(3): 298-307

Wrobel AJ, Shapiro NE. Conducting research with urban elders: issues of recruitment, data collection, and home visits. Alzheimer Disease and Associated Disorders. 1999; 13 (Supplement 1), S34-38

SIDA

Barry M. Ethical considerations of human investigation in developing countries; the AIDS dilemma. NEJM 1988; 319:1083

Christakis NA, Lynn LA, Castelo A. Clinicl AIDS research that evaluates cost-effectiveness in thedeveloping world. IRB: Review Human Subjects Research 1991; 13:6-8

Corneli A, Sorenson J, Nkhoma J, Moses A, Zulu C et al. Evaluation of three informed consent processes for a clinical trial on the prevention of mother-to-child transmission of HIV through breastfeeding in Lilongwe, Malawi. Oral presentation at XV international AIDS Conference in Bangkok, Thailand.

Crouch RA, Arras JD. AZT trials and tribulations. Hastings Center Report 1998; 28(6):26-34

Fauci AS. The AIDS epidemic- considerations for the 21st century. NEJM 1999; 341:1046-50

Gaillard P, Fowler MG, Dabis F, Coovadia H, Van der Horst C, van Rompay K, Ruff A, Taha T, Thomas T, de Vincenzi I, Newell ML for the Ghent IAS Working Group on HIV in Women and Children. Use of antirretroviral drugs to prevent HIV-1 transmission through breastfeeding: from animal studies to randomized clinical trials. Journal of Acquired Immune Deficiency Syndromes 2004; 35(2):178-187

Garcia-Calleja JM, Marum LH, Cármamo CP, Kaetano L, Muttunga J, Way A. Lessons learned in the conduct, validation and interpretation of national population based HIV surveys. AIDS, 19 (Supplement 2):S9-S17

Grant RM, Buchbinder S, Cates W Jr et al. Promote HIV chemoprophylaxis research, don’t prevent it. Science 2005; 309(5744):2170-2071 (sic)

Joint United Nations Program on HIV.AIDs (UNAIDS). Ethical considerations in HIV preventive vaccine research: UNAIDS guidance document. Geneva. Switzerland: Joint United Nations Program on HIV/AIDs (UNAIDS)

Karim QA, Karim S, Coovadia HM, Susser M. Informed consent for HIV testing in a South African hospital: is it truly informed and truly voluntary? AJPH 1998; 88:637-640

MacQueen KM, Shapiro K, Karim QA, Sugarman J. Ethical challenges in international HIV prevention research. Accountability in Research 2004; 11:48-61

MacQueen KM, McLoughlin K, Alleman P, burke HM, Mack N. Partnering for care in HIV prevention trials. Journal of Empirical Research and Human Research Ethics 2008; 3(4): 5-18

McGrory, CE, Friedland BA, Woodsong C, MacQueen KM. Informed Consent in HIV prevention trials: report of an international workshop. New York City: Population Council and Family Health International. 2005 http://www.popcouncil.org/pdfs/ICWorkshop.pdf

Milford C, Wassenaar D, Slack C. Resources and needs of research ethics committees in Africa: preparations for HIV vaccine trials. IRB Ethics and Human Research 2006; 28 (2)1-9 http://www.who.int/vaccine_research/diseases/hiv/docs/Resources_needs_HIV_vaccine_trials.pdf

Mills E, Nixon S, Singh S, Dolma S, Nayyar A, Kapoor S. Enrolling women into HIV preventive vaccine trials: an ethical imperative but a logistical challenge. PloS Medicine 2006; 3(3)e94. http://medicine.plosjournals.org/archive/1549-1676/3/3/pdf/10.1371_journal.pmed.0030094-L.pdf

Mills E, Rachlis B, Wu P, Wong E, Wilson K, singh S. Media reporting of tenofovir trials in Cambodia and Cameroon. BMC International Health and Human Rights 2005; 5(6)

Murphy DA, O’Keefe ZH, Kaufman AH. Improving comprehension and recall of information for an HIV vaccine trial among women at risk of HIV: reading level simplification and inclusion of pictures to illustrate key concepts. AIDS Education and Prevention 1999; 11:389-399

Page-Shafer K, Saphonn V, Sun LP, Vun MD, Cooper DA, Kaldor JM. HIV prevention research in a resource-limited setting: the experience of planning a trial in Cambodia. The Lancet 2005; 366(9495):1499-1503

Santolaya Perrín R, Garcia López FJ. Incremental drug treatment cost in HIV-positive patients in industry-sponsored clinical trials. The Annals of Pharamcotherapy 2008; 42:1586-1591 http://www.theannals.com/cgi/content/abstract/42/11/1586

Slack C, Stobie M, Milford C, Lindegger G, wassenaar D, Strode A, Ijsselmuiden C. Provision of HIV preventive vaccine trials: a developing country perspective. Social Science and Medicine 2005; 60(6):1197-1208

Slomka J, Ratliff EA. et al. Decisions to participate in research: views of underserved minority drug users with or at risk for HIV. AIDS Care 2008; 20(10):1224-1232

Tucker T, Slack C. Not if but how? Caring for HIV-1 vaccine trial participants in South Africa. The Lancet 2003; 362 (9388):995

UNAIDS. Joint United Nations Program on HIV/AIDS. Ethical considerations in HIV preventive vaccine research. UNAIDS guidance document. Geneva: UNAIDS, 2000

Weijer C, LeBlanc G. The balm of Gilead: Is the provision of treatment of those who seroconvert in HIV prevention trials a matter of moral obligation or moral negotiation. Journal of Law, Medicine and Ethics 2006; 34(4):793-808

Woodsong C, Karim QA. A model designed to enhance informed consent: experiences from the HIV prevention trials network. AJPH 2005; 95 (3): 412-419. http://www.ajph.org/cgi/content/abstract/95/3/412

Urgencias

DeIorio N, McClure K. Does the emergency exception from informed consent process protect research subjects? Academic Emergeny Medicine 2005; 12(11): 1056-1059

DeIorio N, McClure K, Nelson M, McDonnell J, Schmidt T. Ethics committee experience with emergency exception from informed consent protocols. Journal of Empirical Research on Human Research Ethics 2007; 2(3):23-30

Quest T, Marco CA. Ethics seminars: vulnerable populations in emergency medicine research. Academic Emergency Medicine 2003; 10(11): 1294-1298

Smithline HA, Mader TJ, Crenshaw BJ. Do patients with acute medical conditionshave the capacity to give informed consent for emergency medicine research? Academic Emergency Medicine 1999; 6: 438-445

Vacunas

Barry M, Molyneux M. Ethical dilemmas in malaria drug and vaccine trials: a bioethical perspective. Journal of Medicine Ethics 1992; 18:189-92

Berkley S. Thorny issues in the ethics of AIDS vaccine trials. The Lancet 2003; 362(9388):992

Fairhead J, Leach M, Small M. Public engagement with science? Local understandings of a vaccine trial in the Gambia. Journal of Biosocial Science 2006; 38 (1):103-116

Fitzgerald DW, Pape JW, Wasserheit JN, Counts GW, Corey L. Provision of treatment in HIV-1 vaccine trials in developing countries. The Lancet 2003; 362 (9388):993-994

Geissler PW, Kelly A, Imoukhuede B, Pool R. ”He is now like a brother, I can even give him some blood” – Relational ethics and material exchanges in a malaria vaccine ”trial community” in the Gambia. Social Science and Medicine 2008; 65(5):696-707

Gikonyo C, Bejon P, Marsh V, Molyneux S. Taking social relationships seriously: lessons learned from the informed consnt practices of a vaccine trial on the Kenyan Coast. Social Science and Medicine 2008; 67(5): 708-720

Joint United Nations Program on HIV.AIDs (UNAIDS). Ethical considerations in HIV preventive vaccine research: UNAIDS guidance document. Geneva. Switzerland: Joint United Nations Program on HIV/AIDs (UNAIDS)

Lie KR. Ethical issues in clinical trial collaborations with developing countries – with special reference to preventive HIV vaccine trials with secondary endpoints. Geneva: OMS. http://www.ethica.uib.no/who.pdf

Milford C, Wassenaar D, Slack C. Resources and needs of research ethics committees in Africa: preparations for HIV vaccine trials. IRB Ethics and Human Research 2006; 28 (2)1-9 http://www.who.int/vaccine_research/diseases/hiv/docs/Resources_needs_HIV_vaccine_trials.pdf

Murphy DA, O’Keefe ZH, Kaufman AH. Improving comprehension and recall of information for an HIV vaccine trial among women at risk of HIV: reading level simplification and inclusion of pictures to illustrate key concepts. AIDS Education and Prevention 1999; 11:389-399

Preziosi MP, Yam A, Ndiaye M,Simga A, Simondon F, Wassilak S. Practical experiences in obtaining informed consent for a vaccine trial in rural Africa. NEJM 1997; 336(5):370-3

Slack C, Stobie M, Milford C, Lindegger G, wassenaar D, Strode A, Ijsselmuiden C. Provision of HIV preventive vaccine trials: a developing country perspective. Social Science and Medicine 2005; 60(6):1197-1208

Tucker T, Slack C. Not if but how? Caring for HIV-1 vaccine trial participants in South Africa. The Lancet 2003; 362 (9388):995

modificado el 28 de Noviembre de 2013


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