Benefits and burdens of participation in a longitudinal clinical trial

Journal of Empirical Research on Human Research Ethics

Volumn 4, Issue 3, 2009, Pages 89-97

  Lazovski, Jaime ^a   Losso, Marcelo ^a   Krohmal, Benjamin ^b   Emanuel, Ezekiel J ^b   Grady, Christine ^b   Wendler, David ^b  

^a Argentina Sites Coordinating Center for the ESPRIT Study   (Argentina)

^b NATIONAL INSTITUTES OF HEALTH   (United States)

Author keywords

Benefits; Burdens; Longitudinal clinical trial

Indexed keywords

ANTIRETROVIRUS AGENT; INTERLEUKIN 2;

ADULT; ARTICLE; FEMALE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INFORMATION PROCESSING; LONGITUDINAL STUDY; MALE; MULTICENTER STUDY (TOPIC); PATIENT PARTICIPATION; PATIENT SATISFACTION; PSYCHOLOGICAL ASPECT; RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK ASSESSMENT;

ADULT; ANTI-RETROVIRAL AGENTS; DATA COLLECTION; FEMALE; HIV INFECTIONS; HUMANS; INTERLEUKIN-2; LONGITUDINAL STUDIES; MALE; MULTICENTER STUDIES AS TOPIC; PATIENT PARTICIPATION; PATIENT SATISFACTION; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RISK ASSESSMENT; YOUNG ADULT;

EID: 70349521847     PISSN: 15562646     EISSN: 15562654     Source Type: Journal    
DOI: 10.1525/jer.2009.4.3.89     Document Type: Article

References (19)

1. ARDUINO, R. C., NANNINI, E. C., RODRIGUEZ-BARRADAS, M., SCHRADER, S., LOSSO, M., RUXRUNGTHAM, K., ALLENDE, M. C., EMERY, S., FOSDICK, L., NEATON, J., TAVEL, J. A., DAVEY, R. T., & LANE, H. C., for the ESPRIT Vanguard Group and the ESPRIT Executive Committee. (2004). CD4 cell response to 3 doses of subcutaneous interleukin-2: Meta-analysis of 3 Vanguard studies. Clinical Infectious Disease, 39(1), 115-122.
2. Council for International Organizations of Medical Sciences (CIOMS). (2002). International Ethical Guidelines for Biomedical Research Involving Human Beings. Geneva, Switzerland: CIOMS. Available online at http://www.cioms.ch/frame_guidelines_nov_2002.htm.
3. DAUGHERTY, C. K., BANIK, D. M., JANISH, L., & RATAIN, M. J. (2000). Quantitative analysis of ethical issues in phase I trials: A survey interview of 144 advanced cancer patients. IRB: Ethics & Human Research, 22(3), 6-14.
4. EMERY, S., ABRAMS, D. I., COOPER, D. A., DARBYSHIRE, J. H., LANE, H. C., LUNDGREN, J. D., NEATON, J. D., & the ESPRIT Study Group. (2002). The evaluation of subcutaneous proleukin (interleukin-2) in a randomized international trial: Rationale, design, and methods of ESPRIT. Controlled Clinical Trials, 23(2), 198-220.
5. HIETANEN, P., ARO, A. R., HOLLI, K., & ABSETZ, P. (2000). Information and communication in the context of a clinical trial. European Journal of Cancer, 36(16), 2096-2104.
6. HUSSAIN-GAMBLES, M. (2004). South Asian patients' views and experiences of clinical trial participation. Family Practice, 21 (6), 636-642.
7. 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(9295), 1772-1777.
8. 3. Journal of Infectious Diseases, 181(5), 1614-1621.
9. MADSEN, S. M., HOLM, S., DAVIDSEN, B., MUNKHOLM, P., SCHLICHTING, P., RIIS, P. (2000). Ethical aspects of clinical trials: The attitudes of participants in two non-cancer trials. Journal of Internal Medicine, 248(6), 463-474.
10. MADSEN, S. M., MIRZA, M. R., HOLM, S., HILSTED, K. L., KAMPMANN, K., & RIIS, P. (2002). Attitudes towards clinical research amongst participants and nonparticipants. Journal of Internal Medicine, 251 (2), 156-168.
11. MARKOWITZ, N., BEBCHUK, J. D., & ABRAMS, D. I. for the Terry Beirn Community Program for Clinical Research on AIDS. (2003). Nadir CD4+ T cell count predicts response to subcutaneous recombinant interleukin-2. Clinical Infectious Disease, 37(8), e115-e120.
12. MATTSON, M. E., CURB, J. D., MCARDLE, R., & Amis and Bhat Research Groups. (1985). Participation in a clinical trial: The patients' point of view. Controlled Clinical Trials, 6(2), 156-167.
13. National Bioethics Advisory Commission (NBAC). (2001). Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries. Bethesda, MD: NBAC. Available online at http://www.bioethics.gov/reports/past_commissions/nbac_international.pdf.
14. PENMAN, D. T., HOLLAND, J. C., BAHNA, G. F., MORROW, G., SCHMALE, A. H., DEROGATIS, L. R., CARNRIKE, C. L., JR., & CHERRY, R. (1984). Informed consent for investigational chemotherapy: Patients' and physicians' perceptions. Journal of Clinical Oncology, 2(7), 849-855.
15. RUXRUNGTHAM, K., SUWANAGOOL, S., TAVEL, J. A., CHUENYAM, M., KROON, E., UBOLYAM, S., BURANAPRADITKUN, S., TECHASATHIT, W., LI, Y., EMERY, S., DAVEY, R. T., FOSDICK, L., KUNANUSONT, C., LANE, H. C., PHANUPHAK, P., & the Vanguard Study Group. (2000). A randomized, controlled 24-week study of intermittent subcutaneous interleukin-2 in HIV-1 infected patients in Thailand. AIDS, 14(16), 2509-2513.
16. SIMON, C. M., SIMINOFF, L. A., KODISH, E. D., & BURANT, C. (2004). Comparison of the informed consent process for randomized clinical trials in pediatric and adult oncology. Journal of Clinical Oncology, 22(13), 2708-2717.
17. U.S. Code of Federal Regulations. (1991). The Common Rule for the protection of Human Participants. Federal Register, 56, 28,012.
18. World Medical Association. (2008). Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. Seoul, Korea: 59th WMA General Assembly. Available online at http://www.wma.net/e/ policy/b3.htm.
19. YOULE, M., EMERY, S., FISHER, M., NELSON, M., FOSDICK, L., JANOSSY, G., LOVEDAY, C., SULLIVAN, A., HERZMANN, C., WAND, H., DAVEY, R. T. JR., JOHNSON, M. A., TAVEL, J. A., & LANE, H. C. (2006). A randomised trial of subcutaneous intermittent interleukin-2 without antiretroviral therapy in HIV-infected patients: The UK-Vanguard study. PLoS Clinical Trials, 1(1), e3.