Enrolling research subjects from clinical practice: Ethical and procedural issues in the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial

Psychiatry Research

Volumn 141, Issue 2, 2006, Pages 193-200

  Alpert, Jonathan E ^a   Biggs, Melanie M ^b   Davis, Lori ^c,d   Shores Wilson, Kathy ^b   Harlan, William R ^e   Schneider, Gregory W ^b   Ford, Amy L ^f   Farabaugh, Amy ^a   Stegman, Diane ^b   Ritz, A Louise ^e   Husain, Mustafa M ^b   MacLeod, Laurie ^b   Wisniewski, Stephen R ^g   Rush, A John ^b  

^a MASSACHUSETTS GENERAL HOSPITAL   (United States)

^b UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER   (United States)

^c VETERANS AFFAIRS MEDICAL CENTER   (United States)

^d UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^e NATIONAL INSTITUTE OF MENTAL HEALTH   (United States)

^f UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

^g UNIVERSITY OF PITTSBURGH   (United States)

Author keywords

Major depressive disorder; Randomized clinical trial; Recruitment

Indexed keywords

ANTIDEPRESSANT AGENT;

ADULT; AGED; ARTICLE; CLINICAL PRACTICE; COGNITIVE THERAPY; CONTROLLED STUDY; HEALTH CARE COST; HUMAN; MAJOR CLINICAL STUDY; MAJOR DEPRESSION; MENTAL HEALTH SERVICE; OUTPATIENT; PRIORITY JOURNAL; RESEARCH ETHICS; RESEARCH SUBJECT; VALIDITY;

ADOLESCENT; ADULT; AGED; ANTIDEPRESSIVE AGENTS; COGNITIVE THERAPY; COMBINED MODALITY THERAPY; DEPRESSIVE DISORDER, MAJOR; ETHICS, CLINICAL; FEMALE; HUMANS; MALE; MIDDLE AGED;

EID: 33645032387     PISSN: 01651781     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.psychres.2005.04.007     Document Type: Article

References (27)

1. P.S. Appelbaum Clarifying the ethics of clinical research: a path toward avoiding the therapeutic misconception American Journal of Bioethics 2 2002 22 23
2. P.S. Appelbaum, L.H. Roth, D.W. Lidz, P. Benson, and W. Winslade False hopes and best data: consent to research and the therapeutic misconception Hastings Center Report 17 1987 20 24
3. P.S. Appelbaum, T. Grisso, E. Frank, S. O'Donnell, and D. Kupfer Competence of depressed patients for consent to research American Journal of Psychiatry 156 1999 1380 1384
4. L. Baer, M. Blais, P. Cukor, M. Fava, D.G. Jacobs, R. Kessler, B. Kopans, L. Leahy, K. Magruder, J. Meszler-Reizes, J. Murphy, and J. O'Laughlen Development of a brief screening instrument: the HANDS Psychotherapy and Psychosomatics 69 2000 35 41
5. H.K. Beecher Ethics and clinical research New England Journal of Medicine 274 1966 1354 1360
6. R.J. Bielski, and R.B. Lydiard Therapeutic trial participants. Where do we find them and what does it cost? Psychopharmacology Bulletin 33 1997 75 78
7. N. Dickert, and C. Grady What's the price of a research subject? Approaches to payment for research participation New England Journal of Medicine 341 1999 198 203
8. M. Edwards, and K. Chalmers Double agency in clinical research Canadian Journal of Nursing Research 34 2002 131 142
9. M. Fava, D.J. Kupfer, P.W. Lavori, A.A. Nierenberg, F.M. Quitkin, J.F. Rosenbaum, A.J. Rush, M.E. Thase, M.H. Trivedi, H.A. Sackeim, S.R. Wisniewski for the STAR*D Investigators Group Background and rationale for the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study Psychiatric Clinics of North America 26 2003 1 38
10. E. Frank, A.J. Rush, M. Blehar, S. Essock, W. Hargreaves, M. Hogan, R. Jarrett, R.L. Johnson, W.J. Katon, P. Lavori, J.P. McNulty, G. Niederehe, N. Ryan, G. Stuart, S.B. Thomas, G.D. Tollefson, and B. Vitiello Skating to where the puck is going to be: a plan for clinical trials and translation research in mood disorders Biological Psychiatry 52 2002 631 654
11. A.L. Grimes, M.E. Kunik, L.B. McCullough, V. Molinari, and R.H. Workman Informed consent and neuroanatomic correlates of intentionality and voluntariness among psychiatric patients Psychiatric Services 51 2000 1561 1567
12. P. Lavori, A.J. Rush, S. Wisniewski, J.E. Alpert, M. Fava, D.J. Kupfer, A.A. Nierenberg, F.M. Quitkin, H.A. Sackeim, M.E. Thase, and M.H. Trivedi Strengthening clinical effectiveness trials: equipoise-stratified randomization Biological Psychiatry 50 2001 792 801
13. C.W. Lidz, and P.S. Appelbaum The therapeutic misconception: problems and solutions Medical Care 40 suppl. 2002 V55 V63
14. F.G. Miller, and D.L. Rosenstein The therapeutic orientation to clinical trials New England Journal of Medicine 348 2003 1383 1386
15. F.G. Miller, D.L. Rosenstein, and E.G. DeRenzo Professional integrity in clinical research JAMA 280 1998 1449 1454
16. F.C. Murphy, J.S. Rubinsztein, A. Michael, R.D. Rogers, T.W. Robbins, E.S. Paykel, and B.J. Sahakian Decision-making cognition in mania and depression Psychological Medicine 31 2001 679 693
17. C. Pace, F.G. Miller, and M. Danis Enrolling the uninsured in clinical trials: an ethical perspective Critical Care Medicine 31 2003 S121 S125
18. M.P. Pigone, B.N. Gaynes, J.L. Rushton, C.M. Burchell, C.T. Orleans, C.D. Mulrow, and K.N. Lohr Screening for depression in adults: a summary of the evidence for the U.S. Preventive Services Task Force Annals of Internal Medicine 136 2002 765 776
19. L.W. Roberts Ethics and mental illness research Psychiatric Clinics of North America 25 3 2002 525 545
20. J.R. Rosenbaum Educating researchers: ethics and the protection of human research participants Critical Care Medicine 31 suppl 3 2003 S161 S166
21. A.J. Rush, M. Fava, S.R. Wisniewski, P.W. Lavori, M.H. Trivedi, H.A. Sackeim, M.E. Thase, A.A. Nierenberg, F.M. Quitkin, T.M. Kashner, D.J. Kupfer, J.F. Rosenbaum, J. Alpert, J. Stewart, P.J. McGrath, M.M. Biggs, K. Shores-Wilson, B.D. Lebowitz, L. Ritz, G. Niederehe for the STAR*D Investigators Group Sequenced Treatment Alternatives to Relieve Depression (STAR*D): rationale and design Controlled Clinical Trials 25 2004 118 141
22. D.L. Shtasel, R.E. Gur, P.D. Mozley, J. Richards, M.M. Taleff, C. Heimberg, F. Gallacher, and R.C. Gur Volunteers for biomedical research. Recruitment and screening of normal controls Archives of General Psychiatry 48 1991 1022 1025
23. R.L Spitzer, K. Kroenke, J.B. Williams and the Patient Health Questionnaire Primary Care Study Group Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study JAMA 282 1999 1737 1744
24. K.B. Wells Treatment research at the crossroads: the scientific interface of clinical trials and effectiveness research American Journal of Psychiatry 156 1999 5 10
25. S.R. Wisniewski, D. Stegman, M. Trivedi, M.M. Husain, H. Eng, K. Shores-Wilson, J. Luther, M.M. Biggs, D. Burroughs, A.L. Ritz, M. Fava, F. Quitkin, A.J. Rush for the STAR*D Investigators Group Methods of testing feasibility for Sequenced Treatment Alternatives to Relieve Depression (STAR*D) Journal of Psychiatric Research 38 2004 241 248
26. M. Zimmerman, J.I. Mattia, and M.A. Posternak Are subjects in pharmacological treatment trials of depression representative of patients in routine clinical practice? American Journal of Psychiatry 159 2002 469 473
27. W.W. Zung A self-rating depression scale Archives of General Psychiatry 12 1965 63 70