-
1
-
-
0003392972
-
-
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Washington, DC: Department of Health, Education, and Welfare
-
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, DC: Department of Health, Education, and Welfare; 1979.
-
(1979)
The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research
-
-
-
3
-
-
8544222138
-
-
Department of Health and Human Services. Title 45, part 46; revised as of March
-
Department of Health and Human Services. Rules and Regulations. Title 45, part 46; revised as of March 1983.
-
(1983)
Rules and Regulations
-
-
-
6
-
-
0034737962
-
What makes clinical research ethical?
-
Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA. 2000; 283: 2701-2711.
-
(2000)
JAMA.
, vol.283
, pp. 2701-2711
-
-
Emanuel, E.J.1
Wendler, D.2
Grady, C.3
-
8
-
-
36849069884
-
Clinical trials and medical care: Defining the therapeutic misconception
-
Henderson GE, Churchill LR, Davis AM, et al. Clinical trials and medical care: Defining the therapeutic misconception. PLoS MeE. 2007; 4: e324.
-
(2007)
PLoS Med.
, vol.4
-
-
Henderson, G.E.1
Churchill, L.R.2
Davis, A.M.3
-
9
-
-
42149126151
-
What should research participants understand to understand they are participants in research?
-
Wendler D, Grady C. What should research participants understand to understand they are participants in research? Bioethics. 2008; 22: 203-208.
-
(2008)
Bioethics.
, vol.22
, pp. 203-208
-
-
Wendler, D.1
Grady, C.2
-
10
-
-
20344403771
-
The quality of informed consent in a clinical research study in Thailand
-
Pace C, Emanuel EJ, Chuenyam T, et al. The quality of informed consent in a clinical research study in Thailand. IRB. 2005; 27: 9-17.
-
(2005)
IRB.
, vol.27
, pp. 9-17
-
-
Pace, C.1
Emanuel, E.J.2
Chuenyam, T.3
-
11
-
-
4644281540
-
Interventions to improve research participants' understanding in informed consent for research: A systematic review
-
Flory J, Emanuel E. Interventions to improve research participants' understanding in informed consent for research: A systematic review. JAMA. 2004; 292: 1593-1601.
-
(2004)
JAMA.
, vol.292
, pp. 1593-1601
-
-
Flory, J.1
Emanuel, E.2
-
12
-
-
0014019552
-
Ethics and clinical research
-
Beecher HK. Ethics and clinical research. N Engl J Med. 1966; 274: 1354-1360.
-
(1966)
N Engl J Med.
, vol.274
, pp. 1354-1360
-
-
Beecher, H.K.1
-
13
-
-
0028059859
-
Informed consent in European multicentre randomised clinical trials-are patients really informed?
-
Williams CJ, Zwitter M. Informed consent in European multicentre randomised clinical trials-are patients really informed? Eur J Cancer. 1994; 30A: 907-910.
-
(1994)
Eur J Cancer.
, vol.30 A
, pp. 907-910
-
-
Williams, C.J.1
Zwitter, M.2
-
14
-
-
0037180808
-
Descriptions of benefits and risks in consent forms for phase 1 oncology trials
-
Horng S, Emanuel EJ, Wilfond B, Rackoff J, Martz K, Grady C. Descriptions of benefits and risks in consent forms for phase 1 oncology trials. N Engl J Med. 2002; 347: 2134-2140.
-
(2002)
N Engl J Med.
, vol.347
, pp. 2134-2140
-
-
Horng, S.1
Emanuel, E.J.2
Wilfond, B.3
Rackoff, J.4
Martz, K.5
Grady, C.6
-
15
-
-
0032887488
-
Strategic physician communication and oncology clinical trials
-
Albrecht TL, Blanchard C, Ruckdeschel JC, Coovert M, Strongbow R. Strategic physician communication and oncology clinical trials. J Clin Oncol. 1999; 17: 3324-3332.
-
(1999)
J Clin Oncol.
, vol.17
, pp. 3324-3332
-
-
Albrecht, T.L.1
Blanchard, C.2
Ruckdeschel, J.C.3
Coovert, M.4
Strongbow, R.5
-
16
-
-
0037080325
-
When the treatment goal is not cure: Are cancer patients equipped to make informed decisions?
-
Gattellari M, Voigt KJ, Butow PN, Tattersall MH. When the treatment goal is not cure: Are cancer patients equipped to make informed decisions? J Clin Oncol. 2002; 20: 503-513.
-
(2002)
J Clin Oncol.
, vol.20
, pp. 503-513
-
-
Gattellari, M.1
Voigt, K.J.2
Butow, P.N.3
Tattersall, M.H.4
-
17
-
-
22244439577
-
A study of the opinions and behaviors of physicians with regard to informed consent and refusing treatment
-
Atac A, Guven T, Ucar M, Kir T. A study of the opinions and behaviors of physicians with regard to informed consent and refusing treatment. Mil Med. 2005; 170: 566-571.
-
(2005)
Mil Med.
, vol.170
, pp. 566-571
-
-
Atac, A.1
Guven, T.2
Ucar, M.3
Kir, T.4
-
18
-
-
0031672335
-
Information in the ICU: Are we being honest with our patients? The results of a European questionnaire
-
Vincent JL. Information in the ICU: Are we being honest with our patients? The results of a European questionnaire. Intensive Care Med. 1998; 24: 1251-1256.
-
(1998)
Intensive Care Med.
, vol.24
, pp. 1251-1256
-
-
Vincent, J.L.1
-
19
-
-
3042555607
-
Cancer diagnosis: Do we want to know the truth?
-
Rubio Arribas V, Sampedro Martinez E, Zapirain Sarasola M, Gil Benito I, Ayechu Redin S, Tapiz Ibanez V. Cancer diagnosis: Do we want to know the truth? Aten Primaria. 2004; 33: 368-373.
-
(2004)
Aten Primaria.
, vol.33
, pp. 368-373
-
-
Rubio Arribas, V.1
Sampedro Martinez, E.2
Zapirain Sarasola, M.3
Gil Benito, I.4
Ayechu Redin, S.5
Tapiz Ibanez, V.6
-
20
-
-
0003395324
-
-
Advisory Committee on Human Radiation Experiments. Oxford: Oxford University Press
-
Advisory Committee on Human Radiation Experiments. The Human Radiation Experiments. Oxford: Oxford University Press; 1996.
-
(1996)
The Human Radiation Experiments
-
-
-
22
-
-
0035944839
-
Quality of informed consent in cancer clinical trials: A cross-sectional survey
-
Joffe S, Cook EF, Cleary PD, Clark JW, Weeks JC. Quality of informed consent in cancer clinical trials: A cross-sectional survey. Lancet. 2001; 358: 1772-1777.
-
(2001)
Lancet.
, vol.358
, pp. 1772-1777
-
-
Joffe, S.1
Cook, E.F.2
Cleary, P.D.3
Clark, J.W.4
Weeks, J.C.5
-
23
-
-
0028674772
-
Comprehension and recall of the informational content of the informed consent document: An evaluation of 168 patients in a controlled clinical trial
-
Miller C, Seaeright H, Grable D, Schwartz R, Sowell C, Barbarash R. Comprehension and recall of the informational content of the informed consent document: An evaluation of 168 patients in a controlled clinical trial. J Clin Res Drug Dev. 1994; 8: 237-248.
-
(1994)
J Clin Res Drug Dev.
, vol.8
, pp. 237-248
-
-
Miller, C.1
Seaeright, H.2
Grable, D.3
Schwartz, R.4
Sowell, C.5
Barbarash, R.6
-
24
-
-
33646828023
-
Informed consent document in gastrointestinal endoscopy: Understanding and acceptance by patients
-
Vila JJ, Jimenez FJ, Inarrairaegui M, Prieto C, Nantes O, Borda F. Informed consent document in gastrointestinal endoscopy: Understanding and acceptance by patients. Rev Esp Enferm Dig. 2006; 98: 101-111.
-
(2006)
Rev Esp Enferm Dig.
, vol.98
, pp. 101-111
-
-
Vila, J.J.1
Jimenez, F.J.2
Inarrairaegui, M.3
Prieto, C.4
Nantes, O.5
Borda, F.6
-
25
-
-
33344476296
-
Improving comprehension of informed consent
-
Kusec S, Oreskovic S, Skegro M, Korolija D, Busic Z, Horzic M. Improving comprehension of informed consent. Patient Educ Couns. 2006; 60: 294-300.
-
(2006)
Patient Educ Couns.
, vol.60
, pp. 294-300
-
-
Kusec, S.1
Oreskovic, S.2
Skegro, M.3
Korolija, D.4
Busic, Z.5
Horzic, M.6
-
26
-
-
0038281518
-
Women's knowledge of prenatal ultrasound and informed choice
-
Kohut RJ, Dewey D, Love EJ. Women's knowledge of prenatal ultrasound and informed choice. J Genet Couns. 2002; 11: 265-276.
-
(2002)
J Genet Couns.
, vol.11
, pp. 265-276
-
-
Kohut, R.J.1
Dewey, D.2
Love, E.J.3
-
27
-
-
0031720825
-
Patients' assessment and recall of surgical information after laparoscopic cholecystectomy
-
Kriwanek S, Armbruster C, Beckerhinn P, Blauensteier W, Gschwantler M. Patients' assessment and recall of surgical information after laparoscopic cholecystectomy. Dig Surg. 1998; 15: 669-673.
-
(1998)
Dig Surg.
, vol.15
, pp. 669-673
-
-
Kriwanek, S.1
Armbruster, C.2
Beckerhinn, P.3
Blauensteier, W.4
Gschwantler, M.5
-
28
-
-
0034014871
-
Informed consent in neurosurgery: Patients' recall of preoperative discussion
-
discussion 8-9
-
Krupp W, Spanehl O, Laubach W, Seifert V. Informed consent in neurosurgery: Patients' recall of preoperative discussion. Acta Neurochir (Wien). 2000; 142: 233-238; discussion 8-9.
-
(2000)
Acta Neurochir (Wien)
, vol.142
, pp. 233-238
-
-
Krupp, W.1
Spanehl, O.2
Laubach, W.3
Seifert, V.4
-
29
-
-
4844231881
-
Informed consent: How informed are patients?
-
Jebbin NJ, Adotey JM. Informed consent: How informed are patients? Niger J Med. 2004; 13: 148-151.
-
(2004)
Niger J Med.
, vol.13
, pp. 148-151
-
-
Jebbin, N.J.1
Adotey, J.M.2
-
30
-
-
14744281035
-
Informed consent in endoscopic sinus surgery: The patient perspective
-
Wolf JS, Chiu AG, Palmer JN, O'Malley BW Jr, Schofield K, Taylor RJ. Informed consent in endoscopic sinus surgery: The patient perspective. Laryngoscope. 2005; 115: 492-494.
-
(2005)
Laryngoscope.
, vol.115
, pp. 492-494
-
-
Wolf, J.S.1
Chiu, A.G.2
Palmer, J.N.3
O'Malley, B.W.4
Schofield, K.5
Taylor, R.J.6
-
31
-
-
27644564383
-
Information required to provide informed consent for endoscopy: An observational study of patients' expectations
-
Brooks AJ, Hurlstone DP, Fotheringham J, Gane J, Sanders DS, McAlindon ME. Information required to provide informed consent for endoscopy: An observational study of patients' expectations. Endoscopy. 2005; 37: 1136-1139.
-
(2005)
Endoscopy.
, vol.37
, pp. 1136-1139
-
-
Brooks, A.J.1
Hurlstone, D.P.2
Fotheringham, J.3
Gane, J.4
Sanders, D.S.5
McAlindon, M.E.6
-
32
-
-
0023319217
-
False hopes and best data: Consent to research and the therapeutic misconception
-
Appelbaum PS, Roth LH, Lidz CW, Benson P, Winslade W. False hopes and best data: Consent to research and the therapeutic misconception. Hastings Cent Rep. 1987; 17: 20-24.
-
(1987)
Hastings Cent Rep.
, vol.17
, pp. 20-24
-
-
Appelbaum, P.S.1
Roth, L.H.2
Lidz, C.W.3
Benson, P.4
Winslade, W.5
-
33
-
-
0028788544
-
Medical eligibility, comprehension of the consent process, and retention of injection drug users recruited for an HIV vaccine trial
-
Harrison K, Vlahov D, Jones K, Charron K, Clements ML. Medical eligibility, comprehension of the consent process, and retention of injection drug users recruited for an HIV vaccine trial. J Acquir Immune Defic Syndr Hum Retrovirol. 1995; 10: 386-390.
-
(1995)
J Acquir Immune Defic Syndr Hum Retrovirol.
, vol.10
, pp. 386-390
-
-
Harrison, K.1
Vlahov, D.2
Jones, K.3
Charron, K.4
Clements, M.L.5
-
34
-
-
0019838828
-
How informed is informed consent? The BHAT experience
-
Howard JM, DeMets D. How informed is informed consent? The BHAT experience. Control Clin Trials. 1981; 2: 287-303.
-
(1981)
Control Clin Trials.
, vol.2
, pp. 287-303
-
-
Howard, J.M.1
DeMets, D.2
-
35
-
-
0033816160
-
Information and communication in the context of a clinical trial
-
Hietanen P, Aro AR, Holli K, Absetz P. Information and communication in the context of a clinical trial. Eur J Cancer. 2000; 36: 2096-2104.
-
(2000)
Eur J Cancer.
, vol.36
, pp. 2096-2104
-
-
Hietanen, P.1
Aro, A.R.2
Holli, K.3
Absetz, P.4
-
36
-
-
0031968804
-
Getting meaningful informed consent from older adults: A structured literature review of empirical research
-
Sugarman J, McCrory DC, Hubal RC. Getting meaningful informed consent from older adults: A structured literature review of empirical research. J Am Geriatr Soc. 1998; 46: 517-524.
-
(1998)
J Am Geriatr Soc.
, vol.46
, pp. 517-524
-
-
Sugarman, J.1
McCrory, D.C.2
Hubal, R.C.3
-
37
-
-
11444265912
-
The ethics of research in developing countries: Assessing voluntariness
-
Pace CA, Emanuel EJ. The ethics of research in developing countries: assessing voluntariness. Lancet. 2005; 365: 11-12.
-
(2005)
Lancet.
, vol.365
, pp. 11-12
-
-
Pace, C.A.1
Emanuel, E.J.2
-
38
-
-
2642670291
-
Informed consent for HIV testing in a South African hospital: Is it truly informed and truly voluntary?
-
Abdool Karim Q, Abdool Karim SS, Coovadia HM, Susser M. Informed consent for HIV testing in a South African hospital: Is it truly informed and truly voluntary? Am J Public Health. 1998; 88: 637-640.
-
(1998)
Am J Public Health.
, vol.88
, pp. 637-640
-
-
Abdool Karim, Q.1
Abdool Karim, S.S.2
Coovadia, H.M.3
Susser, M.4
-
39
-
-
84988214507
-
Is consent to participate in research voluntary?
-
Hewlett SE. Is consent to participate in research voluntary? Arthritis Care Res. 1996; 9: 400-404.
-
(1996)
Arthritis Care Res.
, vol.9
, pp. 400-404
-
-
Hewlett, S.E.1
-
40
-
-
0031950501
-
Informed consent, parental awareness, and reasons for participating in a randomised controlled study
-
van Stuijvenberg M, Suur MH, de Vos S, et al. Informed consent, parental awareness, and reasons for participating in a randomised controlled study. Arch Dis Child. 1998; 79: 120-125.
-
(1998)
Arch Dis Child.
, vol.79
, pp. 120-125
-
-
van Stuijvenberg, M.1
Suur, M.H.2
de Vos, S.3
-
41
-
-
11444260689
-
Quality of parental consent in a Ugandan malaria study
-
Pace C, Talisuna A, Wendler D, et al. Quality of parental consent in a Ugandan malaria study. Am J Public Health. 2005; 95: 1184-1189.
-
(2005)
Am J Public Health.
, vol.95
, pp. 1184-1189
-
-
Pace, C.1
Talisuna, A.2
Wendler, D.3
-
42
-
-
0346093911
-
Informed consent and decision making by cataract patients
-
Kiss CG, Richter-Mueksch S, Stifter E, Diendorfer-Radner G, Velikay-Parel M, Radner W. Informed consent and decision making by cataract patients. Arch Ophthalmol. 2004; 122: 94-98.
-
(2004)
Arch Ophthalmol.
, vol.122
, pp. 94-98
-
-
Kiss, C.G.1
Richter-Mueksch, S.2
Stifter, E.3
Diendorfer-Radner, G.4
Velikay-Parel, M.5
Radner, W.6
-
43
-
-
0024454770
-
Research consent forms: Continued unreadability and increasing length
-
LoVerde ME, Prochazka AV, Byyny RL. Research consent forms: Continued unreadability and increasing length. J Gen Intern Med. 1989; 4: 410-412.
-
(1989)
J Gen Intern Med.
, vol.4
, pp. 410-412
-
-
LoVerde, M.E.1
Prochazka, A.V.2
Byyny, R.L.3
-
44
-
-
16844365481
-
Improving the readability and processability of a pediatric informed consent document: Effects on parents' understanding
-
Tait AR, Voepel-Lewis T, Malviya S, Philipson SJ. Improving the readability and processability of a pediatric informed consent document: effects on parents' understanding. Arch Pediatr Adolesc Med. 2005; 159: 347-352.
-
(2005)
Arch Pediatr Adolesc Med.
, vol.159
, pp. 347-352
-
-
Tait, A.R.1
Voepel-Lewis, T.2
Malviya, S.3
Philipson, S.J.4
-
45
-
-
0032490122
-
Informed consent for clinical trials: A comparative study of standard versus simplified forms
-
Davis TC, Holcombe RF, Berkel HJ, Pramanik S, Divers SG. Informed consent for clinical trials: A comparative study of standard versus simplified forms. J Natl Cancer Inst. 1998; 90: 668-674.
-
(1998)
J Natl Cancer Inst.
, vol.90
, pp. 668-674
-
-
Davis, T.C.1
Holcombe, R.F.2
Berkel, H.J.3
Pramanik, S.4
Divers, S.G.5
-
46
-
-
0024584580
-
Implementation of a multicomponent process to obtain informed consent in the Diabetes Control and Complications Trial. The DCCT Research Group
-
The DCCT Research Group
-
The DCCT Research Group. Implementation of a multicomponent process to obtain informed consent in the Diabetes Control and Complications Trial. The DCCT Research Group. Control Clin Trials. 1989; 10: 83-96.
-
(1989)
Control Clin Trials.
, vol.10
, pp. 83-96
-
-
-
47
-
-
9044245705
-
Telephone-based nursing intervention improves the effectiveness of the informed consent process in cancer clinical trials
-
Aaronson NK, Visser-Pol E, Leenhouts GH, et al. Telephone-based nursing intervention improves the effectiveness of the informed consent process in cancer clinical trials. J Clin Oncol. 1996; 14: 984-996.
-
(1996)
J Clin Oncol.
, vol.14
, pp. 984-996
-
-
Aaronson, N.K.1
Visser-Pol, E.2
Leenhouts, G.H.3
-
48
-
-
0242407387
-
Informed consent for cataract surgery: What patients do and do not understand
-
Scanlan D, Siddiqui F, Perry G, Hutnik CM. Informed consent for cataract surgery: What patients do and do not understand. J Cataract Refract Surg. 2003; 29: 1904-1912.
-
(2003)
J Cataract Refract Surg.
, vol.29
, pp. 1904-1912
-
-
Scanlan, D.1
Siddiqui, F.2
Perry, G.3
Hutnik, C.M.4
-
49
-
-
0018141691
-
A simple technique for increasing cancer patients knowledge of informed consent to treatment
-
Morrow G, Gootnick J, Schmale A. A simple technique for increasing cancer patients knowledge of informed consent to treatment. Cancer. 1978; 42: 793-799.
-
(1978)
Cancer.
, vol.42
, pp. 793-799
-
-
Morrow, G.1
Gootnick, J.2
Schmale, A.3
-
51
-
-
0033428993
-
The addition of an audiocassette recording of a consultation to written recommendations for patients with advanced cancer: A randomized, controlled trial
-
Bruera E, Pituskin E, Calder K, Neumann CM, Hanson J. The addition of an audiocassette recording of a consultation to written recommendations for patients with advanced cancer: A randomized, controlled trial. Cancer. 1999; 86: 2420-2425.
-
(1999)
Cancer.
, vol.86
, pp. 2420-2425
-
-
Bruera, E.1
Pituskin, E.2
Calder, K.3
Neumann, C.M.4
Hanson, J.5
-
52
-
-
77953094314
-
Improvement of the educational process by computer-based visualization of procedures: Randomized controlled trial
-
Enzenhofer M, Bludau HB, Komm N, et al. Improvement of the educational process by computer-based visualization of procedures: Randomized controlled trial. J Med Internet Res. 2004; 6: E16.
-
(2004)
J Med Internet Res.
, vol.6
-
-
Enzenhofer, M.1
Bludau, H.B.2
Komm, N.3
-
53
-
-
0028787379
-
Informed consent for percutaneous lung biopsy: Comparison of two consent protocols based on patient recall after the procedure
-
White CS, Mason AC, Feehan M, Templeton PA. Informed consent for percutaneous lung biopsy: Comparison of two consent protocols based on patient recall after the procedure. AJR Am J Roentgenol. 1995; 165: 1139-1142.
-
(1995)
AJR Am J Roentgenol.
, vol.165
, pp. 1139-1142
-
-
White, C.S.1
Mason, A.C.2
Feehan, M.3
Templeton, P.A.4
-
54
-
-
0023656185
-
Physician response to informed consent regulations for randomized clinical trials
-
Taylor KM, Shapiro M, Soskolne CL, Margolese RG. Physician response to informed consent regulations for randomized clinical trials. Cancer. 1987; 60: 1415-1422.
-
(1987)
Cancer.
, vol.60
, pp. 1415-1422
-
-
Taylor, K.M.1
Shapiro, M.2
Soskolne, C.L.3
Margolese, R.G.4
-
55
-
-
0028130499
-
Fundamental dilemmas of the randomized clinical trial process: Results of a survey of the 1,737 Eastern Cooperative Oncology Group investigators
-
Taylor KM, Feldstein ML, Skeel RT, Pandya KJ, Ng P, Carbone PP. Fundamental dilemmas of the randomized clinical trial process: Results of a survey of the 1,737 Eastern Cooperative Oncology Group investigators. J Clin Oncol. 1994; 12: 1796-1805.
-
(1994)
J Clin Oncol.
, vol.12
, pp. 1796-1805
-
-
Taylor, K.M.1
Feldstein, M.L.2
Skeel, R.T.3
Pandya, K.J.4
Ng, P.5
Carbone, P.P.6
-
56
-
-
0023007738
-
Randomised comparison of procedures for obtaining informed consent in clinical trials of treatment for cancer
-
Simes RJ, Tattersall MH, Coates AS, Raghavan D, Solomon HJ, Smartt H. Randomised comparison of procedures for obtaining informed consent in clinical trials of treatment for cancer. Br Med J (Clin Res Ed). 1986; 293: 1065-1068.
-
(1986)
Br Med J (Clin Res Ed)
, vol.293
, pp. 1065-1068
-
-
Simes, R.J.1
Tattersall, M.H.2
Coates, A.S.3
Raghavan, D.4
Solomon, H.J.5
Smartt, H.6
|