-
1
-
-
84555178455
-
Burdens on research imposed by institutional review boards: the state of the evidence and its implications for regulatory reform
-
Silberman G., Kahn K.L. Burdens on research imposed by institutional review boards: the state of the evidence and its implications for regulatory reform. Milbank Quarterly 2011, 89(4):599-627.
-
(2011)
Milbank Quarterly
, vol.89
, Issue.4
, pp. 599-627
-
-
Silberman, G.1
Kahn, K.L.2
-
2
-
-
77956401725
-
Equipoise lost: ethics, costs, and the regulation of cancer clinical research
-
Stewart D.J., Whitney S.N., Kurzrock R. Equipoise lost: ethics, costs, and the regulation of cancer clinical research. Journal of Clinical Oncology 2010, 28(17):2925-2935.
-
(2010)
Journal of Clinical Oncology
, vol.28
, Issue.17
, pp. 2925-2935
-
-
Stewart, D.J.1
Whitney, S.N.2
Kurzrock, R.3
-
3
-
-
58149214622
-
Clinical governance and research ethics as barriers to UK low-risk population-based health research?
-
van Teijlingen E.R., Douglas F., Torrance N. Clinical governance and research ethics as barriers to UK low-risk population-based health research?. BMC Public Health 2008, 8:p396.
-
(2008)
BMC Public Health
, vol.8
, pp. p396
-
-
van Teijlingen, E.R.1
Douglas, F.2
Torrance, N.3
-
4
-
-
67651093762
-
Grinding to a halt: the effects of the increasing regulatory burden on research and quality improvement efforts
-
Infectious Diseases Society of America Grinding to a halt: the effects of the increasing regulatory burden on research and quality improvement efforts. Clinical Infectious Diseases 2009, 49(3):328-335.
-
(2009)
Clinical Infectious Diseases
, vol.49
, Issue.3
, pp. 328-335
-
-
-
6
-
-
59149084349
-
Pruning the regulatory tree
-
Kim S., Ubel P., De Vries R. Pruning the regulatory tree. Nature 2009, 457(7229):534-535.
-
(2009)
Nature
, vol.457
, Issue.7229
, pp. 534-535
-
-
Kim, S.1
Ubel, P.2
De Vries, R.3
-
7
-
-
84908186074
-
-
[accessed 15.04.14]
-
European Commission and Health and Consumers Directorate-General.Revison of the 'Clinical Trials Directive' 2001/20/EC Concept Paper Submitted for Public Consultation, Brussels 2011, http://ec.europa.eu/health/files/clinicaltrials/concept_paper_02-2011.pdf [accessed 15.04.14].
-
(2011)
Concept Paper Submitted for Public Consultation, Brussels
-
-
-
8
-
-
84908204331
-
U.S. Code for Federal Regulations
-
CFR 46; revised.
-
U.S. Department of Health and Human Services (DHHS). U.S. Code for Federal Regulations, 45 CFR 46; revised 1991.
-
(1991)
, vol.45
-
-
-
13
-
-
0003177157
-
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human us
-
European Parliament and Council of the European Union Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human us. Official Journal of the European Communities 2001, L121:34-44.
-
(2001)
Official Journal of the European Communities
, vol.L 121
, pp. 34-44
-
-
-
15
-
-
77956076285
-
-
[accessed 15.04.14]
-
European Science Foundation (ESF) Forward look. Investigator-driven clinical trials 2009, http://www.esf.org/fileadmin/Public_documents/Publications/IDCT.pdf [accessed 15.04.14].
-
(2009)
Forward look. Investigator-driven clinical trials
-
-
-
16
-
-
84908186073
-
-
[accessed 15.04.14]
-
European Clinical Research Infrastructures Network (ECRIN), and on behalf of the "Roadmap Initiative for Clinical Research in Europe" Multidisciplinary Workshop on Risk Based Approach in Clinical Trials. Meeting Report 2010, http://www.ecrin.org/fileadmin/user_upload/public_documents/News/Activities/Report Roadmap Workshop on Risk-based regulation Barceona 18 Jan 2010-1.pdf [accessed 15.04.14].
-
(2010)
Multidisciplinary Workshop on Risk Based Approach in Clinical Trials. Meeting Report
-
-
-
18
-
-
84908186072
-
-
[accessed 15.04.14]
-
U.K.National Research Ethics Service (NRES) Proportionate Review Review Service 2011, http://www.nres.nhs.uk/applications/proportionate-review/ [accessed 15.04.14].
-
(2011)
Proportionate Review Review Service
-
-
-
21
-
-
84908186071
-
U.S. Code of Federal Regulations
-
CFR parts 50, 56 and 31; revised.
-
U.S. Department of Health and Human Services (DHHS). U.S. Code of Federal Regulations, 21 CFR parts 50, 56 and 31; revised 2013.
-
(2013)
, vol.21
-
-
-
22
-
-
80054756021
-
The role of risk in regulatory processes
-
Oxford University Press, Oxford, R. Baldwin, M. Cave, M. Lodge (Eds.)
-
Black J. The role of risk in regulatory processes. Oxford handbook of regulation 2010, 302-349. Oxford University Press, Oxford. R. Baldwin, M. Cave, M. Lodge (Eds.).
-
(2010)
Oxford handbook of regulation
, pp. 302-349
-
-
Black, J.1
-
23
-
-
80051605726
-
A framework for risk-benefit evaluations in biomedical research
-
Rid A., Wender D. A framework for risk-benefit evaluations in biomedical research. Kennedy Institute of Ethics Journal 2011, 21(2):141-179.
-
(2011)
Kennedy Institute of Ethics Journal
, vol.21
, Issue.2
, pp. 141-179
-
-
Rid, A.1
Wender, D.2
-
25
-
-
34247177049
-
Proportional ethical review and the identification of ethical issues
-
Hunter D. Proportional ethical review and the identification of ethical issues. Journal of Medical Ethics 2007, 33(4):241-245.
-
(2007)
Journal of Medical Ethics
, vol.33
, Issue.4
, pp. 241-245
-
-
Hunter, D.1
-
26
-
-
36048962697
-
Efficiency and the proposed reforms to the NHS research ethics system
-
Hunter D. Efficiency and the proposed reforms to the NHS research ethics system. Journal of Medical Ethics 2007, 33(11):651-654.
-
(2007)
Journal of Medical Ethics
, vol.33
, Issue.11
, pp. 651-654
-
-
Hunter, D.1
-
27
-
-
84859140135
-
Research ethics. To protect human subjects, review what was done, not proposed
-
Klitzman R., Appelbaum P.S. Research ethics. To protect human subjects, review what was done, not proposed. Science 2012, 335(6076):1576-1577.
-
(2012)
Science
, vol.335
, Issue.6076
, pp. 1576-1577
-
-
Klitzman, R.1
Appelbaum, P.S.2
-
28
-
-
84938331714
-
Risk and risk-benefit evaluations in biomedical research
-
Springer, Dordrecht, S. Roeser (Ed.)
-
Rid A. Risk and risk-benefit evaluations in biomedical research. Handbook of risk theory 2012, 179-211. Springer, Dordrecht. S. Roeser (Ed.).
-
(2012)
Handbook of risk theory
, pp. 179-211
-
-
Rid, A.1
-
29
-
-
1642458616
-
How do institutional review boards apply the federal risk and benefit standards for pediatric research?
-
Shah S., Whittle A., Wilfond B., Gensler G., Wendler D. How do institutional review boards apply the federal risk and benefit standards for pediatric research?. Journal of American Medical Association 2004, 291(4):476-482.
-
(2004)
Journal of American Medical Association
, vol.291
, Issue.4
, pp. 476-482
-
-
Shah, S.1
Whittle, A.2
Wilfond, B.3
Gensler, G.4
Wendler, D.5
-
31
-
-
83455162670
-
A proposal and prototype for a research risk repository to improve the protection of research participants
-
Rid A., Wendler D. A proposal and prototype for a research risk repository to improve the protection of research participants. Clinical Trials 2011, 8(6):705-715.
-
(2011)
Clinical Trials
, vol.8
, Issue.6
, pp. 705-715
-
-
Rid, A.1
Wendler, D.2
-
32
-
-
0034638297
-
Should patients in quality-improvement activities have the same protections as participants in research studies?
-
Casarett D., Karlawish J.H., Sugarman J. Should patients in quality-improvement activities have the same protections as participants in research studies?. Journal of American Medical Association 2000, 284(14):1786-1788.
-
(2000)
Journal of American Medical Association
, vol.284
, Issue.14
, pp. 1786-1788
-
-
Casarett, D.1
Karlawish, J.H.2
Sugarman, J.3
-
34
-
-
84872415114
-
An ethics framework for a learning health care system: a departure from traditional research ethics and clinical ethics
-
Faden R.R., Kass N.E., Goodman S.N., Pronovost P., Tunis S., Beauchamp T.L. An ethics framework for a learning health care system: a departure from traditional research ethics and clinical ethics. The Hastings Center Report 2013, S16-S27.
-
(2013)
The Hastings Center Report
, pp. S16-S27
-
-
Faden, R.R.1
Kass, N.E.2
Goodman, S.N.3
Pronovost, P.4
Tunis, S.5
Beauchamp, T.L.6
-
35
-
-
0031860018
-
Digoxin use in congestive heart failure. Current status
-
Riaz K., Forker A.D. Digoxin use in congestive heart failure. Current status. Drugs 1998, 55(6):747-758.
-
(1998)
Drugs
, vol.55
, Issue.6
, pp. 747-758
-
-
Riaz, K.1
Forker, A.D.2
-
36
-
-
0031794361
-
Inhibition and induction of cytochrome P450 and the clinical implications
-
Lin J.H., Lu A.Y. Inhibition and induction of cytochrome P450 and the clinical implications. Clinical Pharmacokinetics 1998, 35(5):361-390.
-
(1998)
Clinical Pharmacokinetics
, vol.35
, Issue.5
, pp. 361-390
-
-
Lin, J.H.1
Lu, A.Y.2
-
38
-
-
0034150533
-
Optimal number of response categories in rating scales: reliability, validity, discriminating power, and respondent preferences
-
Preston C.C., Colman A.M. Optimal number of response categories in rating scales: reliability, validity, discriminating power, and respondent preferences. Acta Psychologica 2000, 104:1-15.
-
(2000)
Acta Psychologica
, vol.104
, pp. 1-15
-
-
Preston, C.C.1
Colman, A.M.2
-
39
-
-
84856008161
-
De minimis risk: a proposal for a new category of research risk
-
Rhodes R., Azzouni J., Baumrin S.B., Benkov K., Blaser M.J., Brenner B., Dauben J.W., Earle W.J., Frank L., Gligorov N., Goldfarb J., Hirschhorn K., Hirschhorn R., Holzman I., Indyk D., Jabs E.W., Lackey D.P., Moros D.A., Philpott S., Rhodes M.E., Richardson L.D., Sacks H.S., Schwab A., Sperling R., Trusko B., Zweig A. De minimis risk: a proposal for a new category of research risk. American Journal of Bioethics 2011, 11(11):1-7.
-
(2011)
American Journal of Bioethics
, vol.11
, Issue.11
, pp. 1-7
-
-
Rhodes, R.1
Azzouni, J.2
Baumrin, S.B.3
Benkov, K.4
Blaser, M.J.5
Brenner, B.6
Dauben, J.W.7
Earle, W.J.8
Frank, L.9
Gligorov, N.10
Goldfarb, J.11
Hirschhorn, K.12
Hirschhorn, R.13
Holzman, I.14
Indyk, D.15
Jabs, E.W.16
Lackey, D.P.17
Moros, D.A.18
Philpott, S.19
Rhodes, M.E.20
Richardson, L.D.21
Sacks, H.S.22
Schwab, A.23
Sperling, R.24
Trusko, B.25
Zweig, A.26
more..
-
40
-
-
17644372337
-
The cost of institutional review boards in academic medical centers
-
Sugarman J., Getz K., Speckman J.L., Byrne M.M., Gerson J., Emanuel E.J. The cost of institutional review boards in academic medical centers. New England Journal of Medicine 2005, 352(17):1825-1827.
-
(2005)
New England Journal of Medicine
, vol.352
, Issue.17
, pp. 1825-1827
-
-
Sugarman, J.1
Getz, K.2
Speckman, J.L.3
Byrne, M.M.4
Gerson, J.5
Emanuel, E.J.6
-
41
-
-
33847634741
-
Money and distorted ethical judgments about research: ethical assessment of the TeGenero TGN1412 trial
-
Emanuel E.J., Miller F.G. Money and distorted ethical judgments about research: ethical assessment of the TeGenero TGN1412 trial. American Journal of Bioethics 2007, 7(2):76-81.
-
(2007)
American Journal of Bioethics
, vol.7
, Issue.2
, pp. 76-81
-
-
Emanuel, E.J.1
Miller, F.G.2
-
43
-
-
79952855322
-
A national registry for healthy volunteers in phase 1 clinical trials
-
Resnik D.B., Koski G. A national registry for healthy volunteers in phase 1 clinical trials. Journal of American Medical Association 2011, 305(12):1236-1237.
-
(2011)
Journal of American Medical Association
, vol.305
, Issue.12
, pp. 1236-1237
-
-
Resnik, D.B.1
Koski, G.2
|