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Research Ethics Committees - Bibliography By Topic

Audit Children Consent Legal/Regulation Nursing Pharmaceutical
Research Ethics RECs: General RECs: National RECs: Institutional Review Boards RECs: Multi-centre RECs: Hospital
  RECs: Local RECs: Membership Research Participants Non-clinical Research  

Audit

Cookson, J B
Auditing a research ethics committee,
Journal Of The Royal College Of Physicians Of London, Volume 26, Issue 2, Pages 181-183 (April 1992)

Redshaw, M E; Harris, A; Baum, J D
Research ethics committee audit: differences between committees,
Journal Of Medical Ethics, Volume 22, Issue 2, Pages 78-82 (April 1996)

Robles, P H
Evaluation of healthcare ethics committees: the experience of an HEC in Spain,
HEC Forum: An Interdisciplinary Journal On Hospitals' Ethical And Legal Issues, Volume 11, Issue 3, Pages 263-276 (September 1999)

Shaul, Randi
Reviewing the reviewers: the vague accountability of research ethics committees,
Critical Care (London, England), Volume 6, Issue 2, Pages 121-122 (April 2002)

Wise, P; Drury, M
Pharmaceutical trials in general practice: the first 100 protocols. An audit by the clinical research ethics committee of the Royal College of General Practitioners,
BMJ (Clinical Research Ed.), Volume 313, Issue 7067, Pages 1245-1248 (November 16, 1996)

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Children

Franck, L.S.
Research with newborn participants: doing the right research and doing it right.
J Perinat Neonatal Nurs. 2005 Apr-Jun;19(2):177-86.

Hall, David
Reviewing research involving children: the practice of British research ethics committees,
IRB; a Review Of Human Subjects Research, Volume 10, Issue 2, Pages 1-5 (March - April 1988)

Kopelman, L M
Children as research subjects: a dilemma,
The Journal Of Medicine And Philosophy, Volume 25, Issue 6, Pages 745-764 (December 2000)

Lenk, C; Radenbach, K; Dahl, M; Wiesemann, C
Non-therapeutic research with minors: how do chairpersons of German research ethics committees decide?,
Journal Of Medical Ethics, Volume 30, Issue 1, Pages 85-87 (February 2004)

Mason, S A; Allmark, P J
Obtaining informed consent to neonatal randomised controlled trials: interviews with parents and clinicians in the Euricon study,
Lancet, Volume 356, Issue 9247, Pages 2045-2051 (December 16, 2000)

Ruyter, K W; Nyquist, I
Children as medical research subjects,
Tidsskrift For Den Norske Laegeforening, Volume 119, Issue 19, Pages 2833-2837 (August 20, 1999)

Shah, Seema; Whittle, Amy; Wilfond, Benjamin; Gensler, Gary; Wendler, David
How do institutional review boards apply the federal risk and benefit standards for pediatric research?,
JAMA: The Journal Of The American Medical Association, Volume 291, Issue 4, Pages 476-482 (January 28, 2004)

Thomas, KA;
Safety: when infants and parents are research subjects.
Journal of Perinatal Neonatal Nursing 2005 Jan-Mar;19(1):52-8.

Consent

Annas, G. J.
Reforming Informed Consent to Genetic Research.
Journal of the American Medical Association 286(18): 2326-2328, 2001

Baker, R; Shiels, C; Stevenson, K; Fraser, R; Stone, M
What proportion of patients refuse consent to data collection from their records for research purposes?,
The British Journal Of General Practice: The Journal Of The Royal College Of General Practitioners, Volume 50, Issue 457, Pages 655-656 (August 2000)

Beardsley, Tim; Flanagan, Martin
Consent in clinical trials: will verbal assent suffice?,
Nature, Volume 301, Issue 5899, Page 365 (February 3, 1983 - February 9, 1983)

Bergsma, J
Response to "Ethical concerns about relapse studies" by Adil E. Shamoo and Timothy J. Keay (CQ Vol 5, No 3). Research with vulnerable subjects,
Cambridge Quarterly Of Healthcare Ethics: CQ: The International Journal Of Healthcare Ethics Committees, Volume 6, Issue 2, Pages 233-234 (Spring 1997)

Bro Taf Local Research Ethics Committee
Research on patients unable to give informed consent,
Bulletin Of Medical Ethics, Volume No. 150, Pages 6-7 (August 1999)

Burman, William; Breese, Peter; Weis, Stephen; Bock, Naomi; Bernardo, John; Vernon, Andrew; Tuberculosis Trials Consortium
The effects of local review on informed consent documents from a multicenter clinical trials consortium,
Controlled Clinical Trials, Volume 24, Issue 3, Pages 245-255 (June 2003)

Cassell, J. and Young, A.
Why we should not seek individual informed consent for participation in health services research
Journal of Medical Ethics 28: 313-317, 2002

Cooper, J
The law and ethics of the use of experimental medication in patients incapable of expressing consent: between a rock and a hard place,
Medicine And Law, Volume 19, Issue 2, Pages 189-195 ( 2000)

Daugherty, C K
Impact of therapeutic research on informed consent and the ethics of clinical trials: a medical oncology perspective,
Journal Of Clinical Oncology: Official Journal Of The American Society Of Clinical Oncology, Volume 17, Issue 5, Pages 1601-1617 (May 1999)

Gill, Dennis
Guidelines for informed consent in biomedical research involving paediatric populations as research participants,
European Journal Of Pediatrics, Volume 162, Issue 7-8, Pages 455-458 (July 2003)

Kahn, J.; Mastroianni, A.; and Sugarman,J. eds.
Beyond Consent: Seeking Justice in Research.
New York: Oxford University Press, 1998

Kompanje, E J; Maas, A I; Dippel, D W
Clinical trials on medical products for human use in the case of acutely incapacitated patients within the fields of neurology and neurosurgery; implications of the new European legislation,
Nederlands Tijdschrift Voor Geneeskunde, Volume 147, Issue 33, Pages 1585-1589 (August 16, 2003)

Lafolie, Pierre
Reporting of approval by research ethics committee and informed consent should be included in scientific information. A neglected quality indicator,
Lakartidningen, Volume 99, Issue 51-52, Pages 5180-5181 (December 19, 2002)

Levine, Robert J
Proposed regulations for research involving those institutionalized as mentally infirm: a consideration of their relevance in 1995,
Accountability In Research, Volume 4, Issue 3-4, Pages 177-186 ( 1996)

Little, P; Williamson, I
Informed consent in medical research. Ethics committees and BMJ should continue to consider the overall benefit to patients,
BMJ (Clinical Research Ed.), Volume 314, Issue 7092, Page 1478 (May 17, 1997)

Lynöe, N; Sandlund, M; Jacobsson, L
Research ethics in practice. Research ethics committees do not guarantee the right to informed consent,
Lakartidningen, Volume 89, Issue 25, Pages 2292-2294 (June 17, 1992)

Mason, S A; Allmark, P J
Obtaining informed consent to neonatal randomised controlled trials: interviews with parents and clinicians in the Euricon study,
Lancet, Volume 356, Issue 9247, Pages 2045-2051 (December 16, 2000)

Oberst, M T
Another look at informed consent,
Nursing Outlook, Volume 33, Issue 6, Pages 294-295 (November - December 1985)

M R Robling, K Hood, H Houston, R Pill, J Fay, and H M Evans
Public attitudes towards the use of primary care patient record data in medical research without consent: a qualitative study
J Med Ethics 2004 30: 104-109.

Peto, Julian, Fletcher, Olivia, Gilham, Clare
Data protection, informed consent and research
British Medical Journal 2004;328:1029-1030

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Legal/Regulation

Amatayakul, Margret; American Health Information Management Association
Another layer of regulations: research under HIPAA,
Journal Of AHIMA / American Health Information Management Association, Volume 74, Issue 1, Pages 16A-16D (January 2003)

Bergkamp, L
Research ethics committees and the regulation of medical experimentation with human beings in The Netherlands,
Medicine And Law, Volume 7, Issue 1, Pages 65-72 (January 1988)

E. Bartlett,
'International Compilation of Human Subject Research Protections', International Activities Program, Office for Human Research Protection, Washington US, published online June 2005.

Beyleveld, Deryck
Law, ethics and research ethics committees,
Medicine And Law, Volume 21, Issue 1, Pages 57-75 ( 2002)
medicine & law.htm

Boulay, Harvey; Goldstein, Richard; Zisk, Betty; de Sola Pool, Ithiel
Protecting human subjects of research: proposed amendments to HEW policy,
PS, Volume 13, Issue 2, Pages 202-204 (Spring 1980)

Boyd, Kenneth
The Council of Europe's first Symposium on Bioethics: Strasbourg, Dec 5-7 1989,
Journal Of Medical Ethics, Volume 16, Issue 2, Pages 97-98 (June 1990)

Bradburn NM.
Medical privacy and research.[comment]
Journal of Legal Studies. 30(2):687-701, 2001 Jun.

Bravender-Coyle, P
Medical experiments and the new law: in vitro fertilisation procedures, embryo experimentation and the law,
Law Institute Journal: The Official Organ Of The Law Institute Of Victoria, Volume 59, Issue 1-2, Pages 63-67 (January - February 1985)

Breen KJ. Hacker SM.
Privacy legislation and research.[comment].
Medical Journal of Australia. 177(9):523-4, 2002 Nov 4.

Butler, D
Europe plans convention on social impacts of biomedical technologies,
Nature, Volume 370, Issue 6484, Page 3 (July 7, 1994)

Byk, J C
A proposed draft protocol for the European Convention on Biomedicine relating to research on the human embryo and fetus,
Journal Of Medical Ethics, Volume 23, Issue 1, Pages 32-37 (February 1997)

Cave E. Holm S.
New governance arrangements for research ethics committees: is facilitating research achieved at the cost of participants' interest. [Review] (UK)
Journal of Medical Ethics. 28(5):318-21, 2002 Oct.

Cooper, J
The law and ethics of the use of experimental medication in patients incapable of expressing consent: between a rock and a hard place,
Medicine And Law, Volume 19, Issue 2, Pages 189-195 ( 2000)

Crigger, B J
The Research Freedom Act,
The Hastings Center Report, Volume 21, Issue 1, Page 2 (January - February 1991)

Diamond, A L; Laurence, D R
Better research ethics committees: comments on guidance from the Department of Health and the European Community,
Journal Of The Royal College Of Physicians Of London, Volume 27, Issue 2, Pages 141-146 (April 1993)

Ferris, L E; Singer, P A; Naylor, C D
Better governance in academic health sciences centres: moving beyond the Olivieri/Apotex Affair in Toronto,
Journal Of Medical Ethics, Volume 30, Issue 1, Pages 25-29 (February 2004)

Fielding, James E; Kelly, Heath A
Ethics committees and guardianship legislation,
The Medical Journal Of Australia, Volume 179, Issue 7, Page 390 (October 6, 2003)

Foucar E.
How much oversight is necessary to protect human subjects?[comment] (US).
JAMA. 287(6):716-7, 2002 Feb 13.

Gill, Dennis
Guidelines for informed consent in biomedical research involving paediatric populations as research participants,
European Journal Of Pediatrics, Volume 162, Issue 7-8, Pages 455-458 (July 2003)

Gillam, Lynn
Bioethics and public policy in Australia,
Politics And The Life Sciences: The Journal Of The Association For Politics And The Life Sciences, Volume 13, Issue 1, Pages 87-88 (February 1994)

Glass, K C; Freedman, B
Legal liability for injury to research subjects,
Clinical And Investigative Medicine. Medecine Clinique Et Experimentale, Volume 14, Issue 2, Pages 176-180 (April 1991)

Goodman, N W; MacGowan, A
Are research ethics committees behaving unethically? If committees were sued who would be liable?,
BMJ (Clinical Research Ed.), Volume 314, Issue 7081, Pages 676-677 (March 1, 1997)

Gorski, A.
Recent Changes in the Declaration of Helsinki and their Possible Impact on Health Research.
In Ethics Committees in Central and Eastern Europe. J. Glasa. Strasbourg, Council of Europe (2000).

Gray, Bradford H
Changing federal regulation of IRBs, Part III: social research and the proposed DHEW regulations,
IRB; a Review Of Human Subjects Research, Volume 2, Issue 1, Pages 1-5+ (January 1980)

Greely HT.
Breaking the stalemate: a prospective regulatory framework for unforeseen research uses of human tissue samples and health information (US).
Wake Forest Law Review. 34(3):737-66, 1999 Fall.

Grisso, Thomas; Baldwin, Elizabeth; Blanck, Peter David; Rotheram-Borus, Mary Jane; Schooler, Nina R; Thompson, Travis
Standards in research: APA's mechanism for monitoring the challenges,
The American Psychologist, Volume 46, Issue 7, Pages 758-766 (July 1991)

Hanna, Kathi E; Cook-Deegan, Robert M; Nishimi, Robyn Y
Bioethics and public policy: still seeking a forum,
Politics And The Life Sciences: The Journal Of The Association For Politics And The Life Sciences, Volume 13, Issue 1, Pages 102-105 (February 1994)

Harvey, I; Chadwick, R
Compensation for harm: the implications for medical research,
Social Science & Medicine (1982), Volume 34, Issue 12, Pages 1399-1404 (June 1992)

Healy, D
Clinical trials and legal jeopardy,
Bulletin Of Medical Ethics, Issue 153, Pages 13-18 (December 1999)

Hilgartner, Stephen
Research fraud, misconduct, and the IRB,
IRB; a Review Of Human Subjects Research, Volume 12, Issue 1, Pages 1-4 (January - February 1990)

Holder, Angela R
Revoking the licenses of dishonest academics,
IRB; a Review Of Human Subjects Research, Volume 12, Issue 2, Pages 9-10 (March - April 1990)

Kerrison, Susan; McNally, Nick; Pollock, Allyson M
United Kingdom research governance strategy,
BMJ (Clinical Research Ed.), Volume 327, Issue 7414, Pages 553-556 (September 6, 2003)

Kompanje, E J; Maas, A I; Dippel, D W
Clinical trials on medical products for human use in the case of acutely incapacitated patients within the fields of neurology and neurosurgery; implications of the new European legislation,
Nederlands Tijdschrift Voor Geneeskunde, Volume 147, Issue 33, Pages 1585-1589 (August 16, 2003)

LeBris, S.
National Ethics Bodies
Council of Europe Publications (Strasbourg: 1998).

Lenoir N
Universal Declaration on the Human Genome and Human Rights: the first legal and ethical framework at the global level.
Columbia Human Rights Law Review. 30(1):537-87, 1999.

Levine, Robert J
Proposed regulations for research involving those institutionalized as mentally infirm: a consideration of their relevance in 1995,
Accountability In Research, Volume 4, Issue 3-4, Pages 177-186 (1996)

Lippert, H.-D.
Legal Aspects of Ethics Committees in Biomedical Research.
In Ethics Committees in Central and Eastern Europe. J. Glasa. Strasbourg, Council of Europe (2000).

Lippert, H.-D.
Legal Aspects of the Establishment of Hospital Ethics Committees.
In Ethics Committees in Central and Eastern Europe. J. Glasa. Strasbourg, Council of Europe (2000).

Maloney, Dennis M
Law would remove ability of institutional review boards to waive written consent,
Human Research Report, Volume 11, Issue 8, Pages 1-2 (August 1996)

Mander, Tristan
The legal standing of local research ethics committees,
Medical Law International, Volume 2, Issue 2, Pages 149-168 ( 1996)

Mandl, József; Medve, László; Temesi, Alfreda; Vizi, E Szilveszter
Ethical regulation of biomedical research in Hungary,
Orvosi Hetilap, Volume 144, Issue 2, Pages 73-76 (January 12, 2003)

Martin, S C
Research ethics, data protection and the pre-registration pharmacist
Pharmacy World & Science: PWS, Volume 26, Issue 3, June 2004, Page A66

Martinho de Silva, P.
Ethics and law.
In Ethik und Wissenschaft in Europa. D. Meith. Freiburg/München, Alber: 164-168 (2000).

Mascaro, J.
Clinical Trials and the Impact of the Clinical Trials Directive
For Johnson & Johnson Pharmaceutical R&D, November 2003
Available online at the Pan European Regulatory Forum

Mello, Michelle M; Studdert, David M; Brennan, Troyen A
The rise of litigation in human subjects research,
Annals Of Internal Medicine, Volume 139, Issue 1, Pages 40-45 (July 1, 2003)

Mori, T
National regulation of and achievements in assisted reproduction in Japan. Japan Society of Obstetrics and Gynecology,
Journal Of Assisted Reproduction And Genetics, Volume 9, Issue 4, Pages 293-298 (August 1992)

Normile, Dennis
Genetic privacy. Japan guidelines under fire after protest halts study,
Science, Volume 301, Issue 5636, Page 1039 (August 22, 2003)

Porter, Joan P
The federal policy for the protection of human subjects,
IRB; a Review Of Human Subjects Research, Volume 13, Issue 5, Pages 8-9 (September - October 1991)

President's Commission for the Protection of Human Subjects of Biomedical and Behavioral Research,
Congressional Record: Proceedings And Debates Of The ... Congress. United States. Congress, Volume 124, Issue 168, Pages H13564-H13566 (October 14, 1978)

President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research,
Congressional Record: Proceedings And Debates Of The ... Congress. United States. Congress, Volume 124, Issue 168, Pages H13571-H13573 (October 14, 1978)

Puglisi T.
Protecting human research subjects: ten common problems (US).
Health Law News. 13(3):8, 15, 2000 Jun.

Redsell, S A; Cheater, F M
The Data Protection Act (1998): implications for health researchers,
Journal Of Advanced Nursing, Volume 35, Issue 4, Pages 508-513 (August 2001)

Rodríguez-Villanueva, Julio; Alsar, M Jesús; Avendaño, Cristina; Gómez-Piqueras, Cristina; García-Alonso, Fernando
Pharmacogenetic studies: evaluation guidelines for research ethics committees. Study protocol and patient information sheet (II),
Medicina Clinica, Volume 120, Issue 3, Pages 101-107 (February 1, 2003)

Rodríguez-Villanueva, Julio; Alsar, M Jesús; Avendaño, Cristina; Gómez-Piqueras, Cristina; García-Alonso, Fernando
Pharmacogenetic studies: evaluation guidelines for research ethics committees. Scientific background and legal framework (I),
Medicina Clinica, Volume 120, Issue 2, Pages 63-67 (January 25, 2003)

Sarma, V
Medical research. Mandatory ethics recommendations,
Nature, Volume 301, Issue 5896, Page 103 (January 13, 1983)

Seiler, Lauren H; Veatch, Robert M
Social science research regulations,
The Hastings Center Report, Volume 12, Issue 2, Pages 45-46 (April 1982)

Tangwa, GB.
International regulations and medical research in developing countries: double standards or differing standards?
Notizie di Politeia (67): 46-50, 2002.

G B Tangwa
Between universalism and relativism: a conceptual exploration of problems in formulating and applying international biomedical ethical guidelines
J Med Ethics 2004 30: 63-67.

C Trouet
New European guidelines for the use of stored human biological materials in biomedical research
J Med Ethics 2004 30: 99-103.

Vidal-Martinez, J
The protection of the person in medical research in the Spanish law,
European Journal Of Health Law, Volume 6, Issue 3, Pages 249-264 (September 1999)

Zilgalvis, P.
European Convention on Human Rights and Biomedicine, and Ethical Review of Biomedical Research.
In Ethics Committees in Central and Eastern Europe. J. Glasa. Strasbourg, Council of Europe. 2000.

AAMC Task Force on Financial Conflicts of Interest in Clinical Research
Protecting subjects, preserving trust, promoting progress I: policy and guidelines for the oversight of individual financial interests in human subjects research,
Academic Medicine: Journal Of The Association Of American Medical Colleges, Volume 78, Issue 2, Pages 225-236 (February 2003)

Law No. 503 of 24 June 1992 on the scientific ethics committee system and the examination of biomedical research projects. (Lovtidende, 1992, Part A, 26 June 1992, No. 84, pp. 2017-2020),
International Digest Of Health Legislation, Volume 43, Issue 4, Page Unknown (1992)
Denmark

An act...to establish a program of National Research Service Awards...and to provide for the protection of human subjects involved in biomedical and behavioral research.... Approved 12 Jul 1974,
United States Statutes At Large, Volume 88, 342-354, Pages 2-354 ( 1974)
U.S

Health Research Extension Act of 1985. Public Law 99-158,
United States Statutes At Large, Volume 99, Issue Title IV Sections 1-12, Page Unknown ( 1985)
United States

Federal policy for the protection of human subjects; notice and proposed rules,
Federal Register, Volume 53, Issue 218, Pages 45660-45682 (November 10, 1988)
U.S. Office of Science and Technology Policy

Improved procedures may improve informed consent for neonatal research
J Med Ethics 2004 30: 7.

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Nursing

Ayer, S
Submitting a research proposal for ethical approval,
Professional Nurse (London, England), Volume 9, Issue 12, Pages 805-806 (September 1994)

Buj, A; Solá, R; Artigas, M
Nursing in the ethics committees of clinical research,
Revista De Enfermeria (Barcelona, Spain), Volume 17, Issue 187, Pages 23-25 (March 1994)

Dolan, B
The impact of local research ethics committees on the development of nursing knowledge,
Journal Of Advanced Nursing, Volume 30, Issue 5, Pages 1009-1010 (November 1999)

Gelling, L
Role of the research ethics committee,
Nurse Education Today, Volume 19, Issue 7, Pages 564-569 (October 1999)

Hunt, G
Local research ethics committees and nursing: a critical look,
British Journal Of Nursing (Mark Allen Publishing), Volume 1, Issue 7, Pages 349-351 (July 23 1992-August 13 1992)

Lee, Susan; Kristjanson, Linda
Human research ethics committees: issues in palliative care research,
International Journal Of Palliative Nursing, Volume 9, Issue 1, Pages 13-18 (January 2003)

Madjar, I; Higgins, I
Of ethics committees, protocols, and behaving ethically in the field: a case study of research with elderly residents in a nursing home,
Nursing Inquiry, Volume 3, Issue 3, Pages 130-137 (September 1996)

Oberst, M T
Another look at informed consent,
Nursing Outlook, Volume 33, Issue 6, Pages 294-295 (November - December 1985)

Moore, L; Miller, M.
Initiating research with doubly vulnerable populations
Journal of Advanced Medicine, Volume 30, Issue 5, Page 1035 (1999)

Redman, B K
Responsibility of healthcare ethics committees toward nurses,
HEC Forum: An Interdisciplinary Journal On Hospitals' Ethical And Legal Issues, Volume 8, Issue 1, Pages 52-60 (January 1996)

Redsell, S A; Cheater, F M
The Data Protection Act (1998): implications for health researchers,
Journal Of Advanced Nursing, Volume 35, Issue 4, Pages 508-513 (August 2001)

Tod, A M; Nicolson, P; Allmark, P
Ethical review of health service research in the UK: implications for nursing,
Journal Of Advanced Nursing, Volume 40, Issue 4, Pages 379-386 (November 2002)

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Pharmaceutical

Baños, J E; Farré, M
Clinical pharmacologists and clinical research ethics committees,
Medicina Clinica, Volume 104, Issue 19, Pages 757-758 (May 20, 1995)

Gray, N; Womack, C; Jack, S J
Supplying commercial biomedical companies from a human tissue bank in an NHS hospital--a view from personal experience,
Journal Of Clinical Pathology, Volume 52, Issue 4, Pages 254-256 (April 1999)

Hole, O P; Winther, F O; Straume, B
Clinical research: the influence of the pharmaceutical industry,
European Journal Of Clinical Pharmacology, Volume 56, Issue 11, Pages 851-853 (January - February 2001)

Keating, Bernard
Research ethics and the use of the placebo: the state of the debate,
Medicine Sciences: M/S, Volume 20, Issue 1, Pages 118-125 (January 2004)

Rodríguez-Villanueva, Julio; Alsar, M Jesús; Avendaño, Cristina; Gómez-Piqueras, Cristina; García-Alonso, Fernando
Pharmacogenetic studies: evaluation guidelines for research ethics committees. Study protocol and patient information sheet (II),
Medicina Clinica, Volume 120, Issue 3, Pages 101-107 (February 1, 2003)

Rodríguez-Villanueva, Julio; Alsar, M Jesús; Avendaño, Cristina; Gómez-Piqueras, Cristina; García-Alonso, Fernando
Pharmacogenetic studies: evaluation guidelines for research ethics committees. Scientific background and legal framework (I),
Medicina Clinica, Volume 120, Issue 2, Pages 63-67 (January 25, 2003)

Winther, F O; Hole, O P
Scientific quality of clinical research. An analysis of 40 research projects in pharmacology/pharmacotherapy,
European Journal Of Clinical Pharmacology, Volume 51, Issue 5, Pages 351-354 ( 1997)

Wise, P; Drury, M
Pharmaceutical trials in general practice: the first 100 protocols. An audit by the clinical research ethics committee of the Royal College of General Practitioners,
BMJ (Clinical Research Ed.), Volume 313, Issue 7067, Pages 1245-1248 (November 16, 1996)

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Research Ethics

Aarons, D
Research ethics,
The West Indian Medical Journal, Volume 44, Issue 4, Pages 115-118 (December 1995)

Abbott, A
Stem-cell research delayed by German ethics council,
Nature, Volume 411, Issue 6840, Page 875 (June 21, 2001)

Appelbaum, Paul S
Examining the ethics of human subjects research,
Kennedy Institute Of Ethics Journal, Volume 6, Issue 3, Pages 283-287 (September 1996)

Arcus KD. Kessel AS.
Are ethical principles relative to time and place? A Star Wars perspective on the Alder Hey affair (UK)
BMJ. 325(7378):1493-5, 2002 Dec 21.

Ayer, S
Submitting a research proposal for ethical approval,
Professional Nurse (London, England), Volume 9, Issue 12, Pages 805-806 (September 1994)

Benatar, S R
Reflections and recommendations on research ethics in developing countries,
Social Science & Medicine (1982), Volume 54, Issue 7, Pages 1131-1141 (April 2002)

Bohannon J.
Medical research. UK researchers hope for clarity in tissue use
Science. 298(5600):1867-9, 2002 Dec 6.

Boyd, Kenneth
The Council of Europe's first Symposium on Bioethics: Strasbourg, Dec 5-7 1989,
Journal Of Medical Ethics, Volume 16, Issue 2, Pages 97-98 (June 1990)

Braunack-Mayer, A; Rogers, W
Handling information ethically. Some strategies for discussion,
Australian Family Physician, Volume 29, Issue 10, Pages 1005-1008 (October 2000)

Bravender-Coyle, P
Medical experiments and the new law: in vitro fertilisation procedures, embryo experimentation and the law,
Law Institute Journal: The Official Organ Of The Law Institute Of Victoria, Volume 59, Issue 1-2, Pages 63-67 (January - February 1985)

British Medical Association
Annual report of Council, 1985-1986: medical ethics,
BMJ (Clinical Research Ed.), Volume 292, Issue 6524, Supplement, Pages 25-27 (March 29, 1986)

Bro Taf Local Research Ethics Committee
Research on patients unable to give informed consent,
Bulletin Of Medical Ethics, Volume No. 150, Pages 6-7 (August 1999)

Brody, Baruch A.
The Ethics of Biomedical Research: An International Perspective.
New York: Oxford University Press, 1998

Bross, W.
Ethical issues--clinical research.
Ala Nurse. 2004 Dec-2005 Feb;31(4):21

Brunger, Fern; Weijer, Charles
The forum. The importance of context in international research,
Ethics & Behavior, Volume 12, Issue 4, Pages 371-372, 384-387 (2002)

Burgermeister, Jane
New EU trials database is critised for lack of openness
British Medical Journal 2004;328:1094

Califf, Robert M; Morse, Michael A; Wittes, Janet; Goodman, Steven N; Nelson, Daniel K; DeMets, David L; Iafrate, R Peter; Sugarman, Jeremy
Toward protecting the safety of participants in clinical trials,
Controlled Clinical Trials, Volume 24, Issue 3, Pages 256-271 (June 2003)

Coker, R; McKee, M
Ethical approval for health research in central and eastern Europe: an international survey,
Clinical Medicine (London, England), Volume 1, Issue 3, Pages 197-199 (May - June 2001)

Committee for the Oversight of Research Involving the Dead.
Policy for research involving the dead. (US)
Critical Care Medicine. 31(5 Suppl):S391-3, 2003 May.

Connell, P H; Christie, D J; May, W W
Volunteers at risk,
Journal Of Medical Ethics, Volume 2, Issue 2, Pages 87-92 (June 1976)

Cooper, J
The law and ethics of the use of experimental medication in patients incapable of expressing consent: between a rock and a hard place,
Medicine And Law, Volume 19, Issue 2, Pages 189-195 ( 2000)

Coughlin, M D; Watts, J
A descriptive study of healthcare ethics consultants in Canada: results of a national survey,
HEC Forum: An Interdisciplinary Journal On Hospitals' Ethical And Legal Issues, Volume 5, Issue 3, Pages 144-164 (May 1993)

Council of Europe
Ethical Eye- Biomedical Research
Council of Europe Publications (Strasbourg: 2004)

Couzin, Jennifer
Human subjects. Crossing a frontier: research on the dead,
Science, Volume 299, Issue 5603, Pages 29-30 (January 3, 2003)

Crosby, Sondra; Grodin, Michael A
The forum. The challenges of cross-cultural research in the international setting,
Ethics & Behavior, Volume 12, Issue 4, Pages 371-372, 376-378 ( 2002)

Daugherty, C K
Impact of therapeutic research on informed consent and the ethics of clinical trials: a medical oncology perspective,
Journal Of Clinical Oncology: Official Journal Of The American Society Of Clinical Oncology, Volume 17, Issue 5, Pages 1601-1617 (May 1999)

DeVita MA. Wicclair M. Swanson D. Valenta C. Schold C.
Research involving the newly dead: an institutional response. [Review] (US)
Critical Care Medicine. 31(5 Suppl):S385-90, 2003 May

Diniz, Debora; Guilhem, Dirce Bellezi; Garrafa, Volnei
Biothics in Brazil,
Bioethics, Volume 13, Issue 3-4, Pages 244-248 (July 1999)

Donaldson SK.
Research: Altruistic service in research
Journal of Professional Nursing. 19(2):58, 2003 Mar-Apr.

Easterbrook, P J; Matthews, D R
Fate of research studies,
Journal Of The Royal Society Of Medicine, Volume 85, Issue 2, Pages 71-76 (February 1992)

Easterbrook, P J; Berlin, J A; Gopalan, R; Matthews, D R
Publication bias in clinical research,
Lancet, Volume 337, Issue 8746, Pages 867-872 (April 13, 1991)

Farnell SM
Reflections of an ethicist: research ethics committees and the investigator--a healthy partnership?
Medical & Pediatric Oncology. 41(1):67-8, 2003 Jul

Field MJ, Behrman RE
Responsible research involving children.
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Research ethics committees: principles and proposals,
Health Bulletin, Volume 53, Issue 5, Pages 243-248 (September 1995)

McNeill, P M; Berglund, C A; Webster, I W
Do Australian researchers accept committee review and conduct ethical research?,
Social Science & Medicine (1982), Volume 35, Issue 3, Pages 317-322 (August 1992)

Macer, DRJ.
Delays in Implementing the Lessons from Empirical Studies on Bioethics to Ethics Committees in Asia.
Notizie di Politeia (67): 25-39, 2002.

Macpherson, C C
Research ethics committee: getting started,
The West Indian Medical Journal, Volume 50, Issue 3, Pages 186-188 (September 2001)

Macpherson, C C
Ethics committees. Research ethics: beyond the guidelines,
Developing World Bioeth, Volume 1, Issue 1, Pages 57-68 (May 2001)

Macpherson, C C
Research ethics committees: a regional approach,
Theoretical Medicine And Bioethics, Volume 20, Issue 2, Pages 161-179 (April 1999)

Magill, G.
Ethics Committess and Ethics Consultations for Catholic Health Care in the United States.
In Ethics Committees in Central and Eastern Europe. J. Glasa. Strasbourg, Council of Europe (2000).

Mander, Tristan
The legal standing of local research ethics committees,
Medical Law International, Volume 2, Issue 2, Pages 149-168 (1996)

Mann, Howard
Research ethics committees and public dissemination of clinical trial results,
Lancet, Volume 360, Issue 9330, Pages 406-408 (August 3, 2002)

Maric, J. and Tiosavljeivc, D.
Ethics Committees in Yugoslavia.
In Ethics Committees in Central and Eastern Europe. J. Glasa. Strasbourg, Council of Europe (2000).

Marshall, Tim; Moodie, Peter
Research ethics committees revisited,
BMJ (Clinical Research Ed.), Volume 299, Issue 6713, Pages 1419-1420 (December 9, 1989)

Marshall, Tim; Moodie, Peter
Scrutinising research ethics committees,
BMJ (Clinical Research Ed.), Volume 297, Issue 6651, Page 753 (September 24, 1988)

Martin IR.
Ethics committees and research (New Zealand)
New Zealand Medical Journal. 115(1146):24-5, 2002 Jan 25.

Martini, Nello; Tomino, Carlo; Liberati, Alessandro
Role of a research ethics committee in follow-up and publication of results,
Lancet, Volume 361, Issue 9376, Page 2246 (June 28, 2003)

Miya, P A; Pinch, W J; Holleman, W; Chappell, C
Point and counterpoint. Should academic ethics committees be available to review lapses in scientific integrity?,
HEC Forum: An Interdisciplinary Journal On Hospitals' Ethical And Legal Issues, Volume 5, Issue 1, Pages 44-51 (January 1993)

Negrutiu, F.
Ethics Committees in Romania.
In Ethics Committees in Central and Eastern Europe. J. Glasa. Strasbourg, Council of Europe (2000).

Nevill M.
Ethics committee approval.[comment].
Journal of Sports Sciences. 20(12):949, 2002 Dec.

Nicholl, Jon
The ethics of research ethics committees,
BMJ (Clinical Research Ed.), Volume 320, Issue 7243, Page 1217 (April 29, 2000)

Nightingale, Stuart L
Research and ethics committees,
Lancet, Volume 1, Issue 8338, Page 1389 (June 18, 1983)

Nott, P N; Steel, E A
Scrutinising research ethics committees,
BMJ (Clinical Research Ed.), Volume 297, Issue 6659, Page 1333 (November 19, 1988)

Olofsson, B O; Lynöe, N; Mjörndal, T
Unnecessary work of the research ethics committees? A lot of work is done with studies which are never to be published,
Lakartidningen, Volume 97, Issue 16, Pages 1974-1976 (April 19, 2000)

Pfeiffer, G; Tiedemann, I K
Medical research and ethics committees,
Medizinische Klinik (Munich, Germany: 1983), Volume 84, Issue 11, Pages 557-561 (November 15, 1989)

Pich J. Carne X. Arnaiz JA. Gomez B. Trilla A. Rodes J.
Role of a research ethics committee in follow-up and publication of results. [comment] (Spain).
Lancet. 361(9362):1015-6, 2003 Mar 22.

Pickworth, Emma; Brazier, Margaret
Fees and research ethics committees,
Bulletin Of Medical Ethics, Volume No. 151, Pages 18-20 (October 1999)

Pierce, E
Are research ethics committees behaving unethically? Committees are now being expected to do everything,
BMJ (Clinical Research Ed.), Volume 314, Issue 7081, Page 676 (March 1, 1997)

Redman, B K
Responsibility of healthcare ethics committees toward nurses,
HEC Forum: An Interdisciplinary Journal On Hospitals' Ethical And Legal Issues, Volume 8, Issue 1, Pages 52-60 (January 1996)

Redshaw, M E; Harris, A; Baum, J D
Research ethics committee audit: differences between committees,
Journal Of Medical Ethics, Volume 22, Issue 2, Pages 78-82 (April 1996)

Robles, P H
Evaluation of healthcare ethics committees: the experience of an HEC in Spain,
HEC Forum: An Interdisciplinary Journal On Hospitals' Ethical And Legal Issues, Volume 11, Issue 3, Pages 263-276 (September 1999)

Rodríguez-Villanueva, Julio; Alsar, M Jesús; Avendaño, Cristina; Gómez-Piqueras, Cristina; García-Alonso, Fernando
Pharmacogenetic studies: evaluation guidelines for research ethics committees. Study protocol and patient information sheet (II),
Medicina Clinica, Volume 120, Issue 3, Pages 101-107 (February 1, 2003)

Rodríguez-Villanueva, Julio; Alsar, M Jesús; Avendaño, Cristina; Gómez-Piqueras, Cristina; García-Alonso, Fernando
Pharmacogenetic studies: evaluation guidelines for research ethics committees. Scientific background and legal framework (I),
Medicina Clinica, Volume 120, Issue 2, Pages 63-67 (January 25, 2003)

Rudze, L.
Ethics Committees in Latvia.
In Ethics Committees in Central and Eastern Europe. J. Glasa. Strasbourg, Council of Europe (2000).

Sabatier, S.
Comparative study on National Ethics Committees and Similar Bodies.
In Ethics Committees in Central and Eastern Europe. J. Glasa. Strasbourg, Council of Europe. (2000).

Saunders, John
Research ethics committees--time for change?,
Clinical Medicine (London, England), Volume 2, Issue 6, Pages 534-538 (November - December 2002)

Savulescu, J; Chalmers, I; Blunt, J
Are research ethics committees behaving unethically? Some suggestions for improving performance and accountability,
BMJ (Clinical Research Ed.), Volume 313, Issue 7069, Pages 1390-1393 (November 30, 1996)

Shah, Seema; Whittle, Amy; Wilfond, Benjamin; Gensler, Gary; Wendler, David
How do institutional review boards apply the federal risk and benefit standards for pediatric research?,
JAMA: The Journal Of The American Medical Association, Volume 291, Issue 4, Pages 476-482 (January 28, 2004)

Simek, J.
Responsibility of Scientists, Researchers and the Society, Role of Ethics Committees.
In Ethics Committees in Central and Eastern Europe. J. Glasa. Strasbourg, Council of Europe (2000).

Simek, J., Silhanová, J. and Vrbatová, I.
Ethics Committees in the Czech Republic.
In Ethics Committees in Central and Eastern Europe. J. Glasa. Strasbourg, Council of Europe. (2000).

Slowther, A., Hope T and Ashcroft A.
Clinical Ethics Committees: a worldwide development.
Journal of Medical Ethics 27(suppl. 1), 2001

Soteriou, Tony
Commentary: View from the research and development office
BMJ 2004;329:281-282

Spustová, V.
Good clinical practice and ethics committee.
In Ethics Committees in Central and Eastern Europe. J. Glasa. Strasbourg, Council of Europe (2000).

Suñe-Martin, P; Montoro-Ronsano, J B
Role of a research ethics committee in follow-up and publication of results,
Lancet, Volume 361, Issue 9376, Pages 2245-2246 (June 28, 2003)

Takala, T. and Hayry, M
Ethics Committees in Finland: their levels, methods and point
Notizie di Politeia (67): 60-64, 2002.

Tikk, A. and Parve, V.
Ethics Committees in Estonia.
In Ethics Committees in Central and Eastern Europe. J. Glasa. Strasbourg, Council of Europe (2000).

Tischenko, P. and Yudin, B.
Ethics Committees in the Russian Federation.
In Ethics Committees in Central and Eastern Europe. J. Glasa. Strasbourg, Council of Europe (2000).

Tomlinson, J
Are research ethics committees behaving unethically? Committee would not consider application before payment of 100 pounds,
BMJ (Clinical Research Ed.), Volume 314, Issue 7081, Page 676 (March 1, 1997)

Tripp, J H; Dunstan, G
Why do research ethics committees disagree?,
Journal Of The Royal College Of Physicians Of London, Volume 29, Issue 5, Pages 410-411 (September - October 1995)

Trontelj, J.
Ethics Committees in Slovenia.
In Ethics Committees in Central and Eastern Europe. J. Glasa. Strasbourg, Council of Europe (2000).

Tschudin, V.
European Experiences of Constitutional Ethics Committees
(Lecture Given at Workshop-conference on Ethics Committees, School of Nursing, University of Chile, Santiago, Chile, 24 July 2000)
International Centre for Nursing Ethics

Vallvé, C
Good clinical practices and the Pandora's box (I). Clinical research ethics committees,
Medicina Clinica, Volume 107, Issue 17, Pages 657-659 (November 16, 1996)

Van Essen, Gabrielle L; Story, David A; Poustie, Stephanie J; Griffiths, Max M J; Marwood, Cynthia L
Natural justice and human research ethics committees: an Australia-wide survey,
The Medical Journal Of Australia, Volume 180, Issue 2, Pages 63-66 (January 19, 2004)

Vollmann, J
Do ethics committees hinder progress in medicine?,
Medizinische Klinik (Munich, Germany: 1983), Volume 96, Issue 9, Pages 563-566 (September 15, 2001)

Wald, David S
Bureaucracy of ethics applications
BMJ 2004;329:282-284

Winther, F O
The research ethics committees,
Tidsskrift For Den Norske Laegeforening, Volume 112, Issue 16, Pages 2049-2050 (June 20, 1992)

Wise, P; Drury, M
Pharmaceutical trials in general practice: the first 100 protocols. An audit by the clinical research ethics committee of the Royal College of General Practitioners,
BMJ (Clinical Research Ed.), Volume 313, Issue 7067, Pages 1245-1248 (November 16, 1996)

Wiseman, T W
Rights involve responsibilities for patients. Research ethics committees will approve any protocol unless there are good reasons not to,
BMJ (Clinical Research Ed.), Volume 323, Issue 7304, Pages 108-109 (July 14, 2001)

Law No. 503 of 24 June 1992 on the scientific ethics committee system and the examination of biomedical research projects. (Lovtidende, 1992, Part A, 26 June 1992, No. 84, pp. 2017-2020),
International Digest Of Health Legislation, Volume 43, Issue 4, Page Unknown (1992)
Denmark

Research ethics committees,
BMJ (Clinical Research Ed.), Volume 300, Issue 6721, Pages 395-396 (February 10, 1990)

Research ethics committees,
BMJ (Clinical Research Ed.), Volume 300, Issue 6724, Pages 607-608 (March 3, 1990)

Research ethics committees,
BMJ (Clinical Research Ed.), Volume 300, Issue 6729, Page 943 (April 7, 1990)

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RECs: National

Alderson, Priscilla
A national research ethics committee?,
Bulletin Of Medical Ethics, Volume No. 107, Pages 13-16 (April 1995)

Ales, JE
The situation of clinical trials in Spain - 2001
Investigacion Clinica y Bioetica 360: 21-24

Halila, Ritva
The role of national ethics commissions in Finland,
Bioethics, Volume 17, Issue 4, Pages 357-368 (August 2003)

Ramsay, Sarah
National body unites UK ethics committees,
Lancet, Volume 353, Issue 9157, Page 993 (March 20, 1999)

Riis, Povl
What a national research ethics committee does,
Bulletin Of Medical Ethics, Volume No. 84, Pages 13-16 (December 1992)

White, G B
The work of the National Advisory Board on Ethics in Reproduction,
Nursing Connections, Volume 7, Issue 3, Pages 38-41 (Fall 1994)

Wise, Jacqui
Royal College calls for central research ethics committee,
BMJ (Clinical Research Ed.), Volume 313, Issue 7052, Page 251 (August 3, 1996)

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RECs: Institutional Review Boards

Bergkamp, Lucas
American IRBs and Dutch research ethics committees: how they compare,
IRB; a Review Of Human Subjects Research, Volume 10, Issue 5, Pages 1-6 (September - October 1988)

Brown, JHU; Schoenfeld, Lawrence S; Allan, Patricia W
The philosophy of an institutional review board for the protection of human subjects,
Journal Of Medical Genetics, Volume 55, Issue 1, Pages 67-69 (January 1980)

Campbell, Eric G; Weissman, Joel S; Clarridge, Brian; Yucel, Recai; Causino, Nancyanne; Blumenthal, David
Characteristics of medical school faculty members serving on institutional review boards: results of a national survey,
Academic Medicine: Journal Of The Association Of American Medical Colleges, Volume 78, Issue 8, Pages 831-836 (August 2003)

Caplan, Arthur L
Random-sampling: a modest proposal for reforming IRB review,
IRB; a Review Of Human Subjects Research, Volume 4, Issue 6, Page 8 (June - July 1982)

Cleary, Robert E
The impact of IRBs on political science research,
IRB; a Review Of Human Subjects Research, Volume 9, Issue 3, Pages 6-10 (May - June 1987)

Davis, A J
Ethical issues: a survey of institutional review boards,
Western Journal Of Nursing Research, Volume 2, Issue 2, Pages 536-538 (Spring 1980)

Goldner, J.
Institutional Review Boards and Hospital Ethics Committees in the United States.
In Ethics Committees in Central and Eastern Europe. J. Glasa. Strasbourg, Council of Europe (2000).

Hilgartner, Stephen
Research fraud, misconduct, and the IRB,
IRB; a Review Of Human Subjects Research, Volume 12, Issue 1, Pages 1-4 (January - February 1990)

Hogue, L L
Institutional review boards and consumer surveys,
American Journal Of Public Health, Volume 69, Issue 7, Pages 649-650 (July 1979)

Kallgren, Carl A; Tauber, Robert T
Undergraduate research and the institutional review board: a mismatch or happy marriage?,
Teaching Of Psychology (Columbia, Mo.), Volume 23, Issue 1, Pages 20-25 (February 1996)

Kelley, Susan Douglas
The forum. A contextualized approach to IRB review for collaborative international research,
Ethics & Behavior, Volume 12, Issue 4, Pages 371-376 ( 2002)

Levine, Murray; Lathrop, Vallory G
IRB review as a "cooling out" device,
IRB; a Review Of Human Subjects Research, Volume 5, Issue 4, Pages 8-10 (July - August 1983)

Martin, Douglas K; Meslin, Eric M; Kohut, Nitsa; Singer, Peter A
The incommensurability of research risks and benefits: practical help for research ethics committees,
IRB; a Review Of Human Subjects Research, Volume 17, Issue 2, Pages 8-10 (March - April 1995)

Maloney, Dennis M
Law would remove ability of institutional review boards to waive written consent,
Human Research Report, Volume 11, Issue 8, Pages 1-2 (August 1996)

Maloney DM.
IRBs, data sharing, and privacy of human subjects.
Human Research Report. 17(4):3, 2002 Apr.

Maloney DM
Institutional review boards and approval of new products without human subjects research.
Human Research Report. 17(7):1-2, 2002 Jul.

Maloney DM
IRBs and institutional conflict of interest.
Human Research Report. 17(11):3, 2002 Nov.

Reynolds, D
Protecting the human subjects of social science research--the role of institutional review boards,
Bioethics Forum, Volume 16, Issue 4, Pages 31-36 (Winter 2000)

Rosnow, R L; Rotheram-Borus, M J; Ceci, S J; Blanck, P D; Koocher, G P
The institutional review board as a mirror of scientific and ethical standards,
The American Psychologist, Volume 48, Issue 7, Pages 821-826 (July 1993)

Scher, Stephen R
IRBs and the falsification of research data,
IRB; a Review Of Human Subjects Research, Volume 3, Issue 7, Page 8 (August - September 1981)

Schreier, B A; Stadler, H A
Perspectives of research participants, psychologist investigators, and institutional review boards,
Perceptual And Motor Skills, Volume 74, Issue 3, Part 2, Pages 1067-1072 (June 1992)

Segota, I.
The first Bioethics Committees in Croatia
HEC Forum: An Interdisciplinary Journal on Hospitals' Ethical and Legal Issues, Vol. 11, issue 3, p. 258.

Sengupta, Sohini; Lo, Bernard
The roles and experiences of nonaffiliated and non-scientist members of institutional review boards,
Academic Medicine: Journal Of The Association Of American Medical Colleges, Volume 78, Issue 2, Pages 212-218 (February 2003)

Serbaroli F.
Clinical trials: a medical Catch-22. Researchers, institution boards must take appropriate steps to protect participants (US).
Modern Healthcare. 32(41):23, 2002 Oct 14.

Sieber, Joan E; Baluyot, Reuel M
A survey of IRB concerns about social and behavioral research,
IRB; a Review Of Human Subjects Research, Volume 14, Issue 2, Pages 9-10 (March - April 1992)

Stages of institutional review board activities,
Journal Of Korean Medical Science, Volume 18, Issue 1, Pages 1-2 (February 2003)

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RECs: Multi-centre

Alberti, K G
Multicentre research ethics committees: has the cure been worse than the disease? No, but idiosyncracies and obstructions to good research must be removed,
BMJ (Clinical Research Ed.), Volume 320, Issue 7243, Pages 1157-1158 (April 29, 2000)

Alexander, J I
Multicentre research ethics committees,
Journal Of The Royal Society Of Medicine, Volume 92, Issue 12, Page 662 (December 1999)

al-Shahi, R; Warlow, C P
Ethical review of a multicentre study in Scotland: a weighty problem,
Journal Of The Royal College Of Physicians Of London, Volume 33, Issue 6, Pages 549-552 (November - December 1999)

Benster, R; Pollock, A M
Guidelines for local research ethics committees: distinguishing between patient and population research in the Multicentre Research Project,
Public Health, Volume 107, Issue 1, Pages 3-7 (January 1993)

Boyce, Malcolm; London multicentre research ethics committee 1997-2000
Observational study of 353 applications to London multicentre research ethics committee 1997-2000,
BMJ (Clinical Research Ed.), Volume 325, Issue 7372, Page 1081 (November 9, 2002)

Burman, William; Breese, Peter; Weis, Stephen; Bock, Naomi; Bernardo, John; Vernon, Andrew; Tuberculosis Trials Consortium
The effects of local review on informed consent documents from a multicenter clinical trials consortium,
Controlled Clinical Trials, Volume 24, Issue 3, Pages 245-255 (June 2003)

Dear, R P
Local research ethics committees and multicentre drug trials,
BMJ (Clinical Research Ed.), Volume 310, Issue 6981, Page 735 (March 18, 1995)

Dunn, N R; Arscott, A; Mann, R D
Costs of seeking ethics approval before and after the introduction of multicentre research ethics committees,
Journal Of The Royal Society Of Medicine, Volume 93, Issue 10, Pages 511-512 (October 2000)

Larcombe, I; Mott, M
Multicentre research ethics committees: have they helped?,
Journal Of The Royal Society Of Medicine, Volume 92, Issue 10, Pages 500-501 (October 1999)

Responses of local research ethics committees to a study with approval from a multicentre research ethics committee,
BMJ (Clinical Research Ed.), Volume 320, Issue 7243, Pages 1182-1183 (April 29, 2000)

Tully, J; Ninis, N; Booy, R; Viner, R
The new system of review by multicentre research ethics committees: prospective study,
BMJ (Clinical Research Ed.), Volume 320, Issue 7243, Pages 1179-1182 (April 29, 2000)


Lewis, J C; Tomkins, S; Sampson, J R
Ethical approval for research involving geographically dispersed subjects: unsuitability of the UK MREC/LREC system and relevance to uncommon genetic disorders,
Journal Of Medical Ethics, Volume 27, Issue 5, Pages 347-351 (October 2001)

While, A E
Research ethics committees at work: the experience of one multi-location study,
Journal Of Medical Ethics, Volume 22, Issue 6, Pages 352-355 (December 1996)

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RECs: Hospital

Bignamini, A.
Hospital Ethics Committees - A European Perspective.
In Ethics Committees in Central and Eastern Europe. J. Glasa. Strasbourg, Council of Europe (2000).

Delfosse, M-L and Lebeer, G
L'éthique clinique à l'hôpital: quelques questions
in "Ethica Clinica", 1999, pp. 24-29.

Goldner, J.
Institutional Review Boards and Hospital Ethics Committees in the United States.
In Ethics Committees in Central and Eastern Europe. J. Glasa. Strasbourg, Council of Europe (2000).

Jean, A; Paré, S; Parizeau, M H
Hospital ethics committees in Quebec: an overview,
HEC Forum: An Interdisciplinary Journal On Hospitals' Ethical And Legal Issues, Volume 3, Issue 6, Pages 339-346 ( 1991)

Kluge, E H
The roles and functions of hospital-based ethics committees,
CMAJ: Canadian Medical Association Journal = Journal De l'Association Medicale Canadienne, Volume 154, Issue 7, Pages 1094-1095 (April 1, 1996)

Lebeer, G (ed.)
Ethical Function in Hospital Ethics Committees,
Amsterdam/Berlin/Oxford, IOS Press, 2002.

Lippert, H.-D.
Legal Aspects of the Establishment of Hospital Ethics Committees.
In Ethics Committees in Central and Eastern Europe. J. Glasa. Strasbourg, Council of Europe (2000).

Sugarman, J
Should hospital ethics committees do research?,
The Journal Of Clinical Ethics, Volume 5, Issue 2, Pages 121-125 (Summer 1994)

Thévoz, J M
Research and hospital ethics committees in Switzerland,
HEC Forum: An Interdisciplinary Journal On Hospitals' Ethical And Legal Issues, Volume 4, Issue 1, Pages 41-47 ( 1992)

Viafora, C.
Ethical Function in Hospital Ethics Committees: Personality and Ambiguities.
In Ethics Committees in Central and Eastern Europe. J. Glasa. Strasbourg, Council of Europe (2000).

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RECs: Local

Ahmed, A H; Nicholson, K G
Delays and diversity in the practice of local research ethics committees,
Journal Of Medical Ethics, Volume 22, Issue 5, Pages 263-266 (October 1996)

Beyleveld, D. and Longley, D.
Informing Potential Participants of Local Research Ethics Committee Approval of Research Protocols.
Medical Law International 3: 209-222, 1998

Black, M; Leese, B; Gosden, T
Local research ethics committees. Differences in application process cause problems,
BMJ (Clinical Research Ed.), Volume 311, Issue 7019, Page 1572 (December 9, 1995)

Burman, William; Breese, Peter; Weis, Stephen; Bock, Naomi; Bernardo, John; Vernon, Andrew; Tuberculosis Trials Consortium
The effects of local review on informed consent documents from a multicenter clinical trials consortium,
Controlled Clinical Trials, Volume 24, Issue 3, Pages 245-255 (June 2003)

Clein, P
Local research ethics committees in the UK,
Palliative Medicine, Volume 11, Issue 1, Pages 55-56 (January 1997)

Dear, R P
Local research ethics committees and multicentre drug trials,
BMJ (Clinical Research Ed.), Volume 310, Issue 6981, Page 735 (March 18, 1995)

Dolan, B
The impact of local research ethics committees on the development of nursing knowledge,
Journal Of Advanced Nursing, Volume 30, Issue 5, Pages 1009-1010 (November 1999)

Dudley, H
Local research ethics committees. Attitude of their members is the critical factor,
BMJ (Clinical Research Ed.), Volume 311, Issue 7019, Page 1571 (December 9, 1995)

Ferguson, P
Do researchers feel an LREC hinders research?,
Bulletin Of Medical Ethics, Issue 165, Pages 17-19 (February 2001)

Foster, C G; Marshall, T; Moodie, P
The annual reports of Local Research Ethics Committees,
Journal Of Medical Ethics, Volume 21, Issue 4, Pages 214-219 (August 1995)

Godfrey, E; Wray, E; Nicholson, R
Another look at LREC annual reports,
Bulletin Of Medical Ethics, Issue 171, Pages 13-21 (September 2001)

Hahn, S; Williamson, P R; Hutton, J L
Investigation of within-study selective reporting in clinical research: follow-up of applications submitted to a local research ethics committee,
Journal Of Evaluation In Clinical Practice, Volume 8, Issue 3, Pages 353-359 (August 2002)

Harries, U J; Fentem, P H; Tuxworth, W; Hoinville, G W
Local research ethics committees. Widely differing responses to a national survey protocol,
Journal Of The Royal College Of Physicians Of London, Volume 28, Issue 2, Pages 150-154 (March - April 1994)

Horner, J S
Criteria for decision making in local research (ethics) committees,
Public Health, Volume 107, Issue 6, Pages 403-411 (November 1993)

Hunt, G
Local research ethics committees and nursing: a critical look,
British Journal Of Nursing (Mark Allen Publishing), Volume 1, Issue 7, Pages 349-351 (July 23 1992-August 13 1992)

Jenkins, G C
Local research ethics committees. Problems of students must not be ignored,
BMJ (Clinical Research Ed.), Volume 311, Issue 7019, Page 1571 (December 9, 1995)

Kent, G
Responses by four Local Research Ethics Committees to submitted proposals,
Journal Of Medical Ethics, Volume 25, Issue 3, Pages 274-277 (June 1999)

Lewis, J C; Tomkins, S; Sampson, J R
Ethical approval for research involving geographically dispersed subjects: unsuitability of the UK MREC/LREC system and relevance to uncommon genetic disorders,
Journal Of Medical Ethics, Volume 27, Issue 5, Pages 347-351 (October 2001)

Responses of local research ethics committees to a study with approval from a multicentre research ethics committee,
BMJ (Clinical Research Ed.), Volume 320, Issue 7243, Pages 1182-1183 (April 29, 2000)

Moodie, P
The role of local research ethics committees,
BMJ (Clinical Research Ed.), Volume 304, Issue 6835, Pages 1129-1130 (May 2, 1992)

Moodie, P C; Marshall, T
Guidelines for local research ethics committees,
BMJ (Clinical Research Ed.), Volume 304, Issue 6837, Pages 1293-1295 (May 16, 1992)

Moran, J
Local research ethics committees. Report of the 2nd National Conference,
Journal Of The Royal College Of Physicians Of London, Volume 26, Issue 4, Pages 423-431 (October 1992)

Oddens, B J; De Wied, D
Local research ethics committees. Committees should devise special forms for the social sciences,
BMJ (Clinical Research Ed.), Volume 311, Issue 7019, Page 1572 (December 9, 1995)

Penn, Z J; Steer, P J
Local research ethics committees: hindrance or help?,
British Journal Of Obstetrics And Gynaecology, Volume 102, Issue 1, Pages 1-2 (January 1995)

Pickworth, E
Should local research ethics committees monitor research they have approved?,
Journal Of Medical Ethics, Volume 26, Issue 5, Pages 330-333 (October 2000)

Powell, D E
Local research ethics committees: hindrance or help?,
British Journal Of Obstetrics And Gynaecology, Volume 102, Issue 8, Pages 671-672 (August 1995)

Sandhu, J; Okasha, M
Local research ethics committees,
The British Journal Of General Practice: The Journal Of The Royal College Of General Practitioners, Volume 51, Issue 469, Pages 674-675 (August 2001)

Smith, T; Moore, E J; Tunstall-Pedoe, H
Review by a local medical research ethics committee of the conduct of approved research projects, by examination of patients' case notes, consent forms, and research records and by interview,
BMJ (Clinical Research Ed.), Volume 314, Issue 7094, Pages 1588-1590 (May 31, 1997)

Sonneborn, K; Collier, J
Ethics committees. Wandsworth District Research Ethics Committee,
Lancet, Volume 347, Issue 9004, Pages 833-834 (March 23, 1996)

Tunstall-Pedoe, H
Local research ethics committees. Local committees have strengths too,
BMJ (Clinical Research Ed.), Volume 311, Issue 7019, Pages 1570-1571 (December 9, 1995)

Valdez-Martinez, E; Garduño-Espinosa, J; Martinez-Salgado, H; Porter, J D H
Local research ethics committees of the Mexican Institute of Social Security: results of a national survey
Public Health, Volume 118, Issue 5, July 2004, Pages 329-336

Watling, M I; Dewhurst, J K
Local research ethics committees. Central ethics committee might have to face hostile locals,
BMJ (Clinical Research Ed.), Volume 311, Issue 7019, Page 1571 (December 9, 1995)

LREC resigns unanimously,
Bulletin Of Medical Ethics, Volume No. 128, Pages 3-6 (May 1997)

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RECs: Membership

Coughlin, M D; Watts, J
A descriptive study of healthcare ethics consultants in Canada: results of a national survey,
HEC Forum: An Interdisciplinary Journal On Hospitals' Ethical And Legal Issues, Volume 5, Issue 3, Pages 144-164 (May 1993)

De Vries R. Forsberg CP.
Who decides? A look at ethics committee membership. (US)
HEC Forum. 14(3):252-8, 2002 Sep

McNeill, P M; Berglund, C A; Webster, I W
How much influence do various members have within research ethics committees?,
Cambridge Quarterly Of Healthcare Ethics: CQ: The International Journal Of Healthcare Ethics Committees, Volume 3, Issue 4, Pages 522-532 (Fall 1994)

Robinson, K
The layman's role in a research ethics committee,
Journal Of The Royal College Of Physicians Of London, Volume 25, Issue 1, Page 43 (January 1991)

Savulescu, J
Two deaths and two lessons: is it time to review the structure and function of research ethics committees?,
Journal Of Medical Ethics, Volume 28, Issue 1, Pages 1-2 (February 2002)

Shaul, Randi
Reviewing the reviewers: the vague accountability of research ethics committees,
Critical Care (London, England), Volume 6, Issue 2, Pages 121-122 (April 2002)

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Research Participants

Appelbaum, Paul S
Examining the ethics of human subjects research,
Kennedy Institute Of Ethics Journal, Volume 6, Issue 3, Pages 283-287 (September 1996)

Baker, R; Shiels, C; Stevenson, K; Fraser, R; Stone, M
What proportion of patients refuse consent to data collection from their records for research purposes?,
The British Journal Of General Practice: The Journal Of The Royal College Of General Practitioners, Volume 50, Issue 457, Pages 655-656 (August 2000)

Bernstein, Mark
Payment of research subjects involved in clinical trials is unethical,
Journal Of Neuro-Oncology, Volume 63, Issue 3, Pages 223-224 (July 2003)

Boulay, Harvey; Goldstein, Richard; Zisk, Betty; de Sola Pool, Ithiel
Protecting human subjects of research: proposed amendments to HEW policy,
PS, Volume 13, Issue 2, Pages 202-204 (Spring 1980)

Bro Taf Local Research Ethics Committee
Research on patients unable to give informed consent,
Bulletin Of Medical Ethics, Volume No. 150, Pages 6-7 (August 1999)

Brown, JHU; Schoenfeld, Lawrence S; Allan, Patricia W
The philosophy of an institutional review board for the protection of human subjects,
Journal Of Medical Genetics, Volume 55, Issue 1, Pages 67-69 (January 1980)

Califf, Robert M; Morse, Michael A; Wittes, Janet; Goodman, Steven N; Nelson, Daniel K; DeMets, David L; Iafrate, R Peter; Sugarman, Jeremy
Toward protecting the safety of participants in clinical trials,
Controlled Clinical Trials, Volume 24, Issue 3, Pages 256-271 (June 2003)

Cave, E; Holm, S
New governance arrangements for research ethics committees: is facilitating research achieved at the cost of participants' interest,
Journal Of Medical Ethics, Volume 28, Issue 5, Pages 318-321 (October 2002)

Connell, P H; Christie, D J; May, W W
Volunteers at risk,
Journal Of Medical Ethics, Volume 2, Issue 2, Pages 87-92 (June 1976)

Cooper, J
The law and ethics of the use of experimental medication in patients incapable of expressing consent: between a rock and a hard place,
Medicine And Law, Volume 19, Issue 2, Pages 189-195 ( 2000)

Couzin, Jennifer
Human subjects. Crossing a frontier: research on the dead,
Science, Volume 299, Issue 5603, Pages 29-30 (January 3, 2003)

Ferguson, P R
Patients' perceptions of information provided in clinical trials,
Journal Of Medical Ethics, Volume 28, Issue 1, Pages 45-48 (February 2002)

Gill, Dennis
Guidelines for informed consent in biomedical research involving paediatric populations as research participants,
European Journal Of Pediatrics, Volume 162, Issue 7-8, Pages 455-458 (July 2003)

Glass, K C; Freedman, B
Legal liability for injury to research subjects,
Clinical And Investigative Medicine. Medecine Clinique Et Experimentale, Volume 14, Issue 2, Pages 176-180 (April 1991)

T Hope and J McMillan
Challenge studies of human volunteers: ethical issues
J Med Ethics 2004 30: 110-116.

C Kerr, E Robinson, A Stevens, D Braunholtz, S Edwards, and R Lilford
Randomisation in trials: do potential trial participants understand it and find it acceptable?
J Med Ethics 2004 30: 80-84.

S Y H Kim, R W Millard, P Nisbet, C Cox, and E D Caine
Potential research participants' views regarding researcher and institutional financial conflicts of interest
J Med Ethics 2004 30: 73-79

Kompanje, E J; Maas, A I; Dippel, D W
Clinical trials on medical products for human use in the case of acutely incapacitated patients within the fields of neurology and neurosurgery; implications of the new European legislation,
Nederlands Tijdschrift Voor Geneeskunde, Volume 147, Issue 33, Pages 1585-1589 (August 16, 2003)

Levine, Robert J
Proposed regulations for research involving those institutionalized as mentally infirm: a consideration of their relevance in 1995,
Accountability In Research, Volume 4, Issue 3-4, Pages 177-186 ( 1996)

Little, P; Williamson, I
Informed consent in medical research. Ethics committees and BMJ should continue to consider the overall benefit to patients,
BMJ (Clinical Research Ed.), Volume 314, Issue 7092, Page 1478 (May 17, 1997)

Lynöe, N; Welin, S
Time to change the basis for forming of judgements by the research ethics committees? The treatment of persons involved in trials should be scrutinized for scientific quality,
Lakartidningen, Volume 96, Issue 5, Pages 490-492 (February 3, 1999)

Madjar, I; Higgins, I
Of ethics committees, protocols, and behaving ethically in the field: a case study of research with elderly residents in a nursing home,
Nursing Inquiry, Volume 3, Issue 3, Pages 130-137 (September 1996)

Madsen, S M; Holm, S; Davidsen, B; Munkholm, P; Schlichting, P; Riis, P
Ethical aspects of clinical trials: the attitudes of participants in two non-cancer trials,
Journal Of Internal Medicine, Volume 248, Issue 6, Pages 463-474 (December 2000)

Madsen, S; Holm, S; Riis, P
Ethical aspects of clinical trials: the attitudes of the public and out-patients,
Journal Of Internal Medicine, Volume 245, Issue 6, Pages 571-579 (June 1999)

Maloney, Dennis M
Institutional conflicts of interest and research with human subjects,
Human Research Report, Volume 18, Issue 2, Pages 1-2 (February 2003)

Mason, S A; Allmark, P J
Obtaining informed consent to neonatal randomised controlled trials: interviews with parents and clinicians in the Euricon study,
Lancet, Volume 356, Issue 9247, Pages 2045-2051 (December 16, 2000)

Pappworth, M H
"Human guinea pigs"--a history,
BMJ (Clinical Research Ed.), Volume 301, Issue 6766, Pages 1456-1460 (December 22, 1990 - December 29, 1990)

Porter, Joan P
The federal policy for the protection of human subjects,
IRB; a Review Of Human Subjects Research, Volume 13, Issue 5, Pages 8-9 (September - October 1991)

President's Commission for the Protection of Human Subjects of Biomedical and Behavioral Research,
Congressional Record: Proceedings And Debates Of The ... Congress. United States. Congress, Volume 124, Issue 168, Pages H13564-H13566 (October 14, 1978)

President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research,
Congressional Record: Proceedings And Debates Of The ... Congress. United States. Congress, Volume 124, Issue 168, Pages H13571-H13573 (October 14, 1978)

Reiss, D
Freedon of inquiry and subjects' rights: an introduction,
The American Journal Of Psychiatry, Volume 134, Issue 8, Pages 891-892 (August 1977)

Reynolds, D
Protecting the human subjects of social science research--the role of institutional review boards,
Bioethics Forum, Volume 16, Issue 4, Pages 31-36 (Winter 2000)

Rodríguez-Villanueva, Julio; Alsar, M Jesús; Avendaño, Cristina; Gómez-Piqueras, Cristina; García-Alonso, Fernando
Pharmacogenetic studies: evaluation guidelines for research ethics committees. Study protocol and patient information sheet (II),
Medicina Clinica, Volume 120, Issue 3, Pages 101-107 (February 1, 2003)

Schreier, B A; Stadler, H A
Perspectives of research participants, psychologist investigators, and institutional review boards,
Perceptual And Motor Skills, Volume 74, Issue 3, Part 2, Pages 1067-1072 (June 1992)

Schüklenk, U
Protecting the vulnerable: testing times for clinical research ethics,
Social Science & Medicine (1982), Volume 51, Issue 6, Pages 969-977 (September 2000)

Smith, T; Moore, E J; Tunstall-Pedoe, H
Review by a local medical research ethics committee of the conduct of approved research projects, by examination of patients' case notes, consent forms, and research records and by interview,
BMJ (Clinical Research Ed.), Volume 314, Issue 7094, Pages 1588-1590 (May 31, 1997)

Vidal-Martinez, J
The protection of the person in medical research in the Spanish law,
European Journal Of Health Law, Volume 6, Issue 3, Pages 249-264 (September 1999)

Weijer, C
Selecting subjects for participation in clinical research: one sphere of justice,
Journal Of Medical Ethics, Volume 25, Issue 1, Pages 31-36 (February 1999)

Weijer, C
Evolving ethical issues in selection of subjects for clinical research,
Cambridge Quarterly Of Healthcare Ethics: CQ: The International Journal Of Healthcare Ethics Committees, Volume 5, Issue 3, Pages 334-345 (Summer 1996)

Wiseman, T W
Rights involve responsibilities for patients. Research ethics committees will approve any protocol unless there are good reasons not to,
BMJ (Clinical Research Ed.), Volume 323, Issue 7304, Pages 108-109 (July 14, 2001)

AAMC Task Force on Financial Conflicts of Interest in Clinical Research
Protecting subjects, preserving trust, promoting progress I: policy and guidelines for the oversight of individual financial interests in human subjects research,
Academic Medicine: Journal Of The Association Of American Medical Colleges, Volume 78, Issue 2, Pages 225-236 (February 2003)

AAMC Task Force on Financial Conflicts of Interest in Clinical Research
Protecting subjects, preserving trust, promoting progress II: principles and recommendations for oversight of an institution's financial interests in human subjects research,
Academic Medicine: Journal Of The Association Of American Medical Colleges, Volume 78, Issue 2, Pages 237-245 (February 2003)

An act...to establish a program of National Research Service Awards...and to provide for the protection of human subjects involved in biomedical and behavioral research.... Approved 12 Jul 1974,
United States Statutes At Large, Volume 88, 342-354, Pages 2-354 ( 1974)
U.S

Federal policy for the protection of human subjects; notice and proposed rules,
Federal Register, Volume 53, Issue 218, Pages 45660-45682 (November 10, 1988)
U.S. Office of Science and Technology Policy

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Non-clinical Research

Cleary, Robert E
The impact of IRBs on political science research,
IRB; a Review Of Human Subjects Research, Volume 9, Issue 3, Pages 6-10 (May - June 1987)

Gray, Bradford H
Changing federal regulation of IRBs, Part III: social research and the proposed DHEW regulations,
IRB; a Review Of Human Subjects Research, Volume 2, Issue 1, Pages 1-5+ (January 1980)

Mayor, Susan
Squeezing academic research into a commercial straitjacket
British Medical Journal 2004;328:1036

Oddens, B J; De Wied, D
Local research ethics committees. Committees should devise special forms for the social sciences,
BMJ (Clinical Research Ed.), Volume 311, Issue 7019, Page 1572 (December 9, 1995)

Reynolds, D
Protecting the human subjects of social science research--the role of institutional review boards,
Bioethics Forum, Volume 16, Issue 4, Pages 31-36 (Winter 2000)

Robertson, John A
Social experiments and prior ethical review: the Judicial Conference experiment,
IRB; a Review Of Human Subjects Research, Volume 3, Issue 4, Pages 1-3 (April 1981)

Seiler, Lauren H; Veatch, Robert M
Social science research regulations,
The Hastings Center Report, Volume 12, Issue 2, Pages 45-46 (April 1982)

Sieber, Joan E; Baluyot, Reuel M
A survey of IRB concerns about social and behavioral research,
IRB; a Review Of Human Subjects Research, Volume 14, Issue 2, Pages 9-10 (March - April 1992)

Wax, Murray L; Cassell, Joan
From regulation to reflection: ethics in social research,
The American Sociologist, Volume 16, Issue 4, Pages 224-229 (November 1981)

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