Failure to report and provide commentary on research ethics board approval and informed consent in medical journals

Journal of Medical Ethics - Tập 34 Số 10 - Trang 761-764 - 2008
Katherine A. Finlay1, Conrad V. Fernandez2
1Dalhousie University, Halifax, Nova Scotia, Canada.
2Departments of Pediatrics and Bioethics, Dalhousie University and IWK Health Centre, 5850 University Avenue PO Box 9700, Halifax, Nova Scotia, B3K 6R8 Canada

Tóm tắt

Background:The Declaration of Helsinki prohibits the publication of articles that do not meet defined ethical standards for reporting of research ethics board (REB) approval and informed consent. Despite this prohibition and a call to highlight the deficiency for the reader, articles with potential ethical shortcomings continue to be published.Objective:To determine what proportion of articles in major medical journals lack statements confirming REB approval and informed consent, and whether accompanying commentary alerts readers to this deficiency.Design:Retrospective, observational study.Setting:Online review of five major medical journals.Population:All clinical research articles published online between 1 January 2005 and 31 December 2006 in theBMJ,Lancet, Annals of Internal Medicine, JAMAand theNew England Journal of Medicine.Measurements:Statement of REB approval and informed consent.Results:Of 1780 articles reviewed, 1133 (63.7%) met inclusion criteria (manuscripts reporting human subjects, human tissue or identifiable personal data research), 36 (3.2%) articles lacked a statement of REB approval, 62 (5.5%) lacked disclosure of informed consent and 15 (1.3%) articles lacked both. Articles that did not state REB approval were associated with not stating informed consent (p<0.001). There were no editorial comments to alert readers to the lack of either REB approval or informed consent statements associated with any of the deficient articles.Conclusions:Articles that lack explicit statements of REB approval and informed consent are infrequent but continue to be published in major medical journals without editorial statements to alert the reader to this deficiency.

Từ khóa


Tài liệu tham khảo

World Medical Association Declaration of Helsinki . Ethical principles for medical research involving human subjects. 2004. http://www.wma.net/e/policy/b3.htm (accessed 24 Jul 2008).

10.1001/jama.287.21.2835

10.1001/jama.1997.03540350072037

10.1542/peds.110.2.364

10.1136/bmj.323.7308.318

10.1097/00000542-200311000-00030

Smith, 1997, Informed consent: the intricacies., BMJ, 314, 1059, 10.1136/bmj.314.7087.1059

McDonald, 1985, Ethics and editors: when should unethical research be published?, CMAJ, 133, 803

10.1093/intqhc/mzi068

10.1136/bmj.314.7087.1107

Tobias, 1997, BMJ’s present policy (sometimes approving research in which patients have not given fully informed consent) is wholly correct., BMJ, 314, 1111, 10.1136/bmj.314.7087.1111

10.1136/jme.2005.015115

10.1016/j.jaad.2006.08.072

10.1503/cmaj.070310

Thông tin
Thông tin xuất bản

Journal of Medical Ethics

Tập 34 Số 10

761-764

Thông tin tác giả