User talk:Davidruben

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I usually contribute to the en-version of wikipedia as user Davidruben. Please inform me of deletion notifications on my talk page there, not here.

Davidruben 01:31, 18 September 2007 (UTC)[reply]

Data dump[edit]

David,

I'm half way done sifting through PubMed hits for "publication patient consent" that, judging by titles, may be relevant to patient images on Wikimedia Commons. I have to stop now and won't be able to continue before the clipboard expires, so here is a data dump. --Una Smith (talk) 04:11, 30 June 2008 (UTC)[reply]


82: J Health Serv Res Policy. 2003 Jul;8 Suppl 1:S1:12-6.

Privacy and the secondary use of data in health research in Scotland.

Fraser A.

Scottish Executive, St. Andrew's House, Edinburgh, UK.

In response to new data protection legislation for the UK and widespread concern about its implications, the Scottish Executive set up the Confidentiality and Security Advisory Group for Scotland (CSAGS) to place the use of personal health information in a modern setting. The group affirmed the principle of consent and, more broadly, the importance of involving patients and the public in decisions about their health information. It promoted methods of acceptable anonymisation of data, and the need for good stewardship and disclosure of data uses to the greatest extent possible, where explicit individual consent and anonymisation were not practicable. They did not recommend pursuit of legislation, preferring consensus, informed debate and widespread acceptance of the proposed arrangements. The Scottish Executive is now responding to the work of CSAGS to develop systems that command public and patient confidence, promote good practice for clinicians and researchers, and preserve important public health and research functions.

PMID: 12869332 [PubMed - indexed for MEDLINE]

83: J Health Serv Res Policy. 2003 Jul;8 Suppl 1:S1:8-11.

The Patient Information Advisory Group and the use of patient-identifiable data.

Higgins J.

Manchester Centre for Healthcare Management, University of Manchester, UK.

Patient confidentiality has been a matter of concern in the English National Health Service (NHS) for many years. A number of recent events have triggered the demand for a more concerted programme of change to eliminate the use of patient-identifiable data and to devise more acceptable alternatives. The Caldicott Committee, in 1997, set out the case for change and legislation in 1998 (the Data Protection Act and Human Rights Act) and emphasised the need for urgent action. A number of public inquiries into failures of care in the NHS (at Bristol Royal Infirmary and Alder Hey Hospital) pointed to the failure to seek consent as a major issue for the NHS. Whilst accepting the need for change, the Government, in drafting the Health and Social Care Act 2001, allowed for the fact that some organisations and individuals would need time to move towards anonymisation of data (reversible or irreversible) or to obtain patient consent. Under Section 60 of the Act it established the Patient Information Advisory Group (PIAG). PIAG advises government ministers on circumstances in which the continued use of patient-identifiable data should be permitted, as a temporary measure. PIAG faces a number of challenges as it develops its programme of work: how to maintain the pace of change towards anonymisation, how to ensure compliance with the law, how or whether to share information across organisational boundaries in the interests of citizens, how consent should be obtained and how to achieve 'joined up' working across those organisations that are charged with promoting confidentiality and privacy.

PMID: 12869331 [PubMed - indexed for MEDLINE]

84: Nurse Author Ed. 2003 Summer;13(3):7-9.

Respecting patients' rights in manuscripts: confidentiality, informed consent, and IRB approval.

Ohler L.

linda ohler@aol.com

Patients' rights for privacy and confidentiality extend to publications. This author describes how authors, reviewers, and editors can ensure patient confidentiality in manuscripts.

Publication Types: 

   Case Reports

PMID: 12841087 [PubMed - indexed for MEDLINE]

85: J AHIMA. 2001 May;72(5):suppl 64E-64G.

Practice brief. Consent for the use or disclosure of individually identifiable health information.

Hughes G; American Health Information Management Association.

Publication Types: 

   Guideline

PMID: 12793262 [PubMed - indexed for MEDLINE]

86: IRB. 2002 Sep-Oct;24(5):6-8.

The right of subjects to see the protocol.

Veatch RM.

Kennedy Institute of Ethics, Georgetown University, Washington, DC, USA.

PMID: 12737168 [PubMed - indexed for MEDLINE]

87: BMJ. 2003 Feb 15;326(7385):373.

Comment in: 

   BMJ. 2003 May 10;326(7397):1039.

Patients' consent preferences for research uses of information in electronic medical records: interview and survey data.

Willison DJ, Keshavjee K, Nair K, Goldsmith C, Holbrook AM; Computerization of Medical Practices for the Enhancement of Therapeutic Effectiveness investigators.

Centre for Evaluation of Medicines, McMaster University Faculty of Health Sciences, 105 Main Street East, P1, Hamilton, ON, Canada L8N 1G6. willison@mcmaster.ca

OBJECTIVES: To assess patients' preferred method of consent for the use of information from electronic medical records for research. DESIGN: Interviews and a structured survey of patients in practices with electronic medical records. SETTING: Family practices in southern Ontario, Canada. PARTICIPANTS: 123 patients: 17 were interviewed and 106 completed a survey. MAIN OUTCOME MEASURES: Patients' opinions and concerns on use of information from their medical records for research and their preferences for method of consent. RESULTS: Most interviewees were willing to allow the use of their information for research purposes, although the majority preferred that consent was sought first. The seeking of consent was considered an important element of respect for the individual. Most interviewees made little distinction between identifiable and anonymised data. Research sponsored by private insurance firms generated the greatest concern, and research sponsored by foundation the least. Sponsorship by drug companies evoked negative responses during interview and positive responses in the survey. CONCLUSIONS: Patients are willing to allow information from their medical records to be used for research, but most prefer to be asked for consent either verbally or in writing.

Publication Types: 

   Multicenter Study
   Research Support, Non-U.S. Gov't

PMID: 12586673 [PubMed - indexed for MEDLINE]

88: Ann Emerg Med. 2003 Jan;41(1):82-9.

Journal policy on ethics in scientific publication.

Callaham ML.

Medical journals aspire to select, through peer review, the highest quality science, and their reputations depend on the trust of readers, authors, researchers, reviewers, and patients. Almost every aspect of this process involves important ethical principles and decisions, which are seldom explicitly stated and even less often shared with the readership. A comprehensive policy on publication ethics is summarized in this article. A few of the topics addressed are study design; research subject consent; definitions and responsibilities of authorship; declaration of paid writers; types of potential conflicts of interest; management of conflicts of interest on the part of authors, journal reviewers, and members of the editorial board; blinding and confidentiality of peer review; assessment of peer review quality; public identification of degree of peer review of various portions of the journal; criteria for manuscript decisions; management of author appeals; definitions of prior publication; plagiarism; criteria for advertising and relationship between advertising and editorial matter; allegations of misconduct and journal policies for responding to them; and the relationship of the journal to the sponsoring society. Our goal in publishing these policies is to make the guiding ethical principles of this journal accessible to all of our readers and contributors.

Publication Types: 

   Editorial

PMID: 12514687 [PubMed - indexed for MEDLINE]

89: J Health Law. 2002 Summer;35(3):395-402.

Comment in: 

   J Health Law. 2002 Summer;35(3):387-94.

DHHS wisely proposed to remove the "consent" requirement from the HIPAA privacy standards. Department of Health and Human Services.

Rosati K.

The author contends that requiring advance written consent to use and disclose health information interferes with patient care, is unnecessary in view of other rigorous privacy protections, and imposes an unwarranted burden on healthcare providers. Consequently, the author commends DHHS for taking the "practical and apolitical step" of removing this requirement.

PMID: 12472148 [PubMed - indexed for MEDLINE]

90: J Health Law. 2002 Summer;35(3):387-94.

Comment on: 

   J Health Law. 2002 Summer;35(3):395-402.    J Health Law. 2002 Summer;35(3):403-17.

HIPAA standards for privacy of individually identifiable health information: an introduction to the consent debate.

[No authors listed]

On March 27, 2002, DHHS published proposed amendments to the Privacy Standards under HIPAA. The most controversial of these changes is the removal of the requirement that providers obtain patient consent before using or disclosing protected health information for treatment, payment, and healthcare operations. Some see this change as a rejection of privacy rights, while others see it as an acknowledgement of practical reality. This comment introduces the reader to the issues that are debated immediately following in the articles by Geralyn A. Kidera and Kristen Rosati.

Publication Types: 

   Comment

PMID: 12472147 [PubMed - indexed for MEDLINE]

91: J Med Ethics. 2002 Dec;28(6):377-80.

Clinical issues on consent: some philosophical concerns.

Worthington R.

On occasions, laws on consent are subject to modification, largely on account of being subject to common law rather than statute-for example, in the UK. Guideline publications such as the UK Department of Health Reference Guide to Consent for Examination or Treatment are intended to provide information for clinicians on when and how to apply current laws in everyday clinical situations. While the extent to which guidelines influence clinician behaviour depends on how much they are read and followed, what is also relevant, and sometimes omitted from consideration, is discussion about underlying philosophical concepts. This paper analyses philosophical weaknesses relating to English laws on consent, the main focus of attention being applied ethics and the rights of adults with incapacity. It draws comparisons between the US and the UK, and advocates changes in English law in order to help rectify weaknesses in patient protection. Discussion includes references to Scottish law, and the use of advance directives, and it voices concerns about over-reliance on "best interests" determinations. The problem is partly one of logical analysis, and what can happen is that best interests determinations fail to show proper respect for adults lacking the capacity to consent to examination or treatment on their own behalf. This is fundamentally a matter of rights, and requires further investigation and appropriate legal remedies in order to respond to ethical deficiencies in English law as it now stands.

PMID: 12468658 [PubMed - indexed for MEDLINE]

92: Dtsch Med Wochenschr. 2002 Sep 27;127(39):2021-4.

Comment in: 

   Dtsch Med Wochenschr. 2003 Jan 17;128(3):104.

["Shared decision making". Doctor or patient--who decides?]

[Article in German]

Isfort J, Floer B, Koneczny N, Vollmar HC, Butzlaff M.

Fakultät für Medizin, Universität Witten/Herdecke.

PMID: 12324884 [PubMed - indexed for MEDLINE]

93: Am J Epidemiol. 2002 Aug 1;156(3):286-91.

Women's willingness to share information and participation in prenatal care systems.

Dye T, Wojtowycz M, Applegate M, Aubry R.

Division of Public Health Practice, Department of Community and Preventive Medicine, University of Rochester, Rochester, NY 14642, USA. tim_dye@urmc.rochester.edu

With the expanded use of computerized databases to gather information, a concomitant interest in using databases for public health purposes has developed. The authors investigated correlates of consenting to participate in such databases. The Regional Perinatal Data System combines electronic birth certificate information with questions asked of all women delivering a livebirth. Each woman is asked to consent to share information with 1) her obstetric provider, 2) her infant's pediatric provider, and 3) an immunization registry. From 1996 to 1999, women who responded to the consent question and whose livebirth did not result in death or adoption were included. Odds ratios with 95% confidence intervals denoted the magnitude of association for refusing consent. Women who were "self-pay" (odds ratio = 2.0, 95% confidence interval: 1.7, 2.4), foreign born (odds ratio = 1.9, 95% confidence interval: 1.7, 2.1), and aged 40 or more years (odds ratio = 2.0, 95% confidence interval: 1.6, 2.3) were more likely to refuse to share data. Women eligible for but not participating in the Special Supplemental Nutrition Program for Women, Infants, and Children were significantly more likely to not share their information with others (odds ratio = 1.5, 95% confidence interval: 1.3, 1.6), after controlling for confounders. Refusing to share information with other sources is not random, and women refusing consent often do not participate in publicly available programs.

PMID: 12142264 [PubMed - indexed for MEDLINE]

94: Hum Res Rep. 2000 Jun;15(6):5-6.

Subjects must have access to treatment and research records.

Maloney DM.

The Deem Corporation, P.O. Box 44069, Omaha, NE 68144, USA.

PMID: 11917939 [PubMed - indexed for MEDLINE]

95: BMJ. 2002 Mar 16;324(7338):643.

Comment in: 

   BMJ. 2002 Jul 6;325(7354):43.    BMJ. 2002 Jul 6;325(7354):43.

Use of evidence based leaflets to promote informed choice in maternity care: randomised controlled trial in everyday practice.

O'Cathain A, Walters SJ, Nicholl JP, Thomas KJ, Kirkham M.

School of Health and Related Research, University of Sheffield, Regent Court, Sheffield S1 4DA. a.ocathain@sheffield.ac.uk

OBJECTIVE: To assess the effect of leaflets on promoting informed choice in women using maternity services. DESIGN: Cluster trial, with maternity units randomised to use leaflets (intervention units) or offer usual care (control units). Data collected through postal questionnaires. SETTING: 13 maternity units in Wales. PARTICIPANTS: Four separate samples of women using maternity services. Antenatal samples: women reaching 28 weeks' gestation before (n=1386) and after (n=1778) the intervention. Postnatal samples: women at eight weeks after delivery before (n=1741) and after (n=1547) the intervention. INTERVENTION: Provision of 10 pairs of Informed Choice leaflets for service users and midwives and a training session for staff in their use. MAIN OUTCOME MEASURES: Change in the proportion of women who reported exercising informed choice. Secondary outcomes: changes in women's knowledge; satisfaction with information, choice, and discussion; and possible consequences of informed choice. RESULTS: There was no change in the proportion of women who reported that they exercised informed choice in the intervention units compared with the control units for either antenatal or postnatal women. There was a small increase in satisfaction with information in the antenatal samples in the intervention units compared with the control units (odds ratio 1.40, 95% confidence interval 1.05 to 1.88). Only three quarters of women in the intervention units reported being given at least one of the leaflets, indicating problems with the implementation of the intervention. CONCLUSION: In everyday practice, evidence based leaflets were not effective in promoting informed choice in women using maternity services.

Publication Types: 

   Clinical Trial
   Multicenter Study
   Randomized Controlled Trial
   Research Support, Non-U.S. Gov't

PMID: 11895822 [PubMed - indexed for MEDLINE]

96: BMJ. 2002 Mar 16;324(7338):639.

Comment in: 

   BMJ. 2002 Jul 6;325(7354):43.    BMJ. 2002 Jul 6;325(7354):43.    BMJ. 2002 Jul 6;325(7354):43.    Evid Based Nurs. 2003 Jan;6(1):27.

Qualitative study of evidence based leaflets in maternity care.

Stapleton H, Kirkham M, Thomas G.

Women's Informed Childbearing and Health Research Group, School of Nursing and Midwifery, University of Sheffield, Sheffield S3 7ND. h.stapleton@sheffield.ac.uk

OBJECTIVE: To examine the use of evidence based leaflets on informed choice in maternity services. DESIGN: Non-participant observation of 886 antenatal consultations. 383 in depth interviews with women using maternity services and health professionals providing antenatal care. SETTING: Women's homes; antenatal and ultrasound clinics in 13 maternity units in Wales. PARTICIPANTS: Childbearing women and health professionals who provide antenatal care. Intervention: Provision of 10 pairs of Informed Choice leaflets for service users and staff and a training session in their use. MAIN OUTCOME MEASURES: Participants' views and commonly observed responses during consultations and interviews. RESULTS: Health professionals were positive about the leaflets and their potential to assist women in making informed choices, but competing demands within the clinical environment undermined their effective use. Time pressures limited discussion, and choice was often not available in practice. A widespread belief that technological intervention would be viewed positively in the event of litigation reinforced notions of "right" and "wrong" choices rather than "informed" choices. Hierarchical power structures resulted in obstetricians defining the norms of clinical practice and hence which choices were possible. Women's trust in health professionals ensured their compliance with professionally defined choices, and only rarely were they observed asking questions or making alternative requests. Midwives rarely discussed the contents of the leaflets or distinguished them from other literature related to pregnancy. The visibility and potential of the leaflets as evidence based decision aids was thus greatly reduced. CONCLUSIONS: The way in which the leaflets were disseminated affected promotion of informed choice in maternity care. The culture into which the leaflets were introduced supported existing normative patterns of care and this ensured informed compliance rather than informed choice.

Publication Types: 

   Clinical Trial
   Multicenter Study
   Randomized Controlled Trial
   Research Support, Non-U.S. Gov't

PMID: 11895821 [PubMed - indexed for MEDLINE]

97: Health Care Anal. 2001;9(3):321-35.

Health information: reconciling personal privacy with the public good of human health.

Gostin LO.

Georgetown University, 600 New Jersey Avenue NW, Washington, DC 20001, USA. gostin@law.georgetown.edu

The success of the health care system depends on the accuracy, correctness and trustworthiness of the information, and the privacy rights of individuals to control the disclosure of personal information. A national policy on health informational privacy should be guided by ethical principles that respect individual autonomy while recognizing the important collective interests in the use of health information. At present there are no adequate laws or constitutional principles to help guide a rational privacy policy. The laws are scattered and fragmented across the states. Constitutional law is highly general, without important specific safeguards. Finally, a case study is provided showing the important trade-offs that exist between public health and privacy. For a model public health law, see www.critpath.org/msphpa/privacy.

PMID: 11794835 [PubMed - indexed for MEDLINE]

98: Med Inform Internet Med. 2001 Jul-Sep;26(3):219-34.

A moral approach to electronic patient records.

Fairweather NB, Rogerson S.

Centre for Computing and Social Responsibility, Faculty of Computing Sciences and Engineering, De Montfort University, Leicester, UK.

This paper seeks to establish a morally appropriate balance between the various moral standards that are in tension in the field of Electronic Patient Records (EPRs). EPRs can facilitate doctorpatient relationships, however at the same time they can undermine trust and so harm the doctorpatient relationship. Patients are becoming increasingly reluctant to tell their own doctor everything that is relevant. A number of moral principles and the question of consent to release of records are considered here. There is also explicit mention of the principles for the treatment of the EPRs of the dead. A number of tensions between principles are explored, including that between privacy and promotion of welfare, both in an emergency and in more routine situations. The discussion also includes the tension between access and the right to not know about a condition that may undermine, for example, self-esteem; and the tensions between principles that arise when epidemiology, public health surveillance and healthcare evaluation are conducted. Suggestions are made about an appropriate balance between the principles. It is suggested that the patient's right to informed consent should be dominant.

PMID: 11706931 [PubMed - indexed for MEDLINE]

99: BMJ. 1998 Mar 28;316(7136):1004-5.

Studies that do not have informed consent from participants should not be published.

Goodare H.

PMID: 11645041 [PubMed - indexed for MEDLINE]

100: BMJ. 1998 Mar 28;316(7136):1002-3.

Informed consent -- a publisher's duty.

Warnock M.

PMID: 11645039 [PubMed - indexed for MEDLINE]

101: BMJ. 1998 Mar 28;316(7136):1001-2.

Changing the BMJ's position on informed consent would be counterproductive.

Tobias JS.

PMID: 11645038 [PubMed - indexed for MEDLINE]

102: BMJ. 1998 Jan 17;316(7126):170.

BMJ to act on media abuse.

Abbasi K.

Publication Types: 

   News

PMID: 11645019 [PubMed - indexed for MEDLINE]

103: Anaesthesia. 2001 Sep;56(9):906-7.

Patient consent for case reports.

Hubregtse G, Collins SJ.

Publication Types: 

   Letter

PMID: 11531682 [PubMed - indexed for MEDLINE]

104: J Psychother Pract Res. 2001 Summer;10(3):193-201.

Informed consent for case reports: the ethical dilemma of right to privacy versus pedagogical freedom.

Levine SB, Stagno SJ.

Department of Psychiatry, Case Western Reserve University, Cleveland, Ohio, USA.

A new international standard of editorial policy calls for written informed consent by the subject of every case report. Although this appears to be ethically appealing, the authors posit that in some situations, requesting informed consent may be unethical, can harm patients, and may erode the use of case reports as a valuable teaching method in psychiatry and psychotherapy. The authors discuss concerns regarding this new policy for mental health publication based on issues of transference, countertransference, best interest of the patient, and practicality.

PMID: 11402083 [PubMed - indexed for MEDLINE]

105: BMJ. 2001 May 26;322(7297):1266.

Hospital chief was right to release patient consent forms to media.

Dyer C.

Publication Types: 

   News

PMID: 11375220 [PubMed - indexed for MEDLINE]

106: Genet Med. 2000 Nov-Dec;2(6):353-5.

Informed consent for medical photographs. Dysmorphology Subcommittee of the Clinical Practice Committee, American College of Medical Genetics.

Dysmorphology Subcommittee of the Clinical Practice Committee, American College of Medical Genetics, 9650 Rockville Pike, Bethesda, MD 20814-3998, United States.

Publication Types: 

   Guideline

PMID: 11339658 [PubMed - indexed for MEDLINE]

107: Aust N Z J Psychiatry. 2001 Apr;35(2):240-5.

The humble case report.

Walter G, Rey JM, Dekker F.

Department of Psychological Medicine, University of Sydney, Sydney, Australia. gwalter@mail.usyd.edu.au

OBJECTIVE: There is negligible systematic information about case reports in the psychiatric literature. We aimed to describe case report articles published in the Australian and New Zealand Journal of Psychiatry (ANZJP), to provide data about the quality of evidence they offer, to ascertain changes over time and to make recommendations, based on our findings, about these articles. METHOD: All articles describing cases which appeared in the ANZJP between 1967 and 1999 were identified and examined. RESULTS: 256 articles describing a total of 479 cases were published over the study period. Fifty-five per cent of articles reported an unusual presentation. Thirty-eight per cent of cases had a mood disorder and 24% had a psychosis. Seventy-six per cent of patients had a positive outcome. Cases published in 1989-1999 were more likely to describe pharmacological treatments than cases published earlier. CONCLUSIONS: Clinical descriptions that lead to progress are undervalued. Case reports should retain a place in the ANZJP, provided they convey information that is new and useful (e.g. suggesting or refuting hypotheses) rather than simply document current practice or describe the unusual. Issues of patient consent and anonymity also warrant consideration.

PMID: 11284908 [PubMed - indexed for MEDLINE]

108: Ann Emerg Med. 2001 Feb;37(2):217-9.

Comment in: 

   Ann Emerg Med. 2001 Aug;38(2):189.    Ann Emerg Med. 2001 Feb;37(2):220-2.

Fame, rights, and videotape.

Geiderman JM.

Publication Types: 

   Editorial

PMID: 11174241 [PubMed - indexed for MEDLINE]

109: Int J Psychoanal. 2000 Dec;81 Pt 6:1071-86.

Disguise or consent. Problems and recommendations concerning the publication and presentation of clinical material.

Gabbard GO.

Menninger Clinic, P. O. Box 829, Topeka, Kansas, KS 66601-0829, USA.

The author argues that the use of clinical material for educational purposes or for publication presents the analyst with a conflict of interest between the protection of the patient's privacy and the educational and scientific needs of the field, and also that it places analysts in the position of using confidential patient material in the service of their own professional advancement. The strategies of dealing with this dilemma can be classified as follows: (1) thick disguise, (2) patient consent, (3) the process approach, (4) the use of composites and (5) the use of a colleague as author. Some of these options may, of course, be used in combination with one another. All of these methods have a place, and the author argues against a uniform approach. Each of these strategies is discussed in terms of its advantages and disadvantages. While no choice is without various risks, some guidelines are offered to assist analysts who wish to present or write about clinical cases.

PMID: 11144850 [PubMed - indexed for MEDLINE]

110: J Clin Ethics. 2000 Fall;11(3):213-8.

Patient vignettes in bioethics literature.

Herrera CD.

Department of Philosophy and Religion, Montclair State University in Upper Montclair, New Jersey, USA.

Publication Types: 

   Case Reports

PMID: 11127635 [PubMed - indexed for MEDLINE]

111: Clin Orthop Relat Res. 2000 Sep;(378):83-9.

Ethical responsibilities of editors, reviewers, and authors.

Cowell HR.

Harvard Medical School, Boston MA, USA.

Scientific misconduct, which is neither new nor unique, is prevalent in the medical literature. Although fabrication of data obviously is unethical, and although ethical rules of conduct for certain aspects of medical studies, such as informed consent, are theoretically accepted worldwide, numerous authors do not adhere to ethical rules of conduct. Ethically, the editor is responsible, as a gatekeeper, for ensuring that material to be published is accurate and valid. Thus, the editor's main responsibility is to the reader. Nonetheless, the editor also must serve the author by selecting unbiased reviewers and by providing the assurance that material will be selected for publication based solely on the scientific quality of the material. Peer reviewers are obligated to maintain a posture of confidentiality throughout the review process. Authors are responsible for adequate planning before undertaking a study, and for safeguarding patients' rights during the study. The author must read all cited references completely, strive for accuracy, and be certain that the material reported is valid, because it will be used in the treatment of patients. Hopefully, awareness of the ethical problems related to medical writing will provide a clearer understanding of the ethical aspects of medical writing.

PMID: 10986979 [PubMed - indexed for MEDLINE]

112: Arch Pathol Lab Med. 2000 May;124(5):739-45.

Declining autopsy rate in a French hospital: physician's attitudes to the autopsy and use of autopsy material in research publications.

Chariot P, Witt K, Pautot V, Porcher R, Thomas G, Zafrani ES, Lemaire F.

Unit of Legal Medicine, Hôpital Henri-Mondor, Creteil, France. pchariot@cybercable.fr

CONTEXT: Autopsy rates have been declining throughout the world, although preservation of the autopsy is considered a fundamental principle of medical care. In France, the 1994 bioethics law requires physicians to inform relatives before performing an autopsy. OBJECTIVE: To analyze the following factors that potentially influence hospital autopsy rates: legal constraints, autopsy reporting times, opinions of physicians requesting autopsies and pathologists regarding the usefulness of autopsy in patient care, and use of autopsy material in research publications. DESIGN: Record of the annual numbers of deaths and autopsies during a 10-year period (1988-1997). Record of the delays for transmission of final autopsy report to the requesting physician. Questionnaire analyzing the possible factors influencing autopsy rate. Categorization of articles published by pathologists according to the use of autopsy material. SETTING: A 1000-bed, university teaching hospital in the Paris, France, area. PARTICIPANTS: Questionnaire addressed to physicians, head nurses, and mortuary staff. RESULTS: A total of 1454 autopsies were reviewed. The autopsy rate declined from 15.4% in 1988 to 3.7% in 1997. This decline was marked after 1994 and tended to be slower for neurologic indications than for other indications. The final report had not been communicated within 180 days in 620 (42.6%) of 1454 autopsies. Fifty-five of 105 respondents considered that the bioethics law was one cause of the recent decrease of autopsy rate. Considering the contribution of autopsy to medical research, 94 (81%) of 116 articles dealing with central nervous system but only 28 (6%) of 464 articles dealing with other organs used autopsy-derived material. CONCLUSIONS: The 1994 bioethics law seems to contribute to the decline of autopsy. Inadequate delays for communicating autopsy results are frequent. Except for neuropathologists, autopsy is a minor source of research material.

PMID: 10782159 [PubMed - indexed for MEDLINE]

113: BMJ. 1998 Nov 28;317(7171):1523.

Videos, photographs, and patient consent. Most patients agree to be videoed for teaching and publication purposes.

Nicholl D, Davies D.

Publication Types: 

   Letter

PMID: 9882125 [PubMed - indexed for MEDLINE]

114: J Oral Maxillofac Surg. 1998 Nov;56(11):1364.

A reasonable approach to patient consent for publication.

Leonard MS.

Publication Types: 

   Letter

PMID: 9820228 [PubMed - indexed for MEDLINE]

115: CMAJ. 1998 Sep 8;159(5):503-4.

Comment in: 

   CMAJ. 1998 Sep 8;159(5):443.    CMAJ. 1999 Feb 9;160(3):315.

Patient consent for publication--an apology.

Hoey J.

Publication Types: 

   Editorial

PMID: 9757177 [PubMed - indexed for MEDLINE]

116: CMAJ. 1998 Sep 8;159(5):443.

Comment on: 

   CMAJ. 1998 Apr 21;158(8):1051-3.    CMAJ. 1998 Sep 8;159(5):503-4.

Confidentiality in medical publishing.

Barnes R.

Publication Types: 

   Comment
   Letter

PMID: 9757163 [PubMed - indexed for MEDLINE]

117: BMJ. 1998 Mar 28;316(7136):1009-11.

Comment in: 

   BMJ. 1998 Nov 28;317(7171):1522.

Videos, photographs, and patient consent.

Hood CA, Hope T, Dove P.

Ethox, Division of Public Health and Primary Care Institute of Health Care Sciences, Headington, Oxford.

Publication Types: 

   Research Support, Non-U.S. Gov't

PMID: 9550967 [PubMed - indexed for MEDLINE]

118: BMJ. 1998 Mar 28;316(7136):1000-5.

Comment in: 

   BMJ. 1998 Mar 28;316(7136):949-51.    BMJ. 1998 Oct 3;317(7163):947.    BMJ. 1998 Oct 3;317(7163):947-8.    BMJ. 1998 Oct 3;317(7163):948.    BMJ. 1998 Oct 3;317(7163):948.    BMJ. 1998 Oct 3;317(7163):948-9.    BMJ. 1999 Mar 13;318(7185):736.

Informed consent in medical research.

Doyal L, Tobias JS, Warnock M, Power L, Goodare H.

St Bartholomew's Hospital School of Medicine and Dentistry, London.

PMID: 9550964 [PubMed - indexed for MEDLINE]

119: BMJ. 1998 Mar 28;316(7136):949-51.

Comment in: 

   BMJ. 1998 Oct 3;317(7163):947.    BMJ. 1998 Oct 3;317(7163):948.    BMJ. 1998 Oct 3;317(7163):949.

Comment on: 

   BMJ. 1998 Mar 28;316(7136):1000-5.    BMJ. 1998 Mar 28;316(7136):955.

Informed consent: edging forwards (and backwards)

Smith R.

Publication Types: 

   Comment
   Editorial

PMID: 9550945 [PubMed - indexed for MEDLINE]

120: JAMA. 1997 Dec 24-31;278(24):2139-40; author reply 2140-1.

Comment on: 

   JAMA. 1997 Aug 27;278(8):624-6.

Patient consent for publication.

Ridzon R, Onorato I.

Publication Types: 

   Comment
   Letter

PMID: 9416999 [PubMed - indexed for MEDLINE]

121: JAMA. 1997 Dec 24-31;278(24):2139; author reply 2140-1.

Comment on: 

   JAMA. 1997 Aug 27;278(8):628-9.

Patient consent for publication.

Rothschild BM.

Publication Types: 

   Comment
   Letter

PMID: 9416998 [PubMed - indexed for MEDLINE]

122: JAMA. 1997 Dec 24-31;278(24):2139; author reply 2140-1.

Comment on: 

   JAMA. 1997 Aug 27;278(8):624-6.    JAMA. 1997 Aug 27;278(8):628-9.

Patient consent for publication.

Kirsch M.

Publication Types: 

   Comment
   Letter

PMID: 9416997 [PubMed - indexed for MEDLINE]

123: JAMA. 1997 Aug 27;278(8):682-3.

Comment on: 

   JAMA. 1997 Aug 27;278(8):624-6.    JAMA. 1997 Aug 27;278(8):628-9.

Informed consent for publication.

Fontanarosa PB, Glass RM.

Publication Types: 

   Comment
   Editorial

PMID: 9272905 [PubMed - indexed for MEDLINE]

124: JAMA. 1997 Aug 27;278(8):628-9.

Comment in: 

   JAMA. 1997 Aug 27;278(8):682-3.    JAMA. 1997 Dec 24-31;278(24):2139; author reply 2140-1.    JAMA. 1997 Dec 24-31;278(24):2139; author reply 2140-1.

Obtain informed consent before publishing information about patients.

Clever LH.

PMID: 9272884 [PubMed - indexed for MEDLINE]

125: JAMA. 1997 Aug 27;278(8):624-6.

Comment in: 

   JAMA. 1997 Aug 27;278(8):682-3.    JAMA. 1997 Dec 24-31;278(24):2139-40; author reply 2140-1.    JAMA. 1997 Dec 24-31;278(24):2139; author reply 2140-1.

Patient consent for publication and the health of the public.

Snider DE.

Centers for Disease Control and Prevention, Atlanta, Ga 30333, USA.

PMID: 9272883 [PubMed - indexed for MEDLINE]

126: BMJ. 1997 May 17;314(7092):1481.

Comment on: 

   BMJ. 1997 Apr 12;314(7087):1107-11.    BMJ. 1997 Apr 12;314(7087):1111-4.

Informed consent in medical research. Studies with important conclusions but without patient consent should be published.

Hulbert MF.

Publication Types: 

   Comment
   Letter

PMID: 9167581 [PubMed - indexed for MEDLINE]

127: BMJ. 1997 May 17;314(7092):1477.

Comment on: 

   BMJ. 1997 Apr 12;314(7087):1059-60.

Informed consent in medical research. Doctors are arrogant to think they need to debate issue of patient consent.

Bratt DE.

Publication Types: 

   Comment
   Letter

PMID: 9167569 [PubMed - indexed for MEDLINE]

128: BMJ. 1997 Apr 12;314(7087):1111-4.

Comment in: 

   BMJ. 1997 Apr 12;314(7087):1059-60.    BMJ. 1997 Jul 26;315(7102):247.    BMJ. 1997 Jul 26;315(7102):253.    BMJ. 1997 May 17;314(7092):1477.    BMJ. 1997 May 17;314(7092):1479.    BMJ. 1997 May 17;314(7092):1480-1.    BMJ. 1997 May 17;314(7092):1481.    BMJ. 1997 May 17;314(7092):1482.    BMJ. 1997 May 17;314(7092):1482.

BMJ's present policy (sometimes approving research in which patients have not given fully informed consent) is wholly correct.

Tobias JS.

University College and Middlesex Hospitals, London.

PMID: 9133898 [PubMed - indexed for MEDLINE]

129: BMJ. 1997 Apr 12;314(7087):1127-8.

Comment on: 

   BMJ. 1996 Nov 2;313(7065):1117.

Details of patients' consent in studies should be reported.

Nylenna M.

Publication Types: 

   Comment
   Letter

PMID: 9133905 [PubMed - indexed for MEDLINE]

130: BMJ. 1997 Apr 12;314(7087):1107-11.

Comment in: 

   BMJ. 1997 Apr 12;314(7087):1059-60.    BMJ. 1997 Jul 26;315(7102):247.    BMJ. 1997 Jul 26;315(7102):248.    BMJ. 1997 Jul 26;315(7102):250.    BMJ. 1997 Jul 26;315(7102):253.    BMJ. 1997 Jul 26;315(7102):254.    BMJ. 1997 May 17;314(7092):1477.    BMJ. 1997 May 17;314(7092):1478.    BMJ. 1997 May 17;314(7092):1480.    BMJ. 1997 May 17;314(7092):1480-1.    BMJ. 1997 May 17;314(7092):1481.    BMJ. 1997 May 17;314(7092):1482.    BMJ. 1997 May 17;314(7092):1482.

Informed consent in medical research. Journals should not publish research to which patients have not given fully informed consent--with three exceptions.

Doyal L.

St Bartholomew's and the Royal London School of Medicine and Dentistry, Queen Mary and Westfield College, University of London.

PMID: 9133897 [PubMed - indexed for MEDLINE]

131: Med J Aust. 1997 Mar 3;166(5):230-1.

Publishing and protecting patient confidentiality.

Van der Weyden MB.

Publication Types: 

   Editorial

PMID: 9076263 [PubMed - indexed for MEDLINE]

132: Am J Public Health. 1996 Nov;86(11):1648-9.

Parents' understanding of the CDC's vaccine information material.

Esernio-Jenssen D, Turow V.

Publication Types: 

   Letter

PMID: 8916537 [PubMed - indexed for MEDLINE]

133: BMJ. 1996 Jul 6;313(7048):16.

Commentary: the importance of patients' consent for publication.

Smith R.

PMID: 8664761 [PubMed - indexed for MEDLINE]

134: BMJ. 1996 May 4;312(7039):1163.

Code is needed to protect inpatients from press publicity.

Smith A, Hutchison I.

Publication Types: 

   Letter

PMID: 8620164 [PubMed - indexed for MEDLINE]

135: Nervenarzt. 1996 May;67(5):422-6.

["Informed consent" by the patient for publication of case reports. New guidelines by the "International Committee of Medical Journal Editors" (Vancouver Group)]

[Article in German]

Vollmann J.

Psychiatrische Klinik, Freien Universität, Berlin.

The "International Committee of Medical Journal Editors" has revised its guidelines regarding the protection of patients' rights to privacy in manuscripts submitted to biomedical journals. Information that might identify patients should not be published unless it is essential for scientific purposes and the patient has given written informed consent for publication after having been shown the manuscript to be published. This article discusses the new guidelines in the clinical context of psychiatry and psychotherapy. The ethical and legal problems raised concern (1) the informed consent process, (2) the content of scientific work and (3) the problem of third party consent (e.g. legal guardians).

Publication Types: 

   English Abstract

PMID: 9005356 [PubMed - indexed for MEDLINE]

136: BMJ. 1996 Mar 2;312(7030):578-9.

Publishing information about patients. GMC's guidelines should be followed before information is put on Internet.

Nicholl D, Winters G, Davies D.

Publication Types: 

   Letter

PMID: 8595307 [PubMed - indexed for MEDLINE]

137: BMJ. 1996 Mar 2;312(7030):578.

Publishing information about patients. Obtaining consent to publication may be unethical in some cases.

Vollmann J, Helmchen H.

Publication Types: 

   Letter

PMID: 8595306 [PubMed - indexed for MEDLINE]

138: BMJ. 1995 Nov 11;311(7015):1272.

Protection of patients' rights to privacy.

International Committee of Medical Journal Editors.

The following statement was agreed [upon] by the International Committee of Medical Journal Editors (the Vancouver Group) at its meeting last week in San Francisco. It is a complete revision of the initial guidelines on this subject issued in 1991.

PMID: 11644736 [PubMed - indexed for MEDLINE]

139: BMJ. 1995 Nov 11;311(7015):1245-6.

Comment on: 

   BMJ. 1995 Nov 11;311(7015):1240-1.

GMC finds doctors not guilty in consent case.

Court C.

Publication Types: 

   Comment
   News

PMID: 7496222 [PubMed - indexed for MEDLINE]

140: BMJ. 1995 Nov 11;311(7015):1240-1.

Comment in: 

   BMJ. 1995 Nov 11;311(7015):1245-6.

Publishing information about patients.

Smith R.

Publication Types: 

   Editorial

PMID: 7496217 [PubMed - indexed for MEDLINE]

141: Code Fed Regul Public Welfare. 1995 Oct 1;Title 45(Sections 46-101 to 46-409):Unknown.

Protection of human subjects.

U.S. Department of Health and Human Services.

Publication Types: 

   Government Publications
   Legislation

PMID: 11686173 [PubMed - indexed for MEDLINE]

142: Fed Regist. 1995 Sep 21;60(183):49086-103.

Protection of human subjects; informed consent; proposed rule.

U.S. Food and Drug Administration.

Publication Types: 

   Government Publications

PMID: 11656433 [PubMed - indexed for MEDLINE]

143: Aust N Z J Surg. 1995 Apr;65(4):224-8.

Informed consent in Australia.

Lord RS.

Department of Surgery, St Vincent's Hospital, University of New South Wales, Sydney, Australia.

Recent decisions in Australian courts affirm three important principles relating to consent to therapy. First, patients must be appropriately and adequately informed. Second, the scope and detail of the information supplied should be based on the reasonable patient's need to know rather than on the actions of the reasonable doctor. Third, the doctor must take care to ensure that the information imparted is understood by the patient. This publication reviews the basis of informed consent and traditional beneficent-style consent. The occasions when beneficence is more appropriate are outlined.

Publication Types: 

   Review

PMID: 7717938 [PubMed - indexed for MEDLINE]

144: Pediatrics. 1995 Feb;95(2):314-7.

Comment in: 

   Pediatrics. 1995 Nov;96(5 Pt 1):981-2.

Informed consent, parental permission, and assent in pediatric practice. Committee on Bioethics, American Academy of Pediatrics.

[No authors listed]

The statement on informed consent, parental permission, and patient assent has a long and extraordinary history. The first draft of this document, prepared by William G. Bartholome, MD, was presented to the original American Academy of Pediatrics (AAP) Committee on Bioethics in 1985. Bill put his soul into the manuscript and has watched over it carefully ever since. Now, a decade later, those who have worked on its continued development and urged its adoption as Academy policy applaud its publication. No one is more gratified than its primary author and champion. Those who have had the privilege to know Dr Bartholome share his sense of accomplishment, but cannot help but experience a cruel sense of irony. Just as the work Bill considers his most important contribution has become available for public appreciation, Dr Bartholome suffers from a serious illness that threatens his life. Bill always wanted "the experience, perspective, and power of children" to be taken most seriously. Through the years of the statement's revisions and re-presentation within the Academy, Bill "had faith in the power of the text and the ideas it contained, ... that its time would come." The statement embodies Bill Bartholome's dedication to children. Throughout his career, he worked to make medicine and medical research safer and more friendly for children. The AAP and its Committee on Bioethics, on behalf of all our colleagues, extend heartful thanks to Dr William G. Bartholome for helping us more fully appreciate that children are in the process of becoming, in his words, "intelligent, observant, capable, and responsible persons" who deserve our utmost respect.

Publication Types: 

   Guideline

PMID: 7838658 [PubMed - indexed for MEDLINE]

145: Ethics Behav. 1995;5(1):49-66.

Reports of assent and permission in research with children: illustrations and suggestions.

Range LM, Cotton CR.

This study ascertained reports of assent (affirmative agreement) and permission (agreement by an adult fully capable of being informed) in 114 children's research articles in 1990 in Child Development (CD), Journal of Consulting and Clinical Psychology (JCCP), Journal of Pediatric Psychology, and Journal of Clinical Child Psychology. Of the research projects, 43% failed to specify permission, and 68.5% failed to specify assent. JCCP reported assent significantly more than CD. Assent was reported significantly more in research with older children than with younger children. This lack of sensitivity to assent and permission suggests that many authors, reviewers, and editors consider reporting assent and permission unessential. We recommend specifying assent and permission in all manuscripts, highlighting children's research issues in graduate training, and using specific safeguards when conducting research with children.

PMID: 11654170 [PubMed - indexed for MEDLINE]

146: Time. 1994 Nov 7;144(19):62-3.

Madness in fine print.

Willwerth J.

PMID: 10137484 [PubMed - indexed for MEDLINE]

147: JAMA. 1991 May 22-29;265(20):2720.

Comment on: 

   JAMA. 1991 May 22-29;265(20):2697-8.

Patients have a right to privacy and anonymity in medical publication.

Riis P, Nylenna M.

Publication Types: 

   Comment
   Editorial

PMID: 2023355 [PubMed - indexed for MEDLINE]

148: BMJ. 1991 May 18;302(6786):1182.

Comment in: 

   BMJ. 1991 May 18;302(6786):1168.

Identification of patients in medical publications: need for informed consent.

Nylenna M, Riis P.

Journal of the Norwegian Medical Association, Lysaker.

Publication Types: 

   Guideline

PMID: 2043814 [PubMed - indexed for MEDLINE]

149: Int Dent J. 1991 Apr;41(2):124-6.

Ethics: what can editors do?

Wei SH.

Faculty of Dentistry, Prince Philip Dental Hospital, Hong Kong.

PMID: 2032740 [PubMed - indexed for MEDLINE]

150: Can J Anaesth. 1990 Sep;37(6):706-7.

Comment on: 

   Can J Anaesth. 1989 Nov;36(6):668-74.

Patient identity.

Cohen MM.

Publication Types: 

   Comment
   Letter

PMID: 2278564 [PubMed - indexed for MEDLINE]

151: IME bull. 1988 Nov;44:8-9.

Proper use of medical pictures: guidelines.

Institute of Medical and Biological Illustration (Great Britain).

PMID: 11659067 [PubMed - indexed for MEDLINE]

152: Am J Public Health. 1985 Dec;75(12):1381-4.

What participants understand about a maternal serum alpha-fetoprotein screening program.

Faden RR, Chwalow AJ, Orel-Crosby E, Holtzman NA, Chase GA, Leonard CO.

We investigated the knowledge of pregnant women participating in a maternal serum alphafetoprotein (MSAFP) screening program for the detection of neural tube defects (NTDs) in the fetus. Women participating in the screening program scored higher on two knowledge tests than a comparison group of pregnant women who were not offered screening. However, there were substantial gaps in the knowledge base of women in the program, as measured by one of the tests. Women did not misinterpret a negative test result to mean that the test had identified a potential problem with the fetus; instead, there is a suggestion that they tended to interpret a negative result too positively, as an assurance that the baby was healthy in all respects.

KIE: Pregnant women participating in a maternal serum alpha-fetoprotein (AFP) screening program for the detection of fetal neural tube defects were interviewed to evaluate their understanding of the test, the defects, and the meaning of test results. Although women participating in the screening program scored higher on two knowledge tests than a comparison group not offered screening, there were substantial gaps in knowledge. Poor performance on the free response test (in which definitions of terms were requested) raises concerns about the adequacy of the women's consent to screening. They understood that a positive test result would entail having to make a decision about abortion, but seemed to have interpreted a negative test as an assurance that the baby was healthy in all respects.

Publication Types: 

   Research Support, Non-U.S. Gov't
   Research Support, U.S. Gov't, P.H.S.

PMID: 2415009 [PubMed - indexed for MEDLINE]

153: Clin Res. 1985 Sep;33(3):416.

Informed consent for research publication of patient-related data.

Pinsky L.

Publication Types: 

   Letter

PMID: 4042539 [PubMed - indexed for MEDLINE]

154: Clin Res. 1984 Oct;32(4):404-8.

Informed consent for research publication of patient-related data.

Murray JC, Pagon RA.

PMID: 6509867 [PubMed - indexed for MEDLINE]

155: Hastings Cent Rep. 1983 Dec;13(6):43-4.

No "shortcomings" in commission's report.

Capron AM, Osterweis M.

Publication Types: 

   Letter

PMID: 6654668 [PubMed - indexed for MEDLINE]

156: JAMA. 1982 Dec 17;248(23):3093-4.

Consent for publication.

Murray J.

Publication Types: 

   Case Reports
   Letter

PMID: 7143682 [PubMed - indexed for MEDLINE]

157: JAMA. 1974 Aug 12;229(7):844.

Photographs of patients.

Simonaitis JE.

PMID: 4407830 [PubMed - indexed for MEDLINE]

158: Br Med J. 1974 Aug 3;3(5926):334-8.

Infants, children, and informed consent.

Campbell AG.

PMID: 4413853 [PubMed - indexed for MEDLINE]

159: Drug Res Rep. 1974 Jul;17(28):51-536.

(Reprint of) National Research Act. Conference Report.

U.S. CONGRESS. SENATE.

PIP: This report of a joint House and Senate conference committee amends the Public Health Service Act to establish a national program of biomedical research fellowships, traineeships, and training, and to provide for the protection of human beings in biomedical and behavioral research. The act is to be known as the National Research Act. Title 1 provides for 3-year research awards for training at the National Institutes of Health, the Alcohol, Drug Abuse and Mental Health Administration, and non-Federal public and nonprofit private institutions. Procedures, stipends, and other technical matters are set out in detail. Title 3 establishes an advisory National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. At the end of its 2-year existence, the Commission shall submit a written report to the President. No more than 6 of the 11 member Commission shall be engaged in biomedical or behavioral research on humans. Among its duties, the Commission shall identify the basic ethical principles which should underlie the conduct of biomedical and behavioral research and develop guidelines to assure that research is conducted in accordance with such principles. It shall identify requirements for informed consent for participation in biomedical and behavioral research by children, prisoners, and institutionalized mental patients. It shall study the nature, extent, and purpose of research involving live fetuses. It shall investigate the use of psychosurgery. The amendment also calls for the establishment of a permanent National Advisory Council for the Protection of Subjects of Biomedical and Behavioral Research. It shall be made up of from 7 to 15 people and shall advise the Secretary of Health, Education and Welfare concerning all matters pertaining to human subjects of biomedical and behavioral research. The amendment also states that until the Commission has made recommendations with regard to fetal research, the Secretary of Health, Education and Welfare may not support research on a live fetus unless it is done to aid in the survival of the fetus.

Publication Types: 

   Legislation

PMID: 12333496 [PubMed - indexed for MEDLINE]

160: Phila Med. 1974 Feb;70(2):73+.

The research imperative and human rights.

Stone RS.

PMID: 11664583 [PubMed - indexed for MEDLINE]

161: Med Tech (Stuttg). 1952 Jan 5;1:30-3.

[Right of the patient to withhold consent for publication of his picture.]

[Article in Undetermined Language]

WEISSER G.

PMID: 14940478 [PubMed - indexed for MEDLINE]

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