Publication Ethics at International Journal of Clinical ... · COI: confl ict of interest; rpCOI:...

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Type of acknowledgement Number reported Pharmaceutical funding 15 Non-commercial funding 12 Editorial assistance 8 Hospital departments and colleagues 8 Medical writer 5 Statistical assistance 3 Honoraria 3 Previous presentation at a conference 3 Company paid to perform literature review and literature searches 2 Other investigational sites 1 Authors are employees of the pharmaceutical company that funded the study 1 Acknowledgements, October 2006 to March 2007 Forty-two papers (25%) of the total audited contained an acknowledgement statement describing one or more item (Table 3). T ABLE 3. Analysis of acknowledgements, October 2006 to March 2007. Research ethics, October 2006 to March 2007 Forty-one papers from the total analysed were judged by the reviewers as reporting studies that may have required some form of ethics approval or informed consent. The authors presented the research ethics information from their studies as follows: Both ethical review board approval and appropriate informed consent: 23 papers Informed consent but no ethics: 11 papers Declaration of Helsinki/Department of Health Guidelines but no ethics or informed consent: 2 papers Declaration of Helsinki/Department of Health Guidelines/informed consent but no ethics: 3 papers No ethics/no informed consent: 2 papers C ONCLUSIONS AND RECOMMENDATIONS Change in journal policy improved transparency The journal policy introduced in January 2007 had a significant impact on encouraging disclosure of potential financial conflicts of interest. Author disclosed conflict of interest didn’t correlate with reviewer perceived potential financial conflict of interest rpCOI was present in 12 of the 98 papers that contained an adCOI. Authors seem to be erring on the side of caution, following the maxim ‘if in doubt, disclose’. Make information consistent A variety of headings were used to describe conflict of interest such as ‘disclosure’, ‘financial disclosure’, ‘work attributed to’, and ‘acknowledgement’. Acknowledgements included a variety of statements, including some ‘conflict of interest’ information. Clarity should be provided by the journal regarding appropriate use of ‘acknowledgement’ statements. The journal should encourage consistent use of headings. Make statements explicit ‘Conflict of interest’ statements are often not made explicit, although inferences could be made by readers using other information provided in, for example, separate statements of ‘disclosure’ or ‘acknowledgement’. Authors should be encouraged to make statements explicit. For example, in a published review of XXX inhibitors, the following explicit statement was made: ‘The author has received fees for lectures and advisory work from Novartis, MSD and Bristol-Myers Squibb, all of whom are developing XXX inhibitors’. DISCLOSURES CG is journal publisher, Int J Clin Pract. GJ is editor-in-chief, Int J Clin Pract. AC and EM are employed by GJ. REFERENCES 1. Jackson G. Conflict of interest: Full disclosure is essential. Int J Clin Pract 2006;60:1147–8. C ONTACT Chris Graf, [email protected] No statement published (n=12) ‘Conflicts of interest’ statement (n=11) ‘Disclosure’ statement (n=58) adCOI 11 55 rpCOI 0 0 3 INTRODUCTION A 6-month audit of ethical publication practices was announced by Graham Jackson in his October 2006 editorial in Int J Clin Pract [1]. The audit examined published original (research) papers, review articles (including review articles from the Int J Clin Pract ‘drug focus’ series), and editorials for financial conflict of interest, acknowledgement, and declarations about research ethics. METHODS The audit was conducted between October 2006 and March 2007. Two reviewers external to Int J Clin Pract staff examined the text from each paper in detail to: evaluate papers for potential financial conflict of interest review acknowledgements listed consider whether research ethics were appropriate Reviewer perceived potential financial conflict of interest (rpCOI) was identified and compared with author disclosed conflict of interest (adCOI). The audit was based on the criteria for conflict of interest and acknowledgement presented in the journal’s notes for contributors. A total of 165 papers were examined: 34 editorials, 86 original research papers, 37 reviews and 8 ‘drug focus’ review articles. A change in journal policy in January 2007 meant all papers were required to include a ‘disclosure’ statement on their first page. RESULTS Results are presented for the period before the change in journal policy described above (October to December 2006, n=82) and for the period after this change (January to March 2007, n=83). Conflict of interest, October 2006 to December 2006 Eighty-two papers were examined: 16 editorials, 47 original papers, 14 review articles, 5 ‘drug focus’ review articles. Twenty-nine (35%) papers contained an adCOI statement under the heading ‘conflict of interest’ or ‘disclosure’. Seven of these statements described the authors’ conflicts of interest as ‘none’. One ‘no conflict of interest’ statement also included a list of the authors’ associations with pharmaceutical companies. 53 (65%) papers contained no adCOI statement (Figure 1). rpCOI was present in 5 papers where the authors made no disclosure statement, in 1 paper where a ‘conflict of interest’ statement reported ‘none’, and in 8 papers that included conflict of interest information under the heading ‘disclosure’ (Table 1). T ABLE 1. Analysis of reviewer perceived COI in 82 papers from October to December 2006. COI: conflict of interest; rpCOI: reviewer perceived potential financial conflict of interest; adCOI: author disclosed conflict of interest. Publication Ethics at International Journal of Clinical Practice: A 6-Month Audit of Published Articles for Disclosures of Conflict of Interest, Acknowledgement, and Research Ethics Chris Graf, 1 Alethea Cooper, 2 Elaine McGing, 2 Graham Jackson, 2 1 Blackwell Publishing, Oxford, UK, 2 Guy’s & St Thomas’ NHS Foundation Hospital, London, UK No statement published (n=53) ‘Conflicts of interest’ statement (n=14) ‘Disclosure’ statement (n=15) adCOI 13 7 rpCOI 5 1 8 Conflict of interest, January 2007 to March 2007 Eighty-three papers were examined: 18 editorials, 39 original papers, 23 review articles, 3 ‘drug focus’ review articles. Sixty-nine (83%) papers contained an adCOI statement under the heading ‘disclosure’ on the paper’s first printed page (n=58, 1 of which referred readers to an ‘acknowledgement’ section) or under the heading ‘conflict of interest’ (n=11, 6 of which described a conflict of interest, 5 stated ‘no conflict of interest’) (Figure 2). Twelve (15%) papers did not contain an adCOI statement. Two (2%) papers were excluded: an error in 1 paper resulted in an incorrect disclosure notice; 1 paper contained a ‘work attributed to’ statement. rpCOI was present in 3 papers; in each of these 3 papers the authors had made appropriate disclosures (Table 2). One paper contained a statement of ‘disclosure’ reading ‘none’, but in this case a ‘conflict of interest’ statement was correctly inserted at the end of the article. T ABLE 2. Analysis of reviewer perceived COI in 81* papers from January to March 2007. COI: conflict of interest; rpCOI: reviewer perceived potential financial conflict of interest; adCOI: author disclosed conflict of interest. *Two papers from the total 83 were excluded from this analysis: an error in 1 paper resulted in an incorrect disclosure notice; 1 paper contained a ‘work attributed to’ statement. Impact of change in journal policy Figure 3 illustrates the impact of the change in journal policy in January 2007, which required a disclosure statement from authors on the first page of their paper. adCOI and rpCOI over the 6 months analysed Ninety-eight of the 165 papers analysed contained an adCOI statement. rpCOI was identified in 17 out of the 165 papers analysed. Twelve of the papers identified as containing an rpCOI also contained adCOIs. Five of these papers (all published before the introduction of the new journal policy) did not include an adCOI. ISMP07 science poster2.indd 1 3/30/07 1:18:02 PM

Transcript of Publication Ethics at International Journal of Clinical ... · COI: confl ict of interest; rpCOI:...

Type of acknowledgement Number reported

Pharmaceutical funding 15

Non-commercial funding 12

Editorial assistance 8

Hospital departments and colleagues 8

Medical writer 5

Statistical assistance 3

Honoraria 3

Previous presentation at a conference 3

Company paid to perform literature review and literature searches 2

Other investigational sites 1

Authors are employees of the pharmaceutical company that funded the study 1

Acknowledgements, October 2006 to March 2007Forty-two papers (25%) of the total audited contained an acknowledgement statement describing one or more item (Table 3).

TABLE 3. Analysis of acknowledgements, October 2006 to March 2007.

Research ethics, October 2006 to March 2007Forty-one papers from the total analysed were judged by the reviewers as reporting studies that may have required some form of ethics approval or informed consent. The authors presented the research ethics information from their studies as follows:

Both ethical review board approval and appropriate informed consent: 23 papers

Informed consent but no ethics: 11 papers

Declaration of Helsinki/Department of Health Guidelines but no ethics or informed consent: 2 papers

Declaration of Helsinki/Department of Health Guidelines/informed consent but no ethics: 3 papers

No ethics/no informed consent: 2 papers

CONCLUSIONS AND RECOMMENDATIONS

Change in journal policy improved transparency The journal policy introduced in January 2007 had a signifi cant impact on encouraging disclosure of potential fi nancial confl icts of interest.

Author disclosed confl ict of interest didn’t correlate with reviewer perceived potential fi nancial confl ict of interestrpCOI was present in 12 of the 98 papers that contained an adCOI. Authors seem to be erring on the side of caution, following the maxim ‘if in doubt, disclose’.

Make information consistentA variety of headings were used to describe confl ict of interest such as ‘disclosure’, ‘fi nancial disclosure’, ‘work attributed to’, and ‘acknowledgement’. Acknowledgements included a variety of statements, including some ‘confl ict of interest’ information. Clarity should be provided by the journal regarding appropriate use of ‘acknowledgement’ statements. The journal should encourage consistent use of headings.

Make statements explicit‘Confl ict of interest’ statements are often not made explicit, although inferences could be made by readers using other information provided in, for example, separate statements of ‘disclosure’ or ‘acknowledgement’. Authors should be encouraged to make statements explicit. For example, in a published review of XXX inhibitors, the following explicit statement was made: ‘The author has received fees for lectures and advisory work from Novartis, MSD and Bristol-Myers Squibb, all of whom are developing XXX inhibitors’.

DISCLOSURESCG is journal publisher, Int J Clin Pract. GJ is editor-in-chief, Int J Clin Pract. AC and EM are employed by GJ.

REFERENCES1. Jackson G. Confl ict of interest: Full disclosure is essential. Int J Clin Pract 2006;60:1147–8.

CONTACTChris Graf, [email protected]

No statement published (n=12)

‘Confl icts of interest’ statement (n=11)

‘Disclosure’ statement (n=58)

adCOI – 11 55

rpCOI 0 0 3

INTRODUCTIONA 6-month audit of ethical publication practices was announced by Graham Jackson in his October 2006 editorial in Int J Clin Pract [1]. The audit examined published original (research) papers, review articles (including review articles from the Int J Clin Pract ‘drug focus’ series), and editorials for fi nancial confl ict of interest, acknowledgement, and declarations about research ethics.

METHODSThe audit was conducted between October 2006 and March 2007. Two reviewers external to Int J Clin Pract staff examined the text from each paper in detail to:

evaluate papers for potential fi nancial confl ict of interest

review acknowledgements listed

consider whether research ethics were appropriate

Reviewer perceived potential fi nancial confl ict of interest (rpCOI) was identifi ed and compared with author disclosed confl ict of interest (adCOI). The audit was based on the criteria for confl ict of interest and acknowledgement presented in the journal’s notes for contributors.

A total of 165 papers were examined: 34 editorials, 86 original research papers, 37 reviews and 8 ‘drug focus’ review articles. A change in journal policy in January 2007 meant all papers were required to include a ‘disclosure’ statement on their fi rst page.

RESULTSResults are presented for the period before the change in journal policy described above (October to December 2006, n=82) and for the period after this change (January to March 2007, n=83).

Confl ict of interest, October 2006 to December 2006 Eighty-two papers were examined: 16 editorials, 47 original papers, 14 review articles, 5 ‘drug focus’ review articles.

Twenty-nine (35%) papers contained an adCOI statement under the heading ‘confl ict of interest’ or ‘disclosure’. Seven of these statements described the authors’ confl icts of interest as ‘none’. One ‘no confl ict of interest’ statement also included a list of the authors’ associations with pharmaceutical companies. 53 (65%) papers contained no adCOI statement (Figure 1).

rpCOI was present in 5 papers where the authors made no disclosure statement, in 1 paper where a ‘confl ict of interest’ statement reported ‘none’, and in 8 papers that included confl ict of interest information under the heading ‘disclosure’ (Table 1).

TABLE 1. Analysis of reviewer perceived COI in 82 papers from October to December 2006.

COI: confl ict of interest; rpCOI: reviewer perceived potential fi nancial confl ict of interest; adCOI: author disclosed confl ict of interest.

Publication Ethics at International Journal of Clinical Practice: A 6-Month Audit of Published Articles for Disclosures of Conflict of Interest, Acknowledgement, and Research EthicsChris Graf,1 Alethea Cooper,2 Elaine McGing,2 Graham Jackson,2 1Blackwell Publishing, Oxford, UK, 2Guy’s & St Thomas’ NHS Foundation Hospital, London, UK

No statement published (n=53)

‘Confl icts of interest’ statement (n=14)

‘Disclosure’ statement (n=15)

adCOI – 13 7

rpCOI 5 1 8

Confl ict of interest, January 2007 to March 2007 Eighty-three papers were examined: 18 editorials, 39 original papers, 23 review articles, 3 ‘drug focus’ review articles.

Sixty-nine (83%) papers contained an adCOI statement under the heading ‘disclosure’ on the paper’s fi rst printed page (n=58, 1 of which referred readers to an ‘acknowledgement’ section) or under the heading ‘confl ict of interest’ (n=11, 6 of which described a confl ict of interest, 5 stated ‘no confl ict of interest’) (Figure 2). Twelve (15%) papers did not contain an adCOI statement. Two (2%) papers were excluded: an error in 1 paper resulted in an incorrect disclosure notice; 1 paper contained a ‘work attributed to’ statement.

rpCOI was present in 3 papers; in each of these 3 papers the authors had made appropriate disclosures (Table 2). One paper contained a statement of ‘disclosure’ reading ‘none’, but in this case a ‘confl ict of interest’ statement was correctly inserted at the end of the article.

TABLE 2. Analysis of reviewer perceived COI in 81* papers from January to March 2007.

COI: confl ict of interest; rpCOI: reviewer perceived potential fi nancial confl ict of interest; adCOI: author disclosed confl ict of interest.

* Two papers from the total 83 were excluded from this analysis: an error in 1 paper resulted in an incorrect disclosure notice; 1 paper contained a ‘work attributed to’ statement.

Impact of change in journal policyFigure 3 illustrates the impact of the change in journal policy in January 2007, which required a disclosure statement from authors on the fi rst page of their paper.

adCOI and rpCOI over the 6 months analysedNinety-eight of the 165 papers analysed contained an adCOI statement. rpCOI was identifi ed in 17 out of the 165 papers analysed. Twelve of the papers identifi ed as containing an rpCOI also contained adCOIs. Five of these papers (all published before the introduction of the new journal policy) did not include an adCOI.

ISMP07 science poster2.indd 1 3/30/07 1:18:02 PM