Advertisements, Advertorials, Sponsorship, Supplements, Reprints, and e-Prints - Ethical and Legal Considerations

AMA Manual of Style - Stacy L. Christiansen, Cheryl Iverson 2020

Advertisements, Advertorials, Sponsorship, Supplements, Reprints, and e-Prints
Ethical and Legal Considerations

Regardless of platform or format, the difference between editorial content and marketing messages should be clear to the average reader.

American Society of Magazine Editors1

Commercial activities, such as advertising, sponsorship, reprints, and e-prints, provide a major source of revenue for many scientific publications. With this revenue, publications can offset some of the costs of journal operations, production, and distribution; may be able to set lower subscription rates than would otherwise be possible; and can serve as a source of income for the journal’s owner. Thus, some editors and publishers consider advertising a financial necessity. From a financial perspective, generating revenue is an important goal of advertisers, publishers, and editors—advertisers want to sell more products, publishers want to increase journal revenue, and editors want their journals to remain financially viable and sustainable. However, editors have a larger ethical responsibility to their readers, who must be able to rely on the editor to ensure that the journal’s integrity remains intact and that the information contained in the publication is valid and objective. This responsibility includes ensuring that advertising does not influence editorial decisions or content and having policies and procedures in place that prevent such influence.

Thus, editors should have ultimate responsibility for all content published in their journals, including advertisements and sponsored content (see 5.10, Editorial Freedom and Integrity, and 5.11, Editorial Responsibilities, Roles, Procedures, and Policies). The International Committee of Medical Journal Editors (ICMJE) recommends that editors “have full and final authority for approving print and online advertisements and enforcing advertising policy.”2 New or revised advertisements should be shown to the editor far enough in advance to ensure compliance with advertising guidelines. If an advertisement is deemed to be noncompliant, the advertiser may be offered the opportunity to revise the advertisement. However, some editors may not be able to review and approve specific ads because of limited resources (personnel and time). In these cases, someone representing the journal who understands the advertising policies and who is not in the sales or marketing department should review the ads. Nevertheless, all editors should be involved in the development, enforcement, and evaluation of formal advertising policies for print and online versions of their journals. For example, principles for advertising in print and online are developed jointly by editorial and publishing staff for the JAMA Network journals.3 These principles are used by publishing and editorial staff to determine the suitability of advertising. Although editorial and publishing staff regularly review and discuss these policies and their applicability in specific situations, the JAMA Network journals editor in chief has final authority over all content, including advertisements, and can decide to accept or reject for publication any ads based on the advertising principles.

Advertising must not be allowed to influence editorial decisions.1,2 All editorial decisions must be based on the quality and suitability of the editorial content and should not be influenced by potential revenue or loss of revenue from advertising, sponsorship, sales of reprints/e-prints, or related commercial activities or the influence of ad sales and marketing representatives. This policy is supported by the ICMJE,2 World Association of Medical Editors (WAME),4 and the Committee on Publication Ethics (COPE).5 Complete separation of the roles and functions that determine editorial decisions and advertising sales is critical. Thus, editorial staff must not be involved in the promotion or sale of any advertisements, and the publishing staff who sell advertisements and sponsorship should not be permitted access to editorial content until it is published. Editors should have policies and procedures in place to address reader and online user concerns and complaints, assessment of such concerns, and appropriate remedy or action. The ICMJE recommends that editors consider publishing letters that raise important concerns about advertising content in the same way that they publish letters that raise concerns about articles,2 including asking the advertiser to submit a reply.

5.12.1 Advertisements.

Advertisements appear in print and online journals, email alerts, other online products and services, apps, and other types of media (such as podcasts and blogs). For biomedical publications, advertisements typically include the following:

■Advertisements that promote professional or trade-related products (primarily pharmaceuticals and medical equipment in biomedical publications), services, educational opportunities or products, or announcements (see 5.12.3, Advertorials). For print publications, these are typically called display advertisements. For digital publications online, online advertisements generally take the form of banner placements, including position placements (static, animated, or expanding) that display in fixed locations on a page/screen, interstitial placements (including pop-up windows and floating ads) that launch and cover page/screen content at or following page load and may require user action to close or dismiss, or text-based ads, such as email alerts or other online communications of information (see 5.12.6, Advertising and Sponsorship in Online Publications).

■Advertisements that promote products and services not specifically related to a profession or trade (such as an ad for an automobile or an airline in a medical journal).

■Classified or recruitment advertisements (listings of employment opportunities, educational courses, workshops, announcements, or other services).

In most cases, advertisers pay to place advertisements for their products and services in publications. Those advertisements for which a publisher does not typically charge a fee include public service announcements, ads for nonprofit organizations or charities, and house ads, which promote a product or service provided by the owner of the publication.

Important considerations for editors and publishers are whether paid advertisements and sponsorship invite potential infringements on editorial independence and whether they represent important revenue opportunities for journals in increasingly competitive markets.6,7 The keys to maintaining editorial integrity are to achieve a balance between these seemingly opposing forces, maintain a recognizable separation between the functions and decisions of editorial and advertising departments, and have consistent and publicly available policies on advertising and sponsorship.1,2,3,4,5,6,8,9,10

Although the primary function of most journals is to educate and inform in a neutral manner and that of advertisements is to educate and inform in a promotional manner, advertisers and editors share a common goal—to influence the behavior of readers. Obvious differences between editorial text and advertising copy exist. In biomedical publication, editorial material typically comprises text composed in a consistent scholarly format with data-filled tables and figures, whereas advertisements typically contain colorful formatting, bold statements, and eye-catching graphics. Scholarly editorial material is generally intended to be objective, whereas advertisements are generally intended to be preferential, selective, and persuasive. Problems arise when the means to achieve the common goal—of influencing behavior—are outside expected norms or violate specific regulations and standards. The guidelines of the American Society of Magazine Editors (ASME) state that editors should not permit advertisers to influence or compromise editorial integrity and should not allow advertisements to deceive readers.1

The Principles Governing Advertising in Publications of the American Medical Association is a useful guide for other journals and publications and includes the following3:

These principles, developed jointly by editorial and publishing staff, are applied by the American Medical Association (AMA) to ensure adherence to the highest ethical standards of advertising and to determine the eligibility of products and services for advertising in the AMA’s print and digital publications.

The appearance of advertising in AMA publications is neither a guarantee nor an endorsement by the AMA or the AMA publication of the product or the claims made for the product in such advertising.

The fact that an advertisement for a product, service, or company has appeared in an AMA publication shall not be referred to in collateral advertising. As a matter of policy, the AMA will sell advertising space in its publications.

To maintain the integrity of the AMA publications, advertising (ie, promotional material, advertising representatives, companies, or manufacturers) cannot influence editorial decisions or editorial content. Decisions to sell advertising space are made independently of and without information pertinent to specific editorial content. AMA publications’ advertising sales representatives have no prior knowledge of specific embargoed editorial content before it is published.

In many countries, advertisers must meet specific criteria established by national regulatory agencies. For example, drug ads are required to follow the regulations of the Food and Drug Administration in the United States,11 the Association of the British Pharmaceutical Industry in the United Kingdom,12 and the Pharmaceutical Advertising Advisory Board in Canada.13 The International Federation of Pharmaceutical Manufacturers Associations14,15 and the World Health Organization16 have guidelines for pharmaceutical marketing practices that may be helpful for countries without well-defined regulations. However, these regulatory agencies have been criticized for not enforcing their regulations, and a number of studies17,18,19,20 have found evidence of misleading advertisements published in biomedical journals.

5.12.2 Guidelines for Advertisements Directed to Physicians and Other Health Care Professionals.

The editorial and publishing staff of the JAMA Network journals have developed general eligibility requirements and guidelines for advertising copy to ensure that advertisements published in these journals are appropriate (see Boxes 5.12-1 and 5.12-2).3 The ASME also has developed a set of principles for advertisements.1

Box 5.12-1. Eligibility Requirements to Advertise in Journals Published by the American Medical Association (AMA)a

1.The AMA, in its sole discretion, reserves the right to decline any submitted advertisement or to discontinue publication of any advertisement previously accepted. By submitting ads for consideration, all advertisers agree to the Principles Governing Advertising in Publications of the American Medical Association and all Rate Card provisions, as amended from time to time.

2.Products or services eligible for advertising shall be germane to, effective in, and useful in (a) the practice of medicine, (b) medical education, and/or (c) health care delivery and shall be commercially available.

3.In addition to the above, products and services that are offered by responsible advertisers that are of interest to physicians, other health professionals, and consumers are also eligible for advertising.

4.Pharmaceutical products for which approval of a New Drug Application by the Food and Drug Administration (FDA) is a prerequisite for marketing must comply with FDA regulations regarding advertising and promotion.

5.Institutional advertising germane to the practice of medicine and public service messages of interest to physicians may be considered eligible for appearance in AMA publications.

6.Alcoholic beverages and tobacco products may not be advertised.

7.Equipment, Instruments, and Devices: The AMA determines the eligibility of advertising for products intended for preventive, diagnostic, or therapeutic purposes. Complete scientific and technical data concerning the product’s safety, operation, and usefulness may be required. These data may be either published or unpublished. Samples of equipment, devices, or instruments should not be submitted. The AMA reserves the right to decline advertising for any product that is involved in litigation with a governmental agency with respect to claims made in the marketing of the product.

8.Food Products: (a) general-purpose foods, such as bread, meats, fruits, and vegetables, are eligible; (b) special-purpose foods (eg, foods for carbohydrate-restricted diets and other therapeutic diets) are eligible when their uses are supported by acceptable data; and (c) dietary programs: only diet programs prescribed and controlled by physicians may be eligible.

9.Dietary Supplements: Advertisements for dietary supplements and vitamin preparations are not eligible unless the safety and efficacy of the product have been reviewed and approved by the FDA for a disease claim.

10.Books: A book may be requested for review to determine its eligibility to be advertised.

11.Insurance Coverage: Claims made in advertisements for insurance coverage must conform with the following specific criteria: (a) claims relating to policy benefits, losses covered, or premiums must be complete and truthful; (b) claims made shall include full disclosure of exclusions and limitations affecting the basic provisions of policy; (c) claims incorporating quoted testimonials must meet the same standards as other claims; and (d) each advertisement for insurance products and services must include a statement indicating either the states in which the products or services are available or the states in which the products or services are not available.

12.CME Programs: Advertisements for continuing medical education (CME) programs are not eligible unless the CME sponsor is accredited by the Accreditation Council for Continuing Medical Education and is an accredited medical school (or hospital affiliated with such a school), a state or county medical society, a national medical specialty society, or other organization affiliated with the American Board of Medical Specialties member boards.

13.Miscellaneous Products and Services: Products or services not in the above classifications may be eligible for advertising if they satisfy the general principles governing eligibility for advertising in AMA publications.

aReproduced from Principles Governing Advertising in Publications of the American Medical Association.3

These guidelines are intended for advertisements for US-based companies, products, and services. See references 12 through 16 for examples of relevant guidelines for other countries

Box 5.12-2. Guidelines for Advertising Copy in Journals Published by the American Medical Association (AMA)a

1.The advertisement should clearly identify the advertiser of the product or service offered. In the case of pharmaceutical advertisements, the full generic name of each active ingredient shall appear.

2.Layout, artwork, and format shall be such as to be readily distinguishable from editorial content and to avoid any confusion with the editorial content of the publication. The word “advertisement” may be required.

3.Unfair comparisons or unwarranted disparagement of a competitor’s products or services will not be allowed.

4.Advertisements will not be acceptable if they conflict with either the Principles of Medical Ethics of the American Medical Association or the advertising guidelines in Current Opinions of the Council on Ethical and Judicial Affairs of the American Medical Association.

5.It is the responsibility of the manufacturer to comply with the laws and regulations applicable to the marketing and sale of its products. Acceptance of advertising in AMA publications should not be construed as a guarantee that the manufacturer has complied with such laws and regulations.

6.Advertisements may not be deceptive or misleading.

7.Advertisements will not be accepted if they are offensive in either text or artwork, or contain attacks or derogations of a personal, racial, sexual, or religious nature, or are demeaning or discriminatory toward an individual or group on the basis of age, sex, race, ethnicity, religion, physical appearance, or disability.

a Reproduced from Principles Governing Advertising in Publications of the American Medical Association.3

The following criteria for print pharmaceutical ads are adapted from the guidelines prepared by the World Health Organization16 and the International Federation of Pharmaceutical Manufacturers Associations14:

Advertising text should be presented legibly.

Pharmaceutical ads in print journals must include the following (in online ads, this information may be included on a website to which the ad links):

Name of the product, typically the trade (brand) name

The active ingredients, using either the international nonproprietary names or the approved generic name of the drug

The drug’s main indication, precautions, most frequent or severe adverse events, contraindications, and clinically relevant interactions and warnings

Name and address of the manufacturer or distributor and how to contact them

Date of production of the advertisement

Abbreviated prescribing information, which should include an approved indication or indications for use together with the dosage and method of use and a succinct statement of the contraindications, precautions, and adverse effects

For a “reminder” advertisement (a “short advertisement containing no more than the name of the product and a simple statement of indications to designate the therapeutic category of the product”14), the abbreviated prescribing information may be omitted (see 5.12.3, Advertorials).

When published studies are cited in promotional material, standard retrievable references with complete bibliographic information should be included (see 3.0, References). Information in advertisements and other promotional material, such as excerpts from the medical literature or quotations from personal communications, must not change or distort the intended meaning of the author(s) or the significance of the relevant work or study. Prepublication peer review and editorial evaluation of articles help to reduce problems associated with misleading or inappropriate information from published articles, but ads do not typically undergo the same level of evaluation before publication. Several studies18,19,20,21,22,23 have documented problems with advertisements in medical journals, including promotional statements not being accurately supported by references, references cited to support promotional statements that are not retrievable (eg, “data on file”), and numerical distortion of data presented in tables and graphs.

According to the International Federation of Pharmaceutical Manufacturers Associations,14 the same requirements that apply to printed materials should also apply to electronic promotional materials, including audiovisuals. Specifically, in the case of pharmaceutical product—related websites, the identity of the pharmaceutical company and of the intended audience should be readily apparent, the content and presentation should be appropriate for the intended audience, and country-specific information should comply with local laws and regulations15 (see 5.12.6, Advertising and Sponsorship in Online Publications). Typically, an online advertisement links to a company’s website, where the details about the prescribing information as listed above are provided.

The following issues should be addressed in any journal’s policy on advertising:

1.Advertising to editorial content ratio

2.Advertising placement and positioning: including interspersion of ads within editorial content, advertising-editorial juxtaposition (adjacency), and placement of ads on journal covers

3.Separation of advertising sales and influence from editorial decisions

4.Appropriate advertising content

5.12.2.1 Advertising to Editorial Content Ratio.

For print publications that have an abundance of advertising, setting an advertising to editorial page ratio (ie, limiting the advertising content to no more than a certain proportion of total annual pages) may help protect the perceived integrity of the publication.24 The ICMJE recommends that journals not be dominated by advertising.2 If possible, journals should avoid publishing advertisements from only 1 advertiser; otherwise readers may perceive that the journal is sponsored by this single advertiser or that this advertiser has influenced the editor and the editorial content. For print journals, compliance with relevant postal regulations in some countries may also need to be considered if the number of ad pages exceeds the number of editorial pages. The ratio of editorial to advertising in digital versions of journals should also follow these general principles.

5.12.2.2 Advertising Placement and Positioning.

5.12.2.2.1 Advertising Interspersion.

Placing advertisements between articles and interleaving them within articles may attract advertisers, but such practices may also diminish the perceived credibility of the publication—especially if the ads create difficulty for the reader in reading or finding editorial content. For scholarly biomedical journals, ads should not be interleaved within a scientific or clinical article in print or online. Many print publications group or stack their ads in the front and back of their journals, leaving a separate section of editorial content (an editorial well) in the middle of the publication for articles that are not interspersed with ads. Some advertisers may avoid journals that stack ads because they want their ads to be placed next to editorial material. For that reason, some journals place popular editorial features (such as news articles) in the front and back of the journal to allow for ad interspersion of those sections and maintain an ad-free editorial well for the original research and other major articles. Ordinarily, ads should not appear on a print journal’s front cover. For discussion of online advertising interspersion, see 5.12.6, Advertising and Sponsorship in Online Publications.

5.12.2.2.2 Advertising-Editorial Juxtaposition (Adjacency).

Advertisers may request placement of their ads next to related editorial content to help promote their products. Although common in consumer publishing, this practice is discouraged by the ICMJE and WAME.2,4 The ASME offers this broad principle that applies to both print and online advertising: “advertisements should not be integrated into editorial content” to avoid the implication of editorial endorsement of the product or service promoted in the ad.1 Ad adjacency, like interspersion, may be an impediment to readers and may diminish the perceived integrity of a scholarly publication. The Principles Governing Advertising in Publications of the American Medical Association state that “placement of advertising adjacent to (ie, next to or within) editorial content on the same topic is prohibited.”3 To avoid the occurrence of adjacent ads and editorial content on the same topic, even by chance, the editorial and production staff of the JAMA Network journals reviews the entire makeup (imposition or rundown) of the print issue of the journal after the ad deadlines have closed and before the journal is printed. If an ad is scheduled to appear adjacent to an article on the same or a closely related topic, the editors ask the production staff to move the ad or may decide to move the article. For those journals that permit online ads on pages with editorial content, ad adjacency policies should be developed that maintain the journal’s editorial integrity. (See 5.12.6, Advertising and Sponsorship in Online Publications, for additional discussion of advertising-editorial adjacency in online publications.)

5.12.2.2.3 Advertising on or Around Journal Covers.

Although advertisements ordinarily should not be placed on print journal covers, some journals permit ads to be attached to covers (with removable cover tips), around covers (with belly bands), or as unattached ads (outserts) that are placed in a transparent polybag with the journal provided that these ads do not conceal the journal’s title/logo or the postal address of the recipient if being sent through the mail.

5.12.2.3 Separation of Advertising Sales and Influence From Editorial Decisions.

Specific advertising and commercial content should not influence editorial decisions and content. The ICMJE states that “advertising must not be allowed to influence editorial decision.”2 COPE concurs, adding that “advertising departments should operate independently from editorial departments.”5 Providing advertising sales representatives with editorial calendars that include specific content scheduled for upcoming issues invites pressure for advertising-editorial adjacency and other attempts from industry to interfere with editorial decisions. The ASME advises that editorial content of any kind should not be submitted to advertisers for approval.1 Recognizing the need for inherent separation between the planning and scheduling of editorial content and advertising, the ICMJE states that advertising should not be sold on the condition that it will be juxtaposed with specific editorial content.2 Journal editors and publishers can respond to industry pressure by reminding advertisers of the importance of the journal’s integrity. Advertisers understand this issue because without integrity a publication will have few readers, and without readers, the advertiser cannot reach potential users and purchasers of their products. For this reason, advertising sales staff should not have access to the specific embargoed editorial content until after publication. However, sales staff may know about general editorial plans, such as plans for theme issues, proceedings, symposia, or sponsored supplements (see 5.12.4, Sponsored Supplements).

5.12.2.4 Appropriate Advertising Content.

Appropriate ads must meet the following requirements3,14,16:

■No false claims

■No implied false claims

■Ability to substantiate claims

■No omissions of important facts

■No distortion of data

■Good taste (although this is difficult to define objectively)

■Clear identification of the advertiser of the product or services being offered

■Layout, artwork, and format that differ from those of the editorial content so that readers can clearly distinguish the advertising and editorial content

5.12.3 Advertorials.

An advertorial is an advertisement that imitates editorial content or presents content in an editorial-like format, such as using text, tables, or figures in a manner similar to the journal’s editorial content. During the early 1990s, following a decline in the biomedical advertising market, advertorials became more common. The ASME principles state: “Regardless of platform or format, the difference between editorial content and marketing messages should be clear to the average reader” and that “advertisements that mimic the ’look and feel’ of the print or digital publication in which they appear may deceive readers and should be avoided.”1 The ASME previously published guidelines for special advertising sections25; these guidelines have been replaced by general guidelines that emphasize transparency.1 See Box 5.12-3 for ASME guidelines relevant to special advertising sections and for differentiating editorial content and advertising.

Box 5.12-3. ASME Guidelines to Differentiate Editorial Content and Advertisinga

■Regardless of platform or format, the difference between editorial content and marketing messages should be clear to the average reader. On websites populated by multiple sources of content, including user-generated content, aggregated content and marketer-provided content, editors and publishers must take special care to distinguish between editorial content and advertising. Advertisements that mimic the “look and feel” of the print or digital publication in which they appear may deceive readers and should be avoided.

■Print and digital advertisements that resemble editorial content should be identified as advertising in compliance with Federal Trade Commission regulations. 73 FTC 1307 (1968) states that when a marketing message “uses the format and has the general appearance of a news feature and/or article for public information which purports [to give an] independent, impartial and unbiased view . . . the Commission is of the opinion that it will be necessary to clearly and conspicuously disclose it is an advertisement.”

■The United States Postal Service also requires the labeling of editorial-like print advertisements: The USPS Domestic Mail Manual states that “under 18 USC 1734, if a valuable consideration is paid, accepted, or promised for the publication of any editorial or other reading matter in a Periodicals publication, that matter must be plainly marked ’advertisement.’ ”

■To ensure that such labeling is clear and conspicuous, ASME recommends the use of terms such as “Advertisement,” “Advertising,” and “Special Advertising Section” for print advertising units and further recommends that these terms should be printed horizontally and centered at the top of each advertising unit in readable type.

■ASME also recommends that native advertising on websites and in social media should be clearly labeled as advertising by the use of terms such as “Sponsor Content” or “Paid Post” and visually distinguished from editorial content and that collections of sponsored links should be clearly labeled as advertising and visually separated from editorial content.

a Reproduced with permission from the American Society of Magazine Editors.1

Companies may submit advertisements that provide information on a topic that pertains to a product the company markets (or plans to market) but that do not name any commercial product. It is essential that such ads are clearly labeled “Advertisement,” have a different format from the journal’s editorial content, and include a prominent display of the company name, logo, or both so that readers can quickly ascertain that the information is an advertisement from the company and not part of the journal’s editorial content.

5.12.4 Sponsored Supplements.

Sponsored supplements are collections of articles, usually on a single topic, and are published as an extra edition or a separate section of a journal, often after a meeting or symposium. Studies have found that articles published in sponsored supplements are less likely to undergo formal peer review and are more likely to have promotional attributes, such as misleading titles, focus on a single-drug topic, and use of brand names only.26,27,28,29 Because of the promotional and biased quality of such industry-sponsored supplements, the JAMA Network journals do not publish them. In addition, the US National Library of Medicine will not index articles in sponsored supplements unless sponsorship is clearly indicated and certain disclosure conditions regarding authors and editors are met.30 The BMJ published a debate on the pros and cons of publishing sponsored content, including the following arguments29 in favor: (1) they provide added value if safeguards are followed and (2) excluding industry is unrealistic; and opposed: (1) reader confusion, (2) risk to the journal’s brand and reputation, and (3) editors cannot avoid being influenced.

Supplements can serve useful educational purposes, provided the content is objective, balanced, independent, and scientifically rigorous and sponsorship is transparent.1,2,29,30 Sponsored supplements also may provide additional revenue to publishers. Recognizing this, the ICMJE developed a set of recommendations to guide editors when considering the publication of sponsored supplements.2 The ICMJE recommendations, listed below, should help avoid bias in the selection of content for inclusion in industry-sponsored publications2:

The journal editor must be given and must take full responsibility for the policies, practices, and content of supplements, including complete control of the decision to select authors, peer reviewers, and content for the supplement. Editing by the funding organization should not be permitted.

The journal editor has the right to appoint one or more external editors of the supplement and must take responsibility for the work of those editors.

The journal editor must retain the authority to send supplement manuscripts for external peer review and to reject manuscripts submitted for the supplement with or without external review. These conditions should be made known to authors and any external editors of the supplement before beginning editorial work on it.

The source of the idea for the supplement, sources of funding for the supplement’s research and publication, and products of the funding source related to content considered in the supplement should be clearly stated in the introductory material.

Advertising in supplements should follow the same policies as those of the primary journal.

Journal editors must enable readers to distinguish readily between ordinary editorial pages and supplement pages.

Journal and supplement editors must not accept personal favors or direct remuneration from sponsors of supplements.

Secondary publication in supplements (republication of papers published elsewhere) should be clearly identified by the citation of the original paper and by the title.

The same principles of authorship and disclosure of potential conflicts of interest discussed elsewhere in this document should be applied to supplements.

5.12.5 Other Forms of Sponsorship.

Other forms of sponsorship include sales of bulk subscriptions or content licenses to commercial entities for distribution or access to individuals or groups, noncommercial sponsorship or grants to support specific editorial sections, and grants to support publication of journals in resource-poor communities. With each type of sponsorship, the funding source should be clearly indicated to recipients and readers/users, and all editorial content should be under the complete authority of the editor, should undergo the journal’s usual editorial evaluation and peer review, and should not be influenced by the sponsor(s).

5.12.6 Advertising and Sponsorship in Online Publications.

Online ads are not restricted by the physical limits of a printed page. For example, an advertiser or content user can increase the type size of the prescribing information that appears in small type in an online pharmaceutical ad. Ads can rotate, expand, be animated, or pop up on or float into a screen with or without the user’s initiated action. An ad for a particular drug, product, or service can be hyperlinked to the manufacturer or provider’s website. In addition, ads can be targeted for specific users or a specific user experience. Online publication and technologic innovation have challenged the traditional print-based standards that separate advertising and editorial content. However, the general principles for protecting editorial integrity of print publications apply to advertising in online publications and other electronic products, such as websites, email, audio and video recordings, apps, social media and blogs, and online databases, especially for publications in clinical and health-related fields.1,2,4,5 For example, just as a print reader can choose to read an ad or skip over it, an online user should have the same choice. Online ads should display in a distinct position that does not overlap editorial content or, when overlapping is unavoidable (eg, with interstitial ads or expanding banners), they should be easily dismissible through an automatic or user-initiated close function to not interfere with the reading and use of editorial content and should not dominate the online content. Online ads and sponsored content should be readily distinguishable from editorial content. As stated by the ASME, “on websites populated by multiple sources of content, including user-generated content, aggregated content and marketer-provided content, editors and publishers must take special care to distinguish between editorial content and advertising.”1

5.12.6.1 Privacy Concerns Related to Advertising.

Privacy rights of online journal users and visitors must be maintained. If any specific or personal information about users is to be collected and specifically distributed or sold to third parties (such as advertisers), users should be informed in advance and given the opportunity to not have their information shared with others. Aggregate demographic information about numbers and types of users may be provided to advertisers to guide decisions about placing advertisements in specific journals in the same manner that circulation numbers are provided to advertisers and used for decisions to place print ads. This information may also be used by publishers to set advertisement rates and fees. Data on digital advertising metrics that do not capture or convey personally identifiable user information, such as overall numbers of users, impressions (ie, number of times an advertisement has been observed), and banner ad click-through numbers and rates (percentage of user-initiated banner clicks to impressions), generally are acceptable to share with advertisers. As digital advertising technologies evolve, new categories of activity tracking measures may allow advertisers and publishers to leverage functionality and measure user behavior (eg, views, impression downloads, interaction or hover data) as well as mitigate concerns about illegitimate data (eg, invalid increases from robotic nonhuman traffic or humans committing fraud). Wherein the function and intent of established and evolving advertising technologies do not capture or convey personally identifiable user information and provided they do not violate other journal advertising policies, user data generally can be shared with advertisers. The Interactive Advertising Bureau provides useful standards and best practices about digital advertising for advertisers, publishers, and other media, including guidelines for digital advertising display, compliance with legislation and regulation, and sharing of user data.31

5.12.6.2 Guidelines for Online Advertising and Sponsorship.

As the technology advances, online advertising will provide additional opportunities and ethical dilemmas for publishers and editors. Accordingly, guidelines for online advertising and sponsorship will also continue to evolve. The guidelines developed for use in online versions of the JAMA Network journals3 provide guidance for advertising in online publications and appear in Box 5.12-4.

Box 5.12-4. Advertising in Digital Publicationsa

The current standards for ensuring the editorial integrity of print publications apply to advertising in electronic publications and derivative products, such as online journals, websites, and online databases, especially for publications in clinical and health-related fields.

In-text linking within an article to an advertisement is not permitted.

Advertisements that appear on journal website pages may coincidentally be related to the subject of an article, but such juxtaposition must be random.

Viewers will not be sent to a commercial site unless they choose to do so by clicking on an advertisement.

Expanding advertisements will expand only if a viewer scrolls over or clicks on them.

Interstitial and riser advertisements may appear for nonauthenticated audiences and may require user-initiated actions to close or dismiss the advertisements.

Advertisements with audio will play audio only if a viewer clicks on the advertisement.

A.Advertising

1.Digital advertising may be placed on the JAMA Network journal websites.

2.Digital advertisements must be readily distinguishable from editorial content and the word “Advertisement” must be displayed. Advertisements may link off-site to a commercial website.

3.Digital advertisements may appear as static or animated advertisements.

4.Digital advertisements may not be sold to be intentionally juxtaposed with, appear in line with, or appear adjacent to an article on the same topic. However, because ads rotate in various positions, adjacency may occur coincidentally or at random.

5.JAMA Network journals’ logos may not appear on commercial websites as a logo or in any other form without prior written approval by the individuals responsible for the respective areas within the AMA.

6.Websites shall not frame the JAMA Network journal website content without express permission, shall not prevent the viewer from returning to the JAMA Network journal website or other previously viewed screens, and shall not redirect the viewer to a website the viewer did not intend to visit. The JAMA Network journals reserve the right to not link to or to remove links to other websites.

7.All online advertising (including email advertisements) must be reviewed and approved by the JAMA Network journals’ editorial and publishing staff. Such review will include the website landing page to which the advertisement links. Specific requirements are provided below.

B.Website Advertisement Requirements

1.Articles will not include internal links to advertisements.

2.Advertisements must follow the Guidelines for Advertising Copy and must not include unsubstantiated claims.

3.The word “Advertisement” will appear adjacent to the advertisement and will be hyperlinked to a landing page that states the following: This is a paid advertising placement and the JAMA Network journals do not endorse the advertised product. Advertisements must adhere to the JAMA Network journals’ Online Advertising Principles.

4.The website URL to which the advertisement links must be provided to editorial and publishing staff for review and prior approval and must contain the following elements: (a) company sponsoring the website is clearly displayed and (b) no registration of personal information is required before reaching the website

C.Requirements for Advertisements in Email Alerts

1.Email alerts may have HTML advertisements embedded in the email (top and/or bottom).

2.The word “Advertisement” must appear adjacent to the advertisement.

3.Advertisements must follow the Guidelines for Advertising Copy and must not include unsubstantiated claims.

4.The website URL to which the ad links must be provided for review and must contain the following elements: (a) the company sponsoring the website is clearly displayed and (b) no registration of personal information is required before reaching the website.

a Reproduced from Principles Governing Advertising in Publications of the American Medical Association.3

15.12.6.3 Online Sponsorship.

The ICMJE acknowledges that “various entities may seek interactions with journals or editors in the form of sponsorships, partnerships, meetings, or other types of activities” and that standards should be followed to preserve editorial independence.2 The following recommendations are offered for journals that publish sponsored content online:

■Editorial content of any sponsored product (eg, online publications, websites, email, audio and video recordings, apps, social media and blog posts, and online databases) should be determined by the standard editorial process.

■The sponsor should have no influence over the editorial content of any sponsored product.

■Sponsorship policies should be clearly noted, either in text accompanying the product or on a disclosure page, and should clarify that the sponsor had no input into or influence over the content.

■All financial or material support for sponsored content should be acknowledged and clearly indicated (eg, on the home or landing page as well as on any packaging and collateral material included).

■These acknowledgments should not make any claim for any supporting company product(s). The final wording and positioning of the acknowledgment should be determined by the journal, with review and approval by the editor. The wording could be similar to “Produced by [Journal Name] with support from [Company Name].”

■The acknowledgment of the sponsor’s support may be linked to the sponsor’s website.

■Journal names and logos should not appear on the sponsoring company website without prior written approval by the journal.

■Journal search engines should not include content from sponsors unless the results of such searches clearly indicate the difference between sponsored and nonsponsored content. Sponsors should not receive preferential treatment in search programs and search results.

■Journals should carefully consider the pros and cons of use of digital native advertisements (online ads presented in the same format as editorial content and interspersed within editorial content), and, if permitted, transparent indication of sponsored content and the name of the sponsor should be provided.

See 5.12.4, Sponsored Supplements.

5.12.7 Reprints and e-Prints.

Publishers of journals may sell reprints and eprints of journal articles as a source of revenue. Reprints and e-prints may be purchased by authors for personal use, by others for educational purposes, or by commercial entities for promotional purposes. In biomedical journal publishing, a reprint is the republication of an article or collection of articles in which the content is unchanged from the original publication (except perhaps for the inclusion of postpublication corrections). An e-print is a digital reproduction of or an online link to an article or collection of articles, usually PDF files(s). For example, publishers of the JAMA Network journals sell reprints to authors (at relatively low cost) as a service for authors and to the pharmaceutical industry as a source of revenue. Many journals permit authors to post e-prints of their articles (usually PDF files) on personal or other archival/institutional websites and to deposit copies in public repositories to meet requirements of funders (see 5.6.2, Public Access and Open Access in Scientific Publication), and some journals permit commercial entities to purchase and post copies of eprints on their websites. Note: Reprints and e-prints differ from preprints, which are print and online versions of articles/manuscripts made formally available to others before publication in a peer-reviewed journal.

Journals should establish and follow consistent policies and procedures on the production, sale, review or approval, and distribution or dissemination of reprints and e-prints. For an example of such standards, see those developed for JAMA in 5.6.9, Standards for Commercial Reprints and e-Prints. Editorial decisions must be free of any influence from the potential for sale of reprints and e-prints, and all such sales must not be permitted to occur until after publication of the original article. Reprinted articles should not be abridged or altered by the purchaser and should not include an advertisement or the advertiser’s logo or other commercial content. A publisher may incorporate or append a correction to a previously published article in a reprint/e-print as long this is noted in the reprint/e-print.

Principal Author: Annette Flanagin, RN, MA

Acknowledgment

I thank the following for review and helpful comments: Karen Adams-Taylor, JAMA Network; Howard Bauchner, MD, JAMA and JAMA Network; Carissa Gilman, American Cancer Society, Atlanta, Georgia; Timothy Gray, PhD, JAMA Network; Iris Y. Lo, JAMA Network; and Sean O’Donnell, JAMA Network.

References

1.American Society of Magazine Editors. ASME guidelines for editors and publishers. April 15, 2015. Accessed January 1, 2019. http://www.magazine.org/asme/editorial-guidelines

2.International Committee of Medical Journal Editors. Recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals. Updated December 2018. Accessed January 1, 2019. https://www.icmje.org/recommendations

3.American Medical Association. Principles Governing Advertising in Publications of the American Medical Association. Revised February 2016. Accessed January 1, 2019. https://jamanetwork.com/DocumentLibrary/Advertising/AMA_Advertising_Principles_Feb2016.pdf

4.World Association of Medical Editors. Recommendations on publication ethics policies for medical journals. Accessed January 1, 2019. http://wame.org/recommendations-on-publication-ethics-policies-for-medical-journals

5.Committee on Publication Ethics. Principles of transparency and best practice in scholarly publishing. Updated January 15, 2018. Accessed January 1, 2019. https://publicationethics.org/resources/guidelines-new/principles-transparency-and-best-practice-scholarly-publishing

6.Fletcher RH. Adverts in medical journals: caveat lector. Lancet. 2003;361(9351):10-11. doi:10.1016/S0140-6736(03)12185-X

7.Tsai AC. Conflicts between commercial and scientific interests in pharmaceutical advertising for medical journals. Int J Health Serv. 2003;33(4):751-768. doi:10.2190/K0JG-EXG1-FB12-0ANF

8.Smith R. Medical journals and pharmaceutical companies: uneasy bedfellows. BMJ. 2003;326(7400):1202-1205. doi:10.1136/bmj.326.7400.1202

9.Callaham M. Journal policy on ethics in scientific publication. Ann Emerg Med. 2003;41(1):82-89. doi:10.1067/mem.2003.42

10.Lexchin J, Light DW. Commercial influence and the content of medical journals. BMJ. 2006; 332(7555):1444-1447. doi:10.1136/bmj.332.7555.1444

11.US Food and Drug Administration. Title 21: Food and Drugs. Chapter 1: Food and Drug Administration, Department of Health and Human Services. Subchapter C: drugs: general. 21CFR 202.1. Current as of April 1, 2018. Accessed January 1, 2019. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=202.1

12.Prescription Medicines Code of Practice Authority. Code of Practice for the Pharmaceutical Industry 2016. Accessed January 1, 2019. http://www.pmcpa.org.uk/thecode/Pages/default.aspx

13.Pharmaceutical Advertising Advisory Board. The PAAB code of advertising acceptance. Updated January 1, 2018. Accessed January 1, 2019. http://code.paab.ca/pdfs/paab_code_PDF_official.pdf

14.International Federation of Pharmaceutical Manufacturers Associations. IFPMA Code of Pharmaceutical Marketing Practices. 2012. Accessed January 1, 2019. https://www.ifpma.org/resource-centre/ifpma-code-of-practice/

15.Francer J, Izquierdo JZ, Music T, et al. Ethical pharmaceutical promotion and communications worldwide: codes and regulations. Philos Ethics Humanit Med. 2014;9:7. doi:10.1186/1747-5341-9-7

16.World Health Organization. Ethical Criteria for the Promotion, Advertisement, and Publicity of Medicines. World Health Organization; 2013. Accessed January 1, 2019. http://apps.who.int/medicinedocs/en/m/abstract/Js22161en/

17.Brushwood DB, Knox CA, Liu W, Jenkins KA. Evaluating promotional claims as false or misleading. Am J Health Syst Pharm. 2013;70(21):1941-1944. doi:10.2146/ajhp130076

18.Othman N, Vitry A, Roughead EE. Quality of pharmaceutical advertisements in medical journals: a systematic review. PLoS One. 2009;4(7):e6350. doi:10.1371/journal.pone.0006350

19.Korenstein D, Keyhani S, Mendelson A, Ross JS. Adherence of pharmaceutical advertisements in medical journals to FDA guidelines and content for safe prescribing. PLoS One. 2011;6(8):e23336. doi:10.1371/journal.pone.0023336

20.Villanueva P, Peiro A, Liberos J, Immaculada P. Accuracy of pharmaceutical advertisements in medical journals. Lancet. 2003;361(9351):27-32. doi:10.1016/S0140-6736(03)12118-6

21.van Winkelen P, van Denderen JS, Vossen CY, Huizinga TW, Dekker FW. How evidence-based are advertisements in journals regarding the subspecialty of rheumatology? Rheumatology (Oxford). 2006;45(9):1154-1157. doi:10.1093/rheumatology/kel073

22.Cooper RJ, Schriger DL. The availability of references and the sponsorship of original research cited in pharmaceutical advertisements. CMAJ. 2005;172(4):487-491. doi:10.1503/cmaj.1031940

23.Cooper RJ, Schriger DL, Wallace RC, Mikulich VJ, Wilkes MS. The quantity and quality of scientific graphs in pharmaceutical advertisements. J Gen Intern Med. 2003;18(4):294-297. doi:10.1046/j.1525-1497.2003.20703.x

24.Rennie D, Bero LA. Throw it away, Sam: the controlled circulation journals. CBE Views. 1990;13(13):31-35. doi:10.2214/ajr.155.4.2119127

25.American Society of Magazine Editors. Guidelines for Special Advertising Sections. 8th ed. American Society of Magazine Editors; July 1996.

26.Bero LA, Galbraith A, Rennie D. The publication of sponsored symposiums in medical journals. N Engl J Med. 1992;327(16):1135-1140. doi:10.1056/NEJM199210153271606

27.Steinbrook R, Lo B. Medical journals and conflicts of interest. J Law Med Ethics. 2012;40(3):488-499. doi:10.1111/j.1748-720X.2012.00681.x

28.Citrome L. Citability of original research and reviews in journals and their sponsored supplements. PLoS One. 2010;5(3):e9876. doi:10.1371/journal.pone.0009876

29.Wedzicha JA, Steinbrook R, Kassirer JP. Should medical journals publish sponsored content? BMJ. 2014;348:g352. doi:10.1136/bmj.g352.

30.US National Library of Medicine. Conflict of interest disclosure and journal supplements in MEDLINE: best practices. Updated December 11, 2017. Accessed January 1, 2019. https://www.nlm.nih.gov/pubs/factsheets/supplements.html

31.Interactive Advertising Bureau. Standards, guidelines, and best practices. Accessed January 1, 2019. https://www.iab.com/guidelines/