Confidentiality - Ethical and Legal Considerations

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

Confidentiality
Ethical and Legal Considerations

Confidentiality promises are widely recognized as an ethical obligation, regardless of the legal duty accompanying them . . .  maintenance of confidentiality promises falls within editorial discretion.

Jeffrey A. Richards1

The author-editor relationship is an alliance founded on the ethical rule of confidentiality. Confidentiality occurs when a person discloses information to another with the understanding that the information will not be divulged to others without permission.2 In the context of scientific publication, this rule provides primarily for authors’ rights to have the information they submit to a journal, whether in manuscript form or in communications to the editorial office, kept confidential and a concomitant duty of editors and reviewers to maintain their obligations to ensure that any information concerning a submitted manuscript is kept confidential. This agreement between author and editor preserves the integrity of the scientific review and publication process. Under this agreement, confidentiality may be breached only in rare circumstances, and all such breaches must be handled with care. Note: The level of confidentiality related to a submitted manuscript may be high, as occurs in journals with double-blind or single-blind peer review, or may permit wider sharing of information at different stages of the evaluation and publication processes, as occurs in journals with various forms of open peer review (see additional discussion in 5.7.1, Confidentiality During Editorial Evaluation and Peer Review and After Publication).

5.7.1 Confidentiality During Editorial Evaluation and Peer Review and After Publication.

Strict confidentiality regarding the review and evaluation of submitted manuscripts, related content, and all relevant correspondence and other forms of communication is essential to the integrity of the editorial process (see 6.1, Editorial Assessment). Authors must feel free to submit manuscripts that contain their unique ideas and information that may affect their reputations or careers or that may be proprietary. Thus, editors and reviewers have an ethical duty to keep information about a manuscript confidential, and authors have a right to expect that confidentiality will be maintained.3,4,5,6,7 Policies that support the confidential nature of the peer review and editorial processes are well described by the International Committee of Medical Journal Editors (ICMJE),3 the Council of Science Editors (CSE),4 the World Association of Medical Editors (WAME),5 and the Committee on Publication Ethics (COPE).6 The existence of a submission of a manuscript to a journal should not be revealed (by confirmation or denial) to anyone other than the editors, editorial staff, peer reviewers, and necessary publishing staff (ie, those essential to producing the journal but not others, such as sales and marketing staff), unless and until the manuscript is released for publication (see 5.13, Release of Information to the Public and Relations With the News Media). In addition, editors should refrain from discussing any aspect of the peer review process of a particular manuscript or any unpublished manuscripts with anyone except authors, reviewers, and editorial staff.

Some journals that have formal relationships with other journals have implemented cascading peer review processes to redirect rejected manuscripts from one journal to another, often from a generalist or more competitive journal to a more specialized journal or one with a higher acceptance rate within the same publishing group or a consortium of journals in the same field8 (see 5.11.5, Editorial Responsibilities, Roles, Procedures, and Policies, Editorial Responsibility for Rejection). For example, the JAMA Network journals offer authors the option to select another journal in the network and the manuscript, correspondence, and any reviews are automatically and immediately transferred to the second journal in the event that it is rejected by the first journal. A number of publishers have implemented similar cascading processes to improve efficiency and reduce time to eventual publication. Authors should be informed in advance if such options are available and if manuscripts, related content, reviews, correspondence, and decisions will be shared with other specific journals.

Even after publication, information and communications about a manuscript, its review (including reviewers’ comments), or the editorial process should not be made public without consent of the author, editor, or reviewer (see 5.6.1.5, Ownership and Control of Data, Record Retention Policies for Journals, and 5.6.7, Copying, Reproducing, Adapting, and Other Uses of Content).

To maintain confidentiality, editors should deny requests or demands for confidential information during editorial evaluation, during peer review, and after publication from any third party, including readers, authors of other manuscripts, owners of the journal, publishing staff other than those essential to producing the journal in print or online, news media, advertisers, governmental agencies, academic institutions, commercial entities, and representatives of those seeking information for use in actual or threatened legal proceedings (see 5.7.3, Confidentiality in Legal Petitions and Claims for Privileged Information). Exceptions to this policy may be made in specific circumstances provided that disclosures are limited and that anyone else given access to confidential information agrees to keep the information confidential. Examples of exceptions include the following:

■A prospective author who is invited by an editor to write an opinion piece commenting on a manuscript that has not yet been published. (Note: Such authors should be reminded about the confidential nature of the unpublished work and not to consult anyone about the manuscript without prior approval of the editor, including the author of the unpublished manuscript.)

■A governmental agency representative consulted by the editor or author on a matter considered a public health emergency or a matter that by regulation requires notification (eg, serious adverse drug event).

■An attorney who is asked to advise an editor if legal concerns are raised or who represents the journal in legal proceedings.

■An institutional or funding authority requested by the editor to investigate an allegation of scientific misconduct related to a manuscript under consideration or a published article (for additional information, see 5.7.2, Confidentiality in Allegations of Scientific Misconduct, and 5.4.4, Editorial Policy and Procedures for Detecting and Handling Allegations of Scientific Misconduct).

■An author’s violation of public journal policy, such as covert duplicate publication or failure to disclose conflicts of interest (see 5.3.2, Editorial Policy for Preventing and Handling Allegations of Duplicate Publication, and 5.5.8, Handling Failure to Disclose Conflicts of Interest).

■An author’s refusal to address an editor’s questions about serious ethical concerns, such as whether research participants provided appropriate informed consent or whether a study was appropriately reviewed and approved, or waived for approval, by an independent ethics committee (see 5.8.1.3, Ethical Review of Studies and Informed Consent, Reports of Unethical Studies).

Journals do not own or have licenses to unpublished works (because copyright and publication licenses are not typically transferred until the event of publication). Thus, editors should not keep print or electronic copies of rejected manuscripts. Copies should be destroyed and/or purged from electronic manuscript systems and databases. However, a journal may choose to keep a copy of a rejected manuscript for a predetermined, limited period (eg, 1 year) if it has a policy that allows for author appeals of editorial decisions (see 5.6.1.5, Record Retention Policies for Journals). Similarly, reviewers should not keep copies of the manuscripts they are asked to assess and should not use or appropriate information accessed during the confidential peer review process. Reviewers should destroy any copies of manuscripts and related content that they have reviewed. Reviewers should not use others’ manuscripts as teaching tools or reveal any information about unpublished manuscripts in any public discourse or presentation, other communications, or social media posts because doing so would violate confidentiality.

Journals should publish details about the confidential nature of the editorial, peer review, and publication processes in their instructions for authors, and editors should inform all reviewers of the confidential nature of peer review in correspondence to and instructions for reviewers3 (see 5.11, Editorial Responsibilities, Roles, Procedures, and Policies). If a journal uses a form of open peer review, authors and reviewers should be informed of the level of confidentiality and openness and of the stages in which more or less openness may occur (eg, before or after the editorial decision and publication).

Journals should inform reviewers in explicit terms what they mean by “confidentiality,” “confidential information,” and “privileged information” (ie, that not subject to disclosure). Journals should also inform reviewers and authors if the review process is single-blinded (ie, only the reviewers’ identities are not disclosed), double-blinded (ie, both the reviewers’ and the authors’ identities are not disclosed), or open (ie, all author and reviewer identities are disclosed to all during review, and for accepted manuscripts reviewer comments may be published with or without attribution). For additional discussion of the various mechanisms of peer review (eg, single-blind, double-blind, open), see 6.1, Editorial Assessment.

5.7.1.1 Confidentiality Requirements During Blind (Anonymous) Peer Review.

Many medical and scientific journals, including the JAMA Network journals, use a single-blind review process, in which the authors’ names and affiliations are revealed to peer reviewers but reviewers’ identities are not revealed to authors. This is also referred to as anonymous review.

Peer reviewers should receive instructions reminding them to maintain confidentiality when they are invited to review and also after they agree to review (see, for example, the instructions in Box 5.7-1 and 6.1, Editorial Assessment). Reviewers should be instructed not to keep copies of manuscripts they have reviewed and to refrain from discussing the information in the manuscript with others, without permission of the journal. Reviewers should never contact authors directly to discuss their review without explicit permission from the editor.

Box 5.7-1. Examples of JAMA Instructions to Peer Reviewers

Instructions for Reviewers About Maintaining Confidentiality Included in Initial Email Requesting Peer Review

We consider this request and the information in this email to be strictly confidential. Please do not forward this email to others and please delete or destroy any copies of this email.

Note: In addition, every email correspondence includes the following: “Confidentiality Note: This communication, including any attachments, is solely for the use of the addressee, may contain privileged, confidential, or proprietary information, and may not be redistributed in any way without the sender’s consent. Thank you.”

Instructions Given to Peer Reviewer Concerning Confidentiality After Reviewer Has Agreed to Conduct Review

We consider this manuscript and your review of it to be strictly confidential. Any use or distribution of the confidential information in this manuscript for any reason beyond performing this review is prohibited. If you download any electronic files or print out copies, please delete and/or destroy these documents once you have completed your review. If you need to consult a colleague to help with the review, please do not share the hyperlink above because it will give them access to your personal account. You may, however, share a printed copy of the manuscript with a colleague so long as you inform them that the information is confidential and that you indicate such consultation has occurred and include that reviewer’s name in your review.

Reviewers’ identities are not revealed to authors or other reviewers. Reviewers should not contact the authors. If you have any questions about this manuscript or the review process, please contact the editor.

In some circumstances, a reviewer may wish to enlist the aid of a colleague to assist with the review. Some journals prohibit such consultation, and other journals require that editorial permission be sought in advance of the consultation. Reviewers who are uncertain about a journal’s policy should contact the editorial office. For example, JAMA informs reviewers that they may enlist the aid of colleagues to assist with the review so long as confidentiality is maintained and all other review policies (such as those pertaining to conflicts of interest) are followed. JAMA reviewers are required to inform editors if such consultation has occurred.

A journal does not have an obligation to send every submitted manuscript for external peer review,3 but editors should share copies of reviewer comments with the authors of those manuscripts that have been sent for review. For example, after an initial editorial decision (eg, rejection or revision) has been made about a reviewed manuscript, JAMA and the JAMA Network journals provide the corresponding author with copies of the reviewers’ comments for those manuscripts that have been sent for external peer review. In addition, reviewers for JAMA and the JAMA Network journals are also asked to provide confidential comments to the editor, which include recommendations of acceptance, revision, or rejection; these reviewer-specific recommendations generally are not shared with the authors. However, comments directed to the editor may be summarized or excerpted and included in a decision letter to the author if necessary.

To provide reviewers with constructive feedback, journal editors should send to reviewers copies of other unnamed reviewers’ comments. The ICMJE encourages editors “to share reviewers’ comments with co-reviewers of the same paper, so reviewers can learn from each other in the review process.”3 Editors should inform reviewers how their reviews will be used and who will have access to the reviews and to the identities of the reviewers (see 6.1, Editorial Assessment). In blind peer review, reviewers have a right to expect that their identities will be protected and not shared with authors without their permission. Some journals that use single-blind review offer reviewers the option to reveal their identities.

An editor may occasionally choose not to send a reviewer’s comments to the author, for example, when comments are considered libelous or hypercritical. Similarly, an editor may choose to remove or mask any unhelpful or derogatory comments from an otherwise valuable review.

5.7.1.2 Confidentiality Requirements During Double-blind Peer Review.

Double-blind peer review, although used less frequently in biomedical publication, is more commonly used in some disciplines (eg, humanities, psychology, nursing). In double-blind review, authors’ and reviewers’ identities are hidden from each other in an attempt to minimize implicit bias toward certain groups (eg, women, junior researchers, those from less prestigious institutions or specific geographic locations).9 In this type of process, authors need to prepare their manuscripts in a way that does not reveal their identity and journals need to provide instructions to facilitate this process and to ensure that overtly identifying information is not included in manuscripts sent for peer review. Some journals offer authors the option to select double-blind review or single-blind review.10

5.7.1.3 Signed Reviews.

Some journals that use blind review offer reviewers the option to reveal their identities to authors. Reviewers may occasionally intentionally identify themselves in their reviews or sign their reviews, even though they know the journal’s peer review process is blind and the option to sign is not formally offered. Although such identification might imply that the reviewer has waived the right to anonymity, it does not relieve the editor or the reviewer of the duty to maintain confidentiality. If the editor of a journal with a blind review process wishes to disclose the identity of a reviewer who has signed a review, the editor should first contact the reviewer to verify that the reviewer actually intended for her or his identity to be revealed. The editor should remind the reviewer and the author that any communication about the manuscript should occur through the editorial office. If the editor does not want to disclose any reviewer identities, the editor may inform the reviewer that her or his identity or signature will be removed from the review.

5.7.1.4 Open Peer Review.

A number of journals have experimented with and implemented forms of open review that encourage or require reviewers to identify themselves to the authors and other reviewers.11,12,13,14,15 The Medical Journal of Australia and Nature conducted early trials that offered authors and reviewers the option of open peer review and found relatively low uptake or benefits over their more traditional single-blind review process.13,14 Other journals, such as the BMJ,11,12 publish signed comments from the reviewers with accepted papers. A further open-review innovation was launched by eLife, which uses online consultation for reviewers to collaborate with each other and the editors during review.15 Here again, authors and reviewers should be informed of policies regarding open review and publication of reviewer comments and identities and be reminded that all communications about the peer review and editorial process should be directed to the editor and editorial staff. Journals should clearly describe such policies in instructions for authors and reviewers and in relevant correspondence to authors and reviewers.

5.7.1.5 Acknowledging and Crediting Reviewers.

An author may want to credit the help of peer reviewers in an acknowledgment. Public acknowledgment of anonymous reviewers is not necessary or informative. However, some journals will honor authors’ requests to thank anonymous reviewers.

Many journals also publish the names of individuals who reviewed for the journal during the previous year, or other specific period, to thank them publicly. Journals can notify reviewers of this plan in their instructions for reviewers or in relevant correspondence. Journals also offer peer reviewers other rewards or forms of recognition for their effort and time: some journals pay reviewers a small stipend; others offer free online access to the journal, provide continuing education credit, or send formal letters that can be shared with employers, supervisors, or others. New services and platforms are available to permit reviewers to claim public credit for reviews with the use of DOIs and researcher identifiers assigned to their specific reviews in a public manner or in a blinded manner associated with reviews performed for specific journals.

An editor may rarely receive a request from an author to include a peer reviewer who has made substantial suggestions for a complete revision as a coauthor. If the author’s request appears justified, the editor should contact the reviewer to discuss the author’s request, and, if appropriate, the author and the reviewer should communicate directly. If such an arrangement occurs, the request must be made early in the process (ie, before the major revision or complete rewrite), and the reviewer would then need to participate fully in the revision and to meet authorship criteria (see 5.1.1, Authorship: Definition, Criteria, Contributions, and Requirements). Such a scenario is unlikely to occur with reports of original research.

5.7.2 Confidentiality in Allegations of Scientific Misconduct.

Allegations of scientific misconduct (eg, fabrication, falsification, and plagiarism) must be considered carefully with regard to rules of confidentiality. In cases of credible allegations of such misconduct, an editor may need to disclose specific confidential information in a very controlled and limited manner.3 For example, after a credible allegation of scientific misconduct, an editor may need to contact an author’s or a reviewer’s relevant institutional, funding, or governmental authority (eg, an academic president, dean, or ethics/integrity officer) to request a formal investigation. In this situation, the editor will need to identify the person about whom the allegation was made. All communications regarding such allegations should be indicated as confidential. During such investigations, editors should avoid posting details, even if rendered anonymous, in email lists or blogs when seeking advice from colleagues. For more details on how an editor should handle such an allegation, see 5.4.4, Editorial Policy and Procedures for Detecting and Handling Allegations of Scientific Misconduct.

5.7.3 Confidentiality in Legal Petitions and Claims for Privileged Information.

A number of cases in US law have served as the foundation for or have directly supported the confidential nature of the editorial and peer review process.

In 1972, the US Supreme Court ruled in Branzburg v Hayes that a reporter could be forced to testify if, during a news gathering, the reporter became a witness to a crime.16 However, the court also noted that individual states could create their own standards with regard to a journalistic privilege (ie, a right) to keep sources of information confidential, allowing lower courts in subsequent rulings to support such privilege. With this understanding, many states have enacted legislation that protects the press from mandatory disclosure of sources, work product, and information.17,18 These state “shield laws” vary in scope but may offer qualified privilege to reporters to protect confidential information in legal settings unless it can be established that (1) the information sought is relevant and/or material, (2) it is unavailable by other means or through other sources, and (3) a compelling need exists for the information.17 However, there have been challenges to journalists’ privilege to keep sources of information confidential.

After the 1993 US Supreme Court ruling in Daubert v Merrell Dow Pharmaceuticals, Inc,19 concerns arose that attempts to breach the confidential nature of the editorial process would increase through subpoenas for journal records.20 In this case, the court identified standards required for admissibility of scientific expert testimony. These standards include, among others, whether the evidence on which the expert opinion is based has been peer reviewed and published, and they have been applied to limit admissibility of unreliable junk science as evidence in specific cases.

In 1994, a legal precedent was set regarding confidentiality and protection from attempts to invade the confidential and privileged nature of the editorial process for peer-reviewed journals.21 In Cukier v American Medical Association, an author whose manuscript had been rejected by JAMA sued to compel the journal to disclose the identity of those persons responsible for allegedly defamatory statements made to the editors concerning the author’s financial interest.21 Citing the confidential nature of the peer review process, the editors refused to disclose the source of this information. The Circuit Court of Cook County, Illinois, ruled that the editors were not required to disclose this information on the basis of the Illinois Reporter’s Privilege Act,22 which provides that members of the news media (in this case, journal editors) cannot be compelled to disclose sources unless the information cannot be obtained elsewhere and such disclosure is essential to the protection of the public interest. This decision was affirmed by the Illinois Appellate Court, and subsequently, the Illinois Supreme Court declined to hear the case.

Other cases that have supported the confidential nature of the peer review process include Henke v US Department of Commerce and the National Science Foundation,23 Cistrom Biotechnology Inc v Immunex Corp,24 and cases concerning subpoenas to many journals in 2007 and 2008, including JAMA and the New England Journal of Medicine, regarding a pharmaceutical company’s marketing and sales practices for 2 nonsteroidal anti-inflammatory drugs and product liability litigation in the states of Illinois25,26 and Massachusetts.27,28 In these cases, attorneys for the pharmaceutical company (which was defending against thousands of lawsuits that alleged false representations in advertising and marketing of these drugs) issued subpoenas to the journals seeking broad categories of documents and information related to manuscripts submitted about these drugs, including “all documents regarding the decision to accept or reject manuscripts, copies of rejected manuscripts, the identities of peer reviewers and the manuscripts they reviewed, and the comments by and among peer reviewers and editors regarding manuscripts, revisions, and publication decisions.”25(p1956) Product liability attorneys have pursued such confidential information to bolster or undermine the testimony of expert witnesses and as legal leverage. In both of these cases, the courts ruled that confidential information was irrelevant to the pending legal claims and that, given the confidentiality of the peer review process, the burden and expense of discovery required by the journals to comply with the company’s broad subpoenas outweighed any benefit of such forced compliance.25,26,27,28

With multiple examples of case law supporting journals in successfully resisting external attempts to obtain confidential information via litigation and quashing subpoenas, journals, editors, and publishers can rely on legal precedents and principles to help them maintain confidentiality of the peer review and editorial process. Parrish and Bruns29 have summarized the reasons journals should resist complying with subpoenas that intrude on such confidentiality as follows:

■Violation of confidentiality obligations for one case may make it more difficult to defend future intrusions, may result in perceived breach of trust that could damage a journal’s reputation among authors and peer reviewers involved in a specific case as well as other current and prospective authors and reviewers, and may result in an author or reviewer suing the journal for breach of confidentiality.

■Compliance with a subpoena disrupts the journal’s activities and processes and consumes the journal’s time and resources.

■Substantial costs can be incurred in responding to a subpoena, collecting documents, and providing depositions.

■A subpoena may be used as a means of harassment to prevent an author or a journal from publishing.

If a journal editor receives a subpoena or request from an attorney for confidential information, the editor should consult the publisher, the journal’s attorney, or both. If the subpoena or request comes to the publisher or journal owner, the editors should be informed. The disclosure of confidential information to an attorney in this context would be protected under attorney-client privilege. However, it is important to limit disclosure of such information to the publisher (eg, protecting the names of authors or reviewers). According to Parrish and Bruns,29 in general, subpoenas are broad; therefore, editors may object to the scope and burden of having to respond to such a request as has been successfully argued and ruled in several courts.21,22,23,24,25,26,27,28 If negotiation with a party who served the subpoena must occur, editors and their legal representatives should request a narrowing of scope of the subpoena, a redaction of all irrelevant confidential information, the destruction or return of all surrendered documents that contain any confidential information, and a limit on who can view any confidential information. In addition, the journal may seek indemnification from the authors or reviewers if they sue the journal for violation of confidentiality. If such negotiations fail or do not protect the journal properly, the journal can file a legal motion to quash the subpoena.25,26,27,28,29

The Council of Science Editors offers similar advice and notes that, unlike formal subpoenas, inquiries from law firms requesting confidential information “are probably best to politely decline, citing confidentiality.”4 The Council of Science Editors also recommends that “generally, editors should resist revealing confidential information when served a subpoena unless advised to do so by legal counsel. Not only is the requested information usually confidential, but often uncovering ALL information (for which lawyers are trained to ask) can be time-consuming, interrupt normal business, and be expensive. Citing, for example, the Avoidance of Undue Burden or Expense Under Rule 45(c)(1) of the Federal Rules of Civil Procedure may be useful.”4 The ICMJE concurs and recommends the following: “Editors therefore must not share information about manuscripts, including whether they have been received and are under review, their content and status in the review process, criticism by reviewers, and their ultimate fate, to anyone other than the authors and reviewers. Requests from third parties to use manuscripts and reviews for legal proceedings should be politely refused, and editors should do their best not to provide such confidential material should it be subpoenaed.”3

5.7.4 Confidentiality in Selecting Editors and Editorial Board Members and in Editorial Meetings.

When editors or editorial board members are interviewed and evaluated for a prospective position with a journal, all participants in the selection process should be reminded that all discussions should remain confidential. In some cases, a signed statement of confidentiality may be requested of members of search/interview committees. Without assurance of such confidentiality, professional reputations and the journal’s relationship with influential academic, research, and professional society leaders may be jeopardized. In addition, editorial board members should be reminded of the confidential nature of board meetings and other editorial meetings (see 5.11.11, Role of the Editorial Board).

Principal Author: Annette Flanagin, RN, MA

Acknowledgment

I thank the following for reviewing and providing helpful comments: Howard Bauchner, MD, JAMA and JAMA Network; Timothy Gray, PhD, JAMA Network; Iris Y. Lo, JAMA Network; Debra Parrish, JD, Parrish Law Offices, Pittsburgh, Pennsylvania; June Robinson, MD, Northwestern University Feinberg School of Medicine, Chicago, Illinois; and Joseph P. Thornton, JD, JAMA Network and American Medical Association.

References

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