Tobacco Regulatory Science adheres to the COPE Core Practices regarding ethical guidelines for publication. In addition, we support use of the Transparency and Openness Promotion (TOP) guidelines regarding journal policies and practices. Included in the COPE and TOP practices are the following:

1. Allegations of Misconduct. Any allegations of scientific misconduct should be immediately brought to the attention of the Editor-in-Chief, and those allegations will be addressed according to COPE standards.

2. Authorship. Listed authors on a manuscript should have made significant contributions to justify their inclusion according to guidelines established by the AMA Manual of Style, 10th Edition, including significant roles in study design, data analysis, study implementation, interpretation of results and paper write-up. Authorship roles should be able to be justified if asked by reviewers or editorial staff. Any concerns about authorship will be addressed according to COPE standards.

3. Complaints or Appeals. Any complaints or concerns about any aspect of the publication process should be directed to the Editor-in-Chief.

4. Conflict of Interest Disclosure Statement. Preventing and addressing real or potential conflicts of interest are essential to assuring confidence in study results and is taken very seriously by the editorial staff and reviewers alike. COPE guidelines are followed, with more specific information requested of all authors on the current Tobacco Regulatory Science website:

Articles published in Tobacco Regulatory Science must be accompanied by a conflict of interest disclosure statement, or a statement that authors have no conflicts of interest to declare (All authors of this article declare they have no conflicts of interest). To execute this policy, all authors must privately disclose to the editors of Tobacco Regulatory Science at the time of their submission ANY and ALL potential conflicts of interest. These include financial and non-financial interests and relationships (see below for definitions), direct employment with a private sector entity (whether full-time, part-time, or on a consultancy basis), and service on private sector and non-profit boards and advisory panels, whether paid or unpaid. Authors also should disclose to editors any conflict of interest that may have influenced either the conduct or the presentation of research, including but not limited to close relationships with those who might be helped or hurt by the publication, academic interests and rivalries, and any personal, religious or political convictions relevant to the topic at hand. In the paper, authors should include a draft statement that discloses all relevant conflicts of interest and affiliations. Relevance for financial conflicts of interest with private firms is defined as a relationship of any value with a firm with a stake in the subject of the manuscript, or its competitors. Relevance for patents is defined as any invention or pending invention connected in any way to one of the authors. Because relevance is often “in the eye of the beholder,” err on the side of full disclosure in drafting the disclosure statement. Editors will check your draft against the private financial disclosure statement, and initiate discussions toward possible adjustments, if necessary.

What to report: Any financial relationship from the past 3 years (dating from the month of submission) of any size should be disclosed. These potential conflicts of interest include:

• • Direct employment, either full or part-time;
  • Grants and research funding (but not grants to your institution or others within your institution on which you did not work); this includes grants from trade associations and non-profits substantially (50% or more) funded by private-sector firms;
  • Consultancies;
  • Travel grants, speaking fees, writing fees, and other honoraria;
  • Paid expert testimony for one side in an adversarial proceeding (this does not include testimony as a factual witness in a civil or criminal case);
  • Patents granted, pending and applications, whether or not generating royalties;
  • Stock ownership, investment in related “sector” funds, or stock options, including those of immediate family members but excluding diversified mutual funds and investment trusts; and
  • Membership on private sector scientific or other advisory boards, whether paid or unpaid.

In addition, any current negotiations regarding future employment or current job offers, either full-time or part-time, must be disclosed.

In disclosing these financial arrangements to editors, authors can include dollar amounts even though they will not be printed in the journal. Editors may choose to exclude this information from publication, but in no case should an editor or author consider an arrangement irrelevant based on its size alone.

Non-Financial Conflicts of Interest: Authors may have strongly-held views about the article being submitted for publication. Authors should consider disclosing and editors may choose to print any affiliations or expressions of these views that may be relevant. These may be personal, political, or intellectual and may include any expression of strongly held views relevant to the subject of the submission. Such disclosures may be original, or they make reference to opinions previously expressed in books or monographs, op-eds or public comments, or to sworn testimony before or lobbying of legislators or legislative bodies. Non-financial conflicts of interest that should be disclosed also include membership or affiliation with non-governmental organizations that have an interest in the submission.

Enforcement: Conflict of interest disclosure relies on the honor system. Editors do not have the time or other resources to be financial auditors or ideological arbiters. Successful disclosure policies depend on the good will and integrity of authors. In all cases of failure to disclose a relevant conflict of interest of which the editors become aware; they will publish an editor’s note that becomes part of the permanent record of that article. In those rare cases where editors uncover a willful desire to conceal financial conflicts of interest, the editors will disallow publication by the author(s) in Tobacco Regulatory Science for a period of up to 3 years.

5. Data and Reproducibility. All studies that report data from a clinical trial must indicate whether or not they have preregistered their study (eg, clinicaltrials.gov). If so, trial number should be included in the paper. It is strongly recommended that all clinical trials be registered.

6. Ethical Oversight. Tobacco Regulatory Science will follow the COPE protocol if there are concerns about ethical concerns regarding a submission, and the following protocols are required of all submissions involving human or animal research.

a. Human Subjects or Animal Approval Statement.

i. Where relevant, include human subjects or animal protection statements indicating institutional review and approval with document number, if possible, or statement of exempt status. More specifically, all studies involving humans should indicate that they meet the ethical standard outlines in Helsinki Declaration of 1975 as revised in 2000, and studies involving animals should indicate that they meet the National Research Council requirements on the Care and Use Laboratory Animals.

b. Informed Consent Requirement

i. Where appropriate, and consistent with institutional review board requirements, Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), European Union Directive 95/46/EC, and other rules specific to the location of where the research was conducted, include a clear indication that informed consent was obtained from all participants in the research.

c. Plagiarism Prevention Process.

i. Prior to submission, all manuscripts are expected to have been checked for unattributed text via one of several automated software programs (eg, Grammarly, Plagiarisma, PaperRater, iThenticate, etc).

7. Intellectual Property. Policies regarding copyright and copyright violations are available on the journal website and other journal practices and policies.

It is the responsibility of the author or authors to obtain the necessary permission to use any quoted material in excess of 25 lines that is incorporated in the manuscript. Permission must be obtained, and credit given, for quotations, tables, and illustrations borrowed from copyrighted material. Letters granting permission should accompany the manuscript when submitted. If there are any questions, contact the Editor-in-Chief.

8. Journal Management. The journal is owned by the Editor-in-Chief and Business Manager. A group of senior scientists in the field serve as Editors; moreover, advice is sought from the SAE panel as needed. In addition, scientists and experts regarding tobacco regulatory science serve on the Review Board, and their primary role is to serve as reviewers for the journal. Additional information can be found on the journal website.

9. Peer Review Processes. To decrease bias during the editorial process, we employ the classic double-blind peer review process. Referees selected are professional scholars in a variety of disciplines including social and behavioral health sciences, health policy, epidemiology, psychology, chemistry, genetics, neuroscience, and other areas relevant to tobacco regulatory science.

• • Upon receipt, a manuscript is assigned a reference number.
  • A copy of the numbered manuscript is electronically sent to a minimum of 3 referees.
  • Referees are selected to match the manuscript with the referee’s area of expertise.
  • Referees evaluate the manuscript according to established criteria on an evaluation form.
  • The Editor-in-Chief transmits reviewer evaluations and comments to the corresponding author, usually within 4 weeks.
  • Final disposition of the manuscript rests with the Editor-in-Chief.

10. Post Publication Discussions and Corrections. Tobacco Regulatory Science includes the option for commentary regarding published articles by submitting a Letter to the Editor. The process for doing so is described on the journal website. In addition, if post-publication corrections are needed, please contact the Editor-in-Chief to determine what corrections can be made. There are no charges to correcting proofs, however, once the manuscript is posted online (post publication) there is a fee for any changes, and that fee will depend on the type and extent of change needed.