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Information For Authors

Manuscripts must be submitted online using the following URL:

http://mc.manuscriptcentral.com/hum

Please read all the instructions to authors before submitting your article.

To help defray the cost of printing, the Publisher requests that page charges of $75 per printed page be paid by all authors who have funds available from research grants or from their institutions. It should be noted that ability to pay page charges is not a prerequisite for publication in the Journal.

Summary of Journals in the Human Gene Therapy Program

Human Gene Therapy (HGT) is our flagship journal having the richest tradition of any journal in the field of cell and gene therapy. Human Gene Therapy just celebrated its 21st anniversary and has published over 3900 papers, reviews, and editorials. Over the last 2 years we launched two sibling journals including Human Gene Therapy Methods and Human Gene Therapy Clinical Development. In assessing your manuscript for submission to one of these three journals, please consider the following criteria.

Human Gene Therapy

The flagship journal will consider papers of very high quality that broadly fall under the scope of cell and gene therapy. Some general categories include: studies evaluating novel approaches of cell and gene therapy in pre-clinical and clinical models; development of novel technologies; studies that help define mechanisms of action of cell and gene therapies; host interactions to vector and transplanted cells; and high-impact new methods and clinical trials. The Editors may quickly reject a manuscript soon after submission without external review if it is felt to fall outside the scope of the Journal or would not likely meet our high standards required for publication. The authors may also be given the option of re-submitting the manuscript to one of the sibling journals as described below.

HGT Methods

We encourage submission of manuscripts to HGT Methods that describe key technological advances. These manuscripts can cover a wide range of topics from techniques for detecting transgene expression, to improved vectors to better manufacturing methods and product testing assays. If the method is of very broad interest and holds the potential to substantially progress the field, it should be directed to Human Gene Therapy by the submitting author. The Editor may make this determination as well.

HGT Clinical Development

This journal includes pre-clinical papers focusing on pharmacology/toxicity/bio-distribution experiments used in the review of proposed clinical trials and will contain sufficient information to allow referencing between products within the same technology platform when appropriate. If the safety studies help define novel mechanisms and/or is of very broad interest to the field, it should be considered for publication in Human Gene Therapy. Recognizing the importance of all clinical data in the formative stages of the field, HGT Clinical Development will publish clinical trials of gene and cell therapy including those which are confirmatory or negative; if the clinical trial is novel and/or reports positive data, it should be considered for publication in Human Gene Therapy.

The criteria for publishing pre-clinical safety studies and clinical trials in HGT Clinical Development will be different than in most journals. We will consider the manuscript appropriate for review if the data are collected in a way that supports the conclusions and are useful in progressing the clinical development of the product; the studies do not have to be novel or to discern mechanisms. HGT Clinical Development is an excellent venue for publishing additional topics including production and characterization data of gene and cell therapy products; selected clinical protocols which describe first-in-human applications of cell and gene therapy; and topical issues related to the commercial development of gene and cell therapy products.

Selection of Journal during the submission process

During submission, you will be asked to designate your manuscript to Human Gene Therapy or Human Gene Therapy Methods or Human Gene Therapy Clinical Development. Alternatively, you may select “Open,” in which case, the Editor-in-Chief will designate your manuscript to the appropriate journal. If the Editor-in-Chief disagrees with your journal selection but believes it is suited for one of the other two journals, the corresponding author will be notified via e-mail and will have 2 weeks to agree or decline to switch Journals. If the corresponding author declines or does not respond within 2 weeks, the manuscript will be automatically withdrawn from Manuscript Central.

 

Changes to Authorship

Changes to the author list are NOT permitted after submission. If it becomes necessary to add or remove an author, the corresponding author should notify the editorial office at hgt@mail.med.upenn.edu. All authors will be required to sign a document acknowledging the change.

Preparation of Manuscript

NOTE:

All submitted manuscripts will be processed through plagiarism detection software. Plagiarized manuscripts will be rejected immediately.

Articles must be submitted via upload in a word processing format, preferably in Microsoft Word. Please do not include artwork within the text document. Figures and tables should be supplied in separate files, be labeled clearly, and should be in TIFF or EPS formats. Please see the Tables and Illustrations section for further details on art submission.

Types of Manuscripts

Research Articles - General

This format represents the majority of papers published in the HGT Journal Program. The general format is summarized below. Please note, however, that the format for pre-clinical safety studies in HGT Clinical Development is different and more structured. Instructions regarding these papers follow the summary for general papers, noted below.

Title page. Title of article, name of author(s), institutional affiliation(s), and the name (with complete address, email and phone number) to whom correspondence should be directed – there can be only one corresponding author. A short title consisting of 50 characters or less should also be included. (The title page must be part of your main text file.)

Abstract. Limit to 300 words.

Introduction

Materials and Methods. Please provide sufficient information to allow for a qualified third party to attempt to reproduce your work.

 

Results. We prefer that the total number of tables and figures in the printed manuscript is not greater than six (6). Feel free to include relevant supporting data in a supplementary information section.* When doing so, please refer to these data in the presentation of results that appears in the published manuscript.

 

Discussion. If appropriate, you may integrate the Results and Discussion into a combined section. This often allows for a more concise and understandable story.

 

Acknowledgments. Any contributor who does not meet the criteria for authorship should be listed in the Acknowledgments section. Examples of a contributor may be individuals who provided technical support, writing assistance, or provided research materials. All funding sources, institutional and corporate, should be listed in this section.

 

Disclosure Statement. Immediately following the Acknowledgments section, there should be a header entitled, Author Disclosure Statement. The corresponding author should prepare this statement and include the appropriate information for EACH author, thereby representing that competing financial interests of all authors have been appropriately disclosed according to the policy of the Journal. It is important that all conflicts of interest, whether they are actual or potential, be disclosed. If no conflicts exist, the authors must state “No competing financial interests exist.” Articles submitted without an “Author Disclosure Statement” will not be reviewed. Conflicts include:

1. Competing Interests. A competing interest exists when an individual (or the individual’s institution) has financial or personal relationships that may inappropriately influence his actions. These competing interests may be potential or actual, financial or other.

2. Personal Financial Interests. Stocks or shares in a company that may gain or lose financially from publication of the article; consulting fees or other remuneration from an organization that may gain or lose financially from publication of the article; patents or patent applications that are owned by or licensed to companies/institutions that may gain or lose value from publication of the article.

3. Funding. Research support by organizations that may gain or lose financially from publication of the article. This support includes salary, equipment, supplies, honoraria, reimbursement or prepayment for attending symposia, and other expenses.

4. Employment. Recent (within the past 5 years), current, or anticipated employment by an organization that may gain or lose financially from publication of the article.

5. Other Competing Interests. Any personal relationship which may inappropriately affect the integrity of the research reported (by an author) or the objectivity of the review of the manuscript (by a reviewer or Editor), for example, competition between investigators, previous disagreements between investigators, or bias in professional judgment.


References. (Updated and revised November 2014)


The reference list should be prepared in numerical order (not alphabetical), and in order of citation within text.     References shouldbe double spaced and include the complete titles of cited articles.  In-text citations should be cited in order of appearance, superscripted, and without parentheses.

 

If more than three authors are listed on an article, list the first three authors and use et al. (not italic) after the third author’s name.

 

Reference Style Examples:

 

Journal citation:

Flotte T.  Gene and cell therapy in 2018:  A look ahead. Hum Gene Ther 2018;29:1-1.

 

Journal Citation (multiple authors): 

Dimmock DO, Brunetti-Pierri N, Palmer D, et al.  Correction of hyperbilirubinemia in gunn rats using clinically relevant low doses of helper-dependent adenoviral vectors.  Hum Gene Ther 2011;22:483-488.

 

[Note:  Abbreviations of journal titles in reference section should follow the style of MEDLINE (http://www.ncbi.nlm.nih.gov/nlmcatalog).]

 

Book citation:

Brosius J. Expression vectors employing A, trp, lac, and lpp-derived promoters. In: Rodriguez RL, Denhardt DT, eds. Vectors: A  Survey of Molecular Cloning Vectors and Their Uses. Stoneham, MA: Butterworth Publishers, 1988: 205–225.

 

When references to an unpublished source are used, supply the researcher’s last name(s) and date of communication in parentheses within the text, followed by a semicolon, and state “unpublished data.”  (Ex:  Jones and Smith, 2018; unpublished data). Do NOT include in the reference list.

 

If work has been submitted** but is still under peer review, supply authors’ names according to the style in the “journal citation” example(s), list the manuscript title, followed by “Submitted; under review, [year of submission].” (Ex: Jones and Smith, 2018; submitted; under review, 2018).  Do NOT include in the reference list.

 

If work has been accepted for publication, but is still in press,** follow the “journal citation” example(s) but include "in press" in parenthesis in place of the volume and page range.  DO include these citations as a formal reference in the reference list.

 

**Note:  “Submitted” and “in press” citations should be updated in the page proofs stage whenever possible.


Reviews, Commentaries and Editorials

These are usually solicited by the Editorial Board, but we welcome unsolicited submissions of this type. A pre-submission inquiry regarding an unsolicited review, commentary, or editorial should be submitted to the Editor-in-Chief at wilsonjm@mail.med.upenn.edu. If found to be of potential interest, a formal submission will be encouraged which, after submission, will be sent out for external review as well as internal review by members of the Editorial board.

Research Articles: Pre-clinical safety assessment for HGT Clinical Development

Manuscripts submitted to HGT Clinical Development describing pre-clinical safety studies should follow a format different than that of regular Research Articles as described in detail below. The organization is: Abstract, Intrduction, and a combined Results and Discussion section. Materials and Methods and any additional data should be included in a supplementary section.

 

Title page and Abstract. Same as for general Research Articles

 

Introduction. Provide sufficient context to understand the importance of the studies. Comment on the disease being treated and cell and gene therapy approaches being considered. Specifically reference and comment on published data which support the feasibility of the therapeutic approach that is the topic of the safety study.

 

Results and Discussion. Combine Results and Discussion and include the following sections:

 

1. Clinical Trial. A brief summary of the proposed clinical trial that the pre-clinical study is/was intended to support should be included in this pre-clinical paper since the reader needs context as to why the pre-clinical study is being performed. Include a description of the investigational agent being evaluated. Refer to the Materials and Methods section for more details regarding the vector/cells.

 

2. Objectives and Study Design. Describe the goals of the pre-clinical study followed by a detailed description of the actual design of the pre-clinical study. Feel free to use tables and/or figures as necessary to describe study design. Provide a rationale for selection of animal species/animal models and/or cell lines used as well as the basis for actual structure of the study. Include a description of the similarities/differences between the model and humans (e.g., pathophysiology, disease progression, and severity). Also comment on the timing of vector/cell administration relative to disease onset and disease progression.

 

3. Summary of Data. Primary data should be presented in the manuscript in summary form. A more detailed description of the data should be provided in supplementary information if it is not thoroughly covered in the printed paper (see below). An important challenge will be determining what of the source data should be included in the paper and how will it be distributed between the Results/Discussion section of the printed manuscript vs. in the supplementary section. Please keep tables and figures in the printed manuscript to no greater than six (6). Some guidance is provided below for general categories of papers.

 

a. Acute in vivo toxicity. Substantial quantities of data are generated in these studies not all of which should be published. The printed manuscript should describe all positive findings (demonstration of efficacy and toxicities) and pertinent negative findings (the notable absence of toxicities in target organs/tissues) at least in summary form. The printed manuscript should list all assays/test performed and note that they were within normal limits if in fact they were all normal. The supplementary information can provide more detailed information of the pertinent negative and positive findings.

 

b. Biodistibution. These data should be described at least in summary form in the printed manuscript; included in the printed manuscript should be details of the assay. The supplementary information can provide data for individual animals if that seems to be of interest.

 

c. Genotoxicity. All data related to the presence or absence of cell transformation should be included in the manuscript. Some ancillary data such as details of integration or sequence analysis can go in the supplement.

 

Conclusions. Please discuss the findings in the context of how they will/have influence the design of the clinical trial. Also consider the data in the context of previous work performed with similar investigational agents. This is important in providing a data base relevant to platform technologies to determine if there are common features of the platform that can help predict toxicity. Examples of platforms include bio-distribution studies with a common AAV capsid or genotoxicity studies with lentiviral vectors that share identical genome structures and envelope proteins.

 

Supplementary information. Feel free to include relevant supporting data in a supplementary information section that will appear online-only. When doing so, please refer to this information and data in the presentation of results that appears in the published manuscript.

 

1. Materials and Methods.

 

a. Investigational agent. Describe how the vector/cells were prepared including sufficient detail to allow for comparisons to studies using similar vectors/cells. Include all data regarding the characterization of the product.

 

b. Assays. Describe each assay used in the analysis of the experiment, including information about controls, assay sensitivity and/or specificity if available. Provide information regarding the state of validation of each assay such as: research based, an internal qualified assay, or a contract assay. For histopathology include details about the criteria used for assessing abnormal findings and how and who read the pathology.

 

c. Procedures. Details regarding non-standard procedures should be provided especially those involving in vivo work such as the conditions of administering the investigational drug.

 

d. Statistical methods.

 

2. Quality assurance. Provide information regarding steps involved in assuring the quality of the data. This can range from a study performed under full GLP to a research based study; the study does not have to be full GLP to be value to the community and relevant to the Journal. Details of the QA program should be provided. Indicate if there was no formal QA program.

 

3. Results. Include more detailed data for all relevant findings including positive results and pertinent negative results. The authors have some latitude as to the amount of detail that is required although it should be much more focused than a final study report but more detailed than just a summary table.

 

Acknowledgments, Disclosure Statement, and References. Same as for regular Research Articles

 

Reviews, Commentaries, and Editorials for HGT Clinical Development

 

These are usually solicited by the Editorial Board. However, we welcome unsolicited submissions of this type. A pre-submission inquiry regarding an unsolicited review, commentary, or editorial should be submitted to the Editor-in-Chief at wilsonjm@mail.med.upenn.edu. If found to be of potential interest, a formal submission will be encouraged which, after submission, will be sent out for external review as well as internal review by members of the Editorial Board.

 

Clinical Protocols for HGT Clinical Development

 

In selected cases, we will consider publishing clinical protocols without clinical data. Criteria for acceptance will be the novelty of the proposed trial giving priority to first in human studies. Please submit a pre-submission inquiry to the Editor-in-Chief at wilsonjm@mail.med.upenn.edu before submitting the protocol focusing on the novelty of the trial.

 

The Protocol should be no longer than 4500 words and should be organized as follows:

 

1. Introduction. Very brief background including description of disease and pre-clinical and clinical data to support the efficacy and safety of the proposed study.

2. Study Objectives

3. Study Design. including primary and secondary endpoints. Include in this section a discussion of the dose levels/dose regimens and how they were selected based on pre-clinical data or other clinical studies which use the same or a similar investigational agent.

4. Subject Selection and Withdrawal

a. Inclusion Criteria

b. Exclusion Criteria

c. Subject Recruitment and Screening

d. Informed Consent: Include an example of a consent document in Supplementary information

5. Study Drug. Brief description of the investigational agent and how it is produced

6. Study Procedures. Include a table of events. Also describe in some detail the specifics of the vector/cell infusion.

7. Statistical Plan

8. Safety and Adverse Events

a. Definitions

b. Reporting of serious adverse events and unanticipated problems

9. Risk/Benefit Assessment

 

Tables and Illustrations

 

Use Arabic numerals to number tables. Do not repeat information that is given in the text, and do not make a table for data that can be given in the text in one or two sentences. Provide titles for all tables. Define all acronyms in table footnotes. All other types of table footnotes should be designated using superscript letters, not symbols.

 

Please follow these guidelines for submitting figures:

 

  • Upload each image as a separate file. Do NOT include figures and/or tables in the manuscript file.
  • Do NOT embed art files into a Word or PDF document. Figures provided in this format cannot be used for production purposes.
  • Line illustrations must be submitted at 900 DPI.
  • Halftones and color should be submitted at a minimum of 300 dpi.
  • Save as either TIFF or EPS files. JPEG files are for screen representation-quality only and will print very poorly during the printing process. To ensure proper print quality, please submit only TIFF or EPS files.
  • Color art must be saved as CMYK - not RGB. (NB: If RGB files are submitted, the files will be converted to CYMK and some color variation will occur.)

    Black and white art must be submitted as grayscale – not RGB.

  • Do NOT submit PowerPoint, PDF, Bitmap, or Excel as figure or table files.
  • When naming your figure files, please label them with the main author’s last name, followed by the figure number. (Ex: SmithFigl; SmithTable1). Avoid using punctuation in file names if possible.
  • Label figures and tables inside the files in addition to naming the file with the figure or table number. (ie: When figures or table files are opened, the figure or table number should appear inside the file.)

 

Additional Information About Converting Figure Files:

 

Converting Word or Excel files: The best and easiest way to convert Word or Excel files into a format which is suitable for print is to scan them using the below guidelines:

 

  • All files should be scanned at 100% size
  • 300 dpi
  • Final color mode: CMYK

  •  Save file as: .TIF or .EPS

If you need directions on how to convert a Power Point slide to acceptable format go to: www.liebertpub.com/MEDIA/pdf/ppconvert.pdf

 

A legend should be supplied for each illustration, and all legends numbered consecutively and provided (double spaced) in a separate file. Do not include the figure legend as part of the figure file. All symbol definitions should be in the figure legend, not as a key within the figure. If possible please use Arial font for figure text. Figures should be numbered in the order cited in the text. Images should not show the name of the manufacturer or reveal patients’ names. Please keep in mind that most figures will need to be sized according to journal style, so please do not submit large figures/graphs that contain small type, as the text within the figure will not be readable after reduction.


The Journal will publish color photographs, but the author will be charged for the cost of color printing. For further details, contact the Publisher.

 

INFORMED CONSENT, STUDY ETHICS APPROVAL, AND SUBJECT CONFIDENTIALITY

 

Patients and Study Participants

All manuscripts must comply with the privacy and confidentiality requirements outlined on the Uniform Requirements for Manuscripts Submitted to Biomedical Journals website. For more information, visit http://www.icmje.org/ethical_5privacy.html

 

When articles include reports of studies on human subjects, state in the Methods section that an appropriate institutional review board or ethics committee approved the study. Authors who do not have formal ethics review committees should follow the principles of the Declaration of Helsinki. In the Methods section, state that informed consent was obtained from subjects (specify written or verbal).

 

The principal author must state that if animals were used experimentally, permission was obtained from the appropriate committee(s), and that the animals were treated humanely and the standards conformed to those of current ethical animal research practices.

 

In addition, text and photographs should not reveal any identifying information unless it is essenti al for scientific purposes (in which case, consent should be obtained). Masking the subjects’ eyes in photographs is often insufficient to protect their identity.

 

ETHICAL CONSIDERATIONS IN THE CONDUCT AND REPORTING OF RESEARCH:

PROTECTION OF HUMAN SUBJECTS AND ANIMALS IN RESEARCH*

 

When reporting experiments on human subjects, authors should indicate whether the procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2008. If doubt exists whether the research was conducted in accordance with the Helsinki Declaration, the authors must explain the rationale for their approach and demonstrate that the institutional review body explicitly approved the doubtful aspects of the study. When reporting experiments on animals, authors should indicate whether the institutional and national guide for the care and use of laboratory animals was followed.

 

*This portion of the Instructions for Authors has been quoted directly from the Uniform Requirements for Manuscripts Submitted to Biomedical Journals website. For more information, visit www.icmje.org/ethical_6protection.html

 

Permissions

 

The author must obtain permission whenever it is required in conjunction with the reproduction of material such as figures and tables from copyrighted material. Written permission must be obtained from the publisher of the journal or book concerned. The publication from which the figure or table is taken must be listed in the reference list. Finally, a footnote to a reprinted table, or of the legend of a reprinted figure should read, “Reprinted by permission from Jones et al.” and list the appropriate reference. All permissions listings must be shown in the manuscript—they cannot be entered on proofs.

 

Competing Interest for Reviewers

 

The Editors leave it to the discretion of the invited reviewer to state whether or not they have any type of conflict with any of the authors on the manuscript. Such conflicts might include recent or ongoing collaborations with the authors; having previously reviewed the manuscript in its draft stages; the reviewer is in direct competition with the authors or has a financial interest in the outcome of the manuscript. Editors will take this information into consideration when deciding whether or not to use the reviewer, or in evaluation of the reviewer’s comments. Should the reviewers feel they cannot be objective in their review for financial, personal or other reasons, they should decline to review the manuscript.

 

We do not exclude reviewers who previously reviewed a specific manuscript for another journal. The comments offered by a qualified reviewer are valuable to the peer-review process and it is important for the reviewer to consider that the author may have already revised the manuscript based on his/her previous comments.

 

Competing Interest for Editor-in-Chief and Associate Editors

 

The Editor-in-Chief and Associate Editors will recuse themselves from participating in the review process of any manuscript in which there is a potential or actual competing interest.

 

Confidentiality

 

Editors and Reviewers must maintain strict confidentiality of manuscripts during the peer-review process. Sharing a manuscript in whole or in part, outside the scope of what is necessary for assessment, is impermissible prior to the manuscript’s official publication date.

 

Sharing of Materials Policy

 

Authors must honor any reasonable request for materials, methods, or data necessary to reproduce or validate the research findings.

 

Cover Art

 

Authors of manuscripts accepted by the flagship journal, Human Gene Therapy, who have interesting images related to their paper, regardless of whether the images are published within the manuscript itself, are encouraged to submit them for consideration for the Journal cover. Please ensure they are not submitted or published elsewhere. Images should be high resolution—at least 300 dpi and measuring 5"×5"—.EPS or .TIFF files, and saved as CMYK, not RGB. Send images or questions to hgt@mail.med.upenn.edu.

 

Preprints

Human Gene Therapy recognizes the growing popularity of community non-peer-reviewed preprint repositories such as bioRxiv, arXiv, ChemRxiv, PeerJ Preprints, etc. Deposition of a preprint on a preprint server will not impact consideration of any manuscript submitted to Human Gene Therapy. The existence of a publicly available preprint should be declared upon submission.

 

Reprints

 

Reprints may be ordered by following the special instructions that will accompany the proofs, and should be ordered at the time the corresponding author returns the corrected page proofs to the Publisher. Reprints ordered after the issue is printed will be charged at a substantially higher rate.

 

Human Gene Therapy, HGT Methods and HGT Clinical Development will distribute or make available short press releases on newsworthy articles.

 

Publisher

 

With the addition of HGT Clinical Development in 2013, 22 issues in the Human Gene Therapy Program are published annually by Mary Ann Liebert, Inc., 140 Huguenot Street, New Rochelle, NY 10801-5215. Telephone: 914-740-2100; Fax: 914-740-2108; Email: info@liebertpub.com; Online: www.liebertpub.com

 

[*] Supplementary information. We encourage the judicious use of a supplementary (online-only) information section. All information/data in the supplementary information should be referred to in the printed manuscript including reference to specific tables and figures in the supplement. Upload supplementary tables, figures, and legend as separate files. The paper should be written so that the paper which appears in the printed journal contains all data which are key to the conclusions and important for the reader to have direct access to when reading the paper. Other supporting data and text are appropriate for the supplementary section.

Mary Ann Liebert, Inc., publishers has partnered with Editage and Impact Science to provide a dynamic suite of specialized editorial services to ensure your manuscript has the impact it deserves.

 

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JOURNAL FEES

  • There is no submission fee for [journaltitle].
  • Page charges for Human Gene Therapy are set at $75.00 USD per typeset page.  Nonpayment of page charges may result in a delay in publication.  Costs for publishing images in color are a separate fee and are not included in the page charge total. 
  • Please contact AuthorBenefits@liebertpub.com for costs for publishing images in color.
  • Open Access and Creative Commons (CC-BY / CC-BY-NC) licensing options are available. Contact our Open Access Manager for more information.
  • For pricing and purchasing reprints, contact our Reprints Manager.
  • Any fees collected or payments associated with a submitted and/or published paper that is subsequently withdrawn and/or retracted for any reason are non-refundable.

 

All Mary Ann Liebert, Inc. journals follow the standards, guidelines, and best practices set forth by the -Committee on Publication Ethics (COPE; publicationethics.org), the International Committee of Journal Medical Editors (ICJME; www.icmje.org), the World Medical Association (WMA); www.wma.net) and the American Medical Association (www.ama-assn.org).

Human Gene Therapy is a single-blinded peer-reviewed journal. All submissions are subject to peer review. Upon submission, manuscripts are assessed by an editor for suitability for the journal.  For those that are deemed suitable, a minimum of two expert reviewers in the area of study will be selected to assess the scientific basis and significance of the manuscript. Following peer review, the Editor and/or Associate Editors will determine if the paper should be accepted, require revision, or is unacceptable for publication.

Confidentiality in Peer Review

Editors and reviewers must maintain strict confidentiality of manuscripts during the peer-review process. Sharing a manuscript in whole or in part, outside the scope of what is necessary for assessment, is impermissible prior to an accepted manuscript's official publication date.

Sharing of Materials during Peer Review

Authors must honor any reasonable request for materials, methods, or data necessary to reproduce or validate the research findings during peer review unless it violates the privacy or confidentiality of human research subjects.

Papers Authored by the Editor-in-Chief and/or Associate Editors

The Editor-in-Chief and Associate Editors will recuse themselves from participating in the review process of any manuscript in which there is a potential or actual competing interest.

Self-Citation and Self-Plagiarism

Human Gene Therapy is committed to maintaining the integrity of the peer review process by upholding the highest standards for all published articles. All manuscripts will be processed through plagiarism detection software prior to peer review. Plagiarized manuscripts will be rejected immediately. While a manuscript submission may contain some redundancy in language and content (i.e., Materials and Methods) compared to work previously published by authors, self-plagiarism can infringe upon copyright. To avoid plagiarism, be sure to properly cite and reference all published works. (Deposition of a preprint on a preprint server is not considered as prior publication and will not impact consideration of any submitted manuscript.)

Time in Review

The Human Gene Therapy journal program aims to maintain a short, but thorough peer-review process. The average time in review for the three components of the journal program is 36 days. However, the Editor(s) will strive to expedite manuscript handling if/when special circumstances dictate.

ATTENTION:  To ensure the receipt of all communications from the journal editorial office and publisher, please whitelist the following domains to prevent spam filter detection or non-deliverables:

  • manuscriptcentral.com
  • amazonses.com
  • liebertpub.com

Failure to whitelist these domains may significantly hinder the progress of peer review on submitted manuscripts, and the production process of accepted papers.
 

AUTHORSHIP

Definition of Authorship

Authorship, as defined by the International Committee of Medical Journal Editors, is based on the following criteria:

  • Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND
  • Drafting the work or revising it critically for important intellectual content; AND
  • Final approval of the version to be published; AND
  • Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Non-Author Contributors

Contributors who meet fewer than all four of the above criteria for authorship should not be listed as authors, but they should be acknowledged in the Acknowledgments section with a description of their contribution to the work.

For further information, visit the International Committee of Medical Journal Editors’ website at: http://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html

ORCID IDs

All submitting authors are required to complete their submissions using an ORCID identifier. Please visit the ORCID website for more information, or to register.

AUTHORSHIP LIMIT

There is a limit of 35 of authors permitted on a single submission, but in cases where there are 20 or more co-authors, Human Gene Therapy recommends that a collective group or consortium name be provided and the individual authors listed in the Acknowledgements.

CORRESPONDING AUTHOR**

One author should be designated as the corresponding author who will be responsible for communication between the authors and the journal editorial office(s) and publisher. This individual will be responsible for ensuring all authors submit copyright forms and coordinating and responding to page proofs, as well as any managing any other necessary contact during the peer review and/or production processes.

**NOTE: Due to configuration restraints, the submission system permits only one author to be identified as the corresponding author of record. However, we recognize that some submissions call for more than one corresponding author to be noted. In such cases, select one author to be the main point of contact and/or corresponding author for all communications regarding the peer review process of the paper, but on the title page of the manuscript, designate additional co-corresponding authors by including an asterisk after the authors' names in the byline, and include an accompanying footnote on the title page that reads, "*Co-corresponding authors."  Please ensure that the title page of the submission page carries the full affiliation details and email addresses of all authors who should be noted as a corresponding author. If the paper is accepted for publication, the full contact information for all desginated co-authors will be listed at the end of the article as per usual journal style.

WORKING GROUPS / TEAM AUTHORSHIP

Working Groups or Teams may be listed in the manuscript byline, but the entire listing of names and affiliations should be included in the acknowledgment section of the manuscript. Do not list the names in a footnote on the title page.

VARIATIONS OF AUTHORSHIP

It is permissible to list up to three authors as co-first authors, or as contributing equally to the work. Include an asterisk (*) next to the authors' names who are considered as first authors. Include a corresponding footnote, using the asterisk, on the title page that reads, "These authors contributed equally to this work and are considered to be co-first authors."

CHANGES IN AUTHORSHIP

Changes in authorship after submission or acceptance of a paper are strongly discouraged, but the editorial leadership recognizes that in certain circumstances, it may be required. The journal's policy for such cases is as follows:

  • A request to alter authorship must be made in writing from the corresponding author to the Editor-in-Chief, with a detailed explanation for the request, and the names and affiliations of the authors requiring addition and/or deletion.
  • Authorship may be altered after submission or acceptance of a paper ONLY with the expressed written approval of all authors named on the manuscript, as well as the individual(s) being added and/or deleted. The Publisher can provide a form for this, if needed.
  • Upon receipt of the request and all written approvals of all involved parties, the Editor-in-Chief will consider the request, render a decision, and notify the corresponding author.
  • There is a one-year post-publication statute of limitation on requests for alterations in authorship.
  • Post-publication changes or alterations to conference abstracts are prohibited.

ATTENTION: To ensure the receipt of all communications from the journal editorial office and publisher, please whitelist the following domains to prevent spam filter detection or non-deliverables:

  • manuscriptcentral.com
  • amazonses.com
  • liebertpub.com

Failure to whitelist these domains may significantly hinder the progress of peer review on submitted manuscripts, and the production process of accepted papers.

EXCLUSIVITY

Manuscripts should be submitted with the understanding that they have neither been published, nor are under consideration for publication elsewhere, in the same form or substantially similar form, except in the form of a conference abstract.  If work was presented at a conference, supply the name, date, and location of the meeting as a footnote on the title page of the submission.

AUTHOR DISCLOSURE STATEMENTS

  • Competing Interests. A competing interest exists when an individual (or the individual's institution) has financial or personal relationships that may inappropriately influence his actions. These competing interests may be potential or actual, financial or other.
  • Personal Financial Interests. Stocks or shares in a company that may gain or lose financially from publication of the article; consulting fees or other remuneration from an organization that may gain or lose financially from publication of the article; patents or patent applications that are owned by or licensed to companies/institutions that may gain or lose value from publication of the article.
  • Funding. Research support by organizations that may gain or lose financially from publication of the article. This support includes salary, equipment, supplies, honoraria, reimbursement or prepayment for attending symposia, and other expenses.
  • Employment. Recent (within the past 5 years), current, or anticipated employment by an organization that may gain or lose financially from publication of the article.
  • Other Competing Interests. Any personal relationship which may inappropriately affect the integrity of the research reported (by an author) or the objectivity of the review of the manuscript (by a reviewer or Editor), for example, competition between investigators, previous disagreements between investigators, or bias in professional judgment.

SELF-CITATION AND SELF-PLAGIARISM

Human Gene Therapy is committed to maintaining the integrity of the peer review process by upholding the highest standards for all published articles. All manuscripts will be processed through plagiarism detection software prior to peer review. Plagiarized manuscripts will be rejected immediately. While a manuscript submission may contain some redundancy in language and content (i.e., Materials and Methods) compared to work previously published by authors, self-plagiarism can infringe upon copyright. To avoid plagiarism, be sure to properly cite and reference all published works.

AFFILIATIONS

Authors should identify as their institution(s) the facility where the work was performed and executed.  Changes in an author’s affiliation after the work was completed but prior to the submission or publication of the manuscript should be noted by including an asterisk as a superscript to the name in the author listing, as well as a corresponding footnote on the title page indicating “Current Address” listing the new affiliation.   Corrections to affiliations or contact information due to relocation after publication is not permitted.

REPRINTS

Reprints may be ordered by following the special instructions that will accompany the proofs and should be ordered at the time the corresponding author returns the corrected page proofs to the Publisher as reprints ordered after the issue is printed will be charged at a substantially higher rate.

Word limits do NOT pertain to the abstract, disclosure statements, author contribution statements, funding information, acknowledgments, tables, figure legends, or references.

Human Gene Therapy will consider manuscripts of very high quality that broadly fall under the scope of cell and gene therapy. Some general categories include studies evaluating novel approaches of cell and gene therapy in pre-clinical and clinical models; development of novel technologies; studies that help define mechanisms of action of cell and gene therapies; host interactions to vector and transplanted cells; and high-impact new methods and clinical trials.

Manuscripts on these topics may be submitted in the form of an original research article or a high impact protocol. Invited review articles and commentaries are usually solicited by the Editorial Board, but we also welcome unsolicited submissions of this type.

The Editors may quickly reject a manuscript soon after submission without external review if it falls outside the scope of the Journal or would not likely meet our high standards required for publication.

Review Articles
•    5,000-8,000-word limit
•    Unstructured abstract of no more than 300 words
•    Maximum of four (4) tables and/or figures
•    A maximum of 50 references is permitted

Original Research Articles
•    3,000-word limit
•    Unstructured abstract of no more than 300 words
•    Maximum of six (6) tables and/or figures

Research Articles – Methods
Methods articles focus on key technological advances in all areas of cell and gene therapy including basic research in the form of original research articles, operational protocols, and invited review articles. Submissions that describe key technological advances such as techniques for detecting transgene expression, improved vector design, manufacturing advancements, and product testing assays are welcomed.
•    3,000-word limit
•    Unstructured abstract of no more than 300 words
•    Maximum of six (6) tables and/or figures

Research Articles – Clinical Development
Clinical Development articles are pre-clinical articles focusing on pharmacology/ toxicity/ bio-distribution experiments used in the review of proposed clinical trials and contain sufficient information to allow referencing between products within the same technology platform when appropriate. Recognizing the importance of all clinical data in the formative stages of the field, HGT will publish clinical trials of gene and cell therapy including those which are confirmatory or negative.
The criteria for publishing pre-clinical safety studies and clinical trials in HGT is different than in most journals. We will consider the manuscript appropriate for review if the data are collected in a way that supports the conclusions and are useful in progressing the clinical development of the product; the studies do not have to be novel or to discern mechanisms. The Clinical Development section of HGT is an excellent venue for publishing additional topics including production and characterization data of gene and cell therapy products; selected clinical protocols which describe first-in-human applications of cell and gene therapy; and topical issues related to the commercial development of gene and cell therapy products.
•    3,000-word limit
•    Unstructured abstract of no more than 300 words
•    Maximum of six (6) tables and/or figures

HGT Protocols is a specific category encouraging the publication of operating procedures for methodologies which allow key advances in the field of gene therapy. The scope of acceptable protocol submissions for HGT encompasses all aspects of vector and vaccine development including production and purification methodologies, assessment of immunotoxicity and/or genotoxicity, regulation of transgene expression and monitoring approaches for cell and gene therapy. The step-by-step protocol provided in HGT Protocols is intended to establish novel peer-reviewed methodologies and enable technical improvements for specialists and non-specialists in the gene therapy field. The protocol submission should describe a method that has already been used to produce results in a peer-reviewed original research article and should describe a considerable technological advancement when compared to the “state-of-the art” methodology.

Methods Protocols
•    3,000-word limit
•    Unstructured abstract of no more than 100 words
•    Maximum of six (6) tables and/or figures

Clinical Protocols
•    4,500-word limit
•    Unstructured abstract of no more than 300 words
•    Maximum of six (6) tables and/or figures

Pathways in Gene Therapy
•    2,000-word limit
•    No abstract
•    Maximum of two (2) tables and/or figures

Commentaries
•    1,200-word limit
•    No abstract
•    No tables or figures

News and Views
•    1,000-word limit
•    No abstract
•    No tables or figures

Letters to the Editor
•    500-word limit
•    May include one figure OR table
•    Reference citations are identical in style to those of full original articles, but should not exceed five (5).

 

INTERNAL REVIEW BOARD APPROVALS/WAIVERS

(as described and defined on the World Medical Association's website; www.wma.net)

When reporting research involving human data, authors should indicate whether the procedures followed have been assessed by the responsible review committee (institutional and national), or if no formal ethics committee is available, were in accordance with the Declaration of Helsinki as revised in 2013. If doubt exists whether the research was conducted in accordance with the Helsinki Declaration, the authors must explain the rationale for their approach and demonstrate that the institutional review body explicitly approved the doubtful aspects of the study. Approval by a responsible review committee does not preclude editors from forming their own judgment whether the conduct of the research was appropriate.

If the study is judged exempt from review, a statement from the committee is required. Informed consent by participants should always be secured. If not possible, an institutional review board must decide if this is ethically acceptable. This information should be outlined in the cover letter accompanying the submission, and in a sentence declaring adherence should be included in the Materials and Methods section of the manuscript.

ETHICS OF EXPERIMENTATION

All articles involving the use of human fetuses, fetal tissue, embryos, and embryonic cells must adhere to the US Public Law 103–41, effective December 13, 2001. (http://ethics.od.nih.gov/).

ETHICAL TREATMENT OF ANIMALS

All peer-reviewed submissions containing animal experiments must comply with local and national regulatory principles and contain a statement in the Materials and Methods section stating whether their national and institutional guidelines for the care and use of laboratory animals were followed.

For further information, consult the World Medical Association’s website: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/

AUTHOR DISCLOSURE STATEMENTS

  • Competing Interests. A competing interest exists when an individual (or the individual's institution) has financial or personal relationships that may inappropriately influence his actions. These competing interests may be potential or actual, financial or other.
  • Personal Financial Interests. Stocks or shares in a company that may gain or lose financially from publication of the article; consulting fees or other remuneration from an organization that may gain or lose financially from publication of the article; patents or patent applications that are owned by or licensed to companies/institutions that may gain or lose value from publication of the article.
  • Funding. Research support by organizations that may gain or lose financially from publication of the article. This support includes salary, equipment, supplies, honoraria, reimbursement or prepayment for attending symposia, and other expenses.
  • Employment. Recent (within the past 5 years), current, or anticipated employment by an organization that may gain or lose financially from publication of the article.
  • Other Competing Interests. Any personal relationship which may inappropriately affect the integrity of the research reported (by an author) or the objectivity of the review of the manuscript (by a reviewer or Editor), for example, competition between investigators, previous disagreements between investigators, or bias in professional judgment.

INTERNAL REVIEW BOARD APPROVALS/WAIVERS

(as described and defined on the World Medical Association's website; www.wma.net)

When reporting research involving human data, authors should indicate whether the procedures followed have been assessed by the responsible review committee (institutional and national), or if no formal ethics committee is available, were in accordance with the Declaration of Helsinki as revised in 2013. If doubt exists whether the research was conducted in accordance with the Helsinki Declaration, the authors must explain the rationale for their approach and demonstrate that the institutional review body explicitly approved the doubtful aspects of the study. Approval by a responsible review committee does not preclude editors from forming their own judgment whether the conduct of the research was appropriate.

If the study is judged exempt from review, a statement from the committee is required. Informed consent by participants should always be secured. If not possible, an institutional review board must decide if this is ethically acceptable. This information should be outlined in the cover letter accompanying the submission, and in a sentence declaring adherence should be included in the Materials and Methods section of the manuscript.

COPYRIGHT AGREEMENT FORM

Upon acceptance of any manuscript, all authors will receive an email with detailed instructions and a unique, author-specific link to access and complete our online Copyright Agreement form. It is critical to ensure the accuracy of ALL authors' email addresses when uploading submissions to Manuscript Central to ensure the proper delivery of all email communications. FAILURE BY ALL AUTHORS TO SUBMIT THIS FORM WILL RESULT IN A DELAY OF PUBLICATION. The corresponding author is responsible for communicating with coauthors to ensure they have completed the online copyright form. Authors not permitted to release copyright must still return the form acknowledging the statement of the reason for not releasing the copyright. Copyright forms may also be completed by logging in to the system using an author's credentials. After logging on, click on Author Center and complete the forms located under "Manuscripts I Have Coauthored."

Published manuscripts become the sole property of the Journal and will be copyrighted by Mary Ann Liebert, Inc., unless alternate arrangements are made prior to publication, including CC-BY licensing (see below). By submitting a manuscript to the Journal, the author(s) agree(s) to each of the above conditions. In addition, the author(s) explicitly assign(s) any copyrighted ownership he/she (they) may have in such manuscript to the Journal.

OPEN ACCESS / CC-BY LICENSING

Human Gene Therapy is a subscription-based peer-reviewed journal with Open Access options. Creative Commons CC-BY and CC-BY-NC licensing is available for all articles published open access for a standard Article Processing Charge (APC) of $3,200.00 USD. Please contact our Open Access Manager to order open access for your article. Learn more about open access publishing on our website.

PERMISSIONS

When reproducing copyrighted material such as figures, tables, or excerpted text, the author(s) of the submitted paper must obtain permission from the original publisher and submit it concurrently with the manuscript. The publication from which the figure or table is taken must be listed in the reference list. Finally, a footnote to a reprinted table or the legend of a reprinted figure should read, "Reprinted by permission from Jones et al." and list the appropriate reference. All permissions must be supplied at the time of submission.  Authors are responsible for any fees that may be incurred by securing permission to reproduce or adapt material from other published sources.

REUSE OF MATERIAL POSTED ON SOCIAL MEDIA

As material posted on social media platforms is usually not peer-reviewed content, it is not permitted as an official citation and/or reference.

Mary Ann Liebert, Inc., publishers permits the use of accepted pre-published manuscripts for the sole purpose of pitching to news organizations under strict embargo, and with the approval of and expressed collaboration with the publisher. A watermarked PDF version of the article (not a Word document or any other editable version) may be shared only with named, personal contacts at trusted news sources upon request. News sources must be informed upon delivery of the PDF that the manuscript is for reference-only purposes and can be used only in preparation of their news coverage of the article. It is strictly prohibited to publicly share, post, or otherwise distribute the PDF in any media format. Upon official publication of the article, news organizations must link directly to the published article on the publisher’s journal website. To coordinate publication timing and press efforts, please contact the Director of Marketing, Kathryn Ryan (kryan@liebertpub.com).

DATA SHARING

Human Gene Therapy strongly advocates the sharing and archiving of the data and any other artifacts that define and support the results stated in a manuscript in a suitable public repository (in accordance with valid privacy, legal, and ethical guidelines). A data availability statement should be included in the manuscript (in the Methods section or as a separate section at the end of the manuscript), describing the location of the data, with details on how it can be accessed as well as any licensing information. If the data is not publicly available or accessible, that information should also be provided.

Datasets should be cited in the reference list by Author (Year). Title. Publisher. Identifier/DOI.

Important: Please check with your funding agencies to ensure that are you following their data sharing polices. If your funding agency has additional requirements exceeding our policy, you must follow the requirements of your funder.

PREPRINT SERVERS

A preprint is a complete draft of a research paper that is shared on a public preprint server prior to submission to a journal for peer review.
 
Mary Ann Liebert, Inc., allows for papers that were previously deposited on preprint servers to be submitted to our journals, with the proviso that the author updates any preprint versions with a link to the final published article.  All submissions are subject to peer review and allowing the submission of preprint manuscripts does not guarantee publication in any Mary Ann Liebert, Inc., journal.
 
The submitting author of a paper that was previously deposited to a preprint server should include a disclosure on the title page of the manuscript indicating the name and website of the server and include the DOI number of the preprint.
 
Referencing/citing non-peer-reviewed material that is found on any preprint server is generally discouraged by Mary Ann Liebert, Inc., journals, but if it is necessary, the citation must make it clear that the content is not officially published in a journal, and can only be found on a preprint server.

 

RESEARCH FUNDER COMPLIANCE (FundRef)

Upon submission of a manuscript, the submitting agent will have an opportunity to enter funding/grant information. If funding information is entered correctly, the publisher will deposit the funding acknowledgements from the article as part of the standard metadata to FundRef. The entered information should include funder names, funder IDs (if available), and associated grant numbers.  Special care should be taken when entering this information to ensure total accuracy. (See https://www.crossref.org/services/funder-registry/ for a listing of more than 13,000 international funding agencies.)

GOVERNMENT FUNDED RESEARCH

Human Gene Therapy is fully NIH-, HHMI-, RCUK, and Wellcome Trust-compliant.

OPEN ACCESS

Our open access publishing solutions allow you to comply with the open access policies of your institution, government, and funding body. If you are employed or funded by the National Institute of Health (NIH), the Wellcome Trust, Research Councils UK (RCUK), or Howard Hughes Medical Institute (HHMI), you can find more information below:

  • NIH and HHMI Public Access Policy–In order to assist our authors who have NIH funding to comply with this policy, Mary Ann Liebert, Inc. publishers will deposit the final paginated version of the published article to PubMed Central (PMC) on behalf of the authors after a 12-month embargo period. Authors need not take any action. This service is provided free of charge. Authors who wish to remove the 12-month embargo period are encouraged to consider publishing with Open Option.
  • Wellcome Trust Policy–To easily comply, you can choose to have your article published open access under the Creative Commons Attribution (CC BY) license. The publication charge will be covered by the Wellcome Trust.
  • Research Councils UK (RCUK)–To easily comply, you can choose to have your article published Open Access under the Creative Commons Attribution (CC BY) license. The publication charge will be covered by the RCUK.

ATTENTION: To ensure the receipt of all communications from the journal editorial office and publisher, please whitelist the following domains to prevent spam filter detection or non-deliverables:

  • manuscriptcentral.com
  • amazonses.com
  • liebertpub.com

Failure to whitelist these domains may significantly hinder the progress of peer review on submitted manuscripts, and the production process of accepted papers.

POST-ACCEPTANCE / PRODUCTION

The three components of the Human Gene Therapy (HGT) journal program (HGT,  HGT Methods, and HGT Clinical Development) publishes all accepted papers within 72 hours of the return of all signed copyright forms in their unedited, uncorrected format on the journal's website in the "Instant Online Articles" submenu of the "New Articles" tab.  It is important to note that the information that is published online, and in all indexing services, is pulled directly from the data that is populated into the fields in Manuscript Central – NOT from the manuscript file – when the paper is originally uploaded to the system for peer review.  Consequently, any errors contained in the system will remain on our website and all indexing services, including Medline, until the next revision** of the article is published.  As such, it is critical that authors enter all authors’ names correctly into the system at the time of submission.  Any errors within the manuscript will remain on our website until the subsequent online version** is published.

**The next revision will take place after the corresponding author sees page proofs, makes any necessary corrections, and returns the changes to the Publisher.  Once the alterations are completed, the revised version will be published on our website, and the newly corrected information will then be released to Medline/PubMed, as well as any other indexing services in which the HGT journal program is included.

Please note that the typical time between acceptance of a paper and page proof distribution is approximately 3-6 weeks depending on the length and complexity of the paper, and the timing of the corresponding author's responses to page proofs.

AFTER  INSTANT ONLINE  PUBLICATION

ll accepted manuscripts will go through copyediting, typesetting, figure sizing and placement, author proofing, corrections, revisions (from corrected proofs), online-ahead-of-print release, and lastly, issue assignment. Depending on the length and complexity of any accepted submission, these steps typically take 3-6 weeks from acceptance.  Changes or alterations to a submission are not permitted after acceptance, but should be addressed in page proofs.

PAGE PROOFS

Page proofs will be sent to the corresponding author as designated in Manuscript Central when the manuscript was submitted. It is the corresponding author's responsibility to share the page proofs with co-authors, if desired, and to coordinate all authors' corrections into one proof. The Publisher will not accept corrections from multiple authors/sources.

AUTHOR RESPONSE TO GALLEY PROOF

  • The corresponding author is responsible for returning corrected galley proofs generally within 72 hours of receipt.
  • If the corresponding author does not respond within that timeframe, the manuscript may be delayed in the publication schedule, or published as is, at the discretion of the Editor and Publisher.
  • If the corresponding author expects to be unavailable during the time the manuscript is in production, the publisher should be provided with an alternate contact. 
  • Only corrections directly related to errors in typesetting and/or layout will be allowed.
  • Any requested changes related to content, or that alter the outcome of a study, will require the approval of the Editor, and may require further peer review.

REPRINTS

Reprints may be ordered by following the special instructions that will accompany the proofs and should be ordered at the time the corresponding author returns the corrected page proofs to the Publisher as reprints ordered after the issue is printed will be charged at a substantially higher rate.

POST-PUBLICATION CORRECTIONS

In the event an error is discovered after publication of an article, the corresponding author should submit the correction in writing to the editorial office for consideration.  After editor approval, alterations will be made to the online version of the article, and if the errors are significant, an official correction statement will be issued.

  • Changes to author affiliations or contact details due to relocation after publication are not permitted.
  • Corrections to meeting abstracts will be made only to the online version.  The Journal does not issue formal correction statements for corrections to meeting abstracts, regardless of the nature of the correction.
  • Correction Statements/Errata to published articles that require the reproduction of color figure(s) and/or table(s) may incur additional costs to the author(s).

RETRACTIONS**

The journal and its publisher are committed to upholding the proper protocols and established standards of peer review.  Published papers found to be in violation of any of the misconduct noted above, or in the accepted principles of peer review and scientific publishing, will be officially retracted from the literature.  An official retraction notice explaining in full detail the circumstances surrounding the need for a retraction.

**Any publication fees for retracted and/or withdrawn articles are nonrefundable in any circumstance.

STUDY DESIGN AND ETHICS

RESPONDING TO ALLEGATIONS OF POSSIBLE MISCONDUCT

The Publisher is committed to helping protect the integrity of the public scientific record by sharing reasonable concerns with authorities who are in the position to conduct an appropriate investigation into an allegation. As such, all allegations of misconduct will be referred to the Editor-In-Chief of the Journal who in turn will review the circumstances, possibly in consultation with associate editors and/or members of the editorial board. Initial fact-finding will usually include a request to all the involved parties to state their case and explain the circumstances in writing. In questions of research misconduct centering on methods or technical issues, the Editor-In-Chief may confidentially consult experts who are blinded to the identity of the individuals, or if the allegation is against an editor, an outside expert. The Editor-In-Chief will arrive at a conclusion as to whether there is enough reasonable evidence that the possibility of misconduct occurred.

When allegations concern authors, the peer review and publication process for the manuscript in question will cease while the process described herein is researched. The investigation will be taken to completion even if the authors withdraw their paper. In the case of allegations against reviewers or editors, they will be replaced in the review process while the matter is investigated.

Editors or reviewers who are found to have engaged in scientific misconduct will be removed from further association with the Journal, and reported to their institution.

If an inquiry concludes there is a reasonable possibility of misconduct, the Editor-in-Chief will retract the paper from the Journal and the scientific record. If the paper is still under peer review, the Editor-in-Chief will withdraw the paper from consideration to the Journal.

All allegations will be kept confidential.

DEFINITIONS OF SCIENTIFIC MISCONDUCT

Mary Ann Liebert, Inc., publishers follows the guidelines and rules regarding scientific misconduct put forth by the Committee on Publication Ethics (COPE), the International Committee of Medical Journal Editors (ICMJE), and the Office of Research Integrity (ORI).

Scientific misconduct and violation of publishing ethics vary and can be intentionally or unintentionally perpetrated. Some examples of misconduct and violations include, but are not limited to, the following:

  • Scientific Misconduct: Fabrication, falsification, concealment, deceptive reporting, or misrepresentation of any data constitutes misconduct and/or fraud.
  • Authorship Disputes: Deliberate misrepresentation of a scientist's contribution to the published work, or purposefully omitting the contributions of a scientist.
  • Misappropriation of the ideas of others: Improper use of scholarly exchange and activity may constitute fraud. Wholesale appropriation of such material constitutes misconduct.
  • Violation of generally accepted research practices: Serious deviation from accepted practices in proposing or carrying out research, improper manipulation of experiments to obtain biased results, deceptive statistical or analytical manipulations, or improper reporting of results constitutes misconduct and/or fraud.
  • Material failure to comply with legislative and regulatory requirements affecting research: Including but not limited to serious or substantial, repeated, willful violations of applicable local regulations and law involving the use of funds, care of animals, human subjects, investigational drugs, recombinant products, new devices, or radioactive, biologic, or chemical materials constitutes misconduct.
  • Conflict of Interest: Nondisclosure of any conflicts, direct or indirect, to the Journal which prevents you from being unbiased constitutes misconduct.
  • Deliberate misrepresentation: of qualifications, experience, or research accomplishments to advance the research program, to obtain external funding, or for other professional advancement constitutes misconduct and/or fraud.
  • Plagiarism: Purposely claiming another's work or idea as your own constitutes misconduct and/or fraud.
  • Simultaneous Submission: Submitting a paper to more than one publication at the same time constitutes misconduct.

RETRACTIONS

The journal and its publisher are committed to upholding the proper protocols and established standards of peer review.  Published papers found to be in violation of any of the misconduct noted above, or in the accepted principles of peer review and scientific publishing, will be officially retracted from the literature.  An official retraction notice explaining in full detail the circumstances surrounding the need for a retraction.

Three versions of the article format versions are referenced in the below policy guidelines:

•    Original Submission: The article version that is submitted by the author for consideration, before peer review.
•    Accepted Version: The article version that has been formally accepted after peer review, prior to any typesetting for the journal. This is the version accepted by the editor, before proofs, corrections, and typesetting. Also known as the “raw” accepted version of a manuscript.
•    Article of Record: This article version is the “version of record” that has been formally copyedited, typeset, and published online epub ahead of print and/or in a journal issue. It is the same version published in the “Online Now” section of the journal website.

Self-Archiving Policy

Mary Ann Liebert, Inc., publishers offers authors many options and opportunities to self-archive their work. Self-archiving of work is also referred to, or known as, publishing “Green Open Access”.

Authors can self-archive the original submission version of their article on any website or repository without embargo.

Additionally, authors can self-archive the accepted version of their article on their personal websites or institutional repositories only, without embargo. Any archiving of the accepted version for inclusion in subject-based repositories, such as PubMed Central (PMC), should follow the requirements of the funder of the work.  

Authors are not allowed to publish or self-archive the article of record on any website, social media platform, or repository without permission from Mary Ann Liebert, Inc., publishers, unless they publish their paper Gold Open Access (OA). Learn more about publishing your work Open Access here.

Mary Ann Liebert, Inc., publishers’ society partners or associated affiliates may set self-archiving policies independently, outside of the below -mentioned general policies. Authors should refer to the copyright policy of their chosen journal, which can be found on the Journal Collection Page or by contacting the specific journal editorial office directly. In addition, specific funding organizations have separate agreements and authors should refer to the policies of those specific funding agencies prior to the submission of their manuscript.

Original Submission Version

The original submission version of an article is the author's version that has not been peer reviewed.

This version may be placed on:

•    The author's personal website
•    The author's company or institutional repository or archive
•    Any not-for-profit subject-based preprint servers or repositories

Self-archiving of the original submission version is not subject to an embargo period.

If your submission is formally accepted after peer review in one of our journals, authors must include an acknowledgement of acceptance for publication on all archive sites and, following online publication, authors must include the following notice on the first page:

This is the original submission version (pre-peer review) of the following article: [full citation], which has now been formally published in final form at Human Gene Therapy at [link to final article using the DOI]. This original submission version of the article may be used for non-commercial purposes in accordance with the Mary Ann Liebert, Inc., publishers’ self-archiving terms and conditions.

The original submission version posted may never be updated or replaced with the article of record version unless the author chooses to publish their paper OA under any of the Creative Commons Licenses available through the publisher. If you are interested in publishing your work OA, please feel free to review our Open Access policies and Licenses or contact us.

Accepted Version

Authors may only archive the accepted version of their manuscript on their personal and professional websites, and/or the author’s institutional repository or archive. Any archiving of the accepted version for inclusion in subject-based repositories, such as PubMed Central (PMC), should follow the requirements of the funder of the work. This process may impose additional embargo periods.  

The accepted version may be placed on:
•    The author's personal website
•    The author's company/institutional repository or archive

The accepted version posted must include the following notice on the first page:

This is the accepted version of the following article: [full citation], which has now been formally published in final form at Human Gene Therapy at [link to final article using the DOI]. This original submission version of the article may be used for non-commercial purposes in accordance with the Mary Ann Liebert, Inc., publishers’ self-archiving terms and conditions.

The posted accepted version may never be updated or replaced with the article of record version unless the author chooses to publish their paper Open Access under any of the Creative Commons Licenses available through the publisher. If you are interested in publishing your work OA, please feel free to review our Open Access policies and Licenses or contact us.

Article of Record

The article of record version may never be archived on a website, or in a repository or research network, unless published Gold Open Access under any of the Creative Commons Licenses available through the publisher. If you have questions, please contact us for more information. You can also review our Open Access policies and Licenses.

Funder Requirements

Mary Ann Liebert, Inc. publishers adheres to national and international funder requirements. Various funders, such as the National Institutes of Health (NIH), Wellcome Trust, Howard Hughes Medical Institute (HHMI), The Bill & Melinda Gates Foundation, and UK Research and Innovation (UKRI), for example, have specific requirements for depositing the accepted version and/or the article of record version of the author manuscript in a repository after an embargo period. Authors funded by these organizations should follow the self-archiving terms and conditions of these separate agreements based on the policies of the specific funding institutions. If you have questions, please contact us for more information.

Terms and Conditions for Use of All Self-Archived Article Versions

Authors may use either the original submission version or accepted version in the following ways:

•    For purposes of your own curriculum or teaching, dissertation, thesis, or book provided that all posted versions include the aforementioned notices, and follow all guidelines and requirements specified.
•    To share with researchers and research colleagues provided that such sharing is not for commercial purposes.

The self-archived submitted and accepted versions may only be used in non-commercial capacities. Individual users may view, print, download, and copy self-archived articles, as well as text and data mine the content conditions for non-commercial and non-promotional research and private study purposes, under the following requirements:

•    The authors' moral rights are not compromised and there is clear "attribution" of the author(s) in the shared work.
•    The authors’ integrity remains intact; the work should never be altered in such a way that the author's reputation or integrity may be damaged.
•    Any reuse complies with the copyright policies of the owner of that content.
•    Self-archived content may never be republished verbatim in whole or in part in print or online formats.

 

 

The Office of Foreign Assets Control (OFAC) of the US Department of the Treasury administers and enforces economic and trade sanctions based on US foreign policy and national security goals against targeted foreign countries and regimes, terrorists, international narcotics traffickers, those engaged in activities related to the proliferation of weapons of mass destruction, and other threats to the national security, foreign policy or economy of the United States. (Source: https://www.treasury.gov/about/organizational-structure/offices/pages/office-of-foreign-assets-control.aspx)

Our journal editors welcome contributions from researchers around the world; however, they are also required to follow sanction laws and regulations. Upon the date of this update (August 2020), sanction measures imposed by the United States, United Nations, European Union, and Australia are currently in place against the following countries: Cuba, Crimea, Iran, North Korea, and Syria. Journal editors will treat with caution any submission from a sanctioned country regarding the subject matter and will seek appropriate legal advice from the publisher if necessary.

Papers from sanctioned countries that are submitted to any Mary Ann Liebert, Inc., journal MUST contain a confirmation statement after the conclusion section of the manuscript which indicates that EACH listed author confirms that their research is supported by an institution that is primarily involved in education or research.

For further questions, please contact our Director of Production and Editorial Operations.

ARCHIVING AND PRESERVATION

Mary Ann Liebert, Inc., deposits and archives all publications in Portico for long-term digital preservation. Your article will be easily searchable on Google, Google Scholar, and other search engines.

PUBLISHER

Human Gene Therapy is owned and published by Mary Ann Liebert, Inc., publishers, 140 Huguenot Street, 3rd Floor, New Rochelle, NY 10801; Tel: 914-740-2100; Email: Info@liebertpub.com; Website: www.liebertpub.com/HUM

The views, opinions, findings, conclusions and recommendations set forth in any Journal article are solely those of the authors of those articles and do not necessarily reflect the views, policy or position of the Journal, its Publisher, its editorial staff or any affiliated Societies and should not be attributed to any of them.

Society Affiliations

The Official Journal of nine international societies:

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