SHS Publication and Presentation Policy and Forms

(Updated on November 10, 2016)

 

_ Download paper and thesis proposal forms

_ Paper proposal approval policy

_ Manuscript IHS,IRB & tribal approval policy

_ Meta-analysis manuscript approval policy

_ NIH Public Access Policy

_ Thesis approval policy

_ Abstract approval policy

_ Strong Heart Study Dormant Manuscript Policy

 

PLEASE NOTE:

1.      As an integral part of the manuscript approval process, the IHS IRBs in the three centers require that if one or more co-authors are IHS employees, the manuscripts must contain the following disclaimer (verbatim):  “The opinions expressed in this paper are those of the author(s) and do not necessarily reflect the views of the Indian Health Service.”  Journals differ with respect to where they will allow insertion of a disclaimer, but the usual places in a paper would be as part of the Acknowledgments section or as a footnote on the first page of the paper.

2.      All abstracts of SHS papers to be presented at meetings require approval by the Aberdeen Area IRB (AAIRB) and Oklahoma City Area IHS IRB (see below – Approval of Abstracts).  The AAIRB requires inclusion of a LAY SUMMARY together with the abstract of the work to be presented.  If an NIH employee is a co-author, the abstract must be submitted to the NHLBI for review   -   email your abstract to: ebpdocs@nhlbi.nih.gov

 

 

 

I.     Paper proposal approval policy

      A formal paper proposal reviewed by all authors must be submitted using the P&P paper proposal format (this form can be downloaded – see link above) to the P&P Committee Chair (please email to: Ying Zhang, MD PhD at ying-zhang4@ouhsc.edu) at least one week prior (no late than the first day of the month) to the next P&P monthly discussion. The P&P Committee shall discuss monthly, or as needed, proposals submitted for a manuscript or a thesis (and any other publication matters).

      Upon review for completeness (including preliminary review of the analysis plan by a statistician), the proposal will be added to the agenda of the next P&P Committee meeting for action. The Chair is responsible for distributing copies of the proposal to the members of the Committee.

      A formal paper proposal must include the following as a minimum:

1.1  Title (to maintain a cohesive body of literature, each publication using SHS data/infrastructure should include the phrase "Strong Heart Study" or “Strong Heart” in its title. Exceptions can be made for papers arising from consortium collaborations and big meta-analysis papers, e.g., Emerging Risk Factor Collaboration manuscripts which involve more than 50 studies. Paper proposals with titles not meeting this guideline will be returned to authors for revision at the time of manuscript proposal submission).

1.2  Primary author's name, contact information including fax and e-mail, and affiliation. Via distribution of P&P Committee minutes, the P&P Committee will periodically report its decisions to the SHS Steering Committee (SC).

1.3  Suggested co-authors (SC may nominate additional co-authors for any papers approved by the P&P Committee.)

1.4  Suggested key words (Please include “Strong Heart Study” as a keyword if allowed.)

1.5  A detailed outline which includes:

a)  Introduction (rationale)

b) Methods

c)  General analysis plan

1.6  Analysis responsibility (authors or Coordinating Center, CC)

1.7  References (the timeliness and originality of a proposal should be supported by the supplied references).

1.8  When submitting a proposal, authors are encouraged to send a copy of any journal articles that would support their choices for methods of statistical analysis. This will simplify the review process on the part of the statistician performing the preliminary review of the proposal.

1.9  Prior to submission, all proposals must be approved by a SHS PI.

1.10                   The P&P Committee shall review all formal proposals and make the following decisions: Approval (or approval with recommendation(s)), deferral, or disapproval (with reasons).

1.11                   Upon approval, the paper is given a SHS Paper Approval Number.

1.12                   In the event a proposal does not receive full approval (approved with recommendations or disapproved), the P&P Committee will supply the author with a complete explanation and recommendations for re-submission, when applicable.

1.13                   The P&P Chair will forward the decision of the P&P Committee to the submitting author.

1.14                   Along with an approval memo from the Chair, the author of each approved manuscript proposal will receive an Agreement for Data Distribution/Paper/Thesis Proposal form (an SHS author/investigator agreement must be signed by the author obtaining SHS data for a paper), Request for Data form, a Request for Data Analysis form, and a Data Analysis Monitoring System form (Data Request/Analysis forms are to be used by the author as needed). For maintaining better tracking, each form will be marked with the assigned SHS Paper Approval Number. The author needs to complete, sign, and return the forms to the P&P Committee. CC (or the appropriate SHS PI) then provides required data to the authors. All primary authors must sign an agreement form before CC or the appropriate PI will provide the data.

1.15                   If data analysis from the Coordinating Center (CC) is requested, the CC will assign a statistician to work with the primary author after the proposal is approved and all the required forms are returned to P&P Committee by the author. The paper may then be given a priority score if analyses are to be done by the CC. For those authors who choose to analyze their own data, CC representatives will be available for consultation.

1.16                   For manuscripts written by investigators outside of SHS, the SHS PI co-author or the SHS PI who is closely affiliated with any of the authors must advise the P&P Committee during the review of the proposal whether the manuscript should be sent to the P&P Committee for review prior to submission to a journal. The Chair will send the paper to 2 or more reviewers, and the comments of the reviewers will be communicated to the submitting author. Additionally, if no SHS PI is a co-author and if the analysis is not performed by the CC, the final manuscript must be sent to CC for statistical review.

1.17                   NHLBI: If any co-author is an NIH employee, prior to submission to a journal, the paper must be submitted to the author’s NIH institute for review if an NIH institute requires such review. NHLBI authors should submit their manuscript to NHLBI for review. Please email the paper for NHLBI review using the following email address: ebpdocs@nhlbi.nih.gov. Comments will be returned to the email address provided by the author submitting the manuscript.

                        NOTE: Please cc Mona A. Puggal, MPH, Project Officer-Strong Heart Study, (mona.puggal@nih.gov) when emailing your manuscript to the above NHLBI email address.

                        Please also NOTE: Papers that are likely to result in press coverage or substantial press/media interest require notice in advance to the NHLBI (contact Mona) so that the staff and public information office can be prepared.

                  The IHS co-authors: Please note that as an integral part of the manuscript approval process, the IHS IRBs in the three centers require that SHS manuscripts written by any IHS coauthors must contain the following disclaimer (verbatim) (usually in the Acknowledgments or in a footer on the first page):

                  “The opinions expressed in this paper are those of the author(s) and do not necessarily reflect the views of the Indian Health Service.”

1.18                   The P&P Chair will maintain a list of SHS papers both published and in press: http://strongheart.ouhsc.edu/pip/SHSPapersinPrint.html

            The Chair also maintains a complete list of all approved SHS papers at each stage of preparation from approval to the In Print stage. In order to help update the status of all papers in the SHS publication list, authors are required to notify the P&P committee by sending the cover letter each time when submitting their papers to the NIH and/or to the IRBs/Tribes and to a journal. Also they are required to notify the P&P when the papers are accepted by a journal for publication and when published. If using electronic transmission to submit papers, they need to copy Dr. Ying Zhang (mailto:Ying-Zhang4@ouhsc.edu).

1.19                   After an article is published, the primary author must send at least one reprint of the published article to the NHLBI Project Officer

                        Mona A. Puggal, MPH

                        Email: mona.puggal@nih.gov

            and to each of the three persons designated in the field centers (listed as 1)-3) in Rule 2.1: Arizona, Cynthia West, cynthia.l.west@medstar.net; Dakota, Wendy Lawrence, wendy.lawrence@mbiri.com; Oklahoma, Ying Zhang, Ying-Zhang4@ouhsc.edu), who will then distribute the published articles to Tribes and Service Units in their center. The primary author should also send reprints of the published article to all co-authors.

1.20                   To track the progress of approved paper proposals, the P&P Committee distributes a status survey of the approved papers by emailing a Paper Tracking Status Form every six months. The authors must fill out the respective space regarding the progress/current status of their paper and return the form to the committee.

1.21                   If the P&P Committee determines that progress on a manuscript is taking an unduly long time, the Chair will communicate with the author, asking for a plan of action for completing the paper or for the author(s) to release the topic for authorship by someone else.

1.22                   In rare cases, the P&P Committee may need to make a recommendation to the Steering Committee regarding reassignment of a paper topic.

1.23                   NOTE: It must be recognized that any step of this approval process may entail requested revisions and re-submissions by the authors.

 

 

 

II.            Manuscript IHS IRB and tribal approval policy

2.1  IHS IRB and tribal approvals: The primary author will first send the paper to the co-authors for their input. All Strong Heart Study manuscripts must have IHS IRB and tribal approvals. When the primary author feels the paper is ready for IHS IRB and tribal review, he/she should submit required files to the contact person of each of the three field centers (see below) with the clear designation that the paper is being sent for IHS IRB and tribal review.

            Files needed for obtaining IHS IRB and tribal approval: 1) an early version of the manuscript, 2) a lay summary that includes a sentence indicating the time of data collection (SHS study phases), and 3) the name of the intended journal. The three field centers will process the IHS IRB and tribal review within 90 days. Contact information:

1)     Dakota Center: Wendy Lawrence, RN

                                                  Strong Heart Study

                                                  Missouri Breaks Industries Research, Inc.

118 S. Willow Street

PO Box 1824

Eagle Butte, SD 57625

Phone: (605) 964-1260

Fax: (605) 964-1263

                                                  Email: wendy.lawrence@mbiri.com

2)     Oklahoma Center: Ying Zhang, MD PhD

                                                  Univ. of Oklahoma Health Sciences Center

                                                  801 N.E. 13th Street, Room 303

                                                  Oklahoma City, OK 73104

Phone: (405) 271-2229 x48073

                                                  Fax: (405) 271-4390

                                                  Email: Ying-Zhang4@ouhsc.edu

3)     Arizona Center:    Cynthia West

                                                  MedStar Health Research Institute

                                                  1616 East Indian School Rd., Suite 240

                                                  Phoenix, AZ 85016

                                                  Phone: (602) 526-1110

Fax: (602) 277-5979

Email: cynthia.l.west@medstar.net

            The three individuals listed in 1)-3) above are responsible for sending the manuscript for approval by Indian Health Service IRBs and the Tribes.

2.2  Before submitting a manuscript to a journal, please check online approval logs of the three centers at http://strongheart.ouhsc.edu/TALogs/TALogs.html, or confirm with the contact persons in the Arizona Field Center (Cynthia West, cynthia.l.west@medstar.net), Dakota Field Center (Wendy Lawrence, wendy.lawrence@mbiri.com), and Oklahoma Field Center (Ying Zhang,Ying-Zhang4@ouhsc.edu) that the approvals from respective IHS IRB and tribes have been obtained. Failure of obtaining IHS IRB and tribal approvals before the publication of a manuscript may result in withdrawal of a manuscript and a report to respective IRB. The primary author is responsible for making sure that all approvals have been obtained prior to journal submission.

2.3  Flow chart

image001

 

2.4The author must include a Tribal/lay summary for all manuscripts, since such summaries are essential for obtaining Tribal and IHS IRB approval. The Tribal/lay summary should be no longer than one page of easily understandable text. One or two graphics illustrating major points could be included. Such summaries are critical to ensure tribal understanding of research results, and, hopefully, maintain tribal support for SHS research. The intended journal should be mentioned for all papers in the cover letter/memo.

 

 

 

III.         Meta-analysis manuscript approval policy

      Meta-analysis papers include unpublished individual data collected in SHS should be treated the same as all other SHS manuscripts in P&P, tribal and IHS/IRB approval procedures. SHS P&P approval, IHS IRB, and tribal approvals should be obtained for those papers. The SHS authors included in the meta-analysis papers should help with the tribal/IHS submissions.

      The SHS PIs involved in the collaborations should inform respective outside collaborators regarding this policy.

 

 

 

IV.        NIH Public Access Policy

      All papers on NIH-supported research must have open access. Thus, ALL SHS papers must be submitted to PubMed Central within one year of acceptance by a journal. Please see: http://publicaccess.nih.gov/

      Please submit your paper’s PMCID to Dr. Zhang as soon as available (email: Ying-Zhang4@ouhsc.edu).

 

 

 

V.             Thesis approval policy

5.1  A college student who wishes to use SHS data for a thesis must submit a thesis proposal (this form can be downloaded - see below) to the P&P Committee Chair.

5.2  The Thesis Proposal must include the Prospectus for the Doctoral Thesis/Dissertation or an Outline for a Masters/Bachelor Thesis. If a prospectus is not required by the doctoral degree program, the student needs to submit a detailed outline.

5.3  A thesis proposal must include: Title of Thesis, Name of Degree Candidate, Type of Degree, Candidate Affiliation including the contact information (full address, telephone, fax and email) and name of the Primary Mentor, including the same type of contact information.

5.4  Upon approval, the thesis/dissertation is given a SHS Thesis/Dissertation Number, and the P&P Chair notifies the student of the committee decision. The student is provided with the Agreement for Data Distribution/Paper/Thesis/Dissertation Proposal form, Request for Data form, and a Data Analysis Monitoring System form to complete, sign, and return to the P&P Committee. CC (or the appropriate SHS PI) then provides required data to the student.

5.5  As part of the agreement, the student agrees to write at least one paper based on the approved thesis proposal. At the time the student is ready to develop a paper for publication, the student must submit a separate paper proposal to the P&P Chair and follow all of the P&P paper approval procedures described above.

 

 

 

VI.          Abstract approval policy

6.1  It is assumed that all SHS abstracts will have at least one SHS PI as a co-author. The PI co-author is responsible for ensuring that the abstract abides by SHS standards and guidelines. If none of the PIs is a co-author, the abstract must be approved by the PI who works most closely with the authors. The title of the abstract should include the phrase "Strong Heart Study" whenever possible.

6.2  If the abstract has an NIH co-author, it must be submitted for NHLBI review. Comments will be returned to the email address provided by the author in the submission process. Please submit the abstract to the following email address for NHLBI Review:

ebpdocs@nhlbi.nih.gov

6.3  Abstracts must be sent to Dakota Center and Oklahoma Center for approval by their IRBs which include area IHS IRBs. The Arizona Center does not have this requirement. Please include a brief LAY SUMMARY of the work to be presented. Please specify that the abstract is being forwarded for Dakota/Oklahoma Center IRBs approval, include information about the meeting or other venue intended for the presentation, and send the abstract to:

 

Wendy Lawrence, RN

Strong Heart Study

Missouri Breaks Industries Research, Inc.

118 S. Willow Street

PO Box 1824

Eagle Butte, SD 57625

Phone: (605) 964-1260

Fax: (605) 964-1263

Email: wendy.lawrence@mbiri.com

 

Ying Zhang, MD PhD

Univ. of Oklahoma Health Sciences Center

801 N.E. 13th Street, Room 303

Oklahoma City, OK 73104

Phone: (405) 271-2229 x48073

Fax: (405) 271-4390

Email: Ying-Zhang4@ouhsc.edu

 

6.4Prior to presenting the paper, the presenting author should verify (if notice has not been received) that the Dakota Center IRB (Aberdeen Area IRB) and Oklahoma Center IHS IRB approval has been obtained. The information can be found at http://strongheart.ouhsc.edu/TALogs/TALogs.html

 

 

 

VII.                   Strong Heart Study Dormant Manuscript Policy

The Strong Heart Study (SHS) is under obligation by its various agreements and understandings with its participants and funding agencies to disseminate the results of its studies in a timely fashion. The following policy is meant to assist its investigators in achieving this goal.

Definitions:

1)               Dormant manuscript – A manuscript that has not been accepted for publication in a journal within 2 years of the date of its approval by the SHS Publications and Presentations Committee (P&P).

2)               Primary author – the author that has been granted approval by the SHS P&P to move the manuscript forward for publication.

3)               This policy applies to primary SHS paper proposals. It also applies to paper proposals that use new data generated from SHS ancillary studies and SHS sub-studies that are submitted one year or more after the completion of the ancillary and sub-studies.

Policy Implementation:

1)     The following steps will be implemented by the SHS P&P.

2)               On a yearly basis, the SHS P&P will review the list of approved SHS manuscripts and contact the primary author of dormant manuscripts to provide the following information for a plan to move the manuscript to publication. The primary author will be given 2 weeks to provide the information:

a.      The status of the manuscript

b.     A plan to incorporate any new progress in the field

c.                A timeline (less than or equal to 6 months) to submission of the manuscript to a journal, or

d.               For manuscripts that have been rejected by a journal, a plan for submission to a different journal within 6 months.

e.                If s/he so chooses, a request that a co-author assume the primary author role (in which case the new primary author will need to provide the requested information).

f.                If s/he so chooses, a request that the proposal be withdrawn from the SHS approved paper proposal list.

3)               The SHS P&P will review the plan, and

a.      Approve of it, or

b.     Approve of it with required modifications, or

c.      Reject it, with reasons for the rejection.

4)               For plans rejected in #3 above, the primary author will be given 2 more weeks to provide a new plan to move the manuscript to submission to a journal within 6 months.

5)               For manuscripts with an approved plan to move to submission to a journal, the SHS P&P will re-contact the primary author on the progress of its submission to a journal after 6 months.

6)               For manuscripts that do not move to submission to a journal within 6 months (#5 above), or have a plan that is rejected after consideration in #3 or #4 above, the manuscript will be brought to the attention of the SHS Steering Committee. The SHS Steering committee may

a.                Find a co-author to lead the publication with inclusion of the primary author

b.               Offer the manuscript topic to other investigators

c.                Incorporate the topic into other ongoing investigations

d.               Determine that the topic is no longer of interest to the field, and remove the manuscript from the SHS approved paper proposal list.

 

Forms for Paper and Thesis Proposals

 

The SHS Paper and Thesis Proposal Forms can be downloaded for submitting to the P&P Committee.  Or upon receiving requests from the SHS authors, these forms will be transmitted electronically by email, so that email or word processing software may be easily implemented for form completion and submission.  "Cut and Paste" or other electronic means may be used to download the proper form, to fill it in (electronically expanding the space as much as needed for each section), and to submit the form to the P&P Chair by email, or more traditional means if desired.  An electronic file containing the SHS Publication Policy will also be included with the proposal form to make the prospective authors aware of the rules and procedures of the SHS P&P Committee.

 

Click here to download the SHS Paper Proposal Form

Click here to download the SHS Thesis Proposal Form

 

 

 

 

 

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