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JACKSON HEART STUDY Publications and Presentations Guidelines Overview The Publications and Presentations Subcommittee (PPS) of the Jackson Heart Study encourages the preparation of abstracts, publications and presentations of high scientific quality. To this end the charge of the PPS is threefold: 1. Set, disseminate and enforce policies for use of JHS data in abstracts, presentations and publications. 2 Maintain an updated file of all JHS manuscript proposals, publications, abstracts, presentations and ancillary or sub-studies. 3. Review all manuscript proposals to determine suitability, protect against overlap with other proposed projects and recommend priority for data analysis. The PPS reviews all manuscript proposals, writing groups, abstracts for scientific meetings, and completed manuscripts prior to submission for journal publication, as well as related media presentations. These guidelines were written for use by persons who are preparing publications and presentations for approval by the PPS, and for the use of the PPS members in the review process. The guidelines address manuscript proposals, completed manuscripts, abstracts for scientific meetings, data analysis, authorship, presentations not requiring an abstract, interviews/ press releases, languishing manuscripts, proposal/abstract limitations and local JHS research forum presentations. The following appendices are attached and are also available on the JHS website (http:www.jsums.edu/~jhs): Appendix A: Schema of Manuscript Development and Approval Process P&P Guidelines 09/09/2008 1

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JACKSON HEART STUDY Publications and Presentations Guidelines

Overview

The Publications and Presentations Subcommittee (PPS) of the Jackson Heart Study encourages the preparation of abstracts, publications and presentations of high scientific quality. To this end the charge of the PPS is threefold:

1. Set, disseminate and enforce policies for use of JHS data in abstracts, presentations and publications.

2 Maintain an updated file of all JHS manuscript proposals, publications, abstracts, presentations and ancillary or sub-studies.

3. Review all manuscript proposals to determine suitability, protect against overlap with other proposed projects and recommend priority for data analysis.

The PPS reviews all manuscript proposals, writing groups, abstracts for scientific meetings, and completed manuscripts prior to submission for journal publication, as well as related media presentations. These guidelines were written for use by persons who are preparing publications and presentations for approval by the PPS, and for the use of the PPS members in the review process. The guidelines address manuscript proposals, completed manuscripts, abstracts for scientific meetings, data analysis, authorship, presentations not requiring an abstract, interviews/ press releases, languishing manuscripts, proposal/abstract limitations and local JHS research forum presentations. The following appendices are attached and are also available on the JHS website (http:www.jsums.edu/~jhs):

Appendix A: Schema of Manuscript Development and Approval Process

Appendix B: JHS Manuscript Proposal Form

Appendix C: JHS Manuscript Proposal Review Form

Appendix D: E-Vote Form

Appendix E: JHS Presentation Form

Appendix F: JHS Manuscript Review Form

The membership of the PPS includes representation from each of the three JHS collaborating institutions: Jackson State University; Tougaloo College and University of Mississippi Medical Center; a representative from the National Heart, Lung, and Blood Institute (NHLBI); a representative from the JHS Director's office; and one or more community representatives. Additional representation of community and scientific perspectives will be included on an ad hoc basis in keeping with the manuscript/abstract topic, including genetics expertise. Ad hoc membership will be sought to assure the

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expertise needed to provide fair review. The JHS Director is an ex officio member of all committees.

Meetings will occur monthly, and more often as necessary. Virtual meetings using e-mail communications that include every member of the PPS or conference telephone calls may supplement meetings of the PPS. A quorum is ½ of the voting members plus one.

Meetings will be scheduled for the third Tuesday of each month. In order for the PPS to review manuscript proposals, abstracts and manuscripts in a timely manner, they must be received by the Administrative Coordinator no later than the first business day of the month. Documents that are received after that date are subject to review at the PPS meeting of the next month.

The NIH Public Access Policy

All JHS authors are responsible for adhering to the NIH Public Access Policy. The NIH Public Access Policy requires scientists to submit journal final peer-reviewed manuscripts that arise from NIH funds to the digital archive PubMed Central (http://www.pubmedcentral.nih.gov/ ). The Policy requires that these articles be accessible to the public on PubMed Central to help advance science and improve human health. Following is a link to Public Access Frequently Asked Questions http://publicaccess.nih.gov/FAQ.htm

Publications Data Base

Tracking tables and data bases will be used to monitor the status of proposals, presentations, abstracts and manuscript publications. A separate listing of all JHS manuscript proposals, abstracts, presentations, and JHS publications (including those in press) will be updated quarterly and maintained on the JHS web site (http://www.jsums.edu/~jhs/) with subject and author-based search capability. 

1. Preparation and Approval Process for Manuscript Proposals

la. Initiation of Manuscript Proposals: Manuscript proposals may be investigator-initiated by JHS or external investigators or study-initiated. JHS investigators include those who are supported by JHS funding and academic staff from the three partner institutions, the JHS Director's office, participating NHLBI staff (Field Site and Project Office) and JHS subcontractors or consultants. External investigators, persons with no direct connection to the JHS data, require involvement of a JHS investigator/sponsor for proposal submission. Also, the PPS or the JHS Steering Committee may designate a topic and identify the lead author and writing group.

The PPS supports students’ requests for data to be used in dissertations and related research projects. In keeping with the philosophy and practice of scientific excellence, the PPS expects that these requests will be submitted in the form of a manuscript proposal.

The body of the manuscript proposal must include a clear statement of the nature of the problem to be addressed, its rationale (including statement on importance/relevance of

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race for this problem), the hypotheses to be addressed, the analytic approach to be used (types of statistical computations and summarization of data likely to be required), a summary/conclusion and pertinent references.  Additional information regarding the proposed manuscript must include the type of study (e.g. full cohort, family study, ARIC/JHS cohort, substudy, ancillary study or case control), type of data (cross-sectional, longitudinal or events), site of analysis (JHS or local), specification of use of genetic/DNA information, as well as identification of any conflict of interest, completion of the JHS Data Sharing Agreement, and results of review of the JHS Publications Data Base for any potential similarities with other manuscripts/proposals.

The lead author initiates the manuscript proposal draft, prepares a list of co-authors and their commitment of responsibility to the study and writing process, and obtains prior review and agreement on the proposal by all co-authors. The lead author is responsible for signing the P&P Signature Sheet indicating his/her responsibility for the manuscript proposal/manuscript, and is responsible for obtaining the signatures of co- authors indicating that they have read and are in agreement with the manuscript proposal/manuscript. The signature sheet is to be submitted along with the manuscript proposal/manuscript.All persons in the Writing Group with access to JHS data must sign the JHS Data Sharing Agreement prior to release of any data. When possible, cross-institutional involvement should be included for all locally generated proposals based on potential interest and areas of expertise.  Interested JHS investigators should have an opportunity to participate. The writing group should be composed of both interested collaborators and experienced investigators. For proposals developed by non-JHS investigators, inclusion of a relevant JHS investigator (sponsor) as a member of the writing group is required.

lb. Proposal Format and Submission: A standardized form (Appendix B, attached, and available electronically on the JHS web site) should be used for manuscript proposal submission. The lead author is responsible for assuring that all elements of the proposal have been completed in full prior to submission. These elements include: outline of manuscript, author contributions checklists, and additional information. Completed proposals should be submitted electronically to the PPS chair and copied to the Administrative Coordinator (AC) (see contact information at end of guidelines). The AC who will review completion status, arrange distribution to the members; maintain appropriate databases, and follow-up communication between prospective authors and the PPS.

lc. PPS Approval of Proposals: Manuscript proposals, including the list of proposed authors and their commitments, along with the P&P Signature sheet, should be submitted to the PPS for approval. The Chair will disseminate all proposals to the full committee and assign two primary reviewers who will complete a written review in accordance with manuscript proposal review guidelines. Review will include assessment of scientific merit, potential overlap with previously approved manuscript proposals, manuscripts, relevance to JHS key scientific questions, statistical consultation, recommendations for members of the writing group and a priority rating. Reviews should be completed within 2 weeks of distribution. The P&P has the right to send back to the primary author and co-authors a manuscript proposal or manuscript that the two reviewers agree does not address the criteria in the P&P Guidelines. In this situation, the manuscript would not be reviewed; a cover letter that will accompany the returned manuscript proposal/manuscript will communicate specific conditions on a case-by-case basis. The reviewers should e-P&P Guidelines 09/09/2008 3

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mail their reviews to the Committee Chairperson and Administrative Coordinator who will send them to the appropriate committee members. They should send a copy of their final reviews to the Administrative Coordinator to be archived. The PPS Chair will send a letter to the lead author specifying the recommendation of the PPS which will be one of the following:

1. Accept as is2. Accept pending revisions3. Reconsider after revisions4. Disapprove for reasons noted

* Definitions attached

When the Chair requests an e-vote, the e-vote form will be sent to committee members along with a brief cover memo, by the Administrative Coordinator.

When proposals are re-submitted to PPS members for review following revision, the Administrative Coordinator will attach to the re-submitted proposal a copy of the letter from the PPS Chair specifying the required revisions and a cover memo indicating that the proposal is a re-submission.

If a PPS member is an author of a proposal to be presented, he/she will recuse himself/herself from the meeting until the presentation, discussion and vote of his/her proposal are completed.

1d. Steering Committee Approval of Manuscript Proposals: Members of the JHS Steering Committee will consider all approved manuscript proposals as part of their meeting agenda. The Steering Committee reserves the right to modify any actions of the PPS.

2. Data Analysis. The writing group is responsible for preparing:

a) A detailed plan for data analysis, containing computational specifications, and submitting it to the Scientific Directions and Data Analysis Unit (SDDAU) for analyses to be completed centrally by that unit

or

b) Statistical computations using the data set distributed by the SDDAU when local analytic assistance is available. (In some cases analyses may be done outside the SDDAU via bio-statistical consultants).

The biostatistician whether from the SDDAU or a consultant, shall be the liaison between the writing group and the SDDAU. All data requests require submission of a “Request for Statistical Computation Form” to the SDDAU (available at the JHS web site), after receiving PPS and Steering Committee approval of a manuscript proposal. The PPS may recommend priority for data analysis.

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3. Authorship and Journal Selection. The initiator of a manuscript proposal generally assumes first authorship. S/he should determine the order of authorship in collaboration with the writing group. The PPS will assist in resolving any conflicts or confusion that occurs with respect to appropriate recognition of authorship. The lead author should elicit specific commitment for involvement in the manuscript from the co-authors, circulate drafts for co-author input, and coordinate revisions. The lead author is responsible for signing the P&P Signature Sheet for Manuscripts and for obtaining the signatures of co- authors indicating that they have read the manuscript and are in agreement with it. Selection of the journal for initial submission is the responsibility of the writing group, with input as requested, from the PPS and JHS Steering Committee. The Lead author is encouraged to provide the PPS with the name of the journal selected for manuscript submission.

4. Coordination with ARIC. Manuscript proposals that involve data from any or all of the four ARIC centers, including Jackson alone, will follow existing ARIC publication policies (http://www.bios.unc.edu/cscc/ARIC/). If other standard criteria are met, approval by ARIC will generally be granted unless a substantially similar manuscript proposal was already approved by ARIC, in which case modification or withdrawal of the new proposal would be necessary. Approval, along with other comments from the ARIC Publications Committee, will be conveyed to the JHS investigators and PPS. In the particular case where proposals include both ARIC and JHS data (e.g. longitudinal designs that include the first JHS exam), formal ARIC consideration will not be required; instead only JHS PPS approval will be necessary. Thus, an exemption from the ARIC review process would be in effect when the manuscript proposal requires JHS data for analysis. The ARIC Steering Committee will send copies of approved proposals and manuscripts to the JHS PPS to facilitate awareness and minimize potential overlap for new proposals. The JHS PPS Administrative Coordinator will submit requests for approval of proposals; abstracts and completed manuscripts involving ARIC data to the designated person at the ARIC Coordinating Center (see contact information).

5. PPS Review of Completed Manuscripts. All completed manuscripts will undergo a peer review coordinated by the PPS. Under exceptional circumstances this review may be waived by the PPS with a majority vote.

The writing group submits the completed manuscript to the PPS for review and approval. The format for the completed manuscript must conform to the anticipated journal or other standard style. All manuscripts must be accompanied by a 300-500-word summary of the study and findings for the JHS community in lay language. The manuscript title should include the phrase: "the Jackson Heart Study" whenever possible and all manuscripts require acknowledgement of funding sources for the JHS contract(s). Additionally, a general acknowledgement of the JHS participants and data collection staff should be included whenever possible. In the case of genetic or family studies no pedigrees will be published.

The PPS Chair distributes the manuscript to the PPS and assigns two JHS reviewers with relevant content and methodological expertise as primary reviewers of the manuscript. Reviewers may be assigned from the full or ad hoc membership of the committee based on the specific needs of the manuscript. Additional external reviewers with special expertise may be assigned by the chair as needed to supplement PPS expertise. A detailed written critique using JHS manuscript review guidelines is expected from the reviewers P&P Guidelines 09/09/2008 5

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within two weeks. The reviewers should e-mail their reviews to the committee Chairperson and Administrative Coordinator who will send them to the appropriate committee members. They should send a copy of their final reviews to the Administrative Coordinator to be archived. If both the primary and secondary reviewers indicate on the Manuscript Review Form that the manuscript is eligible for expedited review, it will be sent to the PPS for an E-Vote. The PPS Chair will send a letter to the lead author specifying the recommendations of the PPS which will be one of the following:

1. Accept as is2. Accept pending revisions3. Reconsider after revisions4. Disapprove for reasons noted

* Definitions attached

The PPS may recommend data verification via the Associate Director for Scientific Direction and Data Analysis based on reviewer comments and prior experience with JHS data analysis, although this will not be required in all instances.

When manuscripts are re-submitted to PPS members for review following revision, the Administrative Coordinator will attach to the re-submitted manuscript a copy of the letter from the PPS Chair specifying the required revisions and a cover memo indicating that the manuscripts a re-submission

If a PPS member is an author of a manuscript to be presented, he/she will recluse himself/herself from the meeting until the presentation, discussion and vote of his/her manuscript are completed.

6. Steering Committee Review of Completed Manuscripts. After approval by the PPS, a listing of the authors, title, and abstract of each manuscript is distributed to the JHS Steering Committee. Steering Committee members may request a full copy of the manuscript for any additional recommendations. Once approved by PPS, members of the JHS Steering Committee will receive a list of all approved manuscripts, as part of their next meeting agenda. The Steering Committee reserves the right to modify any actions of the PPS.

7. NHLBI Review of Completed Manuscripts. In order to stay informed of findings from large studies, and to prepare for press queries, the Division of Prevention and Population Sciences requests as a courtesy that the Project Officer receive copies of manuscripts at the time of journal acceptance or before, particularly for high-profile papers. These generally include the following: (1) Main results papers or key secondary results papers from clinical trials; (2) Papers with direct clinical implications, particularly if they impact NHLBI policies (e.g., for hypertension control); (3) Papers on potentially sensitive topics (e.g., on the relationship between perceived racial discrimination and blood pressure; (4) Papers published in prestige high impact journals, such as Nature, Nature Genetics, Science, NEJM, JAMA and Lancet. The Administrative Coordinator for PPS should routinely provide copies of draft, accepted and published manuscripts to the study Project Officer, however, these will not be routinely reviewed. For papers that include NHLBI coauthors, manuscripts should be sent by email to the Division per previous procedures, including a copy to the Project Officer. Papers that are not deemed P&P Guidelines 09/09/2008 6

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High Impact by the Project Officer will undergo expedited review--within 5 business days. Papers that are deemed High Impact will undergo a detailed review--within 10 working days. In order to minimize any time delays, NHLBI review may take place simultaneously with study Publications Committee or Steering Committee review.

8. Journal Submission of Manuscripts. After notification of PPS and NHLBI approval and documented incorporation of recommended revisions, the manuscript may be formally submitted to a journal for consideration. The lead author must notify the PPS when the manuscript is submitted, the name of the journal to which it was submitted, and whether the manuscript was approved or rejected by the journal (e.g. a copy of paper and cover letter will suffice). Once published, a reprint or copy of the manuscript should be sent to the PPS Administrative Coordinator.

9. Abstracts for Scientific Meetings. Abstracts for upcoming scientific meetings along with a JHS Presentation Form should be sent electronically to the PPS chair via the Administrative Coordinator for approval at least 3 weeks prior to the submission deadline. The abstract and presentation form will be circulated to PPS members for review and recommendations. After approval by the PPS and incorporation of any revisions, the Administrative Coordinator will send the abstract to NHLBI ([email protected]) for review and response (usually takes approximately two weeks.) The PPS Chairperson may, at his/her discretion, request simultaneous e-vote and NHLBI review of abstracts due to extenuating circumstances on a case-by-case basis. In cases where ARIC (Atherosclerosis Risk in Communities) study approval is required, the abstract will be simultaneously submitted to the ARIC Publications Committee in accordance with section 4 of these guidelines. Following communication of these approvals (sent by the Administrative Coordinator) the writing group chair may submit the abstract. The lead author must submit to the Administrative Coordinator a copy of the final abstract, notification of acceptance and, if published, its citation.

10. Presentations Not Requiring Abstract Submission and Approval e.g., Invited Lectures. Presenters are encouraged to notify the PPS Administrative Coordinator of presentations that do not require abstract submission and approval, such as invited lectures, for tracking purposes. The presenter should complete the JHS Presentation Form: This will provide essential data for periodic reports on the numbers and types of presentations made that may include already published JHS data or that do not include any JHS data.

11. Interviews and Press Releases. Discussions with the media and press releases should not be used as a forum to release new information, but may be used to clarify scientific findings for the lay public. In general, scientific findings from the JHS made available to the media will involve those findings presented at scientific meetings and published in the literature. Investigators are requested to keep the NHLBI Project Office informed of contacts with representatives of the major national media and of major national media coverage of information that they have supplied. Release of general descriptive information about the JHS for local use (such as a local newspaper, university newsletter or state medical society journal) does not require prior approval by NHLBI. Use of centrally prepared materials for such purposes is encouraged and can be obtained from JHS investigators associated with the partnering institutions, published journal P&P Guidelines 09/09/2008 7

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articles, previous abstracts or presentations, and other JHS published materials. A copy of the resultant article should be sent to the Project Office and the PPS Administrative Coordinator.

12. Time Line and Languishing Manuscripts. A period of 2 years is allowed for publication of the manuscript from a given proposal from the date of the availability of data. “Languishing manuscripts” (those inactive after 2 years) are eligible for recommendation by the PPS for reassignment to other interested investigators. High priority manuscripts are subject to a recommendation for reassignment when it is determined by the PPS that undue delay in the preparation of the manuscript has occurred.

13. Annual Progress Reports. First authors on all manuscript proposals will be expected to submit an annual progress report each year.

14. Limits on Number of Proposals Submitted by a Single First Author. No investigator may have more than 10 manuscript proposals pending at a given time. This is to prevent the practice of large scale “cornering” of topics by single authors that would tend to block opportunities for other investigators who wish to work in the area. Similarly, the PPS discourages the submission of overly broad topics that block opportunity for access to certain research topics for investigators with similar interests.

15. Limit on number of abstracts: The publication of scientific findings is the goal of the publication process; however, the number of abstracts approved per person will be limited to 3 until previously approved manuscripts are published.

16. Local JHS Research Forum Presentations: In order to promote a high level of scientific discourse, JHS authors and presenters are encouraged to, whenever possible, present their publications and presentations in a local JHS research forum prior to their formal presentation.

Please Note:

Members of the PPS should visit the internal website for the following documents:

1. Manuscript Proposal Tracking Log2. Manuscript Tracking Log3 Tracking Log for Abstracts for Scientific Meetings4. Log for Tracking Presentations Not Requiring an Abstract5. List of Published Manuscripts

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* DEFINITIONS OF REVIEWER RECOMMENDATIONS AND EXPECTATIONS OF LEAD AUTHORS

Proposals

Lead authors of proposals that receive a recommendation of “accept as is” along with reviewer comments, have the option of addressing the comments before the proposal is advanced to the next step. If the Lead author plans to do so, he/she should inform the PPS Chair and Administrative Coordinator that a revised proposal is forthcoming and the expected date.

Lead authors of proposals that are “accepted pending revisions” must address the requested revisions in the proposal and in a cover letter addressed to the PPS Chair.

Lead authors of proposals that are to be “reconsidered after revisions’’ must revise the proposal addressing each required revision and resubmit it along with a cover letter addressed to the PPS chair indicating that the proposal is being resubmitted and describing the revisions.

Disapproved proposals will not be reconsidered.

Manuscripts

Lead authors of manuscripts that receive a recommendation of “accept as is”, along with reviewer comments, have the option of addressing the comments before the manuscript is advanced to the next step. If the Lead author plans to do so, he/she should inform the PPS Chair and Administrative Coordinator that a revised manuscript is forthcoming and the expected date.

Lead authors of manuscripts that are “accepted pending revisions” must address the requested revisions in the manuscript and in a cover letter addressed to the PPS Chair

Lead authors of manuscripts that are to be “reconsidered after revisions” must revise the manuscript addressing each required revision and resubmit it along with a cover letter addressed to the PPS chair indicating that the manuscript is being resubmitted and describing the revisions.

Disapproved manuscripts will not be reconsidered.

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Contact Information:

Brenda W. Campbell-Jenkins, MPH; mail to: [email protected] AssociateJackson Heart Study Jackson Medical Mall, Suite 701350 W. Woodrow Wilson Dr. Jackson, MS 39213(601) 979-8731 Fax: (601) 979-8712

Lynette Ekunwe, MS, MPH, mail to: [email protected] Associate Jackson Heart Study Jackson Medical Mall, Suite 701350 W. Woodrow Wilson DriveJackson, MS 39213(601) 979-8728 Fax: (601) 979-8712

Nimr Fahmy, PhD; mail to: [email protected] Department of MathematicsTougaloo College500 West County Line RoadTougaloo, MS 39174(601) 977-7754

Jane L. Harman, DVM, PhD, mail to: [email protected] NHLBI/DPPS/EB 6701 Rockledge Dr - Ste 10018- MS 7936 Bethesda, MD 20892-7936 Tel: 301-435-1290 Fax: 301-480-1455

Herman Taylor, Jr, MD, MPH, FACC, FAHA; mail to: [email protected] Shirley Professor for the Study of Health Disparities Professor of Medicine Principal Investigator, Jackson Heart StudyJackson Medical Mall, Suite 701350 W. Woodrow Wilson Dr. Jackson, MS 39213(601) 601-979-8744 Fax: (601) 979-8701

Kenneth R. Butler, Jr., PhD, mail to: [email protected] Study Project ManagerDepartment of Medicine-Geriatrics601-984-4939 [office] 601-750-7043 [mobile]

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Patricia Dubbert PhD.; mail to: [email protected] Chief, Mental health (11M)G. V. (Sonny) Montgomery Veterans Affairs Medical Center1500 E. Woodrow WilsonJackson, MS 39216(601) 364-1350 Fax (601) 364-1395

Elise P. Gómez Sanchez, DVM, PhD, mail to: [email protected] of Medicine, University of Mississippi Medical CenterSr. Research Scientist; Jackson VA Medical Center1500 E. Woodrow WilsonJackson, MS 39216(601) 368-3844 Fax: (601) 364-1236

Rajendram V Rajnarayanan, Ph.D, mail to: [email protected]          [email protected] ProfessorChemistry & Natural SciencesTougaloo College500 W County Line RdMail box # 1130Tougaloo, MS 39174Ph: (601) 977-7779 W (601) 914-5639 (703) 795-8569 (H) Frances C. Henderson, R.N., Ed.D: mail to: [email protected]@att.netDeputy Director, Jackson Heart StudyProfessor of Medicine350 Woodrow Wilson Drive, Suite 701Jackson, MS 39213(601) 979-8765- Fax: (601) 815-5050

Sarah Buxbaum, Ph.D, mail to: [email protected] Geneticist Jackson State UniversityJackson Heart Study350 West Woodrow Wilson Drive, Suite 701Jackson, MS 39213601-979-8751

Joseph R. Maher, M.D. mail to: [email protected] for Human Genetics, NB 10.210McDermott Center for Human Growth & Development UT Southwestern Medical Center 6000 Harry Hines Blvd.Dallas, TX 75390-8591(214) 648-5866 Office(214) 648-5876 Lab

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Daniel Sarpong, Ph.D; mail to: [email protected], Director & Co-Principal InvestigatorJackson State University Associate Director, Data Management, Information Technology and Qualtiy Assurance Jackson Heart Study350 West Woodrow Wilson Drive, Suite 701Jackson, MS 39213(601) 979-8748 Fax: (601) 979-8751

Robert Garrison, PhD, mail to: [email protected] Director for Scientific Directions and Data AnalysisUniversity of Mississippi Medical CenterJackson Heart Study350 West Woodrow Wilson Drive, Suite 701Jackson, MS 39213(601) 979-8749

Tereza Holman, Ph.D, mail to: [email protected] ProfessorUMC Department of MedicineVA Medical Center601-362-4471 x 1113

Cecil (Buzz) Burchfiel, Ph.D., mail to: [email protected], Biostatistics and Epidemiology BranchCDC/NIOSH/HELD/BEB1095 Willowdale Road M/S 4050Morgantown, WV 26505(304) 285-6376

Ena Knott-Scott, Ph.D, mail to: [email protected] ProfessorDepartment of PsychologyTougaloo College500 W. County Line RoadTougaloo, MS 39147(601) 977-7791

Rev. Richard T. Middleton, III, Ed.D mail to: [email protected], St Mark’s Episcopal Church944 Royal Oak DriveJackson, MS 39209 (601) 260-1193 (Cell)

Melverta Bender-Brown, MLS, MPH mail to: [email protected] Support Manager, Jackson Heart StudyJackson State University350 W. Woodrow Wilson, Suite 701Jackson, MS 39213(601) 979-8739 Fax: (601) 979-8701P&P Guidelines 09/09/2008 12

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Proposal Revision/Rewrite

PPS Reconsider After Revisions

PPS DisapprovalPPS Approval of Proposal

Manuscript Proposal Initiation

Investigator Initiated JHS Initiated

Manuscript Proposal Submitted to PPS

Steering Committee Approval of Proposal

Data Analysis Process

Via JHS

Proposal Resubmitted to PPS

Outside JHS

Writing Group Development of Manuscript

Writing Group Submission of Manuscript to PPS

Outside CCOutside CC

APPENDIX A

Schema of Manuscript Development and Approval Process Page 1 of 2

---

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Accept as is Accept with Revisions

Disapproval

PPS Review of Completed Manuscript

Writing Group Submission of Manuscript to PPS

SC Rec Revise Resubmit

SC Approval

APPENDIX A

Schema of Manuscript Development and Approval Process Page 2 of 2

APPENDIX B

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Steering Committee Review of Manuscript

W G Revise/Rewrite Manuscript

WG Resubmit Manuscript to PPS

WG Revise Manuscript

NHLBI Review of Manuscript

NHLBI Approval

NHLBI Revise/Resubmit

WG Resubmit Manuscript to PPS

WG Submit to Journal

WG Revise Manuscript

WG Notify PPS of Publication Status

WG Resubmit Manuscript to PPS

Reconsider After Revisions

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 Jackson Heart Study Manuscript Proposal FormPlease read JHS Publications & Presentations protocol before completing this proposal.

JHS MS #

Date of Submission:           (mm/dd/yyyy) Date of Approval:           (mm/dd/yyyy)

PART I. OUTLINE OF PAPER

1.  Title Information

a. Proposal Title: (Please include the phrase “Jackson Heart Study” whenever possible)

b. Abbreviated Title: (50 characters)      

c. Suggested key words:      

2.   Lead Author Name:       

Institutional Affiliation:       

Address:      

Telephone:                                       Fax:       

Email:       

3.   Co-authors, Contact Information, and Responsibilities: (Proposed co-authors, Email address and/or telephone numbers and proposed responsibilities.  Examples of responsibilities include design and concept of study, statistical analysis, data acquisition, methodological expertise, funding acquisition, literature review. Also indicate specific writing assignments including: introduction methods, results, discussion, preparation of tables and figures. Items not assigned to a co-author are assumed to be the responsibility of the lead author. Corresponding author should also be identified if it is not to be the lead author.)         

Name Contact Information Responsibilities

4. Signature Sheet for Manuscript Proposal (attached)

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5.   Relevant JHS Investigators: (Non JHS Lead authors are encouraged to visit the JHS Website http://jhs.jsums.edu/jhsinfo or www.nhlbi.nih.gov/about/jackson/for information on relevant JHS investigators. The JHS Steering Committee may nominate additional authors if special expertise for interpreting JHS data is needed)

6.   Background/Rationale (Include the relevance of this proposal to African Americans and justify the need for the JHS cohort to answer the research question):           

7.   Research Hypotheses:    

8.   Data: (Visits and variables to be used, sample inclusions/exclusions)   

9.   Brief Statistical Analysis Plan and Methods: (Including power calculations, if necessary.)

10.  References: (Maximum 15)     

PART II.  AUTHOR CONTRIBUTIONS

11.  Have all co-authors reviewed and approved this document?           Yes (Required)

12.  Does the lead author (or designee) agree to present findings at a JHS Colloquium? or Seminar?             Yes (required)

Note: A lay summary is required when submitting the completed manuscript draft for JHS and NHLBI approvals.

PART III.  ADDITIONAL INFORMATION

13. Is this manuscript proposal based on an Ancillary Study? _____ Yes ____ No If yes, please provide the ASC # .

14.  Type of Study:

_          Full Cohort                       Family Study               Sub-Study     _          Ancillary Study               Case Control               Other (list):      

15. Type of Data:

_          Longitudinal               Cross-Sectional             Other (list):       

16.  Location of Statistical Analysis:

__        Central (by Jackson Heart Study Staff) _           Local (list site)

17. Genetic Information: 

a. Do you propose use of data from a participant’s DNA?           Yes (see b)            Nob.   If yes, for a primary aim or secondary aim of JHS? (Please check one or both)

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           Primary Aim (heart, vascular disease)           Secondary Aim (other conditions)

18.  Conflict of Interest

a. Are these analyses to involve a for-profit corporation?  _____Yes ____Nob. Do you or any member of your Writing Group intend to patent any process, or aspect of outcome from these analyses?  ______Yes    _______No

19.  Data Sharing Agreement

Has the Lead Author and any co-authors who will have direct access to JHS data signed the JHS Data Sharing Agreement?     ______Yes (Required)

20.  JHS Manuscript Overlap

The Lead Author has reviewed all existing JHS manuscripts / manuscript proposals and found:

a. No similar manuscripts / proposals        ______Yesb. The following manuscripts / proposals with similarities: (List MS # title and Lead Author below) 

Note:  Completion of manuscript preparation is expected in less than two years.  The manuscript proposal will expire if no manuscript draft is submitted for JHS review at the end of the three years from date of approval.  If additional time is needed after three years, please contact JHS for extension. 

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APPENDIX C

Jackson Heart Study Manuscript Proposal Review Form

Reviewer:

Manuscript Proposal Title:

Manuscript Proposal (MS#):

Ratings: 

Excellent Very Good Good Fair Not Acceptable

Importance of Question Originality/innovativeQuality of MethodsOver all Scientific merit

No Slightly Overlap YesOverlap with other JHS manuscript proposals/manuscripts

Overlap with other JHS manuscript proposals/manuscripts

Yes Slightly Modify NoAppropriate writing group/skill set to complete manuscript

Add:

Delete:

Priority:

High Medium LowRelevance to JHS key scientific questionsStatistical consultation from JHS

Recommendation:

____ Accept as is

____ Accept pending revisions.

____ Reconsider after revisions.

____ Disapprove for reasons noted

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APPENDIX D

E-Vote Form

e-voteJackson Heart Study Publications and Presentations SubcommitteePrincipal Investigator/Presenter:Title of Publication/Presentation:Type of Publication/Presentation:Date of Presentation:Committee Member:

_____ Manuscript Proposal

_____ Manuscript

_____ Oral Presentation

_____ Poster Presentation

Date of E-Vote:

_____ Accept as is

_____ Accept pending revisions ____________________

_____ Reconsider after revisions ________________

_____ Disapprove for reasons noted _____________________________________________

Comments: ___________________________________________

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APPENDIX E

JHS PRESENTATION FORM

A. INFORMATION ON PRESENTER:

1. DATE OF REQUEST: __________/ ________/ ___________

2. REQUESTED BY: ______________________________________________

3. CONTACT INFORMATION (phone and email): _________________________ _______________________________________________________________

B. INFORMATION ON THE PRESENTATION/MEETING

1. TITLE OF PRESENTATION:

2. AUTHOR NAME, TITLE/PRESENTER NAME, TITLE (If different from author):

3. TYPE OF PRESENTATION: ______PAPER ______ORAL _____OTHER

4. PURPOSE OF THE PRESENTATION:

a. NATIONAL MEETING __________ If yes, complete items 7 & 8

b. LOCAL MEETING __________

c. TEACHING/CLASSROOM __________

d. OTHER __________

e. SPECIFY _____________________________________________________________________________________________________

5 PRESENTATION LOCATION: ____________________________________

6. DATE OF PRESENTATION: __________/ ________/ ___________

7. TITLE OF THE MEETING: _______________________________________

8. DUE DATE FOR MEETING ABSTRACT SUBMISSION: ______/ ________/ ________

C. INFORMATION ON DATA

1. WILL PRESENTATION INVOLVE THE INITIAL RELEASE OF JHS RESULTS?YES NO

2. WILL JHS DATA BE USED IN PRESENTATION? YES NO

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3. MANUSCRIPT PROPOSAL NUMBER, IF RELATED TO JHS MANUSCRIPTPROPOSAL? ______________

D. COMMITTEE DISPOSTION:

APPROVED: ____________ DISAPPROVED: ____________

COMMENTS:

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APPENDIX FJackson Heart Study Manuscript Review Form

Reviewer:

Reviewer Number:

Manuscript (MS#):

Date of Review:

Please prepare separate comments for the author on the accompanying page Return your review by FAX or email. If you need to write on the manuscript,

please confine such comments to minor corrections and return the accompanying manuscript. If possible, make such comments using, “track changes,” and “insert comment,” from the “tools,” or “insert menu,” and return the corrected manuscript via email. Otherwise, you should destroy the manuscript.

Please review by the due date so that we can send the authors a prompt reply. Thank you.

Excellent Very Good Good Fair Not Acceptable

Importance of Question Originality/innovativeQuality of MethodsOver all Scientific merit

General comments:

In what ways is this manuscript significant for the JHS?

What are the manuscript’s strengths/weaknesses?

Recommendation:

 ____Accept as is

____Accept pending recommendations

____Reconsider after revisions

____Disapprove for reasons noted

In your opinion, is this manuscript eligible for expedited review?

_____Yes

_____No

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JACKSON HEART STUDY PUBLICATIONS AND PRESENTATIONS SIGNATURE SHEET FOR

MANUSCRIPT PROPOSALS/MANUSCRIPTS

Guidelines: The Lead Author is responsible for signing this form and for obtaining the signatures of co- authors.

Lead Author:

My signature below indicates that I assume primary responsibility for the development of the manuscript proposal entitled “ ”.

_______________________________/_______________________________/_________(Print/Type Name) (Signature) (Date)

Co- Author:

My signature below indicates that I have read and am in agreement with this proposal/manuscript”.

_______________________________/______________________________/________(Print/Type Name) (Signature) (Date)

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