HIV Data Repository – Policies and Procedures
DRAFT – 05/07/2015
Southern HIV & Alcohol Research
Consortium (SHARC)
SHARC Data
Policies and Procedures
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HIV Data Repository – Policies and Procedures
DRAFT – 05/07/2015
Table of Contents
I.
CONCEPT SUBMISSION ......................................................................................................................... 3
A.
Concept Investigators ....................................................................................................................... 3
B.
Types of Concepts ............................................................................................................................. 3
C.
Concept Submission, Review, and Approval ..................................................................................... 3
II.
REQUESTS FOR DATA ............................................................................................................................ 4
III.
CONCEPT SHEET TRACKING, REVISIONS, And RETIREMENT ............................................................. 5
IV.
WRITING COMMITTEES and AUTHORSHIP ....................................................................................... 5
V.
ABSTRACTS, PRESENTATIONS, AND MANUSCRIPTS ............................................................................. 6
A.
Abstracts and Presentations ............................................................................................................. 6
B.
Manuscripts for Publication .............................................................................................................. 6
C.
Submission of Manuscripts to NIH .................................................................................................... 7
APPENDIX A: Concept Submission Form ....................................................................................................... 8
APPENDIX B: Abstract/Grant/Paper Submission Form ............................................................................... 10
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I. CONCEPT SUBMISSION
Submission of a Concept Submission Form (CSF) (found at http://sharc-research.org/forinvestigators/) is required for all proposed investigations involving analyses using existing data sets
hosted by the Southern HIV and Alcohol Research Consortium (SHARC). The Concept Submission
Form is used to identify investigators working on the concept and to describe the concept.
A. Concept Investigators
Each concept will have a Lead Investigator, who will be the primary point of contact for the concept,
who will provide updates on the status of the concept, and who will initially lead the writing group for
the concept. Students and non-faculty collaborators should identify at least one faculty member as a
Faculty Sponsor. Students or faculty who are unaffiliated (external) to SHARC should also identify a
collaborator (sponsor) who is currently a core SHARC faculty member (see www.sharc-research.org).
In other words, at least one affiliated SHARC faculty member should be identified on each submitted
concept. Additional persons who will be collaborating on a concept project should also be listed as
concept investigators.
B. Types of Concepts
Concepts can be submitted to request approval for analysis of existing data, to conduct an ancillary
project (add new data collection or modify an existing project).
Concepts related to existing data or specimens. The SHARC HIV database repository includes data
from several ongoing and previously completed projects. Each dataset will have a Principal
Investigator, most datasets will also have a Project Review Committee and/or a list of additional
investigators who should be invited to be part of a Writing Committee. Information about each
available dataset is listed on the SHARC web site. Concept investigators should indicate which
dataset they are interested in, and provide a summary of the key variables of interest. Requests for
access to study specimens (e.g. blood in our repository) may require additional review.
Ancillary Projects. Proposed investigations involving the collection of new data (questionnaires,
clinical and physical measures), modification of consent forms, or modification of study procedures
will be considered Ancillary Projects. Ancillary projects will undergo additional review related to the
types of resources needed to modify an existing project, and to consider the potential burden on
study participants or research staff. Depending on the extent of the request, Ancillary Projects may
require review by the SHARC Executive Committee and/or a Community Advisory Board.
C. Concept Submission, Review, and Approval
Concept submissions include a cover sheet (signed by the Concept Investigator and appropriate
faculty sponsors), and the concept itself. These should either be submitted directly to the SHARC
Research Coordinator (John Delano), or entered directly into our concept submission database from
a link on the SHARC web site. Questions about the process can be answered either by the Research
Coordinator or from Dr. Robert Cook (cookrl@ufl.edu; or 352-273-5869).
Once the concept is received by SHARC, the Research Coordinator will confirm whether all required
information is present, and request additional information from the lead investigator if needed. Once
the concept is confirmed to be complete, the Research Coordinator will circulate the concept to the
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appropriate Proposal Review Committee. Each dataset will have its own Proposal Review
Committee, including the Principal Investigator who is responsible for the dataset.
During a two-week review period, all Concept Review Committee members will have the opportunity
to evaluate the science, assess the feasibility of the study, and consider whether the proposal
overlaps with other existing research. Concept Review Committee members will be asked to vote to
(1) approve as is; (2) approve with minor revisions; (3) suggest major revisions and re-review; (4) or
reject. If there is overlap with existing projects, reviewers may recommend that the project be
combined with other related projects or revised. Concept Review Committee members may also
indicate whether they would like to nominate themselves or someone else to be part of the Writing
Committee for the submitted concept.
After the review period is complete, the PI of each dataset will work with the SHARC Research
Coordinator to identify an overall status of the concept and to identify specific changes that are
needed (if any) to obtain approval. If revisions are needed, the Concept Investigator will receive
written information about what needs to be modified (if anything). If modifications are required, the
Concept Investigator should submit a revised Concept, together with a cover letter that specifically
states how each suggestion from the reviewers was addressed. Revised concept information should
be submitted to the Research Coordinator (or submitted online). The revised concepts can then be
approved by the Research Coordinator and study PI (if revisions were minor), or sent back to the
Concept Review Committee for re-review (if revisions were major).
Once the concept is approved, the Concept Investigator will receive an approval letter from the
SHARC Research Coordinator or study PI, and the concept will be listed as an active concept on the
SHARC website. At this time, the initial Writing Committee will be established to include the
investigators listed on the Concept, as well as additional writing committee members that may be
assigned to the concept.
II. REQUESTS FOR DATA
The SHARC Research Coordinator, Concept Investigator(s), and the SHARC Data Manager will
determine the best strategy to provide access to the data, and also identify any data management or
data analytic needs. Once the Concept is approved, the SHARC Data Manager will create the
dataset. Datasets will only include the variables requested on the approved concept sheet; any
additional data will require a revision of the concept sheet to be approved. The Data Manager
typically requires a one-week time period for the production of an analytic database. If the data
request is complex, additional time may be necessary, and funding support may be required.
Prior to providing the prepared data, the SHARC Research Coordinator will confirm that appropriate
IRB approvals are present for all persons who will have access to the data. Then, the Concept
Investigator, Faculty Sponsor (if applicable), SHARC faculty representative (if applicable), and Project
PI will complete and sign a Data Sharing Agreement (DSA) that outlines specific rules and
responsibilities related to storage of the data, the appropriate uses of the data, and requirements
related to abstracts and manuscript submissions. Once the appropriate data use agreement is
completed, the SHARC Data Manager can provide access to the dataset. In general, datasets will be
kept on secure servers (such a P:drive at University of Florida College of Medicine), and should not
be placed on jump drives or laptops. Data will be de-identified, or will only include limited identifiers
such as ID numbers and dates (with appropriate IRB approval).
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III. CONCEPT SHEET TRACKING, REVISIONS, And RETIREMENT
Tracking. Once a concept is approved, the Concept Principal Investigator will be asked to report any
abstracts or papers that are created from the data to the SHARC Project Coordinator (or to submit an
update online on the SHARC web site). In addition, annual progress reports, beginning one year
after initial concept submission form approval, will be required to keep a project active.
Revisions. Revisions to concepts can be made at anytime, and can be used to make minor
modifications to the research plan, request additional data, or modify the investigators who are
involved with the writing group for the concept. Revisions should include a brief summary of the
revisions being requested, a revised Concept Submission Form, and a revised concept with “track
changes”. The SHARC Project Coordinator will review the revision with the PI of the dataset, and
either approve (or reject) the revisions, or send the revision to the Concept Review Committee. Once
the revised concept is approved, the updated concept will replace the original concept, and additional
data can be provided.
Retirement. If the annual progress report indicates that no activity is occurring on the project, the
project will be considered in probation or retired, and the concept investigator will be asked to justify
the lack of activity. If no progress is made on an approved concept sheet after two years, it may be
automatically retired and removed from the website.
IV. WRITING COMMITTEES and AUTHORSHIP
Once a concept is approved, the Proposal Writing Group will be formed. The Proposal Writing Group
will include the Concept Investigator, additional investigators listed on the Concept Submission Form,
and persons who were assigned to the writing group during the concept review process. The
Protocol Writing Group varies for each dataset, and is defined by the PI of the specific dataset. For
previously collected data, the PI should indicate up front if any other persons need to be considered
for co-authorship (e.g. persons involved in the original collection of the data). For multi-site studies
such as the Florida Cohort, each site that contributed data should have the opportunity to identify a
potential co-author from that site. More than one co-author from a specific site not involved in the
submission of a given concept will require justification (e.g. a second writing group member from a
site who has special expertise or interest in a given topic).
For large writing groups, the SHARC Research Coordinator may help to facilitate a conference call for
all persons on the Proposal Writing Group to discuss the proposal before getting too far into the
analyses. However, it is ultimately the responsibility of the Concept Investigator to ensure that each
of their writing group members have the opportunity to provide input and to participate on abstracts
and papers. If writing group members do not respond to abstracts and papers that are circulating, the
Concept Principal Investigator should let the SHARC Research Coordinator know. The SHARC
Research Coordinator can then confirm whether the writing group member(s) can be dropped from
the writing committee.
Membership in the Proposal Writing Group does not guarantee authorship on papers or abstracts, but
provides the opportunity to participate and to be a co-author if criteria for authorship are met. Final
authorship decisions should be consistent with criteria as outlined by the International Committee of
Medical Journal Editors (http://www.icmje.org/). Specifically, all persons who are listed as a co-author
should have been involved in all three of the following aspects of the abstract or paper:
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1. Participation in one (or more) of the following areas of research:
a) Planning, design, or interpretation of study data.
b) Data collection
c) Writing the primary draft of the paper
d) Data analysis
2) Reading/editing/commenting on a draft of the abstract or paper.
3) Approval of the final abstract/paper for submission.
Order of authorship is at the discretion of the concept investigator, and generally should be based on
the amount of input provided by other writing group members on a specific project. Typically, the
Lead Investigator would be the first author, and the PI of the dataset would have the option to be
listed in the last (senior) author position if desired. If multiple co-authors provide similar amounts of
input, the order can be listed either alphabetically or chosen at random. The PI of the dataset can
also assist with authorship issues, if needed. Persons who contribute to the work but do not meet all
3 criteria for authorship can be listed in acknowledgements.
V. ABSTRACTS, PRESENTATIONS, AND MANUSCRIPTS
A. Abstracts and Presentations
Abstracts and presentations submitted to conferences that include SHARC data must be associated
with an approved Concept. Abstracts must be submitted for reviews by all co-authors in the Proposal
Writing Group, with sufficient time for the authors to respond. Typically, it is common courtesy to give
co-authors and the Concept Review Committee members at least one week to review an abstract or
presentation and provide edits. If any members of the writing group are not responsive to requests for
comments on abstracts or papers, the concept investigator should let the SHARC Research
Coordinator know. Then the SHARC Research Coordinator can confirm whether or not to remove the
writing group member from the writing team for a specific project.
An Abstract-Paper Submission Form (found at http://sharc-research.org/for-investigators/) must be
submitted, together with the final abstract, to the SHARC Research Coordinator (or on the SHARC
web site) prior to submission to the conference. The Abstract-Paper Submission Form must list the
name and dates of the conference, conference abstract submission deadline, abstract title, list of coauthors, and a copy of the abstract.
Once an abstract has been submitted, the concept investigator must inform the SHARC Research
Coordinator about the result of the abstract submission (accepted or not, poster or oral). Accepted
abstracts will be posted to the SHARC website. We also will request copies of final posters and slide
presentations to be submitted to the SHARC Research Coordinator for possible posting on the
SHARC website, as well.
B. Manuscripts for Publication
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A first draft of a manuscript should be circulated to all members of the Proposal Writing Group, with
sufficient time to consider incorporation of any suggestions made by writing group members. All
persons who will be co-authors of a paper should comment on the first draft or a subsequent draft
that is not the final paper draft. If a writing group member does not respond in a timely manner, the
SHARC research coordinator can help to confirm whether or not the person is able to contribute in a
co-author role.
Once a manuscript is ready for submission, it should be submitted with an Abstract-Paper
Submission Form to the SHARC Research Coordinator for final approval for submission. The
SHARC Research Coordinator will confirm that manuscripts meet guidelines for submission, including
appropriate acknowledgements of funding sources. In addition, the PI of the dataset will need to
approve the manuscript for submission. The SHARC Research Coordinator will inform the concept
investigator that the manuscript is approved for submission, or if any changes are suggested prior to
submission.
The concept investigator is responsible for informing the SHARC Research Coordinator about the
status of the manuscript. Once a manuscript is accepted for publication, SHARC can assist with press
release or other publicity related to the article.
C. Submission of Manuscripts to NIH
The National Institute of Health (NIH) requires all investigators who are participating in studies which
are funded by NIH, to make their peer-reviewed final manuscripts available to other researchers and
to the public at the National Library of Medicine’s (NLM) PubMed Central (PMC)
(http://www.pubmedcentral.nih.gov) within 12 months of the publication date. If your approved
concept uses NIH data (see list of NIH Data on the HIV Data Repository or contact the SHARC
Research Coordinator for clarification), please make sure to follow the NIH’s PubMed submission
request for your manuscript(s). Once you have submitted your manuscript to PubMed, please notify
the SHARC Research Coordinator of your submission with confirmation.
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Southern HIV & Alcohol Research Consortium (SHARC)
Concept Submission Form
APPENDIX A: Concept Submission Form
Please provide the following information in order to track research projects using the following data
(Choose ONLY ONE):
 HIV Surveillance Data/ Medical
Monitoring Project (MMP)
 HIV & Aging Study
 Florida Cohort Project (Phase 1)
 The ARCH Study
 WHAT-IF (Pharmacotherapy for Hazardous Drinking in
HIV-infected Women)
 Florida Cohort Project (Contact Registry)
 Project Support
Concept Investigator (Print Name):
Credentials:
Email Address:
College/Department:
Phone number:
Signature:
SHARC faculty/staff or SHARC student?
□YES
□NO
(If NO, please complete SHARC collaborator information)
SHARC Collaborator (Print Name):
Credentials:
College/Department:
Signature:
Faculty Mentor (if applicable – Print Name):
Credentials:
College/Department:
Email Address:
Signature (REQUIRED if Concept Investigator is a student):
Team Members:
Expand table to add additional members. Your SHARC collaborator is required to be an author on your paper.
Please add the SHARC collaborator as a team member.
Name
Role with Project
Relevant
Degree(s)
College/Department
Will individual
need access to
data?
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Southern HIV & Alcohol Research Consortium (SHARC)
Concept Submission Form
Project Information (use a separate page)
1. Title of proposal
2. 2-3 line summary that will be posted on public web site once approved
3. Attach 2-3 page abstract using the following guidelines:
 Include: Brief background, specific aims/questions, and brief summary of analysis plan
 Identify specific primary outcome variable(s) and primary predictor (independent)
variable(s)
4. Indicate any special support you will need to complete the project (e.g. data analysis)
5. Clarify any new data or specimens that will be added to the project from the data that you will
receive. Please explain.
6. What are the goals of this work (i.e. abstract, paper, grant, etc.)
7. Will you have any need for receiving identifiers in the data set? Please explain.
Once you have completed the concept submission form and the project description, please click the
following link to upload the file.
https://redcap.ctsi.ufl.edu/redcap/surveys/?s=PyDYQnh8yt
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Southern HIV & Alcohol Research Consortium (SHARC)
Abstract/Grant/Paper Submission Form
APPENDIX B: Abstract/Grant/Paper Submission Form
Please indicate which document you intend to submit (Choose only one, if you have multiple
submissions, please complete a new form for each abstract/paper submission):
 Abstract for scientific conferences
 Support letter for grant submission
 Manuscript for publication
Concept ID #:
Corresponding Author:
Name:
College/Department:
Co-Author(s):
Name
Affiliation
Conference Name and Date (if applicable):
Grant Name (if applicable):
Targeted Journal (if applicable):
Submission Deadline:
Faculty Mentor Name (if student):
Faculty Mentor Email Address (if student):
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Southern HIV & Alcohol Research Consortium (SHARC)
Abstract/Grant/Paper Submission Form
Abstracts/Grant/Paper Information:
Please provide the following information and copy it here. Please upload the file through SHARC
Abstract/Grant/Paper Submission survey. Please contact the research coordinator and the
coordinator will send you the survey link.
I.
II.
Abstracts (for conference/grant submissions)
a. Title of Abstract
b. A draft or the final version of the abstract
Manuscripts submission
a. Title of Paper
b. A draft or the final version of the paper
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