TGEN - PE DATA USE AGREEMENT.PDF

DATA USE AGREEMENT 
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DATA USE AGREEMENT FOR THE SHARING OF PUBLIC HEALTH DATA BETWEEN  
MARICOPA COUNTY BY AND THROUGH ITS DEPARTMENT OF PUBLIC HEALTH 
AND THE TRANSLATIONAL GENOMICS RESEARCH INSTITUTE 
 
WHEREAS, Maricopa County Department of Public Health (“MCDPH”) is a department of Maricopa 
County established to promote and protect public health and welfare through the operation of health-related 
programs within the county. 
 
WHEREAS, The Translational Genomics Research Institute (“Recipient”) is a private Arizona non-profit 
corporation. 
 
WHEREAS, MCDPH is a Public Health Authority as defined by 45 CFR § 164.501 and pursuant to the 
Health Insurance Portability and Accountability Act (HIPAA), that routinely collects environmental exposure 
data.  
 
WHEREAS, MCDPH and Recipient recognize the need to set forth and define the terms under which 
MCDPH will provide Limited Data Sets to Recipient, pursuant to 45 CFR § 164.512(e).  
 
NOW, THEREFORE, in consideration of the mutual promises and representations set forth in this Data 
Use Agreement (“Agreement”), MCDPH and Recipient mutually agree as follows: 
 
1. DEFINITIONS  
 
Capitalized terms are defined as follows: 
 
1.1. 
"Authorized Persons" means Recipient employees, agents, contractors, consultants, or 
other personnel who have a need to know or otherwise access the Limited Data Sets for 
purposes of conducting Research (as defined below) in conformance with the 
requirements of this Agreement and who are bound in writing by confidentiality obligations 
sufficient to protect the Limited Data Sets in accordance with the terms and conditions 
of this Agreement and applicable law. 
 
1.2. 
“Limited Data Sets” means Protected Health Information that excludes direct 
identifiers of the individual or of relatives, employers, or household members of the 
individual, as set forth in 45 CFR § 164.514(e)(2), which are provided by MCDPH to 
Recipient pursuant to this Agreement. The data contained in the Limited Data Sets is 
generally described in Section 2.2 below.  
 
1.3. 
“Protected Health Information (PHI)” means protected health information as defined in 
the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), at 45 C.F.R. 
§160.103. 
 
1.4. 
“Research” means a systematic investigation, including research development, testing 
and evaluation, designed to develop or contribute to generalizable knowledge. Activities 
which meet this definition constitute research for purposes of this Agreement, whether or 
not they are conducted or supported under a program which is considered research for 
other purposes. For example, some demonstration and service programs may include 
research activities within the meaning of this definition.  
 
1.5. 
“Security Breach” means any act or omission by Recipient that materially compromises 
either the security, confidentiality, or integrity of the Limited Data Sets or the physical, 
technical, administrative, or organizational safeguards put in place by Recipient or any 
Authorized Persons that relate to the protection, security, confidentiality, or integrity of 
Protected Health Information. 
 
 
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2. 
PURPOSE AND SCOPE OF AGREEMENT 
 
2.1. 
Purpose 
 
This Agreement sets forth the terms and conditions under which MCDPH will permit 
Recipient to access and use Limited Data Sets. This Agreement also sets forth the security 
requirements that such access and use is conditioned upon, including the responsibilities 
the Recipient agrees to assume in connection with such access and use of the Limited 
Data Sets, all permutations of the Limited Data Sets, and the procedures for security, 
transfer, use, retention, ownership, and confidentiality of the Limited Data Sets. 
   
2.2. 
Scope 
 
MCDPH will provide Limited Data Sets to the Recipient, via an encrypted file sharing 
system. The Limited Data Sets will be used exclusively for nonclinical, non-commercial 
research by Recipient, and will not be used in the diagnosis or treatment of humans. 
Recipient’s use of the Limited Data Sets will be in compliance with all applicable federal, 
state and local laws and regulations.  
 
The following data will be provided by MCDPH to the Recipient: de-identified case Limited 
Data Sets from the Medical Electronic Disease Surveillance Intelligence System 
(“MEDSIS”) in an Excel file format. Specifically, the Limited Data Sets will contain the 
morbidity, zip code of residence, and date of positive test. MCDPH may provide additional 
variables as requested by the Recipient. If the parties agree to share additional variables 
and/or types of Limited Data Sets under this Agreement subsequent to its execution, 
before the provision of such Limited Data Sets, the parties will document in writing the 
specifics of such additional variables or types of Limited Data Sets and written 
documentation shall be maintained by the parties as an Amendment to this agreement. No 
individually identifiable health information will be provided to Recipient under this 
Agreement.  
 
3. 
TERM OF THE AGREEMENT 
 
The term of this Agreement shall commence upon signature of both parties (“Effective Date”) 
and shall continue for a period of five (5) years, unless earlier terminated or canceled in 
accordance with Section 6 below. 
 
4. 
CONTRACT EXTENSION 
 
This Agreement may be extended by mutual written agreement signed by the authorized 
representatives of both parties. 
 
5. 
NON-FINANCIAL 
 
This is a non-financial agreement. Neither party shall compensate the other party in any manner 
for the other party’s performance under this Agreement. 
 
6. 
TERMINATION 
 
This Agreement may be terminated or canceled under the following terms and conditions: 
 
6.1. Termination without Cause 
 
Either party may terminate this Agreement at any time with 30 days’ prior notice 
to the other party, in writing, specifying the termination date. Such notices shall be 
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DATA USE AGREEMENT 
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given by personal delivery or by certified mail, return receipt requested, and in 
accordance with Section 20 below. 
 
6.2. Termination for Default 
 
Either party may terminate this Agreement due to the failure of the other party to 
comply with any material obligation, term, or condition of this Agreement. The 
terminating party shall provide the other party with written notice detailing the area 
of alleged lack of compliance or non-performance and to allow (10) days from 
receipt of such notice for the other party to correct the default. If the identified lack 
of compliance or non-performance is not corrected within (10) days, this 
Agreement will be terminated when the terminating party serves the breaching 
party with notice of termination.  
 
6.3. Cancellation for Conflict of Interest 
 
Pursuant to A.R.S. § 38-511, MCDPH may cancel this Agreement without 
penalty or further obligation if any person significantly involved in initiating, 
negotiating, securing, drafting or creating the Agreement on behalf of MCDPH 
is, or becomes at any time while the Agreement or an extension of the 
Agreement are in effect, an employee of or a consultant to any other party to 
this Agreement with respect to the subject matter of the Agreement. The 
cancellation shall be effective upon receipt of the written notice of cancellation 
unless the notice specifies a later time. 
 
 
 
7. 
SECURITY OF CONFIDENTIAL INFORMATION 
 
7.1. 
Recipient shall monitor the use of all Limited Data Sets disclosed to it by MCDPH under 
this Agreement. 
 
7.2. 
Survival of Duty to Protect Confidential Information 
 
The obligations set forth in this Section 7 shall survive the expiration, termination, or 
cancellation of this Agreement, except as otherwise expressly provided. 
 
7.3. 
Minimum Safeguards Limited Data Sets 
 
Recipient shall carefully restrict use and access of the Limited Data Sets solely to 
Authorized Persons and shall implement the following minimum safeguards, designed to 
protect against a Security Breach, in a manner consistent with the requirements of this 
Agreement or applicable law. Recipient safeguards shall, at the minimum, require that 
Recipient and its Authorized Persons to: 
 
7.3.1. 
Prohibit Limited Data Sets supplied under the terms of this Agreement from being 
released or disclosed to anyone not working on the Research as an Authorized 
Person, unless Recipient obtains MCDPH’s written approval prior to such release 
or disclosure. 
 
7.3.2. 
Ensure that any Authorized Persons to whom Recipient provides the Limited Data 
Sets under this Agreement, is informed of and agrees in writing to be bound by the 
restrictions and conditions that apply through this Agreement to Recipient with 
respect to such Limited Data Sets, including any such restrictions and conditions 
that survive after expiration, termination, or cancellation of this Agreement. 
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7.3.3. 
Store all Limited Data Sets shared pursuant to this Agreement only on secured 
servers or encrypted devices, which, at the termination of this Agreement, shall 
be securely deleted upon the written request of MCDPH consistent with the 
requirements of this Agreement and applicable law. 
 
7.3.4. 
Provide MCDPH, upon written request, with a description of the security measures 
that are in place to maintain the confidentiality of the Limited Data Sets being 
received under this Agreement.  
 
7.3.5. 
Provide MCDPH, upon written request, proof of the complete destruction of the 
original Limited Data Sets and any copies or subsidiary Limited Data Sets that are 
developed from the original Limited Data Sets upon the conclusion of this 
Agreement or at such time that such destruction is required by applicable law. 
 
 
7.4. Notwithstanding the foregoing, Recipient’s obligations set forth above shall not apply to 
information that: 
7.4.1. 
Was already known to, or in the possession of, the receiving party prior to the 
time of first disclosure, as demonstrated by contemporaneous, written 
documentation;  
 
7.4.2. 
Is received without any obligation of confidentiality from a third party having a 
legal right to disclose the same;  
 
7.4.3. 
Is independently developed by the receiving party by individuals without access to 
such information, as demonstrated by contemporaneous, written documentation;  
 
7.4.4. 
Is, or subsequently becomes, available to the public through no act or omission of 
the Recipient; or 
 
7.4.5. 
Is required to be disclosed pursuant to a legally enforceable order, subpoena, 
or other regulation, provided, however, that such disclosure shall be limited to 
only that information necessary to comply. 
 
7.5. 
Security Breach 
 
Recipient shall promptly notify MCDPH in writing within five (5) business days of 
Recipient’s initial awareness of any Security Breach, or suspected Security Breach 
involving Limited Data Sets in Recipient’s possession.  Notwithstanding the general notice 
provision in this Agreement (Section 20), such notice shall be made to MCDPH, Office of 
Epidemiology Program Manager, or his/her designee. Recipient shall cooperate in good 
faith with MCDPH in the investigation of any Security Breach. 
8. 
RECORDS AND RIGHT OF INSPECTION 
 
Under A.R.S. § 35-214 and § 35-215, Recipient shall retain all data and other records 
(collectively, “Records”) relating to the Agreement for a period of five years after the expiration, 
termination, or cancellation of the Agreement, unless alternative disposition of the “Records” is 
otherwise requested in writing by MCDPH. During the term of this Agreement, MCDPH has the 
right to inspect or audit, at reasonable intervals and during normal business hours, any and all 
“Records” relating to performance of this Agreement for any purpose including but not limited to 
monitoring and evaluating performance, compliance, and for quality assurance purposes. 
MCDPH will request access to Recipient’s premises in writing for the purposes of 
conducting such “Records” inspections or audits and Recipient will provide MCDPH with 
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access to its premises and to “Records” related to this Agreement, including data access logs at 
reasonable intervals, to permit such inspections and audits.  
When fully executed, this Agreement itself is not considered confidential information pursuant to 
the Arizona Public Records Act, Arizona Revised Statutes §§ 39-121 and 41-151.18 (the 
"Records Statutes"). The Recipient’s confidentiality obligations under this Agreement shall be 
subject in all respects to compliance with all applicable Records Statutes as well as to any and  
all applicable Arizona and Federal laws governing HIPAA, Public Health Data, and PHI. 
 
9. 
AMENDMENT AND ASSIGNMENTS 
 
No amendment or modifications to this Agreement, including any amendment or modification of 
this Section, shall be effective unless the same is in writing signed by the parties. This Agreement 
cannot be assigned or transferred, in whole or part, without a written agreement signed by the 
authorized representatives of both parties.  
 
10. 
ARIZONA LAW 
 
The law of Arizona shall apply to this Agreement. Any dispute related to this Agreement shall be 
filed in the appropriate court in Phoenix, Arizona.  
 
11. 
RELATIONSHIP OF PARTIES 
 
Neither party to this Agreement shall be deemed to be the employee or agent of the other party to 
the Agreement. This Agreement does not create any partnership or joint venture between the 
parties.  
 
12. 
SEVERABILITY 
 
The provisions of this Agreement are severable. Any term or condition deemed illegal or 
invalid shall not affect any other term or condition of the Agreement. 
 
13. 
NO PAROLE EVIDENCE 
 
This Agreement is intended by the parties to be a final and complete expression of their agreement. 
No course of prior dealings between the parties and no usage of the trade shall supplement 
or explain any terms used in this document. 
 
14. 
NO WAIVER 
 
Either party’s failure to insist on strict performance of any term or condition of the Agreement shall 
not be deemed a waiver of that term or condition even if the party accepting or acquiescing in the 
nonconforming performance knows of the nature of the performance and fails to object to it. 
 
15. 
HEADINGS 
 
Headings are for organizational purposes only and shall not be interpreted as having legal 
significance or meaning. 
 
16. 
ADVERTISING AND PROMOTION OF CONTRACT 
 
Neither Recipient nor MCDPH may use the name, trademark, logo, symbol, or other image or trade 
name of the other party or its employees and agents in any advertisement, promotion, or other form 
of publicity or news release or that in any way implies endorsement without the prior written consent 
of an authorized representative of the other party whose name is being used. Any action for 
commercial benefit is forbidden without the prior written approval of the other party’s authorized 
representative. 
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DATA USE AGREEMENT 
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17. 
DATA USE AND OWNERSHIP 
 
17.1. 
The Limited Data Sets shared under this Agreement are exclusively for use by Recipient 
and its Authorized Persons. Data will not be transferred, distributed, disclosed, or released 
to any third party, other than Authorized Persons of Recipient, unless prior written 
permission is obtained from MCDPH. Without limiting the foregoing, Recipient 
acknowledges and agrees that the Limited Data Sets may not be taken or sent to a third-
party institution or company without written permission from MCDPH. Both parties agree to 
comply with any applicable U.S. export control laws, rules, and regulations with respect to 
the use and any permitted distribution of the Limited Data Sets. 
 
17.2. 
Recipient will (i) provide MCDPH with a copy of any publication that contains experimental 
results obtained from the use of the Limited Data Sets, and (ii) follow the procedures in the 
MCDPH Division of Epidemiology and Informatics (DEI) Clearance Process for Abstracts, 
Manuscripts, and Presentations, attached as Exhibit A. 
 
17.3. 
With respect to any results the Research that Recipient may share with MCDPH arising 
from Recipient’s use of the Limited Data Sets supplied under this Agreement, MCDPH 
shall keep all such Research results confidential and secure until such results have been 
published or otherwise made available to the public in accordance with Exhibit A; provided, 
however, that MCDPH may disclose those results (or portion thereof) to the extent required 
by applicable law or by a court order from a court with competent jurisdiction. MCDPH 
shall give Recipient prompt and advance written notice of such required disclosure and, 
to the extent possible, provide Recipient with sufficient opportunity to object to the use or 
disclosure of the results or to request confidential treatment of the results prior to 
Recipient’s disclosure. It is understood and agreed by the parties that the confidentiality 
obligation contained in this Section 17.3 shall survive the expiration or termination of this 
Agreement, unless otherwise expressly provided herein.  
 
17.4. 
MCDPH retains exclusive ownership of the Limited Data Sets shared with Recipient under 
this Agreement. Any release, or modified re-release of Limited Data Sets shared under this 
Agreement requires prior MCDPH written approval. 
 
17.5. 
Recipient shall not commercialize any product that contains Limited Data Sets without the 
prior written approval of MCDPH, which shall not be unreasonably withheld and MCDPH 
agrees to respond to such request for approval in a timely manner. Recipient is free to file 
patent application(s) claiming inventions made by Recipient through use of the Limited Data 
Sets but agrees to notify Provider within 60 days after any such filing.  
 
18. 
DISCLAIMER 
 
18.1. 
The Limited Data Sets provided are experimental in nature and are provided “AS IS” 
WITHOUT ANY WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT 
LIMITATION WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A 
PARTICULAR USE. MCDPH MAKES NO REPRESENTATION AND PROVIDES NO 
WARRANTY THAT THE USE OF THE LIMITED DATA SETS WILL NOT INFRINGE 
ANY PATENT OR OTHER PROPRIETARY RIGHT. IN NO EVENT SHALL MCDPH BE 
LIABLE FOR ANY INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES IN 
CONNECTION WITH THIS AGREEMENT, EVEN IF ADVISED OF THE POSSIBILITY 
OF SUCH DAMAGES.  
 
18.2. 
ANY RESEARCH RESULTS, DATA, OR OTHER INFORMATION PROVIDED BY 
RECIPIENT TO MCDPH ARE PROVIDED “AS IS” AND WITHOUT ANY WARRANTIES, 
EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION WARRANTIES OF 
MERCHANTABILITY AND FITNESS FOR A PARTICULAR USE OR ACCURACY. 
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RECIPIENT MAKES NO REPRESENTATION AND PROVIDES NO WARRANTY THAT 
THE USE OF ANY SUCH RESULTS, DATA, OR INFORMATION WILL NOT INFRINGE 
ANY PATENT OR OTHER PROPRIETARY RIGHT. IN NO EVENT SHALL RECIPIENT 
BE LIABLE FOR ANY INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES IN 
CONNECTION WITH THIS AGREEMENT, EVEN IF ADVISED OF THE POSSIBILITY 
OF SUCH DAMAGES. 
 
18.3. 
Except to the extent prohibited by law, each party assumes all responsibility for 
damages or costs that may arise from its or any of its employee’s, agent’s, contractor’s 
or other personnel’s use of the Limited Data Sets, Research results, or other 
information received from the other party pursuant to this Agreement, unless such 
damages or costs arise from the other party’s gross negligence, willful misconduct, or 
violation of applicable law. 
 
19. 
INDEMNITY 
 
Recipient agrees to indemnify, defend, and hold harmless MCDPH, from and against any and 
all claims, losses, liabilities, damages, costs, or expenses (including reasonable attorney’s 
fees) (collectively referred to as “Claims”) by any third party arising out of or related to this 
Agreement, to the extent such Claims are caused by the act, omission, negligence, misconduct, 
or other fault of Recipient or any of its officers, agents, employees, subcontractors or 
personnel; except to the extent such Claims arise out of or are related to the use or disclosure 
of any results of the Research by MCDPH or any of its officers, agents, employees, 
subcontractors or personnel. 
 
20. 
NOTICES, CORRESPONDENCE, AND REPORTS 
 
20.1. 
Notices and any other required communication hereunder to Recipient shall be sent to: 
 
The Translational Genomics Research Institute 
445 N. Fifth Street, Suite 600 
Phoenix, AZ 85004  
Attn:  Tess Burleson, Chief Operating Officer  
*With a copy mailed to Recipient’s General Counsel at the above mailing address. 
 
20.2. 
Notices, correspondence, and reports to MCDPH shall be sent to:  
 
Jennifer Collins 
Epidemiology Manager 
Division of Epidemiology and Infomatics 
Maricopa County Department Public Health 
4041 N Central Avenue, Suite 600 
Phoenix, AZ 85012 
Email: Jennifer.Collins@Maricopa.gov 
 
21. 
SURVIVAL 
All provisions of this Agreement that by their express terms shall survive, or by virtue of their nature 
or the context are reasonably intended to survive, shall survive the expiration or termination of this 
Agreement. 
 
 
 
 
 
 
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22. 
SIGNATURES FOR APPROVAL 
 
FOR: Maricopa County, by and through its 
FOR: The Translational Genomics 
Research Department of Public Health: 
 
Institute:      
 
 
       
 
 
______________________________ 
__________________________ 
Jack Sellers, Chairman 
Fanny Zylstra 
Board of Supervisors 
Director of Operations 
 
_____________________________ 
__________________________ 
Date 
Date 
 
ATTEST: 
 
______________________________ 
 
Office of the Clerk of the Board       DATE 
 
APPROVED AS TO FORM: 
 
________________________________ 
Attorney for County                         DATE 
 
 
 
 
 
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Exhibit A 
MCDPH Division of Epidemiology and Informatics (DEI) Clearance Process  
for Abstracts, Manuscripts, and Presentations 
Authorship Guidance: 
Should a MCDPH DEI employee contribute to an abstract in at least one of the following categories or 
contribute to a manuscript in at least two of the following categories, the MCDPH DEI employee should 
be included as an author. All identified authors must agree to take public responsibility for the accuracy 
and integrity of the work, and collectively ensure that any questions regarding accuracy or integrity are 
appropriately addressed.  
 
Make substantial contributions to idea conception or project design (e.g., draft sections of the 
MCDPH Project Proposal form or the project plan) 
 
Make substantial contributions to the development of data collection materials (e.g., be a 
contributing member to the survey design team, develop or guide selection of data collection 
methods for de novo data collection, or draft new SAS code to pull and clean specific data from 
MEDSIS) 
 
Make substantial contributions to data analysis and interpretation (e.g., draft SAS code, guide 
selection of analysis techniques, contribute to interpretation and conclusions) 
 
Draft sections of the abstract or manuscript or critically review drafts for content (e.g., to highlight 
or correct key analytic or thematic content, not just for writing style) 
 
Shepherd the abstract through final approval of the published version (does not include reviewing 
solely for article clearance process)  
 
Maricopa County employees who contribute through the following activities only and who did not make 
any additional contributions may be included in acknowledgements. 
 
Funding acquisition 
 
General supervision of a research group 
 
General administrative support 
 
Writing assistance, technical editing, language editing, and proofreading 
 
Scientific advisors (with no other duties) 
 
Critical review of study proposal (with no other duties) 
 
Data collection 
 
For additional information on MCDPH DEI’s expectations for first, last, and corresponding authors, please 
see Roles and Responsibilities for First and Last Authors section below.  
 
If MCDPH DEI staff will be listed as co-authors: 
Clearance Process: 
Prior to drafting any abstracts or manuscripts that will be submitted to a scientific meeting or training, 
conference, or journal publication, an author must complete the MCDPH Project Proposal form and 
submit it to the designees in DEI.  
 
After clearance of the MCDPH Project Proposal form, the abstract or publication draft must be approved 
by all co-authors, the Division Administrator, Public Health Scientists, and MCDPH Medical Directors prior 
to conference or journal submission. If pursuing submission to a conference, please attach appropriate 
materials and include the conference name, call for abstracts including website link, submission deadline 
date, all co-authors in order, date, location, the type of presentation, word count, and the length of time for 
your talk (if applicable). If pursuing a publication, please include the journal name, link to journal website, 
all co-authors in order, deadline submission date, type of article, and length of manuscript if applicable.  
 
Timelines: 
Prior to write-up and submission, abstracts or manuscripts must be sent to MCDPH DEI based on the 
timelines below.  
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 
4+ weeks prior to submission: the MCDPH DEI co-author(s) shall receive an email with the title 
and proposed abstract or manuscript for edits and review.  
 
3 weeks prior to submission: the co-author(s) will return any edits back to the corresponding 
author for review.  
 
2 weeks prior to submission: the revised version shall be sent to the MCDPH co-author(s); co-
authors will share with Public Health Scientists for final approval. Public Health Scientists will 
facilitate review by leadership team (Division Administrator and/or MCDPH Medical Directors) for 
scientific integrity and departmental approval by both levels.  
 
24-48 hours prior to submission: if approved, the final version will be returned to the first author 
for submission.  
Note: Expedited approval can be requested but is subject to MCDPH availability and is not guaranteed. 
 
If substantive comments are made during peer-review which lead to changes in the discussion, 
conclusions, alteration of analytic methods, or further analysis, then the updated draft highlighting these 
changes should be submitted to MCDPH for re-approval. 
 
If a submission is rejected by a conference or journal, the first author should discuss with the co-authors 
whether to submit to another conference or journal. If the same manuscript will be submitted elsewhere, 
notification should be made to all reviewers, but re-approval of the abstract or manuscript is not needed. 
 
MCDPH may elect to reject the submission, with possible request for significant revision, if one of the 
following conditions are met: 1) MCDPH is unable to approve due to tight submission deadlines, 2) 
MCDPH disapproves of the abstract/manuscript, 3) MCDPH has significant edits which will create a 
significant delay or lead to fundamental changes in the body of work.  
 
Once submission is complete, receipt of submission should be shared with all co-authors including a final, 
clean version of the product and proof of submission. The first author will be responsible for 
communicating any status updates for an abstract or manuscript to co-authors as soon as possible. This 
can include acceptance, rejection, revise and resubmit, or other statuses.  
 
Presentation or Poster Approval Process:  
If an abstract has been selected for a presentation or a poster at a conference, the lead presenter/first 
author shall determine the conference submission date as soon as possible. Please attach appropriate 
materials and include the conference name, date, location, the type of presentation accepted, any 
requirements outlined by the conference, and the length of time for your talk. This will follow a similar 
process as outlined in the timelines. Expedited approval can be requested but is subject to MCDPH 
availability and is not a guarantee.  
 
 
If no MCDPH staff will be listed as authors: 
Clearance Process: 
If pursuing submission to a scientific meeting, training, or conference, please attach appropriate materials 
and include the conference name, call for abstracts including website link, all co-authors in order, date, 
location, the type of presentation, word count, and the length of time for your talk (if applicable). If 
pursuing a publication, please include the journal name, link to journal website, all co-authors in order, 
deadline submission date, type of article, and length of manuscript if applicable. 
 
If substantive comments are made which lead to changes in the conclusions, alteration of analytic 
methods, or further analysis, then the updated draft highlighting these changes should be submitted for 
review. 
 
If a submission is rejected and the same manuscript will be submitted to another journal, notification 
should be made to all reviewers, but re-approval of the manuscript is not needed. 
 
 
 
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Timelines: 
Prior to write-up and submission, abstracts, posters, or manuscripts must be sent to MCDPH DEI based 
on the timelines below.  
 
2 weeks prior to submission: the revised version shall be sent to the MCDPH contact person or 
Public Health Scientists for final approval. Public Health Scientists will facilitate review by 
leadership team (Division Administrator and/or MCDPH Medical Directors) for scientific integrity 
and departmental approval by both levels. 
 
24-48 hours prior to submission: if approved, the final version will be returned to the first author 
for submission.  
 
Roles and Responsibilities of First, Last, and Corresponding Authors 
Responsibilities of the first author 
“The first author will have responsibility for the integrity of the work as a whole from inception to 
publication. First authors also are responsible for providing leadership in determining order of the other 
co-authors, establishing writing assignments, providing direction for reviews and revisions, and compiling 
drafts. The first author should ensure an open forum for co-authors to share their concerns and 
suggestions and should ensure that all ethical considerations (e.g., IRB review, disclosure of conflicts of 
interest) have been addressed.”1 
 
Additional responsibilities for MCDPH DEI first authors include2: 
1. Organize, coordinate, delegate, and monitor progress on clearly defined external and internal 
collaborator roles and expectations in agreed upon timeframe. 
2. Ensure all administrative requirements are met in a timely manner including submission to an 
institutional review, human subjects review, or data monitoring board if deemed necessary and in 
close consultation with MCDPH DEI Public Health Science Branch prior to submission. 
3. Lead development of all final products (including project proposal) for grammar and scientific 
tone, to ensure compliance with standards set by governing organization (e.g., journal, national 
membership organization, call for abstracts, etc.) 
4. Obtain all necessary approvals and sign offs before dissemination including co-authors, MCDPH 
clearance process, and any external clearance processes. 
5. With support from their direct supervisor, the first author will need to demonstrate that they can 
dedicate adequate bandwidth to achieve all outlined responsibilities below within the agreed-upon 
timeframe with Public Health Science Branch (no longer than 6 months from approval to project 
completion unless otherwise predetermined)  
a. Supervisors and first authors should discuss how the project aligns with their 
performance goals and how time will be managed along with day-to-day responsibilities; 
(note: some supervisors may elect to reprioritize job duties; some supervisors may allow 
employees to work more than 40 hours per week to meet responsibilities and deadlines) 
b. At the deadline, participate in conversations with MCDPH DEI Public Health Science 
Branch and project team to determine next steps and if role transfers will need to occur, 
including first or last author. 
 
Responsibilities of last (senior) author 
The last (often referred to as senior) author is responsible for guiding the project from inception to 
completion. They serve as the ‘back up’ to the project lead (first author).  
 
Additional responsibilities for MCDPH DEI senior authors include2:  
1. Mentorship of first author and project team throughout project. 
2. Ensure all administrative requirements are met in a timely manner including submission to an 
institutional review, human subjects review, or data monitoring board if deemed necessary and in 
close consultation with MCDPH DEI Public Health Science Branch prior to submission. 
3. Coordinate appropriate internal and external collaborators to guide project work and provide 
expertise, as needed, in consultation with first author’s branch lead. 
4. Advisement of best practices for scientific writing. 
5. Responsible for project design, analysis, and final decision making. 
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6. Thoroughly edit all products (including project proposal) for grammar and scientific tone, to 
ensure compliance with standards set by governing organization (e.g., journal, national 
membership organization, call for abstracts, etc.). 
7. Provide knowledge and support in navigating peer review process, including response to 
comments and editorial requests for changes. 
8. Guide incorporation of feedback and lead discussion from project proposal through final scientific 
publication. 
9. Ensure alignment of department priorities with project objectives prior to proposal submission and 
lead communication between branch lead(s), public health science, or leadership as needed. 
10. Being an accessible resource to the first author for all project needs. 
11.  Dedicate adequate bandwidth to achieve all outlined responsibilities below within the agreed-
upon timeframe with MCDPH DEI Public Health Science Branch (no longer than 6 months from 
approval to project completion unless otherwise predetermined). 
a. At the deadline, facilitate conversation with Public Health Science Branch and project 
team to determine next steps and if role transfers will need to occur, including roles of 
first or last author. 
 
Responsibilities of the corresponding author 
“The corresponding author is the one individual who takes primary responsibility for communication with 
the journal during the manuscript submission, peer-review, and publication process. The corresponding 
author typically ensures that all the journal’s administrative requirements, such as providing details of 
authorship, ethics committee approval, clinical trial registration documentation, and disclosures of 
relationships and activities are properly completed and reported, although these duties may be delegated 
to one or more co-authors. 
 
The corresponding author should be available throughout the submission and peer-review process to 
respond to editorial queries in a timely way, and should be available after publication to respond to 
critiques of the work and cooperate with any requests from the journal for data or additional information 
should questions about the paper arise after publication. Although the corresponding author has primary 
responsibility for correspondence with the journal, the ICMJE recommends that editors send copies of all 
correspondence to all listed authors.”3 
 
Resources 
1. https://www.cdc.gov/mmwr/author_guide.html  
2. Division of Epidemiology and Informatics Authorship Guidance, MCDPH, last updated 01/09/2024. 
3. ICMJE | Recommendations | Defining the Role of Authors and Contributors, 
https://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-
and-contributors.html 
 
 
 
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