NFL Collective Bargaining Agreement
Appendix XNFL Player Scientific & Medical Research Protocol
This Appendix outlines the authorizations required and sets forth the protocols to obtain the requisite approval for the dissemination and use of NFL player injury data and related information for research. Each request must follow the steps outlined in the relevant section below — a failure to obtain the necessary consent/approval at any step in the process will result in the request being denied (i.e., where the approval of multiple parties is required, the denial by any one party will result in the request being denied).
Every Club is responsible for distributing this Protocol to its medical team. Failure to obtain the approvals required prior to initiating a research project or disseminating NFL Player medical data will subject the Club to sanctions at the discretion of the Commissioner. In addition, failure by a member of an NFL medical or scientific research committee to obtain required approvals prior to the initiation of a research project or dissemination of NFL Player medical data without the required approval will result in that member being removed from the committee.
I. Active/Interventional Player Research
Club-related or third-party request to conduct “active” or interventional research on an NFL Player or Players (e.g., conducting diagnostic tests for the purpose of gathering data rather than as clinically or medically indicated; circulating questionnaires or interviewing Player or Players directly; or administering any form of medication and/or blood testing for the purpose of the research rather than as clinically or medically indicated).
Approvals Required (In Sequence):
NFL Medical Committee (and assignment of individual committee member for oversight)
Mt. Sinai or other University-affiliated Institutional Review Board (IRB)
NFL Players Association Legal
NFL Management Council Legal
NFLPA Medical Director
NFL Chief Medical Officer
NFL EVP Health and Safety Initiatives
Individual NFL Player Participant - Consent Required (using form approved by Mt. Sinai or other University-affiliated IRB and NFLPA)
Data Dissemination Permitted:
Data or analysis may be shared outside of the Club provided: (a) IRB approval is attained and current; (b) Player privacy concerns are addressed with prior notice to and approval as set forth above by the NFL, NFLPA and relevant medical committee(s); and (c) notification and dissemination of findings and reports to aforementioned parties is provided 60 days prior to submission and 30 days prior to publication (final paper upon acceptance).
The process to conduct active or interventional research on NFL Players, prior to study start, is as follows:
- The NFL Chief Medical Officer will review the proposal and assign to the relevant NFL medical/scientific committee for review
- Obtain the approval and “sponsorship”5 of the relevant NFL medical committee through submission of full protocol;
- Share proposed Institutional Review Board (IRB) submission with NFL Management Council Legal and NFLPA Legal;
- Obtain the approval of the Mt. Sinai or other University-affiliated IRB;
- Obtain the written consent of the Player(s) involved (using a form approved by the relevant IRB, NFL medical committee, NFLPA Legal and NFL Management Council Legal);
- Obtain the approval of NFLPA Legal, by providing the required information through the NFL MRAP website;
- Obtain approval of the NFLPA Medical Director;
- Obtain the approval of NFL Management Council Legal (also via the NFL MRAP website);
- Obtain the approval of the NFL Chief Medical Officer;
- Obtain the approval of the NFL EVP Health and Safety Initiatives.
The approvals will be processed through the NFL MRAP website. Once the project has successfully completed all nine steps of the approval process, it may begin. Player participation in any research project must be and remain entirely voluntary; Players will retain the right to withdraw their consent at any time and no longer participate in the research project.
Prior to publication or presentation of results, the researcher shall send a draft of the report or manuscript regarding the study to the NFL (NFL Chief Medical Officer and NFL Management Council Legal) and the NFLPA to ensure that any Player privacy concerns are appropriately addressed. This must occur 60 days prior to submission and 30 days prior to publication (final paper upon acceptance), and applies to any abstracts or presentation given or submitted based on the study. The NFL and NFLPA may offer non-binding comments but shall not have editorial control or input.
Should an NFL Club Physician engage in active or interventional Player research without obtaining the requisite approvals described above, it may result in discipline being imposed against the Club with which that physician is affiliated—in addition to other such remedies that may be available to individual Players or CBA claims by the NFLPA.
II. NFL Club Physician EMR Data Request—Internal/Club Use Only
Approvals Required (In Sequence):
IQVIA feasibility review NFL Management Council Legal
NFL Chief Medical Officer
NFL EVP Health and Safety Initiatives
Data Dissemination Permitted:
Data or analysis may not be shared outside of the Club in any form.
The process for application for and conduct of NFL Club Physician EMR-based research is as follows:
Each NFL Club may access the data related to its own Players. (Clubs may not obtain identified data related to players on other Clubs). Clubs may request analysis of their own Player data by submitting the request form, attached at Appendix A to IQVIA, which will comment on the feasibility and resources needed for the project. The requesting Club must also submit a proposal through the NFL MRAP website. IQVIA’s comments and the request form will then be forwarded to NFL Management Council Legal, the NFL Chief Medical Officer and the NFL EVP Health and Safety Initiatives for approval. The project will pass through the approvals required as set forth above, via the NFL MRAP website. Projects will be approved and prioritized according to the complexity of the analysis and availability of resources. The NFL reserves the right to require the individual Club to pay for the analysis. Data produced under this section may not be disclosed to anyone who is not affiliated with the Club. In other words, a Club medical team member may not use data produced under this section in any publication or presentation to any audience outside of the Club.
III. NFL Medical Committee Member — Internal Committee Use Only — De-Identified Data
Data requested by an individual NFL medical committee member for review by the larger committee or to identify potential issues6. NO public dissemination permitted.
Approvals Required (in sequence):
IQVIA feasibility review
NFL Management Council Legal
NFL Chief Medical Officer
NFL EVP Health and Safety Initiatives
*NFL will give notice to the NFLPA Legal of such request and provide a copy of such data prior to sending such data to the requesting committee.
Dissemination Permitted:
Only to NFL medical committee members and meetings. NO public or third-party disclosures permitted.
The process for application for and conduct of NFL medical committee member research is as follows:
NFL medical committees shall be given access to de-identified Player data in connection with their respective missions. Data produced under this section may not be disclosed to anyone who is not affiliated with the committee. In other words, an NFL medical committee member may not use data produced under this section in any publication or presentation to any audience outside of the committee, NFL or NFLPA, absent the consent of the parties above.
NFL medical committee members may request de-identified Player analyses or data by submitting the request form, attached at Appendix B to IQVIA, which will comment on the feasibility and resources needed to perform the recommended project. The requesting NFL medical committee member must also submit a proposal through the NFL MRAP website. IQVIA’s comments and the request form will then be forwarded to NFL Management Council Legal, the NFL Chief Medical Officer and the NFL EVP Health and Safety Initiatives for approval. The project will pass through the approvals required as set forth above, via the NFL MRAP website. Data produced under this section may not be disclosed to anyone who is not affiliated with the committee.
IV. NFL Medical Committee Member — Internal Committee Use Only — Identified or Identifiable Data
Data that includes the names of Players or would be identifiable by virtue of the dataset or information included (e.g., date of game, type of injury, position) requested by an individual NFL medical committee member for review by the larger committee or to identify potential issues. NO public dissemination permitted.
Approvals Required (in sequence):
IQVIA feasibility review
NFL Management Council Legal
NFL Chief Medical Officer
NFL EVP Health and Safety Initiatives
NFL Players Association Legal
Dissemination Permitted:
Only NFL medical committee members and meetings. NO public or third-party disclosures permitted.
The process for application for and conduct of NFL Medical Committee Member research is as follows:
NFL medical committees shall be given access to Player data in connection with their respective missions. NFL medical committee members may request analysis of identified or identifiable Player data by submitting the request form, attached at Appendix B, to IQVIA, which will comment on the feasibility and resources needed to perform the recommended project. The requesting NFL medical committee member must also submit a proposal through the NFL MRAP website. IQVIA’s comments and the request form will then be forwarded to NFL Management Council Legal, the NFL Chief Medical Officer and the NFL EVP Health and Safety Initiatives for approval. NFLPA Legal must also consent to the production of this data. The project will pass through the approvals required as set forth above, via the NFL MRAP website. Data produced under this section may not be disclosed to anyone who is not affiliated with the committee. In other words, an NFL medical committee member may not use data produced under this section in any publication or presentation to any audience outside of the Club.
V. NFL Club Physician/NFL Medical Committee Member: EMR Data Research — Publication/Public Disclosure Intended — De- Identified, Identifiable and Identified Data
Approvals Required:
NFL medical committee IQVIA feasibility and scientific review
Mt. Sinai or other University-affiliate IRB
NFL Players Association Legal
NFL Management Council Legal
NFL Chief Medical Officer
NFL EVP Health and Safety Initiatives
Data Dissemination Permitted:
Data or analysis may be shared after final approval.
The process for application for this research is as follows:
NFL Club Physicians (Head Orthopedic and Head Internal Medicine Physicians only) or members of NFL medical committees may request either their Club-specific or League-wide data with the intent to publish the results. In order to obtain such data, the Club Physician or NFL medical committee member must submit the request form through the NFL MRAP website, which will direct the request to IQVIA, which will ensure that the request is feasible and request additional detail should that be required to evaluate the request. If IQVIA determines that the request is feasible, it will forward the request to the NFL Chief Medical Officer, who will, upon approval, direct the request to the appropriate NFL medical committee chairperson. The committee will review all proposals to determine whether or not the proposal raises an issue of substantial relevance to the general NFL population and is worthy of the dedication of resources required to gather the data requested. If approved by the committee, IQVIA and the NFL Chief Medical Officer shall be responsible for monitoring the project’s progress and providing periodic updates to the committee.
Upon approval of the relevant NFL medical committee, the request will be directed to the remaining individuals identified above, in the sequence above, for approval.
The final draft of the article or report must be presented to IQVIA and the relevant medical committee chairperson 60 days prior to submission and 30 days prior to publication (final paper upon acceptance), and this requirement applies to any abstracts or presentation given or submitted based on the study. No submissions or presentations may occur until approvals are provided. The NFL and NFLPA may offer non-binding comments but shall not have editorial control or input. The manuscript must be finalized within 24 months from the initial request date and IRB approval must remain up-to-date for the full course of the project; updated approvals must be provided to IQVIA. ICMJE guidelines for review and authorship must be followed.7
VI. NFL Club Physician/NFL Medical Committee Member: EMR Data Research— Publication/Public Disclosure Intended—Case Study
Approvals Required:
NFL Players Association Legal
NFL Management Council Legal
NFL Chief Medical Officer
NFL EVP Health and Safety Initiatives
Mt. Sinai or other University-affiliated IRB
Individual Player Consent Required
NFL Medical Committee
Data Dissemination Permitted:
Data or analysis may be shared after approval from NFL & NFLPA.
NFL Club Physicians (Head Orthopedic and Head Internal Medicine Physicians only) or NFL medical committee members may request either their Club-specific or League-wide identified Player data, in furtherance of a specifically defined research project, with the intent to publish the results. In order to obtain such data, the Club Physician or committee member must submit the request through the NFL MRAP website, which will direct the request through the required approvals, as set forth above. The submission to the NFL and NFLPA must include a proposed individual consent form for Players whose data will be the subject of the research to execute.
Upon approval from those entities, the proposal will be submitted to the Mt. Sinai or other University-affiliated IRB. Such submission to the IRB must include a proposed individual Player consent form. Following approval of the IRB, the consent form must be used to obtain the consent of individual Players whose identifiable data will be the subject of the research. Upon approval of the Mt. Sinai or other University-affiliated IRB and the individual Player(s) whose identified data will be the subject of the research, the proposal shall be sent to the Chairperson of the NFL Health and Safety Committee for designation to the appropriate NFL Medical Committee Chairperson. The NFL Medical Committee Chairperson will assign the project to a Committee Member for review and presentation to the Committee. The Committee will review all proposals to determine whether or not the proposal raises an issue of substantial relevance to the general NFL population and is worthy of the dedication of resources required to gather the data requested. If approved, the designated committee member shall be responsible for monitoring the project’s progress and providing periodic updates to the committee.
The final draft of the article or report by which the results of the study will be publicly released must be presented to and approved by the designated committee member and NFL Chief Medical Officer. This must occur 60 days prior to submission and 30 days prior to publication (final paper upon acceptance), and applies to any abstracts or presentation given or submitted based on the study. The NFL and NFLPA may offer non-binding comments but shall not have editorial control or input.
VII. Research By Third-Parties Without NFL Affiliation
A. Data Requests
Approvals Required:
NFL Medical Committee
Mt. Sinai or other University-affiliated IRB
NFL Management Council Legal
NFL Players Association Legal
Data Dissemination Permitted:
Data or analysis may be shared after approval from NFL & NFLPA.
Pursuant to the terms of this collectively bargained NFL Player Scientific & Medical Research Protocol, NFL Player medical data will not ordinarily be available for third-party research, absent agreement by the NFL Management Council and NFL Players Association. Should the parties agree that a proposed research project presents a clear opportunity to enhance NFL Players’ health and safety and has not been duplicated by previous or ongoing NFL research, the parties may consent to the disclosure of NFL Player data. In such an instance, the research project must follow the steps outlined in Section III above provided, however, the NFL and NFLPA shall provide threshold review of any such request.
B. Requests for NFL Player Participation in non-NFL/NFLPA related active research (on field)
Approvals Required:
NFL Chief Medical Officer
NFLPA Medical Director
Mt. Sinai or other University-affiliated IRB
NFL Management Council Legal
NFLPA Medical Director
NFL Players Association Legal
Data Dissemination Permitted:
To be jointly determined by NFL and NFLPA
Parties seeking participation of one or more NFL Players in an active research project must first obtain that Player’s written consent and provide proof of such consent to NFL Management Council Legal and NFLPA Legal. Should an NFL Player desire to voluntarily participate in an active research project that: (1) is being conducted by a thirdparty that is not affiliated with the NFL, NFLPA, an NFL Club or any of the Parties’ scientific and medical advisory boards and (2) requires the Player to wear a device or engage in any activity that would not otherwise be required by his NFL employment (e.g., Player desires to wear a prototype device that allegedly will reduce/eliminate a certain type of injury or is required by the study to have additional blood or other medical testing) during an NFL game or NFL practice; the project must receive the approvals listed above in order for the Player to participate. For purposes of clarity, a Player may not engage in any such research or testing on an NFL field or practice facility unless the foregoing approvals have been obtained. The foregoing notwithstanding, this provision is not intended to and does not in any way limit an NFL Player’s ability to wear a device or otherwise engage in any activity when the same is not a part of an active research project as outlined above.
The NFLPA, on behalf of any research partner receiving medical research funds pursuant to Article 12, Section 5 of this Agreement, may request data generated or collected through the Injury Surveillance System and/or EMR system, for purposes of the activities described in this Appendix X and subject to the terms, conditions and limitations imposed herein. The NFL’s approval of any such request may not be unreasonably withheld. The NFLPA will bear the expense of any such request and is solely responsible for, and bear all risks resulting from the dissemination of the data.
5 Once an active research project obtains the approval of the relevant NFL medical committee, that committee shall designate one of its members to serve as the “sponsor” of the research project. The project sponsor is responsible for monitoring the progress of the research and periodically reporting back to the larger committee. The project sponsor shall also serve as the liaison between the researcher and the NFL for any logistical issues.
6 A committee member or chairperson may request access to data to consider for broader distribution to the committee by simply contacting the NFL CMO and IQVIA. Should the committee member/chairperson conclude that the broader committee would benefit from distribution of the data- the protocol reflected in this Section shall apply.
7 International Committee of Medical Journal Editors [Internet]. Philadelphia: American College of Physicians; c2017 [cited 2017 Feb 08]. Roles & Responsibilities: Defining the Role of Authors and Contributors. Available from: http://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html