Clinical Research in the National Football League: The Player Scientific and Medical Research Protocol

Abstract

Introduction Sport is an international obsession for many people. Ensuring that athletes can compete in as safe of an environment as possible is vital not only in terms of the players' individual health and the teams' success in competition but also serves as a point of public health impact and as an example to young athletes. Sports injury surveillance and player health research is an essential component of injury prevention, reduction, and ultimately, player wellness. The National Football League (NFL) has established a robust injury research structure across all facets of athlete health (1,2). Consistent with established ethical principles and good practice for medical research, the NFL and NFL Players Association (NFLPA) jointly developed a Player Scientific and Medical Research Protocol Approval Process (MRAP) through which NFL player electronic injury and illness data may be used for the purposes of observational and interventional research. MRAP was agreed to by the NFL and NFLPA as a side letter agreement to the 2011 NFL-NFLPA Collective Bargaining Agreement (CBA), dated January 26, 2015, and has been updated over time. This process provides oversight of the access, utilization, and management of NFL health data to: 1) ensure that the potential research is feasible, valuable, and methodologically sound; (2) protect the confidentiality interests of NFL players and assure that appropriate personal information is not released to the public; and 3) avoid the duplication of research efforts between the NFL's medical committees, with the overall goal of ensuring that the goals of the intended research are consistent with the interests of the patient (player) and institution (NFL). The establishment of this process acknowledges the sensitivity of the workplace injury and illness data shared by NFL athletes, as well as the value of these data toward driving actionable evidence for injury prevention and player care. While these are supremely fit, talented young men, they are at risk for sustaining significant injuries and developing medical conditions throughout their time playing football — both at amateur and professional levels — based on the inherent risks associated with American football. Collaborative development of MRAP by the NFL and NFLPA ensures that both the League and the player representatives agree to the principles of conducting research on these “player-patients” with the goal of understanding and improving health and safety in a sound and ethical fashion within a collectively bargained employment environment. The steps within the application process and various levels of approval required to conduct research using NFL player workplace injury and illness data are defined in the MRAP protocol. The level of approval is based on whether the research is: 1) active (interventional) or observational (noninterventional); 2) the intended use of the data; and 3) the sensitivity of the requested data. Sequential approvals by each party in the process are required; denial at any point by either party results in the full request being denied. Additionally, MRAP establishes a process whereby a research product (e.g., manuscript, presentation) is submitted for approval prior to submission for public presentation or editorial review and subsequent dissemination. However, it is stated explicitly in the MRAP protocol that “the NFL and NFLPA may offer nonbinding comments but shall not have editorial control or input” into any scientific publication or professional presentation. This caveat applies to all types of research disseminated via the MRAP governance structure. Player-related research approved through MRAP is based on data that are collected directly on active players by NFL team medical staff or NFL team medical/scientific consultants, rather than data compiled and promoted by external public or private sources. Data pertaining to prospective players evaluated at the National Invitational Scouting Combine who do not sign an NFL contract are not eligible for use in MRAP research. This approach ensures that the medical research data obtained from NFL players and its subsequent analyses and interpretation are as consistent and accurate as possible, particularly with regard to completeness, injury classification, and diagnosis. Studies describing the incidence of, and prognostic implications following specific injuries among NFL players have recently been published (3–23); these studies are most frequently based on convenience samples obtained from publicly reported sources, such as the lay press or dedicated web logs (blogs), which may be inaccurate and incomplete, and are likely to reflect more severe injuries or the experiences of more popular players. Use of a comprehensive, curated electronic medical record-based injury system linked with official game statistics, player demographics, and injury mechanisms provides the most reliable and robust data. Such data are necessary to capture accurate injury statistics, which are essential for impact assessment of these injuries. Every NFL club is responsible for distributing this MRAP protocol to its medical team. Club research requests for approval may only be submitted by the club's head team orthopedist, head team medical physician, or head team athletic trainer (AT). Requests to undertake research also may come from an NFL club or a member or consultant of the NFL's Medical Committees (24) (e.g., health and safety, musculoskeletal, head, neck and spine, general medical). Failure to obtain the requisite approvals prior to initiating a research project or disseminating NFL player injury data will result in removal of the responsible member from their respective committee and/or sanctions to the club at the discretion of the NFL Commissioner. The purposes of this article are to outline the MRAP governance structure (which explains the details of the medical research processes in the NFL) and highlight the importance of a structured, multilevel research approval process in a professional sport league whose injury and illness data are governed by a collectively bargained agreement. MRAP Protocol Components and Resources There are two components to the MRAP governance structure: 1) The MRAP Protocol details the process for seven distinct pathways of approval based on the (a) person requesting data, (b) intent of research (i.e., publication/external presentation vs. occupational/internal club, league or committee use), and (c) sensitivity/identifiability of data requested (Table 1). 2) Initial request form through which applications are initiated, designated by MRAP as Appendix A (Supplemental Digital Content 1, https://links.lww.com/CSMR/A47). This form requires disclosure of the study objectives, the data being requested, identification of the intended audience, and intended use of the data. Table 1: Research pathways and approved dissemination of NFL medical research.Based on the information submitted in the initial request form, the research proposal request is assigned to one of the seven pathways outlined within the MRAP protocol, which specifies the sequential reviews and approvals required for the request. All requests are made via a dedicated web site and reviewed by an independent third-party research company (IQVIA, Durham, NC) specializing in health information technology, analytics, and clinical research. The initial request initiates a feasibility review to assess whether: 1) data are available for the requested research; and 2) the research methodology is scientifically valid. Each approval party then reviews the proposal with consideration toward the strength of the scientific aims, availability and sensitivity of the data being requested, relative importance of the research objectives, and whether there is overlapping research underway by one of the NFL's medical committees and advisors. MRAP Protocol The MRAP protocol contains seven pathways of approval for research activity, each with specific, sequential requirements. These are detailed below, and the language is taken nearly verbatim from the NFL-NFLPA CBA side letter agreement. 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 players directly; or administering any form of medication and/or blood testing for the purpose of research rather than as clinically or medically indicated). Process Once an interventional research project obtains the approval of the relevant NFL medical committee, that committee designates 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 serves as the liaison between the researcher and the NFL for any logistical issues. Data or analysis may be shared per NFL and NFLPA determination provided: 1) institutional review board (IRB) approval is attained and current; 2) 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 3) notification and dissemination of findings and reports to aforementioned parties is provided 60 d prior to submission for publication and 30 d prior to publication (final article upon acceptance). Player participation in any research project must be and remain entirely voluntary. Players 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 must 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 d prior to submission and 30 d prior to publication (final article upon acceptance) and applies to any abstracts or presentation given or submitted based on the research. As mentioned previously, the NFL and NFLPA may only offer nonbinding comments and has neither editorial control nor input. If an NFL club physician engages in active or interventional player research without obtaining the requisite approvals described above, discipline may be imposed against the club with which that physician is affiliated. Other remedies also may be available to individual players and/or the NFLPA pursuant to the CBA. II NFL Club Physician EMR Data Request: Internal/Club Use Only Each NFL club may access the data related to its own players; clubs may not obtain identified data related to players in other clubs. Beginning in the 2019 season, individual NFL clubs have access to an injury dashboard showing injury incidence overall and by setting trends over time, and return to play metrics for players from their own club, as well as comparison with select aggregate results across the League. For many injuries and health-related conditions, NFL clubs can compare their injury/health condition data with league averages, which are provided to the club by IQVIA. Process Clubs may request analysis of their own player data by submitting the request form to IQVIA, which will comment on the feasibility and resources needed for the project. The requesting Club also must submit a proposal through the NFL MRAP web site. IQVIA's feasibility assessment, when applicable, and the request form will then be forwarded to NFL management council legal, the NFL chief medical officer and the NFL executive vice president (EVP) of Health and Safety Initiatives for approval. The project will pass through the approvals required as set forth within Table 2 via the NFL MRAP web site (https://legacy.nflfoundation.org/mrap/login). Please note that one cannot log in or view anything on the site unless they are provided with login information by the NFL. Projects will be approved and prioritized according to the complexity of the analysis and availability of resources. 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 research pathway in any publication or presentation to any audience outside of the club.Table 2: NFL medical research approval process summarya.III NFL Medical Committee Member: Internal Committee Use Only/De-Identified Data NFL medical committees shall be given access to deidentified player data in connection with their respective missions. Data produced via this research pathway may not be disclosed to anyone who is not affiliated with the relevant 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, the NFL, or the NFLPA, absent appropriate approval. The NFL will give notice to the NFLPA legal of such a request and provide a copy of such data prior to sending the data to the requesting committee. In addition, a committee member or chairperson may request access to research results to consider for broader distribution to relevant NFL medical advisors by contacting the NFL chief medical officer and IQVIA. Should the committee member/chairperson conclude that the broader committee would benefit from distribution of the data, the protocol reflected in this research pathway shall apply. Process NFL medical committee members may request deidentified player analyses or data by submitting the request form to IQVIA, which will assess the feasibility and resources needed to perform the recommended project. The requesting NFL medical committee member also must submit a proposal through the NFL MRAP web site. IQVIA's assessment and the request form will then be forwarded to NFL management council legal, the NFL chief medical officer and the NFL executive vice president of Health and Safety Initiatives for approval. The project will pass through the approvals required as set forth within Table 3, via the NFL MRAP web site. Data produced under this section may not be disclosed to anyone who is not affiliated with the committee.Table 3: NFL MRAP approval parties by research pathway.IV NFL Medical Committee Member: Internal Committee Use Only — Identified or Identifiable Data NFL medical committees shall be given access to player data in connection with their respective missions. Identified or identifiable data may include the names of players or could be identifiable by virtue of the data set or information included (e.g., date of game, type of injury, position). These data may be requested by an individual NFL medical committee member for review by the larger committee or to identify potential issues. Process NFL medical committee members may request analysis of identified or identifiable player data by submitting a request to IQVIA, which will assess the feasibility and resources needed to perform the recommended project. The requesting NFL medical committee member also must submit a proposal through the NFL MRAP web site. IQVIA's assessment and the request form will then be forwarded to NFL management council legal, the NFL chief medical officer and the NFL executive vice president of Health and Safety Initiatives for approval. NFLPA legal also must consent to the production of these data. The project will pass through the approvals required as set forth within Table 3, via the NFL MRAP web site. 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. V NFL Club Physician/NFL Medical Committee Member: EMR Data Research — Publication/Public Disclosure Intended — De-identified, Identifiable, and Identified Data NFL club or head head club or members of NFL medical committees may request either their or data with the intent to the Process obtain such data, the Club or NFL medical committee member must submit the request form through the NFL MRAP web which will the request to the NFL chief medical officer who upon the request to the appropriate NFL medical committee The committee will review all to whether or not the proposal an of to the general NFL and is of the of resources required to the data If approved by the committee, analyses which ensure that the request is and may request it be required to the request. approval of the relevant NFL medical committee, the request will be to the parties for approval (Table The draft of the article or report must be to and the relevant medical committee chairperson 60 d prior to submission and 30 d prior to publication (final article upon and this applies to any abstracts or presentation given or submitted based on the or may occur approvals are The manuscript must be within from the initial request date and review must remain for the full of the updated approvals must be provided to IQVIA. Committee of Medical for review and must be NFL Club Physician/NFL Medical Committee Member: EMR Data Research — Publication/Public Disclosure Intended — NFL club and head club head or NFL medical committee members may request either their or identified player data, in of a defined research with the intent to the Process obtain such data, the head club or committee member must submit the request through the NFL MRAP web which will the request through the required as set forth in Table The submission to the NFL and NFLPA must include a individual consent form for players whose data will be the of the research to approval from the proposal will be submitted to the Such submission to the must include the individual player consent approval of the the approved consent form must be used to obtain the consent of individual players whose identifiable data will be the of the research. approval of the and the individual whose identified data will be the of the research, the proposal shall be to the chairperson of the NFL Health and Safety Committee for to the appropriate NFL medical committee The NFL medical committee chairperson will the project to a committee member for review and presentation to the committee. The committee will review all to whether or not the proposal an of to the general NFL and is of the of resources required to the data If the designated committee member shall be responsible for monitoring the progress and to the committee. Data or analyses may be shared approval from NFL and the The draft of the article or report by which the results of the study will be publicly released must be to and approved by the designated committee member and NFL chief medical This must occur 60 d prior to submission and 30 d prior to publication (final article upon acceptance) and applies to any abstracts or presentation given or submitted based on the As in all other research the NFL and NFLPA can offer nonbinding comments but do not have editorial control or input. Research by without NFL Data Requests to the terms of the collectively bargained NFL Data NFL player medical data will not be available for third-party research, absent agreement by the NFL management council and Should the parties agree that a research project a to NFL players' health and safety and has not been by or NFL research, the parties may consent to the disclosure of NFL player data. In such an the research project at a the steps outlined in Data or analysis may be shared approval from NFL and The MRAP governance structure was to of research and appropriate use of data by agreed oversight of the use of NFL player workplace injury and illness data within clinical research. The goals of this process are to ensure that research provides value to the NFL and its is and methodologically patient (player) and the duplication of research efforts among the NFL's medical to American or and research governance in and the of the MRAP serves to protect the and of research NFL the interests of the institution In general and Research Committees are with an independent that research is of and is with to protect Such research governance are given the to or research in their institution or of the relative or purpose of the research. this and through a committee of and at one the of the research research (e.g., patient are designated as from medical research governance approval processes they to and do not the relative value the research provides to the institution or to and may not have detailed of the and risk of the patient to be The NFL and NFLPA MRAP governance structure of scientific all in the of the of conducting scientific research in the of a collectively bargained The seven distinct pathways of MRAP ensure that approvals specific to the use of the data and the risk the research to the players are MRAP also the and for research as to avoid resources to studies whose have clinical to the NFL player have been or that cannot be in a with the methodology or available data. NFL players are members of a and MRAP has been collectively all NFL player research evaluated through this process must be approved by the players' the The structure of MRAP and the required by an independent by of oversight by both NFL and NFLPA medical legal and level as well as in injury data In this all — the NFL, and NFLPA — have their interests This can serve as a for other or that may to perform clinical research that benefit of MRAP is the of research data that is used either by each NFL club or made publicly available through or research studies have been published in the medical that use injury press and team web to obtain injury data in an to injury incidence or This practice can be there is no that the publicly reported data are accurate or In the publicly collected injuries may the data within the NFL's electronic medical However, the incidence is to in many may For the injury in is of a that not result in playing time then this severe injury may not be by these public data sources. As a injuries will likely be in publicly available data sources, to of an injury incidence and/or a inaccurate report of specific injury these public data may not report injuries that occur in players whose are and into or who are on the practice to for each injury, severe injuries that are not also may to inaccurate regarding when results to a specific all NFL medical research is approved through the appropriate data set for the research is to be Use of a comprehensive, curated injury system linked with official game statistics, player demographics, and injury mechanisms provides the most reliable and data, and these data through external researcher access for on use of the data, of understanding of and ultimately, appropriate MRAP was developed through the efforts of the NFL and NFLPA to oversight of the access and of NFL player electronic workplace injury and illness data for the purposes of clinical research. across all research to ensure each project is methodologically and confidentiality and privacy the interests of the (player) and institution (NFL) remain to the goals of the intended research. MRAP has in its and could be for other and of research

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