Knowledge Platform Governance Overview
The Accelerating Medicine Partnership in Parkinson’s Disease AMP PD Knowledge Platform operates under comprehensive governance policies. These policies delineate AMP PD Knowledge Platform users’ rights and responsibilities. They also specify the rights and responsibilities of AMP PD Knowledge Platform operations governed by the AMP PD Data Working Group and the AMP PD Access and Compliance Team (ACT).
The following sections specify the AMP PD Knowledge Platform Terms and Conditions of Use. These establish the use, disclaimers, and limitation of liability governing the use of the AMP PD Knowledge Platform. For example, this document states users must adhere to all applicable laws and regulations to protect the privacy of research participants’ data. By using the AMP PD Knowledge Platform, you are agreeing to abide by each of these terms and conditions.
Data Use Procedure
The following section describes the standard data operating procedure for the AMP PD Knowledge Platform. For example, it defines controlled access and non-controlled or open access data. This policy clarifies the requirements for interacting with the AMP PD Knowledge Platform Terra environment developed by the Terra platform operators. Researchers agree to abide by the Terra terms of service. This policy also addresses the requirements for using non-controlled (open access) and controlled access data on the AMP PD Knowledge Platform.
Open access data is defined as aggregate data available on the public site, or through limited queries of aggregate data on the public site. This access does not require creating an account.
Controlled access data is defined as individual level data files within the AMP PD Knowledge Platform. Controlled access requires creating an account for access, acceptance of the DUA, screening of account requests by the AMP PD data access committee and 2-factor authentication of the account requestor.
Access and Usage of the Platform
AMP PD Platform usage may be monitored, recorded, and subject to audit, and use of AMP PD indicates consent to monitoring and recording.
Unauthorized use of the AMP PD Platform is prohibited and subject to criminal and civil penalties.
User Code of Conduct
The following is the Code of Conduct that research investigators agree to abide by as a Registered User of data received through the AMP PD Knowledge Platform. Failure to abide by any term within this Code of Conduct may result in revocation of approved access to any or all datasets and tools obtained through the AMP PD Knowledge Platform. The elements of the AMP PD Knowledge Platform Code of Conduct for AMP PD Data Use include:
- Investigator(s) will make no attempt to identify or contact individual participants from whom these data were collected;
- All collaborators must sign and agree to the terms of the AMP PD Data Use Agreement. Data may not be shared with individuals who have not signed this agreement. In order to create the best platform possible for sharing and collaborating in research, including best practices for data security (*), AMP PD encourages cloud analysis and seeks to understand use cases for data downloads. Users who want to download AMP PD genomics or neuroimaging data to local servers must provide an institutional signature verifying that their host institution adopts responsibility for the security of the downloaded data. Such users will also be required to document in the Portal why they are downloading the data. Users who download data will be responsible for the download costs.
- Investigator(s) will adhere to computer security practices that ensure that only authorized individuals can gain access to data files;
- Investigator(s) acknowledge the Intellectual Property Policies as specified in the Data Use Agreement; and,
- Investigator(s) will report any inadvertent data release in accordance with the terms in the Data Use Agreement including breach of data security or other data management incidents to AMP PD ACT.
(*) Cloud processing increases security by reducing the number of copies of the data and increases collaboration by encouraging all data users to create a knowledge base within a single tool.
Oversight, Audits and Adjudication
The AMP PD ACT monitors public activities on the AMP PD Knowledge Platform through periodic audits to assess compliance with the AMP PD governance policies. For example, through these audits, the ACT verifies that public content shared on AMP PD Knowledge Platform has appropriate Conditions for Use. The ACT does not monitor activities or content placed in private projects. The ACT supports ethical use of the AMP PD Knowledge Platform, including adjudicating suspected unauthorized and/or unethical use of data. The ACT relies on the community of researchers and research participants for vigilance against unauthorized and/or unethical use of the AMP PD Knowledge Platform. Additionally, AMP PD relies on the community to hold itself to the highest standard of collegial behavior. People unable or unwilling to meet these standards will have their access to the AMP PD Knowledge Platform revoked. You should not hesitate to get in touch with the ACT (firstname.lastname@example.org ) if you have questions or suggestions about AMP PD Knowledge Platform governance, including the policies, ethics, or rules for data sharing through the AMP PD Knowledge Platform.
ACT membership includes: 1 representative from the NINDS, 1 representative from the AMP PD Platform working group knowledgeable in NIH privacy requirements, 1 non-NIH representative from the AMP PD Data Use Policies working group.
It is your responsibility to contact the AMP PD ACT (email@example.com) if:
- You suspect that data is improperly shared on the AMP PD Knowledge Platform
- You are concerned that data shared on AMP PD Knowledge Platform is improperly or incompletely de-identified
- You suspect unauthorized use of AMP PD Knowledge Platform data
Data Sharing Plan for the AMP PD Knowledge Platform
AMP PD Partners
- AMP PD partner access: All harmonized clinical data and raw and processed data from biosample analysis will be made available, following quality assessment, through the AMP PD Google Cloud environment, to all registered AMP PD partners during the beta staging of the AMP PD Knowledge Platform and new data additions.
- AMP PD working group access: During the beta staging of the AMP PD Knowledge Platform, some registered AMP PD working group members will have access to specific working group data (i.e. whole genome sequencing data, transcriptomic data, clinical data, etc.) through the AMP PD Google Cloud projects to facilitate data uploads to the cloud, data cleaning, data compression and data pipeline processing. Each AMP PD working group must develop a plan for data upload, cleaning and pipeline processing that includes a pilot phase for testing of these elements and timeline for completion, during the beta staging of the AMP PD Knowledge Platform. This plan will be approved by the AMP PD Data Working Group prior to AMP PD Google Cloud access. During beta staging of the AMP PD Knowledge Platform, AMP PD working group members may also be given access to the Terra Google Cloud computing environment to build notebooks and perform additional QC analysis of data available in the portal.
AMP PD Registered User Access (non AMP PD Partners)
- AMP PD user group access: During the beta staging within the AMP PD Knowledge Platform, the AMP PD data working group may establish specific user groups to provide feedback on the AMP PD Knowledge Platform utility, such as, but not limited to data accessibility, visualization, and Portal navigation. To enable AMP PD user feedback, temporary access to the AMP PD Google Cloud environment may be provided. Non AMP PD partners who are given advanced access to the portal may not publish independently.
- AMP PD registered user access: Following the production launch of the AMP PD Knowledge Platform, registered user access to AMP PD data (raw and processed) will be granted through electronic acceptance of the AMP PD Data Use Agreement (DUA) and verification of the email address. All registered AMP PD Knowledge Platform users must agree to follow the AMP PD Knowledge Platform Code of Conduct.
- AMP PD Data Explorer access: Following the production launch of the AMP PD Knowledge Platform, all AMP PD registered users will have access to visualize the data through the different AMP PD Data Explorers.
- AMP PD Terra access: The AMP PD Researcher Workbench is provided by the Terra platform. Use of the Terra platform is covered by the Terra Terms of Service. AMP PD Knowledge Platform Access to the AMP PD Researcher Workbench requires registering the researcher's Google account with Terra. When the user is registered in Terra a special Google Group is created for that user called a Proxy Group. A Proxy Group is specific to an individual user and contains both the user's Google address as well as one or more Google service accounts.
- AMP PD Data Explorer access: Following the production launch of the AMP PD Knowledge Platform, all AMP PD registered users will have access to visualize the data through the different AMP PD Data Explorers.
AMP PD Publication Policy
AMP PD Consortium Manuscripts – Suggested Authorship Guidelines
The overall premise of this consortium is to work together in a pre-competitive manner to speed and advance research observations. This approach requires a culture of trust and respect between all AMP PD investigators. These guidelines are designed to ensure that culture is represented within our scientific output. They are designed explicitly for manuscripts that arise from cross-consortium
efforts. Individual teams are not expected to adhere to these guidelines when publishing their own work.
AMP PD Authorship Designations:
Consortium authorship: “AMP PD consortium” will be included as an author on all manuscripts resulting from consortium-wide results. This will index an inclusive list of consortium members, with each partner designating the appropriate individuals to be included to represent their work. The AMP PD data coordinator will work with the AMP PD working groups to make an initial list of consortium members. Co-chairs from the individual working groups will be responsible for keeping their working group membership list up-to-date, as people are added to or subtracted from the working group.
Cohort authorship: Biosamples and clinical data utilized in AMP PD were derived from a number of independently funded cohort studies and as such publications utilizing either the clinical data (including imaging) and/or the biosample data derived from the use of the cohort biosample collections must acknowledge the cohort(s) based on the terms outlined in the AMP PD Data Use Agreement.
Named authorship: Individuals that directly contributed to the work described in the manuscript will be directly named as authors, as follows:
- Authors will represent all academic and industry teams that contributed data or analysis to the manuscript. Team authorship will include both researchers actively involved in the work described in the manuscript and their PI(s) or lead manager(s).
- When data were collected as part of team depositions to the AMP PD Knowledge Platform, representation will be by the bioinformatics lead(s) and PI(s) responsible for data generation and deposition, and overall PIs of the project/grant that supported data generation.
- When data were generated directly for analysis represented in the manuscript (e.g., sample swap data), the data generation team(s) will provide a list of individuals that contributed to data generation.
- All individuals that contributed active analyses to the manuscript and their PIs will be authors. Authorship will require individuals contributing analyses to also contribute to manuscript write-up by describing and interpreting their work.
- Authorship order will be determined by contribution with opportunities for multiple individuals to be represented as either first author or corresponding author.
- Where applicable, every effort will be made to promote junior or early stage investigators in lead authorship positions.
The AMP PD consortium will work together to ensure transparency in all authorship designations. Researchers interested in submitting a manuscript on behalf of AMP PD will develop the author list according to the above guidelines and will provide this author list to the AMP PD publication coordination team by submission to firstname.lastname@example.org. Consortium papers will be presented in advance to the AMP PD Steering Committee. The coordinating team will distribute the list to all AMP PD partners for review. AMP PD partners will typically be provided 2 business days to submit any concerns or amendments to the proposed author lists – though turnaround for time-sensitive items such as conference abstracts may be shorter. Disputes to authorship lists will be settled prior to manuscript submission. If the AMP PD publication coordinating team cannot resolve a dispute or has a conflict of interest, resolution will be provided by the AMP PD co-chairs.
The AMP PD publication coordination team (PCT) will consist of 1 NIH representative, 1 representative from each of the cohort studies and 1 non-NIH partner representative.
AMP PD Non-Consortium Authorship
Researchers using AMP PD data will submit manuscripts to the AMP PD PCT at email@example.com two weeks prior to planned journal submission for review of AMP PD authorship citations. Response from the AMP PD PCT will be within 2 working days of receipt of the manuscript by the AMP PD PCT members. Non-response within the 2 business day time window will correspond to concurrence of authorship information provided in the manuscript. Authors are required to notify the AMP PD PCT of acceptance or rejection of the manuscript and to provide the AMP PD PCT with the manuscript citation and, if possible, URL to article, upon acceptance.
AMP PD Registered Data User Data Access Requests
Sharing AMP PD data with the general scientific community is an objective established by the Accelerating Medicine Partnership (AMP) Executive Committee. In preparation for this level of data sharing, each of the cohort studies included in AMP PD incorporated broad data sharing language within subject consent documents.
The AMP PD Steering Committee has created and charged the AMP PD Data Use Policies working group (DUP WG) with the task of establishing policies to implement this requirement, as well as recommending procedures for dealing with acknowledgment issues. The intent of these policies is to facilitate the sharing of data with all interested investigators, to encourage academic productivity, and to provide a mechanism for tracking and archiving data requests, intended analyses and publications related to and resulting from AMP PD data.
AMP PD Data Access Committee
The AMP PD Data Access Committee will include 1 NIH representative, 1 representative from the AMP PD Data Use Policies working group and 1 non-NIH AMP PD partner representative. Any data access requests that cannot be resolved within 2 business days will be sent to the AMP PD DUP WG for resolution.
The expectation of AMP PD Steering Committee is that AMP PD de-identified data would be made available to the general scientific community within a very short timeframe.
Therefore, we recommend full, open access of all de-identified AMP PD imaging, clinical and biomarker data to individuals who register through the AMP PD Knowledge Platform and agree to the conditions in the “AMP PD Data Use Agreement” and who undergo screening by the AMP PD Data Access Committee and who agree to follow security best practices, such as enabling 2-factor authentication for the account used to access AMP PD data.
Data Request Application and Tracking
A web-based, semi-automated Data Sharing Application and Tracking system will be instituted to manage the data requests. Users will complete a web-based application form and a Data Use Agreement. When the application is received, the prospective user will be required to verify contact information through 2 factor authentication prior to data access approval. Once approved, the applicant will be given permission to access the data through the AMP PD Knowledge Platform.
Applicants will be required to provide the following information:
- Address and Contact information
- Academic Affiliation (if any) or Institution/Company Name
- Proposed analyses with a named lead investigator on each analysis
- Certification to each point of the Data Use Agreement.
Applicants will receive annual requests to update the registration information. These requests will also solicit responses to the following queries about manuscripts:
- Title of each manuscript in development
- Lead (or senior) author of each manuscript in development and contact information for that author
- Status of each manuscript in development (In development, In submission, In press/published)
- Citation of each published manuscript
- Upload a file of each published manuscript
Non-compliance with the required updates will jeopardize further access to AMP PD data.
Tracking of Data Use and Publications for Registered AMP PD Knowledge Platform users
If AMP PD data are used in publications, authors will be required to:
- Add AMP PD acknowledgment (see Data Use Agreement)
- Add AMP PD cohort(s) acknowledgment(s) if data used is derived from the cohorts represented in AMP PD (see Data Use Agreement)
- Include recommended language describing AMP PD methods and data gathering
- Cite AMP PD sponsors (see Data Use Agreement)
- Provide manuscript to AMP PD publication coordination team for review 2 weeks prior to planned submission (see Data Use Agreement)
- Apprise AMP PD publication coordination team of acceptance or rejection at firstname.lastname@example.org
- Provide manuscript citation to AMP PD publication coordination team upon acceptance at email@example.com
- Provide URL to published work, if possible.
AMP PD Data Use Agreement
I request access to data available through the AMP PD Knowledge Platform (AMP PD Data) for scientific investigation, teaching or the planning of clinical research studies and agree to the following terms:
- I acknowledge and agree that this AMP PD Data Use Agreement (Agreement or DUA) grants me permission as set forth below to use the AMP PD Knowledge Platform and data contained within and describes my obligations with respect to the AMP PD Knowledge Platform and data.
It is the policy of AMP PD to make analyzed data available to investigators as quickly as possible. Data analysis for the AMP PD Project is expected to take years as methods for data analysis evolve. Therefore, I understand that any curated data and/or results that I access might be preliminary. Finally, because “preliminary data” will be posted on the database, in the event that I download data from the AMP PD Knowledge Platform for the purposes of analysis and future publication in the form of abstracts, manuscripts, or other publications, I will (a) note in such abstracts, manuscripts, or other publications the defined version of the data used in my analysis and the date of download, (b) prior to my submission of any material for publication, do due diligence to check the AMP PD Knowledge Platform to determine if updated data is available, and (c) if the data is updated, note in such material for publication that the data has been updated in the AMP PD Knowledge Platform.
I will have access to de-identified data and will not attempt to establish the identity of, nor attempt to contact, any of the subjects included in the BioFIND Clinical Study, The Harvard Biomarker Study (HBS), Parkinson’s Progression Markers Initiative (PPMI), or the Parkinson’s Disease Biomarkers Program (PDBP) or subjects from any other studies (collectively, the “Studies”), the data from which is added to the AMP PD Knowledge Platform.
I will not attempt to directly contact the cohort Principal Investigators (PIs) or staff associated with the Studies concerning additional information regarding individual subjects, provided that, for clarity, contacts that are not specifically related to individual subjects are permitted.
I will use the AMP PD Knowledge Platform solely to access and analyze the AMP PD Data in accordance with this Agreement.
I will not disclose or use these data beyond the permitted disclosures and uses outlined in this Agreement. I will require anyone on my team who wants to utilize the AMP PD Data, or anyone with whom I will share these data to comply with this Agreement by becoming a registered user of the AMP PD Knowledge Platform and agreeing to these terms through signing of the DUA. I may disclose these data to any individuals who are registered users of the AMP PD Knowledge Platform.
I will use appropriate administrative, physical and technical safeguards to prevent use or disclosure of the data other than as provided for by this Agreement.
Upon request by the AMP PD Access and Compliance Team (AMP PD ACT), I will provide accurate information regarding persons who will use the AMP PD Data and the analyses that are planned with these data and I will respond promptly and accurately to annual requests by the AMP PD ACT to update this information.
I will comply with any rules imposed by my institution and its institutional review board, as well as any federal, state and local laws and regulations, in each case, that apply to the use of these data, provided such institutional rules do not conflict with the obligations owed by me under this Agreement.
I acknowledge that the data included in the AMP PD Knowledge Platform was generated under and is subject to an existing arrangement that has the following AMP PD Intellectual Property Policy that states: “AMP PD users agree not to file patent applications on research discoveries made using the AMP PD Data, except in the rare instance when a consensus of FNIH and the AMP PD Steering Committee and AMP PD Executive committee agree that it is in the best interests of the partnership and public health to do so. Intellectual property developed under NIH awards are subject to applicable Federal law, regulation, and NIH policy.” Accordingly, it is in the rare instance that the AMP PD Partnership, through an approval protocol, will deem that it is in the best interest of the AMP PD Partnership and the public health to grant an exception. If an exception is granted, I agree to grant the funding partners of the AMP PD Partnership a nonexclusive, worldwide, royalty-free, sublicensable license to use and/or disclose the intellectual property rights therein for noncommercial research purposes.
I understand in accessing the AMP PD Knowledge Platform I am not granted any intellectual property rights and I will not seek any right, title or interest in the clinical data, analysis results, or other intellectual property uploaded into the AMP PD Knowledge Platform that is owned by other individuals or entities without the express written consent of the individuals or entities who uploaded the information to AMP PD.
I agree, subject to Section 10 above, that all data and discoveries generated by me from analyses of AMP PD Data in the AMP PD Knowledge Platform (collectively, the “Study Materials Results”) will become and be deemed part of the public domain through the AMP PD Knowledge Platform. I will not seek intellectual property protection of the Study Materials Results and will make the Study Materials Results freely available without charge to the research community through the AMP PD Knowledge Platform.
By accessing the AMP PD Knowledge Platform, I waive any and all claims against AMP PD and its research partners with respect to my use of the AMP PD Knowledge Platform or the AMP PD Data.
If I seek to publish manuscripts incorporating AMP PD Data or Study Materials, I agree to comply with the AMP PD Publications Policy guidelines, including sending manuscripts to the AMP PD Publications Committee (PC) for administrative review prior to publication of a final manuscript.
In my manuscripts and presentations incorporating AMP PD Data or Study Materials, I will acknowledge the cohorts PPMI, BioFIND, PDBP, and HBS personnel and other cohorts who provided AMP PD Data and/or the funding of the Studies, and will include language in manuscripts similar to the following:
AMP PD Acknowledgment
"Data used in the preparation of this article were obtained from the AMP PD Knowledge Platform. For up-to-date information on the study, https://www.amp-pd.org.
“AMP PD – a public-private partnership – is managed by the FNIH and funded by Celgene, GSK, the Michael J. Fox Foundation for Parkinson’s Research, the National Institute of Neurological Disorders and Stroke, Pfizer, and Verily.
AMP PD Cohort Acknowledgments
“Clinical data and biosamples used in preparation of this article were obtained from the Michael J. Fox Foundation (MJFF) and National Institutes of Neurological Disorders and Stroke (NINDS) BioFIND study, Harvard Biomarkers Study (HBS), the NIA International Lewy Body Dementia Genetics Consortium Genome Sequencing in Lewy body dementia case-control cohort (LBD), the MJFF LRRK2 Cohort Consortium (LCC), the NINDS Parkinson's disease Biomarkers Program (PDBP), MJFF Parkinson’s Progression Marker Initiative (PPMI), and the NINDS Study of Isradipine as a Disease Modifying Agent in Subjects With Early Parkinson Disease, Phase 3 (STEADY-PD3).
“BioFIND is sponsored by The Michael J. Fox Foundation for Parkinson’s Research (MJFF) with support from the National Institute for Neurological Disorders and Stroke (NINDS). The BioFIND Investigators have not participated in reviewing the data analysis or content of the manuscript. For up-to-date information on the study, visit michaeljfox.org/biofind.”
“Genome sequence data for the Lewy body dementia case-control cohort were generated at the Intramural Research Program of the U.S. National Institutes of Health. The study was supported in part by the National Institute on Aging (program #: 1ZIAAG000935) and the National Institute of Neurological Disorders and Stroke (program #: 1ZIANS003154).”
“The Harvard NeuroDiscovery Biomarker Study (HBS) is a collaboration of HBS investigators [full list of HBS investigator found at https://www.bwhparkinsoncenter.org/biobank/ and funded through philanthropy and NIH and Non-NIH funding sources. The HBS Investigators have not participated in reviewing the data analysis or content of the manuscript.”
“The LRRK2 Cohort Consortium is coordinated and funded by The Michael J. Fox Foundation for Parkinson’s Research. Data used in preparation of this article were obtained from the MJFF-sponsored LRRK2 Cohort Consortium (LCC). The LCC Investigators have not participated in reviewing the data analysis or content of the manuscript. For up-to-date information on the study, visit https://www.michaeljfox.org/biospecimens.”
“PPMI – a public-private partnership – is funded by the Michael J. Fox Foundation for Parkinson’s Research and funding partners, including [list the full names of all of the PPMI funding partners found at www.ppmi-info.org/fundingpartners. The PPMI Investigators have not participated in reviewing the data analysis or content of the manuscript. For up-to-date information on the study, visit www.ppmi-info.org.”
“Parkinson’s Disease Biomarker Program (PDBP) consortium is supported by the National Institute of Neurological Disorders and Stroke (NINDS) at the National Institutes of Health. A full list of PDBP investigators can be found at https://pdbp.ninds.nih.gov/policy. The PDBP Investigators have not participated in reviewing the data analysis or content of the manuscript.”
“The Study of Isradipine as a Disease Modifying Agent in Subjects With Early Parkinson Disease, Phase 3 (STEADY-PD3) is funded by the National Institute of Neurological Disorders and Stroke (NINDS) at the National Institutes of Health with support from the Michael J. Fox Foundation and the Parkinson Study Group. For additional study information, visit https://clinicaltrials.gov/ct2/show/study/NCT02168842. The STEADY-PD3 investigators have not participated in reviewing the data analysis or content of the manuscript.”
“The Study of Urate Elevation in Parkinson’s Disease, Phase 3 (SURE-PD3) is funded by the National Institute of Neurological Disorders and Stroke (NINDS) at the National Institutes of Health with support from the Michael J. Fox Foundation and the Parkinson Study Group. For additional study information, visit https://clinicaltrials.gov/ct2/show/NCT02642393. The SURE-PD3 investigators have not participated in reviewing the data analysis or content of the manuscript.” “The LRRK2 Cohort Consortium (LCC) was created to assemble and study groups of people with and without Parkinson’s disease who carry mutations in the LRRK2 gene. The LRRK2 Cohort Consortium is coordinated and funded by The Michael J. Fox Foundation for Parkinson’s Research. The investigators within the LCC contributed to the design and implementation of the LCC and/or provided data and/or collected biospecimens, but did not necessarily participate in the analysis or writing of this report. The full list of LCC investigators can be found at www.michaeljfox.org/lccinvestigators.”
16. I will provide either (i) a copy of the manuscript upon its acceptance for publication or (2) the full citation of all published manuscripts to the AMP PD Publications Committee. Citations will be listed on the AMP PD website and available to the public through PubMed.
17. I ACKNOWLEDGE AND AGREE THAT THE DATA IS PROVIDED AS IS AND NO WARRANTIES, EXPRESS OR IMPLIED, ARE OFFERED AS TO THE MERCHANTABILITY OR FITNESS FOR ANY PURPOSE OF THE DATA PROVIDED UNDER THIS AGREEMENT. THERE ARE NO WARRANTIES OR
AMP PD Data Transfer Agreement
THIS DATA TRANSFER AGREEMENT (the “Agreement'') is made and entered into as of the ____ day of _________, 201_ (the “Effective Date”), by and between _________________, a [State & company type], located at ____________________ (“Provider”) and the National Institute of Neurological Disorders and Stroke on behalf of the Accelerating Medicine Partnership in Parkinson’s Disease (AMP PD) (“Recipient”). Collectively, Provider and Recipient shall be referred to as “Parties” and individually as a “Party”. WHEREAS, Accelerating Medicines Partnership (“AMP”) is a public-private partnership between the National Institutes of Health (“NIH”), the U.S. Food and Drug Administration (“FDA”), 10 biopharmaceutical companies and multiple non-profit organizations aiming to transform the current model for developing new diagnostics and treatments by jointly identifying and validating promising biological targets for therapeutics with the ultimate goal of increasing the number of new diagnostics and therapies for patients and reducing the time and cost of developing them; and
WHEREAS, Recipient will collect and process data related to AMP PD clinical, genetic and biosample analysis and
WHEREAS, Provider has agreed to provide certain de-identified human genetic, clinical and biomarker data (“Data”) to Recipient in order to further the mission of the AMP PD; and
WHEREAS, Recipient will make the raw and processed data derived from genetic, clinical and biomarker analyses of the Data available through a web-based Portal (“AMP PD Knowledge Platform ”) to other members of the AMP PD as well as shared with the broader biomedical research community (the “Purpose”);
NOW THEREFORE, it is mutually agreed as follows:
- Provider agrees to transfer the Data described in Exhibit A for use in the AMP PD.
- Provider represents that the Data will be de-identified and all Protected Health Information, as defined by the Federal Health Insurance Portability and Accountability Act (HIPAA, 45 C.F.R. 164) (“HIPAA”) will have been removed prior to sending the Data to Recipient. Notwithstanding the foregoing, if Recipient believes it has received identifiable patient information hereunder, it will hold such information in strict confidence indefinitely, immediately inform Provider and comply with Provider’s instruction at Provider’s expense, with respect to return or destruction of the same.
- Recipient agrees to retain control over Data received from Provider and further agrees not to provide the Data, with or without charge, to any other entity or any individual other than registered AMP PD Knowledge Platform users. Nothing in this Agreement shall preclude the Provider from transferring its solely owned Data to other third parties for commercial or research purposes.
- Recipient shall use reasonable technical, administrative, and physical safeguards to protect the Data from unauthorized access, use, or transmission. Recipient shall promptly (in no event less than one (1) business day) notify Provider if any Data is accessed, used, or transmitted in an unauthorized manner.
- Recipient shall use appropriate technical and organizational security measures to protect the Data against unauthorized or unlawful processing and against accidental loss, destruction, damage, alteration or disclosure, by (i) ensuring a level of security appropriate to the harm that may result from such unauthorized or unlawful processing or accidental loss, destruction, damage, alteration or disclosure, and appropriate to the nature of such Data, (ii) regularly testing such measures to validate appropriateness and effectiveness, and (iii) implementing corrective action where deficiencies are revealed by such testing.
- Recipient shall comply with all applicable laws, rules, and regulations related to the use of such Data, including but not limited to HIPAA.
- This Agreement is not transferable to another facility that is not under the control of Recipient.
- No option, license, or conveyance of rights, express or implied, is granted by Provider to Recipient in connection with the Data provided under this Agreement, except the right to use the Data strictly in accordance with the terms of this Agreement.
- No rights of Recipient under this Agreement may be assigned or otherwise conveyed to any party, including a purchaser of Recipient, without the specific written agreement of Provider.
- Provider acknowledges that Recipient shall make Data available to users through the AMP PD Knowledge Platform. Recipient agrees that Provider shall have access to the Data through AMP PD Knowledge Platform, at no charge, for its research, education and publication purposes.
- Recipient agrees to implement a policy, as further detailed in , which will require users of the AMP PD Knowledge Platform to appropriately cite data acquired from the AMP PD Knowledge Platform in their publications.
- Recipient agrees that it will not use the Data to establish the individual identities of any of the subjects from whom Data were obtained.
- NO WARRANTIES, EXPRESS OR IMPLIED, ARE OFFERED AS TO THE MERCHANT ABILITY OR FITNESS FOR ANY PURPOSE OF THE DATA PROVIDED UNDER THIS AGREEMENT. THERE ARE NO WARRANTIES OR REPRESENTATIONS AS TO THE PURITY, ACCURACY, SAFETY OR USEFULNESS OF THE DATA OR THAT THE USE OF THE DATA WILL NOT INFRINGE ANY PATENT OR OTHER PROPRIETARY RIGHT.Provider certifies and Recipient acknowledges that the conditions for use of Data are approved by the Institutional Review Board (IRB) of the Provider in accordance with Department of Health and Human Services regulations at 45 CFR Part 46. Recipient agrees to comply fully with all such conditions with respect to making the Aggregate Data available to the broader scientific community. Recipient remains subject to applicable laws or regulations and institutional policies which provide additional protections for human subjects.
- Recipient agrees to use the Data solely for the Purpose and the terms of this Agreement.
- Provider may terminate this Agreement if Recipient is in breach of this Agreement and if such breach has not been cured within thirty (30) days after the date of written notice by Provider of such breach. Upon termination of this Agreement, Recipient agrees to return all Data to Provider, or provide Provider with written certification of destruction of the Data, at the election of Provider.
- Failure to comply with any of the terms specified herein may result in disqualification of Recipient from receiving additional Data from Provider.
- The parties will comply with all applicable international, national, state, regional and local laws and regulations, including all applicable import and export control laws, in exercising their rights or performing their duties under this Agreement.
I understand that failure to abide by these guidelines may result in termination of my privileges to access the AMP PD Knowledge Platform.
[Investigators will be asked to sign this agreement electronically at https://www.amp-pd.org]
IN WITNESS WHEREOF, the Parties hereto have duly executed this Agreement as of the Effective Date by their authorized representatives.
THE NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE ON BEHALF OF THE ACCELERATING MEDICINE PARTNERSHIP IN PARKINSON’S DISEASE