Policy Title: Research Data Management Policy
Research Policy Owner: Policy Office
Approved by: President Effective
Date: December 22, 2023
RELATED DOCUMENTS
Research Integrity Policy, Moroccan Law 09-08 on Protection of Personal Data.
SECTION 1 POLICY STATEMENT
1.1. University Mohammed VI Polytechnic (UM6P) researchers, faculty, collaborators, staff, trainees, and students as well as any other person related to UM6P are obliged to retain research data in appropriate form, archive it for a reasonable length of time, and make it available for collaborative research and for review under the appropriate circumstances.
1.2. UM6P and its respective affiliated entities have the right to collect, store, share and properly dispose of all study-related documents for each research study in a manner and timeframe compliant with university, international, and sponsor requirements and best practices.
1.3. UM6P encourages Responsible Open Access, meaning that research data should be made accessible to the research community if appropriate and possible.
SECTION 2 SCOPE AND APPLICABILITY
2.1. This policy document applies to faculty, staff, students, trainees, and other individuals engaged in scientific and scholarly activities at UM6P.
2.2. It also applies to all research data regardless of whether the research is funded or unfunded.
SECTION 3 PURPOSE
3.1 Research Data Management is part of the research process. This policy provides guidelines and provisions that seek to optimize the efficiency, quality, value, and integrity of research. It describes the basis of data ownership and the standards for the collection and retention of data, in addition to requirements for data access.
SECTION 4 DEFINITIONS
The following definition(s) apply to this policy document:
4.1. Research: Any systematic investigation, including research development, testing, reporting, study, evaluation, demonstration, or survey designed to develop or contribute to generalizable knowledge or specific knowledge by establishing, discovering, developing, elucidating, or confirming information about, or the underlying mechanism relating to the matters to be studied. The term encompasses basic research, applied research, and research training activities.
4.2. Research Data: Information recorded for the purpose of a research study, regardless of form or the media on which it may be recorded, whether physical or digital. For the purposes of this policy document, Research Data are further defined as including any records that would be used for the reconstruction and evaluation of reported or otherwise published results. Research Data may include materials such as unmodified biological specimens and environmental samples. Research Data differ among disciplines. Examples of Research Data and Materials include laboratory and other notebooks, notes of any type, photographs, films, digital images, original biological and environmental samples, protocols, numbers, graphs, charts, numerical raw experimental results, instrumental outputs from which research data can be derived, case report forms, patient charts, and other source documentation for human research studies. Personal and private data that may be needed for any research project shall be submitted to appropriate authorization by duly authorized authorities in accordance with applicable laws.
4.3. Research Results: Data, material, models, drawings, plans, software, inventions, discoveries, and information resulting from a research project or the provision of services. Without limiting the scope of the above, the term Research Results also refers to results which are patentable and those which are not patentable.
4.4. Principal Investigator (PI): The lead researcher and primary point of contact for a research project. The PI is responsible for the overall design, execution, and management of the research, as well as the interpretation and communication of the results. The PI is often the individual or senior researcher who conceptualizes the project, secures funding, assembles a research team, and oversees the progress and outcomes of the study.
4.5. Research Data Management (RDM): RDM concerns the organization, storage, preservation, and access of data collected and used in a research project.
4.6. Research Data Management Plan (RDMP): An RDMP is a document that describes how researchers will collect, manage, and share project research data and records during and after a research project according to the applied legal obligations.
4.7. Metadata: is structured information that describes, explains, locates, or otherwise makes it easier to retrieve, use, or manage an information resource. Metadata is often called data about data or information about information.” It ensures that the context for how your data was created, analyzed, and stored, is clear, detailed and therefore, reproducible.
SECTION 5 PROVISIONS AND GUIDELINES
General Provisions
5.1. University Mohammed VI Polytechnic (UM6P) requires that research data and records be retained in sufficient detail and for an adequate period to enable appropriate responses to questions about accuracy, authenticity, primacy, and compliance with laws and regulations governing the responsible conduct of research. Research records must be stored in a manner that ensures confidentiality, security, and accessibility.
5.2. The Principal Investigator (PI) is accountable for filing, storing, sharing, and properly disposing of all study-related documents for each research study as required by law and university policy. The Pl may delegate the task of maintaining accurate and complete records to another qualified study team member, but they may not delegate accountability. Access to research records must be controlled to prevent unauthorized use, disclosure, removal, or destruction records. An orderly system of data organization should be adopted and clearly communicated to all members of the research group and to the appropriate administrative personnel, where applicable. Particularly for long-term projects, the PI should establish and maintain procedures for the protection of essential records.
5.3. The collection of personal and private data for a research project must be approved by duly authorized authorities (La Commission Nationale de Contrôle de la Protection des Données Personnelles (CNDP)) prior to the collection of such data in accordance (also see Human Subjects Research policy).
Ownership and Responsibilities
5.4. Unless superseded by specific terms of sponsorship and contractual agreement, the university owns all research data developed or acquired by the faculty, fellows, students, and employees of UM6P through research projects conducted at or under the auspices of the university regardless of funding source. Although the university, as owner of the research data, must meet the requirements of sponsors for custodians of research data, Principal Investigators and other researchers are stewards of research data, and shall retain the principal responsibility, and are accountable, for custody of the data.
Access to Research
5.5. Research data are to be accessible to members of the UM6P community, external collaborators, and others as appropriate (e.g., patent applications or journal submissions). The Principal Investigator has primary responsibility for oversight and access to the research data generated by the project. Any other faculty, staff, student, or person involved in the creation of research data may have the right to review that portion of the research data that he or she created. The university will have access to the research data as necessary for technology transfer, compliance, and other purposes. The university also has the option to take custody of the research data as determined by the appropriate institutional official. Such option will not be invoked without cause and subsequent notification of the Principal Investigator. In some instances, a research sponsor has a legal right of access or access may be requested through the sponsoring agency. Requests for data access will be coordinated through the Research Management Office.
5.6. In cases of multi-institutional studies, the institution of the primary study director shall be responsible for arranging appropriate access to, use of, and retention of research data unless otherwise specified in the terms of the particular study.
5.7. When necessary to assure needed and appropriate access (e.g., research misconduct investigations), the university may take custody of research data in a manner specified by the Research Integrity Policy.
Research Data Management Plans (RDMP)
5.8. A Research Data Management Plan (RDMP) is an important part of good research data management. The RDMP should be created at the start of a project, ideally at the proposal level. The RDMP should be written in a way that enables the researcher(s) to plan and structure research data from the beginning. It should be a living document and be kept up to date throughout the research project. All partners in a collaborative research project should contribute to the development of the RDMP. The RDMP should describe how data will be collected, managed, and shared. It should include the following:
5.8.1 The types and formats of data that will be collected, processed and/or generated;
5.8.2 The methodology and standards that will be applied;
5.8.3. The documentation and metadata that will accompany the data.
5.8.4. A plan for the management of any ethical, compliance and legal consideration such as safeguarding the privacy and confidentiality of personal data (generally, one should follow the EU General Data Protection Regulation (GDPR) and Law 09-08 on the protection of personal data for Moroccan data). Furthermore, any communication of data shall be made in accordance with the principle of data sovereignty applicable to Moroccan territory.
5.8.5. Management of intellectual property and copyright aspects affecting data ownership;
5.8.6. Plans for storage and backup of data, including virtual and physical);
5.8.7. A statement regarding access, sharing and security of data; and
5.8.8. A statement of how data will be curated and preserved, including beyond the end of the project.
5.9.Generally, unless otherwise specified in a collaborative research agreement, research data is owned by UM6P. This ownership may be shared as appropriate.
Data Retention
5.10. It is the responsibility of the Pl to preserve, where feasible, all research data generated at the university for a minimum period of five (5) years from the date of the last publication or the date of the final report issued upon completion of the project, whichever is later, unless the law or another norm says otherwise. A detailed list of record retention requirements is presented in the Addendum to this policy document. In addition, any of the following circumstances may justify longer periods of retention:
5.10.1. Research data must be kept for as long as may be necessary to protect any intellectual property resulting from the work.
5.10.2. If litigation or other dispute resolution, claim, financial management review or audit related to the research project is started before the expiration of the five year period, or commenced after the five year period, the research data and other project records must be retained until all litigation/dispute resolution, claims, financial management review or audit findings involving the records have been resolved and final action taken.
5.10.3. If any charges regarding the research arise, e.g., an allegation of research misconduct, research data must be retained in a manner consistent with the Research Integrity Policy, or as otherwise instructed by the Research Management Office or Legal Services.
5.10.4 If a student or trainee is involved in research, that research data must be retained at least until the degree is awarded to the student, the training is complete, or it is clear that the student has abandoned the work.
5.10.5. When research is funded by an award or contract that includes specific provisions regarding ownership, retention of and access to technical data, the provisions of that agreement will supersede this policy.
5.11. Beyond the period of retention specified herein, the destruction or permanent de-identification of research data is at the discretion of the PI. Destruction of research data must follow applicable regulations, sponsor requirements and other applicable guidelines.
5.12. Research data will normally be retained by the unit/department where they were produced, in accordance with university practices for the secure storage of information.
University Responsibilities
5.13. The university’s responsibilities with respect to research data include, but are not limited to:
5.13.1. Ensuring that a research data management platform is available for the storage of research data;
5.13.2. Complying with the terms of sponsored agreements;
5.13.3. Ensuring the appropriate use of project resources (e.g., animals, human subjects, recombinant DNA, biological agents, radioactive materials, etc.);
5.13.4. Protecting the rights of researchers, including but not limited to their right of access to data from research in which they participated; and
5.13.5. Maintaining confidentiality of research data, where appropriate and as may be required pursuant to the terms of an applicable sponsored agreement.
Researcher Responsibility
5.14. UM6P faculty, staff and students engaged in research shall keep clear, accurate and complete records of all research data and definitions.
5.15. The researchers shall ensure that data is stored securely to protect against theft, misuse, damage, or loss. The university shall ensure that a research data management platform is available for the storage of research data.
5.16. Research data should be shared responsibly, when appropriate.
5.16.1 ata sharing may not be possible due to contractual constraints with a sponsor or due to confidentiality reasons. In such cases, the signed agreement shall govern the sharing of data.
5.17. It is the responsibility of the principal investigator to ensure that confidentiality is maintained when the data includes information related to human subjects.
5.18. The research shall disseminate research findings responsibly and accurately. The research must not change or remove data without explicit and proper justification. The research is to be clear about uncertainties, contradictions, and limitations.
The Principal Investigator’s Responsibilities
5.19. The PI’s responsibilities with respect to research data include, but are not limited to:
5.19.1 Developing a research data management plan, ensuring its updates as needed, and overseeing its implementation through the entire research lifecycle.
5.19.2 Ensuring proper management and retention of data in accordance with this policy;
5.19.3 Establishing and maintaining appropriate procedures for the protection of research data and other essential records, particularly for long-term research projects;
5.19.4 Ensuring compliance with sponsor program requirements;
5.19.5 Maintaining confidentiality of research data, where appropriate and as may be required pursuant to the terms of an applicable sponsored agreement; and
5.19.6 Complying with applicable national laws and regulations.
Researcher Leaving the University
5.20. When the PI of a research project leaves the employment of UM6P and the research project will no longer be conducted at the university, instead moved to another institution, ownership of the original data may be eligible for transfer to the PI’s new institution. Upon request from the PI, a legal agreement on the disposition of research data must be negotiated between the Pl and their head of department, in consultation with the Research Management Office, concerning possession of research data, notebooks, and other data retention materials and unique resources to be transferred to the departing investigator. If the departing faculty member is the head of department, he or she will work directly with the Research Management Office. To fulfill obligations to funding sources and others, such agreements may provide for UM6P to retain copies of the research data, where feasible.
5.21. If research data must remain at the university, as mandated by the university, by law, or as required by the funding agency or commercial sponsor or other applicable policies, the PI will have the right to access and, where practical, copy such research data produced by him/her subject to any restrictions set forth in a sponsored agreement.
5.22. Upon the death of a PI, the head of department shall appoint a researcher to assume stewardship of the research data.
5.23. When individuals other than the PI, such as collaborating investigators, fellows, students, or other trainees, leave the university, they may take copies of research data for projects on which they have worked or have the right to reasonable access to such data, subject to relevant confidentiality restrictions and/or restrictions set forth in a sponsored agreement.
Research Data Ownership Dispute Resolution
5.24. In general, data ownership issues and related matters should be freely discussed and decided upon early during the research process. Disagreements between or among researchers should be resolved in a collegial manner.
5.25.When matters of data ownership cannot be resolved in a satisfactory manner the principal investigator should present the controversy in writing to the head of department. The head of department should meet with the individuals involved in the dispute, collect, and retain appropriate information, and make a recommendation in writing. When the data ownership dispute involves the chair, or if the dispute involves more than one department, then a neutral mediator will be appointed by the president (or designee).
5.26. If a dispute between investigators from multiple research centers arises, the solution to the dispute should arise from within the organizational structure of the multi-center study. If a dispute cannot be resolved, the principle of academic freedom generally indicates that an investigator has the right to present those data for which he/she is contract custodian. However, this right should be tempered by the concept of collegial collaboration.
5.27. If a satisfactory resolution is not achieved by the head of department or by a neutral mediator, then the president (or designee) will appoint three senior faculty members to investigate the dispute. The review group will not include individuals with personal responsibility for the research but should include faculty members with unique qualifications relative to the dispute in question (i.e., research expertise, training of graduate students, experience with clinical trials, active peer-reviewed research, etc.). In addition, the Research Integrity Officer will serve as an ad hoc member. The committee will make a recommendation to the president.
5.28. The president of UM6P has final responsibility for oversight of, and resolution of, disputes. The decision of the president is final.
SECTION 6 RESPONSIBILITIES
6.1 The university is responsible for providing all necessary facilities to ensure that research data can be stored, managed, and archived.
6.2 The Research Management Office is responsible for ensuring compliance with all regulations relevant to data management.
6.3 Head of the department and/or any other responsible for research staff and students should ensure that researchers in their areas are aware of the research data management policy and its associated guidelines and procedures.
SECTION 7 REVIEW AND MONITORING STATEMENT
7.1 This policy document is reviewed once every four (4) years, or more frequently when requested by the president or subsequent to published changes to national regulations or accreditation requirements.
Record Retention Schedule
The Record Retention Schedule is a guideline that sets forth the length of time research records should be retained. This guideline applies to all records listed on the schedule to the extent they are maintained by the university, including storage areas. The schedule is intended to cover records for which there is a legal, regulatory or management retention requirement.
The records retention schedule applies to records in the inactive phase of their life cycle. The inactive phase of a record begins at the conclusion of an ongoing matter, such as completion of research pursuant to a grant. Unless otherwise specified, the retention period set forth in the schedule begins at this point in time.
RESEARCH RECORDS | |
Research Grant Proposals, including tenders | 5 years after the submission; if funded; 7 years after the project end date |
Research Awards (grants, contracts, etc) | 5 years after the project end date |
Material transfer / Data transfer agreements | 25 years after expiry of agreement |
Consultancy Agreements | 25 years after expiry of agreement |
Progress reports to sponsors | 5 years after the project end date |
Final reports to sponsors | 5 years after the project end date |
Primary research data | 5 years after the project end date |
Research Ethics Committee (Human and Animal) Records | 5 years after the project end date |
Invention Disclosures where no patent is filed | 25 years |
Patent Filings and associated invention disclosure | 25 years after expiry of the patent, SPC or other similar extension |
Trade Mark | 25 years after mark has been abandoned |
Licensing Agreements | 25 years after all rights / obligations are extinguished |
Assignment Agreements | 25 years after all rights are extinguished |