ORIENT study

Data access committee for the ORIENT study data

Access to ORIENT Project Data will be granted to qualified researchers for approved use and will be governed by the provisions laid out in the associated informed consent of individual data subjects for the ORIENT cohort and/or of the associated ethics committee approval of the ORIENT cohort, and the Data Access Procedure set forth below. A qualified researcher refers to a senior investigator who is employed or legitimately affiliated with an academic, non-profit or government institution and who has a track record in the field. Access to Project Data is available by application to the ORIENT Data Access Committee. Researchers granted access to Project Data must feedback the results of their research to the Committee, after publication in accordance with the ORIENT publication policy set forth in the UMCG Data Access Agreement. Access is conditional upon availability of Project Data and on the signed agreement by the researcher(s) and the responsible employing institution to abide by the policies and conditions related to publication, data ownership, data return, intellectual property rights, data disposal, ethical approval, confidentiality and commercialization referred herein. Applications for access to Project Data must be made to the ORIENT Data Access Committee (hereafter referred to as “DAC”). Data Access Procedure: 1. Application for Access The handling of applications, the issue of Project Data and any associated operations, administration and audits will be performed by the University Medical Center Groningen (hereafter “UMCG”). Applications for access to Project Data must be submitted using the Application Form for Access to ORIENT Data, which can be provided upon request. The information disclosed in the application will be treated as confidential and will only be disclosed to the persons evaluating the application. All incoming applications will be documented, including any conjunct agreements with the applicants. Unless explicitly consented for by the applicant, this information will not be used for purposes other than evaluation of the application. In cases where an application contains classified plans, know-how or trade secrets, the applicant may request the conclusion of a separate confidentiality agreement. 2. Multiple applications Applicants agree to use the Project Data for the approved purpose and project described in the application; use of the Project Data for a new purpose or project will require a new application and approval. The DAC will consider applications that include named collaborators, but each institution must sign a separate Data Access Agreement. In the event an applicant wishes to share the Project Data with additional collaborators not previously approved, these additional collaborators must make a separate application for access to the Project Data. In the event two or more applications overlap, the DAC may propose the respective applicants to align their applications. 3. Assessment criteria Applications, which seek to reserve Project Data for unspecified research goals, will not be taken into consideration. Applications for access to Project Data must be Specific, Measurable, Attainable, Resourced and Timely (SMART). Specifically, the DAC will assess each application to determine whether: i. it has been submitted by a qualified researcher or researchers, who is/are employed by or legitimately affiliated with a recognized research institution that can provide institutional responsibility for appropriate research governance; ii. its proposed use of the Project Data is in accordance with and meets the objectives of the Project and the objectives of the associated cohorts and collections; iii. its proposed use of the Project Data constitutes research in the context of the individual sample donor consent process, and is likely to be understood as such by the individual sample donors; iv. it would breach any of the ethical permissions or restrictions in the consent forms for any component cohort; v. all required ethico-legal approvals, restrictions and commitments for the proposed use of the Project Data have been obtained and adhered to; vi. the proposed research has any adverse potential impact, specifically whether the proposed research could affect minorities; vii. the nature of the funding of the application and the applicant; viii. the research proposal has been peer-reviewed and, if not, whether the proposal satisfies applicable scientific standards; ix. the requested Project Data are, quantitatively and qualitatively, suitable and not excessive for the applicant’s proposed research; x. there are any similar applications pending or granted; xi. the proposed use of the Project Data has the potential to produce information that will enable identification of the individual sample donors. xii. the applicant has warranted that he/she has obtained all required ethico-legal approvals, restrictions and commitments, without limitation his/her data subject informed consent and the approval of his/her pertinent medical ethical review board, for his/her proposed use of his/her data in combination with the Project Data. 4. Access decision The DAC will decide on an application within a reasonable period of time after it has received all pertinent information. If the DAC grants an application, additional agreements may be made regarding authorships along the lines set forth in the Publication Policy attached to the Data Access Agreement, available upon request. Rejections of applications will be motivated. Mode of Access to Data; restrictions and authentication The UMCG will make the anonymized Project Data available by means of either secure download from the data SFTP server, or courier transfer by encrypted portable hard-drive (costs for the receiving party) or a custom method agreed upon by both parties. Issue of Project Data may be subject to restrictions pursuant to data subject’s or ethics committee’s consent. Prior to issue of Project Data applicants will be subject to authentication. The issue of Project Data and the Data Access Agreement will be administered by UMCG. Data Access Conditions Access to Project Data is conditional on prior receipt by the Consortium of the Data Access Agreement attached as Appendix 2 hereto, signed and dated by the applicant(s) and the responsible employing Institution(s).