Table 1. A summary of the types of data and data sharing in the KEMRI Wellcome Trust programme Data type How collected Custodianship Data sharing Collected by MoH in Kenya and other Custodianship is held by relevant MoH. Programme researchers may not consider parts of Africa [e.g. Malaria Public Programme researchers are recipients of requests for data sharing unless described Health department’s use of malaria data the terms of a Data Transfer in the DTA/MOU. This restriction applies to indicator data from Malaria Control Agreement (DTA) or Memorandum of requests from other researchers within the Programmes] Understanding (MOU). Programme who were not party to the ROUTINE original DTA. CLINICAL/ Collected by programme researchers Custodianship is held by the relevant Requests for data sharing should be HEALTH DATA or MoH in Kenya or other parts of MoH. Programme researchers’ use of approved by the relevant MoH, including: i) Africa, including through collaborations data is governed by a Memorandum of Applications from researchers within the between these parties [e.g. DPHR Understanding (MOU) or DTA developed Programme for uses not described in the collection of clinical data in to support the collaboration. MoU/DTA; ii) Applications from researchers collaboration with Kenyan MoH] external to the Programme. Data collected by programme Custodianship is held by the Programme, Requests for data sharing should be made researchers under KEMRI SSC/ERC devolved to the study PI while working in to the PI while they hold custodianship9. STUDY approved proposals; including in the Programme. The PI can opt to include the DGC in SPECIFIC collaboration with other research access decisions, including to meet funding DATA institutions. or publishing requirements. KILIFI Integrated data archive comprising: i) Custodianship is jointly held by the For internal requests, those covered by an INTEGRATED Routine and study specific clinical data Programme and Kilifi MoH, under terms of SSC proposal are released through an DATA collected at KCH and surrounding informed consent for its collection, unless automated audited system. Other routine MANAGEMENT health facilities; and ii) Data collected specified otherwise. internal requests are released after DGC SYSTEM under KHDSS to support public health review. Non-routine internal or external (KIDMS) and research systems. requests are reviewed by DGC & CSC and may be referred to SSC where a new proposal/external review is recommended.
Table 1. A summary of the types of data and data sharing in the KEMRI Wellcome Trust programme Data type How collected Custodianship Data sharing ROUTINE CLINICAL/ HEALTH DATA Collected by MoH in Kenya and other parts of Africa [e.g. Malaria Public Health department’s use of malaria indicator data from Malaria Control Programmes] Custodianship is held by relevant MoH. Programme researchers are recipients of data the terms of a Data Transfer Agreement (DTA) or Memorandum of Understanding (MOU). Programme researchers may not consider requests for data sharing unless described in the DTA/MOU. This restriction applies to requests from other researchers within the Programme who were not party to the original DTA. Collected by programme researchers or MoH in Kenya or other parts of Africa, including through collaborations between these parties [e.g. DPHR collection of clinical data in collaboration with Kenyan MoH] Custodianship is held by the relevant MoH. Programme researchers’ use of data is governed by a Memorandum of Understanding (MOU) or DTA developed to support the collaboration. Requests for data sharing should be approved by the relevant MoH, including: i) Applications from researchers within the Programme for uses not described in the MoU/DTA; ii) Applications from researchers external to the Programme. STUDY SPECIFIC DATA Data collected by programme researchers under KEMRI SSC/ERC approved proposals; including in collaboration with other research institutions. Custodianship is held by the Programme, devolved to the study PI while working in the Programme. Requests for data sharing should be made to the PI while they hold custodianship9. The PI can opt to include the DGC in access decisions, including to meet funding or publishing requirements. KILIFI INTEGRATED DATA MANAGEMENT SYSTEM (KIDMS) Integrated data archive comprising: i) Routine and study specific clinical data collected at KCH and surrounding health facilities; and ii) Data collected under KHDSS to support public health and research systems. Custodianship is jointly held by the Programme and Kilifi MoH, under terms of informed consent for its collection, unless specified otherwise. For internal requests, those covered by an SSC proposal are released through an automated audited system. Other routine internal requests are released after DGC review. Non-routine internal or external requests are reviewed by DGC & CSC and may be referred to SSC where a new proposal/external review is recommended.
Data-Sharing-guidelines-KIDMS.docx