APCA Standard Data Sharing and Use Agreement (C-POS)

1. PARTIES TO THE AGREEMENT

This Data Sharing and Use Agreement ("Agreement") is entered into on the date of the last signature between:

Provider
African Palliative Care Association (APCA)
Plot 95 Dr. Gibbons Road
Makindye, Kampala, Uganda
Email: research@africanpalliativecare.org
Represented by: Dr. Eve Namisango
Title: Executive Director

AND

User Institution
Institution: [To be filled]
Address: [To be filled]
Principal Investigator / Programme Lead: [To be filled]
Email: [To be filled]
Telephone: [To be filled]

2. BACKGROUND

The African Palliative Care Association (APCA) is committed to strengthening palliative care research, clinical practice and programme implementation across Africa through the promotion of standardized, high-quality outcome measures.

The Children's Palliative Care Outcome Scale (C-POS) is a validated outcome measure developed to assess symptoms, concerns and quality of life among children receiving palliative care and their families.

APCA serves as the regional custodian and authorized distributor of the Children's Palliative Care Outcome Scale and seeks to promote responsible use of the instrument while facilitating collaborative learning through ethical sharing of anonymised datasets generated from its use.

The User wishes to use the Children's Palliative Care Outcome Scale for research, programme evaluation, quality improvement or clinical practice under the terms of this Agreement.

3. PURPOSE

The purpose of this Agreement is to:

• regulate access to and use of the Children's Palliative Care Outcome Scale;
• protect the intellectual property associated with the instrument;
• ensure ethical collection, management and protection of data;
• facilitate sharing of anonymised datasets with APCA for pooled analyses, validation studies and shared learning; and
• promote responsible publication and dissemination of findings.

4. DEFINITIONS

For purposes of this Agreement:

• Instrument means the Children's Palliative Care Outcome Scale (C-POS), including all approved versions, translations, manuals, scoring guides and supporting documentation.
• Data means all information collected using the Instrument.
• Anonymised Data means data from which all direct and indirect identifiers have been permanently removed so that individual participants cannot reasonably be identified.
• User means the institution and individuals authorized to use the Instrument under this Agreement.
• Provider means the African Palliative Care Association (APCA).

5. OWNERSHIP OF THE INSTRUMENT

The Children's Palliative Care Outcome Scale and all associated manuals, guidance documents, translations, scoring systems and supporting materials remain the intellectual property of APCA and/or its licensors.

Nothing in this Agreement transfers ownership of the Instrument to the User.

The User is granted a non-exclusive, non-transferable, non-commercial licence to use the Instrument solely for the purposes approved under this Agreement.

6. PERMITTED USE

The User is granted a non-exclusive, non-transferable and non-commercial right to use the Children's Palliative Care Outcome Scale solely for the following purposes:

• research;
• programme monitoring and evaluation;
• routine clinical care;
• quality improvement;
• service evaluation; and
• education and academic training

The Instrument shall not be used for commercial purposes, modified, reproduced, sublicensed or distributed to any third party without the prior written approval of APCA.

7. USER RESPONSIBILITIES

The User agrees to:

• obtain all required ethical and regulatory approvals before using the Instrument;
• comply with national laws and applicable data protection legislation;
• obtain informed consent where required;
• ensure participant confidentiality;
• use only the official version supplied by APCA;
• ensure that only authorized personnel access the Instrument;
• maintain accurate records relating to use of the Instrument.

8. DATA COLLECTION AND MANAGEMENT

The User shall ensure that:

• data are collected according to approved protocols;
• participant confidentiality is maintained at all times;
• identifiers are stored separately from research datasets;
• appropriate technical and organizational safeguards are implemented to protect study data;
• all electronic data are password protected and encrypted where feasible.

9. DATA SHARING WITH APCA

As a condition of using the Children's Palliative Care Outcome Scale, the User agrees to share with APCA an anonymised dataset generated through use of the Instrument.

The shared dataset shall:

• contain no direct or indirect participant identifiers;
• include a data dictionary or codebook where applicable;
• include information on the country, setting, language version and population studied;
• be transferred using secure methods approved by APCA.

The dataset should normally be submitted within six (6) months of completion of data collection, project completion or publication, whichever occurs first.

Where participant consent or national regulations restrict data sharing, the User shall notify APCA in writing.

10. USE OF SHARED DATA BY APCA

APCA shall use anonymised datasets shared under this Agreement solely for legitimate scientific, educational and programmatic purposes aimed at advancing children's palliative care. Such purposes may include:

• improving and refining the Children's Palliative Care Outcome Scale;
• validating translated and culturally adapted versions of the Instrument;
• conducting pooled analyses and multicountry research;
• establishing regional and global benchmarks for children's palliative care outcomes;
• strengthening the evidence base for children's palliative care;
• developing reports, policy briefs, educational materials and training resources;
• supporting quality improvement initiatives and programme evaluation; and
• informing future research, policy and practice in children's palliative care.

APCA shall maintain the confidentiality of all shared datasets and shall implement appropriate administrative, technical and organizational safeguards to protect the data from unauthorized access, disclosure, alteration or misuse.

APCA shall not attempt to identify or re-identify individual participants or institutions from anonymised datasets, nor shall it use the shared data for commercial purposes without the prior written consent of the User and any additional approvals required by applicable laws or regulations.

Where APCA intends to undertake collaborative analyses or publications using shared datasets, the contributing User(s) may be invited to participate in accordance with internationally accepted authorship and publication guidelines. Nothing in this Agreement shall be construed as transferring ownership of the original study data from the User to APCA.

11. CONFIDENTIALITY

The Parties shall maintain the confidentiality of all non-public, proprietary and confidential information exchanged under this Agreement, including the Children's Palliative Care Outcome Scale, supporting materials, shared datasets and any other information designated as confidential.

The User shall ensure that all research data collected through the use of the Instrument are handled in a manner that protects the privacy and confidentiality of research participants and complies with applicable ethical approvals, institutional policies, national laws and data protection regulations.

Confidential information shall not be disclosed, shared or made available to any third party without the prior written consent of the disclosing Party, except where disclosure is required by law, regulatory authorities, ethical oversight bodies or a valid court order.

The Parties shall ensure that access to confidential information is limited to authorized personnel who require such access for the purposes of the approved project and who are bound by appropriate confidentiality obligations.

The obligations of confidentiality under this Agreement shall continue during the term of this Agreement and for a period of five (5) years following its expiry or termination, except where a longer period is required by applicable law.

12. DATA SECURITY

The User shall implement appropriate administrative, technical and physical safeguards to protect the confidentiality, integrity and security of all data collected through the use of the Children's Palliative Care Outcome Scale and to prevent unauthorized access, disclosure, alteration, loss or destruction.

At a minimum, the User shall ensure that:

• research data are stored on secure, password-protected systems with access restricted to authorized personnel only;
• electronic data are encrypted during storage and transfer, where feasible;
• appropriate physical safeguards are in place to protect paper records and electronic devices containing study data;
• data are transferred using secure methods that protect against unauthorized access or interception;
• regular data backup and recovery procedures are implemented, where appropriate;
• temporary working files and duplicate copies containing study data are securely deleted or destroyed when no longer required; and
• all data security measures comply with applicable institutional policies, national data protection legislation and ethical approval requirements.

Any actual or suspected data breach, unauthorized access, loss or disclosure of research data shall be reported to APCA without undue delay and managed in accordance with applicable legal, regulatory and institutional requirements.

13. PROHIBITED ACTIVITIES

The User shall not:

• modify the Instrument without written approval from APCA;
• distribute the Instrument to third parties;
• upload participant-level data into public repositories;
• upload participant-level data into public artificial intelligence platforms;
• attempt to identify participants;
• use the Instrument for commercial purposes without written authorization.

14. TRANSLATION AND CULTURAL ADAPTATION

Any translation or cultural adaptation of the Instrument shall:

• follow internationally accepted translation procedures;
• include forward translation, back translation and pilot testing;
• be submitted to APCA for review and approval before implementation.

Approved translations shall become part of APCA's repository for future use.

15. PUBLICATIONS

The User agrees to:

• acknowledge APCA in all publications arising from use of the Instrument;
• appropriately cite the Children's Palliative Care Outcome Scale;
• provide APCA with copies of publications, reports, conference abstracts and presentations arising from use of the Instrument.

Where pooled analyses or collaborative publications are undertaken, authorship shall follow internationally accepted authorship guidelines.

16. BREACH NOTIFICATION

The User shall notify APCA within forty-eight (48) hours of becoming aware of any:

• data breach;
• unauthorized disclosure;
• unauthorized access;
• attempted participant re-identification;
• loss of confidential information.

17. RETENTION AND DISPOSAL

The User shall retain all research records, including study data and related documentation generated through the use of the Children's Palliative Care Outcome Scale, for a minimum period of five (5) years following completion of the approved project, or for a longer period where required by applicable laws, regulations, funding requirements or institutional policies.

The User shall maintain appropriate administrative, technical and organizational safeguards to ensure the confidentiality, integrity and security of all research records throughout the retention period.

The Children's Palliative Care Outcome Scale, including any manuals, scoring guides and supporting materials provided by APCA, shall not be copied, distributed, sublicensed or shared with any third party without the prior written approval of APCA.

Upon expiry of the retention period, the User shall securely destroy or archive research records in accordance with applicable legal, ethical and institutional requirements. Where requested by APCA, the User shall return or securely destroy all copies of the Instrument that are no longer required for regulatory, legal or audit purposes and shall provide written certification of such return or destruction.

The obligations relating to confidentiality, intellectual property, data protection and restrictions on further distribution of the Instrument shall survive the expiry or termination of this Agreement.

18. TERM AND TERMINATION

18.1 Commencement and Duration

This Agreement shall take effect on the date of the last signature by the Parties and shall remain in force for a period of five (5) years, or until completion of the approved project and fulfilment of all obligations under this Agreement, whichever is later, unless terminated earlier in accordance with this Section.

Where the User continues to use the Children's Palliative Care Outcome Scale beyond the initial five year period, the Agreement may be renewed or extended by mutual written agreement between the Parties.

18.2 Termination by Either Party

Either Party may terminate this Agreement by providing thirty (30) days' written notice to the other Party.

Termination shall not relieve either Party of any obligations that accrued before the effective date of termination.

18.3 Immediate Termination

APCA may terminate this Agreement immediately upon written notice where the User:

• breaches confidentiality or data protection obligations;
• violates participant rights or ethical requirements;
• misuses or distributes the Instrument without authorization;
• attempts to re-identify participants from anonymised datasets;
• uses the Instrument for unauthorized commercial purposes; or
• otherwise fails to comply with the terms of this Agreement.

Upon termination, the User shall immediately cease using the Instrument and, upon request by APCA, return or securely destroy all copies of the Instrument that are not required to be retained for regulatory, legal or audit purposes.

18.4 Survival of Obligations

Termination or expiry of this Agreement shall not affect the continued application of provisions relating to confidentiality, data protection, intellectual property, publication obligations, data sharing commitments, dispute resolution, or any other provision which by its nature is intended to survive termination.

19. GOVERNING LAW

This Agreement shall be governed by and construed in accordance with the laws of the Republic of Uganda.

The Parties shall comply with all applicable laws and regulations relating to research ethics, privacy and data protection, including the Data Protection and Privacy Act, 2019, the Data Protection and Privacy Regulations, 2021, and the Uganda National Guidelines for Research Involving Humans as Research Participants (2025), where applicable.

Where the Instrument is used outside Uganda, the User shall also comply with the applicable laws, regulations and ethical requirements of the country in which the Instrument is used, provided that such compliance does not diminish the obligations set out in this Agreement.

ANNEX 1 – MINIMUM DATASET TO BE SHARED WITH APCA

The anonymised dataset should include, where applicable:

• Country
• Study title
• Study design
• Healthcare setting
• Sample size
• Age categories
• Diagnosis
• Language version of C-POS used
• Date of data collection
• Outcome variables
• Data dictionary/codebook

No participant names, contact details, identification numbers, addresses, consent forms or linkage files shall be shared.