Consent Form Template University of Manchester

CONSENT FORM: RESEARCH PARTICIPATION AND DATA PROCESSING

Document Control

• Effective Date: [Insert Date]
• Version: 1.0
• Jurisdiction: England and Wales
• Scope: The University of Manchester (the "University") / Data Controller

1. OFFICIAL LEGAL NOTICE AND DISCLAIMER

This document is a formal legal instrument. It is designed to satisfy the informed consent requirements under the General Data Protection Regulation (UK GDPR) and the Data Protection Act 2018 (DPA 2018). Disclaimer: This template serves as a foundational architectural framework. It does not constitute specific legal advice. Investigators are responsible for ensuring that study-specific protocols, ethical approval references, and data retention schedules are correctly inserted.

2. PARTIES AND DEFINITIONS

• The Participant: [Full Legal Name of Participant] (“Participant”)
• The Investigator: [Principal Investigator Name] (“University Representative”)
• The Institution: The University of Manchester, Oxford Road, Manchester, M13 9PL, UK.
• The Project: [Insert Official Project Title and Ethics Reference Number]

3. OPERATIVE CLAUSES

1. Voluntary Participation: The Participant acknowledges that participation in The Project is entirely voluntary. The Participant reserves the right to withdraw from the study at any time without providing a reason and without prejudice to their legal rights or relationship with the University.
2. Data Processing: The University acts as the Data Controller. Personal data shall be processed in accordance with the University’s "Research Participant Privacy Notice." Data will be processed for the purpose of [Clearly define the purpose of the research].
3. Storage and Security: Data will be stored in secure, encrypted environments in compliance with the University’s Information Governance policies. Access is restricted to authorized project personnel.
4. Retention: Data will be retained for a period of [Insert Duration, e.g., 5 years] following the completion of The Project, after which it will be securely destroyed or anonymized in accordance with institutional data retention schedules.
5. Rights of the Data Subject: The Participant retains the right to access, rectify, or request the erasure of their personal data, subject to legal limitations regarding the integrity of the research study.
6. Publication: Anonymized results of The Project may be published in academic journals or presented at conferences. No information that could identify the Participant will be disclosed without express written consent.

4. ACKNOWLEDGMENT AND SIGNATURE BLOCK

I, the Participant, hereby confirm that:

• I have read and understood the information provided regarding The Project.
• I have had the opportunity to ask questions and receive satisfactory answers.
• I understand that my participation is voluntary and I am free to withdraw at any time.
• I consent to the processing of my personal data as described in Clause 3.

Participant:

Signature: __________________________
Date: [DD/MM/YYYY]

University Representative (Obtaining Consent):

Name: [Insert Name]
Title: [Insert Title]
Date: [DD/MM/YYYY]

5. STEP-BY-STEP EXECUTION GUIDE

1. Ethics Verification: Before distribution, ensure the document includes the specific Research Ethics Committee (REC) approval number. Failure to include this invalidates the consent under University of Manchester compliance protocols.
2. Information Sheet: This form must be accompanied by a "Participant Information Sheet" (PIS) written in plain language. Consent is not "informed" if the PIS is not provided or understood.
3. Digital Execution: If collecting via digital platforms (e.g., Qualtrics or RedCap), ensure the platform logs the IP address and time-stamp of the consent event. Retain the exported audit log as an immutable part of the study record.
4. Storage: The original signed hard copy (or secure digital image) must be archived in a locked, controlled-access environment, separate from the raw research data, to maintain confidentiality and ensure compliance with auditing requirements.