Ethical Engagement Policy
 | Ethical Engagement Policy |
| Document Owner: Office of the Registrar | |
| Date of Creation: 1 Feb 2024Date of Review: 1 May 2024 | Members of the Review:John ClarkTom Mallinson |
| Document Type: Internal Regulations | Contact/Creator: Tom Mallinson |
Vision Statement:
The College of Remote and Offshore Medicine (CoROM) aims for purposeful engagement, guided by its core values, with various local, national and international external entities and individuals. CoROM prioritizes partnerships and endeavours aligned with its strategic plan, mindful of potential negative impacts, while upholding a position of “do no harm” and ensuring that the highest standards of integrity, compassion, and professionalism are maintained.
Purposeful engagement encompasses research, knowledge exchange, philanthropy, teaching, business development, and employer interactions that contribute to fulfilling the College’s strategic goals while adhering to the principle of ‘do no harm’. As a prominent institution internationally, the College embraces a proactive and outward-facing approach, seeking diverse external partnerships to advance its strategic objectives.
The College strives to instil a deep sense of responsibility towards patients, communities, and global health outcomes, ensuring that every interaction and decision reflects our unwavering dedication to doing good while minimizing harm.
Criteria:
The College upholds the principle that all activities conducted under its auspices will not cause harm.
The College will refrain from engaging in partnerships with external entities or accepting funding from external sources if such involvement:
- Poses a risk to the academic freedom, reputation, or independence of the College;
- Has the potential to undermine the College’s admission criteria (which are solely based on academic achievement or equivalence) for student enrolment in a course of study;
- Compromises the College’s stance of ‘party political’ neutrality;
- Involves receiving funds directly linked to the tobacco industry
- Involves activities directly and exclusively related to the development, manufacturing, or sales of weapons;
- Leads, or potentially leads, to research involving genetic modification of organisms;
- Leads, or potentially leads, to research including animal testing on vertebrates, including humans, being conducted outside the relevant licensing, ethical guidelines and species protection arrangements;
- Conducts research knowingly involving the development or use of new or emerging technology with the understanding that it may compromise the principle of ‘do no harm’.
Roles and Responsibilities:
These procedures are applicable to all potential relationships with the College as defined in this policy, irrespective of the financial worth of these relationships.
Individual College employees, or employees of academic partners responsible for advancing a new initiative or accepting a philanthropic donation deemed to fall within the scope of this policy on behalf of the College or academic partners, shall evaluate the proposed initiative or philanthropic donation against the principles outlined in this policy. If, following this assessment, there is any uncertainty regarding whether the proposed initiative or philanthropic donation aligns with the College’s values, the employee must have an informal discussion with their supervisor/line manager or the CREC.
Ethics in College Aligned Research
Everyone bears the responsibility to assess how their actions, whether conducting, hosting, or supporting research, affect both the research community and society at large.
Although all communications will be handled confidentially, should any individual hold particular concerns regarding the integrity of research conducted by the College, these can be raised directly with the Dean.
Research Data Management
Data Availability
There is a growing emphasis from all funding entities on maximising the openness of research data. This drive must be balanced against the principles of confidentiality and the principle of “do no harm”.
Further information about Research Data Management is available:
The tool available at https://dmponline.dcc.ac.uk/ can assist in developing specific data management processes.
FAIR Principles in Research Data Management
The FAIR principles ensure that research outputs are easily discoverable, accessible, interoperable, and reusable, ultimately enhancing data visibility and potential for reuse.
When developing a research data management plan, it’s crucial to consider who will have access to the data, the conditions of access, and how these may evolve over the course of the project. If circumstances change, the data management plan should be reviewed and updated accordingly.
A fundamental aspect of enhancing data sharing practices is adhering to the FAIR principles:
- Findable: Data should be accompanied by metadata and assigned a persistent identifier for easy discovery.
- Accessible: Both data and metadata should be retrievable through a free and open communications protocol. Metadata should remain accessible even if the data itself is not.
- Interoperable: Metadata should utilise controlled vocabularies, be machine-readable, and include references to other relevant metadata. Data should be in open formats whenever feasible.
- Reusable: Metadata should conform to established standards to maximise reusability, ensuring clarity for both humans and machines. Additionally, data should be accompanied by a clear and accessible licence governing its reuse.
It’s important to note that accessibility does not necessarily imply openness. There may be legitimate reasons for restricting access, such as privacy concerns, national security, or commercial interests. In such cases, it’s essential to provide explanations for why the data is not openly accessible and outline any conditions for access.
College Research Ethics Committee
The College Research Ethics Committee (CREC) is the overarching Committee at the College of Remote and Offshore Medicine for the consideration of ethical issues arising from research .
The remit of the College Research Ethics Committee (CREC) includes:
- Reviewing and approving research projects involving human or animal participants or personal data. This may involve establishing specialised sub-committees as needed to address specific areas.
- Consensus will be considered by a majority agreement of the CREC.
- Where needed, creating associated procedures and recommending any necessary changes to the Dean based on the committee’s experience.
- Establishing and maintaining a procedure for handling appeals against decisions made by the CREC to withhold, suspend, or withdraw approval of research projects.
- Advising on training opportunities for individuals involved in reviewing applications for research projects involving human or animal participants or personal data, as well as for researchers conducting such studies.
- Providing advice to the Dean on the formulation and implementation of policies and procedures related to research integrity.
Current Membership of the CREC
Mr John Clark (Dean and Chair)
Dr Csaba Dioszeghy
Dr Fenella Corrick
Dr Tom Mallinson
Mr Aebhric O’Kelly
Member of the Community (layperson)
CoROM CREC Ethical Review
The College’s CREC is dedicated to providing a thorough and impartial ethical review process tailored to the potential risks involved. The College acknowledges that, in many instances, the involvement of an ethics committee may not be necessary. Nevertheless, it expects all researchers engaged in projects involving human participants or personal data to assess the ethical implications of their work and, when uncertain, to seek relevant guidance.
Any project recognised at the outset (by the researcher, supervisor, Faculty, or Department) as necessitating ethical review should be referred to the CREC.
Process for Ethical Review for Research
The following guide is appropriate for CoROM students and faculty.
A note on specific project modalities:
Clinical Audit
Clinical Audit is a quality enhancement procedure aimed at improving patient care and outcomes by methodically reviewing care against specific criteria (Gold Standards) and implementing changes. Selected aspects of care structure, processes, and outcomes are systematically assessed against defined criteria. When necessary, changes are introduced at individual, team, or service levels, and ongoing monitoring is utilised to validate improvements in healthcare provision. Randomisation is not involved. The decision on treatment, care, or services lies with the healthcare professional and patient/service user, in accordance with standard guidance, professional standards, and/or patient/service user preferences.
Clinical audit does not usually necessitate review by the CREC.
Quality Improvement/Service Evaluation Studies
Service evaluation aims to define or assess current standards and should address the question
“What level of quality does this service attain?”
It evaluates the current service without comparing it to a predefined standard and involves implementing only existing interventions (e.g. treatment selection is at the discretion of the clinician and patient, following the usual guidance, professional standards, and/or patient preference, and must precede service evaluation). Randomisation is not involved.
Service evaluation typically entails analysing existing data but may also incorporate interviews or questionnaire administration.
Service development or improvement endeavours to determine potential enhancements within the service itself.
It may introduce a new intervention or service or one previously unused in that context, but randomisation is not permissible. The decision on treatment, care, or services lies with the healthcare professional and patient/service user, in accordance with standard guidance, professional standards, and/or patient/service user preferences.
Service evaluation/improvement/development activities do not necessitate review by the CREC.
Policy Review
Review and update this policy every three years or as necessary to reflect changes in educational standards and program requirements.