Introduction

The Tavistock and Portman NHS Foundation Trust (the Trust) is committed to maintaining the integrity of academic research and upholding ethical standards in line with the professional, regulatory, legal, and statutory guidelines. To this end, the Directorate of Education and Training (DET) ensures that research is of high quality and conducted according to recognised standards and guidelines, including the Concordat to Support Research Integrity and Research Ethics Support and Review in Research Organisations.

This procedure outlines the principles, framework, and processes through which ethical review of student-led research projects in DET is managed.

This procedure applies to all student-led research projects undertaken within DET. All projects undertaken at the doctoral level are classified as research. However, this procedure does not apply to Trust Quality Improvement (QI) projects, even if students are involved in the project.

The Trust Research Ethics Committee (TREC) is responsible for the implementation and monitoring of this procedure. This procedure operates in conjunction with other relevant policies and procedures, such as the Trust’s Research and Academic Misconduct Procedures and Professional Codes of Conduct.

This procedure supersedes all previous versions and is effective as of October 2025. The Trust reserves the right to amend or update this procedure at its discretion. In the event of any changes, a summary of revisions will be provided, along with an updated version number, to ensure transparency and clarity.

Principles and commitment to ethical practice in research

To ensure that research adheres to ethical, legal, and professional standards and aligns with good practices, the following general principles should be observed:

Minimising harm and prioritising wellbeing

Research should be designed to avoid or minimise any risks of physical or psychological harm or distress to participants at all stages. The involvement of participants must be proportional to the potential benefits of the research. At all times, the safety, wellbeing, rights, and dignity of participants should take precedence.

Informed consent

Whenever possible, participants should provide informed consent based on clear, concise, and relevant information about the aims, purpose, and methods of the research, as well as the potential storage and use of their data. This includes providing details about what participation entails, along with any associated risks or benefits.

Research involving deliberate deception and post-hoc consent

If obtaining informed consent prior to data collection could compromise the scientific validity of a study—such as in covert research—consent should be obtained afterward. Deception or covert methods should only be employed when no viable alternatives exist and when measures are in place to mitigate risk and potential harm.

Voluntary participation

Participation in research must always be voluntary, free from coercion, and without undue inducement. Participants have the right to withdraw their consent at any time without explanation or fear of negative consequences. They should also be informed about the time for withdrawal and the point at which their data can no longer be excluded, adhering to UK General Data Protection Regulation (GDPR) and the Data Protection Act 2018 and the provisions of the Data Use and Access Bill 2025 as it is implemented over a period of time.

Privacy, confidentiality, and anonymity

Participants’ privacy, confidentiality, and anonymity must be respected unless there is a legal or ethical obligation to breach confidentiality, such as disclosures involving harm to self or others, illegal activities, or professional misconduct. In cases where participants are named for scientific purposes (e.g., oral histories), this must be explicitly stated in participant briefing documents. Information sheets and consent forms should clearly outline how participants data is being used, how personal details are being protected, if and in what format participant information and research outcomes are being shared throughout and following data collection, and who has access to participant information. This also needs to include any conditions under which confidentiality may be breached or participants identified.

Cultural sensitivity and respect

Research should be conducted in a culturally sensitive manner, respecting the dignity and rights of all individuals, groups, and communities.

Data Security and Compliance

All data must be securely processed and stored in accordance with the UK General Data Protection Regulation (GDPR) and Data Protection Act 2018 and the provisions of the Data Use and Access Bill 2025 as it is implemented over a period of time to ensure participant privacy and compliance with legal standards.

Trust Research Ethics Committee (TREC)

TREC must operate in alignment with this procedure and adhere to the standard operating procedures outlined herein. Reviews should be independent, transparent, and free from conflicts of interest.

Scope

All members of DET and DET students are expected to uphold professional, legal and ethical standards in accordance with this procedure, ensuring the integrity of research and safeguarding the Trust’s reputation. Staff and students must adhere to the processes for ethical review and comply with DET ethics guidelines, and the ethical standards set forth by research funders and relevant professional bodies.

This procedure applies to DET students engaged in research activities, including both taught and research students. A student is someone enrolled on a programme of study where research is a credit-bearing activity. In this respect, a DET staff member can be classed as a student, if the research referred to here is undertaken as part of their enrolment onto one of DET’s programmes of study.

The procedure encompasses all types of research conducted by DET students, as specified in the following section.

If there is any uncertainty about whether a project qualifies as research, please refer to the NHS HRA decision tool in the first instance.

Research involving human participants

Projects involving human participation and the collection of personal data require a full ethics review either through TREC or the Integrated Research Application System (IRAS).

• Research involving human participation, including activities such as observations, photography, audio or video recordings, surveys, questionnaires, interviews, focus groups, physical activities, or other interventions. This also includes the use of materials collected by a third party.
• Research involving the collection, use, or storage of human tissue or bodily materials (e.g., blood, saliva, or urine), whether obtained directly or through a third party.
• Research involving access to, collection, or use of personal human data or property, including images or data drawn from social media.

Projects requiring ethical approval from IRAS

For projects involving NHS staff, NHS patients, service users, or individuals lacking mental capacity, researchers must seek research and ethical approval from the Integrated Research Application System (IRAS).

For projects involving the collection, use or storage of human tissue or bodily materials (e.g. blood, saliva, or urine), whether obtained directly or through a third party, requires specialist training, and expert advice should be sought if such research is proposed. Researchers must then seek research and ethical approval from IRAS.

Guidance and support are available through NOCLOR who act as sponsors of NHS research for both the Trust and DET students. No additional review by TREC is required; once approved, a copy of the IRAS ethics application and approval should be registered with and retained by TREC.

Projects requiring ethical approval from TREC

For all other student-led projects involving research with participants who are not NHS staff or patients, service users, or individuals lacking mental capacity. researchers must seek research and ethical approval from TREC.

Research involving animals

As it is rare for the Trust to engage in animal research, advice on animal welfare in research must be sought if such research is proposed. All research involving animals needs to be conducted in line with appropriate policies guiding such research.

Research outside of the scope of this procedure

Certain types of research fall outside the scope of the DET’s ethical review framework. These include:

• Desk-based studies, involving literature reviews and systematic literature reviews, and theoretical studies
• Secondary data collection and analysis that utilise secondary data, such as meta-analyses, provided the secondary data is publicly available and does not require additional consent or permissions for access or use. The collection of secondary personal data (e.g., from social media) requires a full ethics review.

Staff or supervisors who are unsure whether an ethics review is required should seek guidance from the Chair of TREC. It is the applicant’s responsibility to ensure that the project does not raise ethical concerns requiring review.

Additional project considerations requiring TREC review

Certain types of research, including activities listed in 3.4, may raise broader ethical concerns beyond those associated with human participant, human tissue, or animal research. These concerns may arise in studies that are politically, environmentally, or socially sensitive, or where there is potential for financial or reputational risk. Examples include:

• Politically or socially sensitive research that could significantly impact the welfare or interests of the wider community or society.
• Projects posing reputational risks to the Trust, partner organisations, or academia at large including research on radicalisation, terrorism, or the armed forces.
• Involvement of sponsors, participants, or associates whose interests or connections might compromise, or appear to compromise, the impartiality of the research process from design through to publication or exploitation.
• Collaboration with external sponsors, associates, or organisations that have a controversial ethical or human rights record, such as entities selling harmful products, or where the source of funding could compromise the Trust’s position as a public institution.
• Activities conducted in countries under oppressive political regimes, with poor human rights records, or deemed dangerous by the Foreign and Commonwealth Office.
• Issues of research integrity, including the accurate reporting of results and authorship concerns.

These projects may require TREC review. Any concerns or issues related to such projects should be referred to the Chair of TREC for advice. The Chair of TREC may involve appropriate parties for due diligence.

Audit and service evaluation

Student projects involving audit or service evaluation are considered part of research training and are therefore subject to ethical review. If the audit or service evaluation involves NHS patients, service users, staff, or premises, the NHS HRA decision tool must be used to determine if ethics review is necessary.

DET Research Ethics Review Framework

Requirements for ethics review

All student-led research conducted within DET at the Trust, as defined in Section 3 (Scope), is subject to TREC ethics review. Students must obtain approval for their projects before recruiting participants or collecting data and must adhere to the processes outlined in this procedure. If any significant changes* to the research design are made following ethical approval that could have a potential impact on the dignity, rights, safety and wellbeing of participants, the applicant must submit a change request to determine if further ethical review and approval are required. Students unsure whether their changes qualify as “significant” should seek guidance from their supervisor or the Chair of TREC.

*A ‘significant change’ refers to a new research approach or method that, had it been planned at the time, would have been mentioned on the original research ethics approval application and any ethical implications arising identified.

Ethical breaches

Ethical breaches can have profound consequences, including potential harm or distress to participants and significant reputational risks for both researchers and the DET. Examples of ethical breaches include:

• Failing to submit an ethics application before commencing research.
• Starting participant recruitment or data collection before completing the ethics review process and obtaining approval to proceed.
• Implementing significant changes to a project without submitting and receiving approval for a change request after ethical approval has been granted.

Any breaches of ethics must be taken seriously and addressed appropriately. Staff-related breaches will be handled through the Research Misconduct Procedure, while student-related breaches will be addressed via the Academic Misconduct Procedure.

TREC: Role and overview of the two-tier research ethics framework

TREC oversees all applications for ethical approval within DET. All DET Students’ ethics applications require sign-off by the supervisor and course lead (or delegate) prior to submission to TREC. TREC employs a two-tier review process, defined by the level of the student researcher (Master’s vs Doctoral level) as well as the risk identifier of the proposed research (higher vs. lower). The latter is assessed via the TREC application form.

Definition of higher-risk applications

Higher-risk research activities include:

• Research involving children aged under 18 and adults where there are safeguarding concerns
• Research taking place overseas
• Research that, either directly or indirectly, refers to trauma, abuse, or illegal activity
• Research which may lead to disclosures of harm to self, others, or illegal activity, and which requires reporting to relevant authorities
• Carries risk of substantive emotional distress
• Presents legal, reputational, or safety concerns for researchers
• Physical activities presenting significant risks to participants.
• Covert research or research using deliberate deception.

Applicants must indicate the perceived risk level of their research in the application form.

Doctoral-level research

Lower risk applications: each application is assigned by TREC to a reviewer, an academic staff member within DET. Feedback is provided via correspondence and their assessments of applications are discussed at TREC.

Higher-risk applications: each application is assigned by TREC to two reviewers, at least one of which is a TREC member. The reviewers make recommendations to TREC, which are presented and discussed at TREC. TREC ratifies or rejects these recommendations.

Master’s level research

Lower risk applications: a subcommittee of TREC, namely a Masters Portfolio Ethics Review Panel, is responsible for reviewing ethics applications from taught Masters courses.

Higher-risk applications: as outlined in the DET research ethics procedure document section ‘Doctoral-level research’