FREC School of Nursing and Advanced Practice

NAH Students – your study can be registered/reviewed by NAH FREC if it conforms to the requirements of a NAH student project – listed below:

1. Any non-validated tool must only be completed/used by LJMU staff/student participants
2. Participant informed consent and/or withdrawal procedures must be consistent with accepted practices
3. Participants with whom the NAH students will interact must be provided with the contact details of the student, their supervisor and the chair of the REC so they know whom to contact in case of questions or complaint.
4. Participants must not receive payments / incentives for their participation
5. Participants must not be considered vulnerable (vulnerable populations include children, persons lacking capacity, those in a dependent or unequal relationship, people with learning or communication difficulties, people in care, people in custody or on probation, people who have suffered physical or psychological trauma and people engaged in illegal activities, such as drug abuse)
6. Data collection or associated activities must not pose significant risk to the investigator and/or participants (or any third party) of causing/inducing physical harm
7. The NAH student project must not involve physically invasive/intrusive procedures (such as any test in which the skin of the participant is broken, an implement inserted into any opening of the human body, taking of body samples, scanning, drugs or other substances, vigorous physical activity or techniques such as hypnosis) that would not usually be encountered during everyday life
8. The NAH student project must not involve deception of, or purposefully withholding information from participants
9. Primary data collection must not be on an area of public or social objection (e.g. terrorism, paedophilia) and no aspect of the proposed study will bring the University into disrepute
10. Any data collected (including video/audio recordings) must only be accessible to authorised individuals and must only be made public with the explicit consent of the participants
11. The NAH student project must not involve observing individuals (including ethnography) in a non-public venue or private/semi-public space (e.g. public areas of a building; if members of the general public cannot access a location without permission/membership/”insider” access etc.), either physical or virtual (e.g. a private chat room) where adult participants might object to being observed or reasonably expect that their behaviour would not be observed by third parties for research purposes
12. The NAH student project must not collect or reveal data/information that enables individuals, groups or organizations to be identified in such a way that they could experience a significant risk of having an adverse effect on their personal well-being (e.g. physical and psychological health), social wellbeing (e.g. social standing, social connectedness) or economic well-being (e.g. employment, employability, professional standing)
13. Identifiable personal data must not be extracted from inside to outside of the European Economic Area
14. It must be unlikely that the study topic will lead to disclosures from the participant concerning their own involvement in illegal activities or other activities that represent a threat to themselves or others (e.g. sexual activity, drug use, or professional misconduct) whereby the investigator would be obliged to breach confidentiality
15. The NAH student project must not raise issues relevant to the Counter-Terrorism and Security Act (the Prevent duty), which seeks to prevent people from being drawn into terrorism
16. Undergraduate NAH students are not permitted to conduct a project that involves the NHS or the participation of those in social care (e.g. the result when completing the NHS decision tool is "you need ethical review by NHS REC")
17. PGT NAH student projects can involve the NHS or the participation of those in social care? (e.g. the result when completing the NHS decision tool is "you need ethical review by NHS REC") as long as:

• Studies defined as service evaluation/audit by the HRA are approved by the NHS trust service evaluation/audit approval service
• Studies defined as research by the HRA have approval from the required gatekeeper for the study to be conducted as proposed and the study will not be conducted at more than one NHS site and the study does not involve an intervention

Download NAH ethics application form

NAH FREC Process of ethics for NAH students

NAH PGT students conducing service evaluation or audit within the NHS or involving the participation of those in social care must complete the NAH FREC process of ethics shown above

Written permission to undertake a service evaluation is required from the responsible Trust or Authority. Information about how the HRA defines research, service evaluation or audit is available in the links copied below:

Defining research/service evaluation/audit table 

A Guide for Clinical Audit, Research and Service Review 

Service evaluation, audit and research: what is the difference? 

NAH PGT students conducting research within the NHS or involving the participation of those in social care must complete the NAH FREC process of ethics shown above

The research study must have approval from the required gatekeeper for the study to be conducted as proposed AND the study must not be conducted at more than one NHS site AND the study must NOT involve an intervention. Information about how the HRA defines research is available below:

HRA decision tools: Is my study research? 

Please note – the HRA have changed their policy – A PGT student projects that involve the NHS or the participation of those in social care should be reviewed by a university REC rather than a NHS REC

The principles set out below cover all studies involving human subjects at LJMU. It is the responsibility of supervisors to ensure that their students become familiar with LJMU research ethics policy and related guidance. All LJMU students and staff (in their capacity as investigators or supervisors) must comply with the LJMU Code of Practice for Research. The key principles can be summarised as follows:

1. The dignity, rights, safety and wellbeing of participants must be a primary consideration in any study. All participants must be warned in advance about any potential risks of harm. Harm to those involved in or affected by the study must be minimised. If you anticipate any potential harm to participants your study is not eligible for minimal risk registration and you should complete an ethics application form.

2. Central to the protection of participants is ensuring a transparent process of consent is in place. As part of this process, investigators are normally expected to provide potential participants with the following information:

• Purpose of the study. The purpose of the study and comprehensive explanation of what their participation would involve (e.g. what is involved, when, how much time they will be expected to contribute, how often, with whom, where the study will take place etc.).

• Potential risks (including physical, psychological, professional, reputational and legal risks) and how those will be mitigated.
• Security of data, including personal details (e.g. encryption and password protected to ensure secure storage).
• Will the data from participants be collected anonymously, or will it be anonymised by the investigator? (Anonymity means that the provider of the information cannot be identified, even by the person doing the study. This requires techniques such as using an anonymous questionnaire platform (Bristol online survey tool, etc.) or a web forum that employs pseudonyms. Data can also be anonymised after collection, by removing identifiers from the data.
• Information on the intended audience of the study and how it will be presented to that audience (e.g. examined dissertation, peer reviewed article or book, conference paper).
• How participants will be identified or referred to in the final report (i.e. fully identified, partially anonymous, directly attributable quotes etc.) (It must be made clear to participants if you intend to use direct quotes they have provided during the study, and their permission must be obtained. If specific comments are to be attributed to a person, the terms under which this will happen should be negotiated clearly in advance to avoid confusion).

• Contact information for the investigator and/or supervisor.

As a general rule, investigators should provide all potential participants with an Information Sheet and Consent Form based on the LJMU templates. Where traditional written consent is not obtained (e.g. signing a consent form), investigators must be able to demonstrate that informed consent has been obtained (e.g. by audio recording/ transcribing verbal consent etc.).

3. Investigators must respect the participant’s right to withdraw themselves or their data from the study either during or after participation without having to provide a reason. Withdrawal of data from the study should be facilitated up until the point that is no longer practically possible.

4. All study data and personal data obtained from participants should be securely stored in line with data protection legislation and LJMU guidance

5. Ensuring that all participants understand that they are under no obligation to take part in a study. Participants should make their choice regarding participation freely, without any pressure from the investigator or any other individuals (e.g. gatekeepers).

6. Individual investigators must take personal responsibility for the conduct of their study. Investigators undertaking a study that involves human participation or personal data that requires ethical review must not begin their study until approval has been obtained. Investigators are also responsible for ensuring that any other approvals or permissions (e.g. gatekeeper approvals, DBS clearance) required to conduct the study are in place before the study commences. If investigators are in any doubt as to the appropriate conduct of their study or its ethical implications they should discuss their concerns with their supervisor in the first instance (where appropriate) or members of the School, Faculty or University Research Ethics committees.

Any queries email NAH FREC