Investigations Involving Human Participants

Investigations involving human participants are undertaken within Schools at Loughborough University as part of teaching, innovation and research. The University seeks to ensure that the conduct of staff and students carrying out such work, whether biological, psychological or sociological, conforms to accepted professional standards and is known to do so and that visiting investigators carrying out investigations on campus conform to the relevant sections of this guidance.

Investigators conducting investigations involving human participants should complete the Ethics Review Form available within the University’s online ethics system, LEON. This covers a wide range of activities from observation studies, secondary data analysis and anonymous questionnaires to physical intervention studies or biomedical research.  Student applicant submissions must be signed by their project supervisor who will be the responsible investigator for ensuring the submission is accurate and the study is conducted appropriately.

The Ethics Review Sub-Committee is responsible for review of submissions.  Details of the current membership, remit, meeting dates and submission deadlines are provided on the Sub-Committee’s website.  Further details explaining the Ethics Review Process are also available.  Studies must not be undertaken until a favourable ethics decision has been issued.

The purpose of this policy is to:

• Clarify whether activities involving humans require ethics review.
• Clarify the requirements for conducting investigations involving human participants.
• Clarify the requirements for submission of ethics proposals.

All investigations involving human participants undertaken for academic purposes in any discipline fall within the scope of this guidance and must conform with the appropriate University guidelines.  This includes, but is not limited to, research investigations, teaching experiments/demonstrations/investigations, innovation activities, taught student projects, PhD studies and staff projects.

The scope of this policy does not apply to:

• procedures undertaken as part of NHS patient care which are expected to contribute to the benefit of the individual participant. Advice must be sought from the relevant NHS Trust.
• post-mortem examination which is regulated by the Human Tissue Act 2004. This is not covered by the University’s HTA Licence.
• research which involves working only from anonymous historical data and/or literary databases and documents and does not involve working with ‘live’ participants
• experimentation on animals which is covered by a separate ethics review process. This is strictly regulated by the Home Office under the provisions of the Animals (Scientific Procedures) Act 1986. Staff are advised that it is an offence to carry out scientific work controlled by the Act without the appropriate licences.
• Patient and Public Involvement (PPI) events undertaken as part of the design of a study do not require ethical review providing it does not involve increased risk to participants, vulnerable participants or invasive procedures.
• Service evaluation/Audit and Operational Activities carried out in the course of the University’s business (e.g. the Staff Survey, module feedback from students, experiments of new operational processes, marketing, recruitment etc.) do not require ethical review.
• Peer feedback or feedback from tutors/technicians/technical experts on students’ academic work as part of a teaching activity or coursework does not need ethical review. (Formal collection of study data from peers is not excluded.)

All investigators are responsible for familiarising themselves with the appropriate external guidelines for their own discipline/area of research.  Some studies with fall within the remit of external ethics committees.  These may include:

• Health Research Authority (HRA)/NHS Research Ethics Committee (NHS REC) – for studies involving NHS patients, staff or data
• His Majesty’s Prison and Probation Services (HMPPS) – for studies involving Conducting Research in Prisons, Probation or HMPPS Headquarters.
• Ministry of Defence Research Ethics Committee (MODREC) - research involving human participants either undertaken, funded or sponsored by MOD
• Mental Capacity Act - Studies involving participants who are ‘lacking capacity’ e.g. who are unable to give consent under the Mental Capacity Act 2005, require approval from the National Social Care REC. The Social Care REC is recognised by the Secretary of State as an ‘appropriate body’ for this purpose.  University Research Ethics Committees are not recognised as appropriate bodies under the terms of the Act.
• Radiation – studies involving the use of ionising radiation on participants e.g. x-rays, require ethics review from an NHS REC.
• Clinical trials of medicinal products or medical devices are strictly regulated by the MHRA. The appropriate licencing would need to be obtained along with ethics review through the HRA/NHS REC.

Where ethical review has been obtained from external bodies, such as an NHS Research Ethics Committee, Social Care Research Ethics Committee, MODREC, HMPPS, another University REC etc, a full application to the Sub-Committee may not be required.  A copy of the external application and decision must be submitted through LEON for review.  If this meets the appropriate standard of review it will be accepted instead of requiring a separate submission.  If it does not meet the appropriate standard a new submission will be required.

Researchers must be mindful of the different civil, legal, financial and cultural conditions when working overseas, or conducting research involving participants who are located overseas, and are expected to refer to international guidelines and conform to relevant local regulations for the country or countries where the research is taking place. 

Where necessary researchers working overseas must obtain local ethical review in addition to a favourable decision from Loughborough University when conducting research overseas involving human participants.  Where a local ethics committee does not exist, permission from any organisation or location where the research will be conducted must be sought in addition to a favourable decision from Loughborough University.

It is expected that the research will comply with Loughborough University’s research ethics policies and guidelines as well as other relevant policies and procedures.

The Ethics Review Sub-Committee will consider protocols on a 'generic' basis where it is the intention to adopt the same procedure in a number of related investigations. A generic protocol will be cleared by the Sub-Committee for use by those investigators named on the submission under the direction of the Responsible Investigator.

Individuals wishing to use the protocol who are not named on the list of investigators must apply to a named investigator for permission to practise the generic procedure.  It will be the responsibility of the named investigator to ensure that such individuals are fully competent to use the protocol before permission is given. The names of individuals cleared through this procedure must be added to the list of investigators.

The Ethics Review Sub-Committee will consider submissions from academic staff for module level review where student investigators complete low-risk activities.  Module applications can be made when students taking the module will all be conducting the same type of activity as investigators and using the same broad methods and procedures.  This will usually apply to part A and B modules, e.g. research methods modules. The Sub-Committee will not review separate submissions from each student on the module.

Students undertaking distinct research projects (e.g. dissertations), or whose plans deviate significantly from the taught module submission, must each submit their own submission.

Investigations involving human participants must not involve unnecessary risk to their physical or mental well-being.  All risks must be justified against the benefit of the study.  All risks must be fully explained to participants, including precautions taken to minimise those risks.  Investigators must consider the appropriate recruitment criteria for their study and the mitigation of any risks to participants.

Appropriate supporting documents must be provided for participants ensuring that participants are fully informed regarding the study.  These documents must be included in the ethics submission.

Changes to the study design, extension requests or the addition of investigators must be submitted for review using the amendment form in LEON.  Substantial changes may require re-submission to the Ethics Review Sub-Committee.

The Ethics Review Sub-Committee cannot give a retrospective ethical opinion for studies which have already been conducted or have already commenced.  This does not prohibit contacting potential sites to discuss feasibility.

Favourable opinions can be withdrawn, and research studies halted, if ethical issues arise during the progress of the study until these concerns have been addressed.

Any unusual or unexpected symptoms arising or any significant adverse event affecting a participant during or after an investigation must be communicated promptly with the individual's consent to the participant's own doctor, and to the Ethics Review Sub-Committee using the Adverse Events Report form in LEON. The study must be stopped for the individual concerned and it must be considered whether it is advisable to stop the investigation as a whole.

In studies where incidental findings are possible, for example, studies involving blood tests or MRI scans, investigators must request permission to inform the participant’s GP of incidental findings before the start of the study.  GP details must be collected for this purpose from participants before they commence the study.  Investigators should advise participants to seek professional guidance and must not offer advice on incidental findings.

The favourable opinion on the study will apply from the date it is issued until the end date provided on the Ethics Review Form in LEON.  Requests for extensions can be submitted using the minor amendment form in LEON.   Final reports may be requested from selected studies.

The University maintains in force a Public Liability Policy, which indemnifies it against its legal liability for accidental injury to persons (other than its employees) and for accidental damage to the property of others. Any unavoidable injury or damage therefore falls outside the scope of the policy.  It is the responsibility of the applicant to ensure insurance cover is arranged for the project if it falls outside of the normal activities of the University through liaison with the Insurance Support office, see Appendix 1.