I. Introduction

The Research Ethics Code of Practice provides the ethical framework within which the ethical review process will operate across campus. Reference may in addition be made to different professional ethical codes in relation to different subject areas where this is appropriate. A list of  related codes of ethics  is appended to this document.  Ethical approval will be needed prior to commencement of non-clinical research projects concerning human participants whether undertaken by staff or students.  It should be noted that it is unlikely that ethical approval will be mandatory prior to submitting an application for research funding.  

II. Basic Principles

1. Researchers must respect the rights, interests and dignity of participants and related persons in research.
2. Research must be undertaken in accordance with any relevant common law or legislation.
3. Informed consent should normally be obtained from participants.
4. Consent itself should be given freely without force or coercion.
5. Researchers have an obligation to protect research participants wherever possible from significant harm consequent upon the research.
6. The confidentiality of information supplied by research participants and any agreement to grant  anonymity to  respondents should be respected
7. All research involving human participants whether undertaken by academic staff, other university staff or students is to be subject to ethical approval. Where research projects fall within the scope of the NHS Research Governance Framework such research should be referred to an appropriate NHS Research Ethics Committee[1]. All other research concerning human participants should be dealt with through the University research ethics review structure.
8. Both the design of research and its conduct should ensure integrity and quality.
9. Research is to be undertaken subject to the principle of academic independence. Where any conflicts of interest or partiality arise, these must be clearly stated prior to ethical approval being obtained.

NOTES:

1. For these purposes the definition of human participants includes living human beings, research involving deceased people with living relatives and human material.
2. Excluded from the requirement for ethical review is “routine audit, performance reviews, quality assurance studies, testing within normal education requirements, service evaluations, polling on current public policy issues, and literary or artistic criticism.” In addition use of published material, newspaper articles concerning individuals, radio or television broadcasts will not require ethical review. [2]
3. “Harm” may cover physical harm, psychological stress or discomfort. The degree of ethical review should be proportionate to the likely harm which may arise.

III. Specific Issues

(a) Consent

1. “Informed consent” should normally be obtained.[3]   Information should be provided as to the nature and purpose of the research project. Reasonable steps should be taken to ensure that the research participant is aware of the nature of the research and their involvement in it and that they have freely agreed to participate in the research. Researchers should address in their application for ethics approval both how informed consent can be achieved and demonstrated. Generally good practice would suggest that these objectives should be achieved through   the provision of an information sheet and the signing of a consent form copies of which must be provided to the research participant.  However it should be noted that in some circumstances, for example where written consent may pose a risk to the research subject, oral consent may be sufficient.  In addition it should not be presumed that the fact that a form has been signed means that the individual has given consent to inclusion in the research.
2. Participants have a right to withdraw consent to participation in research. They may choose to withdraw their participation at any time. Separate guidance will be issued regarding the withdrawal of consent using samples and data already obtained.
3. If it is proposed to undertake research in situations in which consent has not be obtained for example, covert research then this will require separate justification.

(b) Vulnerable Groups

Criminal Records Bureau

Research involving “vulnerable groups” may necessitate Criminal Records Bureau disclosure to ensure that their background is suitable for working with children and vulnerable adults (see further http://www.disclosure.gov.uk). Guidance on this provision can be sought from the University Personnel Office..

Children

Research involving children gives rise to particular sensitivities. (A child is a person under 18 years of age). Normally consent to a child’s participation in research should be obtained from the person with parental responsibility.  Parental consent itself may not be sufficient, particularly in situations where it might be inferred that a child refused consent themselves. In addition as far as possible consistent with their capacity consent should be obtained from the child themselves in additional to parental consent. Children may possess decision-making capacity if they are deemed to have “sufficient maturity to do so”[4]. In addition in situations in which children are not perceived to possess decision-making capacity steps should nonetheless be taken to ensure that wherever possible they provide “assent” to their involvement. Additional more extensive guidance concerning research in children will be issued early in 2007.

Adults lacking Mental Capacity

Research governing intrusive research concerning adults lacking mental capacity is to be subject to the Mental Capacity Act 2005 which is due to come into force in April 2007. This will introduce a totally new legal regime into this area. At present the legal principles on inclusion of adults lacking mental capacity are subject to common law and there are many uncertainties.  Until the new legislation comes into force the current situation is that invasive non-therapeutic research concerning adults lacking mental capacity appears to be unlawful. The University will issue further guidance upon research concerning adults lacking mental capacity when the Mental Capacity Act Codes of Practice and Regulations have been finalised by the Government.

(c) Confidentiality and Data Protection

Researchers may guarantee confidentiality and anonymity to research participants and such a guarantee should be respected. Such a guarantee is likely to give rise to a legal obligation of confidentiality. Failure to maintain such confidentiality may give rise to an action in the civil courts for breach of confidence. In some exceptional situations confidentiality may be broken and information disclosed where this is in the public interest to do so.

Storage and use of participant information must be undertaken in accordance with the Data Protection Act 1998.  Further guidance on the operation of the Data Protection Act can be obtained from the University of Leicester Data Protection officer.

(d) Use of Human Material-(issues consequent upon Human Tissue Act 2004).

Today the use of human material including tissue etc is regulated under the Human Tissue Act 2004.  This Act sets out a general structure of regulation including mandating consent with regard to use of such material, subject to statutory exceptions and making specific provision for adults lacking mental capacity and children. While the majority of these issues are envisaged to fall within the remit of the NHS committee this will not necessarily be the case regarding all holdings of DNA/ use of archival material etc. In addition consideration needs to be given to the use of blood samples from non-clinical volunteers. The University Committee is to provide further guidance as to the relationship with the NHS Committee on this issue shortly.

(e) Research projects which are intended to operate in conjunction with researchers outside the university and outside the jurisdiction.

Where a joint research project with another institution was proposed the principal investigator is required to secure ethical approval from their own institution.

Where it is proposed to undertake research outside the jurisdiction, researchers have an obligation to comply with laws, regulations and cultural practices of that jurisdiction as appropriate.

In addition it should be noted that compliance with ethical principles which may be regarded as appropriate in the jurisdiction where the research is being undertaken is not a substitute for ethical approval from the University of Leicester.

(f) Dissemination of research

There is an obligation upon researchers to accurately and appropriately disseminate research.

(g) Student Projects

Students, whether undergraduate or postgraduate are subject to the University ethical review procedures.  They are to be provided with such training in research ethics as is appropriate for their level of study and subject discipline.

Supervisors are required to ensure that they have satisfied themselves that the students are aware of any ethical issues which may arise consequent upon student projects.

Further guidance on this will be provided by the University. Review of student projects will become operational from 1^st October 2007.

(h) Risk of Harm to Research Participants from Third Parties

If when undertaking research it is discovered that there is a risk of serious harm to a research participant e.g. a child or other vulnerable person then this should be disclosed to an “appropriate authority” which may include the police or social services.

(i) Risk to Researchers

Research projects must be designed in such a way to minimise risk to the researcher as well as to the participant.  Due regard should be given to any possible health and safety considerations when designing the research project.

(j) Researchers’ Responsibilities.

Researchers are responsible for obtaining ethical approval for their project. While the ethics officer and/or research ethics committee will provide scrutiny of the proposed research project it should be noted that it is the researcher who is personally responsible for the conduct of their project. They are responsible for ensuring that the project complies with any legal or organisational requirements which may be applicable.  They must ensure that the project is undertaken as approved by the University research ethics approval process.  Any major divergence from the approved project must be subject to further ethical approval.

(k) Complaints Procedures

Staff or students will have reference to complaints procedures regarding the conduct of research or of the University’s ethical review process through the University grievance procedures.

(l) Monitoring

The University Committee will monitor the ethical approval process. Annual returns are required from Faculties and Department. In addition the University Committee will undertake annual sampling of those applications considered at Departmental/Faculty level. The ethical review process does not extend to the period once the project is in operation. As noted above the responsibility for the conduct of the research falls upon the researcher. 

IV. Scrutiny of Projects by Research Ethics Committee

(a) Remit

The remit of the Committees concerns non-clinical research concerning human subjects. In addition the Committees may, as appropriate, engage with such ethical issues as may arise consequent upon research in the University.

(b) Procedure for Dealing with Applications

(i)  Initial Scrutiny and “Light Touch” Review

1. Applicants will fill in an “ethics form”. This will ask them to address issues including risks, proposed participants, procedures in relation to consent/confidentiality etc. 
2. The form will be submitted to the Departmental Ethics Officer who will undertake initial scrutiny.
3. The Departmental Ethics Officer is required to declare any conflict of interest in relation to an application under his/her scrutiny. In such a case then the application must be referred to a deputy for consideration.
4. At this stage the project may be found to raise no ethical issue and it may be recommended that it is formally accepted.
5. If concerns or ethical issues which need the involvement of the Committee are raised eg it involves more than “minimal risk” then the matter should be referred to the formal Departmental/School/Faculty committee as appropriate.

(ii) Consideration of “Minimal Risk”

In determining whether a project should be referred for determination by a full committee it must be determined as to whether it would involve “minimal risk”. Guidance as to what constitutes “more than minimal risk” is provided by the ESRC

 “The following research would normally be considered as involving more than minimal risk:

• research involving vulnerable groups – for example, children and young people, those with a learning disability or cognitive impairment, or individuals in a dependent or unequal relationship
• research involving sensitive topics – for example participants’ sexual behaviour, their illegal or political behaviour, their experience of violence, their abuse or exploitation, their mental health, or their gender or ethnic status
• research involving groups where permission of a gatekeeper is normally required for initial access to members – for example, ethnic or cultural groups, native peoples or indigenous communities
• research involving deception or which is conducted without participants’ full and informed consent at the time the study is carried out
• research involving access to records of personal or confidential information, including genetic or other biological information, concerning identifiable individuals
• research which would induce psychological stress, anxiety or humiliation or cause more than minimal pain
• research involving intrusive interventions – for example, the administration of drugs or other substances, vigorous physical exercise, or techniques such as hypnotherapy. Participants would not encounter such interventions, which may cause them to reveal information which causes concern, in the course of their everyday life.”[5]

It should be noted that such research is not precluded, rather the fact that research falls within these categories should act as a trigger for further ethical review. 

(iii) Composition of the Departmental/School/Faculty Committee

The Committee should be constructed in accordance with principles of equality and non-discrimination and should e.g. include both men and women. The Committee should also be multi-disciplinary.  In establishing departmental committees Departments should note that the ESRC Guidelines require that

“a REC must have at least one academic member from outside the Department conducting the research and at least one appropriately trained lay member.”[6]

In addition it should be noted that the ESRC document provides that

“RECs would also benefit from including individuals who reflect the ethnic diversity of the local community; users of specialist health, education or social services where these are the focus of research activities, individuals with experience of professional care or counselling and individuals with specific methodological expertise (for example, statistics or qualitative methods) relevant to the research they review.” [7]

Note:  In order to comply with Funding Council guidelines all Committees must contain

(a)   An “independent” member. This member must be a “lay member from the local community with no affiliation to the university or research institution in question.”

(b)   At least one member “experienced in ethics”.

(c)   Should normally contain at least seven members

(iv) Applications considered by the Department/School/Faculty Committee

Applications submitted to the Committee should address the following criteria

•  “aims of the research
• scientific/academic background of the research
• study design
• participants – who (inclusion and exclusion criteria), how many, how potential participants are identified and recruited, vulnerable groups
• methods of data collection
• methods of data analysis
• response to any conditions of use set by secondary data providers
• principal investigator’s summary of potential ethical issues and how they will be addressed
• benefits to research participants or third parties
• risks to participants or third parties
• risks to researchers
• procedures for informed consent – information provided and methods of documenting initial and continuing consent
• expected outcomes, impacts and benefits of research
• dissemination (and feedback to participants where appropriate)
• measures taken to ensure confidentiality, privacy and data protection.”[8]

(v) Procedure of the Departmental/School/Faculty Committee

1. The Committee will consider applications on a regular basis. The frequency of such meetings will be determined by the number of applications which arise for the Committee but there will be a minimum of one meeting per University term.  The dates for the meetings must be published and available on the web-site.
2. A Committee member must declare any conflict of interest which they may have in relation to an application under consideration and withdraw from the proceedings.
3. The Committee must be quorate- i.e. there must be a minimum of 5 members present.
4. Normally the applicant would not be called to make representations before the Committee. However Faculty/departmental REC’s may hear applicants in person where either the applicant has requested to be able to make an application in person or in where in exceptional circumstances the REC asks for attendance in order to clarify an application.
5. Where an application raises issues which relate to the substantive nature of the project the Committee may seek further advice through obtaining an independent peer review of that application.
6. The Committee may  make one of the following determinations
1.  accept the project without amendment,
2.  accept conditional upon  minor amendment
3.  accept subject to major revisions
4.  reject 

(vi)  Criteria to be applied

The consideration of the ethics of a research project shall be in accordance with the statement of “Basic Principles” above. The Committee should consider the ethical probity of such proposals and any discipline-specific ethical issues which may arise[9]. In particular consideration shall be given to ethical issues arising from the design and proposed conduct of the research[10].    In considering the research project account should be taken of the following provisions contained in the ESRC guidelines. The project should…

“ be considered in terms of the ethical issues raised (for example, whether the method of recruitment proposed puts undue pressure on individuals to participate) and the way they are addressed. The scholarly or scientific standards of the proposal should be evaluated by appropriate peer review, typically provided by the funding agency as part of the refereeing process. Where the REC queries the scientific or scholarly merit of a proposal, it should seek the advice of an independent researcher with experience and expertise in the research methods and paradigm described in the proposal.”

It should be noted that a particular research project may also give rise to legal questions. Where an issue of concern arises this issue should be referred to the Research and Development Office or Registrar’s Department as appropriate for clarification.

(vii)  Provision for reference to the University Committee

1. Appeal  

a. The University Committee may consider an appeal by an applicant from a Departmental/School/Faculty Committee (first-level Committee).

b. In considering the appeal the University Committee will consider the record of proceedings at the first-level Committee. The applicant has a right to be heard before the Committee[11] . In addition the Committee may call such persons as it regards as appropriate to appear before them in reaching their determination.

c. Members of the University Committee must declare any conflict of interest and withdraw from the proceedings.

d. The University Committee may  make one of the following determinations

1. accept the project without amendment,
2. accept conditional upon  minor amendment
3. accept subject to major revisions
4. reject

2.         Special reference

Issues may also be referred to the University Committee under the “special reference” procedure from the first-level Committee. Such a “special reference” will be appropriate where an issue of principle arises on which further guidance is sought and which it is necessary to review centrally.  In such an instance the Committee would consider the matter of principle but then refer the matter back to the first-level Committee to determine the issue on the facts.

3.    Extraordinary Determination

Finally, in very exceptional circumstances where a case which arises before a Faculty/departmental committee raises an issue of acute difficulty and where it is impossible to differentiate policy from the factual issues such as to fall within the “special reference procedure” the University Committee has the power to determine the full case as a matter of initial rather than appellate jurisdiction. In such a situation the procedure to be adopted is as of a Departmental/School or Faculty Committee as stated above.

[1] Department of Health Research Governance Framework for Health and Social Care ( 2^nd ed) London: DOH (2005)

[2] ESRC Research Ethics Framework Swindon: ESRC,(2005) para 1.3.2.6.

[3]  There may be circumstances e.g. where research is being undertaken through observation in public places in which informed consent is impossible to obtain.

[4]  See further Gillick v West Norfolk and Wisbech AHA. [1985]  2 WLR 413

[5]  ESRC Research Ethics Framework, para 1.2.2.

[6]  ESRC Research Ethics Framework, para 3.

[7]  Note the ESRC Research Ethics Framework at para 1.5.2.

[8]  ESRC Research Ethics Framework, para 1.8.1.

[9]  ESRC Research Ethics Framework para 1.9.2.

[10]  ESRC Research Ethics Framework para 1.91.

[11]  It is suggested that this should be included not simply to accord with principles of natural justice but to facilitate an effective examination of the application ensuring that the Committee has the opportunity to ask questions as appropriate.