51ÂÒÂ×»»ÆÞ

• 51ÂÒÂ×»»ÆÞ
• 51ÂÒÂ×»»ÆÞ QMU
• Quality
• Committees, Regulations, Policies and Procedures
• Regulations, Policies and Procedures
• Ethics Regulations

Research Ethics Guidelines, Procedures and Regulations

Section 1: Ethical Principles to guide research involving human participants

Ìý

1. Introduction

Ethics permeates all research, so only by getting it right can research excellence be achieved. It is essential for researchers to gain an understanding of ethical principles, because in practice ethical issues are often complex, relative to the particular research project, relative to the competence of the research team and require the reasonable anticipation of likely future risks and problems. The core of ethical research is the ethical sensitivity of the research team, which is an art based on principles rather than a rule-governed process, or a set of tick box barriers to be overcome before the real work can begin.

Ethical research requires a balance to be struck between minimising probable harm and advancing academic knowledge, being appropriate in terms of human dignity, and in social and cultural impact. Researchers should use the basic ethical principles outlined here to guide their decisions about how to conduct research, how to treat their research participants and how to handle the data that they gather about them. For much research the relevant decisions are straightforward or have sound precedents.

Issues such as protection of identity, privacy, obtaining informed consent, communicating appropriately with participants, ensuring participant autonomy and freedom of choice, and ensuring that no harm comes to participants or researchers are among the many ethical issues that people planning research must have in their minds. Additionally, researchers have a moral responsibility to tell the truth and to preserve participant confidentiality.

However, in some cases deciding on an acceptable ethical approach within a study may be more difficult. Top quality research is by definition innovative and may pose new ethical challenges. For these reasons, although the competence of the research team is critical (imagine surgery by the untrained), neither the track record of the team, nor the prestige of the institution waives the need for an adequate ethical review process.

The ethics review process at QMU aims to be collaborative and constructive. In considering ethical issues from the conceptual stage of a proposal it is intended to enhance the quality of research and increases the chances of productive funding and publication outcomes. In cases where ethical approval is not granted at the first stage, the aim is that discussion with members of the School or University Ethics Panel is used to achieve an acceptable approach that should also facilitate positive research outcomes for students and staff.

2. The Main Ethical Principles

There are four ‘clusters’ of moral principles which provide a framework for making decisions about the ethical aspects of a study (Beauchamp and Childress, 2001).

• Respect for people’s autonomy
• Non-maleficence; do no harm
• Beneficence; do good
• Justice

It is hard at the ethical approval stage for research to guarantee doing good and being just, but it is critical for it to avoid disrespecting people’s autonomy or harming them.

2.1 Respect for AutonomyÌý

2.1.1 DignityÌý

Participants in research should be treated with appropriate dignity. A rule of thumb test is for researchers to ask whether they would consider it appropriate for a beloved family member to participate in the research. Historical cases abound of research participants being treated in undignified, even brutal, ways that are clearly unethical. Nonetheless, sometimes research requires intrusive, invasive, tedious or unpleasant treatment of participants. Participating can be boring, stressful, challenging, upsetting or even painful. Such ‘invasive’ research protocols need to be justified by the potential benefits of the research. It is essential to consider also the social impact of the research results, independently of the scientific impact. Cases have occurred where because of the rarity or uniqueness of participants, their anonymity has easily been violated and social stigma and other harm has resulted.

2.1.2 Informed Consent

Respect for autonomy also requires ensuring that research participants have truly consented to participate in the research, of their own free will, without coercion or manipulation of any kind and fully informed of the risks, benefits and consequences of their participation. This is not simply about getting the required signature on the consent form.

All research involving human beings requires informed consent. This applies even to tissue samples or data acquired about those people for other purposes.

To ensure genuine informed consent, it is essential that researchers consider the extent to which the people being recruited are capable of fully and freely giving their informed consent. There are two common restrictions on this, which often need to be dealt with. First, when the people to be recruited are, in some sense, vulnerable or limited in their capacity to consent in an autonomous fashion. Researchers who are working with vulnerable people such as children, prisoners, those with some form of mental illness or incapacity or the very sick or old will need to pay particular attention to the way in which they gain informed consent. The process of gaining informed consent from young people and children is complex and must be informed by current legislation (BMA, 2000).

Second, when the demand characteristics of the social situation where the research occurs implicitly or explicitly coerces people into participating in the research. Examples include potential participants believing that the research will benefit them, believing that their therapy or treatment will suffer if they do not participate, believing that significant others, whether friends, family or professionals, will think badly of them, and believing that they will, in some sense, ‘stand out’ or be incriminated by refusal. For example, does refusal imply that they have something to hide?

A third, rarer, limitation is when research offers money or other benefits that are so large as to easily persuade people to participate for the benefits alone. This is generally considered to exclude modest payments to cover the costs of travel and inconvenience. Pay and other benefits offered should be modest in proportion to the effort required to participate.

2.1.3 Who Should Consent?

Only persons able to freely understand, question and refuse without fear of sanction or reprisal can give informed consent. For research involving participants who may lack the capacity for understanding and questioning, such as children, people with mental or intellectual difficulties, or people severely ill or heavily medicated, consent should be obtained from a parent, carer or other person serving in a responsible capacity AND from the participant themselves, to the extent that they are capable of understanding and offering consent. Ingenuity needs to be exercised in providing satisfactory consent procedures in such cases. Consent from the parent or carer alone is rarely adequate.

The freedom to refuse to participate in research is potentially threatened where there is a power imbalance between the prospective participant and the researcher, along with their perceived allies. For example, students may believe that refusing to participate in staff research will not count well for them when they are being educationally assessed. This can occur even if the researcher is not directly one of the student’s teachers. The two key methods of ensuring true refusal are:

• to ensure whenever possible that the research team is completely independent of anybody in a position of power over the potential participants, and
• that the procedures to ensure independence are explicit during the informed consent process. For example, should the medical consultant be one of the research team (as is often the case), it should be clear that they will have no knowledge of whether an individual patient has participated or not. Where this is impossible, other means of enabling true refusal should be actively written into the research protocol.

It is also important to remember that research on groups, societies, organisations, institutions and their members also ‘involves human beings’ who ought to consent to it occurring. This does not necessarily mean obtaining consent from everybody, but appropriate procedures should be in place for collective consent, treating the organisation as the ‘participant’.

2.1.4 The Process of Informed Consent

All international declarations stipulate that, prior to consent, each participant in a research project should be clearly informed of its goals, its possible adverse events, and the possibility to refuse to enter or to retract at any time with no consequences. How to inform is a critical part of the process. Participants are rarely able to recall what they have agreed upon when signing an informed consent form. An example Information Sheet and Consent Form can be found in Appendix 2.

The following strategies may help to safeguard informed consent:

• Close attention to the language and readability of written material, which includes translation procedures for non-native language speakers.
• Honest explanation of the possible risks and benefits of participation. Particular caution should be exercised to avoid ‘lies of omission’; if the research procedure is boring, unpleasant or simply lengthy, it is best to make this clear.
• The opportunity for potential participants to discuss the project and ask questions with somebody sympathetic who understands the research: Ideally one of the research team.
• Use of alternative media, such as visual information.
• In complex or hazardous cases, the informed consent procedure should involve a detailed interview and discussion, rather than the mere signing of paperwork.

2.1.5 The Informed Consent FormÌý

This usually includes an actual form to be signed, along with an information sheet and as much additional material as is appropriate. This entire pack constitutes ‘the consent form’.

Two general questions should be answered on the information sheet:

• What are the likely benefits of the research for science, for society and for the research participants? This should enable potential participants to make an informed choice to participate, even if there are risks. Researchers should avoid the temptation to exaggerate about benefits.
• How will participants and the data about them be protected? This should include explanation of how confidentiality will be ensured and what data will be retained where, in what format.

Other information that should be included in the information sheet includes:

• A clear explanation of who is involved in the research, what their roles are, and who to contact for further information or in case of concern.
• A clear and appropriately brief description of the research explaining its purposes, how long participation will take, what will happen and which, if any, parts of the research involve new or experimental procedures.
• An explanation of any screening procedures used to select participants.
• An accurate description of any reasonably foreseeable risks or discomforts. Notably, much research interviewing people poses some risk of participant distress, should the topics covered include ones sensitive to individual people.
• A modest description of any benefits that may reasonably be expected as a result of participating, to the participants and to others.
• In research involving more than minimal risk, an explanation of insurance and compensation procedures, should harm occur.
• An explanation of the procedures that will be followed should the research discover important information about the participant. Two common dilemmas are:
  • When research incidentally discovers signs of disease or abnormality. In most cases the appropriate procedure is to notify the participant and refer to appropriate health care professionals. In some cases it is appropriate for the participant to choose to not be informed, or be informed, as part of the consent procedure. Genetic screening research is one example.
  • When research incidentally discovers a significant risk of harm to the participant by others, or by the participant to others. With children under 16, researchers are legally obliged to disclose such risks to appropriate people and this is a limit on confidentiality.
• In research involving interventions or treatments, a clear explanation of alternative approaches that participants might use instead.
• An explanation of procedures used to preserve confidentiality and anonymity (see 2.4.1).
• A statement explaining that participation is entirely voluntary and that participants may withdraw at any time, for any reason, without explanation or obligation to the research team and without repercussions elsewhere.

2.2 Non-Maleficence; Do no harm

Researchers must not harm their study participants. But, even simple time-wasting can be harmful, so it is the research team’s duty to weigh up the potential for harm against the benefits of the study and to come to a justifiable conclusion. It is also the team’s duty to ensure that research which carries a risk of harm should only be conducted by competent research teams. Many potential ethical issues can be resolved by ensuring that the research team has sufficient competence to manage problems appropriately. For example, a badly designed survey by an undergraduate may waste participants’ time, where a well-designed one would not.

2.2.1 Competence

The normal model for a research team is that there are one or more researchers who directly interact with participants and one or more supervisors who oversee. Part of the ethics review process is to establish that the research team is competent to (a) minimise harm, (b) conduct research that is like to be of sufficient quality to be worth any risks of harm, which at the mildest level includes wasting participants’ time and effort, and (c) manage serious harm should it arise, even if it is very unlikely. Competence is a function of relevant skills, experience, training to be achieved during the research process and the devotion of appropriate time and effort to the research project. A good research team has an appropriate mix of competencies. When researchers are less competent, then supervisors need to be more competent and supervise more closely. Therefore, particular care should be exercised in decisions about what types of research can be conducted by undergraduates. Staff teaching loads can sometimes make close supervision difficult, so unless a student has special demonstrable competencies caution should be exercised in developing undergraduate research that raises major ethical issues. Conversely, a team with specialist expertise can conduct research that might be unethical conducted by a team without such competencies. Where appropriate, it is important to report on the team’s competence in the ethics application. A track record of publications in the area is not always sufficient. There are also specialised competencies that need to be considered. For instance, researchers working with young people or other vulnerable groups will need to be police checked according to current Disclosure Scotland guidelines () Researchers who intend to work with children should consider this when planning the timescale of their research.

2.2.2 Risk Assessment and Risk Management

In order to address the issue of ‘risk of harm’, researchers must demonstrate that they have exercised a standard of due care. As well as being competent, this involves identifying the likely risks, assessing the probability that they will occur, evaluating the risk to determine its acceptability in relation to the objectives of the research and finally managing the risks which involves the steps that can be taken to minimise them (Beauchamp and Childress, 2001:199).

Common examples of managing risk include:

• Screening procedures that identify participants more likely to come to harm through the research.
• Competence to work with participants who become distressed, including being able to listen and communicate appropriately about the distress and being able to refer to further counselling should this be required
• Sufficient knowledge to provide advice about services or help as a result of discussing needs which are not being met
• Sufficient knowledge to discuss the benefits of appropriate interventions
• Adequate post-research debriefing, including offering explanations of any necessary deception or withholding of information.
• Appropriate research training on the proposed research techniques: For example, appropriate specialist interview skills; specific experimental methods; specialist biological sampling.
• Appropriate risk assessment for the conduct of the research, including any physical or biological risks faced by researchers and participants.
• Adequate supervisory procedures to address researchers’ difficult thoughts and feelings about the research and the participants, to reduce harm to researchers.

2.3 Beneficence: Do Good

Will the research truly benefit the individual participants, or those like them? Will the research truly benefit some wider or more abstract entity such as science, knowledge, or society? Naturally, researchers generally hope the answer to at least some of these questions is ‘yes’. However, in justifying research it is important to reflect upon and respect conflicting notions of benefit. It is unethical to assume that benefit to participants, to science, or to society are an absolute good. Contemporary disagreements abound: For example, over animal rights, over the age at which the foetus becomes a person, or the appropriate balance between eroding individual liberties and promoting safety.

When research can genuinely indicate likely beneficence, then this is important ethically and may justify research that would otherwise seem excessively hazardous to participants. However, this situation is relatively rare. Usually, ethical research involving human participants is about minimising harm, rather than increasing likely benefits.

2.4 Justice

It is important to treat people equally and fairly and ensure that they are accorded their full rights. In research practice, much of this occurs under issues of truly informed consent (see 2.4.2). It is also worth mentioning the need to consider issues of participant selection criteria. There are often legitimate reasons for restricting a study to a specific gender, or excluding non-native speakers of the predominant language, or excluding specific ethnicities. However, sometimes these choices are made mainly for convenience, which may be ethically debatable and can require justification. There are many instances where convenient sampling criteria have resulted in a consequent lack of knowledge of whether findings apply to excluded groups. Any inclusion or exclusion criteria to be employed in the research should be clearly outlined and justified in the ethical approval application. There are also issues, now widely recognised by research councils and the NHS, of the extent to which research participants are entitled to help form the research agenda. Participant involvement in research design is good practice.

2.4.1 Confidentiality

As well as being a basic rule of research ethics, confidentiality is also the subject of considerable literature and legislation including the Data Protection Act 2018. It is important to keep confidentiality distinct from anonymity.

Anonymity involves the protection of the participant so that even the research team cannot link them to the information provided. Nowadays, this not only requires the avoidance of names, but also other identifier information such as postcodes. Moreover, particularly in small-scale more qualitative studies, some participants may be identifiable solely by the data they provide. Consequently, true anonymity from start to finish is relatively rare in research and should not be offered unless it is really provided.

Confidentiality in contrast involves the prevention of disclosure of identity other than to authorised people, for authorised purposes. For example in the NHS, patient records are confidential, but may be accessed by any NHS staff for appropriate purposes; but not for inappropriate ones. Using records for malicious gossip would be a serious breach of confidentiality.

In most research projects confidentiality is a process, rather than a condition. It is important to make clear to participants what confidentiality involves and what measures will be in place to protect participants from unwanted violations of confidentiality.

If the data are retained for further research researchers need to ensure that the informed consent form explains and justifies this. Applicants should describe the measures taken to encode or anonymise stored data. Generally, data sets should be anonymised as soon as it is reasonable to do so, even if this requires the loss of potentially useful information. Even where only anonymised data are used, adequate security for storage and handling of such data must be demonstrated. This includes avoiding the unnecessary duplication of electronic data sets, which increases the chances of their being misused.

2.4.2 Data Storage

The data protection act and confidentiality requirements (see above) pose a dilemma for data storage, which is another ethical requirement of research. If research is not going to be published in the public domain, but was conducted primarily for educational purposes, then raw data should be destroyed once the research work has been educationally assessed. Any data retained electronically should have all personal identifying information removed. QM has electronic (eResearch, QMU Research Repository: ) and physical data repositories and is developing a thesis repository (). Please contact Information Services for further details. For research that may be published in the public domain whether this is student or staff work, raw research data needs to be stored for a reasonable period of time so that it can be re-accessed and checked should issues or queries arise (for example from conflicting findings by other research teams). The QMU Retention Policy is that raw data, including interview tapes, completed questionnaires, and other material, generally should be retained for five years after the research programme is completed, although this can vary depending on funder and other requirements. Additionally, signed consent forms should be kept separately from the data for 12 months on campus and thereafter in remote secure storage for the duration of the retention of the physical data. It is the responsibility of the principal researcher to comply with current data protection legislation and store data securely for the appropriate length of time. Storage will normally be in the Subject Area.

2.5 Academic freedom and restrictions on publication

QMU policy is opposed to research that has restrictions placed on the publication of findings (see Appendix 4). These restrictions are usually placed by some funders, including some NHS, government and industry sources. Sometimes there are legitimate ethical reasons for restricting publication, for example to protect commercial interests. However, is becoming more common for funders to stipulate that they own the intellectual rights to research they have funded, simply to control the information and, potentially prevent or manage its release into the public domain. This is contrary to the spirit of academic inquiry and such research is arguably unethical because it colludes in the suppression of information. Research at QMU should not be contracted with strong clauses restricting publication. This should have been negotiated during the funding application process, but the Ethics Panel reserves the right to challenge the ethical probity of research where publication of findings has been restricted by the funding contract.

Ìý

Section 2: Procedures for Ethical Approval

Ìý

1. Submission of an application for ethical approval

Ìý

Without recorded ethics approval, under no circumstances can a research project proceed at QMU. The process of applying for ethical approval at QMU is described in this section, and is outlined in the flowchart in Appendix 1. The research team are responsible for applying for approval in a timely manner.

Research should not collect any data from participants, or use other data that is not in the public domain until Ethical Approval has been granted. So doing potentially constitutes serious research misconduct. In some circumstances, the data collected may be inadmissible. In serious cases students or staff involved may be subject to disciplinary procedures. If anyone becomes aware that research data is being collected or used without Ethical Approval, then they should immediately notify their Head of Division/Research Centre and the Research Ethics Panel. At minimum, staff and students will be required to suspend data collection/use immediately until Ethical Approval is obtained. The Research Ethics Panel cannot guarantee that approval will be granted retrospectively for data already collected.

The first step in gaining ethical approval is to complete an ‘Application for Ethical Approval for a Research Project’. This form is available here.

Most questions on the form are self-explanatory. Section 1 of this document – Ethical Principles to guide research – should be read before the Application for Ethical Approval is completed.

It is the researcher’s responsibility to ensure that the Application for Ethical Approval form is fully completed, legible and literate, and has any supplementary material such as consent forms or information sheets attached as appropriate. Any form that deviates markedly from this standard will be returned to the applicant by the Head of Division, without review.

2. ​The role of the Head of Division/ Research Centre or other authorised person

The completed application with information sheet and consent form included as appropriate, should be submitted to the Head of Division/Research Centre for consideration. The Head of Division/Research Centre will review the application and supplementary material, and will make a decision from four possible alternatives. External applicants wishing to conduct research using staff or students at QMU should apply directly to the University Research Ethics Panel, providing a copy of the approved ethics application obtained from their own organisation. If ethical approval has not been granted by their own organisation then they should complete the QMU standard form and submit it to the Secretary of the Research Ethics Panel.

2.1 If the application has been incorrectly completed, relevant information omitted or necessary supplementary material not included, the Head of Division should tick ‘I refer this application back to the applicant because…’ The reason(s) for referring the form back should be given, and the form signed and returned to the applicant. No record of the application need be kept by the Head of Division in this case.

2.2 If the application has been completed correctly and all relevant information included, there are three remaining alternatives, which should be considered in the order they are listed. The first, ‘I refer this application to the Research Ethics Panel’, should be chosen if any of the following circumstances apply:

• where any non-routine harm, physical or psychological discomfort, or physical, biological or psychological risk is involved;
• where participants are used who are under 16 or over 65 years of age or whose ability to give voluntary consent is limited, including cognitively impaired persons, prisoners, persons with a chronic physical or mental condition, or those who live in or are connected to an institutional environment;
• where any invasive technique is involved, DNA testing, or collection of bodily fluids or tissue;
• where a degree or duration of exercise or physical exertion is involved that might be painful, stressful or hazardous to some participants;
• where manipulation of cognitive or affective human responses are involved which could cause stress or anxiety;
• where drugs, including liquid and food additives or other substances, are administered for research purposes;
• where deception of participants is used of a nature which might cause distress or which might reasonably affect their willingness to participate in the research;
• where highly personal, intimate or other private or confidential information is sought;
• where payment is made to participants other than to cover expenses or time involved.
• Where restriction is intended on the publication of results (see Appendix 4)
• Where the research involves a ‘sensitive’ research topic. Researchers, in particular undergraduate students, should carefully consider the implications of conducting research in sensitive topic areas which may cause emotional distress to participants or the researcher themselves, for example:
  • domestic abuse
  • rape or sexual assault
  • psychological disorders e.g. Self-harm, eating disorders
  • Illegal or unethical activities e.g., crime, drug abuse
  • acute or terminal illness

Please note this list is not exhaustive.

Unless there are established research procedures at QM to deal with a specific sensitive topic that have previously been agreed to be minor invasive, research involving sensitive topics should be referred to the REP.

2.3 The second option, ‘I find this application acceptable and an application for ethical approval should now be submitted to a relevant external committee’, should be chosen if any of the following apply:

• The proposed research includes use of NHS patients or employees as subjects, NHS data, or it will be carried out (wholly or partly) on NHS premises.
• The applicant has indicated that ethical approval from another body will be required.
• The Head of Division knows that ethical approval from another body will be required.

Where a student is submitting to an external committee, the application should be seen and checked by the Head of Division before it is submitted externally.

2.4ÌýThe third option, ‘I grant ethical approval for this research’, should be chosen if none of the above bullet points apply and the Head of Division (or other authorised person) is satisfied that the research can proceed ethically.

2.5 In all three cases, once signed by the Head of Division/Research Centre, the application form must be submitted to the Secretary to the Research Ethics Panel to be logged on a centrally-maintained record of applications. Applications referred to the Research Ethics Panel must be received before the submission deadline in order to be considered at the next review period. Submission deadlines will be published by the Secretary to the Panel at the start of the academic year, and reminders will be circulated throughout the year.

3. The role of the Research Ethics Panel

The Research Ethics Panel reviews applications on a monthly basis. The application submission deadline will be the second Friday of each month and the dates will be published online before the start of each academic year. The Panel’s membership and remit can be found in Appendix 3. External applicants wishing to conduct research using staff or students at QMU should apply directly to the University Research Ethics Panel (see 2. above).

3.1 Applications for ethical approval referred to the Panel by a Head of Division/Research Centre are reviewed by three members of the Panel and a decision regarding approval is reached. The members’ comments are submitted to the Secretary who will communicate the Panel’s decision to the applicant in writing approximately two working days after the decision is reached.

3.2 There are three possible options available to the Panel when considering an application. The first, ‘The Panel agrees that full ethical approval could be granted for the research’, will be chosen when the Panel are satisfied that the researcher has taken all necessary steps to ensure that the research will be conducted ethically, and that any potential risk to applicants has been considered and minimised.

3.3 The second option is ‘The Panel agrees that amendments to the application are required before ethical approval can be granted for the research’. This will be chosen when the Panel supports the proposed research in principle, but agree that amendments to the application must be made before ethical approval can be granted. The amendments required by the Panel will be communicated to the applicant in writing by the Secretary. The amended application should be submitted to the Secretary in the first instance. It will then be reviewed by three members of the Panel and the Convener. If satisfied that the required amendments have been appropriately completed, ethical approval may be granted by Convener’s Action.

3.4 The third option available to the Panel is ‘The Panel invites the applicant to resubmit a revised application to its next meeting’. This option will be chosen when the Panel agrees that the proposed research involves significant ethical issues that have not been adequately addressed by the applicant in the application for ethical approval. The issues raised by the Panel when considering the application will be notified to the applicant in writing by the Secretary, along with the submission deadline and date of the next meeting. The revised application should be submitted to the Secretary for review by the Panel members that reviewed the original application. If the applicant chooses to resubmit on another topic, an application should be submitted to the Head of Division/Research Centre in the first instance and should be treated as a new application.

3.5 Where applicants require an urgent decision on their application, a special request for fast track approval should be lodged with the Secretary. Fast track involves the review process described above, but reviewers’ comments are returned directly to the Convener for decision. The Panel reserves the right to delay fast tracked applications to the next application cycle, should the Convener deem this necessary.

3.6 Please note that fast tracking should only be requested in exceptional circumstances. Researchers should allow sufficient time in the planning of their research for completing the ethical approval process, including, if necessary, revisions to the application or resubmission to the Panel.

4. Attendance of the applicant at a panel meeting

If the application has been referred by the Head of Division/Research Centre to the Research Ethics Panel, the applicant may be invited to attend a meeting of the Panel to answer further, verbal questions. The purpose of attendance would be to help Panel members gain a better understanding of the proposal. This could speed up the process of approval.

Staff applicants would normally attend the meeting on their own. Undergraduate and MSc students should be accompanied by the supervisor of the research project as named on the application form, or an alternate if the supervisor is not available. Professional doctorate candidates and PhD candidates have the option of attending alone or with their supervisor.

The Secretary of the Panel will inform applicants of the date of the relevant meeting and ask that this time is kept free. Applicants will be informed approximately three days in advance of the meeting whether attendance will be necessary.

5. Continuing responsibilities of the researcher

Any changes to the programme of research which are made following the granting of ethical approval and which would result in different information being given in any section of the Application for Ethical Approval form, should be notified to the Secretary to the Research Ethics Panel, who will advise on any action required. A report is also required should there be any adverse occurrences or any results that raise questions about the safety of the research. Notification should be submitted to the Panel on completion of the research.

6. Defining different research procedures - non invasive, minor invasive and major invasive research methods and procedures

These distinctions originated in medical research, where the distinctions are relatively obvious in terms of physical harm or disturbance. Invasive procedures involve the possibility of major harm, even if there may also be major benefits. Minor invasive procedures pose a risk of some harm and non-invasive procedures are unlikely to be harmful at all. These distinctions can also be applied to research with human participants that is not physically invasive.

6.1 A non-invasive procedure in humans would be one where it was unlikely that anybody would find participating at all stressful, upsetting, disturbing or psychologically or socially harmful. Usually, this requires a short procedure, a topic not controversial, stigmatising or distressing, no deception or discomfort during the procedure and highly confidential data handling procedures. Truly non-invasive procedures require only the addressing of standard ethical issues, clear demonstration that they are non-invasive, and should generally be approved by School/ Subject ethics committees.

6.2 A minor invasive procedure, in contrast, might be stressful, upsetting, disturbing, or psychologically or socially harmful, but probable harm would be brief and limited in nature relative to the participants’ lives. For example, some participants will find somewhat invasive any procedure that involves any overt or implied element of personal appraisal, because they have concerns about doing things properly or appropriately. On the other hand, someone suffering from a serious illness might find an interview about it only mildly invasive, compared to the invasion and upset already associated with their clinical care. To judge research non-invasive it is important to make a positive case that upset is highly unlikely and/or worth the benefits to participants and research. Minor invasive procedures additionally require the addressing of procedures to recognise and minimise upset should it occur and clear demonstration that the procedure is not major invasive. When the same or similar procedures have been used before at QMU, then these may be approved by the School/ Subject ethics procedures. Minor invasive procedures commonly used in the subject should be referred to the University Ethics Panel on first use at QMU and part of the application should document their common use in the subject beyond QMU.

6.3 Major invasive procedures are those where some participants are likely to find participation stressful, disturbing, or psychologically or socially harmful, and probable harm could be protracted or severe. That only a small minority of participants may respond in this manner does not render the procedure minor invasive. In addition to requirements for minor and non-invasive procedures, applications for ethical approval for major invasive techniques should explain how risks are to be minimised and how the research team is collectively competent to minimise and manage harm, should it occur. Major invasive procedures should be referred to the University Ethics Panel.

A research procedure being major invasive is a function of the nature of the participants, the research topic, the research procedures themselves and the competence of the research team. Vulnerable participants, intimate, illegal, stigmatised or controversial research topics, protracted, demanding, physically stressful or tedious research procedures and a less competent team make it more likely that the procedure will be major invasive.

6.4 The Panel delegates responsibility for approving non-invasive and established minor invasive research procedures to the Schools. As discussed above, these criteria are relative to (a) the participants, (b) the researchers and (c) the research topic. Significant changes in any of these should be referred to the Research Ethics Panel in the first instance. For example, that some staff commonly use a technique does not justify its use by a student not supervised by any staff member experienced in the technique. Another example is that the invasiveness of questionnaires or interviews is heavily topic-dependent.

A reasonable principle is often that research procedures approved for vulnerable participants, less experienced researchers and more sensitive topics can often be conducted unproblematically with less vulnerable participants, more experienced researchers and less sensitive topics.

It is the responsibility of the Head of Division or Subject Area Ethics Committee if applicable to keep an updated list of approved methods in that school or subject and to provide the University Ethics Panel with this list at least once a year. This list will include relevant information about any restrictions on this approval in terms of researchers, participants or topics.