Question

ethical considerations, ethical review and approval

ethical considerations

Answer 1

Ethical considerations

For any research investigation involving human subjects, there must be careful consideration of ethical issues that may arise in the planning, conduct, and reporting of the study. With very few exceptions, such research is not permitted unless the study has been approved by at least one formal ethics review committee (ERC). All research funding agencies require approval of the research by the appropriate ERC(s) before they will confirm an award for an intervention study. Often ethical review will be required from more than one such committee, for example, by both an institutional and a national ethics review committee, and/or in each of the countries involved in a trial. The ethics committee(s) will not only review the study protocol but usually will require full details of the study plan and procedures and will usually have specific application forms that must be completed. They may require payment of an administration fee for considering an application, irrespective of the outcome of the application. The committee will pay particular attention to informed consent documents and how consent to take part in the research will be obtained from potential study participants. Any significant changes in the study plan, either before it starts or during the conduct of the study, such as adding new objectives, extending the trial catchment area, or adding/removing inclusion or exclusion criteria, require approval by the ERC.

It is imperative that ethical issues are considered during the formulation of the evaluation plan. Ethical considerations during evaluation include

• Informed consent
• Voluntary participation
• Do no harm
• Confidentiality
• Anonymity
• Only assess relevant components

Informed consent

Informed consent means that the person participating in the evaluation is fully informed about the evaluation being conducted. Participants need to be made aware of the purpose of the project, who or what group is funding it, how the findings will be used, if there are any potential adverse impacts of their participation and who will have access to the findings. The main purpose of informed consent is that the participant is able to make an informed decision as to whether they will participate in the evaluation or not. Additional information should also be provided in the event that the participant becomes distressed in any way during their participation.

Voluntary participation

Voluntary participation means that people participate in the evaluation free from coercion. Participants are free to withdraw their participation at any time without negatively impacting on their involvement in future services or the current program and relationships with any of the researchers or research bodies involved. It can be challenging to encourage high risk youth to become engaged in a program and it is therefore difficult when participants choose not to continue in a program. It is the right of participants to leave a program of this nature at any time, therefore no pressure should be placed on those who choose not to continue. Explanations are also not required.

Do no harm

Harm can be both physical and/or psychological and therefore can be in the form of: stress, pain, anxiety, diminishing self-esteem or an invasion of privacy. It is imperative that the evaluation process does not in any way harm (unintended or otherwise) participants.

Confidentiality

Confidentiality means that any identifying information is not made available to, or accessed by anyone but the program coordinator. Confidentiality also ensures such identifying information is excluded from any reports or published documents. Given that there are often small numbers in peer based programs, it is very important to consider how reports are worded to ensure that there is no opportunity for people to be identified even though names are not used.

Anonymity

Anonymity is a stricter form of privacy than confidentiality, as the identity of the participant remains unknown to the research team. This is more difficult to achieve than confidentiality as participants in the context of social research are usually known to the program coordinator.

Only assess relevant components

Only assess those components that are of relevance to the program/initiative being conducted. High risk populations are sometimes being used as guinea pigs or a captive audience to ask all sorts of questions in evaluations that are of interest to groups conducting the program/initiative but not relevant to the program nor will be to the group who are involved in the program. It is important to keep evaluations as simple as possible and to remain focused on the intention of the evaluation and what the data gathered will be used for.

Ethical review and approval

If you plan to apply for ethical approval for research involving human participants or personal data from one of the University’s research ethics committees their applications forms and local guidance will help you to understand what to include in your application and what issues need to be addressed.

The information requested by your local committee will depend on your discipline and the type of research that you intend to undertake.

There are, however, some core issues that ethics committees will normally expect you to have addressed as part of your application:

Respecting autonomy

Wherever possible, ethics committees will expect you to demonstrate that you intend to respect the autonomy of individuals involved in your research. Normally this will include:

• Providing research participants with sufficient information to make an informed decision as to whether to take part in research (informed consent);
• Ensuring that participants are not subject to coercion to take part or penalty for not taking part;
• Ensuring that participants are, and are aware that they are, free to withdraw from the research at any time without giving a reason and without a prejudice;
• Protecting and respecting personal data provided by participants through rigorous and appropriate procedures for confidentiality and anonymisation.

Maximising benefit

Ethics committees will expect you to show that your research is worthwhile and will have beneficial effects that outweigh the risks posed by the project (see below). The recipient of the benefit will vary from project to project, but may include, among others, society, science, scholarship, health, and/or the participant themselves. The potential benefits of research should be presented realistically and not be exaggerated.

Ensuring that you maximise the benefits of your work is part of your obligation to research participants and scholarship and ethics committees will normally expect you to have taken efforts to do so. This would normally include:

• Designing, reviewing and conducting research in a manner that ensures quality and integrity and maximises the chance of obtaining useful results;
• Ensuring that research is effectively and appropriately disseminated;
• Ensuring that the aims of the research are transparent and that the methodology used is appropriate to addressing them.

Minimising harm

Ethics committees will expect you to have thoroughly considered the potential (and potential severity) for harm to come to research participants or others as part of your research.

You will be expected to consider all possible risks of harm that might be posed by your research, keeping in mind that certain harms, such as distress, embarrassment or anxiety, can be subjective and difficult to predict.

Harm (where identified) should normally be avoided and you will be expected to show how you will do so. Where the risk of harm cannot be avoided, an ethics committee will expect to see that you have taken robust precautions to mitigate the potential for harm and deal with harm should it occur.

It will normally be expected that the degree of risk (and potential severity) of harm should be proportionate to the potential benefits of the research. Research posing a high risk of harm or a risk of severe harm will require careful consideration by the researcher and ethics committee before being approved.

Being fair

Research ethics committees will also expect research to be, where possible, fair to those participating in research.

The nature of your research will not always allow the benefits, risks and costs of the research to be distributed in a strictly fair manner, but ethics committees will normally expect you to show that you have made efforts to do so wherever possible and that your research does not unfairly discriminate against certain individuals or groups.

Behaving with integrity

Researchers have an obligation to conduct their research with integrity and transparency. Research ethics committees will expect you to declare any actual or potential conflicts of interest that affect your research and to be honest and transparent throughout the ethical approval process and the research process. Any plans to withhold information from research participants should be explained and justified in your application for ethical approval.