Demystifying ethical review
Demystifying ethical review
This paper aims to provide an overview of the process of ethical review and how it may apply to those outside of a "research organisation" who wish to conduct research or evaluate their own programs.
Conducting research that meets high ethical standards is a priority for most researchers. Ethical review processes have been established to safeguard both those who participate in research and the individuals and organisations who conduct human research from unethical conduct. While horror stories of unethical and cruel research exist, thankfully, they are rare.
The process of ethical review can seem mysterious and difficult at first. However, it is often not as difficult as imagined. As will be outlined in this paper, some research and evaluation projects can be approved with expedited reviews, and others, such as those that solely utilise previously collected data (e.g., pre- and post-program participant surveys) and so pose no risk of harm to participants often do not require formal ethical approval at all.
Principles of ethical research conduct
In Australia, The National Health and Medical Research Council (NHMRC) website provides the key document for informing and understanding ethical research processes. The National Statement on Ethical Conduct in Research Involving Humans is an excellent place to start to understand the ethical review process, as it provides easy-to-read and use guidance and advice for researchers and ethics committee members.
According to the National Statement, ethical conduct of research is based on the principles of respect, merit, justice and beneficence:
Respect encompasses recognition of the intrinsic value of every human and their right to autonomy. Issues such as informed consent to participate in research fall into this category. Informed consent means ensuring that research participants understand what is expected of them through their participation in the project, what the potential risks and benefits of participation are, and that they participate in the project accordingly.1
Research merit is dependent on balancing the potential benefits of the research against possible risk to research participants. The research must be conducted in a scientific manner that will meet the identified aims of the research and answer the research question.
Justice assumes that the risk and benefit associated with research will be evenly distributed and no group will be disadvantaged by participation in the research.
Beneficence goes beyond the concept of "doing no harm". Essentially it is the expectation that the research will generate "good" or benefit. Participants may not benefit directly from the "good", but overall the project must benefit the wider community. The other principles of justice and respect are closely linked to beneficence.
Application of the principles of ethical conduct must be inherent throughout the research - from the conception and design of the project through to participant selection, data collection, analysis and interpretation through to dissemination of results of the research.
Example of considering the ethical principles when planning a research/evaluation project
A large family support service is planning on offering a protective behaviours program as part of an after-school care program for children between the ages of 6 and 10. The program has been conducted and evaluated in other settings with children of the same age group, and peer-reviewed publications have indicated that the program has been successful in improving child knowledge of protective behaviours. However, the service providers want to evaluate the program, both to ensure that it is having the intended effect of improving children's knowledge of protective behaviours, and to identify ways in which the program could be improved.
Parents have been consulted and provided written consent for their children's participation in the program. The information sheet provided to parents informed parents that the program would be evaluated.
Questionnaires used in the program evaluation are administered prior to the commencement of the program, and again at the end of the program, with children answering questions that describe their knowledge of safe behaviours and feelings. These questionnaires are part of the program design and children are not required to write their names on the questionnaires. Program staff will examine the questionnaires and analyse results to determine changes and gaps in knowledge and the program will be modified accordingly for future groups.
The research results of the evaluation will be published in a report available to all branches of the organisation to inform their practice. Additionally those involved in the evaluation want to present the results at a number of conferences and workshops.
This research evaluation would rely on data collected in the process of program delivery (i.e., Quality Assurance data) and, as such may not require an independent ethical review. No additional information outside the conduct of the normal program is collected and the questionnaires do not identify individual children. If focus groups with parents were conducted to gain feedback on the program then an expedited approval process may suffice for ethical approvals (this is dependant on individual ethic committee criteria so may vary from committee to committee). If the focus groups delved more deeply into information about family home life and experiences of sexual abuse children may or may not have had then a full ethics review would be warranted.
Consideration of ethical principles
Respect: Confidentiality and autonomy has been considered through parental consent to participation. In order to give informed consent, participants must understand what is expected of them, what the risks are if they participate, and be capable of balancing that against potential good. For most children, parents (or a designated caregiver) who are responsible for their wellbeing provide consent. However, even with parental consent, if a child chooses not to participate in the program - including the questionnaires administered at the beginning and the end - that choice must be respected.
Research merit: The methods are designed to appropriately answer the research question. Previous research has demonstrated that the program has been effective in other settings and any risks associated for participants are low. The research is being conducted as part of the existing program.
Justice: There is no additional risk imposed on any child through participation in this evaluation beyond their involvement in the program per se. Each child who participates in the program is included in the evaluation. The "burden" of participation is not greater for any child as it is part of the program being administered to all children. The results of the research are used for program improvement and are widely disseminated to other practitioners (within and external to the this agency) to inform program development on a broader scale.
Beneficence: The evaluation of this program may not directly benefit children who participate in the evaluation, however children who participate in future iterations of the program will benefit from the knowledge gained in the evaluation. The "risk" associated with participation is not greater for those who participate than the potential benefit gained for children who receive the program in the future.
What is a Human Research Ethics Committee?
Human Research Ethics Committees (or HRECs) are committees established to review research proposals and ensure they meet the requirements of the National Statement on Ethical Conduct in Human Research. Committees are comprised of at least eight members of varying backgrounds, including lay people, those with knowledge of care of people (e.g., nurse or counsellor), pastoral carers, and those with law and research backgrounds.
There are different protocols, forms and requirements for each HREC, but it is essentially the researcher's responsibility to demonstrate how their project complies with all ethical principles and does so in language that allows all members of the committee to understand and evaluate the proposal. The committee is responsible for evaluating the proposal in terms of those principles and, if they determine there are issues, communicating their concerns to the research team so that the project can be amended to meet requirements.
It is not necessary for all organisations to establish and maintain their own HRECs to conduct research. If the research is conducted in partnership with an organisation that already has an established HREC the review can take place by that committee or access to another committee can be negotiated as needed. Where an organisation agrees to conduct an ethical review for an external organisation, occasionally a fee for service or indemnification is charged.
Do all projects require ethical review?
All research directly involving research participants requires ethical review. Human research is any research "with or about people, or their data or tissue" (National Statement p. 8). This includes surveys, interviews or focus groups, psychological testing, behavioural observation, access to personal documents or identifiable (or re-identifiable data) collected for purposes other than the research. Any research that involves these processes must have approval prior to commencement. However, not all research needs to be reviewed by an HREC. Organisations can choose to establish other processes for exempting research that has only negligible risks or establish other levels of review for low-risk research (see pages 78-79 of the National Statement)
Where risk to participants is low (e.g., use of non-identifiable questionnaires by a service provider for clients to provide feedback on programs they have participated in), researchers may be eligible for expedited review by an HREC. In an expedited review, the full committee does not need to meet and review the proposal but the committee chair can make a determination. Access to expedited approval may depend on the committee, their processes, and their procedures.
Additionally, some research projects and evaluations may not require a full ethical review, as they rely solely on data that has already been collected for other purposes. For example, an original analysis of previously collected, publicly available statistical data would not necessarily require full ethical review. Similarly, organisations often choose to exempt from their formal HREC process any research or evaluation projects that rely on quality assurance data (e.g., pre- and post-program surveys collected as part of program implementation). Projects aiming to monitor, evaluate or improve services by a provider may be deemed to be "Quality Assurance" if they:
- do not impose any risk on participants;
- use existing data already collected by that organisation in the conduct of their work;
- ensure analysis is conducted by either members of that organisation or someone working with the organisation who is bound by a professional code of ethics;
- do not infringe the rights or reputation of the carers, providers or institution; and
- do not violate the confidentiality of the client.2
Example of a full ethical review
Proposed project: Evaluation of Family Dispute Resolution program
A large organisation has been conducting Family Dispute Resolution (FDR) for a number of years and counsellors have become concerned about those cases where the parenting agreement has broken down. They decide to investigate what caused the agreement to break down, whether parents expected the initial agreement to work, what may have contributed to making the agreement work or not work, an the impact the breakdown had on the parental wellbeing and that of their children.
Parents who re-enter FDR are asked if they are willing to participate in the study, and an independent staff member (e.g., not the counsellor who will be involved in their case) conducts an interview with them. Results are tabulated and analysed in house with a view to improving the program and reducing the number of families where parenting agreements break down.
This study, while it may be considered to be an evaluation of the FDR process, is one that organisations are more likely to classify as needing a full ethical review by an HREC. The research is gathering additional information beyond what would be needed to conduct the FDR. Additionally, the potential for clients to be traumatised or re-traumatised through discussion of what went wrong and the impacts of the parenting agreement breakdown exists therefore there is a risk of "harm" to the participants beyond their participation in FDR.
Example of an expedited review
Proposed project: Investigation into the experience of members of a youth advisory panel
A youth advisory panel was established in a rural community where there were issues of violent conflict between different cultural groups. One of the local providers sought to understand the experiences and perceptions of those young people who participated in the advisory council. The participants were interviewed and asked a series of open-ended questions relating to whether or not they felt their participation contributed in a meaningful way, how the experience could be improved and whether or not they felt the experience was something they could build on for their future.
As the questions were not likely to relate to trauma, involved no more than an interview about their thoughts and were unlikely to have a negative impact on the future of the youth, an expedited approval may be appropriate for this study. Because the research collected additional information to what would normally be included in their participation in the panel, the study would be unlikely to qualify as Quality Assurance. It is important to remember, however that each organisation makes a decision as to what is appropriate for expedited approval and that this may vary from one organisation to another.
Example of a Quality Assurance application
Proposed project: Evaluation of fathering program
A community centre in an urban setting ran a program to help dads connect with their pre-school children through play. The fathers came into the centre each week and spent a half hour playing with their children, under supervision. Initially centre staff were actively involved in the play session, offering advice and interacting with the father and the children, but as the sessions progressed they withdrew, until the father and child were alone in the play session. Each session was video recorded. Following the play session the fathers reviewed the play session to review their own responses to their children and identify areas where they could improve.
In order to evaluate the program, the same videos that the fathers reviewed were used. Staff evaluated the father's ability to identify strengths and weaknesses and staff responses during the sessions. The evaluation was conducted by members of the organisation who were not involved in the program. No additional information was collected. The evaluation considered the number of fathers who were able to identify strengths and weaknesses and the number who improved their connection based on the father's evaluation and an independent assessment of staff responses by the evaluator. Fathers were asked for their consent to use the videos for the evaluation process prior to program participation and again when they finished the program.
The evaluation could be classed as quality control as the aim was to ensure the program was achieving the goal of assisting dads to connect with their children. Because no further information was collected, the evaluation was done "in house" and the fathers were aware that their videos were to be used for evaluation, HREC approval would not be needed.
Even for Quality Assurance projects such as this, organisations have an obligation to follow an explicit policy for reviewing such activities to be sure the project complies with Quality Assurance guidelines and does not require external review by an HREC.
What kinds of feedback do ethics committee normally give?
If a project is designed with the major principles of respect, research merit, justice and beneficence, it is unlikely to be rejected outright by an ethics committee. However, often ethics committees will make recommendations on changes to the project before it can proceed. In some cases all that is required is for the researchers to clarify their research and answer some questions. Some ethics committees will ask for key documents describing the project to potential participants (e.g., information sheets, consent forms) to be amended.
The NHMRC website has a great deal of information on ethics and ethics committees. The NHMRC Ethics guidelines can be downloaded and additional information found to guide an application.
The NHMRC website also offers a number of publications that may be of interest, including an archived version of When Does Quality Assurance in Health Care Require Independent Review?
For any research proposal it is worth speaking to an ethics committee prior to deciding what ethics approvals are needed. Often a spokesperson for that committed can provide guidance and assistance to smooth the process of applying for ethics approvals, or reassuring researchers that expedited or Quality Assurance approvals are relevant for their research.
For more information see:
National Statement of Ethical Conduct in Human Research (National Health and Medical Research Council)
1 The issue of informed consent can be complex, especially when research participants have diminished capacity to understand potential risk and benefits associated with their participation. Further guidance on issues of consent can be found in Chapter 2.2 and additional information involving research with specific vulnerable groups in Chapter 4 of the National Statement on Ethical Conduct in Human Research.
Authors and Acknowledgements
This paper was compiled by Deborah Scott, Research Fellow with the Child Family Community Australia information exchange at the Australian Institute of Family Studies.
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