8.0 Recruiting Human Participants
- 8.1 Introduction
- 8.2 Identifying potential participants
- 8.3 First contact with potential participants
- 8.4 Compulsory activity and embedded research
- 8.5 Reimbursement, incentive and risk
- 8.6 Screening and exclusion
- 8.7 Justice and selection of participants
- 8.8 Over researched populations
The recruitment phase of a human research project is fundamental to the success of a project and is also a key area of ethical concern. During this phase of a project:
- potential participants are identified,
- some form of contact is made between the research team and potential participants before any screening or exclusion occurs, and
- preparations are made to seek informed consent from the potential participants.
This process establishes the nature of the relationship between you, the researcher, and the research participants.
If the recruitment phase of your project is handled poorly - or unethically - your project could:
- contravene the principles of ethical and appropriate conduct of research - as defined by both the National Statement and Deakin University;
- undermine the rights and welfare of the potential participants;
- have a lower than expected participation rate;
- impact upon future attempts to recruit the potential participant pool for other research projects; and
- be subject to official complaints about the project and / or research team.
Increasingly, people are conscious of their right to privacy, and sensitive to misuse or potential misuse of information about them. If you, as researcher, contact people directly, you must tell them how their details have been accessed to assure them that their privacy is not being infringed.
Our experience shows that the recruitment phase of human research is the most common source of concerns and complaints about the conduct of research.
You will identify potential participants by related, but separate, processes.
- Identify the type or category of people who are the most appropriate participants for your project
(eg patients with a particular condition).
- Identify the particular individuals to approach about participation in the project
(eg patients attending a particular clinic which treats the condition).
- Identify an appropriate method of contact with that particular group.
The Human Research Ethics Unit finds that many researchers focus on the type of participants to be recruited, and don't give enough information about how individuals will be identified, or about the recruitment process itself.
Where the recruitment process will involve some form of direct contact, significant ethical and legal questions can be raised by how the direct contact will be made.|
The most common forms of recruitment are discussed here, but issues such as privacy, capacity to consent and a respectful means of approaching potential participants need to be considered in any recruitment scenario.
In clinical research, participants are often located through the use of medical records. This raises significant ethical and privacy concerns, as these are personal records created (in most cases) for use in the treatment of the person, and not for research purposes. In Victoria, access to such records is governed by the Health Records Act (Vic) 2001.
Access to such records for the purposes of research without consent can only be authorised in specific circumstances and with the prior approval of an HREC.
Records which have been included in a databank for research purposes, are excluded from this requirement where the databank has appropriate consent from the people whose information has been stored, though you will still need to seek ethics approval prior to accessing these data for your specific project.
In general where medical records will be used for first contact, you should provide participant materials (letters, plain language statements, flyers) to be distributed to potential participants on your behalf by people who have access to the information in the normal course of their work or other activities.
A common mechanism for identifying potential participants is via an organisation's mailing, client or employee list (eg, a list of all parents maintained by a school). While such a list may be the most appropriate mechanism for identification, there are ethical and legal requirements about how such a list should be used for a direct first contact with potential participants.
- Where the list is available to the public (eg, the phone book or an employee contact list on an organisation's website), the contact details may be used.
- If the people on the list have already agreed to be contacted for research purposes, their contact details may be released.
- In most cases privacy requirements prevent the release of contact details to researchers without prior consent from the people on the list or a waiver of the requirement for consent from an human research ethics committee
- If a contact or mailing list is used to recruit participants and you do not have the consent of the people on the list to access their details, you will normally be required to provide recruitment information to the custodians of the list for them to distribute on your behalf. The custodians should not release information to you without consent.
In some cases recruitment is by direct contact with previously unknown people. This can include:
- Random approach to strangers in a location
- Approach to users of a particular service
Participants are identified by their location (eg a person approached in a shopping centre can be assumed to be a user of that shopping centre) so their identities are not known at the point of recruitment. There are no specific ethical or legal pre-requisites to this form of recruitment, though you should be conscious of any sensitivites that may exist (eg approaching people unexpectedly at an Alcoholics Anonymous meeting).
You may also choose to approach people you already know by:
- Individual approach to each potential participant
- Introduction by a third party known to the potential participant
- Address to a group (club, class, workplace)
If the research involves known individuals (whether known personally to you, introduced by a third party, or members of a group addressed collectively by you) then the issues of inappropriate access to information are avoided but other issues are raised.
|You should arrange the contact so that the person approached will not feel pressured to be involved because of the existing relationships being brought to bear (eg, approach from a co-worker, or introduction from a nurse at a clinic the person regularly attends).|
Potential participants can also be identified by a process - commonly referred to as 'snowballing' - where contact with one participant results in a lead to another participant, and so on.
The term can be a little confusing, as it refers both to
- participants providing contact details of other people to the researcher,
- participants passing on information from the researcher to another who might be interested, who then contacts the researcher directly.
To protect privacy, the latter option should be adopted, with participants passing information to other potential participants, who then decide whether or not to contact the researcher.
This type of recruitment will not produce a random sample of participants, as recruitment will follow existing lines of community contact between people with interests in common.
Handled poorly, snowballing can raise privacy, coercion and other concerns - especially when the project relates to sensitive matters.
Self-identification, where potential participants identify themselves to the research team, is perhaps the most ethically simple way of identifying potential participants. Such self-identified participants are usually responding to an advertisement, flyer, etc.
Once you have identified potential participants , you will need to plan for the first contact with those potential participants. The process of identification and first contact can be intertwined, but it is useful to separately consider some of the ethical issues and practicalities of first contact.
The nature of the first contact with a potential participant is a very common source of ethical concern. Even where your first contact process is in both ethical and appropriate, it must be clear and evident to the potential participant.
For example, where participants are chosen randomly from the phone book, but this is not made clear to them, they may believe that information about them has been inappropriately obtained from another source.
Where first contact is made by correspondence: distribution of a letter, email etc., always include the following information:
- whether personal information has been disclosed to you (the researcher),
- an introduction of the project and research team,
- whether third parties (including the agency that distributed the information, if there was one) can identify individuals who decide to be involved in the project.
Make it clear that participation is entirely voluntary.
If another agency or organisation is distributing recruitment materials on your behalf:
- emphasize that participation (or not) will not disadvantage the person's relationship with that agency or organisation.
- clearly state that no personal information of potential participants has been supplied to the researcher.
- clearly state whether:
- interested parties are invited to contact the researchers directly, or
- provide their consent for the organisation or agency to pass on their details to researchers.
Include a copy of the proposed participant recruitment correspondence in your application for ethics approval.
The same principles apply as for approach by correspondence. As there is no letter or email, please include a copy of the proposed phone 'script' in your application for ethics approval.
When designing and conducting a telephone-based recruitment strategy, you must remain conscious that the immediacy and intrusiveness of such approach can cause a potential participant distress – especially if they are otherwise vulnerable. Distress can be further compounded if the subject matter of the research is sensitive.
The most usual use of phone recruitment is when the phone is proxy for 'in person' interview. This occurs where it is not practicable to undertake 'in person' interviews because distance, number of participants or extreme confidentiality is involved.
When you recruit participants over the phone always:
- ensure the potential participant understands that the telephone call is about a Deakin University research project, and include a way to confirm that the participant has a contact number for the research team, and the complaints clause contact details,
- where possible, have a 'cooling off' period before collecting sensitive data, and
- ensure there is an appropriate way to record the consent process.
|Where your participant pool will include vulnerable persons or the subject matter is especially sensitive, design your recruitment mechanism to allow time for thought before consent is given. This can be done in a number of ways, eg by providing written information ahead of time (where the participants are a known group), or by calling first to gauge interest, then making a time for the 'interview'.|
This type of approach will reduce the anxiety of the potential participant, and may also increase the chances that the potential participant will provide the information being sought.
'Cold calling' is where participants in research are contacted and immediately asked to answer questions without any other consent process. In this case the information, consent and data collection processes may all happen within the space of one phone call. Cold calling gives little
opportunity to consider the project or confirm that the researcher is who they say they are.|
The Deakin HREC considers that cold calling should only be used for low risk research.
Ethical issues in telephone based research are discussed in section 37.
The same principles apply as for approach by phone. Direct approach to potential participants also requires some special measures:
- Recognise that some people may find being approached threatening or annoying, and conduct yourself in a way which reduces the likelihood of this.
- Start by introducing yourself as a Deakin University researcher.
- If the person you approach does not wish to speak to you, they are free to decline.
- Consider your own safety and security (eg consider the locale, time and context in which face-to-face contact will be made).
- If you will be recruiting in a shopping complex, club or other closed area, you may need prior approval from the management.
- If you intend to recruit people attending a private meeting where sensitive issues may be discussed (eg a support group for parents after the loss of a child) you should ask the facilitator to inform potential participants ahead of time when you will be in attendance and the reason for your visit.
Your approach needs to provide potential participants with enough time and space to consider their participation in research.
- If your project will involve significant burdens and/or significant potential risks, do not ask for consent 'on the spot'. Instead, provide participants with information about the project and invite them to contact the research team if they wish to take part.
- If there are no significant burdens or risks you may choose to seek consent at the point of first approach.
When potential participants are people you know (or you are introduced by a trusted third party), this can raise other ethical issues, especially if the first contact about the research will be a direct approach. It is important to think these matters through and give a clear rationale for the approach that has been chosen.
It is possible that the person approached may feel obliged or pressured by your relationship to participate. This can be particularly fraught if you are in an authority position (eg the participants are your students or junior to you at work). In some situations (eg recruitment within particular ethnic or religious communities) an approach by a trusted person is the most appropriate way to recruit.
When you recruit by face-to-face contact with known people:
- Use an approach that negates any assumption, implicit or otherwise, that potential participants will agree to be involved.
- Ensure your approach won't be seen as intrusive or inappropriate.
- Provide potential participants with enough time and space to consider their participation in research.
- Where your project will involve significant burdens and/or significant potential risks, do not ask for consent 'on the spot'. Instead, provide participants with information about the project and invite them to contact the research team.
- Where there are minimal burdens or risks you may choose to seek consent at the point of first approach.
- Will your recruitment method expose potential participants to any risks? The risk may stem from something as simple as their known involvement with (or exclusion from) the project. Can these be addressed by adjusting the research design?
- Does the potential participants' existing association with you create any risk for them? Eg where you are their superior at work and interviewing and them about workplace practices.
- Use an approach that avoids triggering peer pressure to be involved - consent must be voluntary and free of coercion.
Where the initial contact will be conducted via a third party, such as by correspondence or snowballing, you must ensure that:
- Using a third-party does not establish any degree of coercion – overt or implicit. This can be especially acute when an unequal power relationship exists between the potential participant and the person conducting the recruitment.
- The recruitment process clearly distinguishes between the research project and the normal relationship between the third-party and potential participant.
You must provide a copy of the proposed participant recruitment materials in your application for ethics approval.
The third party:
- provides the approved information about the project to the potential participant.
- invites the potential participant to contact the research team if they are interested in participating.
- does not know which individuals approached ultimately participate in the research.
This reduces the likelihood that potential participants will be exposed to any risks due to their existing association with the third-party.
In this case, potential participants identify themselves as being interested in participating in the research by responding to an advertisement, notice or flyer giving details of the research.
Take extra care that the language and features of the 'advertisement' material give a succinct and accurate description of who you wish to recruit and what participation will involve. You must provide a copy of the proposed 'advertisement' material in your application for ethics approval.
Human research will often be conducted as a component of a compulsory activity in which participants must be involved, eg:
- students participating in class activities for a course,
- staff implementing a required work process or practice, or
- people completing prescribed activities as part of a judicial order.
Research in these situations will normally be either an evaluation of the program (class, practice, activity), or an inquiry into the experience of people undertaking the program.
In such cases, you are not recruiting participants to take part in these activities, which will go ahead with or without the research component. Recruitment and consent relate not to the program, but to the evaluation or inquiry that is being conducted in relation to it.
You must distinguish between the elements relating to the research – about which the participants have a choice – and those which are a mandatory element of the program, independent of the research. All participants in the program must understand that their involvement in the research is entirely voluntary, and that the research has been designed to be separate from participation in the program.
In practice the usual arrangement is either:
- individuals who do not consent to participate in the research will only take part in the compulsory activity, not the research activities; or
- individuals will participate in both the compulsory and research activities, but data will not be collected, analysed or used that relates to those who have not given their consent.
Your choice of arrangement will depend on the nature of the program and whether it is practical to separate the program and data collection.
Your offer of any form of payment to a participant has the potential to undermine the voluntary nature of the consent obtained. Yet, handled carefully, the following offers of payment can be ethical, appropriate and even desirable.
|Justice, one of the four key principles that underpin the National Statement, requires that all potential participants get equal access, and the burden of participation is shared fairly.|
Participants in research may incur costs as a result of their involvement eg travel to a laboratory or clinic. Deakin HREC will usually approve reimbursement of out-of pocket expenses to participants.
The National Statement also allows for payment for time involved in appropriate cases. Payment for time involved is usually considered an incentive for participation rather than a reimbursement, unless the time required is very significant (eg several hours spent in testing a new computer program).
|Any 'reimbursement' for costs or time which is so substantial it is likely to encourage participants to take risks they would not otherwise take, is ethically unacceptable.|
In general, incentives which take the form of either a small gift (eg cinema vouchers or food items) or token amount of money (eg $10 or $20) do not raise significant issues.
Ethical questions arise where there is disparity between the incentive, the cost of participation and the risk to participants. A substantial payment may serve to coerce participation thereby undermining voluntary consent.
Deakin HREC tends to be conservative when considering the use of substantial amounts of money as an incentive, but each research project is considered on its merits.
- If there is a high burden or long hours involved in the project, you will have a better chance of making a successful case for a substantial or desirable incentive.
- The value of the incentive may be relative to the potential participants: a $50 book voucher may have substantial value to a student, but much less to a practicing accountant.
- Consider the potential risks or burdens associated with the research will affect your use of incentives.
|Any incentive which is so substantial it is likely to encourage participants to take risks they would not otherwise take, is ethically unacceptable.|
Rather than offer every participant an incentive, you may elect to enter participants into a draw where one will 'win' the incentive. At first glance, this seems to remove all question of coercion, as the incentive is tiny – merely the possibility of an incentive. There are however other ethical issues associated with encouraging participants to engage in gambling behaviours. All projects including prize draws will be considered on an individual basis.
The actual prize draw must be conducted by an independent party (not by a member of the research or recruitment team).
Further information regarding the legal requirements for conducting a prize draw can be found on the Victorian Commission for Gambling and Liquor Regulation website.
Where you offer any form of payment for participation, the participants must be informed of:
- the maximum dollar value of the reimbursement,
- the proof or documentation which must be provided to obtain reimbursement, and
- at what point in the process payments will be made.
Occassionally, researchers may chosse to provide a gift of appreciation to participants at the conclusion of a study but choose not to inform them ahead of time so there is no potential for coercion. This is ethically acceptable.
Where recruitment is based on particular characteristics (eg. age, gender, race, profession) you will need to establish the relevance of these characteristics to the project.
In section 6.1.1 of the NEAF you will be asked to nominate particular groups of people who may be designated as
- the primary focus of the research,
- probable coincidental recruits (where you are more likely than not to recruit people in this group), or
- specifically excluded from the study.
In section 6.2 of the NEAF you will be asked to describe each group of participants that you plan to recruit and explain why these characteristics are relevant to the project.
|Only include or exclude potential participants for reasons which are relevant to your project design.|
Where your potential participant pool includes people who
- are particularly susceptible to the identified risk factors, or
- will suffer greater consequences if the risk factors do occur.
your recruitment process must include a mechanism to identify these people with a view to them being excluded from the project.
In 188.8.131.52 and/or 6.5.2 of the NEAF, you will be asked for details of this mechanism and the reason for its inclusion. You should also include this information in the materials provided to potential participants, so they can:
- understand that, for some people, the risks associated with their participation are higher;
- appreciate why, despite their interest in participating, such people will be excluded; and
- identify themself to your or the recruiter, where they recognise they belong to an excluded group, or simply exclude themselves.
The mere fact of inclusion or exclusion from a research project may expose participants to risk, eg a project studying coping strategies amongst emergency service personnel might expose excluded people to risk, if an exclusion criterion was the presence of significant psychological difficulties. This is known as secondary risk.
You are required to minimise such secondary risk associated with your project. In the example above you would arrange that nobody but the individual would know that they had been excluded.
8.6.3 Screening prior to consent
Some research projects may require a screening process prior to the actual conduct of the formal recruitment phase and therefore prior to informed consent being sought from potential participants.
For example – a project design which requires access to a hospital's patient records to look for individuals who are symptomatic for a particular condition with particular other associated factors. Only following this identification will recruitment be conducted.
Screening before consent raises significant privacy ethical and legal issues that must be addressed.
Justice is one of the four key principles that underpin the National Statement. Paragraph 1.4 describes the requirements of recruitment in just research. Justice requires that the 'selection exclusion and inclusion' of participants in research is fair, that there is no unfair burden on particular groups, and that the benefits of research are fairly distributed.
Deakin University accepts that for practical reasons, it may sometimes be necessary for a project to seek to exclude some categories of participants. For example – it may be necessary to exclude potential participants on the basis of the fact that there have impaired mental capacity and are wards of the state, because it is not practical to obtain appropriate and legal consent for their participation within a useful timeframe. However, where possible, researchers are encouraged to design their research in a way that would enable compliance with this ethical principle.
If any potential participant is excluded from a project (or are selected) on the basis of their race, gender, age, disability, etc, they must be provided with a clear explanation of why this has occurred. This is especially important where a willing potential participant has been excluded from a project and the reasons for this exclusion may not be immediately apparent to them.
Where you intend to exclude potential participants as described above, you will need to include details of how and why this will be done in yoru ethics application.
Some populations are of particular interest to researchers. When these populations are relatively small or unique this can lead to them being over-researched. It is vital both to ensure adherence to the ethical principle of justice, and to ensure the continued involvement of these groups in research, that researchers are sensitive to this situation and to other research which may involve the same participant groups.
Issues that researchers should consider when planning research with 'over researched' populations are:
- Will there be a flow of benefits back to the participants, or will the benefits of the research be enjoyed elsewhere and/or by others?
- Will the group receive useful feedback on the results of the research? Sometimes the flow of such results may be the only real value associated with participation in the research. In some cases, the flow of aggregated/ non-identifiable results to the representatives and/or spokespeople for such groups can be an important, and often neglected, benefit.
- Is the research seeking to address an issue which they consider to be of significance?
- Does the research address, or compound, inequalities or other problems faced by the group?