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Table 1 An ethically conscious framework for public involvement at the research design stage

From: A framework for public involvement at the design stage of NHS health and social care research: time to develop ethically conscious standards

Suggested Order Areas of concern for Public Involvement at the Research Design Stage Potential Ethical Issues for Involving the Public at the Research Design Stage Suggested Solutions, including any related guidance that is available.
1). Allocating sufficient time for public involvement Inadequate allocation of time could result in public involvement not having the fullest impact upon the funding application and may contribute to stress and burden felt by those involved. Building in realistic timelines, including at the research design stage: for example, offering the public involved at least two weeks to read and feedback on a funding application.
2). Avoiding tokenism When preparing a funding proposal public involvement activities at the research design stage are only listed in a ‘tick box’ (e.g. Stage 1 of the RfPB application process) without providing details anywhere else in the application. Make any public contributions visible. Detail throughout the research application how the public have been involved in the research design stage and what difference it made. Who was involved? What did they do and contribute? How exactly did their input help shape the research proposal?
Funding bodies to provide guidance on how and where research design stage public involvement activities could be “woven” throughout the application form? (e.g. how to supplement the public involvement tick box information for NIHR RfPB stage 1).
3). Registering of research design stage public involvement work early with NHS Research and Development (R&D) Trust Office Trust R&D offices not being informed of research design stage public involvement funding (e.g. RDS Public Involvement Fund) and that involvement of the public may sometimes occur on NHS premises (which may raise indemnity issues). INVOLVE recommend that organisations and researchers include the governance of public involvement in their research accountability. Trust R&D offices can provide practical support around local governance arrangements.
4). Communicating clearly from the outset Not communicating clearly about public involvement roles and expectations at the research design stage can lead to disengaged and disenfranchised members of the public, unable to contribute to the study. The public involved at the research design stage require the same information as the rest of the research team, but communicated in ways that they can access and understand.
Use plain English to inform the public about the study and public involvement roles and responsibilities (verbally and/or print) to help people make informed decisions about becoming involved in the first instance (including research design stage). This is more likely to help them to be well informed and remain engaged.
In consultative activities some group members can dominate if the consultation is not facilitated skilfully leading to some people not being able to communicate their ideas.
See also: Bagley et al.(2016) [23] Appendices 5&6: doi/10.1186/s40900-016-0029-8
Wright et al. (2010) [21] Table 2. P.365: doi/10.1111/j.1369-7625.2010.00607.x :
Consider group facilitation skills training to help manage dominant group members in order to capture the range of public involvement contributions.
Some RDSs offer a consultation facilitation service in addition to public involvement funding.
5). Entitling public contributors to stop their involvement for any unstated reason (s) In order that the public who get involved do not become overwhelmed by what they are asked to do Inform lay people early on that they can cease their involvement activities (including research design) at any time and without detailing their reasons for so doing
See also: Wright et al. (2010) [21] Table 2. P.365: DOI: 10.1111/j.1369-7625.2010.00607.x
6). Operating ‘fairness of opportunity’ Not taking issues around diversity and inclusion into account at the research design stage may result in disempowering, discriminatory research. Respecting and valuing all forms of difference in individuals.
If a research question is specific to a particular group or community, it is in the researcher’s interests to specifically engage and consult that community at the research design stage.
7). Differentiating between public involvement activities and qualitative research methods Reference to research design stage public involvement activities (e.g. consultations) using research terminology can confuse those who get involved about whether they are helping design the research or are participants in the research. It may also lead to conflicts of interest. Avoid research terminology (e.g. ‘focus groups’) when referring to consultative public involvement activities.
Do not combine qualitative research methods and public involvement activities; keep them separate. There is no reason why those who are involved in a study cannot also participate in some aspect of it but the difference needs to be made explicit. Researchers should also carefully consider whether this might present those involved with any potential conflicts of interest.
Research Design Services (RDS) can help advise on the use of qualitative research methods and consistent practice and terminology in involving the public at the research design stage.
Ambiguity around terminology may be linked to lack of clarity about exactly when ethical approval is required.
8). Working sensitively Some of those involved at the research design stage may find the experience emotionally upsetting (particularly those with lived/carer experience of the condition under investigation). They may be reminded of negative health experiences or learn of risk factors or negative long term consequences of their condition for the first time. They may also become unwell making continued involvement difficult or impractical Researchers need to avoid emotionally upsetting, sensitive situations and undertake public involvement sensitively at all times (including at the research design stage) especially with those with lived/carer experience of the condition under investigation and vulnerable people. Counselling or other support may be required. Additional time may be required if those involved are too unwell to perform their tasks.
See also: Wright et al. (2010) [21] Table 2. P.365: DOI: 10.1111/j.1369-7625.2010.00607.x :
Are service users well enough to participate? Will service users become distressed?
9). Being conscious of confidentiality Disclosure of personal, sensitive information during research design consultations (particularly when these take place in a group) can occur. Ensure that a confidential environment is fostered at the beginning of every research design consultation. If the discussions are audio recorded, the reason for this and how the information will be used must be made clear. Permissions will need to be gained and confidentiality assured. See also area 7 above: if the information that was recorded is to be used to answer the research question in any way then this is research not involvement and ethical approval will be needed [18].
Permissions to record the consultation may be overlooked.
Research ideas may be disclosed by public reviewers who have not been appropriately instructed about protocol confidentiality. When the public are involved in reviewing protocols those doing so must adhere to a confidentiality agreement in the same way as any other reviewers.
See also: Bagley et al.(2016) [23] Appendices 5&6: doi/10.1186/s40900-016-0029-8
Wright et al. (2010) [21] Table 2. P.365: DOI: 10.1111/j.1369-7625.2010.00607.x
10). Valuing, acknowledging and rewarding public involvement Not valuing, acknowledging and rewarding the contributions of the public involved at the research design stage may lead to them feeling disempowered and marginalised. Value and acknowledge public involvement at the research design stage by faithfully capturing contributions from the public in the research proposal and also via individual reward and recognition (i.e. payment; training opportunities)
Out of pocket payments should be offered. Alert researchers to RDS Public Involvement Funding (available for research design consultations).
There can be financial burdens for those involved at the research design stage, which if not addressed may deter people from getting involved.
See also: Bagley et al.(2016) [23] Appendices 5&6: doi/10.1186/s40900-016-0029-8
Wright et al. (2010) [21] Table 2. P.365: DOI: 10.1111/j.1369-7625.2010.00607.x
  1. Approaches to avoid ethical issues in involving the public in health and social care research prior to submitting for funding or receiving ethical approval (i.e. the research design stage)