Elements of a Communication plan

The elements of a communication plan described below are ones that the Beyond the Form project discussed with site staff and participants. We recommend that you form a reference group to help co-create your project, and to co-design the communication between the project staff and participants. There may be other communication elements that are relevant to your situation, but these illustrate the high-level principles found in the Beyond the Form project.

Skip directly to each element using these links:

Primary Point of Contact

A clear and consistent point of contact is essential to supporting participants throughout a research project. Having a designated contact person or team member who communicates with participants using their preferred channels—whether it be phone calls, texts, or face-to-face meetings—can significantly enhance their experience and trust in the research process. This contact should be knowledgeable, compassionate, and well-equipped to answer questions, ensuring participants feel informed and supported. Providing clear contact options, empowering staff with guidance on appropriate communication, and offering accessible contact information can make the process smoother for participants, particularly those with specific needs or disabilities.

  • Participants should have a clear point of contact within their research team. Ideally, there should be one person (or group using a common phone number and/or address) from which they receive all communication.
  • The primary point of contact for a participant is usually managed at the site, so the plan should consider any site-level constraints. This may include the staffing profile of the site: are staff working as a team across many projects or is there one (or more) dedicated person per project?
  • Many people have distinct preferences for how they communicate in general, such as preferring text messages over phone calls or vice versa. We recommend working with participants to determine what channel of communication will work best for them, and use that channel wherever possible.

  • Participants wanted consistency in who they spoke to, and for that point of contact to be able to find answers to any questions.
  • They wanted the person to be confident in what they could and couldn’t tell them about the project or know who to contact to find out answers.
  • Quotes:
    • I don't need a friendly person: I need this process to be very smooth and clear. 
    • I want one method of communication, clearly labelled or spoken about at the beginning and that's it. 
    • Do you have people with disabilities in your cohort? Then you have to work out what kinds of disabilities and cater to them, instead of just a general standard.
    • Over the two years I had a lot of rotating registrar doctors, so they didn’t know a lot about the study. The trial nurse probably should have, but seemed reluctant to provide information. I had to re-educate the doctors each time they started. It would have been nice to have someone who was prepared to share information with me.
    • I prefer to communicate either face-to-face or via phone. I hate texts because they can be misinterpreted. I always prefer to talk to people.

  • Provide clear channels for participants to contact the research team, including a dedicated phone number for calls or texts. If participants are able to program a specific number into their phone they are more likely to be able to find it quickly if needed, and to trust messages sent from that number.
  • Ask participants for their preferred communication channel and use that channel. For instance, that could mean using text messages to set up a convenient time for a phone call if that is required by the protocol.
  • Staff should be trained to communicate with empathy and respect. This may require communication strategies specific to the target population if there are specific communication issues related to the participants’ health status, primary language, or culture.
  • Provide guidance to site staff about what can and can’t be discussed with participants, so that they are empowered to discuss as much as possible.

Support Person

Participants should be given the option to have project communication materials shared with a trusted person to support their understanding of these materials, particularly if there are any likely communication issues, such as those related to language, culture, or health status. Participant preferences for logistical or emotional support from these people may change over the course of their involvement, so there should be the functionality to adjust participant preferences during the project.

  • This sharing of information may be in addition to having professional interpreters present.
  • For some groups of participants, a support person may be part of the research project (e.g. guardians of minors, or carers of people who can’t provide consent). In these cases, the communication needs of the support people also need to be considered.

  • Support people may provide invaluable assistance to the participant by translating or simplifying language used in the research project, or by providing logistical, emotional or decision-making support with research events or tasks.
  • They can also provide a “second set of ears” to help with processing and recalling what can be quite complicated or overwhelming information, especially for major milestones or disease assessment visits.
  • Quotes:
    • There's a change in how people interact as they get as they pass through different ages, but the other thing that can happen during the course of the trial is that your ability to interact with the information may change due to your health condition, or various other things. You may become more or less able to interact with the information that the study is handing out.
    • I'm not happy to engage or bring somebody with me in the initial studies unless I need to. I think it all depends on the different stages of the study.
    • You may nominate a person not to necessarily have all the information, but I think it's really helpful for families supporting and walking their journey alongside to have information that they understand of what their loved one is going through. Even if you're not involved, it's just that understanding and they're not always able to share that information in a way that you can understand.
    • Having the option to have a support person to assist them to do a research project might make the difference for whether someone takes part.

  • Participant preferences for support people should be checked regularly and contact lists kept up to date.
  • Any communication needs or preferences for the support person should also be considered.
  • Including a support person in communications should be opt-in, unless required by the design of the research project.

Opportunities for Health Education

Participants in clinical research are often very interested in opportunities for education about their health. Depending on the type of research, health education materials may either be used as part of a research intervention (if the impact of the materials is measured or different materials are used between groups) or may be provided as part of an engagement and retention strategy. Participants may also receive health education through in-person or online events where researchers can talk about their broader research program rather than project specifics.  These events can provide a greater understanding of the condition and provide a valuable opportunity for participants to ask questions of researchers directly.

  • Materials that are part of the research intervention would need to be reviewed by the ethical review body. Researchers should discuss with their ethical review bodies if a communication plan outlining how participant contact information will be managed would be sufficient.
  • Materials that are not part of the intervention should be provided with an opt-in approach, as not all participants will want additional information. This will also help avoiding overwhelming participants with unwanted information.

  • Health education could be achieved through offering education events (such as in-person seminars or expos relevant to the research topic), using educational materials created by relevant groups (e.g. condition newsletters), or creating resources specific to your population.
  • If using existing resources, it can be useful to provide site staff with a brief about any content particularly relevant to the study so that they can engage with the participant about that section.
  • Ask your consumer reference group about the most relevant materials or experiences for the target population.
  • If your trial is blinded, be careful to set boundaries for situations where participants are talking to each other to discourage speculation on which arm of the trial they are in.
  • Quotes:
    • I was asked if I wanted to be connected to different resources relevant to my condition, which was really useful for me.
    • I had no idea about stroke whatsoever when it happened to me, and that meant that I was eating up information wherever it came from.
    • I think it's positive for a lot of people have more personal knowledge about their condition.
    • You want to make the information supportive but not smothering. It's about keeping it simple. 
    • If you don't direct someone to the right information, then you risk increasing their anxiety. Not everybody knows about their disease, even though they've got the disease. So that's why I think it’s more useful to have a trial specific newsletter.

  • Health education could be achieved through offering education events (such as in-person seminars or expos relevant to the research topic), using educational materials created by relevant groups (e.g. condition newsletters), or creating resources specific to your population.
  • If using existing resources, it can be useful to provide site staff with a brief about any content particularly relevant to the research project so that they can engage with the participant about that section.
  • Ask your consumer reference group about the most relevant materials or experiences for the target population.
  • If your trial is blinded, be careful to set boundaries for situations where participants are talking to each other (such as events) to discourage speculation on which arm of the trial they are in.

Expressions of Gratitude

Expressions of gratitude may be delivered at various timepoints in a project, such as a thank you card or letter, a phone call or video message, or a certificate of completion. Expressing gratitude can be a powerful recognition of the contribution research participants make to the research endeavour. However, when done poorly this can also come across as tokenistic and potentially be counterproductive, so the timing and messages should be co-designed with consumer representatives.

  • If these types of messages are to be provided at multiple timepoints in a study, researchers could seek ethics approval by submitting a communication plan and relevant templates.
  • Consider the practicalities of sending out messages so that site staff are properly resourced for this activity.

  • Expressing gratitude to research participants can be impactful if they are personalised, but the sponsor needs to carefully consider if they are right for the project.
  • Quotes:
    • I truly believe that appreciation goes a long way, whether it's in research or other areas of life.
    • When my son had finished 27 months of cancer treatment, I had to request a certificate for him. It was cheap and nasty looking, so I’m still triggered by that.
    • It’s a nice surprise – it’s always nice to show gratitude – but I don’t think it’s a given.
    • I think a personal phone call as a thank you would be much better for me.
    • Something as simple as a personalised thank you card makes participants feel more comfortable that maybe their best interests are being taken into consideration, and they are not just a number.

  • Discuss best timing and content for the messages with consumers and site staff, as they can come across as insensitive if poorly done
  • Consider the participants’ current circumstances before sending, and check if there are communication preferences or support people who should be included.
  • The message could also be a thank you call or video recording, or include artwork from participants in the research
  • The message could be combined with sending updates about research progress or individual results
  • Personalising the item may be best done by the research staff who interacted with the participant.

Individual Results

Results from research tests that are not part of standard care may still be of interest or medically relevant to research participants. Participants should be given the option to receive these results, and they should be provided in a way that they can share with their healthcare team, if this isn’t done automatically. Care should be taken to provide a clear interpretation of the results for participants, preferably in person.

  • Research teams should consider how to ethically share individual results wherever possible.
  • The formatting and language of results should be co-designed with consumer representatives to make sure they are easy to understand.
  • When seeking ethics approval to share results, researchers could provide a template for what would be included in any individual results sent to participants. This should include the formatting for any graphs or tables, so that the clarity and relevance of the information to be supplied to participants can be reviewed.

  • Participant should be given the option to receive their personal results wherever possible and appropriate, depending on the design of the research project.
  • Any written results provided to participants should include a clear summary and explanation of the information and any medical terms used. While these terms may be explained by clinical staff in a meeting with the participant, staff should be aware that participants may want revisit the document later or share it with others.
  • Layering of the information (for instance through links to websites) so that people can seek more information if they want may be a useful approach.
  • Quotes:
    • I found it really traumatising when I didn’t know what was happening. The staff learned that I needed to know, so they would print my fortnightly blood results and explain them to me.
    • You need to be sure that people have the capacity to take the information on board. There are ways to format it, like infographics or an in-person, audio or video explanation, that can make the results easier to understand.
    • I asked if I could get the result, and the staff said “no-one’s ever asked that before, I don’t know”.

  • Share clear expectations on what can or can’t be shared with participants depending on the design of the project.
  • Ask each participant if they would like to receive their results.
  • Any graphics and wording in written results should be co-designed with consumers.
  • Discussion points likely to be encountered should be shared with site staff.
  • The format chosen for written results should be sharable with their health care team. This may include the research staff communication directly with the participant’s health care team.

Research Progress Updates

There may be a significant time between when a participant enrols in a project and when any outcomes from the research are available. This may be due to the project's duration, or the time taken to recruit the number of participants needed for data analysis. In these cases, it shows respect to the participant to provide updates on the progress of the project. Such updates, including the number of participants or active sites, are considered meaningful by many participants.

  • Researchers could seek approval for planned progress updates via a template outlining the content that will be included, the channels that may be used (such as via a written document, a video or audio version of the same content, or a conversation between the research staff and the participant), and the triggers for sending this information.
  • Researchers could usefully discuss with ethics review bodies whether every instance of the progress updates need prospective review or if another form of oversight (such as a Submission for Acknowledgement, or notification in the Annual Report) would be appropriate for lower risk communications.
  • Updates that contain only information that is already publicly available and non-promotional in intent (e.g., on the ANZCTR, or peer reviewed publications) or that are focused on increasing familiarity with the site, or site staff, may not require ethics approval for each instance.
  • Studies may also be abandoned for a number of reasons, which cannot be planned for in advance and any updates of this nature would need ethics approval.

  • Updates about research progress are particularly important for projects where there is a long involvement period for the participant, or there is a long time between when the participant’s involvement finishes and the research results are released.
  • If a research project closes early, participants should be told why.
  • Quotes:
    • A single sheet where I could see at a glance where the study is at, with pictorials and things like that, would be far more beneficial than having a lot of information overload.
    • I don't think you need to do it just for the sake of it, but there might be certain milestones where it is important.
    • On my first trial people were dying which was distressing. If it was that kind of situation, you’d need to ask how much information people want at the beginning.
    • Trials get stopped for many reasons, as we know, and even that information is important for participants.
    • I’m 13 years into a clinical trial, and I’ve never received any updates. The only way I know anything is because I have a professional role, and I see it at scientific meetings.

  • Milestones for sending updates should be pre-set in discussion with consumers and site staff to develop a schedule that is feasible to implement and not overwhelming for participants and/or research staff.
  • Updates could be about progress with recruitment or changes in staffing or sites if updates about interim results are not available.
  • Updates do not need to be long, and should be formatted like a press release, with the key points in simple language up front.
  • Updates can include a reminder of how participants can share any feedback to the research team. They could also raise awareness of any opportunities for participants to get involved in related activities. such as joining relevant consumer advisory groups.
  • Possible formats include phone calls, texts, emails, newsletters, podcasts, or presentations or workshops in the community.

Research Outcomes

Participants are very keen to understand the outcomes of the research they were involved in, but they commonly report that these outcomes weren’t shared with them. While there may be logistical challenges for sponsors in sharing these results (particularly for pharmaceutical companies testing new medications), this is widely recognised as an important way to demonstrate respect for the research participants.

  • Generally, sponsors are responsible for communicating research outcomes with site researchers, who are then responsible for the contact with participants. As such, sponsors are encouraged to maintain relationships with site Primary Investigators until the research outcomes are ready for ethics review and distribution, or to develop a plan to communicate these results to participants after they have closed the site.
  • Equally, ethics review bodies should question sponsors about their plans if they seek to close their trial at a site before they have submitted a plain language summary for their review.
  • Research projects that are testing therapeutic goods need to be aware of Australian therapeutic goods law and regulations in how they frame and distribute research outcomes to avoid promoting unregulated therapeutic goods.

  • Most workshop participants reported that they had never received information about the outcomes of the research, even if these had been promised.
  • Sharing the research outcomes was consistently seen as a way of demonstrating respect to the participants.
  • Quotes:
    • Any type of communication - doesn't matter how little it is - about the outcomes of the study is amazing and phenomenal. Just to know that the study is taking the next step, or we've developed data, or we have some outcomes. The bare minimum would be fantastic.
    • If people want information at the end of the trial when you offer it during the trial, then you need to step up to the mark and actually do what you say you're going to do.
    • To be able to share a short video about the trial with family and friends would be great, because sometimes it can be quite difficult to explain what you're involved in.
    • When you are a research participant, knowing and understanding that you have actually contributed to finding an answer to a problem is really powerful: it had a conclusion, and you know what the result was.

  • Set expectations on what type of outcomes or results will be shared, and when they are likely to be available.
  • Having layered information will increase the accessibility of the results. This could be by having a plain language dot point summary followed by more detail or sharing publications on request.
  • If there are plans to change standard care, let participants know how they could track that progress.
  • Negative results or nil results, and any plans for future research on the topic are also useful for participants to know.
  • Have the option for the information to be in a format participants can share with their care team (e.g.: something they can download and print out). This can also increase the translational impact of the research project.