Cheryl B. Thomas, MS, CGC, Research Subject
Advocate, Mayo Clinic
Abstract
Going “beyond the regulations” that govern informed consent and understanding the perspective of research participants is crucial to obtaining truly informed consent. This article describes the aspects of informed consent that involve human experience and interactions. Positive and negative feedback from research participants is reviewed to illustrate common issues in participation in clinical research. Participant suggestions for improving comprehension and the overall informed consent experience are shared.
Disclaimers: The author is sharing her own views based on conversations with many research participants. The federal regulations are not reviewed because many of the problems with informed consent arise even when the study team follows the regulations.
Negative Feedback from Research Participants
As a research subject advocate at Mayo Clinic, the author hears negative and positive feedback from research participants about their experiences during the informed consent process. Table 1 outlines negative feedback shared by research participants.
Not having a chance to read the informed consent document before signing it results in a negative participant experience. For example, a potential participant may be handed a consent document folded to the signature page. This should never be done, because it adds a sense of urgency to the interaction, and sends the message that the study coordinator wants the individual to sign the document without reading it so he or she can be enrolled in the study. Potential research participants must have the opportunity to read the informed consent document and be entirely comfortable with the decision to participate before signing it. However, it is important to note that a participant may feel like there was no chance to read the informed consent document even if the study team member reviewed it in detail with the participant. The timing of the informed consent conversation plays an important role in whether a research participant remembers having read the informed consent document before signing it. A person who is in crisis, such as having a heart attack, may be scared and not remember everything that happened during that time. Or, a potential participant might be trying to process a life-changing diagnosis and cannot give the informed consent conversation the attention that it requires. If consent must be obtained in these situations, the study team should encourage the participant to read the informed consent document when things calm down and provide the participant with contact information for the study team so that they can have a follow-up conversation and all questions can be answered.
The opposite end of the spectrum, where the study coordinator reads the informed consent document to a potential participant word for word, is also a negative experience. Reading a lengthy document to a potential participant does not create an open a dialogue, and the informed consent discussion becomes one-sided. This does not encourage potential participants to ask questions because they may not be paying attention or may not want to drag out the process any longer. Informed consent must be a conversation, which requires that both parties be engaged and communicating.
It is essential that all research participants be told that participation is voluntary. The study coordinator should mention this at the very beginning of the informed consent discussion and reiterate it throughout the conversation. Some people will never want to participate in research; however, they may feel obligated to listen to the study coordinator review the entire document before saying no. Informing potential participants at the outset that they do not have to participate gives them permission to say that they are not interested, saving time for everyone. This also makes them perceive research more positively because the study team gave them an option and they did not have to spend time learning about the study. Also, if an individual decides to participate in the study, it is crucial for the message that participation is voluntary to be repeated frequently.
Another common negative comment is not having enough time to think about participating or to make a decision. Patients often feel rushed in the health care setting. They may feel like they are being shuffled from one thing to the next and are receiving a great deal of information in a short period of time. Many people need time to take a step back and process information, to determine what will be best for them. Unfortunately, not every study allows potential participants time to do this. Whenever possible, the study team should encourage potential research participants to take time to think about whether to participate in the study, to ask questions, and to discuss it with family, friends, and their physicians. People need time to weigh their options and make a decision that is consistent with their goals and values. When given time to carefully consider the study, individuals who decide to participate are more likely to be comfortable with their decision and invest in the study, which benefits both the participant and the study team. Participants who rush into a decision may be less comfortable or ultimately regret that decision, which will make them more likely to have a negative research experience or even withdraw from the study.
Unanswered questions about the study always result in a negative experience. Participants may feel uncomfortable asking the study team questions for a variety of reasons. Many people are not comfortable asking questions because they are embarrassed that they do not know the answers. Many individuals, especially elderly patients, feel that they do not have a voice in their healthcare and will do as their clinicians advise without question. Sometimes potential participants do not think that there is time for them to ask questions, or they have asked questions in the past that were not sufficiently addressed. The onus is on the study team to open the door for questions and constantly check in with participants to ensure that their questions are answered to their satisfaction. While continually encouraging someone to ask questions may seem redundant to the study coordinator, especially if the individual does not have any questions during the conversation, it is vital to continue to ask so that the participant will feel more comfortable asking questions if they arise later.
The manner in which the study team presents information is another factor that significantly impacts whether a participant is comfortable asking questions. For example, a study coordinator may describe a research procedure to a potential participant by saying, “As part of the study, we are going to do an EKG. You know what that is, right?” Most people will respond with “yes” because the study coordinator has implied that they should know what that means and they are embarrassed if they do not. Instead, the study team should not make assumptions about a participant’s knowledge; it should explain all aspects of a study in detail.
As part of the ongoing informed consent process, the study team must be available after the participant signs the informed consent document. Repeatedly calling the study team or sending emails without getting a response is a common negative comment from research participants. If the primary study contact is out of the office, a backup must be designated. Voicemails and emails should be returned in a timely manner. If the participant inquiry requires additional follow-up or the study team does not have an immediate answer, it is still important for the study team to acknowledge the communication from the participant and let him or her know that they are following through. Failure to provide basic customer service will result in a very negative participant experience. The participant may feel as though the study team only cared about him or her until the informed consent document was signed. Study coordinators must make participants feel that they are valued members of the team, and one of the key ways to do that is to address their concerns and questions in a timely manner.
TABLE 1
Negative Feedback from Research Participants
- Not having a chance to read the informed consent document before signing it
- Having the study coordinator read the informed consent document verbatim
- Not being told that participation is voluntary
- Not having enough time to consider the decision to participate
- Having unanswered questions
- Trying unsuccessfully to contact the study team
Positive Feedback from Research Participants
Table 2 outlines positive feedback from research participants regarding their informed consent experiences.
Participants prefer to receive the informed consent document by email or mail before they meet with the study team. They can review the informed consent document at their own pace instead of feeling rushed to skim through it while a member of the study team looks on. It is easier to absorb and process detailed information in the comfort of their own homes, not while they are anxiously sitting in a doctor’s office. Many participants find it easier to think of questions when they do not feel like they are on the spot during the informed consent discussion, and they can write notes and questions in the margins for follow-up during the discussion with the study team. Potential participants also like the chance to do their own research before consenting to a study. They want to learn more about the study intervention, the science behind the study, and other research of the investigator. They want to discuss the study with their families and their physicians. All of this enables participants to make confident informed decisions.
The research participants who report having the best experiences are often given additional background information about the study and understand how their participation fits into the bigger picture. They generally understand the science behind the study because the study team takes the time to answer their questions using language that they understand. When the study team shares background about the scientific goals of the study and the purpose of the study procedures, their participants are more likely to be invested in and committed to the research. Working together toward a shared goal creates a better experience for both participants and the study team.
Research participants want to feel that they are active valued members of the study team. Having an open line of communication with the study team, where the participant feels comfortable contacting the study team because they are accessible and answer questions promptly, helps to achieve this goal. Keeping research participants informed about what is happening with the study is vital to keeping them engaged throughout the study.
Giving potential research participants sufficient time to decide whether to participate leads to a positive experience. One research participant admitted to the author that he was “difficult” from the outset because he had many questions for the study team and wanted to know everything about the study. He took a long time to decide whether to participate. The study team was very understanding and accommodating. They told him to take the informed consent document home and think it through carefully, and they encouraged him to call with any questions or concerns. The gentleman called the study team multiple times, and someone always answered his questions or got him the information that he requested. At the end of every conversation, he was told to take his time because the study team wanted him to be completely comfortable with his decision. In the end, he decided to participate in the study and had a great experience. Because he was knowledgeable about the study and was able to consider his options without feeling pressured to make an immediate decision, he was able to confidently make a decision that was consistent with his values.
Another common positive comment from research participants is that the study team treated them well. When the author asks research participants to share any positive or negative feedback regarding their research experience, the vast majority of participants talk about their personal interactions with the study team. It makes a positive impression on participants if the study team members are personable and clearly care about their participants’ well-being. Long after research participants have forgotten what the study involved, they remember the personal connections they made with the study team. That is what makes participating in the study a rewarding experience and will directly impact whether they participate in research again in the future.
TABLE 2
Positive Feedback from Research Participants
- Receiving the informed consent document in advance of the discussion
- Receiving additional background information about the study
- Feeling comfortable contacting the study team
- Having a study team that keeps participants informed about what is happening with the study
- Having a study team that responds promptly to participant communications
- Giving participants sufficient time and information to decide whether to participate
- Being treated with kindness and respect
Suggestions from Research Participants
Informed consent documents are not always the best way to communicate information to research participants. The study team must bridge the gap between a lengthy high-level document and participants with varying backgrounds, experiences, and medical literacy. This is not an easy task, and it requires that study team members be flexible and effective communicators to meet their participants’ educational needs.
Table 3 highlights suggestions from research participants to improve the informed consent process. The first two suggestions, providing a quick reference guide and an easy-to-read schedule of appointments and procedures, require approval by the institutional review board. The one-page quick reference guide is intended to supplement the informed consent document and would give a high-level overview of the important details of study participation; for example, what will happen during the study, the length of participation, the main risks associated with participation, and contact information in the event of problems. An easy-to-read schedule helps participants plan ahead and consider any arrangements that are needed (e.g., childcare or taking time off from work) to participate. Participants could then refer to the informed consent document if they needed more detailed information.
Participants appreciate ongoing communication from the study team. Communication should not end when the research participant signs the informed consent document. Ongoing communication throughout the study is vital to keeping participants active and engaged. Study team members should not wait for research participants to contact them. Research participants want updates, even if they are as simple as appointment reminders.
If the study requires multiple visits, letting participants know that they have an upcoming appointment is very helpful. One research participant told the author that she received email reminders before every appointment in a long study and found this invaluable. In every email, the study coordinator reminded her what was going to happen at the appointment and indicated whether she should wear loose-fitting clothing. This enabled the research participant to plan for the appointments and feel better prepared. It was very simple for the study coordinator to send the emails, and it had a tremendous impact on the participant’s experience.
Even if the study team does not need to see a research participant at a study visit, they should stop in to see if the research participant has any questions or concerns and ask how things are going. This shows that the study team cares about the participant’s experience. Checking in during an appointment also provides an opportunity for a participant to share any concerns or complaints with the study team. It is far better for the research participant to share concerns and complaints with the study team directly because they know the participant, are familiar with the study, and therefore are in the best position to address these issues.
Research participants would also like information to be presented differently, for the study team to distill a dense and lengthy document into simpler concepts that will allow them to make an informed decision. The author observed an informed consent conversation for an incredibly complex study with multiple arms, an unusual randomization procedure, and multiple registries and sub-registries. The potential participant was clearly confused by the study description in the informed consent document. To supplement the conversation, the study coordinator showed the gentleman what the study looks like in picture format. On the back of the informed consent document, she drew the different study arms and the chance that he could be randomized to each arm. She drew the different registries and sub-registries and showed how they fit into the larger study scheme. This single page drawing clearly presented the same information that it took three and a half pages to describe in the informed consent document. Not only did this help the potential participant understand the study and make an informed decision, but it gave him something to which he could refer throughout his participation. Study coordinators can do things like this to simplify the information in an informed consent document and help potential participants better understand a study. As a caution however, it might seem that the person obtaining consent assumes extra risk in developing their own materials, especially if a participant was to have a complaint or study-related injury in the future. In this case, the study coordinator should ensure that a copy of the diagram has been placed into the participant’s record, and if the coordinator continues to use the diagram, she should secure institutional review board approval of the diagram. If such a diagram is really of benefit, an official schematic should be developed, officially reviewed for accuracy, approved by the institutional review board, and amended to the protocol for general use in all future informed consent conversations.
Other types of visual representations are also helpful, as informed consent documents are not geared toward visual learners. For example, one study used a video on the sponsor’s website to show potential research participants how investigational heart valves function and are surgically implanted. Many research participants are not familiar with anatomy or medical procedures and cannot visualize what is described in an informed consent document. A video or photo gives them a concrete mental image, which leads to better understanding of what will happen in the study and makes it easier to retain the information learned during the informed consent discussion. Repeated use of videos or photos, if not previously approved by the institutional review board, should be discussed and approved.
Providing research participants with additional resources is extremely helpful. It can be overwhelming for research participants and patients because there is so much medical information available, particularly online, and not all of it is reliable. However, it is not easy for individuals who do not work in healthcare or are not comfortable with medical terminology to make the determination about whether the information is correct. Providing research participants with reliable resources to obtain accurate information reduces confusion as well as the amount of time they spend trying to filter through misinformation. It also helps them make a better and more informed decision about whether to participate in the study.
It is also important not to assume that a patient who has been diagnosed with a specific condition is familiar with the nuances of that condition, the standard of care, and the alternative treatment options. Patients who have a better understanding of their diagnosis and their treatment options will make more informed decisions about research participation than patients who have less of an understanding. However, the study team must to be careful to not blur the line between clinical care and research when providing additional information.
Research participants crave information. They want to learn about prior research that was the foundation for the current study and the goals of the study. They want to know who the study is intended to help, especially if they are not likely to benefit directly. Research participants are curious about how their participation is contributing to science and how the study will further medicine. Taking the time to share this information with research participants helps them see the big picture and provides context to their participation. As one research participant told the author, “People would be more likely to participate and stay in studies if they knew how they are contributing to science.” Many people participate in research for altruistic motives, and the best way for the study team to validate their contribution is to share how they are helping, what the study is trying to achieve, and how the study could advance medicine. Research participants want to see how they are giving back and to know that their participation may prevent someone else from suffering.
Members of the study team work in clinical research because they have an interest in science. They should share that interest and excitement with research participants. If members of the study team do not see value in their studies, research participants will pick up on this and they will not see value in the study either. It is important for research participants to be invested in the research because they will have a better experience and are more likely to feel a sense of accomplishment from their participation. The best way to do that is to ensure that they know the goals of the study so they can play a role in achieving those goals.
Sharing additional scientific information should not end when the participant’s active role in the study concludes. The study team should share study results, press releases, and publications with the research participants who made all of these things possible. These tangible outcomes show participants that they made a difference and validate their efforts and participation. This makes for a better research experience, and these individuals are more likely to participate in other research in the future.
TABLE 3
Suggestions from Participants
- A “quick reference guide” that gives the important details of study participation (must be approved by the institutional review board)
- Easy-to-read schedule of appointments, procedures, etc. (must be approved by the institutional review board)
- Ongoing communication and updates from the study team:
- Appointment reminders
- Check in during study visits
- Present information differently:
- Diagrams or drawings (if used repeatedly should be approved by the institutional review board)
- Videos (should be approved by the institutional review board if part of the informed consent process)
- Provide additional resources with reliable information:
- Where participants can learn more about the study intervention
- Where participants can learn more about their own diagnosis
- Provide additional information about the study:
- Is this study building on past research?
- What is the ultimate goal of this study?
- Who will this study help?
- How are participants contributing to science?
- How will this study further the medical field?
- Validate participant’s contributions by sharing study results and follow-up
Practical Advice
Study team members should put themselves in the research participants’ shoes. If they approach every interaction with empathy and consider what they would want to know if the roles were reversed, this will change the tone of their conversations with participants and result in a more positive experience for both parties.
The best way to get to know research participants is to take the time to talk to them rather than immediately launching into a discussion about the study. The study team should ask how they are doing, ask about their concerns and goals, and really listen to their responses. This information will help the study team tailor the informed consent conversation to an individual’s specific needs. For example, the author observed a study coordinator begin an informed consent discussion by chatting with a potential research participant and his family. The gentleman was from out of state and mentioned that he was tired of routinely making the long drive to the medical facility. When the study coordinator began to discuss the study, she immediately shared that the study would require extra visits to the medical facility, and it sounded like that might be prohibitive to him participating based on what he had said earlier. He confirmed that was the case, and the study coordinator validated his decision and moved on to talk about a different study that did not require additional visits. The gentleman, when asked about his experience, shared that he felt like the study coordinator had personalized the conversation and really listened to his concerns.
This highlights why it is crucial for the study team to ensure that research participants feel like valued members of the team and that their voices have been heard. Research is a partnership between research participants and the study team. Both parties need each other: people cannot participate in research without the study team, and study teams cannot conduct research without participants. Research participants have just as much a vested interest in the study, and often make sacrifices as they work with the study team toward a common goal. It is vital that they have good experiences while participating in a study and feel like they are giving in a meaningful way.
Forging a partnership with research participants starts with establishing rapport (Table 4). Taking a few minutes to chat and get to know potential research participants shows that the study coordinator cares and sees them as people. As discussed, these personal interactions with the study team play a large role in how participants view their research experiences. Making connections with participants leads to a more positive research experience and makes participants feel much more comfortable contacting the study team later with questions or concerns.
TABLE 4
Forging a Partnership with Participants
- Establish rapport
- Listen and validate
- Share information whenever possible
- Follow through on promises
- Show gratitude
Validation is very important when interacting with research participants. It conveys empathy and shows that the study team member is listening to the participant. The goal of validation is to let participants know that what they are feeling is okay and that they are not alone. For example, the study coordinator could validate a participant who is feeling overwhelmed by saying, “I know this is a lot of information all at once. It’s okay if you want to take some time to think about it and talk it over with your family.” Validating questions puts participants at ease and encourages them to ask more questions. For example, a study coordinator might say, “That is a great question, and a lot of people share that concern. Let me tell you about the steps we take to protect your privacy.”
Sharing information whenever possible is a key element of the study team/participant partnership. Ongoing communication throughout the study maintains the connection between the study team and the research participant, facilitates transparency, and keeps the lines of communication open.
The study team must also follow through on their promises. For example, if the study coordinator offers to track down additional information for a research participant, this must be done in a timely manner. Following through shows that the study coordinator did not just offer to do something in order to persuade the participant to sign the informed consent document, and it shows that the research participant is a valued member of the team. It also establishes trust between the study team and the participant, which is crucial to the success of that partnership.
Showing gratitude to research participants is vital. Research participation is not an obligation or expectation. People make enormous sacrifices to participate in some studies. Study teams should show research participants that they honor and appreciate their participation in a study by thanking them early and often.
Truly Informed Consent
Informed consent is a process that lasts throughout the course of the study. It is not a discreet moment in time that ends once the informed consent document is signed. The best way for a study team to ensure that it is a process is to be available by using techniques previously described: encouraging participants to follow up with questions, returning phone calls and emails in a timely manner, and checking in during study visits. The objective is to keep the lines of communication open.
Getting truly informed consent starts with making the time for research participants (Table 5). If the study coordinator or the potential research participant feels rushed, both parties will have a negative experience. The potential research participant may feel pressured to make a quick and uncomfortable decision to participate in the study, which may lead the participant to later withdraw.
TABLE 5
Getting Truly Informed Consent
- Make time for participants and for conversation
- Know the participants
- Encourage questions
- Leave the door open for further communication
Learning the potential research participant’s values, goals, and hopes is part of truly informed consent. This helps the study team to better address questions and personalize the informed consent conversation. If the individual ultimately decides to participate in the study, that shared knowledge will foster trust and help develop a bond between him or her and the study coordinator that will result in a much better research experience for both parties.
Encouraging the research participant to contact the study team with questions throughout the study is crucial to creating and maintaining that personal connection. The study team must return participant communications in a timely manner and should check in during study visits. This sends the message that the study team wants to keep the lines of communication open and that the participant is a valued member of the study team.
The regulations governing informed consent are important, but they are not everything. Following only the regulations does not guarantee truly informed consent. The success of the informed consent process is also dependent on personal interactions between the study team and their participants both during the informed consent discussion and throughout the study. In order to improve the participant experience and obtain truly informed consent, the study team should strive to understand the perspectives of research participants and foster relationships with them that leave the door open for further communication long after the consent document has been signed.