By Stacey Kusterbeck
When a patient is critically ill, researchers may need to obtain consent for study participation from the surrogate decision-maker instead. “The research team needs to ensure that surrogates understand their role in the process and follow established ethical codes of the patient’s known wishes — values called substituted judgement — or, if the patient’s wishes are unknown, their best interests,” says Marc Moss, MD, the Roger S. Mitchell professor of medicine and former head of the Division of Pulmonary Sciences and Critical Care Medicine at the University of Colorado School of Medicine.
Moss and colleagues conducted a study to identify best practices for the surrogate consent process for critical care research.1,2 The researchers surveyed 230 individuals (105 research coordinators [RCs], 90 principal investigators [PIs], 27 surrogates, and eight patients, and held focus groups and interviews for 61 participants [24 PIs, 23 RCs, 11 surrogates, and three patients]). Some key findings include:
- Surrogates preferred to have research staff approach them instead of the PI. “The consensus was that research coordinators have more training in research conduct, are not authority figures, and have fewer conflicts of interest that could influence surrogate decision-makers’ decisions,” says Moss. The clinical team should be aware of the research study, but not actively involved in the surrogate consent process. “This avoids any possibility of coercion,” says Moss. Prior to approaching the surrogate about a potential study, the research team should ensure that the clinical team is supportive, says Moss. This conversation between the research and clinical teams will inform the clinical team about the study and inform the research staff about the patient’s condition.
- Surrogates wanted to be given physical space and a defined period of time to contemplate the decision on whether to enroll their loved one into a study. When research staff were willing to step away, particularly in situations involving a tight window for treatment, this reduced surrogate decision-maker stress. Research staff felt similarly and did not want to rush the surrogates into making a decision.
- Surrogates and/or patients expressed appreciation for the research team’s updates on the patient’s condition. “Sometimes the clinical teams are busy and are not able to spend as much time explaining the situation to the patient’s family,” says Moss. Surrogates appreciated having another team that could update them on the patient’s condition when the clinical team was not immediately available.
- Surrogates perceived that an advantage of being part of a research study was that it ensured adherence to clinical protocols. Sometimes, there are additional clinical protocols that are part of a research study to reduce some of the variation in practice. “Having an extra set of people ensuring that the existing clinical protocols were being very carefully followed was reassuring to the surrogates,” says Moss.
- Surrogates saw the written consent forms as more important than researchers did and were less concerned with its length than researchers. Research coordinators and study investigators viewed written consent forms as too long and not very helpful after the verbal discussion had taken place. In contrast, the surrogates felt that written consent forms were an important component to the informed consent process. All participants thought that in-person consents were more effective than electronic or phone consents.
The research team used these strategies to convey that the patient and surrogate are viewed as humans, not just research subjects:
- asking the clinical team to introduce the research staff to the surrogate, to demonstrate that the research and clinical teams are working together;
- ensuring that the surrogate’s clinical questions were answered before research staff discussed study participation;
- making themselves available to support the surrogate in practical ways (such as providing phone chargers);
- demonstrating empathy (such as asking how the surrogate is doing, acknowledging that the situation is scary, and checking in on the surrogate regularly).
“Surrogates should never feel pressured about potential enrollment of their loved one into a research study,” underscores Moss. The research team conveyed the importance of offering the option to decline, so that surrogates easily could make that choice. The research team identified signs that the surrogate was not interested, indicating that the consent encounter should end. These include the surrogate displaying uncomfortable body language, failing to respond to phone calls, coming up with reasons to avoid signing the consent form, making negative comments about research, or disagreeing with other family members on whether to consent. Research staff politely ended those consent encounters while still leaving the possibility open that the person could choose to participate. “The research study should be considered something that is above and beyond routine clinical care and should not interfere with the current treatment plan for the patient. These are stressful times for the surrogate, as they are concerned about the health and potential recovery of their loved one,” emphasizes Moss.
Before anyone even approaches the surrogate for consent, the clinical team must first determine if the proposed study is appropriate for surrogate consent. “Only trials that must include incompetent patients to meet their hypotheses or aims allow surrogate consent for participation,” says Rebecca D. Pentz, PhD, the research ethicist at Emory University School of Medicine’s Winship Cancer Institute. Otherwise, only competent patients give consent to participate in research. “If this is an appropriate trial, with IRB (institutional review board) approval for this vulnerable population, then the clinical team should check with the research team to ensure eligibility,” says Pentz. After these preliminary checks are accomplished, Pentz sees these two ethical concerns:
- To respect the patient’s autonomy, the clinical team must make sure the critically ill patient really is incompetent. “Call in a psychiatrist or psychologist to do a competency test,” Pentz recommends.
- The clinical team must find the appropriate surrogate who will make sure the patient’s wishes and values are upheld. “Finding the right surrogate is ethically crucial. The research team won’t know who this is, so it is up to the clinical team,” says Pentz. If a legal guardian has been appointed, that person is the appropriate surrogate. If not, sometimes the patient’s living will states whom they wish to make end-of-life decisions and this person may be the appropriate surrogate. Some state laws also outline who is the appropriate surrogate.
Sometimes, family members disagree on whether to give consent for research participation. “The most common kind of conflict that happens is that the patient has appointed two people as surrogates, like both siblings, and then the two surrogates disagree. Ethics consults are often called in these cases,” says Pentz. Pentz recommends this process:
- The ethics team meets with both surrogates and holds family meetings to resolve the conflict, if possible. If it is not possible, no consent for research will be obtained. For example, one sibling surrogate may distrust researchers and make statements such as, “Trial participants are merely guinea pigs, serving the researchers’ goals.” Yet, the other sibling surrogate may be highly in favor of research because it can lead to new treatments and even could benefit the patient. “In this case, the ethics team should meet with each sibling surrogate separately,” says Pentz.
- For the skeptical surrogate, it might be useful to show how the very treatments their sibling has gotten were developed based on past research. This helps the surrogate to make a personal connection with research. The ethics team also can ask if the sibling has experienced anything that makes them distrustful of research. “While listening empathetically, there may be a way to alleviate this mistrust,” says Pentz.
- The ethics team meets with the pro-research sibling and makes sure they are not subject to therapeutic misconception, believing that the research will surely benefit the patient. “Their view that research can help future patients should be supported and applauded,” says Pentz.
- After the individual meetings, the ethics team meets with both siblings and guides them in making a decision about research participation. Even if the correct surrogate is identified and consents to research participation, the patient may object when meeting the research team and want to be left alone. “Even though this individual is incompetent, his or her wishes should be respected out of respect for the individual’s dignity. The patient should be withdrawn from the trial and not forced to participate,” says Pentz.
Ethics consults also can be helpful if there is evidence that contradicts the surrogate’s decision. For instance, clinicians may find language in the patient’s living will, or emails or discussions with other family members, that reveal what the patient would have wanted.
“We once had a case in which the surrogate consented to research, but the patient’s physician contacted the ethics team to report that he had been told by the patient that she never wanted to participate in research and that in no instance should an ethics consult be called,” recalls Pentz. The physician explained that the patient’s aunt had a previous bad experience after her situation had been referred to an ethicist.
The physician had documented the patient’s opposition to research in the medical record. Ethicists did proceed with the ethics consult anyway, since the hospital policy was clear that no one could block an ethics consult, although no one had anticipated that the patient would be the objector. Ethicists then showed the surrogate the medical record report of the patient’s wishes. At that point, the surrogate agreed to withdraw their consent for research.
“The patient should not be enrolled in the clinical trial until consensus is reached as to whether trial participation is consistent with the patient’s wishes and values, expressed when competent,” says Pentz.
Stacey Kusterbeck is an award-winning contributing author for Relias. She has more than 20 years of medical journalism experience and greatly enjoys keeping on top of constant changes in the healthcare field.
References
1. Tietbohl CK, Glaros C, Torres KA, et al. Approaches for establishing trust and alleviating stress during the surrogate informed consent process for critical care research. Chest. 2025; Jul 23. doi: 10.1016/j.chest.2025.06.050. [Online ahead of print].
2. Glaros C, Tietbohl CK, Torres KA, et al. The performance of the surrogate informed consent process for critical care research: A multi-modal study of investigators, coordinators, surrogates, and patients. Chest. 2025; Jun 6. doi: 10.1016/j.chest.2025.05.038. [Online ahead of print].
