Research staff may have secured a signed consent form from a study participant, but did they obtain that consent ethically? “True informed consent is something so paramount in research decision-making that it should never be taken for granted,” emphasizes Brandon Brown, MPH, PhD, a health services researcher and professor in the department of social medicine, population, and public health at the University of California, Riverside, School of Medicine.
People considering whether to join a clinical trial may not fully understand the procedures involved, risks and benefits, confidentiality issues, or even that participation is voluntary, depending on how the research is presented. “In short, participants may not know what they are getting into,” Brown says.
Research staff likely have completed courses on ethical conduct of research. “That alone may not be enough,” Brown warns. “There is a difference between reading about the elements of informed consent and obtaining it in the real world.”
Some research staff have worked on the clinical side of informed consent. However, there is a difference between obtaining consent for clinical treatment, and obtaining consent for study participation. “Approaching someone to participate in research the same way as one would address a typical treatment situation can be problematic,” according to Currien MacDonald, MD, CIP, WCG medical chair director.
On the clinical side, patients are requesting to be treated, and healthcare providers are ethically obligated to provide treatment in accordance with the care standard. “Research consent, while similar, is fundamentally different,” MacDonald says.
For example, in clinical care, the central question is, “Do you want this treatment, that treatment, or none?” For research, the central question is, “Do you want to forgo an individual, customized care plan to contribute to general knowledge?”
“Especially when the research care will be their clinical care, both healthcare provider and participant need to understand that difference, and how that changes the relationship between healthcare provider and patient,” MacDonald stresses.
Physicians might obtain consent from a patient by informing him or her what will (or could) happen during treatment. In contrast, research staff are asking for the patient’s choice after giving information about the study. Clinicians might practice shared decision-making and ask for the patient’s choice.
Even so, says MacDonald, the consent conversation in the clinical context — where the patient gives input on the treatment they want based on the acceptable options outlined by the healthcare provider — is different from the research consent conversation, where the patient is making the decision about whether to participate in the study.
With clinical care, the healthcare provider is focused solely on treating the patient. “For research, the healthcare provider gains a second focus — the research,” MacDonald says.
Deviating from a treatment plan based on a person’s situation is normal. “In research, needing to follow the plan makes every step a decision of continuing that care plan or abandoning it,” MacDonald notes.
Some research staff assume that just reading and signing the form equates to informed consent. “Providing information with the goal of achieving understanding, which is the purpose of informed consent, can easily be lost among the physical processes of reading and signing,” MacDonald observes.
Investigators must be confident in each study staff member’s ability to assess capacity to consent, says Meghan K. Mattos, PhD, RN, CNL, assistant professor at the University of Virginia School of Nursing. Some researchers conduct mock informed consent sessions for staff who assess capacity to consent. Experienced investigators can role-play the potential patient, allowing new staff to practice obtaining informed consent. “We require a minimum of three practice sessions without concerns,” Mattos says.
Investigators attend at least one “live” informed consent session with each member of the study staff. “This also allows for observation of potential barriers to challenges related to the study,” Mattos says.
For example, investigators might notice issues with location, consent process, or other concerns voiced by participants. Further, these sessions allow staff to identify and correct mistakes they might make while delivering the consent details (e.g., remembering to ask a comprehension question, remembering to put a signature in the right location). “Study investigators should require documentation of the informed consent process for study records,” Mattos asserts.
This provides an opportunity for other researchers to review procedures and to assess adherence to the protocol. “IRBs should require study protocol acknowledgement of study population-specific factors that may limit capacity to consent,” Mattos adds. For example, emergency department patients likely are to be in acute distress that requires time-sensitive management or snap treatment decisions.
Mattos believes IRBs also should require formal documentation of how investigators determine decision-making capacity for older adults during the consent process. Researchers can do this by asking a few questions that cannot be answered with just “yes” or “no.” For instance, researchers might ask, “Can you tell me the overall purpose of this study?” or “Can you tell me the risks and benefits of participating in this study?”
“If, at any time, there are concerns that the questions were not answered correctly or there were other concerns noted by staff, those concerns should be documented and available for study investigator and IRB review,” Mattos adds.
Research staff may have secured a signed consent form from a study participant, but did they obtain that consent ethically? People considering whether to join a clinical trial may not fully understand the procedures involved, risks and benefits, confidentiality issues, or even that participation is voluntary, depending on how the research is presented.
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