What Makes Informed Consent Informative? Patient, Caregiver, And Provider Perspectives

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“Sign on the dotted line.” We practice signatures for a variety of day-to-day activities. We sign receipts to approve a transfer of funds; greeting cards to show personal support; notes to permit our children to leave school early. In healthcare and research, we are asked to sign lengthy documents often inundated with terms beyond reasonable vocabulary, with the prospect of improving scientific knowledge and clinical practice. Incentivized by the possible benefits of therapeutic treatment, patients may decide to participate in clinical research without fully investigating risks and implications.

A case in point, in one clinical setting, is for hematopoietic cell transplantation (HCT), which is a high-risk intervention for life-threatening cancer. HCT establishes immune functioning in patients with both malignant and nonmalignant conditions. Patients undergoing HCT could be presented with information for up to 10 different clinical studies during one encounter: a burden likened to the mortgage loan process. Each document can be lengthy, with information about the purpose of the study, risks of participating, potential side effects, a discussion of benefits — which may be minimal to the participant, but tremendous for society and science in general — and more. But in the end, participation in research comes down to a signature.

The Common Rule, which provides guidance on informed consent for protection of human subjects, urges that study participants are given enough information to make a well-informed decision about whether or not to participate in clinical studies. In contexts such as HCT, patient decision-making can be a sensitive and emotional process, and it is often supported by families and adult caregivers or guardians who consent to clinical studies on behalf of pediatric patients. Further, patients may be concerned that their standard of care treatment will suffer if they do not participate in studies, or they might agree to participate to maintain positive ties with their physician. Improving informed consent involves ensuring that patients are truly informed when signing their agreement to participate in a study and that they are receiving the information they actually need and value in order to make a decision.

We conducted a study asking patients and caregivers of pediatric patients (n = 21) and providers (n = 20) at the University of Michigan Bone Marrow Transplantation Clinic what types of information they believe is necessary for deciding whether to participate in a clinical study and their relative importance.

The majority of patients and caregivers evaluating the informed consent process components on a 1-10 scale of importance rated information on side effects, drug interactions, benefits to self, benefits to others, and contribution to science at 6 or higher. Among these, drug interactions, benefits to others, and contribution to science were most frequently cited as important (71%, 86%, and 86% of participants, respectively). Significantly, these elements were never mentioned by providers in semi-structured interviews. Additionally, 29% of patients and caregivers rated “involvement or additional commitment” at a 6 or higher. Elements of information not rated by any patients as a 6 or higher were: overview of the research study, goal of the study, personal experience, or experience of others.

One particularly notable element of information that is important to patients and caregivers — that providers may not always think of — is altruism. Patients and caregivers were, unsurprisingly, interested in knowing whether participating in a study could possibly be an effective treatment, but they also conveyed the importance of knowing whether their participation could benefit others in the future, either by advancing scientific knowledge or by informing clinical treatments for patients undergoing HCT.

Researchers are evaluating innovative methods for making the informed consent process streamlined while still comprehensive and comprehensible. Some potential approaches include the use of multimedia information delivery such as infographics via tablet technology as alternatives or supplements to statistics that require numeracy for complete understanding. The informed consent process should engage patients in a discussion such that they can voice their questions or concerns rather than relying solely on documented information that may be complex and even intimidating. Current informed consent processes are under-informed by patient perspectives, and our study can contribute to policies guiding modifications and innovative processes for informed consent.

The healthcare system is urging patient-centered care; simultaneously, clinical research is essential for improving knowledge of treatments and therapies for various complex conditions in order to improve population health. Patients, sometimes participants, are critical contributors to the advancement of scientific and medical knowledge; we must ensure that they are partners in this process. Even if patients and participants are willing to participate in research for the betterment of society, it is still imperative that they know what they are getting into, and that participants are truly informed, not just signatories.

These findings are described in the article entitled Improving the Informed Consent Process in Hematopoietic Cell Transplantation: Patient, Caregiver, and Provider Perspectives, recently published in the journal Biology of Blood and Marrow Transplantation. This work was conducted by Minakshi Raj, Sung Won Choi, Tuba Suzer Gurtekin, and Jodyn Platt from the University of Michigan.

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