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American Journal of Critical Care. 2009;18: 418-426 doi:10.4037/ajcc2009473
Copyright © 2009 by the American Association of Critical-Care Nurses.
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CE Article

Surrogate Consent for Genomics Research in Intensive Care

By Ann K. Shelton, RN, PhD, Anne F. Fish, RN, PhD, J. Perren Cobb, MD, Jean A. Bachman, RN, DSN, Ruth L. Jenkins, RN, PhD, Victor Battistich, PhD and Bradley D. Freeman, MD. Ann K. Shelton is program chair for nursing at ITT-Technical Institute in St Louis, Missouri. Anne F. Fish, Jean A. Bachman, and Ruth L. Jenkins are associate professors, College of Nursing, and Victor Battistich is an associate professor, College of Education, University of Missouri-St Louis, St Louis, Missouri. J. Perren Cobb is professor of surgery and associate professor of genetics and Bradley D. Freeman is associate professor of surgery at Washington University School of Medicine, St Louis, Missouri.

Corresponding author: Ann K. Shelton, RN, MSN, PhD, 1203 Summer Lynne Dr, O’Fallon, MO 63366 (e-mail: stlKshelton @aol.com).


   Abstract
Top
 Abstract
Approaching Surrogates
 Educating Surrogates
 Concluding the Informed Consent...
 Conclusion
 References
 
Surrogate decision makers may be poorly prepared to give informed consent for genomics research for their loved ones in intensive care. A review of the challenges and strategies associated with obtaining surrogates’ consent for genomics research in intensive care patients revealed that few well-controlled studies have been done on this topic. Yet, a major theme in the literature is the role of health care professionals in guiding surrogates through the informed consent process rather than simply witnessing a signature. Informed consent requires explicit strategies to approach potential surrogates effectively, educate them, and ensure that informed consent has been attained.

Notice to CE enrollees:A closed-book, multiple-choice examination following this article tests your understanding of the following objectives:
  1. Understand the challenges associated with obtaining surrogates’ consent for genomics research.
  2. Describe strategies for obtaining surrogates’ consent for genomics research.
  3. Recognize the importance of evaluating surrogates’ understanding of essential information before concluding the consent process.
To read this article and take the CE test online, visit www.ajcconline.org and click "CE Articles in This Issue." No CE test fee for AACN members.

Genomics refers to the interactive relationship of genes within the genome and with the environment.1–3 In the intensive care unit (ICU), circumstances arise in which patients are unable to give informed consent for genomics research.4,5 These patients often experience cognitive impairment associated with illness, trauma, pain, sedation, or anesthesia.5–8 In such circumstances, surrogates are asked to serve as proxies and provide informed consent for genomics research on behalf of a loved one in the ICU.9,10 However, without a basic understanding of genomics, surrogates are poorly prepared to make the informed decision necessary to consent to genomics research.5,7 Beery and Hern1 and others11–16 have described many ethical, legal, and social implications of genomics for patient care, education, and research, including psychological effects, privacy, stigmatization, insurability, and conflicts of interest. These implications have been considered such important issues that the Human Genome Project dedicated 3% to 5% of its total budget to the study of them.17,18

Despite its growing complexity and significance, little is known about surrogates’ experience when asked to consent to genomics research in the ICU or about surrogates’ ability to understand the information disclosed in the consent process.4,9 In addition, surrogates may not know their loved one’s health care wishes.8,12 In addition, written policies on surrogate consent do not provide step-by-step guidelines for clinicians, and policies vary from state to state.4,9

The purpose of this article is to provide a systematic review on the challenges and strategies associated with soliciting surrogate consent for genomics research in the ICU. We integrate studies and expert opinion from medicine, nursing, environmental psychology, critical care, ethics, genomics, and education.

In reviewing the literature, we noted a 3-step process for obtaining informed consent that is used as the framework of our article: approaching surrogates, educating them, and obtaining an informed consent. The literature on approaching surrogates has 5 main themes: surrogate challenges, environment, timing, legal aspects, and misinformation associated with genomics research and with obtaining informed consent. Research on educating surrogates has focused on language and literacy challenges, teaching the elements of consent, choosing a teaching strategy, and using technology. Studies on concluding the informed consent process have emphasized readability of consent forms, evaluating surrogates’ understanding, and ensuring follow-up after consent has been obtained. Although the challenges and strategies associated with soliciting a surrogate’s consent apply to all kinds of research, we focus specifically on genomics research because of the exceptional nature of genetic information (DNA sequence) and our interest locally in addressing this important issue.19 Also, we focus on the ICU as a particularly challenging setting because critically ill patients are often unable to communicate their decisions to a loved one and a degree of decisional immediacy is required in the ICU that is not usually necessary in other patient care settings.12,20


Without basic genomics understanding, surrogates are ill-prepared to make the informed decision about genomics research.

 


   Approaching Surrogates
Top
 Abstract
 Approaching Surrogates
Educating Surrogates
 Concluding the Informed Consent...
 Conclusion
 References
 
Surrogate Challenges
The nature of critical illness and its treatment often prevent direct verbal interactions between staff and patients. Consequently, surrogates in the ICU are approached to supply medical histories, make therapy decisions and provide direction, and act as a link to a patient’s life before illness.21,22 Also, surrogates are called on to make a host of crucial decisions, such as choosing among medical treatments, considering advance directives, meeting other family members’ needs, attending to financial obligations, and arranging for transportation and temporary living arrangements.7 The impact on surrogates of the unfamiliar and emotionally charged environment of an ICU is considerable.23 For example, Pattison24 found that the incidence of posttraumatic stress disorder was high in relatives of patients in the ICU. The initial surprise and subsequent shock of a loved one’s sudden trauma or illness are compounded by an unplanned addition of responsibility that requires clear thinking and the assimilation of rapidly delivered critical and often complex information.21 Within this context, a surrogate decision maker may be psychologically unprepared to accept the additional responsibility attendant to enrolling a loved one in a research study.5


If surrogates feel rushed to make a decision, there may be a perception of coercion.

 

In the context of this challenging situation, information and support can be used as strategies to facilitate surrogates’ decision making.11 The opportunity to talk to a health care professional, share cultural values, and voice concerns can promote understanding and reduce stress.25,26 Another strategy to empower surrogates is to give them access to professionals in the ICU, including physicians, primary nurses, nurse specialists, ethicists, spiritual advisers, independent patient advocates, social workers, and translators.27,28 Arnold and Kellum11 found that an ethics consultation with families of ICU patients was associated with a shortened ICU stay for the patients. When assisted in exploring and clarifying health care issues, surrogates were empowered to make health care decisions.11

Environment
Understanding how a surrogate subjectively perceives the ICU environment can help health care professionals interpret individual needs and behaviors.25,29 Recognizing a surrogate’s sense of contrasting environmental dichotomies is an example. A convolution of perceived isolation within a crowded ICU waiting room often confronts a surrogate.7,26 Even in an atmosphere of hundreds of people in a hospital community, a surrogate may not be able to identify a support system.7 Further, despite the fundamental right to autonomy, surrogates may feel compelled to surrender personal and family control to institutional dictates.9,27,30


Federal law defines a surrogate as one’s legal representative.

 

Environmental psychology theory can help guide practice in working with surrogates in the ICU to improve their decision-making abilities.31 Health care professionals can help surrogates interpret or create alternative perceptions of common ICU stimuli in order to diminish the stressful impact of the stimuli. Demystifying the environment through orientation is an integral component of ethical practice.7 Familiarity with surroundings (sights, sounds, and the "hospital smell") can defuse surrogates’ fear and anxiety. A physical environment and professional culture that facilitate continuity of care by medical and nursing staff, access to information, flexible visiting hours, and spontaneous interactions are essential in facilitating surrogates’ decision making.28 Providing a private environment as needed is often useful.32 Some institutions are achieving therapeutic environments through systems design, practice innovations, and process improvement.25 For example, in the Pebble Project, a consortium of health care organizations, evidence-based models are used to create fundamental changes in hospital design to enhance healing, engage patients’ families, and improve public areas, including the ICU.31

Timing
Deciding when to approach surrogates who may be distressed or distraught, especially soon after an ICU admission, is a significant challenge in obtaining informed consent and, ultimately, participation in research.12,32 If a surrogate feels rushed to make a decision, he or she may also feel coerced and may hesitate to trust or relate to the researcher or the project.27,32 Surrogates need time to gather information about the condition of their loved one before being asked to consider any proposed research.7,32 Consequently, giving surrogates a place to collect the information they need to process the emotional devastation that accompanies a serious diagnosis, the time to rebuild and renew relationships, and the opportunity to gather support systems before approaching them about participation in a research study will facilitate the informed consent process and may increase research participation.33,34

On balance, regular meetings between a patient’s family and the research team, presentation of the study information in a professional and relaxed manner, answers to questions, and the opportunity for a surrogate to consider the information in a private place for 20 to 30 minutes before being asked to give informed consent are fundamental to the ethical conduct of research.21

Legal Aspects
Current regulations about surrogate consent in the United States are under the auspices of Health and Human Services and are provided by the Food and Drug Administration, the National Institutes of Health, and the Offices of Human Research Protection.8,35,36 Federal law defines a surrogate as a person’s legal representative. Federal law generally defers to the states to define specifically who may be a surrogate.14,35 A few states, including California, Arizona, Virginia, and New York, delineate the hierarchy of surrogates from legally appointed representative to spouse, children, parent, and sibling. Some states do not recognize surrogates’ authority to give consent for research.9,37 Because most states lack clear guidelines on surrogates’ consent, researchers in ICU settings rely largely on guidelines from local institutional review boards and state human research protection programs for direction.36,38

Many families and potential surrogates do not discuss advance directives or treatment options before an illness or trauma occurs, much less thoughts on research participation in the ICU.8,12 Azoulay and Sprung21 found that surrogates’ judgment was not necessarily in agreement with the research participants’ own judgment when the loved ones’ capacity returned after critical illness. Coppolino and Ackerson30 studied 100 patient-surrogate dyads to determine how accurately the surrogate would represent the patient’s wishes in 2 nongenomic hypothetical research trials in critical care, one trial involving minimal risk and the other designated as greater-than-minimal risk. The surrogate’s decisions on research participation differed from those of the patient 16% to 20% of the time.

In 2004, the American Thoracic Society hosted a multidisciplinary conference on ethical research in the ICU. The society concluded that a surrogate with decision-making capacity should be identified and that specific laws should be enacted to establish surrogates’ rights and responsibilities. Currently, surrogates are directed to use "substituted judgment" to make decisions about participation in research. Substituted judgment is a proxy decision based on what a surrogate knows about his or her loved one’s specific wishes in a given situation or the decision the loved one would make, if competent.4,39 When the wishes of the loved one are not known, the surrogate must make a decision about research or treatment based on the loved one’s best interest.11,39 Although this approach is not optimal, Arnold and Kellum11 found that more than 90% of ICU patients would have preferred to have a family member make the patients’ health care decisions along with the patients’ doctor rather than have the doctor make these decisions alone. To help a surrogate use substituted judgment, health care professionals can encourage the surrogate, through targeted dialogue, to recall specific conversations with the surrogate’s loved one in which the patient’s desires and values were shared.34

Misinformation
In addition to not always knowing patients’ wishes, surrogates often do not understand the nature of genomics research and may hesitate to enroll loved ones in research studies because of long-held misconceptions.12 Sex, class, race, and cultural characteristics also affect how genomics information is perceived and may perpetuate misconceptions that could have a profound influence on a surrogate’s participation.40,41 A common misconception is the notion of determinism.42 Determinism in this instance refers to the idea that an individual’s genetic makeup will cause him or her to behave in a certain way or cause his or her body to perform in a certain manner, leading to the misconception that genetic predispositions are absolute. For example, the sequence of the human genome, touted as the "Book of Life," may cause consumers of health care to believe that their characteristics and their health are predestined, when, according to estimates, only 50% of phenotype is determined by genetics.43,44


Surrogates’ decisions on research participation differed from patients’ 16%–20% of the time.

 

A second major mistaken notion is the therapeutic misconception.45–47 This mistake occurs when, despite receiving detailed information to the contrary, surrogates enroll their loved ones in studies believing that the patients will receive an immediate and direct therapeutic benefit. In randomized controlled trials, for example, surrogates often do not believe that the research will not benefit a patient directly, that the researchers do not know which treatment a participant is receiving, or that the researchers really do not know which protocol is the better one.10,45


Many surrogates enroll their loved ones in studies believing that their loved ones will receive an immediate benefit.

 

Because of the misconceptions surrogates may have, it is important to approach them in a way that encourages open discussion of preconceived ideas about genomics research in the ICU. Geller et al27 suggest having surrogates examine their own fears and motives when agreeing to genomics research. These authors also advise health care professionals to tactfully elicit personal and cultural perceptions about genomics, correct misconceptions, and develop educational strategies to increase understanding of genomics research. These strategies may help surrogates adopt a more realistic view of research benefits and limitations. Last, it is important that health care professionals emphasize that clinical research is rarely designed to benefit the participants directly.10,46,47 With careful attention to surrogates’ need to understand how their loved ones fit into the research process, it is more likely that surrogates will visualize themselves and their loved ones as an integral part of the research process.45


Clinical research is rarely designed to benefit the participant directly.

 


   Educating Surrogates
Top
 Abstract
 Approaching Surrogates
 Educating Surrogates
Concluding the Informed Consent...
 Conclusion
 References
 
Language and Literacy Challenges
Education of surrogates to facilitate informed decision making becomes even more challenging when language or literacy challenges are added to an already complex process.48,49 For example, the interpreting skills of family translators may be inadequate, resulting in the communication of misinformation, especially health information. Family translators also are not desirable because they may violate patient privacy and may present conflicts of interest. Clearly, professional interpreters should be used when critical or complex information must be conveyed.48 Other strategies to address language and literacy issues include becoming familiar with societal and governmental mandates related to literacy, patient education, linguistic resources, and multicultural resources.10,23,33,47 Offering an audio recording of educational sessions would allow surrogates to review information independently.11 Specially equipped computer communication devices such as translating programs, pictorial supplements to text, and speech recognition also may be useful.48,49 Actively assessing surrogates for language and literacy barriers will help health care professionals choose appropriate techniques to facilitate surrogates’ education.


Recent legal decisions may prevent previously collected specimens from being destroyed.

 

Teaching the Elements of Consent
Greater attention to educating surrogates about critical elements of the informed consent process (see TableGo) is needed. Regarding ownership of stored specimens even when consent is withdrawn, surrogates should know that recent legal decisions may prevent previously collected specimens from being destroyed.55 Finally, surrogates must be taught and must be able to demonstrate an understanding of all of the elements of consent before the consent form is signed.5,56


View this table:
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  		Table Critical elements of surrogates’ informed consent in genomics research

 
Choosing a Teaching Strategy
Because of the challenges associated with surrogates’ learning, using multiple educational strategies based on a surrogate’s preferred learning styles may be useful.27,48,57 Decisional aids and written information that support the educational needs of surrogates may increase surrogates’ satisfaction with decision making and reduce conflicts between surrogates and staff.11,21,27 Surrogates benefit from repetition of information delivered in small increments over time and from repeating concepts back to the educator.27 Ryan and Lauver58 analyzed 20 research studies in which tailored informational interventions in home care were used to improve health outcomes in elderly patients. All outcomes related to the tailored interventions were equal to or better than those associated with the standard informational intervention. In another study, conducted in a community hospital among elderly patients, Tracy et al59 used a multimedia strategy and found increased knowledge about nondrug pain control strategies among patients given a tailored educational program. Additional strategies to enhance the use of multimedia educational tools include printed materials with Braille, large type, serif fonts, and contrasting color.27

Using Technology
Interactive computer- and Internet-based educational tools are attractive options for educating surrogate decision makers in the ICU.11,27,49,57,60 However, much of the research on the use of these approaches has been conducted in patients with chronic illness.57,61 Ideally, interactive computer- and Web-based educational tools would help surrogates increase knowledge, facilitate skill development, enact behavioral change, and enhance decision making.11,49,60,62,63 Using interactive computer programs as teaching tools has many advantages.63,64 The programs can be accessed any time of the day or night, and Web-based programs can be accessed anywhere an Internet connection is available. Learning can be reinforced immediately. The material presented does not vary, and basic information can be provided with links and explanations to more sophisticated and detailed information. Finally, multimedia presentations that provide clear examples can be used.

Although the effectiveness of interactive and Web-based education has not been established, some results have been encouraging. For example, in a Web-based information program for families of nursing home residents, the Technological Readiness Index was used to explore the likelihood that the families would use the technology for education.64

According to the technology acceptance model, people use technology if it is user friendly and provides satisfaction. Participants, the majority elderly with limited computer experience, were able to complete the program and were very satisfied with the intervention.64 Similarly, in the personal education program, computer-based information was designed to supplement face-to-face interactions between nurses and older patients. An evaluation65 of the program indicated that elderly clients were successful in using computerized technology for acquiring information. Also, a randomized controlled trial66 indicated that a computerized interactive multimedia program for asthma control and tracking was a good adjunct to traditional asthma educational interventions in children and care-givers. In another outpatient study, on the effect of providing computerized, anonymous, nonjudgmental information to breast cancer patients, Reis et al67 found that use of the computerized information fostered self-efficacy to a greater degree than did a pamphlet only. Not surprisingly, the Society of Critical Care Medicine and the American Thoracic Society support the development of interactive Web-based education that can empower individual learners to satisfy personal educational needs.58,63

Challenges to the use of these strategies with surrogates in the ICU setting include the substantial cost for computer hardware, software, support, and Web accessibility. Furthermore, factors that interfere with surrogates’ readiness to learn include anxiety, fear, and discomfort.23,24


Using interactive computer programs as teaching tools may be advantageous.

 

Face-to-face follow-up can increase the effectiveness of interactive computerized educational programs for surrogates.37 Although little information is available on surrogate computerized education in the ICU, the surrogates described in other studies are likely to be similar in age and education to surrogates in the ICU setting. Because of the potential usefulness of computer-based programs for educating surrogates in the ICU, developing such learning tools specifically for this unit would be worthwhile.


   Concluding the Informed Consent Process
Top
 Abstract
 Approaching Surrogates
 Educating Surrogates
 Concluding the Informed Consent...
Conclusion
 References
 
Readability of Consent Forms
Concluding the consent process with difficult-to-read forms may provoke frustration, confusion, and doubt.27,45,49 In fact, the readability of consent documents is too complicated for up to 60% of patients and surrogates.49,60 Level of education often does not correlate with reading ability and cannot be used to determine the appropriateness of written material. Davis et al5 recommended developing written materials at a sixth-grade reading level. However, Stead et al45 cautioned that important information may be lost as the document is simplified. Silverman et al10 and Jimison et al49 examined a variety of consent forms and concluded that the forms should be shortened and simplified, use lay language, and include a glossary or video to emphasize important information. Multimedia consent forms, such as computer-based educational programs, may be helpful in many populations of patients.49,60,63


Surrogates’ understanding must be evaluated before concluding the consent process.

 

Evaluating Surrogates’ Understanding
Surrogates’ understanding of essential information must be evaluated before the consent process is concluded.49 Tait et al32 conducted a study involving the parents of 505 pediatric patients in a preoperative environment. Parents were interviewed to determine their level of knowledge and understanding of information presented. Although parents reported that they had a good understanding of the research project that had been described to them, only 59% understood the purpose of the study and only 33% understood the confidentiality policy. Similarly, several months after consent forms were signed, Schats et al68 asked patients and the patients’ relatives to recall critical information presented in the informed consent process. The results indicated that only 14% of participants could spontaneously recall 1 or more details of the essential elements of consent, and none could recall all of the elements. Wendler69 reported that 40% of potential research participants did not understand the essential elements of informed consent after signing the consent form and still might not understand them even after an educational intervention. Nelson et al28 found that half of the families of patients in the ICU did not have a basic understanding of the information the families were given, such as information on treatments, prognosis, or research.

Geller et al27 addressed this concern about surrogates’ understanding of informed consent by using a 2-part consent form. Part 1 explained the study and part 2 asked specific questions about the content of part 1. With such an approach, misconceptions can be corrected, remedial teaching can be done, and questions can be answered. Another strategy is to use the Deaconess Informed Consent Comprehension Test, a verbal test designed to quantify a research participant’s knowledge of the elements of informed consent. A strength of this instrument is the immediate correction of misconceptions.10,69 Additionally, the Quality of Informed Consent for Cancer Trials instrument was developed to evaluate patients’ understanding of essential concepts in the informed consent process and to establish whether the "therapeutic misconception" persists.10,46 Ultimately, whatever methods are used, a signature on an informed consent form should be solicited only after it has been determined that the surrogate understands the materials presented.9,56

Follow-Up After Consent
The consent process does not end after the consent form is signed; the researchers must also provide follow-up afterward, which includes periodically apprising the surrogate of the patient’s situation.14 Continuity of care over time, especially with a patient’s primary physician, facilitates the provision of consistent and clear information.21 Surrogates must have current contact information for the researchers throughout the entire process, including follow-up.27 Finally, if a patient regains decision-making capacity, obtaining consent directly from the patient should be considered.4,12


   Conclusion
Top
 Abstract
 Approaching Surrogates
 Educating Surrogates
 Concluding the Informed Consent...
 Conclusion
References
 
Health care professionals have both an ethical responsibility to protect and advocate for their patients during the informed consent process and the legal accountability that occurs with witnessing a consent document.52,56,70–72 The ICU is a particularly challenging environment in which obtaining a surrogate’s consent may be difficult because of personal, environmental, logistical, educational, and ethical considerations.9,73 Jeffers53 argues that identifying and dealing with ethical issues as genetic and genomics research continues to develop may prevent future conflicts in values, respect, and human dignity.

The 3 steps of the informed consent process—approaching a surrogate, educating the surrogate, and concluding the informed consent process—can be used as a framework to construct, implement, and evaluate human studies policies to effectively and ethically obtain surrogates’ consent for genomics research in the ICU. Beery and Hern1 and Azoulay and Sprung21 encourage institutions to mobilize resources to improve the skill sets of health care professionals in evaluating patients’ families for potential barriers to having a surrogate make decisions. With knowledge in pharmacogenomics, genetic testing, referrals, education, counseling, treatments, and research, health care professionals can take the lead in educating everyone involved about priorities and policies about privacy, the use of information and biological specimens, ethical conduct of research, at-risk individuals and groups, case management priorities, and educational and computer resources as these factors relate to the ICU setting.74–77

Currently available data on obtaining informed consent are insufficient to adequately guide patients, surrogates, and health care professionals in the ICU, reflecting great challenges for the future.18 New research on education and informed consent that make use of the power of computers and the Internet is especially needed.


   ACKNOWLEDGMENTS
 
This research was done at the University of Missouri-St Louis and Washington University in St Louis, Missouri. We acknowledge research training in genetics and genomics provided through the Genetic Summer Institute, Genetics Education Program for Nursing Faculty at Cincinnati Children’s Hospital Medical Center, and the University of Cincinnati, Cincinnati, Ohio, funded by the Ethical, Legal, and Social Implications Research Program of the National Human Genome Research Institute at the National Institutes of Health (R25 HG01516) and the Division of Nursing, Health Resources and Services Administration. We also thank Kathleen Neff, MA, for editorial assistance.

FINANCIAL DISCLOSURES
None reported.

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 Abstract
 Approaching Surrogates
 Educating Surrogates
 Concluding the Informed Consent...
 Conclusion
 References
 

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