Do you think that alternative forms of community consent should be actively pursued? Why or why not? How would you feel if your medical records were examined and included in research without your consent based on an illness in the past?

Nursing Research

Nursing Research

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Assignment 1: Discussion Assignment
To support your work, use Nursing research book by Janet Houser, Nursing books, Nursing journals and articles .As in all assignments, cite your sources in your work and provide references for the citations in APA format.
Ethics in Healthcare
In this assignment, you will study the role of ethics in healthcare.

Based on your research, respond to one of the following discussion questions.
Discussion Question 1
Read the following article:
Shelton, A., Freeman, B., Fish, A., Bachman, J., & Richardson, L. (2015). American Journal of Critical Care, 24(2), 148-155. doi: 10.4037/ajcc2015983
Ethics guidelines now require that individuals give informed consent to participate in research. Existing ethical guidelines do not help us decide how to seek consent and have allowed managerial experimentation to remain unchecked.
Based on your understanding of the topic and the article, answer the following question:
Do you think that alternative forms of community consent should be actively pursued? Why or why not? How would you feel if your medical records were examined and included in research without your consent based on an illness in the past?
________________________________________

A COMPUTER-BASED
EDUCATION INTERVENTION

TO ENHANCE SURROGATES

INFORMED CONSENT FOR

GENOMICS RESEARCH

By Ann K. Shelton, RN, PhD, Bradley D. Freeman, MD, Anne F. Fish, RN, PhD,
Jean A. Bachman, RN, DSN, and Lloyd I. Richardson, PhD
Background Many research studies conducted today in critical care have a genomics component. Patients surrogates asked to authorize participation in genomics research for a loved one in the intensive care unit may not be prepared to make informed decisions about a patients participation in the research. Objectives To examine the effectiveness of a new, computerbased education module on surrogates understanding of the process of informed consent for genomics research. Methods A pilot study was conducted with visitors in the waiting rooms of 2 intensive care units in a Midwestern tertiary care medical center. Visitors were randomly assigned to the experimental (education module plus a sample genomics consent form; n = 65) or the control (sample genomics consent form only; n = 69) group. Participants later completed a test on informed genomics consent.
Results Understanding the process of informed consent was greater (P= .001) in the experimental group than in the control group. Specifically, compared with the control group, the experimental group had a greater understanding of 8 of 13 elements of informed consent: intended benefits of research (P= .02), definition of surrogate consenter (P= .001), withdrawal from the study (P= .001), explanation of risk (P= .002), purpose of the institutional review board (P= .001), definition of substituted judgment (P= .03), compensation for harm (P= .001), and alternative treatments (P= .004).
Conclusions Computer-based education modules may be an important addition to conventional approaches for obtaining informed consent in the intensive care unit. Preparing patients family members who may consider serving as surrogate consenters is critical to facilitating genomics research in critical care. (American Journal of Critical Care. 2015;24:148-155)
©2015 American Association of Critical-Care Nurses doi: http://dx.doi.org/10.4037/ajcc2015983
148 AJCC AMERICAN JOURNAL OF CRITICAL CARE, March 2015, Volume 24, No. 2 www.ajcconline.org

P
atients in the intensive care unit (ICU) often are unable to give informed consent
because of cognitive or physical impairments due to illness, trauma, or sedation.1,2 In such circumstances, a patients family member or proxy is asked to serve as a surrogate and provide informed consent on behalf of the patient.3,4 With increasing frequency, surrogates of ICU patients are being asked to provide consent for
crucial genomics research.5,6 This type of research has an immediate aspect7,8; any delay in consent for enrollment in the study may result in a missed opportunity to collect transient and perhaps vital clinical data.9,10 Furthermore, genomics research is complex and has inherent ethical, legal, and social implications.11,12 Without a basic understanding of the process of informed consent related to genomics research, surrogates may be poorly prepared to consent for their loved ones to participate in the studies.13

The ICU environment is challenging for a patients surrogates because of the immediate need to react to changes in the patients condition.14,15 Because of these multiple stressors,16-18 surrogates giving consent in the ICU may benefit from a focused computer-based educational intervention as an addition to conventional consent forms. However, no studies have specifically examined the effectiveness of such interventions on surrogates understanding of informed consent for genomics research in the ICU. We found 9 high-quality studies19-27 in which investigators examined a computer-based educational intervention and the outcome (understanding informed consent), but the researchers focused on procedures, a medical treatment, or non-ICU research and rarely used a surrogate. Computer-based educational interventions have been effective in enhancing understanding of the process of informed consent in procedural studies (cardiac catheterization, colonoscopy, endoscopy with parent as surrogate, and gastric banding surgery) and in a study on medical treatments (chemotherapy).19-23 Additionally, 4 studies24-27 focused on non-ICU research: 1 involved a cancer clinical trial, 1 had a sample composed of

About the Authors
Ann K. Shelton is an assistant professor, Department of
Primary Care Nursing, School of Nursing, Southern Illinois University Edwardsville. Bradley D. Freeman is a professor, Division of General Surgery, Acute and Critical Care Surgery Section, Washington University School of Medicine, St Louis, Missouri. Anne F. Fish and Jean A. Bachman are associate professors, College of Nursing, and Lloyd I. Richardson is the Curators Teaching Professor, College of Education, University of Missouri-St Louis, St Louis, Missouri.
Corresponding author: Ann K. Shelton, RN, PhD, Southern Illinois University Edwardsville, Box 1066, 2335a Alumni Hall, Edwardsville, IL 62026-1066 (e-mail: ashelto@siue .edu).
schizophrenic patients, 1 had patients parents as surrogates in high- and low-risk clinical trials, and 1 was a genetic tissue repository study. Results were mixed. The computer-based educational interventions used in the studies included video, CD-ROM, and slide presentations, yet no single approach has been more effective than another.26
Specifically, within the principle of respect for persons, we focused on the need to provide full disclosure of information to surrogates who were called on to give informed consent by using substituted judgment, Increasingly patient surrogates are being asked to provide consent for crucial genomics research.
The purpose of this pilot study was to examine the effectiveness of a new, computer-based education module on the understanding of patients surrogates about the process of informed consent for genomics research in the ICU. The framework of the study was the Code of Federal Regulations28 and the principles of respect for persons, beneficence, and justice contained in the Belmont Report.29 and to make sure the surrogates understood the information disclosed.30,31 The term substituted judgment means that the surrogate chooses whether or not to allow a loved one to be entered into a research study on the basis of what the loved one would have wanted.32,33 The premise is that giving surrogates information is beneficial and that subsequently giving them a test on the information will clarify how much of the disclosed information they actually understood.34-36
Methods
Design, Setting, and Sample
An experimental, posttest-only design with random assignment to group was used. The experimental group completed the computer-based education
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module and received a sample genomics consent form; the control group received the sample genomics consent form only. The setting was the waiting rooms of 2 ICUs (surgical-trauma and cardiac) in a Midwestern tertiary care medical center.
The sample
included only those individuals who felt comfortable participating at that time. gible for the study if they were visitors to the ICU waiting rooms, were 18 years or older, and were willing to participate in the study. Visitors were approached unless they appeared to be in crisis or actively grieving. A power analysis indicated that a total of 64 partici-
The participants in the study were adult visitors to the ICU waiting rooms. All of the visitors were considered potential surrogate consenters in the future and therefore were the surrogates for the purpose of this study. Persons were eli-
pants was needed per group to detect a 0.50 effect with a power of 0.80 and a=.05.
During a 4-month period, 827 visitors were approached for the study; of these, 137 agreed to participate in the study. The Figure presents reasons for nonenrollment in the study. Visitors who declined did not have reservations about the study itself; they had personal reasons for not enrolling. Their responses fell into 2 general categories: dealing with the uncertainly related to their loved ones in the ICU and dealing with the ICU environment. The conclusion was that the sample was not biased in any way because it included only those visitors who felt comfortable participating at the time of recruitment.
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Computer-Based Education Module
The education module was presented on a laptop computer and included a series of 36 slides. It was developed by a nurse researcher and was based on the Code of Federal Regulations and on related publications37,38 about the ethical, legal, and social implications for genomics research. An expert panel of 15 ICU physicians approved the content of the slides. The panel included 2 experts who were conducting research on informed consent. The information was written at or below the sixth grade level of reading comprehension. The brightly colored slides were designed to include persons of multicultural backgrounds. In addition, 4 slides had animated material to enhance interest.
The module included an introduction, educational content, and a summary. The educational content included information about the 13 essential elements of informed consent28,29 (Table 1), surrogate consent,2,4 research in general,24,25 and genomics research.8,12 The slides specific to surrogate consent included information on the definition of a surrogate,1,3 definition of substituted judgment,31,33 and requirement that the researcher must provide all of the information that the surrogate needs to make an informed decision about participation in the research.1 The slides on research in general included information about research in the ICU, reasons for participating in research, role of the institutional review board, and who pays for research.1,4 The slides on genomics research included information on the definition of genomics,7 interactions between genes and the environment,11 meaning and implications of DNA,12 and ownership of tissue specimens.39 Finally, 1 slide summarized the elements of informed consent.28,29 The module was pretested with 7 adults.
Sample Genomics Consent Form
The sample genomics consent form was a 7-page form printed on white paper. The information was written at or below the sixth grade level of reading comprehension. The consent form had been approved by the institutional review board, was about ventilator-associated pneumonia in the ICU, and had been used in a recent genomics study at the research site. In content detail, overall structure, and format, it was representative of a typical consent form for genomics research used at the study site. This consent form was used as a sample only, and participants were clearly instructed that their loved ones were not being recruited for a study on ventilator-associated pneumonia.
Instrument
The posttest instrument was a 13-item instrument with a 5-point Likert-type response format (1 = definitely false and 5 = definitely true). The posttest was used to measure surrogates understanding of the process of informed consent. Items on the instrument reflected essential elements of informed consent that the literature had indicated as necessary for surrogates to understand (Table 1). Higher scores indicated greater understanding of the process of informed consent. Content validity was established through the use of a content analysis table and examination by a panel of experts who evaluated the posttest according to the Code of Federal Regulations guidelines and publications on informed consent.28,29 The Cronbach a of the posttest was 0.73.
Data Collection Procedures
The study, approved by the appropriate institutional review board, was carried out in accordance with the ethical standards set forth in the Helsinki Declaration of 1975,38 and was conducted by 1 nurse researcher. The visitors were studied individually; visitors who were together with other family members were asked not to share information about the study. A private consultation room within the ICU waiting room was used to ensure a quiet space for the study. After entering the study room, visitors were randomly assigned to a group by using computergenerated random numbers. Participants read an information sheet written at or below the sixth grade level of reading comprehension, which explained the purpose of the study. Any questions participants
Table 1
Essential elements of informed consenta
1. Intended benefit for future patients
2. Purpose of surrogate consenting
3. Study withdrawal
4. Purpose and length of the study
5. Overall research risks
6. Purpose of the institutional review board
7. Need for and purpose of researchers contact information
8. Sufficient information to make an informed decision
9. The voluntary nature of research
10. Substituted judgment
11. Confidentiality of information
12. Compensation for harm13. Alternative treatment
a Based on the Code of Federal Regulations,28 the Belmont Report,29 and other published material.
form. The control group read the sample genomics consent form only. Both groups completed the posttest and the demographic data form. A posttest key was given to all participants to check their answers. After each participant The posttest measured surrogates understanding of the informed consent process.
had were answered. Participants in the experimental group were shown how to advance the slides on the laptop. The experimental group completed the computer-based education module and then read the sample genomics consent
completed the posttest, the researcher again solicited and answered questions. Additionally, the researcher provided participants contact information in case they had further questions. Visits did not exceed 30 minutes. Visitors received no remuneration for their participation.
Data Analysis
Descriptive statistics, c2 analysis, the Fisher exact test, and independent t tests were used to summarize demographic data. According to the self-reports of the participants relationship to the ICU patients, the loved one was a spouse, fiancée, significant other, parent, sibling, child, friend, or other. Analysis of variance was used to analyze overall total posttest scores. Multivariate analysis of variance was used to determine between-group differences among the items. Top-box statistics were used to describe the percentage of participants who chose the most correct answers (probably true or definitely true) for each posttest item.
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Table 2
Demographic characteristics according to groupa
No. (%) of particiants
Experimental Control
Variable (n = 65) (n = 69) P
Sex .50
Male 20 (31) 25 (36)
Female 45 (69) 44 (64)
Race .76
African American 15 (23) 18 (26)
White 50 (77) 50 (72) Hispanic 0 (0) 1 (1)
Education .63
Less than high school 2 (3) 1 (1)
High school graduate 15 (23) 19 (28)
Some college 23 (35) 24 (35)
College graduate 22 (34) 18 (26)
Postgraduate college 3 (5) 7 (10)
Experience participating in a 5 (8) 6 (9) .68 previous research project
Relationship to patientb
Spouse 10 (15) 10 (14)
Fiancée 0 (0) 3 (4)
Significant other 1 (2) 2 (3)
Parent 13 (20) 7 (10)
Sibling 5 (8) 13 (19)
Child 12 (18) 13 (19)
Friend 2 (3) 2 (3) Other 22 (34) 19 (28)
a Because of rounding, not all percentages total 100. b Because of low numbers in the relationship categories, no statistical tests were
performed.
Results
Characteristics of the Sample
Of the 137 participants, 3 were called away during the session and did not complete the study, leaving a total of 134 visitors in the sample. A total of 65 participants in the experimental group and 69 in the control group completed the study. Participants were 19 to 82 years. The mean age was 49.4 (SD, 15.35) years for the experimental group and 45 (SD, 15.53) years for the control group. Demographic variables did not differ significantly between the 2 groups (Table 2).
Effectiveness of the Education Module
Overall, the experimental group had a greater (P=.001) understanding of the process of informed consent than did the control group. Age, sex, race, education, and previous experience participating in a research project did not significantly influence this finding.
Furthermore, according to the top-box statistic, the percentage of participants who picked the most correct responses (probably true and definitely true) was higher in the experimental than in the control
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group (Table 3). Specifically, compared with the control group, the experimental group had greater understanding of 8 of 13 elements of informed consent: intended benefits of research (P=.02), definition of surrogate consenter (P=.001), study withdrawal (P = .001), explanation of risk (P = .002), purpose of the institutional review board (P=.001), definition of substituted judgment (P=.03), compensation for harm (P = .001), and alternative treatments (P=.004).3,28,29
The 2 groups did not differ significantly for 4 posttest items: the right to know the purpose and duration of the study, the provision of researcher contact information in the event of questions, the voluntary nature of the research, and the confidentiality of information (Table 3). This finding indicates that, if the sample genomics consent form fully covered these items, additional information on these topics provided in the computer-based education module did not significantly improve posttest scores.
The final item that did not differ significantly between the 2 groups was the following: the researcher must give all information needed to make an informed decision about research (Table 3). Information about this item was explicitly stated in words in the computer-based education module but was not addressed in the sample genomics consent form. Both groups of participants had high mean scores on this item, indicating that those in the control group might have had this information as general knowledge or that the item sounded true, so the scores were high.
Discussion
Our study indicated that the computer-based education module was effective in improving surrogates understanding of the process of informed consent for genomics research in the ICU. Our findings are in general agreement with those of Bickmore et al,27 who used a computer-based education module and a sample research consent form on genetics research. Their study and ours differ, however: the study by Bickmore et al had a smaller sample size, was not conducted in an ICU, and did not include use of surrogates.
Care should be taken when approaching possible surrogates in the ICU waiting room for the purpose of obtaining informed consent. Although research participation is important to the researcher, a request to participate in a study may be perceived by surrogates as another demand on their time. An important premise emerged from our study: A balance must exist between the mandate to conduct genomics research and human research protections. The research mandate should not interfere with principles of respect for persons, beneficence, and justice; the inherent right of the surrogate to disclosure of all information needed and to an understanding of the information disclosed; and the opportunity of the surrogate to give voluntary and informed consent.30
The computer-based education module was designed with basic features to enhance surrogates understanding of the process of informed consent, be comprehensive, and provide a single straightforward message: the importance of reviewing and understanding essential elements of informed consent before signing a consent form for a loved one to participate in genomics research in the ICU. A strength of the computer-based approach is that participants found the laptop easy to use; they had to master only a single skill: advancing the slides by using a button on the keyboard. Also, the quality of the education module was high, as judged initially by a panel of experts and then by the researcher collecting data, who noted that the module was used by participants without hesitation or questions.
With further testing, the computer-based education module might be tailored to a specific population of participants, such as those with low reading skills; be revised to include hyperlinks to provide additional information; and be produced in Spanish or other languages. Also the intervention might be used in a kiosk with new touch-pad technologies, permanently affixed in the ICU waiting room for convenient viewing by surrogates, to serve as an adjunct to brochures about the research that would also be available in the waiting room. Visitors could view the education module, read the research brochure, and then call the research nurse if they were interested in learning more about research participation
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for their loved ones. However, before this approach is used clinically, additional research is needed to determine the feasibility and effectiveness of this type of kiosk in ICU waiting rooms.
A posttest-only experimental design was used because pretesting might have resulted in an unwanted sensitization effect in which the pretest itself influenced the posttest answers. Also a pretest would have
The module might be used in a kiosk with new touch pad technologies, permanently affixed in the intensive care unit waiting room. study to limit the research visit to 30 minutes, so it would not be too much of a burden on the participants, who were already dealing with complex issues related to the illness of their loved one. A lack of a pretest might be a problem when the ran-
taken additional time, and we purposely designed the dom assignment does not
work and the 2 groups are not equivalent at baseline. A lack of a pretest also can become a problem when attrition is high. We did not expect and did not experience high attrition.
Other limitations also were identified. First, the use of only 2 ICU waiting rooms at a single medical center might limit the generalizability of the results. Second, we do not know the extent to which the presence of transitory personal factors of participants, such as fatigue, hunger, mood, fear, and anxiety, might have led to errors in measurement. Third, the number of participants in the relationship categories was too small to be correlated with understanding the process of informed consent. That analysis should be conducted in a larger study on informed consent of surrogates in the future. Finally, this study was the first time the posttest was used, although the tests internal consistency reliability was acceptable for a new instrument.40
Conclusion
Computer-based education may be an important addition to conventional approaches for obtaining informed consent in the ICU. Preparing patients family members who may consider serving as surrogate consenters is critical. Further research is needed to examine the multiple challenges that researchers and surrogates face when considering informed consent for genomics research in the ICU.
ACKNOWLEDGMENTS
This research was performed at the University of MissouriSt Louis and Washington University. We gratefully acknowledge the editorial assistance of Kathy Neff, MA.
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FINANCIAL DISCLOSURES None reported.
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