Factors Influencing Parents Decision to Donate Infant DNA for Minimal Risk Genetic Research
Factors Influencing Parents Decision to Donate Infant DNA for Minimal Risk Genetic Research
Qualitative Study Critique- 75 points possible The purpose of this assignment is to develop skills in reviewing and appraising research articles. Specific details are considered to determine quality, utility, and evidence. Review Chapter 4 in: Polit, D. F., & Beck, C. T. (2018). Essentials of nursing research: Appraising evidence for nursing practice (9th ed.). Philadelphia, PA: Lippincott Williams & Wilkins. PLEASE USE THIS TEMPLATE for the assignment – save with your last name and submit in Canvas. Direct quoted material from the article may be used to help explain answers and identify components (must include article page number). Please address all questions – briefly with simple items, phrases, or (if required) a sentence or two. If a yes/no question – please answer as appropriate – if not applicable, please state – not applicable. List references ONLY IF other than the article being reviewed or the course text. Helpful strategy – first view the critique template – to have an idea of what items to keep in mind when reading the article. 1. APA citation (2 points possible) 1.1. Provide the reference (authors, year, title, volume, issue, pages, doi) in correct APA format: (use italics where appropriate, etc.) — (2 pt.) 2. Introduction: Problem and Purpose (4 points possible) 2.1 Is the problem clear, precise and well defined? Briefly identify. literature review/ (1 pt.) 2.2 Is a good argument made for the importance of the problem to clinical practice, research, theory, or knowledge and policy development? Briefly explain. (3 pts) 3.Introduction: Background/ Literature Review (5 pts possible) 3.1 How many articles in the background /literature review are within and after five years of the article’s publication date? (Often in published studies, the literature review is not a separate section titled Literature Review, but a literature review is included in the Introduction or Background section.)(1 pt) 3.2 What is the publication date range of the background/literature review articles? (1 pt.) 3.3 From what type of sources (studies, relevant organizations, media)? (1 pt.) 3.4 Are the current gaps in knowledge clearly presented? Briefly explain? (note: typically related to the purpose for the study) (2 pt.) 4. Introduction: Conceptual/theoretical framework Research Questions or Hypotheses (4 points possible) 4.1 Is a Research Question or PS (Population/Situation) Question presented? If yes, please include here: (1 pt.) 1Quantitative 19SU 4.2 Is a Theoretical or Conceptual Framework presented? If yes, please include here: (1 pt.) 4.3 What is the Main overall topic (in a broad sense) – i.e. childhood obesity, surgical site infections, medical error? (2 pt.) 5. Method: Protection of Human Rights (8 pts possible l) 5.1 Was the study approved by an IRB? (1 pt.) 5.2 What appropriate procedures were used to safeguard the rights (ethics, confidentiality) of all study participants? Explain. (3 pts) 5.3 Were any vulnerable populations used in the study? If yes, who? (2 pt.) 5.4 What risks may subjects be exposed to while participating in the study? (2 pt.) 6. Method: Research Design (9 pts possible) 6.1 What was the type of qualitative research design used? (i.e. phenomenology, grounded theory, ethnography, etc?) (3 pts) 6.2 Were the steps in the method congruent with the qualitative design used? Briefly explain (3 pt.) 6.3 Was the method used appropriate for the study? Briefly explain how? (consider the aim of the study) (3 pts) 7. Method: Population and Participants (10 pts possible) 7.1 Who or what (if the sample includes material items) is identified as the target population/item? (2 pts) 7.2 How were the participants chosen (sampling method: i.e. randomly, convenience sampling, snowball, etc.)? (2 pts) 7.3 How many participants were in the study? If focus groups, how many groups and number in each group? (2 pt.) 7.4 What were the participant inclusion criteria and exclusion criteria? (2 pt.) 7.5 Did any of the participants drop out (attrition)? If yes, was it explained why (please share)? (2 pt.) 8. Method: Data collection and Analysis (7 pts possible) 8.1 How were data collected? (interview, observation) (3 pts) 8.2 Was a software program used for data analysis (i.e. MAXQDA, ATLAS.ti, NUD*IST, NVivo)?(1 pt.) 2Quantitative 19SU 8.3 Were the data collected in a way that decreased bias? Explain. For example, was the staff collecting data appropriately trained, or inter-rater reliability addressed? (credibility) Explain. (3 pts) 9. Results: Trustworthiness (credibility, dependability, confirmability, transferability) (6 pts possible) 9.1 Were any of these steps taken to ensure Trustworthiness? (6 pts.) a. Two independent researchers analyze data separately, briefly explain: b. Participants are given a chance to validate findings, briefly explain: c. Researcher has findings validated by other researchers, briefly explain: 10. Discussion: Interpretation of the Findings (11pts possible) 10.1 What were the major findings presented (themes, core categories)? Briefly Discuss. (4 pts) 10.2 Were tables, figures, and/or models used? (1 pts) 10.3 If a model/diagram was presented, does it clearly illustrate the findings? (2 pts.) 10.4 Were all research questions discussed? (2 pts) 10.5 Can the findings be applied outside of the context of the study (transferability)? Are the results meaningful to others? (2 pts.) 11. Discussion: Limitations (4 pts possible) 11.1 Did the researchers discuss the limitations and strengths of the study? Briefly What were they? (3 pts) 11.2 Were there other limitations that you recognized? (1 pts) 12. Discussion: Implications/Recommendations (5 pts possible) 12.1 Do the conclusions accurately reflect the data? Briefly explain. (2 pts/) 12.2 Are the implications for practice clearly presented? Briefly Explain (1 pts) 12.3 Are suggestions for future research clearly presented? Briefly Explain (1 pts) 12.4 How do you see this research useful in HC? (1 pts) List references ONLY IF other than the article being reviewed or the course text. 3Quantitative 19SU CLINICAL SCHOLARSHIP Factors Influencing Parents’ Decision to Donate Their Healthy Infant’s DNA for Minimal-Risk Genetic Research Linda A. Hatfield, PhD, NNP-BC1 & Margaret M. Pearce, MSN, FNP-BC2 1 Xi, Assistant Professor of Evidence-Based Practice, School of Nursing, University of Pennsylvania and Director of Research and Evidence-Based Practice, Department of Nursing, Pennsylvania Hospital, Philadelphia, PA, USA 2 Eta Beta, Magnet and Patient Outcomes Director, Department of Nursing, Pennsylvania Hospital, Philadelphia, PA, USA Key words Infant, pediatric, genetic research, parents, knowledge Correspondence Dr. Linda A. Hatfield, University of Pennsylvania School of Nursing, Claire M. Fagin Hall-Room 415, 418 Curie Blvd., Philadelphia, PA 19104-6096. E-mail: lhat@nursing.upenn.edu Accepted: May 11, 2014 doi: 10.1111/jnu.12096 Abstract Purpose: To examine factors that influence a parent’s decision to donate their healthy infant’s DNA for minimal-risk genetic research. Design: Grounded theory, using semi-structured interviews conducted with 35 postpartum mother or mother–father dyads in an urban teaching hospital. Data were collected from July 2011 to January 2012. Methods: Audiorecorded semistructured interviews were conducted in private rooms with mothers or mother–father dyads 24 to 48 hr after the birth of their healthy, full-term infant. Data-driven content analysis using selected principles of grounded theory was performed. Findings: Parents’ willingness to donate their healthy infant’s DNA for minimal-risk pediatric genetic research emerged as a process involving three interacting components: the parents, the scientist, and the comfort of the child embedded within the context of benefit to the child. The purpose of the study and parents’ perception of their commitment of time and resources determined their willingness to participate. The scientist’s ability to communicate trust in the research process influenced parents’ decisions. Physical discomfort of the child shaped parents’ decision to donate DNA. Parental perception of a direct benefit to their child affected their willingness to discuss genetic research and its outcomes. Conclusions: Significant gaps and misunderstandings in parental knowledge of pediatric genetic research may affect parental willingness to donate their healthy child’s DNA. Clinical Relevance: Nurses knowledgeable about the decision-making process parents utilize to donate their healthy infant’s DNA for minimal-risk genetic research and the factors influencing that decision are well positioned to educate parents about the role of genetics in health and illness and reassure potential research participants of the value and safeguards in pediatric genetic research. Historically pediatric genetic research has been conducted on children who are at risk for or potential carriers of genetic conditions (Liem, Cole, Pelligra, Mason, & Thompson, 2010). The primary justification for the recruitment of at-risk infants into genetic research has been that the benefits the infant will receive from participation in the research study outweigh the potential study 398 risks (Wilfond & Ross, 2009). The recruitment of healthy infants in genetic research is considered more challenging due to parental attitudes and concerns about the risks for their healthy infant. This article will explore the process and factors that influence parents’ decision to donate their healthy infant’s DNA for minimal-risk genetic research studies. Journal of Nursing Scholarship, 2014; 46:6, 398–407. C 2014 Sigma Theta Tau International Hatfield & Pearce There is a paucity of literature discussing the problems of recruiting healthy children into nontherapeutic research (Gammelgaard, Knudsen, & Bisgaard, 2006). The National Children’s Study (NCS) is a longitudinal cohort study initiated by the U.S. National Institute of Child Health and Human Development (NICHD) in collaboration with the Centers for Disease Control and Prevention, U.S. Environmental Protection Agency, and National Institute of Environmental Health Sciences. The study will examine the effects of genetic and environmental influences on the health and development of more than 100,000 children across the United States, following them from before birth until age 21 (NCS, 2012). Authorized by Congress in 2000 and launched in January 2009, increasing projected costs (from an estimated $3.1 billion to about $6.7 billion; Belluck, 2010) and low enrollment (Savitz & Ness, 2010) are among the problems that hindered the study’s advancement. As of July 2012, the study spent $1 billion to enroll 3,650 participants ($273,972.00 per child; NCS, 2012). The unexpected difficulties the NCS is experiencing in recruitment may be partially explained by parents’ lack of knowledge and their attitudes and misconceptions surrounding pediatric genetic research (Gillam, Poulakis, Tobin, & Wake, 2006). Although most of the literature exploring parental attitudes and beliefs about participation in genetic studies focused on genetic testing rather than genetic research, two articles looked specifically at parental attitudes toward genetic research. Nechuta et al. (2009) assessed attitudes of a multiethnic sample of pregnant women about the smallest amount of compensation required for their participation in five data collection procedures: a 45-min in-person interview, a 15-min telephone interview, maternal and infant medical record abstraction, and an infant physical examination. Willingness to participate in decreasing order were highest for telephone interview (83%), inperson interview (60%), infant examination (57%), and maternal (56%) and infant (54%) medical records. Education greater than high school was associated with increased refusal for infant physical examination. Refusal of all procedures was significant among more highly educated women. About 9% to 34% of pregnant women, depending on the procedure, stated they would not participate in noninvasive research procedures such as medical record abstraction and infant examination, even with compensation. While this study was not population based and therefore may not be generalizable to all pregnant women and the data collection occurred in clinics where pregnant women may feel healthcare providers support the study, it is notable that a significant number of women were quite resistant to noninvasive medical Journal of Nursing Scholarship, 2014; 46:6, 398–407. C 2014 Sigma Theta Tau International Parental Knowledge of Pediatric Genetic Research research during pregnancy and infancy. This is an important message for pregnancy and newborn research. Gillam et al. (2006) conducted 17 semistructured interviews with parents of primary school children who were participating in a pilot hearing test following otitis media with effusion. The focus of the interviews was to explore parents’ understanding of issues surrounding the participation of their infants in genetic research. Overall parents felt positive about their child’s participation in genetic research but had little knowledge of the legal and social issues surrounding the participation of their children in the study. Parents were unfamiliar with genetic research, were concerned about who would have access to their children’s DNA, and wanted to know the outcome of their child’s genetic testing. Although participants in this study were parents of primary school–age children instead of infants, the data identified a need for parental a priori knowledge of genetics and genomics, a complete understanding of what will happen during the study, and disclosure of specimen use after study completion. Minimal risk is an essential concept in this study. Minimal risk is defined as the probability and magnitude of harm or discomfort in the proposed research is not more than ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (U.S. Department of Health and Human Services, 2011). Until quite recently, this was considered the primary risk for genetic research. Debate about the social and policy implications of genetic information and the processes for ensuring the privacy of participants and the confidentiality of the data is vitally important and is occurring on a national and international level. To date, institutional review boards (IRBs) have not reached a consensus for assigning a level of risk to genetic research. As recently as 2011, genetic studies were being designated as minimal-risk research (Desch et al., 2011). Our findings demonstrate that despite IRB assurances the study adequately protects the confidentiality and privacy of the participants, parents perceive the risks associated with genetic research greater than minimal risk. The purpose of this study was to explore the process and factors that influence parents’ decision to donate their healthy infant’s DNA for minimal-risk genetic research. This study answers the following qualitative research questions: What is the process parents utilized to arrive at a decision to enroll their healthy infant in minimal-risk genetic research? What do parents of newborn infants perceive as factors that influence their decision to donate their healthy infant’s DNA for minimal-risk genetic research? 399 Parental Knowledge of Pediatric Genetic Research Hatfield & Pearce Methods Table 1. Sample Characteristics Study Design Variable Grounded theory methodology (Strauss & Corbin, 1998) explored the process and identified factors that parents utilized to arrive at a decision to donate their healthy infant’s DNA for minimal-risk genetic research. Face-to-face, semistructured interviews were conducted with a convenience sample of 35 mothers or mother– father dyads. The institution’s IRB approved the study. Age (years) Maternal Paternal 29.9 (19–40) 33.3 (23–50) Child sex Male Female (n = 18), 52% (n = 17), 48% Number of children First child Siblings at home (n = 8), 23% (n = 27), 77% Marital status Married Unmarried (n = 23), 67% (n = 12), 33% Parental education High school incomplete High school Some college Associate degree Bachelor’s degree Master’s degree Doctoral degree (n = 3), 7% (n = 5), 15% (n = 7), 20% (n = 1), 4% (n = 10), 28% (n = 4), 11% (n = 5), 15% Ethnicity Caucasian African American Hispanic Chinese (n = 19), 54% (n = 12), 35% (n = 3), 9% (n = 1), 2% Interviews Mothers only Father only Mother–father dyad (n = 19), 54% (n = 1), 3% (n = 15), 43% Setting All participants were recruited from an urban teaching hospital postpartum unit located in a major northeastern US city. The 520-bed acute care hospital has the largest number of annual births in the city, approximately 5,000 annually. All interviews took place in the mothers’ private rooms. Sampling Methods Purposive sampling identified parents who met the eligibility criteria. Eligibility criteria included that the parents were fluent in English and had delivered a full-term infant (gestational age greater than 37 weeks), and that the infant was not admitted to the neonatal intensive care or intermediate care nursery and did not present with an acute or chronic illness (e.g., respiratory distress, unable to maintain temperature, feeding difficulties, etc.). Only parents participated in the study. Infants were not enrolled in the study. Sociodemographic characteristics are presented in Table 1. Semistructured Interview Guide All qualitative interviews utilized a semistructured interview format. The format of the interview was a funneling technique that started with demographic questions, progressed toward parental knowledge and attitudes of pediatric genetic research, and then worked toward specific questions about factors that may influence their decision to donate their infant’s DNA (May, 1989). Initial probing questions were open ended, such as “Can you tell me more about that?” and “Can you tell me what you mean by that statement?” Additional probing questions asked about different factors influencing DNA donation, such as prior experience with genetic testing or research, parental time commitment to the study, parents’ resources, the role of the scientist, and the child’s discomfort. The structure of the probing questions mirrored the structure of the interview; probing questions progressed from general to specific. Parental interviews 400 Mean (range), (n) frequency were designed to explore and clarify individual ideas but each mother or mother–father dyad was asked questions in the same focal area to ensure dependability in data (Graneheim & Lundman, 2004). Data Collection The principal investigator (PI) and co-investigator conducted all interviews. Data collection occurred over 7 months, from July 2011 to January 2012. When mothers were admitted to the postpartum unit, registered nurses working on the postpartum unit asked mothers if they would be interested in hearing about the study. If mothers were willing to hear about the study, the registered nurse informed the PI or co-investigator. The PI or coinvestigator met with the parents, explained the study, answered questions, and obtained written informed consent. The interviews were conducted in the mother’s private room. Each interview progressed at a comfortable pace, allowing the participants the opportunity for flexibility and expression, and lasted approximately Journal of Nursing Scholarship, 2014; 46:6, 398–407. C 2014 Sigma Theta Tau International Hatfield & Pearce 20 min. All interviews were audio taped. Field notes reflecting interactions and surroundings were transcribed immediately following the interview. Data Analysis All interviews were completely transcribed, checked against the audio recordings, and imported into NVivo (version 9, QRS International, Victoria, Australia) for analysis. Names of participants and other identifying information were removed from typed transcripts to protect confidentiality. Descriptive statistics depicted demographics and characteristics of categories. Data collection and analysis occurred simultaneously by the PI and co-investigator. Data analysis involved three levels of coding (Strauss & Corbin, 1998). First, interviews were open coded. Substantial notes guided and synthesized the analysis and served as a written record of analytical decisions. Second, constant comparison analysis methodology tested emerging code development and provided an understanding of the interactions within the data. By utilizing inductive comparison of data throughout each stage of the analytic process (quotes, codes, categories, themes), abstract concepts emerged. Categories appeared in level II coding by clustering codes together using their similarities to relevant genetic interactions. Relationships between themes determined whether the themes would collapse into a larger category. Third, selective coding ensured that all available data were associated with an emerging category and that a core category was identified. Theoretical saturation was attained when no new data emerged from further interviews. Axial coding was utilized to describe factors that influence parents’ decision to donate their child’s DNA. Parental Knowledge of Pediatric Genetic Research nition of “benefit to the child,” (excluding federal subsidies provided to children), there is a consistent and compelling view that benefit to the child ensures no risk to the child but may provide some margin of improvement to future outcomes. Benefit to the child was defined in this study as an event that has a positive physical, psychological, or social outcome for the child. The process parents utilize to assess benefit to their child is guided by the interacting components of the model. The interacting components of the process are threefold: the parents, the scientist, and the comfort of the child. Parents’ decisions about study participation in the present were influenced by what was expected of them and their child during the study. Parental concerns for their child’s well-being in the future were focused on how study findings would affect their child’s life. If parents felt there was minimal inconvenience for them and their child in the present and the future, they next wondered about the integrity of the scientist. The scientist influenced parents’ attitudes by presenting information the parents perceived as important (such as disclosing the “real” reason for the study). Parents worried that their child’s privacy and the confidentiality of data could not be protected. They worried that the genetic information could be harmful to their child in the future. Knowledge that the child would be comfortable and not be exposed to study risk or pain influenced parents’ decisions. Parents acknowledged other factors, such as knowledge of genetic testing and knowledge of genetic research, as having a direct role in their decision to participate in genetic research. Final decisions were made when parents evaluated their time and resource commitment, the scientist’s character, and the risks to the child. Each element of the decision to donate healthy infant DNA is described below. Findings Postpartum women (n = 159) were approached and asked if they would be interested in hearing about the study. One hundred and eight women refused to participate, two women did not respond. Forty-nine women agreed to be interviewed. After agreeing to be interviewed, 14 women were unavailable at the time they requested that the investigators return. Data were theoretically saturated at 29 interviews. Six more interviews were conducted with no new comments, categories, or themes emerging. Parents’ willingness to donate their healthy infant’s DNA for minimal-risk genetic research emerged as a process involving a core category (benefit to the child in the present and the future) and three interacting components: the parents, the scientist, and the child’s comfort (Figure 1). Whereas there is no standard defiJournal of Nursing Scholarship, 2014; 46:6, 398–407. C 2014 Sigma Theta Tau International The Context of Benefit to Child All decisions occurred within the context of benefit to child. Parents were concerned about their child’s physical and mental well-being in the present and in the future. All parents expressed reluctance to participate in minimal-risk genetic research if they suspected risk to their child. Parents described newborn experiences that they perceived as harmful or stressful, such as a difficult birth, that influenced their decision: “I would not put him in a study. He has already been through so much. I do not want to put him through anything else.” The child’s legal rights and the impact of the parents’ decision on the child’s future were a concern for parents. One father was unwilling to donate his child’s DNA because of his uncertainty of what that would mean for his child in the future: 401 Parental Knowledge of Pediatric Genetic Research Hatfield & Pearce Parent’s knowledge of genetic testing or research Little or no knowledge Some or extensive knowledge Scientist Unlikely to participate in pediatric genetic research Child’s comfort Benefit to the child Parents Figure 1. Model depicting the process of parents’ decision to donate their healthy infant’s DNA for minimal-risk genetic research. I cannot make this decision. It is not my DNA. This is something he needs to decide. This would be a violation of his rights. I won’t do that. If he decides he wants to do it then it was his decision. Therapeutic misconception was a consistent theme throughout the interviews with parents. If parents perceived a therapeutic benefit to their child, they regarded pediatric genetic research as valuable and were willing to discuss genetic research and its outcomes: “I would do it if there was something wrong with him or his siblings.” Parental perception of benefiting the child was not influenced by the gender of the child. However, there were more negative paternal attitudes than negative maternal attitudes, except in single mother families. Paternal negative attitudes for genetic research involving their infant were predominately absolute: “No, I would not participate for any reason.” When parents were questioned if compensation would influence their decision to participate, mothers and fathers responded that compensation would not change their minds. Probing questions explored whether monetary compensation would influence parental decisions. All parents stated that no amount of money would influence their decision to refuse participation in genetic research. “No. No amount of money. I just won’t do it. It is not worth endangering my child.” The Parents Parents described several factors that motivated their decision to enroll their healthy infant into a pediatric genetic research study: study purpose, duration, frequency 402 of visits, travel, and expense. Seventy percent of parents (n = 21) voiced these concerns as the primary factors influencing their decision. Seventeen percent of parents (n = 6) stated they had no interest in participating in a genetic study. These parents had no questions and stated there were no factors for them to consider. Study purpose. Parents were focused on the purpose of the study. They wanted specific answers to questions about how necessary is the study, what will be done, why, what will the results be used for, who would have access to the genetic findings, and what is expected from the parents and the baby. I want to know what they will be doing and do they know what they are doing? Will it harm the baby? Will I get into trouble for these tests? I watch the sci-fi channel. I see what scientist do; they stick you with a bunch of needles and use your blood for someone else. Utilization of study findings was another concern of the parents. One parent was concerned that the genetic research would be used to encourage unethical behavior: “What kind of tests are they testing? What are they going to do with what they find? Are they going to use it to do something like terminate pregnancies? I want no part of that.” If the study purpose benefited other children, one mother felt she would participate in the research: If it will benefit . . . as far as genetics . . . in finding some type of . . . as long as I know the purpose of the genetic testing is . . . if it is positive, if it can determine some Journal of Nursing Scholarship, 2014; 46:6, 398–407. C 2014 Sigma Theta Tau International Hatfield & Pearce type of results that will help children in the future. I would do it. Duration and frequency of visits. Demands on parents’ and infants’ time was equally important to parents, especially to parents with other children at home. First-time parents were worried about managing the time and travel with a newborn: “I would want to know how long will the study last? How many times do I have to come back? I can’t find anyone to be with my other kids.” And: “If it is not convenient and it’s going to be a long time, I am not interested. I can’t be coming back and forth for this with a baby.” Parental Knowledge of Pediatric Genetic Research like insurance companies. It [giving DNA] is like letting a genie out of the bottle.” The Child’s Comfort Travel and expense. Parental commitment to travel and expense were linked to the duration and frequency of visits. The expense incurred related to the frequency of the visits and influenced the decision to participate. For some parents the distance they would have to travel was a major concern: “I guess I would want to know where would we have to go. I can’t come here. It is too far. It would cost too much.” All parents expressed concern about the method of collecting the DNA. Most were under the impression the collection of DNA would be accomplished by drawing blood from their infant. Thirty-seven percent of parents (n = 11) would refuse to donate their infant’s DNA if they were exposed to study risk or pain: “If there are side effects or a needle involved . . . no. I do not want to hurt him physically or mentally.” Further probing asked parents if donating a sample of their child’s DNA could tell them what genes influence how their child would respond to and adapt to pain, would that influence their decision to allow their child to participate in a genetic study? Interestingly, parents said it would not be a factor in genetic study participation: “Pain is not a big concern, it is a part of life . . . it is something you have to go through, it is not a strong enough idea to study.” The Scientist Other Influences Parents expressed significant mistrust of the scientist. Their concerns focused on the scientist’s accountability and the ability of the scientist to protect their child’s privacy and confidentiality. No parents felt their data were completely secure and worried about the consequences of the loss of privacy and confidentiality. Only three parents trusted the scientist and scientific process. Parents’ understanding of genetics and its implications for their child’s health provided the backdrop for their decision to participate in genetic research. Personal knowledge, experiences with genetic testing, or knowing someone involved in genetic testing influenced parents’ willingness to hear about genetic research, but not their decision to participate. No parent voiced a concern about wanting or needing to know more about genetics or genetic research. Scientist accountability. Parents were concerned the scientist would not be truthful when they explained the study to them. Fifty-seven percent of parents (n = 17) stated they would not participate because they did not believe scientists would be truthful about the study goals. Permission to store their infant’s DNA was refused by 90% (n = 32) of the parents interviewed: “Do care about [her] well-being but . . . I don’t know . . . how can you prove they are actually using the DNA for . . . is it true? How can I trust it is being used for what you say it is?” And: “No to storage. I do not want anyone experimenting with my kid’s DNA. They do different stuff with DNA like clone babies. It is an unnatural way of life.” Protection of privacy and confidentiality. Parents’ mistrust of scientists extended to their ability to protect the privacy and confidentiality of the data. Parents felt the scientist would use the DNA for reasons they did not disclose and the safeguards in place to protect the data were not adequate: “I am worried about privacy issues Journal of Nursing Scholarship, 2014; 46:6, 398–407. C 2014 Sigma Theta Tau International Parents’ knowledge and attitudes of pediatric genetic research. Most parents had little or no knowledge of genetics or genetic research, and all but one parent confused clinical genetic testing with genetic research. Parental knowledge of genetics is an important impediment to parents enrolling their healthy infants into genetic research. Although we did collect data on parental a priori knowledge of genetics, a detailed discussion of the findings is beyond the scope of this article. Our findings suggest that if parents had some a priori knowledge of genetics they would be more willing to hear about the study. Parents having little or no knowledge of genetics stated they would not be interested in hearing about or participating in the study. The distinctions between clinical genetic testing and genetic research testing (i.e., the purpose of the genetic test and who receives the results of the test; Lister Hill National Center for Biomedical Communications, 403 Parental Knowledge of Pediatric Genetic Research 2013) confused parents. Seventy-six percent of parents (n = 27) stated that parents and infants who participate in genetic research should be entitled to the results of the genetic tests. Parents’ knowledge and attitudes of genetics varied widely. Some parents simply answered they did not know anything about genetics and did not (or could not) expand on their answers. Other parents who chose to explain their answer were hesitant and unsure: I don’t really know much. Just that you can get genetic testing while you are pregnant so you know what you are in for.” They do genetic research to find out things that might be wrong with babies, help cure genetic disease, and things like that. Basically, that is what genetic research is for, help cure disease and helps predict when they are coming. Seventy-three percent of parents (n = 26) were opposed to participation in genetic research and storage of DNA and stated that no amount of compensation would influence their decision: Genetic research is just not normal. That’s my only reason. I really don’t have a reason behind that. It probably sounds bad coming out of my mouth, it is just not normal. You have a baby you take it home and enjoy that and that’s it. Like you don’t want to give out DNA and go through all that extra stuff. No one wants to do that. Information source for pediatric genetic research. Parents received their genetic information from disparate sources. Much of their information was inaccurate, applied to genetic testing rather than genetic research, and was obtained from unreliable sources. Personal experience or knowing someone who had genetic testing created the need for genetic knowledge and influenced the acquisition and amount of genetic information parents sought. Parents perceived outside factors such as the media or nonpersonal genetic situations (such as a friend of a friend had a genetic test) as having a direct role in genetic knowledge acquisition: My sister actually told me some stuff. I think she had it done, ‘cause my nephew has autism or something like that. They do stuff like that all the time. But I do not know exactly what they do. I know what I hear on sci-fi TV. It is not really much; they are using it to clone. That is the only thing I heard about. Like cloning a fetus or using DNA to 404 Hatfield & Pearce clone sperm and eggs. In case in one family something happens to one they have another. Discussion Overall, there are considerable misconceptions and lack of knowledge about genetics and genetic research and many disparate factors that influence parents’ decision to donate their healthy infant’s DNA for minimalrisk pediatric genetic research. The findings describe the process parents utilize to arrive at a decision to donate their infant’s DNA by identifying the core variable, the overall context, and main interacting components: the parents, the scientist, and child comfort. Parental willingness to participate in genetic research is influenced by a core variable, parental perception of what is in the best interest of their child. If parents believe that there is direct benefit to the child, they are more likely to participate in the research. Parental knowledge of genetic research represents the first decision point for the parental decision-making process. If parents have a priori knowledge of genetics, they are more willing to hear about the study. Parents who do not have knowledge are less likely to show interest in hearing about the study. If parents are willing to hear about the study, their understanding of the study, their financial and time commitments, and the overall convenience of the study influence parents’ decisions. The scientist affects parents’ attitudes by establishing a positive perception of trustworthiness and securing their confidence that the information provided by the scientist is truthful and can be attained. The child’s comfort influenced the parents’ decisions through communication that the child will not be exposed to study risk or pain. Although parental knowledge of genetics or genomics did not have a direct role in parents’ decision to donate DNA, parental a priori knowledge of genetics and genomics was a factor in parents’ willingness to hear about a genetic study. The generally low level of knowledge about genetics and genetic research demonstrates a need for education directed toward the genetic aspects of the study. Parents arrived at their final decisions after evaluating their time and resource commitment, the scientist’s character, and the comfort and risks to the child. The most influential factors described by the parents were the study purpose and resource and time commitment and the trustworthiness and accountability of the scientist. The purpose of the study and parental commitments were the most frequently cited factors affecting parental decision making. Parental willingness to allocate time and resources to an interesting and valuable study surfaced in three other studies as an Journal of Nursing Scholarship, 2014; 46:6, 398–407. C 2014 Sigma Theta Tau International Hatfield & Pearce important consideration in parental decisions to donate DNA (Gammelgaard et al., 2006; Jenkins et al., 2009; Nechuta et al., 2009). The trustworthiness of the scientist and the ability to safeguard the data collected was the second most important factor in decision making. Many individuals fear that participating in genetic research or genetic testing may result in discrimination against them based on their genetic profiles. In response to these concerns, the Genetic Information Nondiscrimination Act prohibiting discrimination in the workplace and by health insurance issuers was passed into law in 2008. In addition, there are other legal protections against genetic discrimination by employers, issuers of health insurance, and others (National Human Genome Research Institute, 2013). Discussions about genetic research, especially in vulnerable populations such as children, are likely to be ethically contentious or sensitive. To be ethical, research involving children must pose no greater than minimal risk to the child unless the research presents a direct benefit to the child. Healthy infants recruited into pediatric genetic research will most likely not receive direct benefit from the research, and the collection and storage of genetic data are far from risk free. When people are influenced by risk and privacy fears, they not only c
