Datasets:

---

Recag

/

Rp_CommonC_55

like 0

ERROR: type should be string, got "https://www.thehastingscenter.org/briefingbook/assisted-reproduction/\nFor Journalists, Policymakers, and Educators\nBioethics and Policy—A History\nWhy Bioethics Matters Today—A Journalist’s Perspective\nBiobanks: DNA and Research\nBrain Injury: Neuroscience and Neuroethics\nConflict of Interest in Biomedical Research\nConscience Clauses, Health Care Providers, and Parents\nDisaster Planning and Public Health\nDNA and Law Enforcement\nEnhancing Humans\nEnvironment, Ethics, and Human Health\nGene Patents\nGenetic Testing and Screening\nHealth Care Costs and Medical Technology\nIntellectual Property and Biomedicine\nMental Health in Children and Adolescents\nNature, Human Nature, and Biotechnology\nNeonatal Care\nPersonalized Medicine and Genomics\nPhysician-Assisted Death\nPublic Health Ethics and Law\nQuality Improvement Methods in Health Care\nResearch in Resource-Poor Countries\nSports Enhancement\nTorture: The Bioethics Perspective\nFROM BIOETHICS BRIEFINGS\nBy Adrienne Asch, PhD and Rebecca Marmor\nAssisted reproductive technologies—such as fertility-enhancing drugs, in vitro fertilization, and intracytoplasmic sperm injection—can be used to circumvent fertility problems while preserving a genetic connection.\nEthical issues arise around the creation, selection, and disposal of embryos, as well as around cost, coverage, access, and resource allocation.\nAssisted reproductive technologies can also require the use of sperm, eggs, or wombs from third parties who are not expected to play a role in raising the child.\nEthical issues around third-party assisted reproduction are complex and involve the selection and sale of reproductive materials and services, regulation, and the rights and responsibilities of collaborators.\nIn contrast to virtually every other developed nation, U.S. jurisdictions have enacted only piecemeal legislation to deal with such issues.\nFraming the Issue\nAlthough it accounted for just over 1% of U.S. births in 2005, assisted reproduction has fascinated the media and public. It has received less attention from lawmakers. In contrast to virtually every other developed nation, U.S. jurisdictions have enacted only piecemeal legislation to deal with assisted reproduction.\nThere are two significant respects in which assisted reproductive technologies (ARTs) differ from standard medical interventions. First, for the most part, ARTs do not treat the biological problems that give rise to infertility but circumvent them—most ARTs offer ways to create children despite underlying fertility problems. Second, ARTs sometimes require the use of reproductive resources—sperm, eggs, or wombs—from third parties who are not expected to play a role in raising the resulting children. Third party assistance is sometimes required by the infertile heterosexual couples whom ARTs were developed to serve. But they have also enabled same-sex couples and single people to have children to whom they have a biological connection.\nThe more limited use of ARTs to help infertile couples have children with their own reproductive resources poses ethical issues. These are compounded by the more difficult and complex problems raised by the expansive uses of ARTs: to enable any prospective parents, regardless of age, sexual orientation, or marital status, to have genetically or biologically connected children.\nInfertility and Two-Party Assisted Reproduction\nInfertility is commonly defined as the inability to conceive after 12 months of unprotected sexual intercourse. It also refers to an inability to sustain a pregnancy, which is demonstrated by repeat miscarriages. Approximately 7.3 million women and their partners (about 12% of the reproductive-age population) is infertile. Infertility affects men and women in equal numbers.\nBoth men’s and women’s fertility is affected by workplace and environmental toxins. Two leading causes of women’s infertility are delayed childbearing and blocked fallopian tubes (often due to untreated pelvic inflammatory disease). Delayed childbearing is more prevalent among white women than among Hispanic and African American women, whereas tubal impairment is more prevalent among Hispanic and African American women than white women.\nWhen partners expecting to become parents discover that one or both of them have fertility problems, they confront a variety of options to bring a child into their lives. They may try to adopt, or they may choose from an array of medical technologies. They must decide whether they prefer the uncertainties and complexities of the adoption process or of the medical response to infertility. Medical responses run the gamut from noninvasive to highly invasive. All carry significant risks for both the mother and fetus. They may also be expensive, and many of the more invasive techniques are not covered by insurance policies. The three primary means of assisted reproduction are:\nMedication. Drugs such as Clomid, Serophene, and Pergonal can be used to stimulate ovulation and increase a woman’s chances of conceiving. These drugs can also increase the likelihood that the woman will have multiple births, which is potentially risky for both the woman and the fetuses.\nIn vitro fertilization (IVF). IVF, which was first offered in the United States in 1981, is perhaps the most well known method of assisted reproduction. It has resulted in the birth of more than 500,000 children between the years of 1985 and 2006. With IVF, a woman takes fertility drugs to produce more eggs. The physician then retrieves one or more eggs by laparoscopy or by passing a needle through the vaginal wall. The partner’s sperm is then mixed with the eggs in a petri dish, and fertilization may take place.\nIntracytoplasmic sperm insertion (ICSI). ICSI is a technique in which a single sperm is injected into the egg. It can be combined with IVF technology to help men with low sperm counts contribute genetically to a child. If fertilization occurs, the embryo is allowed to develop outside the womb for a few days and is then implanted in the lining of the woman’s uterus with a small plastic tube. Most centers now place two to four embryos in the womb in the hope that one will burrow into the lining and begin to develop normally.\nEthical Issues with Two-Party Assisted Reproduction\nAlthough the use of IVF by heterosexual couples has gained wide acceptance, it nonetheless raises vexing questions concerning embryo creation, selection, and disposition; cost, coverage and access; and resource allocation.\nEmbryo creation, selection, and disposition\nNot only do the expense and lack of insurance coverage deter many infertile couples from pursuing treatment, these financial disincentives encourage the practices of implanting multiple embryos at one time and creating more embryos than the couple will ever need. Patients reduce their costs by fertilizing many eggs at once and implanting several embryos in the hopes that at least one will be carried to term. Multiple implantation increases the chance of multiple births; in 2005, 11.2% of ART cycles resulted in multiple-fetus pregnancies. IVF practice raises questions about how many embryos should be created and stored for future use, what to do when couples disagree on the disposition of unused embryos, and when or whether it is appropriate to use preimplantation genetic diagnosis (PGD) as a means of selecting characteristics of the embryos to implant. These concerns are heightened in a country vexed by the moral status of embryos (see box, “Lack of Oversight”).\nCost, coverage, and access\nThe 422 infertility clinics in the United States operate without any regulation of cost, access, or scope and quality of treatments. The average cost of an IVF cycle in the United States is $12,400. However, it can often take multiple cycles for a couple to achieve pregnancy and birth. The specific laws concerning coverage of infertility treatment vary widely from state to state. Currently, 15 states have laws that require insurers to cover some form of infertility diagnosis and treatment. These cost concerns affect access. Poorer women and those without health insurance are less likely to go to a doctor for fertility assistance. This trend demands that our society confront the question: should we mandate that insurance companies provide coverage for infertility treatment? Mandatory coverage could suggest that conceiving a biologically connected child is preferable to adoption—there is no standard coverage for the expenses incurred in typical adoptions. If coverage is not mandatory, however, the disparity in access to infertility treatments will likely persist. Infertility treatment is seen by many as a luxury, not a medical necessity. Several theorists, however, argue that procreation and parenting are of such central importance to an individual’s identity and life goals that medical insurance should pay for infertility treatment.\nBecause the creation of genetically related children for infertile couples has been viewed as a medical issue, the laws, policies, and practices bearing on ARTs have developed separately from the state and national child welfare systems. In a country concerned about ever-increasing health care costs, unregulated infertility medicine results in expensive treatments for difficult pregnancies with multiple fetuses—treatments that might have been avoided by more conservative implantation practices and by efforts to alleviate the conditions that give rise to infertility in the first place.\nLack of Oversight\nThe American Society for Reproductive Medicine (ASRM) has created guidelines for practitioners about how many embryos to implant in any in vitro fertilization cycle and about treating people whose medical conditions may complicate the typical course of IVF (such as those who are HIV-positive). However, the ASRM lacks the ability to enforce these guidelines. Without governmental oversight, clinicians may practice medicine in accordance with their own beliefs. Variability in the beliefs of different practitioners permits most patients turned down by one clinic to find another where practitioners will feel comfortable treating them.\nNevertheless, the lack of regulation and practitioner variability means that individual decisions about eligibility for ARTs may be arbitrary, biased, and inconsistent, shielding practitioner prejudices, subjecting prospective parents to great uncertainty, and avoiding public discussion of difficult policy issues in reproductive policy.\nThird-Party Assisted Reproduction\nARTs are increasingly sought by those who cannot reproduce using only their own genetic and biological capacities. Heterosexual and same-sex couples and single women and men who seek to have biologically connected children frequently turn to clinics and agencies for “donors” who provide sperm, eggs, or gestational services, usually for a fee.\nTwelve percent of IVF cycles in 2005 used “donor” eggs, most often for women in their forties who discovered that they could not achieve pregnancy using their own eggs. Although the development of ICSI has reduced the number of heterosexual couples requesting sperm donation, IVF is still sought by those who cannot produce sperm at all, as well as by lesbian couples and single women seeking a child genetically connected to at least one rearing parent. If about 52,000 infants were born through IVF cycles in 2005, it is possible that some 6,200 children were born through “donor” eggs; numbers of births through donor insemination are not reported in data on ARTs, but it, too, is probably responsible for several thousands of children annually.\nThe last, least used, but perhaps most controversial form of third-party reproduction is known as surrogate, or contract, motherhood. It is typically employed by heterosexual couples in which the woman can produce her own eggs but cannot carry a pregnancy to term. The partners contract with a woman to carry the fetus formed from their gametes. Some heterosexual couples, single men, or gay male couples achieve parenthood using the services of a woman who provides both genes and gestation and then surrenders the baby upon birth to those who intend to raise the child. Only 571 surrogacy contracts were reported in 2001, accounting at that time for less than 1% of known ARTs. But the recruiting and hiring of women who will gestate children for pay and then turn them over to others has occasioned intense legal and ethical controversy. Few states now accept surrogate motherhood or gestational carrier arrangements. Many states ban them outright; others refuse to enforce contracts if disputes arise among the parties. In contrast, for several decades all 50 states have had laws ensuring that sperm donors who follow prescribed procedures remain anonymous and free of parental rights and duties. Those laws have been readily adapted to cover egg donation.\nIn an effort to avoid confusing state regulations in the United States and the high cost of surrogacy, couples are seeking aid overseas; the president of PlanetHospital, a “medical tourism” agency in California, expects to send at least 100 couples to India this year for surrogacy, up from 25 in 2007. In contrast to the estimated $50,000 spent in the United States, surrogacy in India can typically be done for $10,000–$12,000.\nQuestions Raised By Third-Party Assisted Reproduction\nHow should law and policy recognize and weigh the significance of genes and gestation, as well as post-birth rearing, in establishing parental rights and duties?\nHow should law and policy protect collaborators from exploitation?\nOn what basis, if any, should individual states or the nation restrict who may benefit from third-party reproduction?\nShould individual practitioners remain free to deny services to would-be parents based on marital status, sexual orientation, age, or assessed child-rearing ability?\nShould clinics operate on a medical or a social service model?\nIs a single man or woman or a same-sex couple entitled to the same insurance benefits even when the need for third-party assistance arises from social and not medical reasons?\nSelection and sale of gamete\nShould the United States adopt the approach of countries that permit only true donation of reproductive services?\nIf the nation is going to leave reproduction to the market, should it make any attempt to regulate how much can be paid for participation in the creation of life?\nOnce people purchase gamete and gestation from others, how much trait selectivity is permissible?\nShould the heterosexual couple seeking an egg donor try to find one whose appearance, interests, and background resemble the infertile partner who will become the gestational and rearing mother, or is it acceptable to purchase eggs from someone with very different characteristics?\nRights and duties of collaborators\nShould the young people who will be the preponderant gamete donors—most of whom have not yet started their own families—be required to undergo psychological screening or counseling?\nShould the United States adopt Sweden’s requirement that only people willing to be found will be accepted as collaborators, or should it take France’s position that all collaboration be anonymous?\nShould the states take no position on parental secrecy or donor anonymity, but require practitioners to keep records so that children can trace genetic and gestational parents?\nDoes telling about genetic origins foster the conviction that biology is as—or more—important to the child’s identity than the social reality of day-to-day life with his rearing parents?\nPolicy Questions\nThe variety of options available to prospective parents now enables as many as five people to play some sort of role in the conception, birth, and raising of a child. A sperm and egg donor can each supply gamete that can be fused and then implanted in a surrogate, who will carry the fetus. Upon birth, one or two more individuals can take custody of the baby and raise her. Law and policy have still not grappled adequately with the relationships, roles, and responsibilities in these collaborative arrangements that create children with several people who could claim some parental involvement in their births. The number of people that can now be involved biologically and socially in the creation of a child raises difficult issues about which sorts of reproductive collaboration will be permitted, who can participate in third-party reproduction as a provider or recipient, how the market in reproductive services should be regulated, and what rights and duties should be recognized for collaborators with respect to the children that result.\nFor example, a number of difficult questions are raised by the marketing of reproductive material and services and the selectivity it permits. Although the United States prohibits sale of kidneys or bone marrow, it has taken no position on markets in sperm, eggs, or wombs, thus tolerating a flourishing market in genetic material and reproductive services. Sperm, eggs, and gestational services command different prices from one another; their cost also varies based on the traits of the individuals who offer them. For example, an egg from a Harvard-educated, five-foot-nine pianist might very well cost more than an egg from someone without a college education or without musical or athletic ability.\nLegislators and policymakers confront a plethora of difficult questions about the creation of children and families through ARTs (see box, “Questions Raised by Third-Party Assisted Reproduction”). Perhaps the use of reproductive technologies is best left to the choice of individuals and the vagaries of the market. But if so, that is a decision that should be arrived at by vigorous public debate, not by thoughtless default.\nThe authors would like to thank David Wasserman for discussion and editing of this essay.\nAdrienne Asch, PhD, a Hastings Center Fellow, is director of the Center for Ethics and the Edward and Robin Milstein Professor of Bioethics at Yeshiva University, and Rebecca Marmor, formerly a research and program assistant at the Center for Ethics at Yeshiva, is a medical student who is also pursuing an MA in bioethics at Case Western Reserve University.\n45% of our work is supported by individual donors like you. Support our work.\nThe American Society for Reproductive Medicine. Includes topic index, news, publications, FAQs, and a section for the media.\nThe U.S. Department of Health and Human Services’ source for women’s health information. Includes an infertility FAQs and helpful links.\nThe Centers for Disease Control and Prevention’s reproductive health gateway page. Includes data and statistics, publications and products, a glossary, and related links.\nSusan Markens, Surrogate Motherhood and the Politics of Reproduction, University of California Press, 2007.\nThe Centers for Disease Control and Prevention, ART Success Rates: National Summary and Fertility Clinic Reports, 2005. This and previous reports available at www.cdc.gov/ART\nPresident’s Council on Bioethics, Reproduction and Responsibility: The Regulation of New Technologies, March 2004. Report available at www.bioethics.gov\nhe Ethics Committee of the American Society for Reproductive Medicine, “Human Immunodeficiency Virus and Infertility Treatment,” Fertility and Sterility, February 2002.\nAnne T. Fidler and Judith Bernstein, “Infertility: From a Personal to a Public Health Problem,” Public Health Reports, November-December 1999.\nAdrienne Asch, PhD\nDirector, Center for Ethics, and Edward and Robin Milstein Professor of Bioethics, Yeshiva University 212-960-0834 Email\nRebecca Marmor\nStudent of Medicine and Bioethics, Case Western Reserve University 315-427-1859 Email"

ERROR: type should be string, got "https://www.thehastingscenter.org/irb_article/the-research-and-family-liaison-enhancing-informed-consent/\nIRB: ETHICS & HUMAN RESEARCH\nThe Research and Family Liaison: Enhancing Informed Consent\nBy Halle Showalter Salas, Zuraya Aziz, Nanci Villareale, and Douglas S. Diekema\nVolume: 30, Issue: 4\nThe advancement of medical diagnosis and treatment requires scientifically sound and ethically appropriate research involving human participants. The inclusion of children in research necessitates assuring adequate protection for a population that generally relies on others to safeguard its interests. Although regulations have created a framework to promote ethical research with children, they represent a minimal requirement, and simple adherence to these regulations does not guarantee that a given research project is ethically optimal or meets the highest ethical standards. Family confusion regarding the purpose of research and the therapeutic misconception,1 failure to make child assent a meaningful process,2 cross-cultural challenges,3 and the dual role of the clinician/re-searcher4 can all compromise the ethical integrity of informed consent.\nSome limited studies describe demonstrated solutions or interventions to meet these challenges, but no consensus exists regarding how best to present research information to families, to educate families about the research process, to ensure that families comprehend information presented to them, or to facilitate the voluntary participation of families throughout a research study. There is a growing consensus, however, that more effort should be focused on the informed consent process.5 Our institution addressed these challenges by creating the Research and Family Liaison (RFL) position within the pediatric research setting. This article describes how our institution wrestled with improving the informed consent process through the creation of this position, the methods employed to develop the role of the liaison, and the evolution of the liaison’s role over time. Future plans include a formal evaluation of the liaison role.\nThe Research and Family Liaison\nThe Research and Family Liaison (RFL) is a new staff position whose role was designed to assist families and to collaborate with members of the pediatric research team to facilitate the informed consent and assent processes. The RFL also creates informational materials relevant to the needs of child participants and their families. While the RFL’s role is similar to that of a patient advocate, distinct differences exist.\nThe concept of advocacy discussed in the research ethics literature ranges from advocates who serve in compliance and monitoring roles6 to persons focused solely on the research participant, with many iterations in between.7 The research advocacy role most often referred to in the literature is the Research Subject Advocate (RSA). This advocacy role falls within the compliance/monitoring model and is meant to support investigators who conduct studies at an institutions’ General Clinical Research Center (GCRC) that is funded by the National Center for Research Resources (NCRR).8 Our primary concern was that the RSA works mainly with a specified population (participants in GCRC studies) and does not usually oversee participation in non-GCRC studies. At our institution—a large urban tertiary care pediatric hospital located in the western United States—many research studies fall outside of the GCRC’s purview, thus limiting the RSA’s access to research participants. Another concern is the RSA’s strong focus on compliance and less direct interaction with families or involvement in research staff education. Thus, the RFL role resembles the RSA position with respect to the element of advocacy yet is distinct in its scope and focus.\nWhen selecting a title for the position, we were concerned that the term “advocate” created the potential to generate a perception that families need to be protected from the research team and that team members do not themselves advocate for or seek to safeguard the interests of child participants and their families. This perception might set an adversarial tone in the relationship between an advocate and research team members, making it more difficult for the new staff position to be seen as valuable not just by families, but also by the research team. Thus, we chose the title “Research and Family Liaison.”\nDue to the innovative nature of the project, two individuals were hired to shape the position, support each other in day-to-day role activities, effectively manage the workload, provide different skill sets, and allow for creative interaction. The RFL role requires individuals with excellent communication skills to facilitate interactions between the investigator and family. Bicultural and bilingual communication skills are valuable in this position if an institution is committed to improving the informed consent and assent process for children and families with limited English proficiency. Persons with and without healthcare backgrounds were considered for the RFL positions, but individuals without healthcare backgrounds were ultimately selected. The lack of formal clinical training offers a significant advantage: if the RFL does not understand the consent form or study information presented by the researcher, the child and the child’s family will likely also not understand.\nWhile an RFL can provide insight into communication, he or she must also be able to navigate medical and research cultures in order to be successful. With that in mind, core competencies (Table 1) were developed to guide RFL orientation and skill training.\nThe two RFLs performed an initial literature review to identify problem areas related to informed consent that might benefit from further attention. The RFLs sought out stakeholders’ thoughts and opinions through family focus groups, multiple interviews with researchers, and informal discussions with research staff. Additionally, the RFLs directly observed informed consent conferences between investigators and families. These observations further elucidated needs in the research arena and increased the RFLs’ understanding of the established framework within which they would interact with staff and families.\nResearcher Interviews\nWe conducted nine semistructured interviews using a sample of pediatric investigators from a variety of departments selected to represent the types of research conducted at the hospital, as well as research presenting varying levels of complexity to participants. We employed a qualitative, descriptive approach to characterize researchers’ perceptions of factors that influence informed consent, challenges faced by investigators, and strategies for improving the informed consent process. These transcripts were reviewed along with associated field notes, and a coding scheme was developed. QSR N6 Qualitative Data Analysis Software was used to examine the themes. To assure trustworthiness or reliability of data analysis, a primary researcher read the transcripts and clustered the major themes. A second investigator then did the same. Reviewers identified, clarified, and adjudicated discrepancies.\nFour themes emerged from these interviews. The first involved challenges the RFL would face when interacting with individuals who were physician-researchers. Many investigators who exercised this dual role noted that they were often more knowledgeable about the study than anyone else, and therefore believed they could be an invaluable resource to families who were considering enrolling their child in a study. However, the dual role carries the potential for conflict of interest that could undermine both the clinical and research relationship with the family.\nThe second theme revolved around ambivalence towards the concept of child assent. Many researchers seemed to have trouble distinguishing child assent from informed consent or parental permission. They believed that child assent was merely a version of informed consent for children rather than a separate, more nuanced process. The third theme involved investigators feeling inadequately prepared to appreciate and address cross-cultural issues in the context of research. Researchers anecdotally noted that children and families with limited English proficiency seemed more likely to be confused regarding the informed consent process. Finally, investigators sensed a need for training in ethical issues related to research, recognizing that presenting study information to families in a meaningful way requires skill and training.\nFamily Focus Group\nA family focus group was conducted with nine parents from seven families whose children had been diagnosed with some form of cancer in the past 12 years and who were in remission. RFLs utilized a grounded theory approach for the initial focus group. Grounded theory looks to discover theory by examining concepts grounded in the data; it is a good method to use when inquiring about how processes—in this case, the informed consent discussion—influence the way in which things are accomplished through a given set of social interactions.9 The focus group was semistructured, and the discussion was recorded and transcribed verbatim. RFLs coded and analyzed the data to arrive at the core categories or themes discussed below.\nThe focus group provided the RFLs with further insight into family experiences during oncology trials, parents’ emotional state at the time of the informed consent process, the impact of hearing about research-related side effects, the reasons for enrolling their child in a study, and how laypersons understand clinical trials. Four main themes emerged from the focus group. First, parents agreed that the combination of their emotional state at the time of their child’s diagnosis and medical complexities related to the disease made understanding details of their child’s condition very difficult. The presentation of enrolling their child in research as an option for treatment increased the degree of complexity and required parents to make decisions for which they felt ill prepared. Second, most parents felt a sense of urgency regarding decision-making about their child’s treatment options—a result of their own emotional state, the language and behavior used by physicians, and time constraints dictated by the disease. Third, the parents’ sense of trust in the physicians and institution played a significant role in their decision-making. Finally, parents mentioned several resources they believed would have made their situation easier to handle by reducing some of the burdens they experienced. These resources included: 1) a person assigned to each family who could act as their main point of contact and guide them through their experience and 2) more information, along with different types and formats for receiving that information. Families wanted additional information about general research participation, specific information related to the study in which they had the option of enrolling their child, and a resource sheet to help them formulate questions to ask when considering research participation for their child. Parents also wanted access to this information in both written forms and via the Internet.\nFrom February to December 2006, the RFLs observed more than 65 informed consent conferences to learn about the informed consent process, identify communication needs, and ascertain ways they might be helpful. Utilizing a qualitative descriptive design and an observational approach, they collected data from May to September 2006. This convenience sample consisted of research staff from two departments. A quality improvement instrument developed and pilot-tested by the project was used that focused on the way information was presented, the family’s ability to comprehend that information, and the effect of explanations, descriptions, and examples used during the conference discussions. The RFLs took field notes and also met with the child and parent(s) whenever possible to solicit their impressions of the conference. Data were entered and analyzed using the Statistical Package for the Social Sciences 12.0.1 for Windows. RFL field notes were triangulated with tool results to amplify findings.\nBased on observations of informed consent conferences recorded via the quality improvement tool, the RFLs noted that families appeared to better understand information when medical jargon was avoided, the informed consent conference was limited to an hour, and visual aids were used to assist in the presentation of research information. This was corroborated by discussions with families conducted after the informed consent conference and confirmed during the family focus group. In addition, many families were left with the impression that they had to make a decision rather urgently, but did not know if that sense of urgency translated into hours, days, or weeks. Thus, the RFLs concluded that it would be helpful to families if investigators gave them a specific time frame for making a decision about whether to enroll their children in a study.\nOther factors that appeared to aid families in the research process included: the investigator asking if the family had any questions before beginning the informed consent conference, especially when the family was dealing with a new diagnosis; acknowledging that the family was not expected to remember all the information presented; identifying the consent form as a reference document for information they may not remember; explaining the purpose of research in general; asking families’ preferences surrounding presenting specific information, such as percentages or general ideas; and explaining randomization and why it was used in studies. Families also seemed to have a better understanding of the research study when key issues were highlighted for them (e.g, “The most important things to remember are . . .”). Moreover, it appeared that families participating in informed consent conferences where the presenter was accompanied by another research team member (e.g., a fellow or research nurse) found the presence of that additional person and the ensuing dialogue that occurred between them helpful. Often if one person was not communicating an aspect of the research in a way that was understandable to the family, the other member was able to clarify the matter.\nFinally, the RFLs identified problems in presenting study information to families with limited English proficiency. The presence of an interpreter at an informed consent conference changed its dynamics. At times, research staff would summarize study information, providing less detail than usual, so that even if interpretation was necessary, the conference would not increase in length. The experience research staff had in working with interpreters and the interpreter’s competency and familiarity with research concepts affected the quality of the conference. Cultural views regarding research in general and child assent specifically posed challenges to the research team working with these families.\nRFL Activities and Lessons Learned\nThe RFL position was designed to improve the quality of informed consent, parental permission, and child assent in research at our institution. Based on observations of the informed consent process and discussions with investigators, staff, and families, we identified three RFL activities: direct engagement; education; and consultation. Our experiences with these activities have yielded important lessons for those seeking to improve the informed consent process for pediatric research. These lessons include 1) identifying potential barriers to incorporating the RFL position into the pediatric research setting, 2) clarifying the scope of the RFL’s role, and 3) determining how the RFL will interact with other institutional members.\nPotential Barriers\nWe encountered several challenges when introducing a new staff position in the pediatric research setting that are likely to be common at other institutions. These challenges included finding the resources to support the position, concerns by the current research staff about the RFL’s role and operational barriers.\nWith regard to financial resources, the RFL position was originally funded for two years through a grant from the Health Resources and Service Administration Maternal and Child Health Bureau of the U.S. Department of Health and Human Services. Since the grant ended, our research institute has supported the position so that the RFL can continue to evolve to best meet the needs at our institution. Several research staff questioned the value of the RFL and expressed fear that incorporating such a position into the pediatric research setting might have negative results, such as fewer families agreeing to enroll their child in research. These fears were not realized. This and other concerns have been resolved over time as the research staff continually worked with the RFLs. The majority of staff appreciate and look for ways to further incorporate the RFL in their research activities.\nPerhaps the most significant barrier to incorporating the RFL into the pediatric research setting had to do with operational issues. Ensuring that the RFLs were notified in advance about scheduled informed consent conferences was difficult initially. New activities take time to incorporate into existing routines. The RFLs found ways to alleviate the burden on research staff by familiarizing themselves with research processes in various departments and contacting key individuals who notify them of upcoming consent conferences.\nScope of the RFL’s Role\nA “one-size fits all” approach to informed consent discussions is not optimal since it fails to address the seemingly endless variations that exist among research studies and those presenting the details of a research project to parents and children. The three activities of the RFL—direct engagement, education, and consultation—are an attempt to further clarify and meet the multiple needs of all involved in the research process. Direct engagement, education, and consultation define the scope of the role. These RFL activities will vary with the study, the investigator, and the family.\nDirect engagement involves interactions with families, potential child participants, and research team members related to research and the informed consent process. The RFL’s involvement in a particular study may be due to a recommendation from the Institutional Review Board (IRB) or the request of a principal investigator based on particular features of the protocol (e.g., the study involves multiple study arms). Direct engagement may take a variety of forms depending on the level of risk involved and complexity of the study process.\nOur focus group and RFL observations suggested that difficulty in understanding study information seemed to increase when studies presented complex research concepts (e.g., randomization), when stress levels were higher (e.g., a recent diagnosis), or when the study posed greater than minimal risk (as defined by the federal regulations and determined by the IRB). The RFL may act as a facilitator between families and research team members at such times. While establishing a relationship with the family and the research team, the RFL becomes knowledgeable about the communication styles and preferences of both the family and the investigator. This allows the RFL to act as a liaison and to mediate style and communication differences. It also helps to create an optimal environment within which a meaningful discussion of the research project can occur. Additionally, the RFL may follow the family throughout the entire study, acting as a sounding board for decisions regarding continued participation. An RFL can be a resource to families who may be uncomfortable raising certain issues with the research team. With less complex studies, the RFL is available to work with the presenters to improve their explanation of the study or to engage directly with a specific family if an investigator is concerned about comprehension.\nDirect engagement also includes ongoing focus groups and discussions with families and child participants designed to identify new or recurring issues that need to be addressed. One example of such an activity is a family focus group with Spanish-speaking families led by an RFL. (Spanish-speaking families comprise 70% of our institution’s limited English proficiency patient population.) The purpose of the focus group was to better understand how families with limited English proficiency view and experience the research process and to discover ways to meet these families’ specific needs.\nSeveral factors determine whether direct engagement by an RFL in a particular study will be helpful or necessary. Since an RFL cannot attend every informed consent conference, identifying those aspects related to the study, child participant, family, and research personnel will help clarify when an RFL’s involvement would be most valuable. Some studies may be more difficult to understand because of their complexity, the nature of the risks and benefits, or the setting (e.g., research being introduced within the context of a child’s treatment plan).\nBecause each family is unique, we discovered that the RFL has been helpful in assisting families with different needs and preferences by providing different services. For example, one family may need additional sources of information; the RFL would then gather that information for them with the help of the research team. Another family may require assistance formulating questions that will best help them receive the information they are seeking. It is difficult to say which families will benefit since the needs of each are so unique. However, we have found that, overall, families are assisted by the RFL’s presence.\nResearchers who believe families are struggling with research information can refer them to RFLs. RFL involvement can be valuable when the researcher is also the clinician, when she has little consent process experience, or if she wants to improve her delivery of study information to families.\nAnother activity of the RFL is to educate. The RFLs created the Consent, Assent, and Parental Permission Mentoring Program (CAPP) (Table 2). The program aims to educate new research associates, nurses, fellows, and investigators. RFLs provide educational lectures and discussion sessions on topics such as ethics, research regulations, contextual issues of the informed consent conference, and aspects specific to presenting study information to families with limited English proficiency. The mentoring portion of the program includes two components. In the first, CAPP participants observe other research staff presenting study information to families “in the field,” followed by a discussion with RFLs about what worked well and what could have been improved. The second component involves the RFLs observing each CAPP participant as they present information to families. RFLs then provide these research staff members with feedback on their presentation skills. The CAPP program offers staff the opportunity to discuss issues about the informed consent process and serves as an environment where they feel supported and have access to resources to improve their interactions with families.\nThe RFL is in a unique position to identify issues and needs during the informed consent process. Providing education, training, and mentoring to research staff is a critical aspect of the role since it provides a large number of staff with the opportunity to gain information at one time, creates a forum to discuss challenges in the consent process, and defines methods to meet those challenges. Most institutions will not have the resources to utilize an RFL for each research visit, so training staff will likely become a primary focus of the RFL’s role.\nIn addition, RFLs are currently available at the request of individuals within the institution to consult about ethical issues related to the informed consent process in research. For example, RFLs have helped research teams think about optimal ways to present multiple studies to families during a single research visit and have aided in the construction of parental permission and child assent forms.\nConsultation meets the needs of research teams prior to any interaction with potential participants and families. Consultation can be done at the individual study level, with an RFL assisting the research team in clarifying consent materials—for example, by creating diagrams and flow charts that can be used as visual aids when presenting study information to families. The RFL can also assist at an institutional level by constructing global parental permission and assent form templates and by providing consultation for informed consent and child assent policy.\nThese three activities—direct engagement, education, and consultation—have helped focus the role of the RFL and continue to give it shape as we seek to meet the needs of those involved in research and encourage a truly informed consent process.\nRFL Interaction with Other Institutional Members\nHospital administrators may question why an RFL is needed if an RSA or other similar position already exists at an institution. We will focus on the RSA role since it is currently a position that may be similar to the RFL role. At our institution differences exist between these two roles. The RSA model includes many functions, including unbiased observation, provision of information in higher risk research study scenarios, and monitoring data and safety plans.10 Certainly the role of individual RSAs differ by institution, and certain tasks of a particular RSA may overlap with the activities of the RFL. However, the RFL role was meant to move beyond compliance and observation to further support the informed consent process through direct engagement, education, and consultation. The usual system of IRB review has not been sufficient to genuinely promote informed consent. It produces a consent document but provides little or nothing to help carry out the process of informed consent. The RFL role seeks to support the process of consent, not only its documentation, after IRB approval has been granted.\nMany challenges exist when conducting research with children. The Research and Family Liaison position was conceived after examining current dilemmas in research, investigating advocacy-related literature, and observing and conversing with families whose children were research participants. The lessons that were learned were then applied in a specific research setting. Rather than advocating for an individual or group, the RFL advocates for the informed consent process. Broadening the traditional scope of informed consent (which focuses on recall and understanding), the RFL brings attention to the many factors that affect the presentation of study information such as the setting, the presenter, and the informational and emotional needs and preferences of each family. The RFL has been well received by families and research staff at our institution. The next step is to formally evaluate the impact of the RFL position as it is currently outlined and continue to encourage the evolution of the RFL’s role as a resource for research teams and families.\nThis project was supported by the Department of Health and Human Services Administration grant number H1SMCO6346. Many thanks to James Hendricks, President of Seattle Children’s Hospital Research Institute, for his continued support of the Research and Family Liaison position. Our gratitude to Mary Beth Foglia, who provided consultation and qualitative analysis. Finally, thanks to Dr. Benjamin Wilfond, Dr. Douglas J. Opel, and Carolyn Newcom for assistance in reviewing and editing drafts of this paper.\nThe University of Washington School of Medicine’s IRB approved the researcher interviews, the observation process, the information gathering process, and the family focus groups.\nHalle Showalter Salas, MPhil, is a Research and Family Liaison, Zuraya Aziz, MS, is a Research and Family Liaison, and Nanci Villareale, RN, MSN, is the Administrative Director, Treuman Katz Center for Pediatric Bioethics, Seattle, WA; and Douglas S. Diekema, MD, MPH, is the Director of Education, Treuman Katz Center for Pediatric Bioethics, Seattle, WA, and Professor, Department of Pediatrics, University of Washington School of Medicine, Seattle, WA.\n1. Tait AR, Voepel-Lewis T, Malviya S, et al. Improving the readability and processability of a pediatric informed consent document: Effects on parents’ understanding.Archives of Pediatrics & Adolescent Medicine2005;159(4):347-352; Flory J and Emanuel E. Interventions to improve research participants’ understanding in informed consent for research: A systematic review.JAMA2004;292(13):1593-1601; Kodish E, Eder M, Knoll RB, et al. Communication of randomization in childhood leukemia trials.JAMA2004;291(4):470-475.\n2. Wendler DS. Assent in pediatric research: Theoretical and practical considerations.Journal of Medical Ethics2006;32(4):229-234; Broome ME and Richards DJ. The influence of relationships on children’s and adolescents’ participation in research.Nursing Research2003;52(3):191-197; Denham EJ and Nelson RM. Self-determination is not an appropriate model for understanding parental permission and child assent.Anesthesia & Analgesia2002;94(5):1049-1051.\n3. Simon CM, Zyzanski S, Durand E, et al. Interpreter accuracy and informed consent among Spanish-speaking families with cancer.Journal of Health Communication2006;11(5):509-22; Kleinman A and Benson P. Culture, moral experience and medicine.The Mount SinaiJournal of Medicine2006;73(6):834-839.\n4. Levine RJ. Clinical trials and physicians as double agents.The Yale Journal of Biology and Medicine1992;65(2):65-74; Sollitto S, Hoffman S, Mehlmanet M, et al. Intrinsic conflicts of interest in clinical research: A need for disclosure.Kennedy Institute of Ethics Journal2003;13(2):83-91; Klein J and Fleischman AR. The private practicing physician-investigator: Ethical implications of clinical research in the office setting.Hastings CenterReport2002;32(4):22-26.\n5. May T, Craig JM, Spellecy R. Viewpoint: IRBs, hospital ethics committees, and the need for “translational informed consent.”Academic Medicine2007;82(7):670-674.\n6. Neill KM. Research subject advocate: A new protector of research participants.Accountability in Research2003;10(3):159-174.\n7. DeWolf Bosek MS. Should an ethics consultant serve as a patient advocate?JONA’s Healthcare Law, Ethics, & Regulation2003;5(4):77-81; Morreim EH. Innovation in human research protection: The independent patient advocacy council.Law and Bioethics Report2001;1:3; Morreim EH. By any other name: The many iterations of “patient advocate” in clinical research.IRB: Ethics & Human Research2004;26(6):1-8.\n8. See ref. 6, Neill 2003.\n9. Starks H and Brown Trinidad S. Choose your method: A comparison of phenomenology, discourse analysis, and grounded theory.Qualitative Health Research2007;17(10):1372-1380.\n10. See ref. 6, Neill 2003.\nHalle Showalter Salas, Zuraya Aziz, Nanci Villareale, and Douglas S. Diekema, “The Research and Family Liaison: Enhancing Informed Consent,” IRB: Ethics & Human Research 30, no. 4 (2008): 1-8."