Douglas S. Diekema

Ethics of Social Media Research: Common Concerns and Practical Considerations

Social media Websites (SMWs) are increasingly popular research tools. These sites provide new opportunities for researchers, but raise new challenges for Institutional Review Boards (IRBs) that review these research protocols. As of yet, there is little-to-no guidance regarding how an IRB should review the studies involving SMWs. The purpose of this article was to review the common risks inherent in social media research and consider how researchers can consider these risks when writing research protocols. We focused this article on three common research approaches: observational research, interactive research, and survey/interview research. Concomitant with these research approaches, we gave particular attention to the issues pertinent to SMW research, including privacy, consent, and confidentiality. After considering these challenges, we outlined key considerations for both researchers and reviewers when creating or reviewing SMW IRB protocols. Our goal in this article was to provide a detailed examination of relevant ethics and regulatory issues for both researchers and those who review their protocols.

Impact of Income and Income Inequality on Infant Health Outcomes in the United States

OBJECTIVES: The goal was to investigate the relationships of income and income inequality with neonatal and infant health outcomes in the United States. METHODS: The 2000–2004 state data were extracted from the Kids Count Data Center. Health indicators included proportion of preterm births (PTBs), proportion of infants with low birth weight (LBW), proportion of infants with very low birth weight (VLBW), and infant mortality rate (IMR). Income was evaluated on the basis of median family income and proportion of federal poverty levels; income inequality was measured by using the Gini coefficient. Pearson correlations evaluated associations between the proportion of children living in poverty and the health indicators. Linear regression evaluated predictive relationships between median household income, proportion of children living in poverty, and income inequality for the 4 health indicators. RESULTS: Median family income was negatively correlated with all birth outcomes (PTB, r = −0.481; LBW, r = −0.295; VLBW, r = −0.133; IMR, r = −0.432), and the Gini coefficient was positively correlated (PTB, r = 0.339; LBW, r = 0.398; VLBW, r = 0.460; IMR, r = 0.114). The Gini coefficient explained a significant proportion of the variance in rate for each outcome in linear regression models with median family income. Among children living in poverty, the role of income decreased as the degree of poverty decreased, whereas the role of income inequality increased. CONCLUSIONS: Both income and income inequality affect infant health outcomes in the United States. The health of the poorest infants was affected more by absolute wealth than relative wealth.

Attitudes Toward Risk and Informed Consent for Research on Medical Practices: A Cross-sectional Survey

Editors Notes Context Should research that compares standard medical practices require informed consent from participants? Contribution This survey of 1095 adults examines attitudes about research that evaluates standard practices. Most respondents were willing to participate in such research but preferred that they be asked for permission, even if the research involved only medical record review. Most (70% to 83%) supported oral permission or general notification if written permission made research impracticable. Caution Respondents were not representative of the U.S. population. Implication Adults prefer giving informed consent to participate in research about standard practices, but they may agree to simple approaches to consent rather than precluding such research. The emergence of studies conducted in health care settings that blur the distinction between research and clinical practice has fanned a debate (15) that began in March 2013 when the U.S. Office for Human Research Protections (OHRP) criticized a study (6) comparing target oxygen saturation levels in premature infants (7). The debate revolves around the types of risks that should be attributed to research that compares 2 or more commonly used clinical practices by randomly assigning participants between them. On 24 October 2014, the OHRP announced draft guidance clarifying that, for studies that compare treatments and randomly assign patients, the risks of the treatments should be considered risks of research and disclosed as such (8). But many large ongoing studies of this type, such as those conducted by the National Institutes of Health Collaboratory (9), have not required such disclosures; indeed documented informed consent for such studies may be prohibitively difficult or logistically impossible. According to OHRP, however, in observational studies that compare 2 treatments chosen by clinicians and their patients, the risks of treatment are not considered to be risks of research and thus are not currently required to be disclosed in the informed consent process (6, 10). Research on medical practices (ROMP) poses challenges for the protection of human subjects and informed consent. For such research, which is typically conducted in the context of patients receiving care from their physicians, the assessment of risk and approach to informed consent can differ from research that tests new interventions or that is conducted by researchers not providing care to the patient participants (1114). Current regulations in the United States instruct institutional review boards (IRBs) to consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research) (10). Further, the current regulatory framework uses risk categorization to drive specific approaches to informed consent (15, 16). For example, the ability to alter or waive informed consent is only possible for research that involves no more than minimal risk to the subjects (17). But the draft guidance defines the risks associated with the standard treatments being evaluated as risks of research if a standard of care that at least some of the individual subjects will be assigned to receive will be different from the standard of care that they would have received if they were not participating in the study; further, the guidance requires that these risks must be disclosed to participants (8). The draft guidance is intended to assist institutional review boards in interpreting federal regulations. It may, however, run counter to the ethical principle of respect for persons underlying the regulations to the extent that it takes a narrow view of participant preferences, values, and concerns about research, especially with how participants weigh benefits of research relative to perceived risks (15). Framing the guidance more appropriately is difficult given the absence of data about the views of potential participants. Empirical data can contribute to normative and policy deliberations by examination of how the public considers the risks of randomization and how the public makes tradeoffs between preferences for notification or permission to participate and the ability of researchers to conduct ROMP. We therefore conducted a survey among a sample of U.S. adults to assess these issues in the context of hypothetical research scenarios involving observational or randomized studies of standard medical practices. Methods Overview We conducted a Web-based survey to assess attitudes about ROMP in August 2014. To explain key features of ROMP, we developed 3 narrative videos that were embedded in the survey. We developed the survey questionnaire and pilot-tested the videos using focus groups. This study was approved by the University of Washington and Stanford University Institutional Review Boards. Sample Selection Our sample was obtained from Research Now and derived from members of an online research panel and a river (convenience) sample of Internet users invited to participate when visiting general, social media, and loyalty Web sites. Panel members received a small incentive by a points-based reward program, and their identity was validated by detection of a unique computer ID. Multiple survey completions were avoided by use of a unique URL for each survey. Quota sampling was used to ensure inclusion of key population subgroups by geography (Northeast, Midwest, South, and West), gender, age, race, and ethnicity. Development of Narrative Videos Because this type of research is not familiar to most people, we created 3 animated narrative videos (with Alex Thomas, MD, and health communication specialist Gary Ashwal, both of Booster Shot Media), each 2 to 3 minutes long, that focused on the variability in use of approved antihypertension medications and research to learn which treatments are better. With Booster Shot Media, the research team identified key concepts about ROMP that distinguish it from other clinical research and were addressed in the survey. On the basis of these concepts, Booster Shot Media developed storyboards, scripts, and draft videos, each of which was revised in collaboration with the research team. We showed the videos as part of the focus groups and solicited feedback to inform revisions for clarity (for example, we slowed the narration in response to comments that it was too fast) and overcome common misconceptions (for example, that medical research only compares treatments with placebo, rather than with each other). The first video explains factors that influence variation in clinical practice, the second explains randomization and medical record review, and the third explains 3 approaches to notifying patients about research and obtaining their permission to participate. We used conventional terms for notification (general information), oral permission (verbal permission), and written consent (written agreement). We described the spectrum of medical record review and randomization comparing usual treatments as research on medical practices because such terms as learning health systems, comparative effectiveness research, and pragmatic trials are not commonly used by the public. We believed that research on medical practices was more descriptive, and this was confirmed in our focus groups. Survey Development and Administration To develop the survey, we conducted 8 focus groups of 4 to 7 participants each and 2 small-group interviews of 2 to 3 participants each; participants were recruited from clinics at 3 health care institutions. We revised the survey on the basis of review by expert consultants and through 13 cognitive interviews of participants derived from the focus group sampling frame and patrons of a public library by using the think aloud technique (18). The survey began with questions about attitudes toward research, physicians, and health systems, interspersed with the 3 videos and questions to assess understanding of ROMP concepts. The second section asked questions about preferences for notification and permission to enroll in ROMP, perceptions of risk, and willingness to participate in ROMP in the context of 3 scenarios. The first scenario described a medical record review comparing the outcomes of 3 medications in patients newly diagnosed with hypertension, with the medications being described as approved by the U.S. Food and Drug Administration and prescribed on the basis of physician judgment and patient preferences. The second scenario described a variant of the first scenario in which patients were randomly assigned to one of these medications, in an unblinded manner, with usual clinical follow-up. The scenario stated that the doctor will not change the [assigned] medication unless the doctor or patient has concerns. The third scenario described a similar randomized study comparing 3 medications for a more serious condition that increases your risk for stroke. The last section of the survey consisted of questions about demographic characteristics and experience with health care for serious illness and clinical research. The videos (1921) and the survey instrument (22) are available at the ROMP Ethics Study Web site (https://rompethics.iths.org/). Readers are invited to take the online survey (http://trn.co1.qualtrics.com/SE/?SID=SV_3vISKwFfRv1LV53) from 19 May 2015 to 18 August 2015. Selected survey questions and descriptive data on responses are provided in Appendix Table 1. Participants from the research panel and river sample were invited to take the survey and were sent a single e-mail that contained a link to the survey Web site. Appendix Table 1. Selected Items From the Survey Statistical Analysis Sample characteristics are shown in Table 1 alongside data from the U.S. Census Bureau (23) and the Centers for Disease Control and Prevention National Health Interview Survey (24). The survey required a response to all items, although the r

The OHRP and SUPPORT

A group of medical ethicists and pediatricians asks for reconsideration of the recent Office for Human Research Protections decision about informed consent in SUPPORT.

A critique of criteria for evaluating vaccines for inclusion in mandatory school immunization programs.

Several new vaccines for children and young adults have been introduced recently and now appear on the Advisory Committee on Immunization Practices’ recommended childhood and adolescent immunization schedule (meningococcal, rotavirus, human papillomavirus). As new vaccines are introduced, states face complex decisions regarding which vaccines to fund and which vaccines to require for school or child care entry. This complexity is evidenced by the current debate surrounding the human papillomavirus vaccine. We present a critique to the approach and criteria for evaluating vaccines for inclusion in mandatory school immunization programs that have been adopted by the Washington State Board of Health by illustrating how these criteria might be applied to the human papillomavirus vaccine. We conclude that these 9 criteria can help ensure a deliberate and informed approach to important public policy decisions, but we argue that several clarifications of the review process are needed along with the addition of a 10th criterion that ensures that a new vaccine mandate relates in some manner to increasing safety in the school environment.

Pediatric Wilderness Recreational Deaths in Western Washington State

STUDY OBJECTIVEnTo determine the causes and characteristics of pediatric recreational wilderness deaths.nnnMETHODSnAll deaths of children between 12 months and 20 years of age involving a wilderness recreational activity in 5 western Washington counties between 1987 and 1996 were identified by medical examiners logs. Univariate analysis was used to examine variables such as age, gender, activity, mechanism of injury, adult presence, blood alcohol level, safety equipment, and mode of evacuation.nnnRESULTSnOf 40 cases meeting inclusion criteria, 90% involved male subjects and 83% of victims were 13 to 19 years old. Hiking (33%), swimming (20%), and river rafting (10%) were the most common activities. Death was most often by drowning (55%) or closed head injury (26%). No victim was alone. All children younger than 10 years of age were accompanied by an adult, in contrast to only 26% of individuals 10 years or older. Only 4 victims had drugs or alcohol in their system. No victim wore a personal flotation device or helmet, and only 5% had foul weather gear. Although nearly one third of victims were transported by airlift, more than half of the victims were dead at the scene.nnnCONCLUSIONnMales and teenagers were the 2 major risk groups for recreational wilderness deaths. Traditional activities such as hiking and swimming were the most common causes of death. Children younger than 10 years died despite the presence of an adult, whereas teenagers were usually with groups of peers. The majority of victims were not prepared for adverse events with basic safety equipment.

Dystonic reaction associated with dextromethorphan ingestion in a toddler

INTRODUCTIONnAccidental ingestions of cough and cold preparations containing dextromethorphan (DM) are common in the toddler age group and rarely have serious consequences. Even large intentional overdoses by adults seldom lead to serious morbidity. There have been no previous reports of an extrapyramidal reaction due to a DM ingestion.nnnCASE REPORTnWe report a 30-month-old girl who ingested approximately 38 mg/kg dextromethorphan. She presented with opisthotonus, ataxia, and bidirectional nystagmus. There was no change in her status with the administration of naloxone. The child was given diphenhydramine with clearing of her opisthotonus but persistence of her ataxia and nystagmus.nnnDISCUSSIONnA moderate ingestion of dextromethorphan in a toddler resulted in extrapyramidal symptoms with opisthotonus that responded to diphenhydramine. Dextromethorphan is known to have complex CNS effects and, in sufficient doses, may have dopamine receptor blocking activity resulting in this dystonic reaction.

Personal Belief Exemptions From School Vaccination Requirements

Despite the impact vaccination has had on the control and prevention of many infectious diseases, some parents choose not to vaccinate their children. Although there is no federal law requiring vaccination of children in the United States, all states require evidence of vaccination against at least some diseases as a condition of school entry. Which vaccines are required; how many doses are required; whether entry requirements apply to child care, kindergarten, or middle school; and whether exemptions from vaccine requirements will be allowed all differ by state. All but two states allow some kind of personal belief exemption from school vaccination requirements. This article reviews the history of school vaccination requirements and exemptions, the legal status of state vaccination laws and exemptions, the impact of school vaccination requirements and personal belief exemptions on vaccination rates and disease incidence, and strategies for maintaining adequate vaccination rates in states that allow personal belief exemptions.

Growth-Attenuation Therapy: Principles for Practice

Publication of an account of growth attenuation with high-dose estrogen in a child with profound physical and cognitive disability brought widespread attention to a common and complex issue faced by families caring for similarly affected children, namely, the potentially negative effect of the increasing size of a child on the ability of his or her family to provide independent care, which in turn makes it more difficult for parents to keep the child in the home and involved in family activities. In this article we explore the scientific rationale for, effectiveness and safety of, and ethical considerations bearing on growth-attenuation treatment of children with profound and permanent cognitive disability. Informed responses to key clinically relevant questions are proposed. Our analysis suggests that growth attenuation is an innovative and sufficiently safe therapy that offers the possibility of an improved quality of life for nonambulatory children with profound cognitive disability and their families. Pediatricians and other care providers should include discussion of these options as part of anticipatory guidance around the age of 3 years so that, if elected, potential clinically meaningful benefits of growth-attenuation therapy can be realized. Because of the publicity and debate surrounding the first reported case, ethics consultation is recommended.

Characterisation of organisational issues in paediatric clinical ethics consultation: a qualitative study.

Background: The traditional approach to resolving ethics concerns may not address underlying organisational issues involved in the evolution of these concerns. This represents a missed opportunity to improve quality of care “upstream”. The purpose of this study was to understand better which organisational issues may contribute to ethics concerns. Methods: Directed content analysis was used to review ethics consultation notes from an academic children’s hospital from 1996 to 2006 (N u200a=u200a 71). The analysis utilised 18 categories of organisational issues derived and modified from published quality improvement protocols. Results: Organisational issues were identified in 68 of the 71 (96%) ethics consult notes across a range of patient settings and reasons for consultation. Thirteen of the 18 categories of organisational issues were identified and there was a median of two organisational issues per consult note. The most frequently identified organisational issues were informal organisational culture (eg, collective practices and approaches to situations with ethical dimensions that are not guided by policy), policies and procedures (eg, staff knows policy and/or procedural guidelines for an ethical concern but do not follow it) and communication (eg, communication about critical information, orders, or hand-offs repeatedly does not occur among services). Conclusions: Organisational issues contribute to ethical concerns that result in clinical ethics consults. Identifying and addressing organisational issues such as informal culture and communication may help decrease the recurrence of future similar ethics concerns.