Seeking Approval from Universities to Research the Views of Their Staff. Do Gatekeepers Provide a Barrier to Ethical Research?

A “gatekeeper” controls access to an organization; “gatekeeper approval” is often needed before external research can take place within an organization. We explore the need for gatekeeper approval for research with university staff employing, as a case study, a project which collected data in Australia. This case study addresses known issues, seemingly rarely addressed in the literature. The Human Research Ethics Committee (HREC)'s requirement for approval from individual universities to approach their staff brought significant consequences, exacerbated by the lack of university procedures for such approvals. Simultaneously, since invitations could legitimately be distributed via other avenues, such approval was superfluous. We recommend the HREC's blanket requirement for institutional approval instead be considered on a case-by-case basis depending on the risk of the research, and perhaps waived for low-risk research where participants are able to provide informed consent, and that universities establish processes to deal with requests from external researchers.

Pragmatics of Crime Ethnographies

This chapter lays out some of the “how to” of crime ethnographies, from its early planning stages to securing funding and institutional approval, going through ethics review, and arriving at the field site. It also provides an overview of the difficulties establishing and maintaining a presence in different criminological field sites, the ethical dilemmas involved in carrying out a crime ethnography, and questions about positionality that researchers have to contemplate. It further provides an insight into how ethnographic knowledge is produced in practice, from writing field notes to questions about if, when, and how to record to analyzing data and discusses questions of staying safe and when to leave the field.

Identification of a dynamic middle ear microbiome in healthy adults

Background The entrenched dogma of a sterile middle ear in health is incongruent with its periodic exposure to exhaled air when the tympanic (Eustachian) tube opens while swallowing, yawning or inhaling deeply. Tubal patency is brief but frequent to provide adequate aeration, equalize pressure across the eardrum and drain mucus down the sides of the oropharynx. It also provides a mechanism for aerial dispersal of microorganisms from the aerodigestive tract. Method We designed a pilot study and received institutional approval to collect otic secretions that naturally drain on the sides of the oropharynx, behind the palatopharyngeal arch. This protocol bypassed the need to surgically access the middle ear through or around the eardrum, allowed us to collect samples from individuals with no underlying otic conditions, and prevented sample cross-contamination. As controls, we also collected samples from the center of the oropharynx and buccal mucosae seeded by saliva, which may serve as sources of microbial dispersal into the middle ear. Results We sequenced 16S rRNA-V4 amplicons from otic, oropharyngeal and buccal samples collected from a cohort of 19 healthy young adults. The survey identified in the otic samples a diverse bacterial community with many oropharyngeal and buccal keystone taxa and most of the functional traits of the neighboring oral microbiomes. Neutral community models predicted a large contribution of oral dispersal to the composition of the otic microbiome as well as several taxa responsive to positive selection. This was further supported by the enrichment in the otic communities of obligate anaerobes of Bacteroidetes and Fusobacteria over facultative anaerobic Proteobacteria and Firmicutes. Furthermore, the prevalence of the anaerobic members decreased with the more frequent otic aeration predicted from the equalization training of scuba divers recruited to the study. Conclusions These results challenge the long held view of a sterile middle ear and suggest instead that frequent seeding with oral microbes supports the establishment of a rich and robust otic community dynamically adapted to the episodic ventilation of the tympanic space.

Unconsented linkage between dormant trials and administrative data: practical and regulatory implications

IntroductionHalf of all infants are fed formula milk. However, attrition biases evidence on the long-term safety of formula ingredients. We used unconsented linkage between administrative education and health records of young people who were randomised as infants to formula milks, to determine long-term safety and efficacy. Objectives and ApproachWe used record level data from a series of 9 historical randomised controlled trials (RCTs) conducted in 1982-2002 (n=3,500 participants), which are key to the evidence-base around formula-composition. All later follow-ups are biased by attrition leading to limited evidence around the long-term effects of formula ingredients on cognition and metabolic and cardiovascular health. We sought permissions from data providers and regulatory agencies for unconsented linkage to education and hospital records, as proxy measures for cognitive and health development. We discuss the steps that were implemented to safeguard the participants' privacy and achieve ethical and multi-institutional approval for this project. ResultsAchieving provisional ethical approval took 41 days. Achieving agreement in principle to match trial data to individual level education records took 4 months and 2 weeks, while agreement to match trial data to individual level hospital records is still underway (5.5 months in February 2018). Delays in institutional approval were largely due to unharmonised data security certificates between the two government departments holding the health and education records. Digitising and cleaning all handwritten RCT participant identifiers prior to linkage took 9 months of full-time researcher time. Maintaining separation of identifiers and attribute data required specific secure haven provision. Results on the success of linkage between RCTs and education records will be presented at the conference. Conclusion/ImplicationsWhile directly contributing to the evidence around infant-formula-composition, this project will also act as a proof-of-concept study. Unconsented linkage between dormant RCTs and administrative data could be a novel and cost-effective method to generate evidence on the long-term efficacy and safety of interventions.

Preparing Appropriate Article Type to Publish

Write-up varies with the type of article; authorship criteria are defined; scientific strength, ethics and institutional approval are important. Journal’s requirement is mandatory and new knowledge is expected from any publication.

Who Gets the Credit? Legislative Responsiveness and Evaluations of Members, Parties, and the US Congress

This article considers the hypothesis that the positive actions taken by members of Congress (MCs) influence citizens’ evaluations of them, their party, and Congress as an institution. We begin with a look at the available cross-sectional survey data on contact with legislators and legislator and institutional approval. Their legislative responsiveness appears to have a small spillover effect on institutions. However, when we employ a unique panel design that controls for prior levels of opinion and avoids recall bias, we find no evidence of spillover effects. Overall, we find that constituents who received a response from their own MC evaluate that representative more positively than those who did not receive a response, but legislator responsiveness does not predict evaluations of the MC’s political party or the Congress.

Can Ropivacaine and Levobupivacaine Be Used as Test Doses during Regional Anesthesia?

Background Lower systemic toxicity reported with ropivacaine and levobupivacaine may produce less reliable recognition of inadvertent intravenous injection during regional anesthesia. This study was undertaken to determine whether ropivacaine and levobupivacaine are suitable for use as intravenous test doses by evaluating central nervous system (CNS) symptoms after intravenous bolus injection. Methods Institutional approval and informed consent were granted for the study. One hundred twenty patients scheduled to undergo elective surgery were randomly assigned to receive 5 ml intravenous saline, 100 mg lidocaine, 25 mg ropivacaine, or 25 mg levobupivacaine before anesthesia. Patients reported CNS symptoms after injection and were monitored for hemodynamic change. Results Intravenous ropivacaine or levobupivacaine produced CNS symptoms in only 52% and 57% of patients, respectively, compared with 87% of patients after lidocaine (P < 0.02). Despite preparatory instruction, many patients receiving ropivacaine or levobupivacaine did not spontaneously volunteer symptoms because they were subtle and admitted symptoms only after in-depth questioning by the investigator. Conclusions Plain ropivacaine and levobupivacaine (25 mg) solutions are unsuitable for use as intravenous test doses during regional anesthesia because CNS symptoms are insufficient. When using ropivacaine or levobupivacaine for regional anesthesia, for test dose purposes, the authors recommend the addition of epinephrine to the local anesthetic solution or the use of a separate agent with more predictable CNS characteristics.