Evidence map›Paper›PMID 35802791›Full record

ArticleEthics & human research2022

Developing and Implementing Electronic Consent Procedures in Response to Covid-19 Restrictions.

Julie R Bromberg, Evelyn Nimaja, Andrew W Kiragu, Karla A Lawson, Lois Lee, Isam W Nasr, Charles Pruitt, Stephanie M Ruest, Michael J Mello

Open access · bronzeAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Ethics & human research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
2.0field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 10 citations in OpenAlex.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 7 institutions in 1 country.

Julie R BrombergResearch associate in the Department of Emergency Medicine at The Warren Alpert Medical School of Brown University and a research program manager at the Injury Prevention Center at Rhode Island Hospital-Hasbro Children's Hospital.
Evelyn NimajaSenior research assistant at the Injury Prevention Center at Rhode Island Hospital-Hasbro Children's Hospital.
Andrew W KiraguAssociate professor of pediatrics at the University of Minnesota, an associate of the Children's Respiratory and Critical Care Specialist Group, and a pediatric intensivist at Hennepin Healthcare.
Karla A LawsonDirector of the Dell Children's Trauma and Injury Research Center at Dell Children's Medical Center and an associate professor of surgery and perioperative care at the University of Texas at Austin Dell Medical School.
Lois LeeAssociate professor of pediatrics and emergency medicine at the Harvard Medical School and a senior associate of medicine in the Division of Emergency Medicine at Boston Children's Hospital.
Isam W NasrDirector of the Pediatric Trauma Program in the Division of Pediatric Surgery at the Johns Hopkins Children's Center and an assistant professor of surgery within the Johns Hopkins Department of Surgery.
Charles PruittAssociate professor of pediatrics at the University of Utah and a child advocacy coordinator for the Division of Pediatric Emergency Medicine at Primary Children's.
Stephanie M RuestAssistant professor of the Departments of Pediatrics and Emergency Medicine at The Warren Alpert Medical School of Brown University and a pediatric emergency physician at the Hasbro Children's Hospital.
Michael J MelloProfessor in the Department of Emergency Medicine at The Warren Alpert Medical School at Brown University, a professor of health services, policy, and practice at the Brown University School of Public Health, the director of the Master of Science in Population Medicine program at The Warren Alpert Medical School of Brown University, and the director of the Injury Prevention Center at Rhode Island Hospital-Hasbro Children's Hospital.
Hasbro Children's Hospital · USBoston Children's Hospital · USDell Children's Medical Center of Central Texas · USJohns Hopkins Children's Center · USPrimary Children's Hospital · USRhode Island Hospital · USUniversity of Minnesota · US

Funding

IAMSBIRT: Implementing Alcohol Misuse SBIRT in a National Cohort of Pediatric Trauma CentersR01AA025914 · NIAAA · RHODE ISLAND HOSPITAL · PI MELLO, MICHAEL J · 2017 to 2021
$3.7M
National Institute on Alcohol Abuse and Alcoholism of the National Institutes of Health R01AA025914NIAAA NIH HHS R01 AA025914
6 · The paper itself

Abstract

The Covid-19 pandemic resulted in unprecedented restrictions on many public, private, and workplace activities throughout the United States and elsewhere. When restrictions were imposed, we were conducting a type III hybrid effectiveness-implementation trial in 10 pediatric trauma centers. In response to several pandemic-based restrictions, we had to develop procedures for engaging with potential research participants while limiting nonclinical, in-person interactions. This manuscript describes the procedures and challenges of obtaining electronic informed consent and assent in a multisite trauma center-based research study. We developed, tested, and trained staff to implement three options for obtaining informed consent. Twenty-five participants were enrolled in the effectiveness-implementation multisite trial during the first six months of utilization of the consent options, with eleven of these individuals enrolled using hybrid or electronic consent procedures. The challenges we identified involving electronic consent procedures included confusion over who would complete the electronic consent process and difficulties reconnecting with families. Lessons learned can strengthen electronic consent and assent procedures for future studies. More research is needed to further strengthen this process and increase its utilization.

Indexed as

COVID-19Informed ConsentChildClinical Trials as TopicElectronicsHumansMulticenter Studies as TopicPandemicsUnited StatesassentCovid-19 pandemicelectronic informed consenthuman research ethicshuman subjects researchinformed consent

Identifiers

PMID35802791
PMCPMC9349659
OpenAlexW4284885514

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.