Evidence map›Paper›PMID 25369796›Full record

ArticleClinical trials (London, England)2015

Variation of community consultation and public disclosure for a pediatric multi-centered "Exception from Informed Consent" trial.

Maija Holsti, Roger Zemek, Jill Baren, Rachel M Stanley, Prashant Mahajan, Cheryl Vance, Kathleen M Brown, Victor Gonzalez, Denise King, Kammy Jacobsen and 4 more

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

Article in Clinical trials (London, England), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 2 pooled it
1.0field-weighted citation impact, top 21% 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

11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Creativity in Pediatric Clinical Pharmacology: Study Design and Oral Dosage Forms.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2024
    Article
  8. Review
  9. Meeting unique requirements: Community consultation and public disclosure for research in emergency setting using exception from informed consent.Academic emergency medicine : official journal of the Society for Academic Emergency Medicine · 2021
    Review
  10. Article
  11. 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

14 authors at 8 institutions in 2 countries.

Maija HolstiDepartment of Pediatrics, University of Utah, Salt Lake City, UT, USA The Pediatric Emergency Care Applied Research Network, Salt Lake City, UT, USA Maija.holsti@hsc.utah.edu.
Roger ZemekDepartment of Pediatrics, Children's Hospital of Eastern Ontario, Ottawa, ON, Canada.
Jill BarenDepartment of Emergency Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA The Pediatric Emergency Care Applied Research Network, Salt Lake City, UT, USA.
Rachel M StanleyDepartment of Emergency Medicine, University of Michigan, Ann Arbor, MI, USA The Pediatric Emergency Care Applied Research Network, Salt Lake City, UT, USA.
Prashant MahajanDepartment of Pediatrics, Wayne State University School of Medicine, Detroit, MI, USA The Pediatric Emergency Care Applied Research Network, Salt Lake City, UT, USA.
Cheryl VanceUniversity of California, Davis, Davis, CA, USA The Pediatric Emergency Care Applied Research Network, Salt Lake City, UT, USA.
Kathleen M BrownDivision of Emergency Medicine, Children's National Medical Center, Washington, DC, USA The Pediatric Emergency Care Applied Research Network, Salt Lake City, UT, USA.
Victor GonzalezBaylor College of Medicine, Houston, TX, USA The Pediatric Emergency Care Applied Research Network, Salt Lake City, UT, USA.
Denise KingThe EMMES Corporation, Rockville, MD, USA.
Kammy JacobsenDepartment of Pediatrics, University of Utah, Salt Lake City, UT, USA The Pediatric Emergency Care Applied Research Network, Salt Lake City, UT, USA.
Kate ShreveDivision of Emergency Medicine, Children's National Medical Center, Washington, DC, USA The Pediatric Emergency Care Applied Research Network, Salt Lake City, UT, USA.
Katrina van de BruinhorstUniversity of Texas, Southwestern, Dallas, TX, USA.
Anne Marie JonesUniversity of Texas, Southwestern, Dallas, TX, USA.
James M ChamberlainDivision of Emergency Medicine, Children's National Medical Center, Washington, DC, USA The Pediatric Emergency Care Applied Research Network, Salt Lake City, UT, USA.
Research Network (United States) · USThe University of Texas Southwestern Medical Center · USUniversity of Utah · USBaylor College of Medicine · USChildren's Hospital of Eastern Ontario · CAChildren's National · USEmmes (United States) · USUniversity of California, Davis · US

Funding

NICHD NIH HHS HHSN275201100017C
6 · The paper itself

Abstract

backgroundThe US federal regulation "Exception from Informed Consent for Emergency Research," 21 Code of Federal Regulations 50.24, permits emergency research without informed consent under limited conditions. Additional safeguards to protect human subjects include requirements for community consultation and public disclosure prior to starting the research. Because the regulations are vague about these requirements, Institutional Review Boards determine the adequacy of these activities at a local level. Thus, there is potential for broad interpretation and practice variation.

aimTo describe the variation of community consultation and public disclosure activities approved by Institutional Review Boards, and the effectiveness of this process for a multi-center, Exception from Informed Consent, pediatric status epilepticus clinical research trial.

methodsCommunity consultation and public disclosure activities were analyzed for each of the 15 participating sites. Surveys were conducted with participants enrolled in the status epilepticus trial to assess the effectiveness of public disclosure dissemination prior to study enrollment.

resultsEvery Institutional Review Board, among the 15 participating sites, had a varied interpretation of Exception from Informed Consent regulations for community consultation and public disclosure activities. Institutional Review Boards required various combinations of focus groups, interviews, surveys, and meetings for community consultation, and news releases, mailings, and public service announcements for public disclosure. At least 4335 patients received information about the study from these efforts. In all, 158 chose to be included in the "Opt Out" list. Of the 304 participants who were enrolled under Exception from Informed Consent, 12 (5%) had heard about the study through community consultation or public disclosure activities. The activities reaching the highest number of participants were surveys and focus groups associated with existing meetings. Public disclosure activities were more efficient and cost-effective if they were part of an in-hospital resource for patients and families.

conclusionThere is substantial variation in Institutional Review Boards' interpretations of the federal regulations for community consultation and public disclosure. One of the goals of community consultation and public disclosure efforts for emergency research is to provide community members an opportunity to opt out of Exception from Informed Consent research; however, rarely do patients or their legally authorized representatives report having learned about a study prior to enrollment.

Indexed as

PediatricsAdolescentBiomedical ResearchChildChild, PreschoolDisclosureDouble-Blind MethodEmergency Medical ServicesFemaleFocus GroupsHumansInfantInfant, NewbornInformed ConsentMaleMulticenter Studies as Topiccommunity consultationEmergency researchException from Informed Consentmulti-centered randomized double-blinded controlled studypediatricspublic disclosure

Identifiers

PMID25369796
PMCPMC4344904
OpenAlexW1972532169

What OpenQuestion holds

Textmetadata
LicenceTDM
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.