Evidence map›Paper›PMID 17689261›Full record

Trial reportAnnals of epidemiology2007

The impact of HIPAA authorization on willingness to participate in clinical research.

Anne L Dunlop, Tracie Graham, Zanie Leroy, Karen Glanz, Boadie Dunlop

Open access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Annals of epidemiology, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
3.2field-weighted citation impact, top 8% 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, 28 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. Privacy and confidentiality in pragmatic clinical trials.Clinical trials (London, England) · 2015
    Article
  6. An opportunity for cancer prevention during preadolescence and adolescence: stopping human papillomavirus (HPV)-related cancer through HPV vaccination.The Journal of adolescent health : official publication of the Society for Adolescent Medicine · 2013
    Article
  7. Article
  8. Article
  9. Article
  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

5 authors at 1 institution in 1 country.

Anne L DunlopDepartment of Family & Preventive Medicine, Emory University, Atlanta, Georgia, USA. amlang@emory.edu
Tracie Graham
Zanie Leroy
Karen Glanz
Boadie Dunlop
Emory University · US

Funding

CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR025008 · NCRR · EMORY UNIVERSITY · PI STEPHENS, DAVID S · 2007 to 2011
$29.0M
Atlanta Clinical and Translational Science Institute (ACTSI) RenewalUL1TR000454 · NCATS · EMORY UNIVERSITY · PI STEPHENS, DAVID S · 2012 to 2016
$25.8M
X LINKED NYSTAGMUS SYNDROME WITH FEATURES OF ALBINISMM01RR000039 · NCRR · EMORY UNIVERSITY · PI VACCARINO, VIOLA · 1985 to 2007
$21.3M
Neural Correlates of Loss Aversion in Major DepressionK23MH086690 · NIMH · EMORY UNIVERSITY · PI DUNLOP, BOADIE W · 2009 to 2011
$521k
NCATS NIH HHS UL1 TR000454NCRR NIH HHS M01 RR000039NCRR NIH HHS M01-RR00039NCRR NIH HHS UL1 RR025008NIMH NIH HHS K23 MH086690
6 · The paper itself

Abstract

purposeThis study systematically examined the impact of inclusion of Health Insurance Portability and Accountability Act (HIPAA) authorization on the willingness of African Americans of diverse sociodemographic characteristics to participate in a clinical research study and explored reasons for nonparticipation.

methodsFor a purposive sample of 384 African American outpatients at four metropolitan primary care clinics from August 2005 through May 2006, willingness to participate in a hypothetic clinical research study of an antihypertensive medication under one of two experimental conditions was compared. Interviewees were randomly assigned to undergo informed consent alone (control group) or informed consent with HIPAA authorization (HIPAA group). They were asked whether they would participate and reasons for their decisions.

resultsA smaller proportion of interviewees in the HIPAA group were willing to enroll in the study (27% vs. 39%; p = 0.02), with an adjusted odds ratio of 0.56 (95% confidence interval = 0.36-0.91). Those in the HIPAA group were more likely to give reasons related to privacy (p < 0.001), poor understanding of the form (p = 0.01), and mistrust or fear of research (p = 0.04) for nonparticipation.

conclusionsThe inclusion of HIPAA authorization within the informed consent process may adversely affect the willingness of African Americans to participate in clinical research and may raise concerns about privacy, understanding the forms, and mistrust or fear of research.

Indexed as

Clinical Trials as TopicHealth Insurance Portability and Accountability ActAdultBlack or African AmericanCross-Sectional StudiesEducational StatusFemaleHumansInformed ConsentMalePatient ParticipationResearch SubjectsUnited States

Identifiers

PMID17689261
PMCPMC4096152
OpenAlexW2161477621

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.