Evidence map›Paper›PMID 35836789›Full record

ArticleJournal of clinical and translational science2022

From paper to screen: regulatory and operational considerations for modernizing the informed consent process.

Nichelle L Cobb, Dorothy F Edwards, Erin M Chin, James J Lah, Felicia C Goldstein, Cecilia M Manzanares, Christine M Suver

Open access · goldAbstract read
In one paragraph

Article in Journal of clinical and translational science, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.8field-weighted citation impact, top 29% 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

5 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Article
  5. 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

7 authors at 4 institutions in 1 country.

Nichelle L CobbAssociation for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP), Washington, DC, USA.
Dorothy F EdwardsUniversity of Wisconsin-Madison School of Medicine and Public Health, Wisconsin Alzheimer's Disease Research Center, Madison, WI, USA.
Erin M ChinUniversity of Wisconsin-Madison School of Medicine and Public Health, Wisconsin Alzheimer's Disease Research Center, Madison, WI, USA.
James J LahEmory University, Goizueta Alzheimer's Disease Research Center, Atlanta, GA, USA.
Felicia C GoldsteinEmory University, Goizueta Alzheimer's Disease Research Center, Atlanta, GA, USA.
Cecilia M ManzanaresEmory University, Goizueta Alzheimer's Disease Research Center, Atlanta, GA, USA.
Christine M SuverSage Bionetworks, Seattle, WA, USA.ORCID https://orcid.org/0000-0002-2986-385X
Emory University · USUniversity of Wisconsin–Madison · USAARP · USSage Bionetworks · US

Funding

Wisconsin Alzheimer's Disease Research CenterP30AG062715 · NIA · UNIVERSITY OF WISCONSIN-MADISON · PI Barbara Brigitta Bendlin · 2019 to 2026
$34.5M
The Goizueta Alzheimer's Disease Research CenterP30AG066511 · NIA · EMORY UNIVERSITY · PI Amy D Rodriguez · 2020 to 2026
$29.0M
The Emory Alzheimer's Disease CenterP50AG025688 · NIA · EMORY UNIVERSITY · PI WALKER, LARY C · 2005 to 2019
$25.7M
Wisconsin Alzheimer's Disease Research CenterP50AG033514 · NIA · UNIVERSITY OF WISCONSIN-MADISON · PI SAGER, MARK · 2009 to 2018
$16.2M
NIA NIH HHS P30 AG062715NIA NIH HHS P30 AG066511NIA NIH HHS P50 AG025688NIA NIH HHS P50 AG033514
6 · The paper itself

Abstract

Electronic platforms provide an opportunity to improve the informed consent (IC) process by permitting elements shown to increase research participant understanding and satisfaction, such as graphics, self-pacing, meaningful engagement, and access to additional information on demand. However, including these elements can pose operational and regulatory challenges for study teams and institutional review boards (IRBs) responsible for the ethical conduct and oversight of research. We examined the experience of two study teams at Alzheimer's Disease Research Centers who chose to move from a paper-based IC process to an electronic informed consent (eIC) process to highlight some of these complexities and explore how IRBs and study teams can navigate them. Here, we identify the key regulations that should be considered when developing and using an eIC process as well as some of the operational considerations eIC presents related to IRB review and how they can be addressed.

Indexed as

Common RuleeConsentethical oversightInformed consentIRBregulation

Identifiers

PMID35836789
PMCPMC9257776
OpenAlexW4220668494

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.