ArticleAmerican journal of translational research2023
Protecting human subjects participating in research.
Article in American journal of translational research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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.
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.
Who cites it
0 citing papers in PubMed, 5 citations in OpenAlex.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesInstitutions conducting research involving human subjects establish institutional review boards (IRBs) and/or human research protection programs to protect human research subjects. Our objectives were to develop performance metrics to measure human research subject protections and to assess how well IRBs and human research protection programs are protecting human research subjects.
methodsA set of five performance metrics for measuring human research subject protections was developed and data were collected through annual audits of informed consent documents and human research protocols at 107 Department of Veterans Affairs research facilities from 2010 through 2021.
resultsThe proposed performance metrics were: local adverse events that were serious, unanticipated, and related or probably related to research, including those that resulted in hospitalization or death; where required informed consent was not obtained; required Heath Insurance Portability and Accountability Act authorization was not obtained; non-exempt research was conducted without IRB approval; and research activities were continued during a lapse in IRB continuing reviews. Analysis of these performance metric data from 2010 through 2021 revealed that incident rates of all five performance metrics were very low; three showed a statistically significant trend of improvement ranging from 70% to 100%; and none of these five performance metrics deteriorated.
conclusionsDepartment of Veterans Affairs human research protection programs appeared to be effective in protecting human research subjects and showed improvement from 2010 through 2021. These proposed performance metrics will be useful in monitoring the effectiveness of human research protection programs in protecting human research subjects.
Indexed as
Identifiers
37854232PMC10579004W4387765437What OpenQuestion holds
Registered trials
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.