Evidence map›Paper›PMID 41462395›Full record

ReviewImplementation science communications2025

Ethical considerations in implementation research: a scoping review of key principles, unintended consequences, and emerging ethical guidance.

Emmanuel K Tetteh, Nwaliweaku Anidi, Gifty Aboagye-Mensah, Michelle Doering, Elvin H Geng, Byron J Powell, Mark D Huffman, Alison L Antes

Abstract readReview
In one paragraph

Review in Implementation science communications, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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

1 citing paper in PubMed.

  1. 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

8 authors.

Emmanuel K TettehSchool of Public Health, Washington University in St. Louis, St. Louis, MO, USA. emmanuel.tetteh@wustl.edu.ORCID http://orcid.org/0000-0002-7892-5914
Nwaliweaku AnidiSchool of Public Health, Washington University in St. Louis, St. Louis, MO, USA.
Gifty Aboagye-MensahSchool of Public Health, Washington University in St. Louis, St. Louis, MO, USA.
Michelle DoeringBecker Medical Library, Washington University in St. Louis School of Medicine, St. Louis, MO, USA.
Elvin H GengSchool of Public Health, Washington University in St. Louis, St. Louis, MO, USA.
Byron J PowellSchool of Public Health, Washington University in St. Louis, St. Louis, MO, USA.
Mark D HuffmanSchool of Public Health, Washington University in St. Louis, St. Louis, MO, USA.
Alison L AntesSchool of Public Health, Washington University in St. Louis, St. Louis, MO, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAs dissemination and implementation research advances, research teams seek guidance on how to apply existing ethical standards to implementation research, given its unique study designs, multi-level intervention targets, and associated risks. This scoping review examines ethical principles and concerns in implementation research, identifies potential risks and unintended consequences, and explores ethical frameworks guiding responsible conduct.

methodsWe searched PubMed, Web of Science, and Google Scholar for relevant literature published between January 2010 and January 2024. The search utilized a combination of standardized terms and keywords, including bioethics, ethics, research standards, responsible research, health services research, and dissemination and implementation science. Two reviewers independently extracted data on study characteristics, ethical considerations, and recommendations. We applied thematic analysis using deductive coding to identify key ethical domains and unintended consequences.

resultsThe search returned 1,003 articles, of which 791 unique citations underwent screening. We included 44 articles that discussed ethical principles, risks, unintended consequences, or ethical frameworks in implementation research. The most identified ethical challenges were complexities in informed consent for system or multilevel interventions (55% of articles), equipoise regarding established interventions in new contexts (36%), inconsistencies in regulatory oversight (34%), and the need for robust risk-benefit assessments (32%). Frequently discussed unintended consequences included burnout of health providers (25%), failure to sustain interventions (25%), reduced participant autonomy (23%), stigma (20%), and equity concerns (20%). Three key findings emerged. First, while general ethical principles apply, researchers and review boards struggle with their implementation, particularly in informed consent, equipoise, and risk-benefit assessment. Second, implementation research primarily presents socio-behavioral risks, such as stigma, loss of trust, equity concerns, and burnout, rather than clinical adverse events. Third, existing ethical frameworks remain fragmented, with no consensus standards for oversight.

conclusionsEthical challenges in implementation research require clearer oversight and better-adapted frameworks. Existing guidance remains fragmented, leading to inconsistent risk assessments. Addressing socio-behavioral risks and unintended consequences is crucial. Strengthening ethical oversight will require consensus-driven standards, training, and further empirical research on the unique risks posed by implementation research.

trial registrationThe protocol for this manuscript was registered prospectively and published on the Open Science Framework ( https://doi.org/10.17605/OSF.IO/7XFWY ).

Indexed as

Dissemination and implementation researchEthical considerationsImplementation sciencePragmatic trialsResearch ethicsUnintended consequences

Identifiers

PMID41462395
PMCPMC12911251

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.