ArticleJAMA psychiatry2013
Addressing risks to advance mental health research.
Article in JAMA psychiatry, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled 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.
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
17 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Risks and Safeguards in Social-Behavioural Research With Adults With Developmental Disabilities: A Qualitative Systematic Review.Journal of applied research in intellectual disabilities : JARID · 2025Pooled it
- A multi-site randomized clinical trial to reduce suicidal ideation in suicidal adult outpatients with Major Depressive Disorder: Development of a methodology to enhance safety.Clinical trials (London, England) · 2015Trial
- Transforming patient recruitment in clinical trials: Communication training to manage uncertainties about risks and benefits.Journal of clinical and translational science · 2026Article
- An exploratory study evaluating the 20 medications most commonly associated with suicidal ideation and self-injurious behavior in the FAERS database.BMC pharmacology & toxicology · 2025Article
- Breast cancer-related lymphedema and recurrence of breast cancer: Protocol for a prospective cohort study in China.PloS one · 2023Article
- Whose story is it? Mental health consumer and carer views on carer participation in research.Health expectations : an international journal of public participation in health care and health policy · 2021Article
- Implementation of a Community-Partnered Research Suicide-Risk Management Protocol: Case Study From Community Partners in Care.Psychiatric services (Washington, D.C.) · 2021Article
- Core components and strategies for suicide and risk management protocols in mental health research: a scoping review.BMC psychiatry · 2021Article
- Co-development of a Best Practice Checklist for Mental Health Data Science: A Delphi Study.Frontiers in psychiatry · 2021Article
- Secondary Prevention of Depressive Prodrome in Adolescents: Before and After Attending a Jogging Program on Campus.International journal of environmental research and public health · 2020Article
- The "Ought-Is" Problem: An Implementation Science Framework for Translating Ethical Norms Into Practice.The American journal of bioethics : AJOB · 2020Article
- The risk-benefit ratio of studying psychiatric symptoms via daily diary methods.Accountability in research · 2019Article
- Expanding Access to Cancer Clinical Trials for Patients With Mental Illness.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2019Article
- Ethical standards for mental health and psychosocial support research in emergencies: review of literature and current debates.Globalization and health · 2017Review
- Managing Ethical Challenges to Mental Health Research in Post-Conflict Settings.Developing world bioethics · 2016Article
- Conducting Research on Adolescent Suicide Attempters: Dilemmas and Decisions.The Behavior therapist · 2014Article
- Understanding the Use of Optimal Formatting and Plain Language When Presenting Key Information in Clinical Trials.Journal of empirical research on human research ethics : JERHREArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
Abstract
importanceRisk communication and management are essential to the ethical conduct of research, yet addressing risks may be time consuming for investigators and institutional review boards may reject study designs that seem too risky. This can discourage needed research, particularly in higher-risk protocols or those enrolling potentially vulnerable individuals, such as those with some level of suicidality. Improved mechanisms for addressing research risks may facilitate much needed psychiatric research.
objectiveTo provide mental health researchers with practical approaches to (1) identify and define various intrinsic research risks, (2) communicate these risks to others (eg, potential participants, regulatory bodies, and society), (3) manage these risks during the course of a study, and (4) justify the risks. EVIDENCE REVIEW: As part of a National Institute of Mental Health-funded scientific meeting series, a public conference and a closed-session expert panel meeting were held on managing and disclosing risks in mental health clinical trials. The expert panel reviewed the literature with a focus on empirical studies and developed recommendations for best practices and further research on managing and disclosing risks in mental health clinical trials. No institutional review board-review was required because there were no human subjects.
findingsChallenges, current data, practical strategies, and topics for future research are addressed for each of 4 key areas pertaining to management and disclosure of risks in clinical trials: identifying and defining risks, communicating risks, managing risks during studies, and justifying research risks. CONCLUSIONS AND RELEVANCE: Empirical data on risk communication, managing risks, and the benefits of research can support the ethical conduct of mental health research and may help investigators better conceptualize and confront risks and to gain institutional review board-approval.
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What 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.