ArticleJournal of medical ethics2012
Individual genetic and genomic research results and the tradition of informed consent: exploring US review board guidance.
Article in Journal of medical ethics, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.
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
14 citing papers in PubMed, 22 citations in OpenAlex.
- Reciprocity in research: Participant views on return of results in the WATCH-PD qualitative study.Journal of Parkinson's disease · 2026Article
- Feedback of individual genetic and genomics research results: A qualitative study involving grassroots communities in Uganda.PloS one · 2022Article
- Variation among Consent Forms for Clinical Whole Exome Sequencing.Journal of genetic counseling · 2018Article
- Controversies among Cancer Registry Participants, Genomic Researchers, and Institutional Review Boards about Returning Participants' Genomic Results.Public health genomics · 2018Article
- Preferences for the Return of Individual Results From Research on Pediatric Biobank Samples.Journal of empirical research on human research ethics : JERHRE · 2017Article
- Participant views on consent in cancer genetics research: preparing for the precision medicine era.Journal of community genetics · 2016Article
- Preferences for return of incidental findings from genome sequencing among women diagnosed with breast cancer at a young age.Clinical genetics · 2016Article
- Ethical considerations in malaria research proposal review: empirical evidence from 114 proposals submitted to an Ethics Committee in Thailand.Malaria journal · 2015Article
- Latent variable modeling and its implications for institutional review board review: variables that delay the reviewing process.BMC medical ethics · 2015Article
- Return of Genetic Research Results to Participants and Families: IRB Perspectives and Roles.The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics · 2015Article
- A closer look at the recommended criteria for disclosing genetic results: perspectives of medical genetic specialists, genomic researchers, and institutional review board chairs.Journal of genetic counseling · 2013Article
- Evolving approaches to the ethical management of genomic data.Trends in genetics : TIG · 2013Review
- Clinical analysis and interpretation of cancer genome data.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2013Review
- Incidental variants are critical for genomics.American journal of human genetics · 2013Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 1 institution in 1 country.
Funding
Abstract
backgroundGenomic research is challenging the tradition of informed consent. Genomic researchers in the USA, Canada and parts of Europe are encouraged to use informed consent to address the prospect of disclosing individual research results (IRRs) to study participants. In the USA, no national policy exists to direct this use of informed consent, and it is unclear how local institutional review boards (IRBs) may want researchers to respond. OBJECTIVE AND
methodsTo explore publicly accessible IRB websites for guidance in this area, using summative content analysis.
findingsThree types of research results were addressed in 45 informed consent templates and instructions from 20 IRBs based at centres conducting genomic research: (1) IRRs in general, (2) incidental findings (IFs) and (3) a broad and unspecified category of 'significant new findings' (SNFs). IRRs were more frequently referenced than IFs or SNFs. Most documents stated that access to IRRs would not be an option for research participants. These non-disclosure statements were found to coexist in some documents with statements that SNFs would be disclosed to participants if related to their willingness to participate in research. The median readability of template language on IRRs, IFs and SNFs exceeded a ninth-grade level.
conclusionIRB guidance may downplay the possibility of IFs and contain conflicting messages on IRR non-disclosure and SNF disclosure. IRBs may need to clarify why separate IRR and SNF language should appear in the same consent document. The extent of these issues, nationally and internationally, needs to be determined.
Indexed as
Identifiers
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.