Protection of human participants is a fundamental facet of biomedical research. We report the activities of a health service research study in which there were three institutional review boards (IRBs), three legal departments and one research administration department providing recommendations and mandating changes in the study methods. Complying with IRB requirements can be challenging, but can also adversely affect study outcomes. Multiple protocol changes mandated from multiple IRBs created a research method that was not reflective of how substance use screening would be performed in a clinical setting. There was direct conflict between the IRBs' perceptions of participants' protection with the researchers' need to use research methodology that assures the clinical relevancy of results.
- Scientific research
- policy guidelines/Inst. Review Boards/Review Cttes
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.
Funding Robert Wood Johnson Foundation, Princeton, NJ, USA.
Competing interests None.
Ethics approval This study was conducted with the approval of the MetroHealth Medical Center and Kaiser Permanente IRBs Cleveland, Ohio, USA.
Provenance and peer review Not commissioned; externally peer reviewed.
Read the full text or download the PDF:
Other content recommended for you
- Streamlining the Clinical Research Enterprise
- How does a history of psychiatric hospital care influence access to coronary care: a cohort study
- Recreational and ergogenic substance use and substance use disorders in elite athletes: a narrative review
- Toward stronger evidence on quality improvement. Draft publication guidelines: the beginning of a consensus project
- Assessing research risks systematically: the net risks test
- Substance use and behaviour disorders in Puerto Rican youth: a migrant family study
- Innovations in suicide prevention research (INSPIRE): a protocol for a population-based case–control study
- Leveraging a health information exchange to examine the accuracy of self-report emergency department utilization data among hospitalized injury survivors
- Emergency department use for mental and substance use disorders: descriptive analysis of population-based, linked administrative data in British Columbia, Canada
- Is unhealthy substance use associated with failure to receive cancer screening and flu vaccination? A retrospective cross-sectional study