There is a lack of information available on researchers? attitudes and beliefs regarding incidental research findings and the prevalence of incidental research findings from state of the art imaging studies, such as whole body FDG PET/CT in those without known malignancy, and to our knowledge, no such information available in rheumatology. The Treatments Against RA (Rheumatoid Arthritis) and Effect on FDG PET/CT (TARGET) study provides an unprecedented and unique opportunity to examine the ethics around incidental findings from whole body FDG PET/CT in RA patients without known malignancy. With the evolving technological advancements in healthcare, we will inevitably discover more incidental findings in research. There is consensus that incidental findings of potential clinical significance must be returned to research participants. However, returning incidental findings to participants leaves many unanswered questions for researchers, such as how to explain the risks and benefits of discovering incidental findings in the informed consent process and how to organize follow up for incidental findings. There are a number of publications on participant views on incidental findings in imaging research and researcher views on incidental findings in neuroimaging and genetic testing. However, there is a lack of information available on researchers? attitudes and beliefs regarding incidental research findings from state of the art imaging studies such as whole body PET/CT. Additionally, data regarding the frequency of incidental imaging findings in clinical trials is limited, and even more limited in rheumatology clinical trials. Determining the prevalence of incidental research findings on whole body FDG PET/CT in RA and detection rate of previously unknown malignancies has implications for policy, and to our knowledge, has not been described in a RA population. Most of the data on incidental research findings from whole body FDG PET/CT are in patients with known malignancy rather than in patients without known malignancy. While it is recommended that researchers report incidental findings from research, more specific or standardized guidance for outcome reporting of incidental findings or how researchers should manage incidental findings is lacking. Currently, management of incidental imaging findings are left up to individual sites and investigators, and are based on existing legal and ethical guidelines which are vague and unclear. There is considerable variability in the management of incidental imaging findings between research sites, and no clear consensus among researchers on how to handle incidental findings in imaging research. Therefore, it is important that we 1. Determine researchers? attitudes and beliefs regarding their ethical obligation to return and manage incidental research findings from whole body FDG PET/CT imaging studies and 2. Determine the prevalence of incidental research findings on whole body FDG PET/CT in RA and detection rate of previously unknown malignancies.
There is a lack of information available on researchers? attitudes and beliefs regarding incidental research findings and the prevalence of incidental research findings from state of the art imaging studies, such as whole body FDG PET/CT in those without known malignancy, and to our knowledge, no such information available in rheumatology. The Treatments Against RA (Rheumatoid Arthritis) and Effect on FDG PET/CT (TARGET) study provides an unprecedented and unique opportunity to examine the ethics around incidental findings from whole body FDG PET/CT in RA patients without known malignancy. Gathering data on researchers? attitudes and beliefs regarding incidental findings and the prevalence of incidental findings from state of the art imaging studies will help develop clear policies and procedures for reporting and managing incidental findings in imaging research, refine the informed consent process and standardize reporting, evaluation, and follow up of incidental imaging findings.
| Bathon, Joan M; Giles, Jon T; Solomon, Daniel H (2018) Editorial: Tumor Necrosis Factor Antagonists: Killing Two Birds With One Biologic Stone. Arthritis Rheumatol 70:326-329 |
| Solomon, D H; Ruppert, K; Zhao, Z et al. (2016) Bone mineral density changes among women initiating blood pressure lowering drugs: a SWAN cohort study. Osteoporos Int 27:1181-1189 |
