This interview guide seeks to understand genetic health professionals' experiences with obtaining informed consent for diagnostic genomic sequencing from patients.
Obtaining informed consent (IC) for genetic/genomic research is complicated because most of the ethical issues associated with genetic research are considerations to be disclosed by researchers and weighed by prospective participants during the consent process. These include complicated questions associated with return of results, management of incidental findings (results beyond the aims of the study that are of potential significance to individual participants), and responsibility for reinterpretation of findings.
Sickle cell disease (SCD), characterized by severe pain crisis and progressive organ damage as well as early death, is one of the most common inherited blood disorders in the world. However, since 90% of U.S. patients self-identify as Black and experience neglect as a result of structural racism, until recently, the condition has received very little research funding and minimal attention from the medical research community. Recent advances in human genetics have reinvigorated interest in the genetic underpinnings of SCD and the potential to “cure” it with novel genetic therapies.
This is a printable version of the information from the Clinical Broad Data Sharing Consent Video (see this database). It describes key concepts outlined in the consent form, includes testimonials on the importance of data sharing, and contains information on the risks and benefits involved. The brochure was developed by the Clinical Genome Resource (ClinGen), a not-for-profit, National Institutes of Health (NIH)-funded resource dedicated to sharing genetic data, building knowledge, and improving patient care.
The 10 minute video explains key concepts outlined in the Consent to Share Genetic and Health Information form. It include testimonials on the importance of data sharing as well as information on the risks and benefits involved. The video was developed by the Clinical Genome Resource (ClinGen), a not-for-profit, National Institutes of Health (NIH)-funded resource dedicated to sharing genetic data, building knowledge, and improving patient care.
This one-page consent form helps to faciliate consent and promote broad genomic data sharing in the clinical setting. The language use on the form is consistent with the NIH Genomic Data Sharing Policy and the NHGRI Informed Consent Resource. The consent form was developed by the Clinical Genome Resource (ClinGen), a not-for-profit, National Institutes of Health (NIH)-funded resource dedicated to sharing genetic data, building knowledge, and improving patient care. The file contains two pages; one with the ClinGen logo in the bottom corner and the other without the logo.