Table 1.
Summary of protocol changes implemented by the CRDC to support patient rights and operations.
| Aspects | Consenting principles implemented under CRDC | Use in consent forms prior to CRDC on-boarding |
|---|---|---|
| Rights and interests of the patient | Identified variants are clinically confirmed | Sometimes |
| Rights and interests of the patient | Patient opts for return of primary results, primary and secondary/incidental, or neither | Very rarely |
| Rights and interests of the patient | Patient consents to re-contact to request additional data/samples and being offered enrollment in other research studies | Sometimes |
| Rights and interests of the patient | Patient data protected by NIH certificate of confidentiality | Rarely |
| Sample and data flow | Research consents contain language regarding the use of previously collected clinical data | Very rarely |
| Sample and data flow | Remote consenting and e-consenting are available | Very rarely |
| Sample and data flow | Supports Biobanking at the BCH Biobank | Rarely |
| Sample and data flow | Consent allows the identification of genetic factors | Sometimes |
| Sample and data flow | Consent enables identified CLIA sequencing upfront for streamlined confirmation | Never |
| BCH data use (secondary use, control sample across population) | Samples and data (genomic sequences, medical record information, and registry data) may be used for many types of non-restricted research, including biological and genetic research related and unrelated to the reason for participation in study | Rarely |
| BCH data use (secondary use, control sample across population) | Identified data can be shared with collaborators on IRB protocol and others at BCH | Rarely |
| Broad data use | Language of consent allows engagement with other academic networks and industry sponsors to accelerate discovery and therapeutics development | Sometimes |
Use of the consenting principles in Table 1 prior to the CRDC was evaluated on 26 research protocols, 10 of which have now incorporated the CRDC consenting principles, 8 of which are in the process of incorporating the principles, and 8 for which incorporation was not preferred or impossible. Very rarely incorporated principles were present in <20% of consent forms, rarely incorporated principles were present in <40% of consent forms, and sometimes incorporated principles were present in <60% of consent forms.