Reminder: Do not include any PHI or PII in Confluence. If you require 508 accessibility assistance or any other support for this system, then please send an email to onc-jira-questions@healthit.gov
...
- What types of laws, policies or governance structures could be established to address re-identification issues?
- Should consent forms include information about reidentification risk? Is it feasible to include this type of information in consent forms given the technical complexity of the subject?
- How do you allow individuals the opportunity to control what types of research is conducted with their data?[vi]
- By what methods should data be deidentified to minimize risk of reidentification?
- Is it feasible to include DUA’s clauses where data subjects are the third-party beneficiaries should patient data be deliberately re-identified by researchers?
- What potential group and individual harms exist even when data is de-identified?[vii]
- Is the possibility of reidentification considered new information since it could lead to an accidental/unauthorized disclosure? If so, should participants be contacted and informed or the potential risk,or even re-consented? Should the DUA even include considerations and subsequent steps for this kind of risk of reidentification?
- What additional data may need to be collected for research that in tandem with genetic biomarker data (clinical, environmental or otherwise) might increase the risk of reidentifiability?
- Should the biospecimen samples be destroyed once researchers collect the data of interest? Is this helpful to protectindividualsprotect individuals?
Title | Response |
Description | Researcher collects blood and saliva samples to analyze for particular genetic biomarkers related to disease. |
Primary actor/participant | Researcher (end-user) using in-house repository |
Support actor/participant | Participants, research coalition members |
Preconditions |
|
Postconditions | Ethical best practices are observed for managing and de-identifying genetic data |
Alternatives |
|
Considerations | Resources for contacting and providing indirect benefit to participants |
Data Elements Considered | Genetic biomarkers |
Purpose of the Data Collection | Research
|
Purpose of Data Use | Disease-specific genetic analysis
|
Terms of Transfer to the Data Holders | IRB approval, informed consent |
Terms of Transfer to Researchers | IRB approval |
[i] International HapMap Project. http://hapmap.ncbi.nlm.nih.gov/thehapmap.html.en
[ii] The McDonnell Genome Institute. http://genome.wustl.edu/projects/detail/1000-genomes-project/
[iii] Department of Health and Human Services. National Human Genome Research Institute. Funding Opportunity: Centers for Common Disease Genomics. http://grants.nih.gov/grants/guide/rfa-files/RFA-HG-15-001.html
[iv] National Institutes of Medicine, National Library of Medicine. Genetics Home Reference. https://ghr.nlm.nih.gov/handbook/genomicresearch?show=all
[v] National Human Genome Research Institute. http://www.genome.gov/27563453
[vi] The Precision Medicine Initiative Cohort Program – Building a Research Foundation for 21st Century Medicine. Precision Medicine Initiative (PMI) Working Group Report to the Advisory Committee to the Director, NIH. September 17, 2015. http://www.nih.gov/sites/default/files/research-training/initiatives/pmi/pmi-working-group-report-20150917-2.pdf
[vii] The Secretary’s Advisory Committee for Human Research Protections (SACHRP). http://www.hhs.gov/ohrp/sachrp/index.html
...