identifiability: a useful or decrepit concept in research ethics? sara c. hull, phd faculty,...
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Identifiability: A Useful or Decrepit Conceptin Research Ethics?
Sara C. Hull, PhD
Faculty, Clinical Center Department of Bioethics
Director, NHGRI Bioethics Core
National Institutes of Health
Bethesda, MD
Disclaimers/Disclosures
• No statement in this presentation should be construed as an official position of the National Human Genome Research Institute,National Institutes of Health, or Department of Health and Human Services.
• The speaker declares no financial conflicts of interest.
A Provocation
• “Medical confidentiality, as it has traditionally been understood by patients and doctors, no longer exists…[I]t is a decrepit concept.”
Mark Siegler (1982) NEJM
A Charge
• “Rather than perpetuate the myth of confidentiality and invest energy vainly to preserve it, the public and the profession would be better served if they devoted their attention to determining which aspects of the original principle of confidentiality are worth retaining.”
Mark Siegler (1982) NEJM
Current Definition of“Human Subject”
(f) A living individual from whom an investigator . . . conducting research obtains:
(1) data through intervention or interaction with the individual
(2) identifiable private information
45 CFR 46.102
“Identifiablity” inthe Research Regulations
• “Identifiable, private information” + broad exemptions added in 1981• “Major deregulation from rules in force”• Intention: to distinguish “categories of research
which normally present little or no risk of harm to subjects.”
• Motivated refinement of coding/de-identification strategies
45 CFR 46 FR 8366-01 (1981)
“Identifiablity” inthe Research Regulations
• Goal: Reduce burden of ethics review
• “[T]he workload of IRBs will be significantly reduced”
• “…as will the paperwork burden on scientists whose research will henceforth be exempt.”
• “…less difficulty in recruiting members of IRBs”
• “IRBs will be able to concentrate more productively on projects which most deserve IRB attention.”
45 CFR 46 FR 8366-01 (1981)
OHRP Interpretation:not identifiable = not readily ascertainable
• OHRP does not consider research involving only coded private information or specimens to involve human subjects … if the following conditions are both met: • (1) the private information or specimens
were not collected specifically for the currently proposed research project through an interaction or intervention with living individuals; and
• (2) the investigator(s) cannot readily ascertain the identity of the individual(s)
OHRP Guidance 10/16/08
Role of Confidentiality
• Respect subjects’ individuality and privacy
• Protect against harm• Economic, social, psychological• Stigma and discrimination
• Promote trust• Effective functioning of health, public health,
and research systems• Willingness to divulge information
How Well Is It Working?
• What is “it”?• Informational privacy in research
databases• Oversight of research based on
assumptions about informational privacy
How Well Is It Working?
CRITERIA1. Reduce review burden
2. Prevent risks of harm• De-identification
• Associated harms• Other risks
• To individuals (e.g., autonomy)• To groups
3. Preserve public trust
Reduce of Review Burden
• Prediction• An enormous regulatory gap• [M]ajority of research involving
databanks will be excluded from the Common Rule
• [W]e have to hope that research institutions will [ensure] appropriate oversight.”
Clayton (2004) IRB: Ethics & Human Research
Reduce of Review Burden
• Reality• Significantly fewer studies require
IRB review• Creation of new oversight and
governance structures• Repository-specific governance
• e.g., Data Access Committees
Prevent Risks of Harm
• De-Identification
• Associated harms
Photo Credits: digital ART 2 and Rush the Court NCAA blog
Prevent Risks of Harm
• Evolving research landscape• GWAS*• Next generation sequencing
• Whole exome/genome
Preserve Public Trust
• Attitudinal data• Consent
• parameters• willingness
• Privacy concerns• Trust in research enterprise
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