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.

Overview

1. “Identifiability” as a gatekeeper

2. How well is it working?

3. Outstanding challenges

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)

Identifiability as a Gatekeeper

cannot be identified/de-identifiedidentifiable

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?

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

Prevent Risks of Harm

• Other risks• To individuals• To groups

Preserve Public Trust

• Attitudinal data• Consent

• parameters• willingness

• Privacy concerns• Trust in research enterprise

Outstanding Challenges

• Evaluate effectiveness of “alternative” review mechanisms.• Address gaps

• Rigorous examination of actual risks to identifiability and associated harms

• Ongoing engagement with public and communities• Input re. design and goals• Buy-in to trade-offs