From the event "Specimen Science: Ethics and Policy Implications," held at Harvard Law School on November 16, 2015. This event is a collaboration between The Center for Child Health and Policy at Case Western Reserve University and University Hospitals Rainbow Babies & Children’s Hospital; the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School; the Multi-Regional Clinical Trials Center of Harvard and Brigham and Women's Hospital; and Harvard Catalyst | The Harvard Clinical and Translational Science Center. It is supported by funding from the National Human Genome Research Institute and the Oswald DeN. Cammann Fund at Harvard University. For more information, visit our website at http://petrieflom.law.harvard.edu/events/details/specimen-science-ethics-and-policy

1. 1
Biospecimens, Commercial Research,
and the Elusive Public Benefit Standard
Barbara Evans and Eric M. Meslin
Barbara J. Evans, Ph.D., J.D., LL.M.
Director, Center for Biotechnology & Law
University of Houston Law Center
713-743-2993 • bjevans@central.uh.edu
Specimen Science: Ethics and Policy Issues
Petrie-Flom Center at Harvard Law School
November 16, 2015

2. 2
Grant-funded research at academic institutions
is considered commercial in nature:
• unless it is for “for amusement, to satisfy idle
curiosity, or for strictly philosophical inquiry”
• if it has “definite, cognizable, and not
insubstantial commercial purpose.”
Furthering a university’s teaching and
training mission may count as a commercial
purpose, even at non-profit institutions.
See Madey v Duke (CAFC 2002, cert denied 2003); Embrex v.
Service Engineering (CAFC 2000)
Virtually all biomedical research is commercial

3. 3
Sometimes, you just need identifiers
In “[r]esearch on adverse events using
computer-stored prescription data
linked with hospital data … it is
necessary to have information on
identifiers in order to link the data that
permits the research to be done.”
- Joint Policy Cmte of the Societies of
Epidemiology October 26, 2011

4. De-identification is dead. You
should assume that there’s no
such thing as de-identified data.
Just as there’s no such thing as a de-
identified full-facial photo. Yet we never
took that to mean that we should “own” every
photo that contains a facial image of us.
Your gait is uniquely identifying.
Cut the biospecimen exceptionalism. It’s
not just biospecimens that are intrinsically
identifiable.
Privacy is probabilistic.

5. Ecce Homo
proposed §___.102(e)(1) Human subject
means a living individual about whom an
investigator (whether professional or student)
conducting research … (iii) obtains, uses, or
analyzes biospecimens.

6. National Commission Recommendation
43 Fed. Reg. 56,174, 56,181 (1978)
Unconsented use of identifiable documents,
records, or biospecimens is permissible if :
• Minimum necessary/practicability:
– Identifiability is necessary to accomplish the
research or statistical purpose
• Minimal risk:
– Adequate safeguards to protect from
unauthorized disclosure ..
– Medical provider that maintains the data must
consent to any redisclosure …
6

7. National Commission Recommendation
43 Fed. Reg. 56,174, 56,181 (1978)
• No violation of limitations under which the
record was collected
What, exactly, are they?
• ‘the importance of the research or
statistical purpose for which any use or
disclosure is to be made is such as to
warrant the risk to the individual from
additional exposure of the record or
information contained therein”
… a public benefit standard.
7

8. Current Common Rule Waiver Criteria
45 C.F.R. § 46.116(d)
• No more than minimal risk to the subjects
• The waiver or alteration will not adversely
affect the rights and welfare of the subjects
• Impracticability of consent:
– The research could not practicably be carried
out without the waiver or alteration
• Provide information to subjects when
appropriate
8

9. Proposed Common Rule Waiver Criteria
§_.116(f)(1) IRB can waive or alter consent subject
to the current waiver conditions plus:
(iii) If the research involves accessing or using
identifiable biospecimens or identifiable
information, the research could not practicably
be carried out without accessing/using identifiers
(2) Additional criteria for biospecimens. IRB must
find and document:
(i) Compelling scientific reasons for the research
use of the biospecimens
(ii) The research could not be conducted with other
biospecimens for which informed consent was
obtained or could be obtained
(3) If the individual was asked and refused to give
broad consent for secondary use, IRB cannot waive
consent for biospecimens or information.

10. 10
General Jack D. Ripper
Source: Columbia Pictures
There is a “conspiracy to sap and impurify all of
our precious bodily fluids… without the
knowledge of the individual, certainly without
any choice” This may lead to “loss of
essence… life essence” “It’s incredibly
obvious, isn’t it?” “I do deny them my essence!”
The ethics of
biospecimen use
according to
General Ripper in
Dr. Strangelove

11. 11
The Constitutional Dimension of
Informational Privacy
Factors the Supreme Court has considered
important (Whalen v. Roe 429 U.S. 589 (1977))
- Strong substantive standards of privacy
and data security
- An orderly, representative process for
developing those standards and meaning-
ful possibilities that the standards will be
enforced
Process and substance both matter when
setting privacy and security standards

12. 12
What are Public-regarding Norms?
Norms of due process that ensure the
fairness of decisions that have public
impact and implicate individual rights
1. Notice and opportunity to participate in
decisions that affect you
2. Impartial “non-conflicted” decisionmakers
3. Reasoned, non-arbitrary decisions
4. Transparency and accountability
5. Right to review or appeal of decisions
Trust is reciprocal: There can be no public
trust, unless ethicists trust the public.

13. Good governance does not require
giving individuals veto power
• Individual consent is relevant when individuals
make decisions involving risk to themselves. It is
not relevant when they make decisions involving
risk to others or to the public.
• Some contexts require societies to make binding
collective decisions to serve the common good.
Example: setting a speed limit
• Individuals have a right to expect a voice and a
legitimate, transparent process
• But no right of individual consent to the speed limit
13

14. 14
Other Possible Approaches
Identify uses that presumptively do not benefit
the public and subject them to higher scrutiny
and/or restrictions on specimen access
- drug and device price “scalping” vs. just and
reasonable pricing of discoveries
- reluctance to make public disclosure of the
planned research use
Facilitate specimen access for uses that can
be characterized as “mutually advantageous
exchanges” where everyone contributes, but
everybody gets a benefit.

15. No one spends money collecting these data
to actually learn anything about you. They
want to learn about people like you.
Lawrence Lessig, Code and Other Laws of
Cyberspace 152 (1999).
Develop the distinction between activities that:
- study YOU (which is potentially creepy)
- study PEOPLE LIKE YOU

16. Thank you for your time!
Barbara J. Evans
bjevans@central.uh.edu
713-743-2993