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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

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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

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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

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.

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.

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 …

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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.

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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

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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.

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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

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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

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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.

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

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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.

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

Thank you for your time!

Barbara J. Evans bjevans@central.uh.edu

713-743-2993