November 16, 2015

Suzanne M. Rivera, Ph.D., M.S.W., Assistant Professor of Bioethics

Heide Aungst, M.A., Research Associate & Narrative Medical Writer

Biospecimens: What We Know about What

Donors Think and Other Considerations that

May Sometimes Matter More

Specimens Are Important

• At least 300 million stored samples in the US

• Need even more to answer important

questions that affect human health

• Most valuable when connected to clinical data

Why Donors Give #1: Altruism

“It’s my obligation”

“To benefit future patients”

“Advancing science”

“Gift to society”

Why Donors Give #2: Self-interest

Personal health information through return of results

A long-term contribution to science that benefits

themselves, a relative, a particular disease, or a

population/country

Perception that treatment will be improved by (or in

exchange for) donation

Why Donors Give #3: Trust

“Trust of key actors”

Confidence that specimens will be used appropriately,

as well as that any personal genetic information will be

kept confidential

“Consequences for researchers who violate” an

agreement about how the specimen would be used

Barriers to Donation

• Study of “stigmatizing” diseases

• Results not actionable

• Specimen type

• Religious or cultural objections (or the perception of)

• Mistrust/fear of exploitation

• Lack of knowledge/understanding about safeguards

• Level of educational attainment

• Science fiction (cloning, satanic rituals, monitoring by

government though DNA)

What Donors Want

• Information– as specific as possible

• Protection of personal information

• Results (individual or study-level)

• Ability to specify future uses/disposition

• Re-consent for new uses

• Re-consent at 18 for minor donors

• Option to withdraw at any point

Why That’s Hard to Do

• We cannot know or predict all potential future uses; it’s not

possible to say today every way a specimen could be useful in

the future.

• The more specific our promises about how to handle, store,

share, dispose, the greater likelihood we will inadvertently fail

to honor donor choices.

• Donors move, die, change providers. Re-contacting over time

is notoriously difficult.

Should We Try?

• If we can’t follow-through on our commitments, do

we make it worse by suggesting we can?

• The promise of precision medicine requires huge

numbers of specimens and records to be shared.

This makes it even harder to comply.

• Research exceptionalism is bad for science.

NPRM: Proposed Changes

• Redefines “human subject” to include even “non-identified”

biospecimens

• Introduces concept of ‘‘broad’’ consent form*, through which a

person could consent to storage and eventual future unspecified

research uses

• Waivers of consent for research involving biospecimens (regardless

of identifiability) to occur only in very rare circumstances

* “broad” consent form template to be promulgated by the Secretary of HHS

Ethical Considerations

#1 Lack of Consensus

A majority of the ANPRM commenters (including patient advocacy orgs)

opposed the ANPRM’s suggested requirement of consent for research use of all biospecimens, regardless of identifiability.

Some commenters cited lack of convincing evidence of harm caused by

research use of non-identified clinical biospecimens without consent.

Yet, most of the comments from individual members of the public strongly

supported consent requirements for use of their biospecimens, regardless

of identifiability.

.

Ethical Considerations

#2 Autonomy vs. Beneficence & Justice

Requiring consent for the re-use of existing de-identified specimens gives

greater weight to the principle of autonomy than to the principles of

beneficence and justice:

-limits risks to a few but distributes benefits of science to all;

-may result in lower participation rates in research by underserved

members of society;

-may delay important advances in human health.

Ethical Considerations

#3 Dimensions of Nonmaleficence

While obtaining consent prior to re-use of existing specimens may be

seen as preventing a theoretical dignitary harm, to the extent consent

cannot be obtained, the destruction of existing specimens may require

new/more people to provide specimens to answer important questions (thereby exposing them to unnecessary risks, and exposing all of us to

unnecessary delays).

Given conditions of scarce resources, the expense of collecting new

specimens also should be considered.

Conclusions

• Specimens are valuable and their use advances

human health.

• It’s hard to do what donors want.

• We need to honor beneficence and justice, not just

autonomy.

• It’s time for a different ethos: opt-out rather than opt-in.