1. Broad consent for future research on biospecimens is ethically permissible when it includes initial consent for an unspecified range of future research with some limitations, oversight of future research uses, and potential ongoing communication with donors. 2. Empirical studies show most people want some control over use of their biospecimens and risk, but broad consent reduces burdens compared to specific consent for each study. 3. Public preferences generally support broad consent with initial consent and oversight, though some may not consent to future unspecified use.

1. Broad Consent for Research on Biospecimens
Christine Grady, Department of Bioethics, National Institutes of Health Clinical
Center
Lisa Eckstein, Ben Berkman, Dan Brock, Sara Hull, Bernie Lo, Rebecca Pentz, Carol
Weil, Benjamin S. Wilfond, and Dave Wendler

2. Broad Consent for Research on Biospecimens
Adaptedfrom Grady et al (2015) Broad Consent for Research with Biological Samples:
WorkshopConclusions. AJOB 15(9):34-42
Acknowledgments: 1) Workshop participantsor article authorswho chose not to be chapterauthors: Jeff
BotkinMD MPH; Ellen Wright ClaytonJD MD; Robert Cook-Deegan MD; Stephanie M. FullertonD Phil ;
HankGreely JD ; MatsG. Hansson PhD; Scott Kim MD PhD; Laura RodriguezPhD; Tom TomlinsonPhD; 2)
Authors of the open peer commentaries publishedin AJOB
Disclaimer: Views are those of the authors and do not reflect the official policies or positions of
the NIH, the Department of Health and Human Services, or other institutions.

3. Broad Consent for Research on Biospecimens-
Outline
Workshop conclusionsas reported in AJOB
Proposal for ethically permissible broad consent
Consideration of objections and changing rules

4. Ethical reasons to obtain consent to use
biospecimens for future research
1. Showsrespect for donors and allows them to control whether their samples
are used for research.
2. Allows donors to decide whether research risks and burdens are acceptable
to them.
3. Allows donors to decide whether to contribute to the goals of research, thus
protecting and possibly promoting their non-welfare interests.
4. Makes transparent decisions about biospecimen research, which can
promote public trust and the ongoing viability of research with biospecimens.

5. Empirical Data on research with biospecimens
Empirical studies from around the world, over 100,000 patients, research
participants, family members, religious leaders, the general public.
Vast majority want to decide whether their samples are used for research.
When asked, most are willing to donate samples for research.

6. Control/Respect
Respect for persons requires that persons, to the degree they are competent,be
given the opportunity to choose what shall or shall not happen to them.
Informed consent promotes this opportunity in research and health care.
Most persons care about being treated with respect.
And, when asked, most want to control whether their samples are used for
research.

7. Protecting welfare and non-welfare interests
Majority of persons want to be protected from risks
Risks to donor welfare of future research with biospecimens are low.
With standard safeguards in place, risks to privacy/confidentiality are low.
Ability to choose whether to contribute to research allows
protection/promotion of non-welfare interests

8. Societal Interests
Societaltrust/support is crucial to the ongoing conduct of valuable research.
Importantto ensure that the health benefits society realizes are not the
result of unethical research.
Recent public attention to research with specimens

9. Implications
Moral reasons to obtain consent to use biospecimens for future research--respect for
persons, protection from risks, societal trust.
Yet,
Not clear which method of obtaining consent is preferred
◦ and
Commentators question whether the force of these reasons declines in light of:
• low risks to donors
• the potential value of research with biospecimens
• the challenge of meaningful consent (especially in the clinical environment)

10. Identifying the best method
In light of reasons for and against consent:
◦ Consider methods for obtaining consent
◦ Consider costsand burdens of different methods compared to value added
◦ Consider public preferences
◦ Consider implementation feasibility and challenges

11. Spectrum of Consent
InformedConsent
No consent
Specific consent
Checklistconsent
Broadconsent
Blanketconsent
Presumed

12. Costs and burdens
Burdens on donors (time, stress, confusion)
Burdens on investigators (time, organization)
Burdens on reviewers (determining whether new study consistentwith
original consent)
Burdens on institutions/organizations keeping track
Value of samples (greater limits- reduced value)
Opportunity costs(studies not pursued)

13. Less burden, less control
More burden, more control
TYPE OF CONSENT DESCRIPTION
No consent Do not obtain donor consent
Blanket Consent to future research with no
limitations
Broad* Consent to future research with
specified limitations
Checklist Donors choose which types of
future studies are allowed
Study specific Consent for each specific future
study

14. Public Preferences
Majority of persons surveyed are willing to donate specimens for research but
want to be asked
Details of the future research, such as disease being studied, type of technology,
studytarget or product do not seem to affect the willingness or views of the
majority of respondents

15. Public Preferences
Majority, after initial consent,are willing to have samples used without being
asked for each use, with the exception of a few types of research
Many prefer broad consent:
◦ “I would only have to sign the paper or be asked about research once,” and “Broad
consent allows for research in the future that might not have been considered” (Simon
et al 2011)
◦ Prefer broad consent over blanket consent or specific consent (Tomlinson et al 2015)

16. Public Preferences
Minority (4-40%) would not provide consent for future unspecified use of their
biospecimens
Some groups under-represented

17. Changing landscape
NPRM (2015)- requirement for written consent for collection of biospecimens for future
research use; allows use of a broad consent template
NIH GDS Policy (2014)- require documentation of participants’ consent to broad sharing
of genomic and phenotypic data for future research purposes
HIPAA (2013 amendments)- allow authorization for use and disclosure for future
research purposes
Newborn Screening Saves Lives (2014)– SACHRP recommended that OHRP develop
guidance emphasizing simplified one-time permission though broad consent for future
research

18. Proposal for broad consent
Broad consent for collection of biospecimens for future research use is ethically
permissible, and in many cases, optimal, when it includes:
1. Initial broad consentfor an unspecified range of future research conditional
on a few contentand/or process restrictions
2. A process of oversight/governance for future research use
3. When feasible, a process for providing information or communicatingwith
donors

19. Support for Broad consent proposal
Individuals control whether to donate biospecimens for future research, whether they find the
risks acceptable, and whether contributing to research is consistent with their interests.
Reduces burden on donors of having to consider and make a decision for each new study, and
burden on investigators and institutions
Oversightprocess serves donor interests by ensuring acceptable research uses
Ongoing communicationallows donors easy access to information and option to change their
mind
Exceptions to broad consent should be used when indicated, for example-
◦ Nationalemergency (e.g. public notified, but no consent required)
◦ Very rare disease (e.g. future research limitedto “your disease”)

20. Initial consent
At least:
1. Request to collect biospecimens and store them for broad range of future research
2. Share with other researchers, and conditions under which sharing will occur
3. General health information stored with biospecimens, and data security measures in place
4. Specified Limitations
5. Process of oversight
6. Potential for ongoing communication or re-contact
7. Processes for withdrawal
More controversial:
Wider-ranging description of possible types of research, possibility of controversial research with
specific examples

21. Oversight Process
Investigator description of proposed study and request for samples
Oversight designee review and approval or referral for additional review
Further review prompted when questions about:
◦ Scientific value or rationale
◦ Risks more than usual
◦ Consistencywith specified limitations
◦ Possible conflict with known donor values

22. Information or ongoing communication
Feasibility and format will vary with technological capacities, donor populations,
setting, etc.
Information available to donors about ongoing research (e.g., via web)
Provides opportunities for donors to register concerns, withdraw from research,
re-consentfor new kinds of research
Possibility of follow-up sample/data collection or providing individual results

23. Challenges
Is consent really necessary? Engaging communities?
Is implementing a process of broad consent possible? Meaningful? In all settings?
Are public preference data reliable? Interpretable? Useful?
Other options that should be considered? (notification with opt-out consent, designating a
research power of attorney, meta-consent, cascading consent, loans in trust, consent for
governance, dynamic consent)
Whatlimitations make sense? What should initial consent include?
Will oversight be too onerous?
Need for more research.