Broad Consent for Research on Biospecimens

C h r i s t i ne G ra d y, D e p a rt m e nt o f B i o e t h i c s , N a t i on al I n st i t u te s o f H e a l t h C l i n i c a l C e n t e r

L i sa E c k st e i n , B e n B e rk m a n , D a n B ro c k , S a ra H u l l , B e rn i e L o , R e b e c c a Pe n t z , C a ro l We i l , B e n j a m i n S . Wi l fo n d , a n d D a v e We n d l e r

Broad Consent for Research on Biospecimens

Adapted from Grady et al (2015) Broad Consent for Research with Biological Samples: Workshop Conclusions. AJOB 15(9):34-42

Acknowledgments: 1) Workshop participants or article authors who chose not to be chapter authors: Jeff Botkin MD MPH; Ellen Wright Clayton JD MD; Robert Cook-Deegan MD; Stephanie M. Fullerton D Phil ; Hank Greely JD ; Mats G. Hansson PhD; Scott Kim MD PhD; Laura Rodriguez PhD; Tom Tomlinson PhD; 2) Authors of the open peer commentaries published in 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.

Broad Consent for Research on Biospecimens- Outline

Workshop conclusions as reported in AJOB

Proposal for ethically permissible broad consent

Consideration of objections and changing rules

Ethical reasons to obtain consent to use biospecimens for future research

1. Shows respect 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.

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.

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.

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

Societal Interests

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

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)

Identifying the best method In light of reasons for and against consent:

◦ Consider methods for obtaining consent

◦ Consider costs and burdens of different methods compared to value added

◦ Consider public preferences

◦ Consider implementation feasibility and challenges

Spectrum of Consent

Informed Consent

No consent

Specific consent

Checklist consent

Broad consent

Blanket consent

Presumed

Costs and burdens

Burdens on donors (time, stress, confusion)

Burdens on investigators (time, organization)

Burdens on reviewers (determining whether new study consistent with original consent)

Burdens on institutions/organizations keeping track

Value of samples (greater limits- reduced value)

Opportunity costs (studies not pursued)

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

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, study target or product do not seem to affect the willingness or views of the majority of respondents

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)

Public Preferences

Minority (4-40%) would not provide consent for future unspecified use of their biospecimens

Some groups under-represented

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

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 consent for an unspecified range of future research conditional on a few content and/or process restrictions

2. A process of oversight/governance for future research use

3. When feasible, a process for providing information or communicating with donors

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

Oversight process serves donor interests by ensuring acceptable research uses

Ongoing communication allows donors easy access to information and option to change their mind

Exceptions to broad consent should be used when indicated, for example- ◦ National emergency (e.g. public notified, but no consent required)

◦ Very rare disease (e.g. future research limited to “your disease”)

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

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

◦ Consistency with specified limitations

◦ Possible conflict with known donor values

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-consent for new kinds of research

Possibility of follow-up sample/data collection or providing individual results

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)

What limitations make sense? What should initial consent include?

Will oversight be too onerous?

Need for more research.