April 28, 2017
Transparency is a relatively new concept to the world of health and health care, considering that just a few short decades ago we were still in the throes of a “doctor-knows-best” model. Today, however, transparency is found on almost every short list of solutions to a variety of health policy problems, ranging from conflicts of interest to rising drug costs to promoting efficient use of health care resources, and more. Doctors are now expected to be transparent about patient diagnoses and treatment options, hospitals are expected to be transparent about error rates, insurers about policy limitations, companies about prices, researchers about data, and policymakers about priorities and rationales for health policy intervention. But a number of important legal and ethical questions remain. For example, what exactly does transparency mean in the context of health, who has a responsibility to be transparent and to whom, what legal mechanisms are there to promote transparency, and what legal protections are needed for things like privacy, intellectual property, and the like? More specifically, when can transparency improve health and health care, and when is it likely to be nothing more than platitude?
This conference aimed to: (1) identify the various thematic roles transparency has been called on to play in American health policy, and why it has emerged in these spaces; (2) understand when, where, how, and why transparency may be a useful policy tool in relation to health and health care, what it can realistically be expected to achieve, and when it is unlikely to be successful, including limits on how patients and consumers utilize information even when we have transparency; (3) assess the legal and ethical issues raised by transparency in health and health care, including obstacles and opportunities; (4) learn from comparative examples of transparency, both in other sectors and outside the United States. In sum, we hope to reach better understandings of this health policy buzzword so that transparency can be utilized as a solution to pressing health policy issues where appropriate, while recognizing its true limitations.
Learn more on our website: http://petrieflom.law.harvard.edu/events/details/2017-annual-conference
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Holly Fernandez Lynch, "Transparency in IRB Decision-Making"
1. Promoting IRB Transparency:
What, Why, To Whom, and How
Holly Fernandez Lynch, J.D., M.Bioethics
Executive Director, Petrie-Flom Center
Faculty, Harvard Medical School Center for Bioethics
April 28, 2017
2. Overview:
• What’s an IRB?
• Transparency taxonomy
• Current regulatory requirements
• Current practices
• Arguments in favor of IRB transparency
• Concerns
• Recommendations
3. Institutional Review Boards (IRBs)
• Responsible for oversight of federally-funded “research” with
“human subjects” and FDA-regulated “clinical investigations”
• Initial and continuing review of protocols
– Risks minimized and reasonable in relation to benefits
– Equitable subject selection
– Proper informed consent
• Typically housed within research institutions, but may also be free-
standing (unaffiliated, for-profit)
• May cover a single research site or several
Background
4. IRB Authority
• Step 1. Do the regulations apply?
• Step 2. What type of review (e.g., expedited or full board)?
• Step 3. Can the research be initiated?
• Step 4. Can the research proceed?
Background
5. IRBs are often a black box:
• Closed meetings
• Minutes not made public (beyond IRB/institution)
• Decisions not made public (beyond investigator/institution)
• Poor systems for even internal review/institutional memory
What happens in Vegas…
6. • Transparency ≠ precedent
– Transparency facilitates precedent
• Easier to follow if you know
what came before!
– But is not necessary or sufficient
• IRB could rely on its own
precedent, without
transparency to anyone else
• IRBs could be transparent with
the world, but perhaps no one
will follow if not required to
IRB Transparency
7. IRB Transparency – Taxonomy
Transparency to whom About what By what mechanisms
8. IRB Transparency – Taxonomy
Transparency to whom About what By what mechanisms
• Investigators
• Research participants
• Research institution
• Other IRBs
• Regulators
• The public
• Researchers of IRBs
9. IRB Transparency – Taxonomy
Transparency to whom About what By what mechanisms
• Investigators
• Research participants
• Research institution
• Other IRBs
• Regulators
• The public
• Researchers of IRBs
• Protocol approvals,
disapprovals,
requests for
modification (and
rationale)
• Underlying regulatory
determinations (and
rationale)
• Deliberations
• Correspondence
• Policies
• Board statistics/data
10. IRB Transparency – Taxonomy
Transparency to whom About what By what mechanisms
• Investigators
• Research participants
• Research institution
• Other IRBs
• Regulators
• The public
• Researchers of IRBs
• Protocol approvals,
disapprovals,
requests for
modification (and
rationale)
• Underlying regulatory
determinations (and
rationale)
• Deliberations
• Correspondence
• Policies
• Board statistics/data
• Verbal
communication
• Written
communication
• Open IRB meetings
• Accessible meeting
minutes
• Accessible decisions
• Accessible websites
and training tools
11. • Declaration of Helsinki: IRBs “must be transparent in
[their] functioning”
• CIOMS: IRBs must conduct reviews “according to clear
and transparent procedures”
• Aspirational and vague
Current Requirements
12. Regulatory requirements (45 CFR 46.103,109,113, 115)
IRB DECISIONS
• IRBs must have written procedures for review and oversight of
research, including policies for “reporting its findings and actions to
the investigator and the institution”
• IRBs must “notify investigators and the institution in writing of its
decision to approve or disapprove the proposed research activity”
• Must provide a “statement of reasons” only if disapproved or if
approval suspended or terminated
• GAPS
– Might also want to know why a protocol was approved
– Unclear what counts as an adequate statement of reasons
– Required transparency only to investigator, institution, and regulators
Current Requirements
13. Regulatory requirements (45 CFR 46.103,109,113, 115)
IRB MINUTES
• Minutes must be “in sufficient detail to show” actions taken by
IRB, vote tallies [but not individuals], “the basis for requiring
changes in or disapproving research,” and a “written summary of
the discussion of controverted issues and their resolution”
• OHRP Guidance: minutes must document protocol-specific
information justifying each IRB finding for the regulatory provisions
governing consent waiver and research with special populations
• GAPS
– A lot of discretion about content and detail
– Not required to be shared with investigator or anyone beyond
institution/regulators
Current Requirements
14. • Investigators entitled to some info
• Institutions + regulators have
access to more (if IRBs keep it)
• Everyone else can be left in the
dark…
Current Requirements
15. • Some IRBs are very transparent with investigators and other IRBs
– Outreach to investigators explaining processes, expectations
– Publicly accessible policies
– Investigators invited to meetings – and others may be allowed in
– Extensive explanations for decisions and how to fix problems
– Engagement in national meetings, email lists, etc.
• But many are not
• Typically, IRBs are not writing opinions justifying their actions, meeting
minutes cover little of substance (especially when a protocol is
approved), and entire swaths of stakeholders are shut out
Current Practice
16. • Forces development, articulation of reasons
– Better justified decisions
– Less gut reaction/intuition
• Facilitates accountability
– Permits critique, debate, analysis
– Allows for comparison, empirical analysis
• Avoids confusion/uncertainty
• Provides a foundation for future work
• May help avoid inconsistency between
decision makers
General Benefits of Transparency
17. To the public
• IRBs influence scientific advancement and use of public research
funds – general public claim to access/critique IRB processes,
deliberations, outcomes, etc.
• Some IRBs are part of public institutions – subject to transparency laws
(public records, open meetings, COI rules, etc.)
• Maybe argument that IRBs are delegates of federal regulatory authority
– and we expect government entities to behave transparently
Justifying Broader Transparency
18. To investigators
• Lack of transparency from decisionmakers can lead to distrust and
feelings of arbitrariness and powerlessness
– Improved trust will build partnership with IRBs – facilitate ethical research and avoid
misunderstandings on both sides
• Transparency about expectations, outcomes, and reasons will allow
investigators to build better protocols – more efficient (especially if
examples are provided)
Justifying Broader Transparency
19. To other IRBs
• Avoid reinventing the wheel
• Help flesh out regulatory ambiguities
• May help avoid unjustified variability
– Can lay the foundation for a system of IRB precedent
• May help overcome unnecessary conservativism – fear of being “the
first”
Justifying Broader Transparency
20. To research participants
• Participants may not be aware of IRB or its role – untapped opportunity
to improve trust
• Patient communities may disagree with IRB rationales, view them as
overprotective – direct engagement can avoid paternalism
Justifying Broader Transparency
21. To empiricists
• Need to study IRBs – huge investment of resources, are they working
the way they should?
• Without transparency, must rely on voluntary disclosure – incomplete
and other problems
• Transparency will allow study of:
– Bases for IRB decisions (regs, institutional policy, ethical principles)
– Areas of focus (consent, trial design, etc.)
– Consistency
– Approaches/philosophy
– Outcomes
Justifying Broader Transparency
22. • Concern about confidentiality
– Protocols may have
commercially sensitive info
– Redact minutes/determinations
– And no reason not to share IRB
policies
• Concern about free riders?
– Should result in more
transparency
• Concern about litigation
– Could result in more
conservative approaches, less
candor (empirical question)
– Litigation rare in research, IRBs
have lots of discretion,
transparency can help establish
IRB “standard of care”
• Concern about cost
– Writing opinions, sharing
policies, etc. is one more
burden on overburdened,
under-resourced system
– But foundational!
Objections
23. • Default needs to change: need to justify IRB nontransparency, and
expect transparency in policies, determinations, reasons
• May need regulatory change (guidance more plausible)
– Demand more specificity in IRB minutes and determination letters
– Require sharing of materials
• Regulators could make selected real-world cases available for
training and do their own empirical analyses
• IRBs can voluntarily promote transparency – some examples
through conferences, journals, listserves, etc.
• Investigators can voluntarily share their IRB materials –
submissions and correspondence (ex. TEAR in New Zealand)
– Journals could demand it
Recommendations