Human Subjects Research
Protections: Enhancing Protections
for Research Subjects and Reducing
Burden, Delay, and Ambiguity for
Investigators
Advanced Notice of Proposed Rule
Making
ITHS Town Hall 8/26/2011
Agenda
• Brief overview of the ANRPM
– Process for modification to the Common Rule
– Proposal
• Details of proposals affecting the consent for
and use of biospecimens
– Intent and implications of proposed changes
• Discussion
Process
Advanced Notice of Proposed Rulemaking
Public comment period - closed Sept 26, 2011
Notice of Proposed Rulemaking
Rule
Why
• 45CFR46 Subpart A – the “Common Rule” was
adopted 20 years ago
• Recognition that research has changed
significantly since that time
– Increase in volume
– More multicenter trials
– New informational risks due to use of genetic
information
• Concern that current process requires a lot of
time and resources without the attendant
protection of subjects for which the rules were
intended
Human Subjects Research Protections: Enhancing Protections
for Research Subjects and Reducing Burden, Delay, and
Ambiguity for Investigators
• Proposing agencies: Office of the Secretary,
HHS and the FDA
– http://www.hhs.gov/ohrp/humansubjects/anprm
2011page.html
• Each proposed change is presented followed
by a set of questions
– There are 74 questions to direct the feedback
being requested.
Structure of the ANPRM
• Section I
– Background –why and why now
• Sections II –VIII
– Details of the proposed changes
• Section IX
– Request for information and comment
– How to submit comments
Summary of Proposed changes
1. Refinement of the existing risk-based regulatory framework (Section
II);
2. Utilization of a single IRB review of record for domestic sites of multisite studies (Section III);
3. Improvement of consent forms and the consent process (Section IV);
4. Establishment of mandatory data security and information protection
standards for all studies that involve identifiable or potentially
identifiable data (Section V);
5. Establishment of an improved, more systematic approach for the
collection and analysis of data on unanticipated problems and
adverse events (Section VI);
6. Extension of Federal regulatory protections to all research, regardless
of funding source, conducted at institutions in the U.S. that receive
some Federal funding from a Common Rule agency for research with
human subjects (Section VII); and
7. Improvement in the harmonization of regulations and related agency
guidance (Section VIII).
Section II – ensuring risk-based
protections
• Set mandatory standards for data security and
information protection based on HIPAA
– IRBs would not then be responsible for assessing
adequacy of protection of informational risks
• Default to expedited continuing review even if
original application required full board review
when remaining activities are minimal risk
• Updating list of what qualifies for expedited
initial review and eliminating continuing
review for these studies.
Section II
• Converting “exempt” category to “excused”
category
– Would be subject to the new data security and
information protection standards
– Expand category
– Clarify the definition of “existing” to mean
collected for purposes other than the research and
not that the data and specimens have to exist
when the study starts
– Written consent would be required for use of
existing biospecimens
Section II
• New excused category
– Written consent would be required for use of preexisting data if collected for research purposes
• if collected for non-research purposes, consent only if
identifiable
– Require registration of excused research, not
review of application
– Add a tracking and audit requirement of excused
research
Section III – streamlining IRB review of
multi-site research
• Mandating that all multi-site domestic trials
rely on a single-site IRB
– Would not apply to international research
– Would not apply to FDA regulated device trials
Section IV – improving informed
consent
• Changes to the consent forms
– Specifying required content
– Restricting inappropriate content
– Limiting length
– Reducing institutional “boilerplate” language
– Providing standardized consent form templates
Section IV
• Changes to informed consent process
– Clarification of the waiver criteria
– Allowing more oral consent
– Requiring consent for use of pre-existing
biospecimens regardless of identifiability
Section V – strengthening data
protections
• Aligning Common Rule and HIPAA standards for
de-identified data
• Classifying all biospecimens as identifiable and
requiring consent for use
• Enhancing data security standards
• Data can still be considered de-identified if
investigators see the identifiers but don’t record
them
• Require periodic random audits for enforcement
Section VI – data collection to enhance
oversight
• Standardize data elements for reporting
• Implementing a web-based Federal-wide
portal for safety reporting
• Harmonize safety reporting guidance across all
federal agencies
Section VII – extension of Federal
Regulations
• Extend common rule protections to all
research conducted at institutions that receive
any federal funding for research
and VIII – clarifying and harmonizing
agency guidance
• Reconciling the advantage of consistency
across Federal departments and agencies
providing guidance with need for flexibility
and timeliness of issuance of guidance.
Summary of proposed changes
Improving effectiveness
Enhancing protections
Distinction between types of risk – note
informational risk
Federal oversight expanded
Eliminating some required continuing
review
Central database for adverse events
Improved applicatio n of expedited review Informed consent improvements
for research posing minimal risk
Single IRB review of multisite studies
Written consent for use of biospecimens
Harmonization of guidance
Confidentiality protections
Emanuel and Menikoff: 10.1056/NEJMsb1106942 published July 25, 2011 at
NEJM.org - taken from PRIM&R webinar – Pearl O’Rourke
Ways to comment
• www.regulations.gov - HHS-OPHS-2011-0005
• Mail/Courier to: Jerry Menikoff, M.D., J.D.,
OHRP, 1101 Wootton Parkway, Suite 200,
Rockville, MD 20852
• UW HSD discussion board https://catalyst.uw.edu/gopost/board/sherrye
/22982/
• E-mail Karen Moe by 9/10 at kemoe@uw.edu
• Send comments to the ITHS discussion board
https://catalyst.uw.edu/gopost/board/lalithas
/23060/
Future ITHS Town Hall Discussions
• September 2 – Seattle Children’s Hospital – Wright
Auditorium 9-10:30am
– changes to minimal risk and exempt research (excused);
proposed changes to informed consent
– Moderator - Doug Diekema, MD, MPH, Prof. Pediatric
Bioethics, Chair, Children's IRB
• September 9 – FHCRC, Thomas Building D1-084
– data security requirements and information protection
standards; central IRB review for multi-site studies
– Moderator - TBD