Accreditation of Research Programs: How it Might Affect your Research

Accreditation of Research Programs:
How it Might Affect your Research
Harvey Murff, M.D., M.P.H.
Director of Research Safety
GCRC, Vanderbilt University Medical
Center
Accreditation of Research Programs:
How it Might Affect your Research
The problem that accreditation would
address
 What is accreditation
 Why is it believed that accreditation might
help
 Who will accreditation affect

Accreditation of Research Programs:
How it Might Affect your Research
The problem that accreditation would
address
 What is accreditation
 Why is it believed that accreditation might
help
 Who will accreditation affect

Human Subjects Protection
-Background



Nuremberg Code (1946-1949)
Declaration of Helsinki by World Medical
Association (1963)
National Research Act (1974)
– Formed National Commission for the Protection of
Human Subjects of Biomedical and Behavioral
Research (National Commission)

The Belmont Report (1979)
Human Subjects Protection
-Background

National Commission described what would be
the framework for IRB’s
– Not adopted by all Federal Agencies


The “Common Rule” published (1991)
Office of Inspector General (OIG) issues
Intuitional Review Boards: A Time for Reform
(1998)
– IRB’s facing overwhelming demands
Human Subjects Protection
-Failures in the System

OPRR halts research at Duke (May 1999)
– Several other sites temporarily shut down
– Noncompliant with human protection regulations

Death of Jesse Gelsinger (September 1999)
– Cited for no safety plan in proposal

OIG issues follow up to A Time for Reform
– Again calls into question the effectiveness of IRB’s
– Suggest greater attention to protecting human subject in
any trial (not just gene therapy)
Human Subjects Protection
-Regulatory Guidelines

Secretary of Health and Human Services (2000)
– commissions IOM to review human subjects protection

Two reports
– “Preserving Public Trust: Accreditation and Human Research
Participant Protection Programs” (2001)
– “Responsible Research: A Systems Approach to Protecting
Research Participants” (2002)
Purpose of the IOM Committee
1.
2.
3.
4.
Comprehensive assessment of research participant
protection
Review and consider proposed human research review
program performance standards
Recommend standards for accreditation of HRPPPs,
considering measures of structure, process, and
performance, as well as resource sufficiency
Recommend steps that the organizations and institutions
than conduct research and that the federal government
should take to collect and analyze data to monitor and
evaluate how well the system for protecting human
subjects is operating
The Phases of Human Research
Individual
Participant
Safety Monitoring
Informed Consent
Dissemination
Data Analysis/Study
Close-Out
Data Collection
Recruitment and
Enrollment
Ethical Review
Scientific and Conflict of
Interest Review
Participant Perspective
Protocol Development
Research Question
Statement of Problem



Significant doubt exist regarding the capacity of
the current system to meet its core objectives
IRBs are “under strain” and “in need of reform”
The existing regulatory framework cannot
adequate respond to the complex and everchanging research environment, with weaknesses
related to gaps in authority, structure, and
resources
Human Research Participant Protection
Program
Sponsors
Participants
Research Organizations
IRBs
Investigators
Performance Assessment
Monitoring
and
Feedback
Education
Quality
Improvement
Research Involving Human Participants
Functions of a HRPPP

Comprehensive review of protocols
– Scientific
– Financial conflict of interests
– Ethical reviews



Ethically sound participant-investigator interaction
Ongoing and risk-appropriate safety monitoring
Quality improvement and compliance activities
– What are the types of quality problems?
Common Quality Problems

Most common findings in quality assessment of
clinical trials
– Case report forms and study files incomplete,
inaccurate, and not appropriate for safety tracking
– Failure to distinguish research from standard of care
– Failure to submit or amend IND/IDE to FDA
– Poorly written protocols and data collection tools
– Informed consent form inadequacies/inconsistencies
– No study coordinator with defined authority
– Post-approval monitoring for data integrity inadequate
Source- Sherwin, Research Practitioner, 2002
Accreditation of Research Programs:
How it Might Affect your Research
The problem that accreditation would
address
 What is accreditation
 Why is it believed that accreditation might
help
 Who will accreditation affect

What is Accreditation?

A process based on self- and peer assessment for public accountability
and improvement of performance quality. Peers assess the quality of an
institution or academic program and assist the faculty and staff in
improvement.
– self-study using the accrediting organization’s set of expectations about
quality (standards, criteria) as their guide. “
– A team of peers, selected by the accrediting organization, reviews the
evidence, visits the campus to interview the faculty and staff, and writes a
report of its assessment including recommendation to the commission of
the accrediting organization (group of peer faculty and staff, professionals,
and public members).

Grounded by a set of expectations about quality and integrity, the
commission reviews the evidence and recommendation, makes a
judgment, and communicates the decision to the institution and other
constituencies if appropriate.
Why Accreditation

Accreditation versus regulation
– Benefits
» Reduces cost of government oversight
» More flexible and responsive to change that federal
agencies
» More responsive to the “regulated”
– Disadvantages
» Less accountable

“fox is guarding the henhouse”
Proposed Accreditation Agencies
– National Committee on Quality Assurance
(NCQA)
» Contracted by the VA
» Undergoing pilot testing
» Centers poorly prepared
– Association for the Accreditation of Human
Research Protection Programs, Inc (AAHRPP)
» Few institutions already on board
Who is advocating accreditation?
–
–
–
–
Institute of Medicine
Department of Veterans Affairs
National Bioethics Advisory Commission
Inspector General of the Department of Health
and Human Services
– American Association of Medical Colleges
– Members of Congress
– Office of Human Research Protection (OHRP)
Accreditation of Research Programs:
How it Might Affect your Research
The problem that accreditation would
address
 What is accreditation
 Why is it believed that accreditation might
help
 Who will accreditation affect

How accreditation should improve
quality and safety
Grounded in continuous quality
improvement theories
 Requires measuring of processes and
outcomes, introducing changes, and remeasuring

– Statistical process control
“If you always do what you
always did, you will always get
what you always got”
Definitions:

Quality
– IOM definition:
» “degree to which health services for individuals and
populations increase the likelihood of desired health outcomes
and are consistent with current professional knowledge”

Quality Assurance
» “The policy, procedures, and systematic actions established in
an enterprise for the purpose of providing and maintaining a
specified degree of confidence in data integrity and accuracy
throughout the lifecycle of the data, which includes input,
update, manipulation, and output.”
Model of Continuous Quality Improvement
Act
Plan
Study
Do
Barriers to a Quality Assurance Approach
What’s the evidence?
 What outcomes?
 What methods?
 What resources?
 Local buy-in

Accreditation of Research Programs:
How it Might Affect your Research
The problem that accreditation would
address
 What is accreditation
 Why is it believed that accreditation might
help
 Who will accreditation affect

Who will be evaluated in accreditation
programs?
Institutions
Institutional Review Boards
Investigators
Investigators

VA’s GCP Checklist

– Paperwork to be completed
documenting compliance
with protocol

– Reporting of unanticipated
problems
– Submission of protocol
changes
– Reporting of protocol
deviations
Investigator performance
measures
– Using only trained
individuals to gather
consent
– Documentation of consent
– AE reporting
Investigator
Responsibilities for
Reporting to IRB

Obtaining informed
consent
– When and where
– Opportunity to consider to
participate
– Comprehension
General Recommendations of IOM
1.
2.
3.
4.
Protect Every Research Participant
Refocus the mission of the IRB on the
thorough ethical review and oversight of
research protocols
Recognize research participants’
contribution and integrate them into the
system
Maintain high standards for the continuing
review of HRPPP performance
Protect Every Research Participant

Establish accountability within an ethical
research culture
–
–
–
–

Accountability
Adequate resources
Ethics education programs
Transparency
Provide sufficient funds
Refocus IRB mission on ethical review of
protocols
Distinguish scientific, conflict of interest,
and ethics review mechanisms
 Emphasize risk-appropriate protection
 Increase program productivity

Recognize and Integrate Participant
Contributions
Revitalize informed consent
 Increase system accessibility
 Compensate participants for researchrelated injury

Maintain Vigilance
Collect national level data about the system
 Enhance safety monitoring
 Continuously improve quality
 Manage potential conflicts of interest
 Periodically assess the national system
