Transcript Coming IRB Developments Prompted by AAHRPP and Best Practice

Upcoming IRB
Improvements for
AAHRPP and Best
Practice
4th Friday Research Coordinator Lunch & Learn
8/28/09
Monika Markowitz, PhD, MA, RN, MSN
Director, Office of Research Compliance and Education
Office of the Vice President for Research
Areas to cover:
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FDA related: Change in PI, IRB registration, retaining
data
OHRP and NIH
Conflict of Interests Reporting Form and Supplement
Injury clause in ICF – WIRB and VCU IRB
IDP – investigational use of drugs in out-patient setting
Genetic research: GWAS & GINA
Sampling of WPP enhancements
Processes and structure – Electronic submission & IRB
Leadership and Enhancement Committee
Reminder: CITI Refresher due by end of 2009 for
courses taken in 2007 or before
FDA IRB Inspection (6/22-6/24)
IRB review of change in PI:
Modify WPP VIII-5 Review of Modifications to
Research
Change may be considered minor if the following criteria apply: a) the
individual must have extensive VCU research experience, b) is wellqualified to carry out the research in the designated research role,
and c) has other similar types of research projects with the IRB
IRB ensures the following are checked if criteria not met:
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Disqualified/Restricted/ Restrictions Removed/
Assurance Lists for Clinical Investigators
http://www.fda.gov/ICECI/EnforcementActions/DisqualifiedRestrictedAs
suranceList/default.htm
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FDA Debarment List
http://www.fda.gov/ICECI/EnforcementActions/FDADebarmentList/ucm
2005408.htm
IRB registration with DHHS
New Subpart E - requires all IRBs that review human subjects research
conducted or supported by HHS and that are designated under an
assurance of compliance approved for federalwide use (i.e, a Federalwide
Assurance (FWA)) by OHRP to register with HHS. Effective July 14, 2009
for never registered, September 15, 2009 for changes. Incorporates data
for OHRP and FDA
Additional information to be provided:
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approximate numbers of all active protocols and active protocols involving
research conducted or supported by HHS;
approximate number of full-time equivalent positions devoted to the IRB's
administrative activities.
approximate number of active protocols involving FDA- regulated products
reviewed. For purposes of this rule, an ``active protocol'' is any protocol for
which an IRB conducted an initial review or a continuing review at a
convened meeting or under an expedited review procedure during the
preceding 12 months, and;
description of the types of FDA-regulated products (such as biological
products, color additives, food additives, human drugs, or medical devices)
involved in the protocols that the IRB reviews.
Retaining Data when Subjects
Withdraw from FDA-regulated
Research
Data Retention When Subjects Withdraw from FDARegulated Clinical Trials - Information Sheet (10/2008)
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UC
M126489.pdf
Key Points:
 For FDA-regulated research, when a subject withdraws
from a study, the data collected to the point of withdrawal
stays with the study and may not be removed
 Subject may withdraw from intervention, but may agree
to follow-up and data collection. This requires a
separate IRB-approved consent form and procedure.
OHRP Quality Improvement Activities
FAQ’s - QI vs. Research
Question 4: Can I analyze data that are not individually
identifiable, such as medication databases stripped of
individual patient identifiers, for research purposes without
having to apply the HHS protection of human subjects
regulations?
Answer: Yes. Whether or not these activities are research, they
do not involve “human subjects.”
Question 6: If I plan to carry out a quality improvement project
and publish the results, does the intent to publish make my
quality improvement project fit the regulatory definition of
research?
Answer: No. The intent to publish is an insufficient criterion for
determining whether a quality improvement activity involves
research.
http://www.hhs.gov/ohrp/qualityfaq.html
COMPENSATION FOR INJURY - Proposed language for
VCU/WIRB Consent Template
Note: This language should be used when Sponsor agrees to pay
If you are injured by or become ill from participating in this study, please contact
your study doctor immediately. Medical treatment is available at the Virginia
Commonwealth University Health System (VCU Health System). Your study
doctor will arrange for short-term emergency care at the VCU Health System or
for a referral if it is needed.
The Sponsor will reimburse you or the VCU Health System for the costs of
reasonable and necessary medical care for diagnosis and treatment of a
research injury. A research injury is any injury or illness caused by your
participation in the Study.
If you are injured by a medical treatment or procedure that you would have received
even if you weren’t in the study, that is not a research injury. Fees for medical
treatment of injuries or illness which are not research injuries may be billed to you
or to appropriate third party insurance.
Payment for such things as lost wages, expenses other than medical care, or pain
and suffering will not be offered. To help avoid injury, it is very important to follow
all study directions.
Investigational Drug Pharmacy
& Control of Drugs for Research
VCU IRB INITIAL REVIEW SUBMISSION FORM
11. Will the VCU/VCUHS INVESTIGATIONAL DRUG PHARMACY (IDP) be
utilized (required for all inpatient projects)?
YES NO *
If NO, your research submission must include a descriptive plan
regarding appropriate drug storage and dispensing for any
investigational drugs or biologicals used in the research. Guidance
and the form for describing the management plan is located at
http://<investigational drugs site/plan>. Submit the form to the IDP.
Upon IDP’s receipt of the plan an automated response is sent back.
Include the IDP confirmation AND the completed plan as an
attachment. For assistance, please call the INVESTIGATIONAL DRUG
PHARMACY at 828-7901.
Conflict of Interests Reporting
and Supplement Form
Proposed Clarifications and Rearrangements:
 …the Principal Investigator and all other VCU
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investigators…
…must report financial interests in any external
entity that is related to the work to be conducted
under the proposed project or is interested in the
results of the project.
Move definitions of ‘financial interests’ to the first
page
Supplement Form – Briefly describe the financial
interests and how related to the work…
Genetic Information
Nondiscrimination Act (GINA)
(April 7, 2009) - Guidance on the Genetic Information
Nondiscrimination Act: Implications for Investigators
and Institutional Review Boards
Intended primarily for investigators who conduct, and institutional
review boards (IRBs) that review, non-exempt human subjects
research involving genetic testing or collection of genetic
information. The guidance document provides background on
protections provided by the Genetic Information Nondiscrimination
Act of 2008 (GINA) and discusses some of the implications of GINA
for investigators who conduct, and IRBs that review, genetic
research, particularly with respect to the criteria for IRB approval of
research and the requirements for obtaining informed consent under
the Department of Health and Human Services regulations for the
protection of human subjects (45 CFR part 46).
http://www.hhs.gov/ohrp/news/recentnews.html#20090407
GINA Protections for IRB consideration
BMR ICF template (OHRP language proposed: GINA (45 CFR 46.116(a))
Protections for genetic research:
[Include this language about the
GINA law, see OHRP guidance document at
http://www.hhs.gov/ohrp/humansubjects/guidance/gina.html for
more information]
A new Federal law, called the Genetic Information Nondiscrimination Act
(GINA), generally makes it illegal for health insurance companies, group
health plans, and most employers to discriminate against you based on
your genetic information. This law generally will protect you in the
following ways:
Health insurance companies and group health plans may not request your
genetic information that we get from this research.
Health insurance companies and group health plans may not use your
genetic information when making decisions regarding your eligibility or
premiums.
ICF template continued
Employers with 15 or more employees may not use your
genetic information that we get from this research when
making a decision to hire, promote, or fire you or when
setting the terms of your employment.
All health insurance companies and group health plans
must follow this law by May 21, 2010. All employers with
15 or more employees must follow this law as of
November 21, 2009.
Be aware that this new Federal law does not protect you
against genetic discrimination by companies that sell life
insurance, disability insurance, or long-term care
insurance.
Genome-Wide Association Studies
(GWAS)
What is a genome-wide association study?
Involves rapidly scanning markers across the complete
sets of DNA, or genomes, of many people to find genetic
variations associated with a particular disease. Once
new genetic associations are identified, researchers can
use the information to develop better strategies to detect,
treat and prevent the disease. Such studies are
particularly useful in finding genetic variations that
contribute to common, complex diseases, such as
asthma, cancer, diabetes, heart disease and mental
illnesses.
http://grants.nih.gov/grants/gwas/index.htm
Genome-Wide Association Studies
(GWAS)
NIH accepts data into the GWAS data repository after receiving
certification that IRB has approved submission into GWAS.
Certification assures that:
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Data submission adheres to applicable laws and VCU policies
Appropriate research uses and exclusions are delineated
Identities of subjects not to be disclosed to GWAS repository
Data submission and subsequent sharing for research are
consistent with ICF
Plan for de-identifying data is consistent with GWAS policy
Risks to individuals, families, groups/populations have been
considered
Genotype and phenotype data were collected in a manner
consistent with 45 CFR Part 46.
Clarification/enhancement to
various WPPs
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XVII-1 Research Subjects with Limited English Proficiency
(LEP)
“…not only clinical criteria determine study eligibility. If the subject's
probability and magnitude of risk of participation is great because of
language constraints, the prospective subject may not be considered
eligible for the study.”
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XVII-16 Planned Emergency Research, Exception from
Informed Consent, and Waiver of Applicability of Informed
Consent
“…WPP supplements the FDA Draft Guidance and federal regulations at 21 CFR
50.24 … for…the EFIC protocol…Areas of emphasis are: 1) preliminary
approval of the protocol, 2) approval of a community consultation plan, 3)
approval of public disclosure, 4) approval of the research to begin enrollment.
Processes, structure, reminder
Electronic submission – here in a year!
 IRB Leadership and Enhancement
Committee (ILEC) – Chairs, representative
investigators and IRB non-affiliated
members, devoted to decision making and
consistency; appeals process
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Reminder: CITI Refresher due by end of
2009 for courses taken in 2007 or before