IRB ReviewIRB Review
Institutional Review Board(IRB)
Membership: At least five members of varying backgrounds
– Sufficiently qualified– Not solely of one profession– Gender diversity
At least one non-scientist At least one non-affiliated member Expertise on “vulnerable populations” Outside consultants
IRB Responsibilities
Review and approve, require modifications, or disapprove all covered research
Require that informed consent is in accordance with regulations
Require documentation of informed consent or may waive documentation in accordance with regulations
Notify investigators in writing of decisions Conduct continuing review of research no less than
once per year
IRB Decision Matrix
BENEFICENCE JUSTICE
RESPECT FOR PERSONS
Privacy & ConfidentialityProtection of subjects (especially vulnerable
populations)
Informed consentSurrogate consent
Assent
Risk/Benefit AnalysisExperimental DesignQualifications of PI
Subject selectionInclusion/exclusion
Recruitment
J. Cooper, Albany Medical Center
Expedited Review
Expedited Expedited Review is not Review is not “review light”“review light”
Expedited Review
46.110(b) Expedited Review An IRB may use expedited review for
– Research on list of eligible categories– Minor changes in previously approved research
Carried out by IRB chair or one or more experienced IRB members
Reviewers can exercise all of the authorities of the IRB except disapproval
All IRB members must be informed of research approved under expedited review [46.110(c)]
Expedited Review
Expedited Review Applicability No More Than Minimal Risk Categories Apply Regardless of Age Do Not Apply if Identification Place Subjects at Risk
or Damage or Stigmatization Do Not Apply to Classified Research Standard Informed Consent Requirements Do Apply
http://ohrp.osophs.dhhs.gov/humansubjects/guidance/expedited98.htm
Expedited Review
Clinical Studies (No IDE/IND)
Noninvasive Prospective Collection of Biological Specimens
Noninvasive Data Collection Used in Clinical Practice
Individual / Group
Characteristics or Behavior
Collection of Blood Samples Data, Documents, Records,
Specimens Collected for Nonresearch Purposes
Voice, Video, Digital, or Imaging Recordings for Research
Continuing Review- No new subjects- Minimal risk approved under full review
Expedited Review Categories
Full Review
Convened meeting - no mail reviews (telephone participation OK) Quorum
– Majority of IRB present– At least one non-scientist present– Approval by majority of those present
Members with conflict of interest should be absent during discussion and vote
Should the quorum fail during a meeting (e.g. those with conflicts being excused, early departures, loss of a non-scientist), no further votes can be taken unless the quorum can be restored
IRB Meeting Minutes
Attendance at the meetings. Actions taken by the IRB. Vote on these actions including the number of
members voting for, against, and abstaining. Basis for requiring changes in or disapproving
research. Documentation of specific findings required by the
regulations. Written summary of the discussion of controverted
issues and their resolution.
Continuing Review
Appropriate to the degree of risk and not less than once per year– Should be set for each protocol, not a routine
annual review
No grace period but may use original anniversary date
Must be substantive and meaningful
Continuing Review
Materials: protocol summary and a status report on the progress of the research
– the number of subjects accrued; – a description of any adverse events or unanticipated problems
involving risks to subjects or others and of any withdrawal of subjects from the research or complaints about the research;
– a summary of new information relevant to human subjects, especially information about risks associated with the research; and
– a copy of the current informed consent document One member should review entire protocol
Beyond the Beyond the Consent Consent
FormForm
Informed Consent
The Consent Process
Informed consent is not a single event or just a form to be signed -- rather, it is an educational process that takes place between the investigator and the prospective subject.
The basic elements of the consent process include: full disclosure of the nature of the research and the
subject's participation, adequate comprehension on the part of the potential
subjects, and the subject's voluntary choice to participate.
Tampa Tribune 3/11/00
TAMPA - A lawsuit accusing USF doctors of experimenting on pregnant women without their consent is settled for $3.8 million…. The experiment wasn't considered risky and no adverse effects were documented, plaintiffs in the suit agree. However, the failure to inform … as many as 3,000 ... pregnant women of various experiments conducted between 1986 and 1990 has cost Tampa General Hospital, USF and the state $3.8 million.
General IssuesGeneral Issues
An adversarial relationship between the IRB and investigators puts subjects at risk.
The IRB should not become an IRSThe IRB should not become an IRS
The Myth of Dr. Frankenstein
Current Climate
Reactive Reactive Hyper-Hyper-
ProtectionisProtectionismm
Not the appropriate response!