ohrp electronic access e-mail: ohrp@osophs.dhhs.gov web site:

OHRP Electronic Access

E-mail: ohrp@osophs.dhhs.gov

Web Site: http://ohrp.osophs.dhhs.gov

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!