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IRB-Investigator/ Research Coordinator Mtg. Conducting Research at Non-Columbia Sites Including International Research September 14, 2004 George Gasparis Brenda Ruotolo Columbia University Medical Center IRB. Objectives.

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irb investigator research coordinator mtg
IRB-Investigator/Research Coordinator Mtg.

Conducting Research at Non-Columbia Sites

Including

International Research

September 14, 2004

George Gasparis

Brenda Ruotolo

Columbia University Medical Center IRB

objectives
Objectives

1) Present an understanding of regulatory requirements and ethical considerations.

2) Overview of International Standards.

3) Effective Negotiation Strategies toResolve Regulatory Differences.

international standards for the protection of human subjects ethical standards
International Standards for the Protection of Human Subjects:Ethical Standards
  • Nuremberg Code – 1947
  • Declaration of Helsinki – Revised 8 times between 1964 and 2000
  • Belmont Report – U.S. - 1979
  • Australian National Statement on Ethical Conduct in Research Involving Humans - 1992
international standards for the protection of human subjects procedural standards
International Standards for the Protection of Human Subjects:Procedural Standards
  • Council for International Organizations of Medical Sciences (CIOMS) – 1993, 2002
  • International Conference on Harmonization – 1987
  • Canadian Tri-Council Policy Statement - 1998
  • Ethical Guidelines for Biomedical Research on Human Subjects - 2000
abcs of 45 cfr 46

ABCs of 45 CFR 46

Every institution engaged in DHHS supported or conducted human subjects research needs:

A. Assurance of Compliance Approved by OHRP

B. Board Approval (i.e., IRB, REB, ethics cmte.)

C. Consent Obtained from Each Subject, Unless

Waived by the IRB

federal wide assurance fwa
Federal Wide Assurance (FWA)

Revised Version Released

March 20, 2002

On OHRP Website

international assurance

International Assurance

Can adhere to:

CIOMS

www.cioms.ch

Declaration of Helsinki

www/wma.net

irb registration system
IRB Registration System

Implemented December 3, 2000

Joint Effort with FDA

No requirement for review of Federally funded research

irb registration system cont d
IRB Registration System - cont’d.
  • Simple 3 Page Form
  • All Registered IRBs will be Informed of New Guidance/Updates/Regs.
  • Can Track Registered IRBs on OHRP Website
challenging issues
Challenging Issues

Research that will be Conducted at Distant Site

OHRP Guidance

IRB Knowledge of Local Research Setting

http://ohrp.osophs.dhhs.gov/humansubjects/guidance/local.htm

Provides guidance on the necessary

information that should be obtained about

local research context.

challenging issues1
Challenging Issues

Informed consent

-cultural differences

-regulatory differences

IRB composition

-lack of gender representation

IRB Review

-easy to find for biomedical research,

but not always for behavioral studies

challenging issues2
Challenging Issues

Clinical Research

-will the research benefit the local community?

-will the results be provided to the local community?

-are local officials involved in the design of the study?

-selection of test article; equivalent to std. therapy in developed country?

-use of placebo-controlled studies?

challenging issues3
Challenging Issues

-Capacity Building

-Stigmitization of subjects

international research
International Research

WHO - Spring 2000

Operational Guidelines for Ethics Committees That Review Biomedical

Research

http://www.who.int/tdr/publications/publications/ethics.htm