IRB-Investigator/IRB-Investigator/Research Coordinator Mtg.Research Coordinator Mtg.

Conducting Research at Non-Columbia SitesConducting Research at Non-Columbia SitesIncludingIncluding

International ResearchInternational Research

September 14, 2004September 14, 2004

George GasparisGeorge Gasparis

Brenda RuotoloBrenda Ruotolo

Columbia University Medical Center IRBColumbia University Medical Center IRB

ObjectivesObjectives

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

2)2) Overview of International Standards.Overview of International Standards.

3)3) Effective Negotiation Strategies Effective Negotiation Strategies toResolve Regulatory Differences.toResolve Regulatory Differences.

International Standards for the International Standards for the Protection of Human Subjects:Protection of Human Subjects:

Ethical StandardsEthical Standards

1.1. Nuremberg Code – 1947Nuremberg Code – 1947

2.2. Declaration of Helsinki – Revised 8 times Declaration of Helsinki – Revised 8 times

between 1964 and 2000 between 1964 and 2000

3.3. Belmont Report – U.S. - 1979Belmont Report – U.S. - 1979

4.4. Australian National Statement on Ethical Australian National Statement on Ethical

Conduct in Research Involving Humans - 1992 Conduct in Research Involving Humans - 1992

International Standards for the International Standards for the Protection of Human Subjects:Protection of Human Subjects:

Procedural StandardsProcedural Standards

1.1. Council for International Organizations of Council for International Organizations of

Medical Sciences (CIOMS) – 1993, 2002Medical Sciences (CIOMS) – 1993, 2002

2.2. International Conference on Harmonization – International Conference on Harmonization –

1987 1987

3.3. Canadian Tri-Council Policy Statement - 1998Canadian Tri-Council Policy Statement - 1998

4.4. Ethical Guidelines for Biomedical Research on Ethical Guidelines for Biomedical Research on

Human Subjects - 2000 Human Subjects - 2000

OHRPOHRP

Office For Human Office For Human Research ProtectionsResearch Protections

((formerly OPRRformerly OPRR))

ABCs of 45 CFR 46ABCs of 45 CFR 46

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

A.A. Assurance of Compliance Approved by Assurance of Compliance Approved by OHRPOHRP

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

C.C. Consent Obtained from Each Subject, Consent Obtained from Each Subject, UnlessUnless

Waived by the IRBWaived by the IRB

Federal Wide Assurance Federal Wide Assurance (FWA)(FWA)

Revised Version Released Revised Version Released

March 20, 2002March 20, 2002

On OHRP WebsiteOn OHRP Website

International AssuranceInternational Assurance

Can adhere to:Can adhere to:

CIOMSCIOMS

www.cioms.chwww.cioms.ch

Declaration of HelsinkiDeclaration of Helsinkiwww/wma.netwww/wma.net

IRB Registration SystemIRB Registration System

Implemented December 3, 2000Implemented December 3, 2000

Joint Effort with FDAJoint Effort with FDA

No requirement for review of No requirement for review of

Federally funded Federally funded

researchresearch

IRB Registration System - cont’d.IRB Registration System - cont’d.

Simple 3 Page FormSimple 3 Page Form

All Registered IRBs will be Informed of New All Registered IRBs will be Informed of New

Guidance/Updates/Regs.Guidance/Updates/Regs.

Can Track Registered IRBs on OHRP Can Track Registered IRBs on OHRP

Website Website

Challenging IssuesChallenging Issues

Research that will be Conducted at Distant Site Research that will be Conducted at Distant Site

OHRP GuidanceOHRP Guidance

IRB Knowledge of Local Research SettingIRB Knowledge of Local Research Setting

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

Provides guidance on the necessaryProvides guidance on the necessary

information that should be obtained aboutinformation that should be obtained about

local research context.local research context.

Challenging IssuesChallenging Issues

Informed consent Informed consent

-cultural differences-cultural differences

-regulatory differences-regulatory differences

IRB compositionIRB composition

-lack of gender representation-lack of gender representation

IRB ReviewIRB Review

-easy to find for biomedical research, -easy to find for biomedical research,

but not always for behavioral studiesbut not always for behavioral studies

Challenging IssuesChallenging Issues

Clinical ResearchClinical Research

-will the research benefit the local community?-will the research benefit the local community?

-will the results be provided to the local -will the results be provided to the local

community?community?

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

study?study?

-selection of test article; equivalent to std. therapy -selection of test article; equivalent to std. therapy

in developed country?in developed country?

-use of placebo-controlled studies?-use of placebo-controlled studies?

Challenging IssuesChallenging Issues

-Capacity Building-Capacity Building

-Stigmitization of subjects-Stigmitization of subjects

International ResearchInternational Research

WHO - Spring 2000WHO - Spring 2000

Operational Guidelines for Ethics Operational Guidelines for Ethics Committees That Review Biomedical Committees That Review Biomedical

ResearchResearch

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

OHRPOHRP on the World Wide Webon the World Wide Web

http://dhhs.gov/ohrp/http://dhhs.gov/ohrp/