19791947 1964 20101982 1996 2004

19791947 1964 20101982 1996 2004

199619791964 2004 201019821947

19961964 2004 2010198219791947

19961964 2004 20101979

International Ethical Guidelines for Biomedical Research Involving

Human

1947 1982

19791964 20101982 20041947 1996

19791964 20101982 1996 20041947

19791964 20101982 2001 20031947

19791947 1964 20101982 1996 2004

Informed Consent

Benefit and Risk

Ethics Committee

Respect for Person

Benef icence

Just ice

(1) Approval from relevant regulatoryauthorities

(2) Ethical approval(3) Informed consent

The interests and welfare of the individual should havepriority over the sole interest of science or society.

The role of the REC extends beyond theinitial review

and approval of research study, including:

Conductingregular review ofongoing research

Reviewing allmodificationsand amendments toapproved research

Monitoring activeresearch studies forcompliance

Investigatingproblems that couldimpact the safetyof participants

• Review continues after initial approval:

▫ Amendments/Revisions

▫ Serious Adverse Events

▫ Continuing Review

After Approval

C o n t i n u i n g R e v i e w

IRBAnnually

If requested

Make sure that the informed consent still

reflects current risks, benefits and

alternativespurpose

C o n t i n u i n g R e v i e w

IRBAnnually

If requested

Information desiredNumber enrolled

Problems encounteredIs the study still appropriate (literature

review)?

AE

SAE

Product

•Death• Life threatening•Hospitalisation•Persistent disability/incapacity•Congenital anomaly

Unanticipated

AE

USAE

No Reporting

Reporting in 48 hours

Reporting in 10 days

SignSymptomDisease

AR

•Clinical investigators

•Study coordinators

•Research technicians

•Research officials

•IRB members

•Consulting fees

•Stock ownership

•Honoraria & Salary

•Intellectual propertyrights

•Enrollment bonuses

•Spouse / dependentfinances

•Pressure to publish

•Professional competitions

•Career advancement

Types of Conflict of Interest

Individual Institutional Financial Professional

•Financial holdings ofthe institution

•Decisions regardingresearch funding

•or allocation ofresources forresearch

National CommitteeOf

Bio-Medical Ethics

Monitoring officeOf

Research Ethics

Local Committees

National

KACST

Saudi

Conflict of interest

Just through emails!

Appointed to only one member

Uncompleted IC

……………………

…………

Try to avoid…

Final words