When Do I Need Ethics Board Approval? George Schmid, M.D., M.Sc. World Health Organization/Centers for Disease Control and Prevention

Q3. Does Every OR Proposal need to go through Ethical Review? 1.Yes 2.No

Does Every Study Need to Go Through IRB (Ethics Board)? No…is the project "research," and, does it involve human subjects? What is research? –"A systematic investigation (i.e. gathering and analysis of information) designed to develop or contribute to generalizable knowledge" 1 –"…a class of activities designed to develop or contribute to generalizable knowledge." 2 What are human subjects? –"An individual about whom an investigator… conducting research obtains data through intervention or interaction with the individual or identifiable private information" 1 1 U.S. Office of Research Integrity 2 International Ethical Guidelines Biomedical Research. Council International Organizations Medical Sciences.

Is It Research Involving Human Subjects? Yes No Studying Task Shifting for IMAI Reviewing clinic waiting times records Who makes the determination of whether you need to go to the ethics board? Can use expedited review! Role of the ethics board

Tips to Working with Ethics Boards Ethics boards are made up of people like you (become a member) Ethics boards should be there to help investigators –Perform their research ethically –Perform their research in the best possible way The protocol and its submission reflects the quality of work you will do

Four Things Most Commonly Wrong with Proposals

1.The study cannot achieve its objectives 2.Lack of clarity and detail 3.Inconsistency 4.Poor consent forms –Do not contain all needed information –Too complicated and not understandable

CIOMs Documents Provide General International Guidance to Investigators