U.S. Army Medical Research Institute of Infectious Diseases

Investigator - IRB Member

HRPP Training Seminar

Monday 8 May 2006

1300 – 1700 hrs

Headquarters Conference Room

Agenda:

1300 -1315 hrs. COL George W. Korch, Introductory Comments:
“USAMRIID’S Human Research Protection Program”

1330-1410 hrs. COL Arthur O. Anderson:

"Evolution of Standards for Ethical Research Involving Human Subjects".

1415-1455 hrs. Mr. Douglas G. Osborne

"Research Regulations, and Procedures for Submission, Review and Approval of Protocols."

1500-1530 hrs. Ms. Deborah Coates

"Quality Assurance and Regulatory Compliance Interactions with PI's and Records."

1535-1615 hrs. Ms. Sarah Norris

"Statistical Methods and Scientific Validity."

1620-1650 hrs. COL Laura Brosch of MRMC-ORP

"Hot Topics, Regulatory Inspections and Consequences of FDA or OHRP Inspections"

1650-1700 hrs. Questions and End of Training